Building platform for implementation of GPP in the Republic of Macedonia

Transcription

1 Building platform for implementation of GPP in the Republic of Macedonia A Report of the Project 2012 Pharmaceutical Chamber of Macedonia

2 Authors Professor Lidija Petrushevska-Tozi, PhD Faculty of Pharmacy, University Ss Cyril and Methodius, Skopje, Macedonia Pharmaceutical Chamber of Macedonia Professor Kristina Mladenovska, PhD Faculty of Pharmacy, University Ss Cyril and Methodius, Skopje, Macedonia Pharmaceutical Chamber of Macedonia Contributors Jasminka Patceva, pharm.spec Pharmaceutical Chamber of Macedonia Dr Dick Thromb, EuroPharm Forum, President Kirsten Holme, Professional secretary EuroPharm Forum, Project manager at Pharmakon WHO Collaborative Centar Nina Sautenkova, WHO Europe, programme manager at World Health Organization Acknowledgements The authors and PCoM gratefully acknowledge the EuroPharm Forum and WHO Europe for financial and expert support for the project. We are particularly thankful to Kirsten Holme, Dick Tromb and Nina Sautenkova for their commitment to help pharmacists in Macedonia to implement GPP. We would like to thank the pharmacists in Macedonia (community and hospital) for participating in this study by answering and commenting the questionnaires. All outstanding errors are our own. Suggested citation: Petrushevska-Tozi L, Mladenovska K. Building platform for implementation of GPP in Macedonia. A Report from the project 2012, Pharmaceutical Chamber of Macedonia,

3 Content Introduction 5 Methodology 18 Results 23 I Community pharmacy practice and services 23 I.1. Demographic characteristics and management of community pharmacies 23 I.2. Indicators and components included in the PP and PSs assessment tool and scores from the community pharmacies in the RoM 30 II Hospital pharmacy practice and services 38 I.1. Demographic characteristics and management of hospital pharmacies 38 I.2. Indicators and components included in the PP and PSs assessment tool and scores from the hospital pharmacies in the RoM 44 Discussion and recommendation for improvement of PP and services 54 Legal framework 54 Economic framework 60 Workforce framework 62 Standards for good pharmacy practice 67 Conclusion 78 References 88 Annex 1 93 Annex

4 Glossary RoM MoH HIF HPL DB PCoM MCoM MAP FF-UKIM HIL LMMD NDIC NCP GPP DRG HEI FIP PSs PP PC CPD CE CCE PoM NPoM DPFM-UGD DPUT PK PD TDM MTM ADR CPOE GP Republic of Macedonia Ministry of Health Health Insurance Fund Health Protection Law (Law on Health Protection) Drug Bureau Pharmaceutical Chamber of Macedonia Medical Chamber of Macedonia Macedonian Association of Pharmacists Faculty of Pharmacy at the University Ss Cyril and Methodius Skopje Health Insurance Law (Law on Health Insurance) Law on Medicines and Medical Devices National Drug Information Centre National Centre for Pharmacovigilance Good Pharmacy Practice Diagnoses Related Groups High Educational Institutions Federation International Pharmacy Pharmacy Services Pharmacy Practice Pharmaceutical Care Continuing Professional Development Continuous Education Center for Continuous Education Prescription only medicines Non prescription only medicines Department of Pharmacy at the Faculty of Medicine, University Goce Delcev Stip Department of Pharmacy at the University Tetovo Pharmaco Kinetics Pharmaco Dinamics Therapeutic Drug Monitoring Medication therapy management Adverse drug reaction Computer prescribing order entry system General Practitioners 4

5 Introduction The Republic of Macedonia (RoM) is a landlocked country in the heart of the Balkan Peninsula (Fig. 1), in Southeastern Europe, with about inhabitants and km 2. In autumn 1991, after 45 years union with five other republics in the Socialist Federal Republic of Yugoslavia, the country gained independence in a peaceful secession and established political system as a parliamentary democracy. As foreign policy priorities, peaceful and stable relations with the all neighboring countries and accession to the European Union and the collective security system of the North Atlantic Treaty Organization are considered. Economic reforms have focused on fully establishing market economy structures, including deregulation and introduction of the necessary privatization trends in the public sector, liberalization of international trade, etc. Alongside facing a number of unforeseen obstacles owing to regional instability, reform implementation has been faced with frequent political changes. Since independence, the RoM has seen six prime ministers and 11 different compositions of government. During the same period, 14 ministers of health have been appointed, which indicates the stewardship challenges for continuous and consistent health policy 1,2,3. Fig. 1. Map of the Republic of Macedonia (Source: United Nations Cartographic Section). The population density is inhabitants/km 2, 60 % live in urban areas. The population growth rate is 0.257% (2010 est.). Life expectancy at birth for both sexes has increased slightly from years in 1991 to years in However, this figure is still much lower than in Western Europe and was five years below the EU average of years in Median age is 35.4 yrs (2010) with 11.6% of population over 65 years. In the period , the percent of population up to 14 years decreased from 22.8 to 17.1%, while for population older than 65 years, it increased from 22.8 to 11.6%. Thus, the RoM shows a tendency towards an ageing population with similar problems of health care and social care system as elsewhere in EU. Neonatal mortality rate, under 5 mortality rate, maternal mortality ratio and adolescent fertility rate are lower than average in the region. Immunization coverage is high. Cardiovascular diseases (57.9%) and malignancies (19.4%) are the main causes of mortality, followed by endocrine, nutritive and metabolic diseases with 3.9% 4. 5

6 With a gross national income per capita of around $4120 in 2008, the RoM is a lower middle-income country. GDP per capita (PPP) is $10,500 (2011 est.) Official unemployment is high, 29.1%. Macroeconomic stability is maintained and GDP growth is modest, but positive. According to WHO estimates, total health expenditure as a percentage of GDP in the RoM amounted from 6.8% in 2002 to 6.9% in This represents a significantly lower figure than that of the most of the other ex-yugoslav countries and the EU. In the same year, the health care expenditure in US$ (with purchasing power parity) per capita amounted to US$ 341, with 84.7% of health expenditure coming from public sources. Expenditure for investment in the health sector (0.7%) continued to be insufficient 5. Following independence, the RoM inherited the health care model from the former Yugoslavia. In line with the highly decentralized health system structures that had been in place in the Socialist Federal Republic of Macedonia, the beginning of the 1990s saw a health system that was organized in standalone, self-managing communities, with only the projects requiring large-scale capital investments being centrally coordinated 6. The decentralized system led to fragmentation of service delivery and significant oversupply and duplication of both facilities and services. Moreover, a series of different units were established that frequently contained elements of primary, secondary and tertiary care. From that period until recently, the country has moved from highly decentralized to more centralize structures, while at present, the political aim is to move back to a decentralized system. The RoM set up an insurance-based health system with the Government and the Ministry of Health (MoH) providing the legal framework for operation and stewardship and the Health Insurance Fund (HIF) being responsible for the collection of contributions, allocation of funds and supervision and contracting of providers. Today HIF is an independent institution monitored by the MoH, with a central office in Skopje and branch offices at local level. Numbers of other reform initiatives in the field of health care were undertaken with an aim of sustaining access for the whole population to a comprehensive health system as well as to improve the quality of health services and enhance financial sustainability. But still the system was facing a number of challenges. The Ministry of Health s core functions were focused on health policy formulation and implementation, priority-settings and monitoring of the health system s performance. The need for the MoH to develop a stronger role in policy development, implementation, monitoring and analysis and to establish its role as a leader of strategic development in the health sector, including human resources policy, has long been recognized but has proven difficult to address 7. Against this background, the development of a new law was initiated. The Health Protection Law (HPL) 8 of August 1991 laid the groundwork for the current health system and has served as the framework for health policy ever since. Based on the HCL, Drug Bureau (DB) w as established as a unit of the MoH to take care of pharmaceuticals, registration and licensing procedures for medicines, remedial medicines and medical devices and to participate in the preparation of the essential and positive drug lists. Also, based on the HCL and later by means of a separate Health Insurance Law (HIL) 9, the system of compulsory health insurance was established. Equity, solidarity and reciprocity as well as provision of universal coverage for the population have been defined as its core values. However, the established structures have been characterized by large-scale inefficiencies in performance, the absence of uniform performance standards, inequalities in health care delivery and insufficient financial support from the central budget for the health care system. In 1992, medical, dentists and pharmacists chambers were established, being responsible for licensing/relicensing of health professionals and their continuous professional development; and the responsibility for continuous education was given to the medical, dentists and pharmacists associations. 6

7 The Pharmaceutical Chamber of Macedonia (PCoM) was established as a professional association of all registered pharmacists of Macedonia. It is responsible for protection and promotion of the pharmacists competences and strengthening the role of the pharmacists in all aspects of the heath care system 10. PCoM regulates the ethical aspects of the pharmacy profession, but also protects its interests and/or the interests of the pharmacists. As a professional organization, it assures the continuing education and licensing and re-licensing processes in the manner of professional development. For all the activities, good relations and cooperation with the governmental bodies (e.g. MoH, HIF, DB, Accreditation Agency), non-governmental associations (Medical Chamber of M acedonia (MCoM), Macedonian Association of Pharmacists (MAP), etc.) and academia (Faculties/Departments of Pharmacy) have been established, which can be confirmed by the involvement of the PCoM in all key projects and legislation procedures related to the pharmacy practice and education of pharmacists. PCoM has been involved in drafting Law on medicines and medical devices, Law on health care, Law on recognition of professional qualifications, Health strategy 2020, Contracts between the community pharmacies and HIF and related rulebooks. Considering the education of pharmacists, the PCoM collaborated with the Faculty of Pharmacy at the University Ss Cyril and Methodius (FF-UKIM) in Skopje in the project titled Restructuring of Pharmacy Education in the Republic of Macedonia, financed by TEMPUS program (as a joint project of the Faculties of Pharmacy in Skopje, Copenhagen and Stockholm and the PCoM). The project activities resulted in a modern graduate study program for obtaining title Master in pharmacy organized as a 1 st and 2 nd integrated cycle according to Bologna. Also, partnership with the MCoM was established regarding continuous education and professional development i.e. re-licensing of pharmacists. Besides reform achievements in pharmaceutical sector related to the strengthening of the capacities (e.g. establishing of MoH, HIF, DB, PCoM), the establishment of a National Drug Information Centre (NDIC) in 1998 as an institution responsible for collection, processing and dissemination of information and data concerning drug control, registration and rational prescribing was one of the major achievements. A National Centre for Pharmacovigilance (NCP) was also established in In 1997, it was networked with the WHO Center for Drug Adverse Effects as accompany member, while full membership was obtained in The main task of this Center is to collect data on adverse drug reactions and give recommendations regarding any withdrawal of a drug from the market that may ultimately be necessary 11. Today, health care in the RoM is delivered through a system of health care institutions covering the country s territory relatively evenly. The health facilities range from health care stations and centers at primary health care level and specialty-consultative and inpatient departments at secondary level to university clinics and institutes at tertiary level, with the latter also carrying out research and educational activities. Recent years have seen substantial growth of the private sector, especially in the field of primary health care. The private practice is regulated by the Law on health care of 1991 with amendments in 2004 and In 2005, the private sector employed roughly one third of all physicians working in primary care, the privatization of dentists offices at primary care level has been completed and the process of privatizing publicly-owned pharmacies by sale or leasing has been initiated in 2005 and completed in With the privatization process, pharmacists and pharmacy managers (not obligatory having pharmaceutical education) became owners of the space and equipment only, with the same level and scope of services (i.e. procurement, storage and dispensing of medicines) and lot of professional problems typical for the countries in transition. The privatization system intended to spread liberalization, however, led pharmacy to be increasingly seen as a part of the commercial sector rather than a part of the professional system within health care. 7

8 In order the process of privatization to be supported, the World Bank provided assistance through several projects such as the project for Quality Improvement of Health Services and Licensing by which the model for continuing education and licensing was established based on a modern best practice processes for the health professionals (including pharmacists). In addition, under the Health sector management project 12, also financed by the World Bank, the MoH of the RoM (Project Coordination Unit) and the PCoM prepared and realized training seminars for "Developing pharmacy practice" for community pharmacists conducted by the experts from the university and practice (2007/08). The main goal of the training seminars was to improve the quality of pharmaceutical services in community pharmacies and to increase patient satisfaction by establishing a basis of a modern best practice process and Good Pharmacy Practice (GPP) for the pharmacy professionals in the reformed health care system in Macedonia. The key objectives were focused on preparing appropriate training material on pharmaceutical care and GPP, including pharmacovigilance. Fourteen workshops for about 500 participants from all around the country were carried out. The key outcome included recognition of the new roles, skills and attitudes beyond the scope of the traditional pharmacy practice and within the GPP, which pharmacists need to master in order to become members of multi-disciplinary health care teams as well as added values which they can provide through their professional input and expansion of existing roles. The enthusiasm among the community pharmacists for adopting new roles and responsibilities was evident although aware that the implementation of GPP in community pharmacies was a major problem due to the overall economic development and lot of problems that had to be solved within the overall health system, among which the following with the highest priority: legislation not supporting the best pharmacy practice and pharmaceutical care concept; low level of community pharmacy practice and services; lack of knowledge sufficient for introducing and implementation of pharmaceutical care services in community pharmacies; low level of cooperation (partnership) between the health care providers (e.g. prescriptionists and pharmacists); lack of inter-professional training programs, etc 13. In 2009, FIP Foundation for education and research under FIP approved the PCoM application for the project titled Implementation of GPP in Macedonia under the call for projects Future Implementation Plan for Good Pharmacy Practice (GPP) 14. Implementation of pharmaceutical care services in community pharmacies, improving quality of the pharmacy practice and pharmaceutical care in community pharmacy settings through implementation of GPP standards established on a basis of a modern best practice process were the main objectives of the project. The following aims were also included in the project proposal: (i) review on the current status of Macedonian community pharmacy in both practice and research; (ii) identifi cation of the perceived barriers to implementing best pharmacy practice and pharmaceutical care in the community pharmacy settings; (iii) definition of the main priorities for intervention to improve the quality of the pharmacy practice and pharmaceutical care services in line with the National Drug Policy and WHO/FIP Guidelines on GPP; (iv) setting up a plan of action for stepwise approach and managing pharmacy practice and pharmaceutical care changes; (v) providing assistance in developing mechanisms and tools for monitoring of the implementation process and dissemination of the results. Unfortunately, although approved, this project was never financed by FIP. Today, there are 740 private-owned community pharmacies all around the state with unbalanced distribution in some geographic regions ( Table 1) and 44 hospital pharmacies located in general and clinical hospitals in secondary and tertiary care with in-patients beds (Table 2). Five private hospitals/hospital pharmacies have been established since 2005 covering the following specialties: 8

9 Table 1. Network of community pharmacies per regions/cities Region/Location of Actual Maximum Citizens (total) community pharmacy number* number** Pelagonija Bitola Mogila Novaci Demir Hisar Krusevo Prilep Dolneni Krivogastani Resen Vardar Veles Gradsko Caska Kavadarci Rosoman Negotino Demir Kapija North-East Kratovo Kriva Palanka Rankovce Kumanovo Lipkovo Staro Nagoricane South-West Debar Kicevo Drugovo Zajas Oslomej Makedonski Brod Plasnica Ohrid Debarca Struga Vevcani Skopje South-East Valandovo Gevgelija Bogdanci Dojran Radovis Konce Strumica

10 Bosilovo Vasilevo Novo Selo Polog Gostivar Vrapciste Mariovo, Rostusa Tetovo Brvenica Bogovinje Zelino Jegunovce Tearce East Berovo Pehcevo Vinica Delcevo M. Kamenica Kocani Zrnovci Cesinovo,Oblesevo Probistip Sv. Nikole Lozovo Stip Karbinci *actual number-the number of existing pharmacies **maximum number-the number of maximum needed pharmacies Source: Regulation for Network of Health Institutions (Official Gazette of RoM, No. 81/12) general medicine, gynecology/obstetrics, (cardio)surgery and ophthalmology. A new Rulebook for establishing pharmacies is expected to be issued by the end of the year. The MoH has drawn up a medical map (carte sanitaire 2008) to provide regulatory basis for further expansion of the private sector i.e. in future, licenses for opening private clinics or hospitals or community pharmacy will be issued according to the need. In July 2012, the MoH has drafted a network of health institutions, incl. network of community pharmacies, to ensure proper coverage with health institutions all over the country 15. Health institutions included in the network have signed contracts with the HIF. Contracts with the HIF can be signed only after obtaining license for work issued by the MoH. All state/private health facilities are allowed to apply for contracts with the HIF. HIF, however, have the right to contract selectively, according to the criteria set out in the Rulebook 16. The contracts with the HIF are modified every year in order to best regulate the mutual relationships 17,18. As there is only one HIF in the RoM, the provisions in the contracts are mostly in favor of the HIF. 10

11 Table 2. Network of general and clinical hospitals (with central and satellite pharmacies) in secondary and tertiary health care level with in-patients beds Name / location of the hospital (hospital pharmacy) Ownership/Level of care Clinical Hospital, Bitola Public / Secondary General Hospital, Gostivar Public / Secondary General Hospital, Gevgelija Public / Secondary General Hospital, Veles Public / Secondary General Hospital, Kavadarci Public / Secondary General Hospital, Kicevo Public / Secondary General Hospital, Kocani Public / Secondary City General Hospital 8 th September, Skopje Public / Secondary University Clinic of Surgical Diseases Sveti Naum Ohridski, Skopje Public / Tertiary Psychiatric Hospital, Skopje Public / Secondary University Pediatric Clinic, Skopje Public / Tertiary University Hospital Pharmacy, Skopje Public / Tertiary University Clinic of Hematology, Skopje Public / Tertiary University Clinic of Abdominal Surgery, Skopje Public / Tertiary University Clinic of Gynecology and Obstetrics, Skopje Public / Tertiary University Clinic of Radiotherapy and Oncology, Skopje Public / Tertiary University Clinics of Urgency, Traumatology, Orthopedic, Anesthesiology and Public / Tertiary Reanimation, Skopje Special Hospital for Gynecology and Obstetrics Cair, Skopje Public / Secondary General Hospital, Kumanovo Public / Secondary General Hospital, Ohrid Public / Secondary General Hospital, Prilep Public / Secondary Institute of Nephrology, Struga Public / Secondary General Hospital, Struga Public / Secondary General Hospital, Strumica Public / Secondary Clinical Hospital, Tetovo Public / Secondary Clinical Hospital, Stip Public / Secondary Psychiatric Hospital, Demir Hisar Public / Secondary Psychiatric Hospital, Negorci Public / Secondary Special Hospital for Pulmonary Diseases, Lesok Public / Secondary Institute for Prevention, Treatment and Rehabilitation of Chronic Respiratory, Public / Secondary Non-specific and Allergic Diseases, Otesevo, Resen Special Hospital for Pulmonary Diseases and Tuberculosis, Jasenovo, Caska Public / Secondary General hospital, Debar Public / Secondary Special Hospital for Orthopedic and Traumatology Sveti Erazmo, Ohrid Public / Secondary Re-Medika Hospital, General Hospital, Skopje Private / Secondary Special Hospital for Surgical Diseases Filip Vtori, Skopje Private / Secondary Acibadem Sistina Clinical Hospital, Skopje Private / Secondary Specialized Obstetric Gynecology Hospital Sveti Lazar, Skopje Private / Secondary Special Hospital for Ocular Diseases European Ophthalmology Hospital, Skopje Private / Secondary Health Institute, Kriva Palanka Public / Secondary Institute for Prevention, Treatment and Rehabilitation of Cardiovascular Public / Secondary Diseases, Ohrid Institute of Pediatric Pulmonary Diseases Kozle, Skopje Public / Secondary Institute of Pulmonary Diseases and Tuberculosis, Skopje Public / Secondary Institute of Physical Medicine and Rehabilitation, Skopje Public / Secondary Gerontology Institute 13 Noemvri, Skopje Public / Secondary Sources: Macedonian Association of Hospital Pharmacists, PCoM; Regulation for Network of Health Institutions (Official Gazette of RoM, No. 81/12) 11

12 In the Strategic plan of the MoH for , more improvements in the health care system were planned according to the priorities of the Government. One of these priorities was drafting improved legislation. New Law of health protection was issued in March This Act clearly defines all pharmaceutical activities as part of the health care activities, including purchasing of medicines and medical devices, production of medicines, distribution and drug quality control, giving information on drugs to patients and other health care providers, counseling and education on rational and effective use of medicines and medical devices and therapeutic drug management. This definition gives real opportunity for the pharmacists to perform wide range of pharmaceutical activities and services. The reimbursement of the drugs is on the basis of referent prices 21. At present, the HIF reimbursement practices for pharmaceuticals on the positive list of drugs take insufficient account of the pharmacists overhead costs 22,23. For the community pharmacies, the HIF is paying for the medicaments plus fix margin according to the scale based on referent price of the medicine, lower fee for lower referent price, higher fee for higher referent price (lower is 0,2 euro, higher is 3,33 euro). For the hospital pharmacies, the expenses are calculated according to the DRG system. The reference pricing system was established for the drugs in the primary care. Data collection on drug expenditure in the country is difficult as drug consumption is not monitored closely. In 2007, Law on medicines and medical devices was issued 11. The Law is generally harmonized with the EU legislation, following all the EU provisions concerning pharmaceuticals. Under this Law, the pricing of medicines is regulated, which is not in line with the EU legislation. There is a single act titled Methodology for establishing medication prices 24, adopted by the Government in October, 2011, which strictly defines the establishment of drug prices, on the basis of comparative study conducted in 12 countries (in the region, EU, including Russia and Turkey). The pharmaceutical sector currently operates on the basis of a positive list of drugs (by generic names) that defines which drugs are eligible for reimbursement by the compulsory health insurance. The sector is supervised by the DB. The DB (MoH) and the PCoM issued National Drug Formulary 25 in 2006 The National Drug Registry 26, first time issued in 2006, is updated every year. In the RoM, unlike most of the EU 27 and most world countries, there is no Pharmacy law as a single legislative act to regulate the pharmacy practice and scope of pharmaceutical activities and services. Instead, in the Law on medicines and medical devices from there are 2 articles that outline the activities related to the medicinal retailing within pharmacies. This Act considers pharmacies to be legal entities where purchasing, storage and dispensing of medicines are undertaken. It is very encouraging that this Law creates new opportunity for pharmacies by endorsing the need to introduce quality systems and to organize work process according to the principles of GPP 28. This document is a very short one with only 4 articles, but it provides directions for the evolution of the pharmaceutical activities into the pharmaceutical care concept. The GPP guideline explicitly quotes the need for development of national GPP standards to guarantee professional roles of the pharmacists and to ensure essential conditions are in place for implementation of GPP. Unfortunately, to date neither national standards have been developed, nor the wider professional debate has been initiated by the DB (MoH) to promote the concept of pharmaceutical care on a national basis. In 2007 the Government, MoH and the DB have also clearly recognized the need for improvement in the health policy, decision making process at all level of health protection and the quality and efficiency of health services and health professionals. The activities necessary for overcoming the problems and 12

13 achieving the goals were set out in the Health strategy of the Republic of Macedonia (2020) for safe, efficient and just health system 29. The main objective of the Strategy at the level of primary care is to ensure the population to have a better access to the family- and community-oriented health care services supported by a flexible and responsive health system. The pharmacy practice problems and priorities for improvement are described in a separate chapter (titled Pharmaceutical services) where the weaknesses in the pharmacy practice are identified, such as irrational prescribing of drugs, lack of drugs in the pharmacies, submission of claims for drug cost reimbursement in front of the HIF, lack of data for the overall drug consumption in the country, training of health professionals, etc. Also, it is recognized that a system of compulsory and accredited continuing education required for relicensing has not been established yet. The financing of continuing educational activities was and it is still a problem in a view of the low income of health care professionals, incl. pharmacists. As another major bottleneck, lack of access to internet sources of information was detected. The Strategy also recognizes the steps for improvement of the pharmacy practice and services, including (i) revision of the national drug policy from 2001; (ii) (iii) (iv) renewal of the positive list of essential drugs (based on clinical protocols and guidelines) that will be fully reimbursed by the HIF; establishment of referent prices for drugs, with generic names; strengthening and enlarging the functions of the DB with its transformation into an autonomous Drug Agency authorized to control all phases of drug registration, import and distribution of pharmaceuticals and implementation of GPP in pharmacies. The Strategy also points that the concept of pharmaceutical care is not a dominant form of practice for most of the pharmacists in the RoM. The transformation from commodity-based mercantile operations into a clinical profession is evaluated as very slow. It is emphasized that encouragement and setting appropriate GPP guidelines containing national standards are needed, which would meet professionaldetermined needs for pharmaceutical care. The necessity of developing standards for the pharmacy services which ensure proper co-ordination and communication between the health- and pharmaceutical care providers and consumers is also emphasized. It is recommended the number of the pharmacists (especially in the hospitals) to be increased, partnership between physicians, nurses and pharmacists to be strengthen, the role of the pharmacists in reporting adverse effects to be increased, participation of the pharmacists in clinical studies and ethics committees to be recognized, the communication and co-ordination between the pharmacies and/or pharmacists in the hospitals and community pharmacists to be improved and employment of specialists in clinical pharmacy and pharmacoinformatics in the hospital pharmacies to become obligated. Another similar document, Green Book - Improvement of the Health System in RoM was also issued in 2009/2010 by the Committee for improvement of the health system in the RoM 30. The Committee was established by the MoH with an aim to help the Government to finish the reforms in the health system. Valuable recommendations were gathered by the health experts in five areas: (i) management of the health system; (ii) health care practice; (iii) financing; (iv) pharmacy; and (v) patients rights. PCoM (pharmacy experts) has actively participated in drafting the recommendations. Main recommendations were focused on the need of issuing Law on pharmacy practice as a single legislative act, defining the structure and role of the community/hospital pharmacies/pharmacists, defining the mechanisms for transfer of patients through the levels of health care, defining the roles of the pharmacists in prescribing, strengthening the communication between the health care providers (pharmacists and physicians) and between them and the patients, defining the levels of education and training for the 13

14 pharmacists (depending on their professional needs), establishing standards for the pharmacy structure, developing programs for therapeutic management, stimulating use of clinical guidelines and specialized formularies, increasing the budget for medicines and medical devices, etc. Considering education of pharmacists, accredited high educational institutions (HEIs) in the RoM are the FF-UKIM in Skopje, Department of Pharmacy at the Faculty of Medicine, University Goce Delcev in Stip and the Department of Pharmacy at the State University Tetovo in Tetovo. They are all public HEIs and accredited by the National Accreditation Committee, which is under jurisdiction of the Ministry of education and science of the RoM. Criteria for enrollment in the 1 st and 2 nd level integrated pharmacy study programs include 4-year secondary education (gymnasium or secondary medical school) and state exam, excluding entrance exam. At these HEIs, the students are enrolled as regular full-time students and their education is financed or co-financed by the State. The pharmacy study programs at all HEIs last 10 semesters (1 st and 2 nd cycle integrated, 300 ECTS-credits according to Bologna). In the last (10 th ) semester, professional practice is provided and after graduation, the students obtain a title Master in pharmacy. Professional practice is conducted in community and hospital pharmacy. In the practical teaching and training, professionals from the university clinical centers, and hospital, community and industrial pharmacists are included. In 2009/2010, the Faculty of Pharmacy at UKIM in Skopje in collaboration with the PCoM introduced new pharmacy study program according to Bologna, harmonized with the study programs of several Faculties of Pharmacy in Europe (see above) and with the Directive 2005/36 on recognition of professional qualifications. In the period , new study programs related to pharmacy practice at 2 nd level were also introduced and the existing ones modernized, such as the academic specialist and master study programs in health management & pharmacoeconomy, phytotherapy. At the Departments of Pharmacy/ Faculties of Medicine in Stip and Tetovo, only study programs in pharmacy at 1 st and 2 nd integrated level (300 ECTS-credits according to Bologna) are conducted. After graduation and obtaining diploma Master in pharmacy, additional 6-month professional practice in community and hospital pharmacy and in national/regional drug information centers is required for the pharmacists to obtain license for independent work. The training program is in accordance with the rulebooks issued by the PCoM, which is in compliance with the LHP 8. The internship period of 6 months embraces five pharmacy fields: (i) community pharmacy, (ii ) hospital pharmacy, (iii) clinical pharmacy, (iv) pharmacoinformatics and (vi) pharmacy legislation. After 6-month training, the residents have to pass the state exam in order to become licensed pharmacists i.e. eligible for independent work, registered in the PCoM register. The training program is under supervision of certified mentors and conducted by trained and certified (by the MoH) educators. The training program, state exam and licensing are under jurisdiction of the PCoM and in accordance with the Law on health protection. The state exam is conducted in accordance with the Rulebook on state exam for masters in pharmacy and the Examination committee is consisted of accredited examiners. Under the same LHC, the PCoM is authorized for recognition of the training, state exam and license conducted/obtained abroad for domestic and foreign citizens. During the exam, knowledge and skills in the area of pharmacy practice in hospital and community pharmacy are assessed. Under the Health sector management project 38, the examination process was positively evaluated by external evaluators 39. The comments of the external evaluators were as follows: The assessments are criterion-referenced and are very well designed, reliable and valid. There are mark sheets and supporting documents available for the examiners and the students well prepared. Criteria are clear. The combination of the three forms of assessment gives a good profile of the student s readiness to practice safely and competently. Students receive feedback on their performance and thus the assessments are formative as well as summative. No student has failed the assessment although a couple has been borderline (this is because students 14

15 would not reach this stage without their deficiencies being recognized and addressed by the faculty and the educators and mentors). The assessments, dealing with relatively small numbers, are very well run and organized and are a model of postgraduate assessment). In addition, it was emphasized that a Graduate degree course Five years covering - Basic biomedical sciences (incl. physiology, anatomy, biochemistry, microbiology, pathophysiology, pathology) - Pharmaceutical chemistry - Pharmaceutical technology - Drug quality control - Phytochemistry and phytotherapy - Food and nutritition - Pharmacotherapy - Pharmacy practice Postgraduate pre-registration Six month-training - Pharmacy practice - Regulatory affairs Professional examination - Licensing (entry into the professional register) CE and CPD - All registered pharmacists are subject to relicensing after 7 yrs - Collect credits by attending various types of CPD activities Post-graduate education and training - Many pharmacists voluntarily pursue further postgraduate academic and health professional degrees in fields as clinical pharmacy, drug information, phytotherapy, clinical biochemistry, pharmacy practice, etc. - Gain certificate as (health) specialists in specific fields Fig. 2. Education and training of the pharmacists in the RoM 15

16 good system of communication is in place to identify struggling students and also to improve the assessment and overall learning process. The assessors were evaluated as very competent and well briefed, supportive and encouraging of the students whilst remaining rigorous in their expectations. Starting from 2006, 941 pharmacy residents have passed the internship program and 886 successfully passed the state exam. The masters in pharmacy may/must renew their license after 7 years by fulfilling the following conditions: at least 60% of working time in the profession during this period and participation in continuing education courses and professional development programs. By the same LHP, the temporal and permanent confiscation of license is regulated. According to the Rulebook for types of continuing education activities and professional development programs, criteria and credits allocation for continuing education and professional development 40, the Expert Committee at the PCoM approves accreditation of the educational activities upon submission of the application and allocates credits depending on the type of the continuing education activities and professional development program. For the past 6 years, 205 workshops, seminars, symposiums and other forms of continuous education have been accredited. Continuing education and professional development as well as application of modern scientific and expert achievements in practice are the main objectives and tasks of the Macedonian a ssociation of pharmacists, which is actively involved in organizing educational and scientific events, conventions and congresses which are rated in the CME system. Other institutions are also involved in organizing various types of educational activities, such as the Center for continuing education (CCE) and the NDIC located at and under jurisdiction of the FF-UKIM in Skopje. Pharmacists may also obtain health specialist title in adequate field of health practice according to the LHP 8 and the Rulebook for health specialist and subspecialist studies of health practitioners 41. The Faculty of Pharmacy at UKIM in Skopje is the only designated HEI for organizing health specialist studies for the pharmacists in the RoM. Health specialist study programs were recently (2011) modernized and there are training programs in clinical pharmacy, pharmacoinformatics, medical biochemistry, drug quality control and testing, pharmaceutical technology, sanitary chemistry, toxicological chemistry, herbal drugs (pharmacognosy), medicinal laboratory genetics and pharmacy practice. Health specialist studies are fully regulated by the Law on h ealth protection, by which a system of mentorship and educators was introduced and the responsibilities of the health institutions where training is conducted, in respect to quality, agreement protocols and planning are regulated. 42 Adoption of standards for pharmacy services (PSs) i n 1993 by the International Pharmaceutical Federation under the heading Good pharmacy practice in community and hospital pharmacy settings developed as a reference to be used by national pharmaceutical organizations, governments and international pharmaceutical organizations to set up nationally accepted standards of Good Pharmacy Practice (GPP), their subsequent adoption in a wide number of developing countries 43,44 and significant changes in practice, applied science and technology and pharmaceutical policy that have occurred worldwide in community and hospital settings were the main provocation for the PCoM to propose the project titled Building platform for implementation of GPP in the Republic of Macedonia for financial and expert support by the EuroPharm and WHO. The main goal of the project is to set up a platform for improving the quality of the PP and PSs in community/hospital pharmacy settings through implementation of the GPP standards established on a basis of a modern best practice process (joint WHO/FIP document 2011). For this goal to be 16

17 achieved, a survey for the standards of PP and for the quality of PSs in the RoM was conducted with the aims given below: to define the standards for PP and quality of PSs in the community and hospital pharmacies in the RoM in respect to the standards set in the Joint FIP/WHO guideline on Good Pharmacy Practice (GPP): standards for quality of pharmacy services; to define the regulatory system and political, legal and economic framework supporting the PP and services in the RoM; to identify the gaps and perceived barriers to implementing the best PP and pharmaceutical care (PC) in the community and hospital pharmacy settings in the RoM; to assess the level of education, knowledge and skills of both the community and hospital pharmacists and their attitude towards PP, PC and continuing professional development (CPD); to identify the main priorities for intervention to improve the quality of the PP and PC in line with the National Drug Policy and WHO/FIP Guidelines on GPP based on consideration of the realities, policies, strategies and new roles; to create a document with set of recommendations for improving the PP and set up a plan of action for stepwise approach and managing the PP and PC changes; to provide assessment tool for quantification of PP status and quality of PSs that can facilitate comparison of results over time. 17

18 Methodology For these aims to be achieved, a descriptive indicator study has been used. Structured and standardized questionnaires, separately for the community and hospital pharmacies were designed and as stakeholders, 740 in total (individual and chain-) community pharmacies and 44 (central and satellite) hospital pharmacies were adequately targeted. Simple random sample design was used for both, community and hospital pharmacists, so the questionnaires were delivered to all community and hospital pharmacies by or mail using data base (e -mail addresses) for the pharmacies of the PCoM. For completion of the questionnaire by the community pharmacists, instructions and explanations were given to the responsible pharmacists of the regional offices (8 regional offices). For completion of the questionnaire by the hospital pharmacists, a workshop was organized during which the questionnaire was discussed and explanations for the complex issues were given. In addition, as stakeholders, the DB within the MoH of the RoM, HIF, PCoM and FF-UKIM were also considered in order to define the legal, economic and educational framework for the PP and PC in the RoM. The information from these stakeholders was collected by meetings and from available documentation and legislation. The information from the questionnaire for the community pharmacies was collected partly by or mail (using the Dillman Method) 50 and partly by face-to-face in the pharmacy where the respondent works. The time elapsed before receiving the completed questionnaires was not longer than 5 weeks (May-June, 2012). For the hospital pharmacies, having in regard the relatively low number of hospital pharmacies and participation of the hospital pharmacists at the workshop, the information was completely obtained by in-person. Of 740 total number of community pharmacies, 123 responses were obtained from the chain pharmacies and additional 122 responses from the individual pharmacies. Considering the hospital pharmacies, 31 responses out of 44 were obtained. It is worth to emphasize that in 17 out of these 44 general or clinical hospitals or institutes with in-patient beds, no pharmacists are employed and for the purchasing and dispensing of drugs and for the PC (if any) mostly medical technicians are engaged. Improving the standards of PP and quality of services and recognition of existing and adoption of new pharmacists roles was a motivation for the pharmacists to show enthusiasm and interest to participate in the survey. Improving legislation and creating better climate for PP and PC services was the point of interest for the DA and MoH of the RoM, HIF and PCoM, while for the FF-UKIM, the interest was focused on creating new academic and/or specialist study programs and types of CPD activities (within the CCE established at the FF-UKIM) to increase pharmacists knowledge and skills for performing the best PP. Populations of interest were all the pharmacists and pharmacy technicians employed at the community and hospital pharmacies on the territory of the RoM. According to the data from the Register of the PCoM, there are app community pharmacists, 1225 pharmacy technicians (app. 74 working in the hospital pharmacies) and 56 hospital pharmacists. The number of community pharmacists varies significantly from year to year due to the great variations in the number of pharmacies (app. 30 community pharmacies are opened and 15 are closed per year). Most of the community pharmacists are female, 80% vs. 20% male pharmacists. Average number of pharmacist per community pharmacy is 1.4, while the average number of employees per pharmacy is The average age is 30±5 yrs. For the hospital pharmacists, the proportion of female pharmacists is significantly higher, 95% vs. 5% male pharmacists, with an average age of 35±5 yrs. Average number of pharmacist per hospital pharmacy is less variable and at the first half of 2012 it is 1.27 pharmacists per pharmacy, while the average number 18

19 of employees per pharmacy is 3.79 (incl. cleaning personnel and administration). The number of prescriptions/per year for reimbursed medicines (by HIF) in 2010 was (increasing app per year), while average value per prescription is 1.9 euro. The resources (financial and expert) for designing the questionnaires and conducting the survey were provided dominantly by the EuroPharm Forum, WHO and the PCoM. In creating questionnaires, conducting the survey/interviews and analysis of data collected, 2 professors with a background understanding of GPP from the FF-UKIM (members of the PCoM), Lidija Petrusevska Tozi (president of the PCoM for app. 10 yrs, professor at the FF-UKIM) and Kristina Mladenovska (specialist in clinical pharmacy, 10 yrs working experience in hospital pharmacy, professor at the FF-UKIM) and 1 administrative officer Jasminka Patceva (specialist in pharmaceutical regulatory affairs, 10 yrs working experience in community pharmacy, employed at the PCoM) were involved. The questionnaires were revised by Dr Dick Thromb, president of EuroPharm Forum, and Kirsten Holme, professional secretary EPF, Pharmakon-WHO Collaborative Centar, and Nina Sautenkova, NIS programme manager at World Health Organization, who also participated in creating the overall project proposal. The meetings were organized with the representatives from the stakeholders, the DB (MoH), HIF and FF-UKIM and the data were also collected by inspection in available documentation, laws and rulebooks. With the survey, the issues given below were explored. For the community pharmacies (Annex 1), set of 155 structural process and outcome indicators were identified covering five essential components given below. The indicators describe the highest standards of PP and quality of PPs. Data for the demographic characteristics and management of the community pharmacies were also collected. I Pharmacy structure and practices (60 indicators) - Pharmacy structure (premises, equipment, etc.) - Supplying, storage and stock - Dispensing - Access to drug information II Patient access to patient data, communication, counseling and education (25 indicators) III Manufacturing practice and drug quality control (13 indicators) IV Staff workflow, competency and professional development (25 indicators) - Workflow - Competency, continuing education and professional development V Quality assurance, risk and data management (32 indicators) - Quality assurance - Data management within the pharmacy 19

20 For the hospital pharmacies (Annex 2), set of 191 structural process and outcome indicators were identified covering five essential components, given below. Data for the demographic characteristics and management of the community pharmacies were also collected. I Patient safety (39 indicators) - Patient information - Patient counseling and education II Drugs and medication devices (81 indicators) - Drug & medication device information - Ordering communication - Purchasing, storage, labeling, distribution and administration III Manufacturing practice (13 indicators) - Production - Drug quality control IV Environment, workflow and staff availability and qualifications (30 indicators) - Environment and workflow - Competency, continuing education and professional development V Quality assurance and risk management (28 indicators) For the DB and MoH, the following issues were covered: I Regulations/restrictions on location and number of pharmacies (geographic and demographic criteria) II Regulations/restrictions on ownership (limitation of ownership to pharmacists, limits to the ownership of multiple pharmacies i.e. pharmacy chains) III Criteria for establishing pharmacy (room, equipment, staff) IV Distribution of pharmaceutical products outside a pharmacy V Opening hours As source of information, the Law on health protection, Law on medicines and medical devices, rulebooks relevant for establishing pharmacies and performing pharmacy practice and Regulation for network of health Institutions were considered. 20

21 For the HIF, the following issues were covered: I Pricing regulation II Contracting III Remunerations and incentives mechanisms As source of information, the Law on health insurance, Law on medicines and medical devices, rulebooks relevant for contracting pharmacies and performing/reimbursement of pharmacy practice were considered. For the PCoM, the following issues were covered: I Registration II Licensing and relicensing III Accreditation of CPD activities III Relations with governmental institutions, academia and professional associations As source of information, the Law on health protection, Law on medicines and medical devices, rulebooks relevant for licensing/relicensing, accreditation of CE activities were considered. For the FF-UKIM, the following issues were covered: I Graduate study program in pharmacy, with particular emphasis on PP and PC ( harmonization with Directive 2005/36/EC on the recognition of professional qualifications) II Postgraduate professional (academic and specialist) study programs covering PP and PC (harmonization with Directive 2005/36/EC on the recognition of professional qualifications) III Involvement of the NDIC at the FF-UKIM in PP of the community and hospital pharmacies IV Involvement of the CCE at the FF-UKIM in continuing education and CPD of the community and hospital pharmacists As source of information, the study programs accredited by the Ministry of education and science at the FF-UKIM, relevant rulebooks and the Statutes of the Faculty and University were considered 51,52. In writing the questionnaires, various publications of survey questions and guidelines and already established (published) indicators for assessing specific topics around PP were consulted The chosen PP indicators assess standard requirements for PP which are in line with the official licensing requirements in the RoM. For the community and hospital pharmacists, cross-sectional descriptive surveys were conducted where combined pre-coded open ended and multiple choice closed questions were used with type of response format: A - Activity fully applied; B - Activity partially applied; C - Activity not applied (applicable); D - Activity not applicable (Annex 1 and Annex 2). Multiple choice closed questions were used to create 21

22 assessment tool for quantification of PP status and quality of PSs that can facilitate comparison of results over time within and between the community and hospital pharmacies. When calculating the GPP and PSs score, the maximum score of 100 (20 per section) and minimum zero for both community and hospital pharmacies were given for all the indicators (155 for community and 191 for hospital pharmacies, respectively) if all indicators were responded to A and D, respectively. The weight of each indicator in the section depended on the number of the indicators in the section and if all responded to A, it was calculated by dividing 20 with the number of indicators. For example, if the total sum of indicators per section I is 40 and each indicator responds to A, the weight of each indicator would be (= 20/40). The weight of the indicators responded to C was calculated as a half of the weight of the indicator responded to A (in the given example, it would be 0,500/2 = 0.250), while the weight of each indicator responded to B was calculated by dividing the sum of the weights of the indicators responded to A and C by 2 (i.e. ( )/2 = 0.375). Thus, in the given example if all the indicators were responded to B, the total score would be 15 per section and 10 per section if the answers to all questions were C. The questionnaires were previously tested by involving the target groups/stakeholders (actual respondents) in the design to evaluate the specific questions, format, questions sequences and instructions. During the pilot study, the measurability of the questions, interpretation of the questions by all respondents, whether close-ended questions have a response which applies to all respondents, clarity and understandability of the questions, length of the questions, time for completing and responses from the different response categories, etc., were evaluated. Considering that for almost all indicators a professional background was required to undertake the necessary assessment, both the surveyors and respondents were pharmacists. The manual data collection sheet ensured independent data collection on site of all data required. The sheet contained data collection space for all indicators in the form of structured information. The data were saved by Excel software. Excel-based assessment tool depicts the findings in the form of a histogram and a spidograph of all components calculated for each pharmacy settings. 22

23 Results I Community pharmacy practice and services I.1. Demographic characteristics and management of community pharmacies According to the data obtained with the survey, only 8.43% of the community pharmacists are state or local governance, while independent (owned by the pharmacist itself) and owned by two or more pharmacists (partnership of pharmacists) are 24.1% and 15.61%, respectively. Most of the respondents belong to corporate body owning more than 1 pharmacy (part of pharmacy chain), 53.3%. There is not a single community pharmacy with an international ownership or ownership of non-profit making institution (Fig. 3). international ownership coorporate body partnership indipendant local governence state governence 0 2,41 6,02 15,61 24,1 53, Fig. 3. Ownership/institutions responsible for establishing community pharmacy health centre out of town city suburban rural 16,3 1,2 7,83 3,05 72, Fig. 4. Location of the community pharmacies 23

24 Most of the pharmacies (72.3%) are located in the cities, especially in the centers of the cities. Only 7.83% of the community pharmacies are located in suburban areas, while very few (3.05%) are placed in rural areas. Within or near the health centers, there are 16.3% (Fig. 4) of community pharmacists, which indicates inadequate distribution of the community pharmacies for providing PSs for the patients. The categories that best describe the number of citizens currently served and the number of patients served by the community pharmacy is presented in Fig. 5. over ,3 17, , ,3 24, ,1 31,3 citizens served patients served ,8 12,7 up to 500 3,01 6, Fig. 5. The number of citizens and patients served in/by the community pharmacy over , ,1 38,6 up to , Fig. 6. The number of prescriptions dispensed per month in the community pharmacy Considering the category of patients currently served by the community pharmacies, 31.3% of them dispense medicines for patients and 24.7% serve patients. Approximately similar percentage (12.7%, 14.0% and 13.3%) of the pharmacies dispense medicines to ; and < patients, respectively. Only 3.01% of the respondents serve less than 500 patients per 24

25 month. Comparing the number of citizens and patients served in the community pharmacies, it is obvious that the number of citizens and number of patients go along for the pharmacies that have citizens/patients. It is interested to note that the community pharmacies serving higher number of citizens, serve lower number of patients. Considering the number of prescriptions dispensed by the community pharmacy per month (reimbursed or not by the HIF), most of the pharmacies (38.6) dispense up to 3000 prescriptions. Similar number of pharmacies dispenses medicines for up to 3000 or 5000 prescriptions (21.2% and 24.1%, respectively). Only 15.1% of the community pharmacies dispense over 5000 prescriptions and only 1.2% dispenses more than 6000 prescription (Fig. 6). One of the parameters for evaluating the structure of the community pharmacy was the total size of the pharmacy floor. In only 3.01% of the community pharmacies, the total size of the floor is less than 25m 2, while the community pharmacies with total floor size over 100m 2 are 7.23%. Most of the community pharmacies (45.2%) are with floor size from 25-45m 2 and 26.5% have the size of 45-65m 2 (Fig. 7). Almost all of the community pharmacies (95.8%) are open 12 h/day, six days per week, and approximately 70% of the pharmacies are open for providing services on Sunday and holidays (67.5% and 76.5%, respectively). Only 10.8% of the community pharmacies provide on call services during the whole week. All the community pharmacies have installed a computer system. However, in 39.2% of them it is used as connection to other pharmacies (usually in chain pharmacies) and only 14.5% of the pharmacies use the computer system for gathering information from the NDIC. over 100m2 7, m m2 17,5 26, m2 45,2 up to 25m2 3, Fig. 7. Total size of the pharmacy floor Considering the staff employed in the community pharmacies, the point of interest was the number of full-time or part-time employed with the degree graduated pharmacist or master in pharmacy, but also stuff with a health specialization ( 2 nd cycle according to Bologna, see the Introduction). Almost all community pharmacies are equipped with 1-2 technicians and 1-2 pharmacists as full-time employed, with 1 responsible (licensed) pharmacist. There are no pharmacists with specialist competences such as competence in community pharmacy (d ue to lack of specialized education in this area), clinical pharmacy, pharmacoinformatics, regulatory affairs, nutrition, etc. Full-time employed cleaning personal is 0.38/pharmacy and administrative stuff 0.03/pharmacy (accounting personal). There are no part-time employed pharmacists, pharmacy technicians or administrative staff in the community pharmacies in the RoM, as they are not recognized by the HIF for contracting with the pharmacy. Only 1% of the 25

26 community pharmacies have specialists in certain field of medicine and pharmacy, mostly the specialists in pharmaceutical technology. The pharmacists are involved in all activities in the community pharmacy, administrative and traditional activities (drug supply and dispensing) as well as activities relate d to pharmaceutical care services (patient counseling and education, giving information on medicines and medical devices, etc.) Considering the pharmacy technicians, they are mostly involved in drug dispensing (89.2%), patients counseling (81.9%) and givin g drug information (78.9%). Around 42.2% of the employed pharmacy technicians are involved in drug supply and 23.5% are involved drug and medical devices acquisition, storage and distribution. Only 8.43% are engaged in drug preparation. These data are logical consequence of the actual situation regarding employment in the community pharmacies where usually 1 pharmacist and 1 pharmacy technician are employed (Fig. 8). drug dispensing drug supply Patient counseling Acquisition, storage and distribution Drug information Drug preparation and quality control Fig. 8. Tasks assigned to pharmacy technicians in the community pharmacy Considering purchasing of medicines and medical devices, the survey showed that wholesalers are the main source for acquisition of drugs followed by industry (Fig. 9). Only 3.61% of the community pharmacies have their own production and only 4.22% purchase drugs from other community pharmacies. Most of the community pharmacies purchase medications daily (77.1%), 17.5% twice a week and only 1.2% purchase medications weekly. There is no community pharmacy that supplies medicines monthly. 26

27 group purcharing other pharmacies own production wholesalers industry 3,01 4,22 3,61 6,02 98, Fig. 9. Sources for purchasing of medicines and medical devices by the community pharmacy The types of pharmaceutical (care) services provided on an around-the-clock basis in the community pharmacies are presented in Table 3. In only half of the community pharmacies (53.61%), medicines use is reviewed. In addition, blood pressure is measured in 22.29% of the community pharmacies; hypertension is managed in 19.28%, while diabetes and asthma management is offered in 16.27% of the community pharmacies. Other services are offered in very low number of community pharmacies, there are pharmacies where no additional services other than (repeat) dispensing prescriptions are offered and some of them declared that the structure of the pharmacy does not provide minimum conditions for offering pharmaceutical care services. Table 3. The pharmacy services provided in the community pharmacy The services provided in and by the community pharmacy % Dispensing prescription Repeat dispensing Medicines use review Disposal of medicines waste Blood pressure measurement Hypertension management Glucose measurement Diabetes management Asthma management Pregnancy test Weight measurement 5.42 Smoking cessation 3.01 Cholesterol measurement 1.20 Home care services 1.20 Night services 1.20 Vaccination 0 27

28 According to the data from the survey, the patients obtain information on the services provided in the pharmacy in 72.89% of the community pharmacies. These services are offered regularly in 63.86% of the pharmacies, for all patient groups in 42.17%, but in only 24.70% of the community pharmacies, the pharmacists document the pharmaceutical services they provide. In addition, only dispensing of prescription is reimbursed by the HIF, so 31.33% of the respondents claimed that services are reimbursed (Fig. 10). 43,37 offered on the advice of the pharmacist 42,17 all patients documented 24,7 reimbursed 31, Fig. 10. Information on the services provided in/by the community pharmacy Considering the data obtained for the reimbursement of medicines, one can see that the most of the community pharmacies (95.18%) have a contract with the HIF and almost all of them (96.78%) have fulfilled all the provisions from the contracts with the HIF. The reimbursement is sufficient to satisfy the patient needs for medicines in only 63.05% of the community pharmacies, although the reimbursed medicines are available in the pharmacy each and every day in 83.73% of the community pharmacies. The evidence for reimbursed medicines is kept separately from the evidence for other medicinal products, readily available for inspection in almost all of the community pharmacies (93.98%). The received prescriptions are printed on paper in standardized form in 93.37% of the community pharmacies, in app. 1.21% they are e-prescriptions and in 5.42% they are handwritten in standardized form. The medicines without co-payment are first offered to the patients in 81.33% of the community pharmacies (Fig. 11) The survey also gives data for the management characteristics of the community pharmacies in the RoM. The pharmacies are managed both (internally and externally) in 53.0% of the community pharmacies, but dominantly internally (in 43.4%), while the pharmacy managers respond to the pharmacy owners in app. 64.5% of the community pharmacies. In app. 92% of the community pharmacies, the pharmacy manager is qualified pharmacist. In 73% of the pharmacies, the responsible pharmacist is not the owner of the pharmacy and he/she responds to the pharmacy manager. According to the information gathered during the survey, the pharmacists in the community pharmacies are in a phase of preparation of written SOPs. Up-to-date policies and SOPs established so far and the proportion of community pharmacies incorporating these standards are given below (Table 4). 28

29 sufficient budget 62,05 availability medicines without co-payment 83,73 81,33 separate evidence 93,98 e-prescription 7, % Fig. 11. Budgeting and reimbursement of medicines Table 4. Up-to-date policies and SOPs established in the community pharmacies in the RoM SOPs Community pharmacies (%) Supplies, storage and delivery of products 66.3 Product acquisition, storage and handling 64.5 Fire safety 62.6 Management of disposal of expired stock 61.4 Pest control 57.2 Complain handling 56.6 Cash management 56.6 Hygiene procedures 56.0 Medicines recall 53.1 Documentation 47.6 Personnel education and training and competency evaluation 45.2 Reporting adverse drug reactions 45.0 Key holding 44.5 Personnel access 43.9 Incident management 38.5 Use and maintenance of facilities and equipment 35.5 Contingency in the event no pharmacy is present 33.7 Monitoring environmental conditions 26.5 Products requiring specialized handling 24.1 Labelling 16.9 Movement of materials 10.8 Compounding medicines 9.64 Quality control 8.4 Process validation 7.83 Preparation technique

30 App. 33.1% of the community pharmacies provide residency-training for graduated pharmacists during their licensing period. The training program and final exam are accredited by and under jurisdiction of the PCoM (see Introduction). Approximately 47.2% of the community pharmacists also provide training program approved by the secondary school council and Ministry of health for pharmacy technicians. In nearly half of the pharmacies, the number of residents usually does not exceed five per year. I.2 Indicators and components included in the PP and PSs assessment tool and scores from the community pharmacies in the RoM The first system indicators set out in the section I (Annex 1) intended to assess pharmacy structure (e.g. premises, equipment, etc) and all the activities related to the medicines and medical devices such as ordering communication, supply, storage, dispensing as well as access to drug information. The histogram in Fig. 12 depicts component scores as the actual score compared to the possible maximum score and comparison is also made between the indicators responding to A, B and C, accordingly (Note: the weight of the indicators responding to D is always 0). The results depicting component scores from the actual score point to the value out of 20. Considering indicators assessing the structure of the community pharmacies in the RoM, app. 97% of the pharmacies are clearly identifiable as health care facilities with access for disabled patients. The service areas in the pharmacies are clean, adequately illuminated and free of clutter, distractions, interruptions and noise. Suitable waiting areas, areas for confidential conversation with the patients, separate areas for OTC drugs and dietary supplements, herbal, homeopathic and alternative medicines are fully or partially available in less than 83% of the pharmacies. It is interesting to note that only 39% of the community pharmacies have areas for health promotion as it is a common practice to use the dispensary area for health promotion. In very low number of community pharmacies (only 28 out of 245) there are separate manufacturing areas constructed according to the safety policies. The dispensing area is suitable in size for the prescription volume and provides uninterrupted and safe workflow in app. 84% of the community pharmacies. All pharmacies are equipped with refrigerator, but in only 72% it is used for medicinal products (mainly storage) according to the safety requirements. Each pharmacy is equipped with computerized system, which in app. 95% is used for dispensing medicines, recording prescriptions, financial and stock management, while in 87% of the pharmacies it is fully or partially used for obtaining information on medicines and treatments. However, for the important activity FEFO (first expired first out) it is rarely used (in only 35%), while patient medication records are generated in 17% of the pharmacies. Also, in only 14% of the pharmacies, the computerized system is designed to alert for e.g. over/sub dosing, serious drug interactions, (cross) allergies, contraindications, problematic/similar drug names, packaging and labels, etc. Dispensing system with printer for producing legible and durable labels when dispense medicines re-packed from the bulk is fully or partially used in only 14% of the pharmacies. Barcode scanners for reading of medicinal products and prescriptions are used in every community pharmacy. No pharmacy uses automatic devices for storage, distribution and dispensing of medicinal products. 30

31 ,38 12,1 2,82 1,46 0 Maximum possible score Actual score A B C Fig. 12. Histogram depicting PP and PSs assessment scores for pharmacy structure and practice in community pharmacies According to the survey, half of the community pharmacies have written policies and procedures for ordering, recipe and immediate supply of medicinal products, while in 22% they are in the phase of preparation. Policies and procedures for reception, handling and dispensing of controlled i.e. narcotic drugs are fully or partially established in 40% of the pharmacies and the rest of them do not supply/dispense these drugs. Telephone ordering from reputable distributer/manufacturer is the most exploited way for purchasing medicinal products. Medicines are stored and shelved in designated areas to ensure proper sanitation, temperature, light, ventilation, moisture control, segregation and security in almost all of the community pharmacies (95%). The same percentage of the pharmacies segregate products with similar names and packaging ensuring that they are not stored alphabetically and the place where the products are relocated is clearly marked. Also, in almost all of the pharmacies (90%), hazardous and flammable substances are stored separately in compliance with the legislation. Use of auxiliary warnings or specific labels on packages and storage bins of drugs with similar names, packages and labels is fully applied in only 55% of the community pharmacies. Pharmacy stocks are reviewed at least annually to determine low usage medications and expired or returned products are clearly segregated from the rest of the stock in almost all of the community pharmacies (app. 97%). In every pharmacy, expired or returned products awaiting disposal are clearly and securely segregated from the rest of the stock. The storage areas for medicinal products are under control of the pharmacists in only 38% of the pharmacies, while in the rest of them they are under control of both pharmacist and pharmacy technician. It is interesting to note that in less than 70% of the pharmacies, the structured system for stock management is established and followed and the same percentage of the pharmacies follows policies for maintaining cold chain. As previously said, dispensing practice in community pharmacy was also evaluated. According to the survey, written dispensing procedures are fully established in only 52% of the pharmacies, while in 11% they are in the phase of preparation. The received prescriptions are printed on paper standardized form and routinely checked for legibility, validity and authenticity in all pharmacies. Almost all community pharmacists (97%) regularly obtain relevant patient information before dispensing and evaluate the prescriptions for possible problems prior to dispensing. However, not always the prescriber is contacted 31

32 in cases when potential problem with the prescribed medicines is identified (53%), and even if the pharmacists contact the prescriber they rarely record/document this pharmacy intervention (23%). All of the community pharmacists routinely check expired dates during each dispensing process and the medicinal products in original packages are additionally labeled by the pharmacists (handwriting) providing information on dosage regimen, date and place of dispensing, etc. Limited number of community pharmacies (15%) repacks medicines into unit-dose package when medication doses require less than a full dosage unit. Low number of the community pharmacies (28 out of 245 interviewed pharmacies) that produce pharmaceuticals adequately label the prepared products during dispensing. In all community pharmacies, national medicines formulary and drug catalogues (registers) are available and often used for therapeutic drug management. Pharmacists in the community pharmacy have easy access to user-friendly, up-to-date computerized information systems which include drug information, information on OTC drugs, herbal and alternative medicines and medication devices while working in their respective location. Almost half of the community pharmacies in the RoM are connected with the NDIC and/or another pharmacy, and those which are connected obtain regularly up-to-date and accurate information on medicines and medication devices which are further used in therapeutic drug management. However, access to important databases on biomedical literature, life science journals, online books or their printed editions is limited for most of the community pharmacies in RoM. It is interested to note that app. 43% of the community pharmacies declared that this activity is not applicable due to lack of finances ,98 12,54 2,48 0,96 0 Maximum possible score Actual score A B C Fig. 13. Histogram depicting PP and PSs assessment scores for patient safety in community pharmacy The system indicators set out in the section II (Annex 1) are intended to assess PP and quality of PSs offered to ensure patient safety (e.g. scope of data and mechanisms for obtaining information on the patients, level and quality of pharmaceutical care provided as well as counseling and education provided to all patients by the community pharmacists). The results of the survey point to a very high actual score (15.98 out of 20) (Fig. 13) In app. 80% of the pharmacies, patient demographic data and information on drug history, co-morbid and/or chronic conditions, allergies and patient social and personal habits are obtained and used when dispensing medicines. In dispensing process, the pharmacists ascertain the clinical purpose of each prescription, consider the need for dose adjustments upon available clinical data and take steps to 32

33 understand the cultural issues and overcome language, visual or hearing barriers when communicate with the patients in all community pharmacies. In addition, all pharmacists attempt to identify any drug related problems patients may experiencing and use enough time for patient counseling and education for medicines, therapy and dosage regimens, ADRs and importance of regular therapeutic drug monitoring. In all community pharmacies in the RoM, the patients are encouraged to ask questions about medications they are receiving and pharmacists always answer politely and clearly. During discussions, the patients are informed about the potential errors with medicines known to be problematic (e.g. look alike names, interactions, etc). However, written information on the drugs in the patient primary language (including supplementary information, nutrition, life-habits, etc.) is provided in 52% of the community pharmacies. Adequate information resources to the patients to facilitate proper recognition and use of service for making informed choices are fully or partially available in 75% of the pharmacies. In app. 50% of the pharmacies, a procedure for informing the pharmacy staff when to refer patient exclusively to the pharmacist is established. Patients are referred to other health care providers when necessary in 54% of the pharmacies. Policy to assist individuals who may be abuse/misuse nonprescribed medicines is fully established in 29% of the community pharmacies. Similarly, regular audit carried out by the pharmacist to ensure that abuse/misuse of non-prescription medicines is minimized is carried out in only 12% of the pharmacies. Considering that in most of the pharmacies, only one pharmacist is full-time employed, there are no staff members who are specially trained to provide advice on the use of non-prescription medicines and therefore, they are not visible or approachable. In limited number of community pharmacies (10%), educational programs for all or specific patient groups are developed and organized with the aim to improve the use of medicines. The system indicators set out in the section III (Annex 1) assess manufacturing practice and drug quality control. The histogram in Fig. 14 depicts component scores as very low actual score which is 2.83 vs. maximum possible score of 20. The results from the survey point out that only 28 out of 245 interviewed community pharmacies produce pharmaceuticals for individual patients, while 11 of them for all patients, also. App 75% of the responders declared that this pharmacy activity is not applicable in their respective locations due to the specific structure and low space requirements for establishing a pharmacy, while app. 15% of them replied that there are preconditions for producing pharmaceuticals, but this activity is not applied. Up-to date policies and procedures for manufacturing of the products are fully or partially established and the pharmacy staff is competent for each step of the manufacture process in only 3 of the community pharmacies. Appropriate range of containers for packaging of extemporaneously compounded products is available in only 3 of the community pharmacies, where the responsible pharmacist verifies that the product was compounded accurately with the correct ingredients and quantity of each ingredient. The production of pharmaceuticals complies mostly with the national legislation. 33

34 Maximum possible score 2,83 Actual score 1,32 0,08 1,43 A B C Fig. 14. Histogram depicting PP and PSs assessment scores for manufacturing practice in community pharmacies Analytical procedures for drug quality control of the raw materials and pharmaceutical products are regularly performed in all 28 community pharmacies. In 20 of them, the procedures are performed in the pharmacy, while for rest of them in accredited laboratories outside the pharmacy (contract service). Records for compounded products are easily retrievable and stored in an appropriate manner for at least five years from date of compounding in 2 pharmacies out of 28 that produce pharmaceuticals. (For more detailed inspection into the survey results for the Section III see Annex 1). The section IV uses system indicators to assess workflow and staff availability and qualifications (Annex 1). The histogram in Fig. 15 presents component scores as the actual score which is out of 20 (maximum possible score). The results from the survey point out that adequate, sufficient and trained staff is employed to ensure that patients are timely served in app. 95% of the community pharmacies, working 7 hour/day with 30 min break. It must be emphasized that the staff is sufficient for traditional pharmaceutical services, not considering PCs services for which the staff is sufficient in 10% of the pharmacies. However, an effective back-up plan for days when staffing is short is established in most of the community pharmacies, referring that one pharmacist can work more than 8 hours/day (double shift). All professional activities are carried out under the supervision of the pharmacist in any time in app. 60% of the community pharmacies. Pharmacy students/residents are trained and they work no more than 8 hours/day in app. 60% of the pharmacies. All employed pharmacists are registered at the PCoM, meaning that they possess license for independent work. They are aware of their professional role and the associated boundaries and accountabilities and are regularly educated about new drugs added to the pharmacy inventory and any 34

35 ,52 13,15 0 Maximum possible score Actual score 1,45 0,92 A B C Fig. 15. Histogram depicting PP and PSs assessment scores for workflow, staff availability and qualifications in community pharmacies associated guidelines, restrictions, etc. It was declared that all pharmacists have competences for gathering, analyzing and providing drug information, patient counseling and education, while only 31% of the pharmacies declared that employ pharmacist competent for therapeutic drug monitoring and evaluation of the outcome. Considering management competences, app. 57% declared that have pharmacist with knowledge and skills in management. The pharmacists have professional relations with pharmacists in their pharmacy or from other pharmacies and with other health workers. The pharmacists are actively involved in the selection of the most appropriate medication for the patients. However, in only 61% of the pharmacies, they are allowed to make generic substitution for prescribed medicines. Considering CPD activities, the pharmacist accept the concept of CPD and collect credits by attending educational activities related to their professional practice. For these activities they are supported by the pharmacy manager, however, financial support by the manager is fully or partially provided in only 60% of the pharmacies. App. 42% of the pharmacies declared that their pharmacists prepare annual portfolio for their own continuing education and professional development. App. 88% of the pharmacies declared that newly-employed pharmacists spend a defined time before working independently and the training period is individualized and based on an ongoing assessment of their needs. Pharmacists are trainers of pharmacy students and residents in app. 60% of the pharmacies and they are reimbursed for this activity by the PCoM and faculties, but in only 17% of the pharmacies they have reduced workload on account of the training activities. The pharmacy managers provide formal teamwork training to the staff that incorporates elements of information sharing, conflict management, communication and clarification of team roles and tasks in app. 70% of the community pharmacies. (For more detailed inspection into the survey results for the Section IV see Annex 1). The section V uses system indicators to assess standards of quality assurance, risk and data management (Annex 1). The histogram with component scores presented separately and as the actual score is presented in Fig. 16. The actual score is

36 ,45 10,51 0 Maximum possible score Actual score 1,7 1,24 A B C Fig. 16. Histogram depicting PP and PSs assessment scores for quality assurance, risk and data management in community pharmacies All of the community pharmacies are well supplied with medicines according to the patient needs. However, quality assurance policy is established, implemented and evaluated in accordance with the state provisions for accreditation in only 50% of the community pharmacies, while in app. 65% of the pharmacies, up-to date policies and SOPs to ensure adequate personnel selection, training, supervision, evaluation and reasonable workload levels are established and considered in every day practice. Sufficient personnel to perform tasks adequately 7 h/day are available or partly available in app. 80% of the community pharmacies and the lines of authority and areas of responsibility are clearly defined in all pharmacies. In all of the community pharmacies similarly packed products are stored and positioned in a manner that minimizes the possibility for mix-up, but the products with the narrow therapeutic index are highlighted in only half of the community pharmacies. All community pharmacists make interventions to avoid the errors that may occur during prescribing and dispensing. Also, all pharmacists are instructed to report the medication errors and ADRs occurring in their pharmacy to the NPC, but only 60% of the pharmacies declared that their pharmacists are regularly educated on participating in medication error reduction process. In addition, a non-punitive anonymous medication error reporting system has been fully or partially established in app. 63% of the community pharmacies and there pharmacists involved in serious errors that cause patient harm have professional help and are emotionally supported by their colleagues and manager. When an event involves human error, in 50% of the pharmacies a thorough investigation is undertaken to detect uncover and preexisting factors. Similarly, when/if medication errors reach the patient they are honestly disclosed to patients/relatives in a timely manner. Patients are informed on the complain procedure in only half of the community pharmacies, while the patients satisfaction is fully or partially monitored, evaluated and documented in 56% of the community pharmacies. Engaging outside agency to assist with the quality assurance documentation or to review the quality assurance program is common practice in app. 27% of the community pharmacies. 36

37 The results from the survey about data management within the community pharmacies point out that app. 95% of the community pharmacies in the RoM protect the data obtained from/about the patients/prescriptions in compliance with the provisions of the legislation which arise from the contracts with the HIF. Pharmacists correctly endorse the prescriptions at each dispensing, but in only 69% of the community pharmacists that information is registered in the prescription book and all entries in a chronological order are documented using a system that allow prompt retrieval of each and every prescription dispensed. One can notice that all pharmacies that supply and dispense narcotic drugs (app. 40%) evident these drugs in the controlled drugs register. App. 27% of the community pharmacies evident, fully or partially, dispensed medicines in the patients record and only 2% of the pharmacies obtain written consent from the patients for maintaining their records. In these pharmacies, the patients have access to their records. (For more detailed inspection into the survey results for the Section V see Annex 1). Patient safety Quality assurance and risk management Pharmacy structure and practice Staff availability and qualifications Manufacturing practice Fig. 17. Spidograph depicting PP and PSs assessment scores of the five components The spidograph in Fig. 17 is designed such all five areas are given equal weight with up to 20 as maximum score, independent on the number of questions contributing to the assessment. As previously explained, the questions within each of 5 assessment areas have different weight. The spidograph visualizes the strength and weakness of pharmacy practice of interviewed community pharmacies depicted in one (mean) spidograph thus providing a simplistic visual overview of PP (shaded area), allows for prioritization of interventions and facilitate comparison of results over time. It is obvious that practice and services related to manufacture practice and quality assurance, risk and data management are the areas with priority for intervention to improve the quality of the PP and PC in line with the National Drug Policy and WHO/FIP Guidelines on GPP. A final PP and PSs assessment score was also calculated. This score was based on the score of all indicators as a percentage of the actual score relative to the maximal possible score and for the PP and quality of PSs in the community pharmacy area in the RoM it is out of

38 II. Hospital pharmacy practice and services II.1. Demographic characteristics and management of hospital pharmacies According to the data obtained with the survey, the most of the hospitals where hospital pharmacies are located are state-owned (88.64%) and the rest of th em (11.36%) are investor-owned (profit making institution). There is no hospital (pharmacy) in the RoM which is owned by non-profit making institution or military governed. Approximately 22.73% of the hospital(s) (pharmacies) belong to a group of hospitals with common ownership and/or governance of which 1 hospital (pharmacy) is owned/governed by the hospital group with administration located in the EU-member country (Bulgaria) and 1 by a group with administration located in non EU-member country (Turkey). In addition, one of the hospitals has signed affiliation agreement with a Turkish healthcare group. The rest of the hospital(s) (pharmacies), 70%, are with domestic ownership/governance. Approximately 77.27% of the hospital(s) (pharmacies) are self-governed. Figure 18.Type of the hospital in respect to services offered to inpatients % The categories that best describe the type of the hospital in respect to services offered to inpatients are presented in Figure 18. App. 86% of the pharmacies are central hospital pharmacies located at the clinical and general hospitals. The rest of them are satellite hospital pharmacies located at the university clinics of gynecology and obstetrics, oncology, hematology, pediatrics, abdominal surgery, orthopedics and acute and long-term intensive care. The category that best describes the number of citizens currently served by the hospital (hospital pharmacy) is presented in Fig

39 > , , , , < ,94 5, Figure 19. Number of citizens served by the hospital (hospital pharmacy) Considering the category of patients currently served by the hospital pharmacies, 32.35% of them distribute medicines for in-patients with full hospitalization, only 5.88% dispense medications to outpatients and 61.76% supply, store and distribute/dispense medications for in- and outpatients. Approximately 18.52% of the hospital pharmacies are located in hospital settings with number of inpatient beds up to 100, 22.22% of the hospital pharmacies serve hospitals with in-patient beds, most of them (29.63%) are located in hospitals with in-patient beds, while slightly low number (25.93%) serve hospitals with beds. Only 3.70% are located in large hospitals/university clinical centers serving hospitals with more than beds. The average duration of stay for in-patient per year is fewer than 15 days in 72.73% of the hospitals, in 13.64% it is days and in the same percent of hospitals, the average duration of stay for inpatient per year is from 30 to 60 days. Considering the number of outpatients served by the hospital pharmacies, 52.38% serve fewer than patients, 4.76% from to 5 000, 19.05% from to , to outpatients are served in and by 14.29% of the hospital pharmacies and only 9.52 serve more than outpatients per year. The types of pharmacy services provided on an around-the-clock basis are presented in Fig 20, while availability for providing those services in Fig. 20. One can notice that primarily the pharmacies are focused on acquisition, storage and distribution/dispensing of drugs and medical devices. In 32% of the hospital pharmacies, drug information services are offered followed by clinical pharmacy services in 21%. In only 2 hospital pharmacies, I.V. admixtures are prepared and services in this respect offered, while the percent of hospital pharmacies involved in education and research is even lower (5.9%), mostly in hospital pharmacies located in large clinical and general hospitals in the capital of the state. It is interesting to notice that most of the hospital pharmacies (app. 80%) are opened and available only 8 hours per day with no availability during the weekend (Fig. 21). In addition, only 41.18% of the hospital pharmacies provide 24 hours on call service during the whole week. 39

40 % Fig.20. Types of pharmacy services provided on an around-the-clock basis in hospital pharmacies 8h/day incl. weekends 8h/day exept weekends 12h/day incl weekends 12h/day exept weekends 24h every day incl. weekends 24h every day exept weekends 5,88 5,88 2,94 2,94 2,94 79, % Fig. 21. Availability of the hospital pharmacies for providing services Hospital pharmacy budget for acquisition of drugs per year is lower than 40% of total hospital budget for 55% of the hospital pharmacies. Furthermore, for 25% of the hospital pharmacies it is lower than 30% of the total hospital budget. For only 5% of the hospital pharmacies, over 60% of the budget is available. In addition, overall hospital pharmacy budget of total hospital budget per year is lower than 50% for app. 73% of the hospital pharmacies. For the rest of the hospital pharmacies, it is between 50 and 70%. All 40

41 the responders declared that part of the overall hospital pharmacy budget was not regularly allocated for improvement of pharmacy structure and in this respect for PP and PC services. Considering the staff employed in the hospital pharmacies, the point of interest was the number of fulltime or part-time employed with health specialization (2nd level of study program according to Bologna, see Introduction). The data point that there are 9 in total specialists or residents in clinical pharmacy and 6 specialists or residents in pharmacoinformatics (0.34/pharmacy), 9 specialists in pharmaceutical technology and 1 specialist in drug quality control. There are no pharmacists with specific specialist competences such as the competence in oncology, (par)enteral nutrition, TDM, etc. Full-time employed personnel in the hospital pharmacies include pharmacy technicians 1.68/pharmacy, pharmacists (master in pharmacy degree, 1st and 2 nd integrated level of study according to Bologna) 0.68 /pharmacy, master in pharmacy + health specialist 1.25/pharmacy and cleaning personnel and administrative staff 0.84/pharmacy. Giving information on the drugs and medical devices and their acquisition, storage and distribution are the main tasks assigned to the hospital pharmacists in 55.88% and 82.35% of the hospital pharmacies, respectively. Other tasks include drug preparation and quality control, education and research and administrative work as well (Fig. 22). Considering pharmacy technicians, they are mostly involved in drug preparation and quality control (app %) and drug and medical devices acquisition, storage and distribution (76.19%) (Fig. 23). In some hospital pharmacies, they are involved in drug information and administrative work as well. Fig. 22. Tasks assigned to pharmacists 41

42 Fig. 23. Tasks assigned to pharmacy technicians Considering purchasing of medications and medical devices, the survey showed that there is no group purchasing among the hospital pharmacies in the RoM. In fact, wholesalers are the main source for acquisition of drugs followed by industry (Fig. 24). Only 20.45% of the hospital pharmacies have their own production and only 8.82% of them purchase medicines from other (hospital) pharmacies. group purcharing 0 other pharmacies own production 8,82 20,45 94,12 wholesalers industry 61, Fig. 24. Sources for acquisition of drugs and medical devices The survey also pointed to the management characteristics of the hospital pharmacies in the RoM. The PSs are managed internally in 94.12% of the hospital pharmacies and the pharmacy managers respond to the hospital directors or directors of the clinical centers in app. 94% of the hospital pharmacies. In app. 97% of the hospital pharmacies, the pharmacy manager is qualified pharmacist. 42

43 The pharmacy staff participates in hospital committees (e.g. Pharmacy & Therapeutic Drug Committee, etc.) in 67.86% of the hospitals. Hospital drug formulary is created and used for therapeutic drug management in only 15.91% of the hospital pharmacies, while the other hospital pharmacies use only national list of essential drugs. Hospital drug formulary is updated every year in most of them (85.71%). The hospital formularies are created and implemented with a participation of the hospital pharmacists in app. 43% of the hospitals. Hospital drug formularies usually contain price information (57.14%), information on dosage regimens (42.86%), prescribing information (14.29%), hospital drug use policy (14.29%) and antibiotic prescribing protocols (14.29%). Number of pharmaceuticals in the hospital drug formularies is fewer than 300 in app. 67% of the hospital formularies and in 16,67% it is over Number of chemical entities is lower than 300 in 80% of the formularies. In addition, for therapeutic drug management, own protocols/guidelines based on evidence are used in app. 28% of the hospital pharmacies, app. 43% use national protocols/guidelines, while in the rest of the hospital pharmacies, no protocols or guidelines are used. This response might be related to no participation of the pharmacists in therapeutic drug management. According to the information gathered during the survey, the pharmacists in the hospital pharmacies are in a phase of preparation of SOPs. Up-to-date policies and SOPs established so far and the proportion of hospital pharmacies incorporating these standards are given below (Table 5). Table 5. Up-to-date policies and SOPs established in the hospital pharmacies in the RoM SOPs Hospital pharmacies (%) Compounding sterile products Personnel education, training and competency evaluation Product acquisition, storage and handling Supplies, storage and delivery of final products Use and maintenance of facilities and equipment 25 Appropriate garb and conduct for personnel working in the controlled area Process validation 37.5 Preparation technique Labeling Documentation Drug quality control 25 Personnel access into and near the controlled area 12.5 Movement of materials into and near the controlled area Monitoring environmental conditions in the controlled area 25 Safe use of sterile products once they are distributed out of pharmacy 4.17 Giving drug information 4.17 Considering the capacity for production of pharmaceuticals and their quality control in the hospital pharmacies, representatives of 9 from 31 interviewed hospital pharmacies declared that prepare both sterile and non-sterile pharmaceuticals for use in the hospital. Only 1 of 9 hospital pharmacies sells pharmaceuticals to other hospitals, while no hospital pharmacy prepare pharmaceuticals for intensive care units. All of the hospital pharmacies with capacity for manufacturing practice produce pharmaceuticals for inpatients, 43.75% for outpatients and none of them for homecare patients. Drug quality control and analytical procedures are performed in 44.44% of the pharmacies that prepare pharmaceutical products, while the rest of the pharmacies control their products in accredited 43

44 laboratories outside the pharmacy. In all hospital pharmacies, final pharmaceutical products are analyzed and sterility is tested, chemical content and non-pyrogenicity is tested in 86% of the pharmacies, purity, raw materials and packaging materials are analyzed in 71%, while stability studies are conducted in 57.14% of the hospital pharmacies. More information on the manufacturing practice in the hospital pharmacies can be found in the Annex 2 (Section III). All interviewed hospital pharmacies in the RoM have installed a computer system. However, in 64.52% it is not integrated and/or interfaced with the computer system of the hospital ward. Interfacing with the computer system in the hospital ward was declared in only 3.23% of the hospital pharmacies. In app. 76% of the hospital pharmacies, a pharmacy training program that has been approved by the university/faculty council for training of master of pharmacy students and health specialist residents is provided. The same is the percent of hospital pharmacies that provide residency-training for graduated pharmacists during their licensing period. The training program and final exam are approved and under jurisdiction of the PCoM (see Introduction). Around 67% of the hospi tal pharmacists provide also training program approved by the secondary school council and Ministry of health for pharmacy technicians. In nearly half of the hospital pharmacies, the number of residents usually does not exceed five per year. II.2 Indicators and components included in the PP and PSs assessment tool and scores from the hospital pharmacies in the RoM The first system indicators set out in the section I (Annex 2) are intended to assess PP and quality of PSs offered to ensure patient safety (e.g. scope of data and mechanisms for obtaining information on the patients, level and quality of pharmaceutical care provided as well as counseling and education provided to all in-, out- and homecare patients by the hospital pharmacists). The histogram in Fig. 25 depicts component scores as the actual score compared to the possible maximum score and comparison is also made between the indicators responding to A, B and C, accordingly. Similarly with the data analysis for the community pharmacies, the weight of the indicators responding to D is always 0. The results of the survey point to a very low actual score for this section (7.8 out of 20). It was declared that pharmacists whether in central or satellite hospital pharmacy do not participate or partially participate (22%) in clinician / ward rounds or discuss with the physicians about the patient pharmacotherapy. No information regarding demographics, disease state, allergies, drug history and actual list of prescribed drugs and OTC drugs is available for the pharmacists or stored in electronic records (incl. CPOE) available for the pharmacists. In this respect, there is no activity such as verification by the pharmacist that any patient medication and allergy information is accurately evidenced in the patient record or routine review of medication orders prior to administration of first doses. App. 42% of the pharmacists declared that partially participate in verification of the patient medication record. The pharmacists are not engaged in patient chart and medication use review and/or reconciliation and accordingly they do not document their interventions related to PC activities. This is valid for all type and group of patients. In addition, there is no communication between the pharmacists at the transfer of care. Only 42% of the hospital pharmacists declared that communicate sporadically with the community pharmacists for the individual patient s therapy when the patient discharged from hospital. The responses also point to restricted communication between the patients and the pharmacists. Namely, patient counseling and education for the recommended pharmacotherapy is not routinely 44

45 provided by the pharmacists prior and during the therapy and no pharmacist is skilled to provide counseling and education to patients with special needs (deaf patients, blind patients, etc.). Written information on the drugs, incl. supplementary information important for the outcome of the therapy (nutrition, life-habits, etc.) is not provided in the patient primary language or it is partially provided in app. 19% of the pharmacies. When there is a contact with the patient, the pharmacists politely and clearly answer to all questions. However, as previously said, the contact with the patients is limited and therefore, they or their family members are not encouraged or they are partially encouraged to ask questions about the medications they use. Namely, only 6% and 29% of the interviewed pharmacists declared that apply or partially apply this activity. Although all these activities related to PC and rational pharmacotherapy not applied, almost all of the hospital pharmacies declared that these activities could be applied showing their willingness to increase their knowledge, adopt the PC roles and offer high quality PSs. However, more than half of the interviewed hospital pharmacists point that the structure of the pharmacy does not allow efficacious practice and high quality PSs. (For more detailed inspection into the survey results for the Section I see Annex 2) ,8 5,75 0 Maximum possible score Actual score 0,72 1,53 A B C Fig. 25. Histogram depicting PP and PSs assessment scores for patient safety The system indicators set out in the section II (Annex 2) intended to assess all the activities related to the use of medicines and medication devices such as the ordering communication (e.g. use and availability of prescribing recording system, degree of computerization, etc.) and practice of their purchase, storage, labeling, distribution and administration. In addition, availability and providing up-todate and accurate information on medicines and medication devices to the patients and healthcare givers were also evaluated. The histogram in Fig. 26 depicting component scores as the actual score points to the value out of 20. Less than half of the hospital pharmacies in the RoM (39%) are connected with the NDIC and those which are connected obtain regularly up-to-date and accurate information on medicines and medication devices which are further delivered to the healthcare givers mostly at the hospital units. In only five of the interviewed hospital pharmacies, a designated pharmacist or specialist in drug information is engaged in providing information on medicines and medication devices and only one of the interviewed representatives declares that has easy access to user-friendly, up-to-date computerized information systems while working in his/her respective location. Access to important data bases of biomedical 45

46 literature, life science journals, online books or their printed editions is limited for most of the hospital pharmacies (more than 65%), while protocols or standardized dosing guidelines and/or checklists are not available or they are partly available in 22%. One can say that internationally developed drug information tools (e.g. pocket references, drug information cards, stan dard order sets, checklists, etc.) are not available in most of the hospital pharmacies (available in app. 10%). Pharmacists are (partly) informed about the information technology systems used to assure adequate drug and dosage regimens (in app. 77% of the pharmacies), however, they are not available in most of the hospital pharmacies (more than 90%). Pharmacists are partly involved in the development and implementation of evidencebased drug therapy protocols, hospital drug formularies, guidelines, etc (in app. 29% of the hospitals). However, in app. 65% of the hospitals, no internal risk assessment or ongoing-hospital wide surveillance is made before submitting drug monograph to the Pharmacy & Therapeutics Committee. Only 4 representatives of the hospital pharmacies declare that have a pharmacist responsible for providing upto-date information on medical errors and ADRs and they evaluate his/her activity as partially applied ,54 4,75 2,68 4,11 0 Maximum possible score Actual score A B C Fig. 26. Histogram depicting PP and PSs assessment scores for use of medicines and medication devices As previously said, ordering communication practice was also subject to evaluation. According to the survey, most of the activities in this section are applicable but not applied in more than half of the hospital pharmacies. Only 3 of the hospital pharmacies/pharmacists declared that use CPOE system for order entry and in only 5 hospitals, the medicines/medication devices are ordered from the wards by pharmacists. Verbal or telephone orders are always accepted for oral or parenteral chemotherapeutic agents, incl. chemotherapeutic agents used for non-oncologic indications and they are immediately transcribed and verified in app. 61% of the hospital pharmacies. Also, in most of the hospital pharmacies (app. 77%), the medications are removed from patient unit stock before a pharmacist review the specific patient order because mainly she/he has no access to the medication administration records. Pharmacy interventions regarding potentially harmful medication orders are immediately communicated to the nurses/prescribers in most of the hospital pharmacies (app. 80%). However, pharmacists have no role in off-label drug orders or orders for drugs in atypical doses. The pharmacists involvement in prescribing therapeutic substitution is minor as well as in prescribing of any authorized non-controlled medicine. Only 35% of the pharmacists declared that they are partially authorized to prescribe therapeutic substitution, while authorization for prescribing any licensed medicine, with exception of controlled 46

47 drugs, is partially given to a pharmacist in 16% of the hospital pharmacies. Time for order verification is (partially) consistent and adequate to urgency in 68% of the hospital pharmacies. Pharmacists are actively involved in all medications and medication devices purchasing in all hospital pharmacies and this activity is performed via public tendering procedure. Pharmacy and Therapeutic Committees consisted of one pharmacist at least decide for acquisition of drugs and medication devices in app. 74% of the interviewed hospitals, however, an initial risk assessment to identify the possible difficulties in utilization of medication devices is fully or partially performed in low number of hospitals (app. 20%). In app. 74% of the hospitals, the pharmacists participate in planning of annual budget for acquisition of drugs and medication devices and there they are informed on the budget allocated and the dynamic of expenditure. All drugs in all interviewed pharmacies are stored in a designated area within the hospital pharmacy, however, in only 32% of the hospital pharmacies, the areas are sufficient to ensure proper sanitation, temperature, light, ventilation, moisture control and segregation. App. 80% of the hospital pharmacies declared that the areas for storing alcohol and flammables do not comply fully with the code requirements for storage of volatiles, while 16% declared that they have no separate storage areas for volatiles. In addition, solutions, drugs, supplies and equipment used to prepare or administer sterile products are stored fully in accordance with the manufacturer or Pharmacopoeia requirements in only 48% of the pharmacies. Temperatures in refrigerators and freezers used to store ingredients and finished sterile preparations are fully or partially monitored and documented daily in all of the pharmacies that prepare these pharmaceuticals, however, electronic systems that document temperature ranges and provide immediate problem notification are not used for refrigerators that store critical, temperature-sensitive medications. In addition, SOP for how to handle any breach has not been developed in most of the hospital pharmacies (app. 90%). Also, for more than 90% of the pharmacies, no automatic storage or distribution devices are available. Pharmacy and/or ward stocks are reviewed at least annually to determine low usage in almost all of the hospital pharmacies (in 35% they are reviewed rarely) and similarly, the drugs stocked in wards are carefully selected by considering the needs of each patient care ward. Unit stock is reviewed every day in 58% of the hospital pharmacies, while in 42% of them, this activity is applied rarely. Drugs stocked in wards are available or partially available in the least number of doses, concentrations and forms that meet essential patient needs between replenishment (not exceeding 72 h) in more than 90% of the hospital pharmacies. The packages and labels of new drugs are examined before use and compared to other products to identify any potential for confusion in most of the hospital pharmacies (app. 80%), although auxiliary warning or specific labels are not extensively used to minimize the confusion (if identified). They are partially used in app. 42% of the pharmacies. Bulk chemicals, large-volume bags and bottles of irrigation solutions, organ storage solutions and sterile water are adequately stored and labeled in average 70% of the pharmacies. However, medication containers taken to the bedside are not adequately labeled in most of the hospitals. Only 22% declared adequate labeling. Unit oral doses remain in the original packaging up to the point of actual drug administration at the bedside for checking for compliance with the MAR in half of the hospital pharmacies. Only one pharmacy declared dispensing oral liquid medications in ready-to-use patient specific doses, especially for pediatric patients, while 16% declared the same for parenteral medications. Similarly, doses that require less than a full dosage unit are not repacked by the pharmacy into unit-dose package in more than 77% of the hospital pharmacies and there is no central hospital pharmacy that has a unit-dose or 47

48 robotic packaging/distribution system. Vials of concentrated electrolytes are distributed to authorized patient care units in only 48% of the hospital pharmacies. Barcode readers are not used before drug administration in all of the hospitals and error-reduction strategies, incl. calculation of dosage regimens based on TDM data and double check, have not been established for high-alert and NTI drugs in more than half of the hospitals. For example, more than 70% of the hospital pharmacies do not regularly calculate dosage regimens of NTI drugs, administration rates when using i.v. administration devices are (partially) calculated in less than 68% of the pharmacies, while double check when calculations are necessary is a standard practice in less than 20% of the hospital pharmacies. One can say that there is no practice to validate mathematical skills of the pharmacists responsible for calculations. Considering administration devices, specially designed oral syringes for administering oral/enteral liquid medicines are not available in more than 74% of the hospital pharmacies. In addition, electronic infusion control devices and smart pumps are almost not utilized in drug administration. Enteral feeding catheters that cannot connect with i.v. or other parenteral lines are used in app. 74% of the hospital pharmacies. Self-administration of drugs by patients is permitted only when specifically authorized by the treating or ordering physician in 68% of the pharmacies, while in app. 45% of the pharmacies, the patients are routinely provided with all necessary medications when discharged from hospital. (For more detailed inspection into the s urvey results for the Section II see Annex 2). The system indicators set out in the section III (Annex 2) assess manufacturing practice, incl. production of both sterile and non-sterile medicines and their quality control. The histogram in Fig. 27 depicts component scores as the actual score which is vs. maximum possible score of 20. It must be emphasized that the actual score in this section is based on the responses obtained from 9 hospital pharmacies in which the production of pharmaceuticals (bot h sterile and non-sterile) was declared and where for production of sterile pharmaceuticals, glass bottle production lines are used. Only 3 of the hospital pharmacies declared production of sterile and non-sterile pharmaceuticals for an individual patient. Pharmaceuticals are mostly produced for use in the hospitals and only one of the hospital pharmacies (pharmacists) declared production for sell to other hospitals. The production of pharmaceuticals complies with the national policy in most of the hospital pharmacies and only 2 of them declared compliance with the EU/FDA GMP. Hazardous medicines (e.g. cytotoxic anticancer drugs) and unit-dose medicines for parenteral administration are prepared in biological safety cabinets in app. 43% of the hospitals, but the chemotherapy doses are not prepared under supervision of pharmacist or in a pharmacy department. It is worth to mention that during the survey, a pharmacist was employed for the first time at the University Clinic of Radiotherapy and Oncology in Skopje for performing PP and providing PSs. Up-to-date policies and procedures for compounding sterile products are established and available to the personnel in app. 70% of the interviewed hospital pharmacies producing sterile pharmaceuticals and there, generally, master work and preparation sheets are developed for a batch of each discrete identity and concentration of sterile product and verified by a responsible pharmacist. 48

49 ,23 8,61 0 Maximum possible score Actual score 0,04 A B C 3,58 Fig. 27. Histogram depicting PP and PSs assessment scores for manufacturing practice The responsible pharmacist verifies that the product was compounded accurately with the correct ingredients, quantity of each ingredient, containers and reservoirs in all of the hospital pharmacies producing both sterile and non-sterile pharmaceuticals. Analytical procedures to control the quality of the raw materials and pharmaceutical products are regularly performed in 5 of the hospital pharmacies producing pharmaceuticals. For the rest of them, the quality of pharmaceuticals is controlled in accredited laboratories outside the pharmacy (contract service). Quality control includes stability studies of the formulation (chemical, physical), sterility tests, non -pyrogenicity testing, analysis of chemical content, purity analysis of raw materials and analysis of the final pharmaceutical product. The final sterile products are inspected when prepared in all of the hospital pharmacies. However, in only one of them the final sterile products are inspected when dispensed. Complete documentation for sterile products consisted of master work sheet, preparation and sterilization records, quarantine records, endproduct evaluation and testing results, training and competency evaluation, refrigerator and freezer temperatures, certification of laminar-airflow workbenches is prepared in app. 67% of the corresponding hospital pharmacies. The pharmacists do not participate in clinical studies and therefore they do not prepare medicines for clinical studies. (For more detailed inspection into the survey results for the Section II see Annex 2). The section IV uses system indicators to assess workflow and staff availability and qualifications (Annex 2). The histogram in Fig. 28 presents component scores as the actual score which is out of 20 (maximum possible score). Indicators assessing environment for PP and PSs point to adequate, clean and illuminated space for reviewing medication orders and storing and dispensing of medicines, free of clutter, distractions, interruptions and noise, which enables efficacious performance of these pharmacy activities in app. 39% of the hospital pharmacies. App. 54% of the hospital pharmacists are partly satisfied with the room for performing these activities. In conjunction with the previous finding, only small percent of hospital pharmacies ( less than 10%) have adequate space for manufacturing practice. It is very important to emphasize that in only 3% of the pharmacies, the pharmacists and pharmacy technicians employed are sufficient to perform every-day tasks 24 hours. Moreover, the rest of the hospital pharmacists declare that there are no essential preconditions for employing more staff. To remind, app. 89% of the hospital 49

50 pharmacies are state-owned and in 39% of the hospitals with in-patient beds there is no hospital pharmacist employed. The personnel work 8 hours/day with 30-min break in almost all of the hospital pharmacies, however, an effective back-up plan for days when staffing is short is established in only 22% of the hospital pharmacies. App. 26% of the pharmacists declared that the pharmacy s back-up plan is partially effective. Pharmacy students/residents are partially trained (less than 8 h/day) in app. 38% of the pharmacies, but their role in every-day activities in the pharmacy is insignificant and in addition, they cannot be included in the back-up plan ,53 6,65 2,29 3,59 0 Maximum possible score Actual score A B C Fig. 28. Histogram depicting PP and PSs assessment scores for environment, workflow and staff availability and qualifications Pharmacists control all drug-related logistics in 48% of the hospital pharmacies. Considering their competencies, a dedicated pharmacist offers drug information services in 35% of the hospital pharmacies, clinical pharmacy services in 16% of the hospital pharmacies, in 26% of the hospital pharmacies, information on the evidence and pharmacoeconomic issues for each drug is provided, specialists in pharmaceutical technology are employed in all, while specialist in drug quality control are employed in approximately half of the hospital pharmacies manufacturing sterile and/or non-sterile pharmaceuticals. Pharmacists are encouraged to extent their knowledge in the field of pharmacy management in only 22% of the hospital pharmacies and they are not stimulated or motivated at all to complete postgraduate studies in specific clinical areas, such as the oncology, pediatrics, etc. or in prescribing medications. Pharmacists participate in hospital multi-disciplinary committees as full voting members in app. 22% of the hospital pharmacies. However, they do not participate in ethical and review committees for clinical studies. All newly-employed pharmacists spend a defined time before working independently and the training period is individualized and based on an ongoing assessment of their needs in app. 30% of the hospital pharmacies. In average 35% of the pharmacies, this activity is partially applied. During this training period, pharmacists spend full-time in patient care areas in only 13% of the hospital pharmacies, while in app. 22% of the pharmacies they spend part-time. Pharmacists are trainers of pharmacy students and residents in app. 80% of the pharmacies, they are reimbursed for this activity by the PCoM and faculties, but their workload is generally not reduced in account for the training activities. Only 19% declared that their workload is reduced. All pharmacists working in the hospital pharmacies are licensed by the PCoM 50

51 and they are all subject to relicensing. They collect credits by attending various types of educational activities related to their professional practice. However, for these activities they are not financially supported by the hospital management. Only 19% declared that they are partially supported. Furthermore, the pharmacy managers generally do not provide formal teamwork training to the staff that incorporates elements of information sharing, conflict management, communication and clarification of team roles and tasks. (For more detailed inspection into the survey results for the Section II see Annex 2). The section V uses system indicators to assess standards of quality assurance and risk management (Annex 2). The histogram with component scores presented separately and as the actual score is presented in Fig. 29. The actual score is Quality assurance policy is fully or partially established, implemented and evaluated in accordance with the state provisions for accreditation in app 42% of the hospital pharmacies, while in app. 77% of the hospital pharmacies, SOPs are established and considered in every day practice. Policies and procedures that ensure adequate personnel selection, training, supervision and evaluation have been fully or partially developed in only 23% of the hospital pharmacies. In less than 50% of them there are policies and procedures that ensure reasonable workload levels and working hours. Sufficient personnel to perform tasks adequately 8 h/day are available or partly available in app. 80% of the hospital pharmacies and the lines of authority and areas of responsibility are clearly defined. Safety plans have been established also in around 77% of the hospital pharmacies, while multidisciplinary teams for risk management or quality assurance in not more than 40% of them. However, hospital plans for the implementation of new medication safety technologies have not been established yet. In addition, 32% of the pharmacists declared that they are partly educated about the advantages of technology and/or evidence-based practices that have been implemented in other organization to improve medication safety ,29 6,44 2,2 2,65 0 Maximum possible score Actual score A B C Fig. 29. Histogram depicting PP and PSs assessment scores for quality assurance and risk management One can say that there is no a designated pharmacist in the hospital pharmacies responsible for detection of medication errors, regular review of the medication error tracking form, report of summary data, oversee analysis of their causes and coordination of effective error-reduction plan. Only 3.23% declared oppositely. Multidisciplinary teams for formulating medication safety polices have been fully 51

52 established in 26% of hospitals, while in 12.9%, they are partially established. The same number declared partial establishment of formal drug use evaluation program integrated and coordinated within the overall hospital quality improvement program. App 80% of the hospital pharmacists declared that medication errors are not monitored, tracked and evaluated on a routine basis. Pharmacists are instructed to report the medication errors and ADRs occurring in their hospitals to the NPC, but they are not regularly educated on participating in medication error reduction process. It is worth to mention here that another survey conducted in 2011 showed that there is no report on medication error or ADR that had been submitted by a pharmacist to the NPC, whether community or hospital one 65. In addition, medication error tracking forms have not been created and used for tracing, collection and systematic categorization of data on medication errors in most of the hospital pharmacies (more than 90%). A nonpunitive anonymous medication error reporting system has been completely or partly established in around 30% of the hospital pharmacies and in the same number of pharmacies, the pharmacists thoroughly evaluate medication errors in an open, non-punitive manner. In these pharmacies, the pharmacists involved in serious errors that cause patient harm have professional help and are emotionally supported by their colleagues and manager. However, hospital/pharmacy manager does not reward individuals who report medication errors and ADRs and when an event involves human error, a thorough investigation is not undertaken to detect uncover and preexisting factors, or it is partially undertaken in only 10% of the hospital pharmacies. Thus, the majority of the hospitals or hospital pharmacies (app. 90%) do not or better to say cannot determine where the majority of serious medication errors occur and identify the priorities for intervention to prevent medication errors. If particular medication classes are associated with the majority of medication errors, app. 10% of the hospitals/hospital pharmacies consider implementation of protocols or practice guidelines for the use of those medications. In addition, (computer) markers or triggers for selected drug orders are generally not used to enhance detection of potential ADEs (medication errors and ADRs). (For more detailed inspection into the survey results for the Section II see Annex 2). Fig. 30. Spidograph depicting PP and PSs assessment scores of the five components 52

53 To summarize the complete data from the hospital pharmacy questionnaire, the spidograph in Fig. 30 was designed such all five areas were given equal weight with up to 20 as maximum score, independent on the number of questions contributing to the assessment. As previously explained, the questions within each of 5 assessment areas have different weight. The spidograph visualizes the strength and weakness of pharmacy practice of interviewed hospital pharmacies depicted in one (mean) spidograph thus providing a simplistic visual overview of PP (shaded area), allows for prioritization of interventions and facilitate comparison of results over time. It is obvious that practice and services related to providing patient safety is an area with priority for intervention to improve the quality of the PP and PC in line with the National Drug Policy and WHO/FIP Guidelines on GPP. A final PP and PSs assessment score was also calculated. This score was based on the score of all indicators as a percentage of the actual score relative to the maximal possible score and for the PP and quality of PSs in the hospital pharmacy area in the RoM it is out of

54 Discussion and recommendation for improvement of PP and services Legal framework In the RoM there is no single legislative act for pharmacy practice and services and they are regulated in several documents (e.g. rule books, guidelines, etc.), laws and bylaws 66. One of the most important is the Law on Health Protection 19 (HPL). This Law is relatively new and offers provisions in reference to establishment of the healthcare system and services. The Law is currently being implemented and bylaws have been enacted. The Law offers to some extent a slight improvement in definition of the pharmacy activities, which are broadened and it addresses the entire field of operation of the pharmacists, as it is required by the FIP/WHO Guideline on GPP. It contains also a new and expanded definition of a pharmacy as a healthcare institution defining it as an institution for pharmaceutical health care, with emphasis on supply, storage, dispensing, testing and controlling medicines, sanitary materials and drug substances, preparation of magisterial drugs, counseling on the use of the dispensed medicines, dispensing remedies for pediatric use, dietetic nutrition, orthopedic devices and medical instruments. However, there is no strict definition in the Law related to the GPP. There is a document titled Instruction on the principles of the GPP issued in based on the WHO/FIP Guideline from This document is very obscure giving just the direction that national standards should be established and therefore, not useful for the community and hospital pharmacists. Updated version should be prepared incorporating principles set in the new WHO/FIP Guideline. Other Law regulating pharmacy profession is the Law on Medicines and Medical Devices 11 (LMMD) (updated version in 2011), which regulates the medicines and medical devices for human use, their production, quality control, efficacy and safety requirements, marketing authorization, pricing and post marketing surveillance, including pharmacovigilance. This Law also recognizes the necessity for issuing updated version of the Instruction for GPP. Based on this Law, a Rule Book for dispensing prescription medicines only was issued 67 that regulates the prescription form and dispensing practices. The Law on Health Insurance 9 (HIL) (updated in 2010) regulates health insurance, and rights and responsibilities of the citizens in this respect. According to this Law, in the scope of the basic services covered by the HIF is supply of medicines from the positive list created by the HIF, approved by the Minister of Health and the Government. Based on this Law, Rule Book for the content, rights and obligations for obligatory health insurance is issued regulating also the use of medicines 68 (updated version in 2012). Key national bodies Key national institutions concerning pharmacy practice (regulating and implementing provisions) are Ministry of Health (MoH)/ Drug Bureau (DB), Health Insurance Fund (HIF), Pharmaceutical Chamber of Macedonia (PCoM) and Macedonian Association of Pharmacists (MAP). The Ministry of Health (MoH), with its divisions for primary, secondary and tertiary health care and the Drug Bureau (DB) as a legal organ of the Ministry, is a creator of legislative concerning pharmaceutical sector. The DB monitors the medicines supply, production, distribution and marketing, provides marketing authorizations and issues licenses for production and trade of medicines, auxiliary medicines, medical devices, narcotic and toxic chemicals. It is also authorized for setting criteria for establishing pharmacy and in this respect, issuing licenses for opening pharmacies. In addition, the DB is involved in 54

55 preparing laws and bylaws, prepares information and analyses, reports and opinions for the status of the medicines supply in the RoM. Authorized for providing obligatory health insurance is the Health Insurance Fund (HIF), established by the Law on Health Insurance 9 (LHI). It is a creator of the lists of drugs which are paid or co-paid by the HIF and prescription only medicines (PoMs), and list of medicines that can be re-packed. The HIF is the only institution purchaser of health services on behalf of the insured persons and, depending on the need for healthcare services and the allocated funds for that purpose in the budget of the Fund, it signs or terminates contracts with healthcare institutions, including pharmacies As a professional association, the PCoM is responsible for protecting the interests of the pharmacy profession/pharmacists; strengthening the role of the pharmacists in all aspects of the heath care system; regulating the ethical aspects of the pharmacy profession; protection and promotion of the pharmacists competences. The obligation and responsibility for facilitating and monitoring the professional training (internship) for graduate pharmacists in licensing process, assuring the continuing education and licensing and re-licensing processes in the manner of professional development are delegated to PCoM by the MoH in In addition, professional audit on health institutions and health care service delivery is delegated to the Health Chambers and in this respect, the professional audit of the pharmacy practice in both, community and hospital pharmacies is delegated to the PCoM 20. Continuing education and professional development as well as application of modern scientific and expert achievements in pharmacy practice are the main objectives and tasks of the Macedonian Association of Pharmacists (MAP) which, as a professional association of pharmacists in the RoM, is actively involved in organizing educational and scientific events, conventions and congresses which are rated in the CE system. Location and number of pharmacies (geographic and demographic criteria) The average number of community pharmacies in the RoM is 3,5 per citizens, while 2,8 community pharmacies are distributed in the area of 100 m 2. The market has been much liberalized so far, concentrating the community pharmacies mostly in (the centers of) the cities, with unbalanced access to medicinal products for the patients living in suburban and rural areas. There is still no legislation containing the geographic and demographic criteria for establishing community pharmacies in the RoM. There are general directions in the new LHP 20, but the Rule Book with specific criteria is expected to be issued by the end of the year. The hospital pharmacies are part of the hospitals, mostly general medical/surgical hospitals located in the cities. It is worth to mention that there are more and more requests from the citizens living in rural areas (published in daily press) for opening community pharmacies in their respective locations. As a respond, the new document Regulation for Network of Health Institutions 15 was issued in the first half of this year and it intends to regulate the unbalanced distribution of the community and hospital(s) pharmacies in the country, ensuring equal access to medicinal products for all patients throughout the country. Ownership (limitation of ownership to pharmacists, limits to the ownership of multiple pharmacies i.e. pharmacy chains) There are not strict ownership criteria for the community pharmacies. The health system in the RoM is completely liberalized allowing existence of independent community pharmacies owned by one or more pharmacists. There are also pharmacy chains, with no limitation in number of pharmacies in the chain as 55

56 in other EU countries (e.g. Hungary ) 69. They are not obligatory owned by pharmacists, however, a responsible pharmacist is employed for PP and providing pharmaceutical services. The responsible pharmacist (who can only be responsible for one pharmacy) must be satisfied that the operation of the pharmacy will be safe, taking into account the standard operating procedures, staffing levels on the day and any other relevant circumstances. Regulations/restrictions of ownership do not seem to have any (positive or negative) impact on access, instead they potentially lead to more efficient markets which improves vertical equity and better access by having space capacity. All of the community pharmacies are private-owned, while most of the hospital pharmacies are within the hospitals which are state-owned, with exception of four hospitals that are investor-owned (profit making institution). There are only two hospitals (pharmacies) that are owned/ governed by the hospital groups with administration located in EU member-country (Bulgaria) and in non -EU member-country (Turkey). Criteria for establishing pharmacy (room, equipment, staff) General criteria for establishing pharmacies are given in the Law on Medicines and Medical Devices 11 and Law on Health Protection 19. There are very few articles for community pharmacies stipulating that the medicines will be retailed in pharmacies, that the retailing shall mean supply, storage, keeping and dispensing of medicines and that a pharmacy shall be a legal entity that shall be established and operate in accordance with the Law. The LMMD, HPL and the Rule Book require the pharmacies to fulfill appropriate conditions in respect to pharmacy area 70, not less than 16m 2 dispensary and 10m 2 for the other rooms (e.g. storage area, sanitary area, etc.). All of the community pharmacies fulfill these criteria and they usually have up to 45m 2 of pharmacy floor, which is sufficient and actually used for supply, storage and dispensing medicines. In most of the pharmacies, the patients are advised by the pharmacists in the dispensing/waiting area (in some of them, there is still a glass barrier between the patient and the pharmacist) and there is no area for confidential discussion. The new Rule Book containing criteria for establishing health institutions in respect to room, equipment and staff was recently prepared and it is available for public hearing 71. The area for confidential discussion is not mentioned (even as optional) in the proposed Rule Book and during the public hearing it was recommended by the experts from the FF-UKIM, provision for this area to be included in the corresponding Rule Book. OTC area is also clearly identifiable in most of the community pharmacies; however, it is rarely accessible to the patients, which should be considered for improvement. The space for preparation and quality control of the medicines prepared in the community pharmacy as optional is strictly defined (e.g. storage area for containers 15m 2 at least, room for preparation of contact containers 8m 2 at least, room for preparation of magisterial drugs 15m 2 at least, room for water distillation 6m 2, storage are for final preparations, 12m 2, etc.); however, not many community pharmacies have space for production of medicinal products and their quality control. Considering the hospital pharmacies, the Rule Book 70 stipulates that hospital pharmacy, organized for supplying medicines and sanitary materials, has to have dispensary and storage area at least 25m 2 each, laboratory for preparation of magisterial medicines for the hospital divisions of 20m 2 at least and sanitary area as well. Area for medicines repackaging is not predicted and in all of the pharmacies, medicines are not repacked (even oral medicines) and bulk containers are dispensed to the wards from the central and/or satellite hospital pharmacy. The hospital pharmacy which prepares i.v. solutions and other sterile medicinal products has to have a laboratory with the following areas: washing area for containers, room for water distillation, sterilization area, area for macroscopic control and labeling, room for preparation of medicines, room for storage of final medicines and laboratory for medicine 56

57 quality control (20m 2 at least). These criteria are not related to the size and type of the hospital and the volume of production. In accordance with this Rule Book, the total area of a hospital pharmacy preparing sterile medicinal products has to be 100m 2 at least. All of the hospital pharmacies fulfill the requirements for space, but less than 1/3 of them have the capacity for production of medicinal products and their quality control and all of them are central pharmacies. Area for production and quality control is hardly sufficient for the volume of production in all of them, while the production itself does not comply with the EU/FDA GMP principles 72,73. In other hospitals, where no medicines are produced, injectable medicines are commonly prepared in or near patient care areas, not using laminar airflow hood, and the same is with the hazardous medicines. Specialized biological safety cabinets for cytotoxic drugs are located in chemotherapy rooms and they are prepared without supervision and order review of the pharmacist. In addition, there are no safe practices for parenteral nutrition formulations and no separate rooms for their preparation. According to the HPL 20, all community pharmacies have an appropriate number of employees with higher education in the area of pharmacy (at least 1) and with secondary education in the area of pharmacy (at least 1). With respect to the possibility for staff without a university degree in the area of pharmacy to dispense drugs, the LMMD changed in allows pharmacists with high education and a working license not to be obligatory present in the pharmacy during the opening hours. Thereby, the pharmaceutical technicians are also allowed to dispense all types of medicinal products independently and without supervision from a pharmacist with a working license. This provision intended to solve the problem with the lack of pharmacists. Namely, the pharmacists with a university degree do not want to work in community pharmacies due to low salaries and high workload. In addition, the pharmacies are mostly seen as a part of the commercial sector, rather than part of a health care sector. This provision is valid until 2017 when the completion of the pharmaceutical team is expected. So, at the moment, the pharmacy technicians are much involved in drug dispensing, patient counseling and giving information on drugs (Annex I). Community pharmacists comprise up to app. 65% of the work force and they are the largest sector employing pharmacists. Daily tasks undertaken by the community pharmacists usually include: clinical scrutiny of prescriptions, oversight of safe dispensing processes, providing patients with advice about medicines and treatments, provision of public health information (if required) to patients and customers, and promotion of wellness, assessment and treatment for minor ailments, professional oversight of the sales of OTC medicines and eventually, liaison with other healthcare professionals. Therefore, at the moment, the pharmacists do not have support staff in their shift to ensure that their extended role can be achieved. As with all independent sector providers in the national health system, community pharmacies have their own opportunities and risks. Many of the opportunities could result from visionary pharmacists who are willing to extend their skills, developing strong and effective working relationships with the GPs and nurses, and improve the standard of their premises. It is a moment, the community pharmacists to move from business model that relies predominantly on dispensing services to one that is increasingly reliant on providing clinical and screening services, especially to people who are starting out on a new course of treatment for long-term conditions. The situation in the hospital pharmacies is relatively different. The hospital pharmacies comprise up to 5% of the work force and it is a sector that requires employment of more pharmacists, especially with specialist competences. There is no standard operational communication between the hospital pharmacists, health practitioners, community pharmacists and the patients, and no access to the medication administration records as well. The hospital pharmacists working in central or satellite pharmacies are responsible for drug acquisition and distribution to the drug administrators, but only in 57

58 hospitals employing pharmacists where pharmacy technicians operate under supervision of the pharmacists only. According to the survey data, 0,68 high-educated pharmacists per hospital pharmacy are employed (Annex II), and in some hospitals where no pharmacist is employed, for acquisition, storage and distribution of the medicines, medical technicians are in-charge. It is strongly recommended this status to be changed by employing one pharmacist at least. In addition, not many hospitals employ pharmacists with specialist (e.g. for pharmaceutical care, drug manufacturing and quality control, et c) and specific competences (e.g. for therapeutic drug monitoring, pharmacoeconomy, intensive care, clinical studies, oncology, etc.) and/or they do not support financially continuing education of the pharmacists in these fields. One of the reasons for not employing is the lack of pharmacists with specialist and specific (subspecialist) competences and a positive signal that this problem could be solved is the call from the Government for creating modern health specialist programs for both community and hospital pharmacists and its willingness to help financing the pharmacists applying for the programs that offer education in required (sub) specialist fields. It is expected benefits from these programs, especially important for the hospital pharmacy services, to be visible after four years at least (for detailed information refer to the section Workforce framework). Considering the equipment, the community pharmacies are equipped with essential equipment necessary for establishing pharmacy i.e. for supplying, storage and dispensing of medicines (e.g. computerized system connected with the HIF, bar-code scanner for reading the medicinal products and prescriptions, refrigerator). However, the computerized system is not used for generating patient medication profiles, to alert for overdose, serious drug interactions, (cross)allergies, contraindications, etc. The computer system is connected with the NDIC, however, there is no access to the important data bases of biomedical literature useful for rational pharmacotherapy and providing PC services. Automated devices are not used for storage, distribution and dispensing, there is no dispensing system with printer producing legible and durable labels, etc. It is obviously that advanced technologies should be introduced in the pharmacy practice not only for effective drug supply and dispensing but also for providing services related to the pharmacy care and health assessments. It is advantageous that the electronic health card was recently introduced in the health care system, by which one of the essential prerequisites for providing pharmaceutical care, especially at transfer of care, is fulfilled. Considering the hospital pharmacies, the actual situation in respect to the necessary equipment is the same. There is no computer prescribing order entry (CPOE) system with a pharmacy interface in any of the hospital pharmacies, no access to the patient data at all, no communication with other health care workers except by phone (mostly for urgent ordering of medicines), com puter software with screening capabilities to detect drug allergies, drug interactions, therapeutic duplication and inappropriate dosing alone or as a part of the CPOE is unavailable in any of the pharmacies. In addition, there is no computerization of patient information (e.g. diagnosis, laboratory parameters, etc.) or interface between the hospital mainframe computer and the pharmacy computer system. So, no pharmacy services, especially those associated with morbidity and mortality rates could be provided (e.g. drug use evaluation, ADRs management, drug protocol management, drug admission histories, etc). Considering medication administration, no bar-coding technology is used for patent identification at bedside, advanced administration technologies, such as the smart pumps-infusion devices for i.v. medicines are not implemented and to prevent wrong-route errors, oral syringes are not always available instead of i.v. for oral medications, etc. In this way, medication errors are more difficult for preventing, monitoring and documenting. Alarm systems are not used to secure the storage areas and in most of the hospital pharmacies, refrigerators are not equipped properly with locks and alarms (same is in community pharmacies). 58

59 Automated medicine storage and distribution devices in patient care areas are not used as well as automated prescription-filling systems. Considering the opening hours of the hospital pharmacies (see below!), the use of this devices could be particularly helpful in urgent case situations and for audit of controlled substances. The use of unit dose drug distribution systems should be also considered, especially in emergency departments, considering the positive influence of this type of distribution systems (e.g. improved pharmacy control of medicine use, automated restocking, improved security and labeling, saved time for the pharmacist without compromising patient safety, etc.). Considering the equipment necessary for the preparation of medicines in hospital settings, automatic packaging systems are not used, even in large hospitals, repacked doses (if repacked!) are labeled manually not by bar codes or other machine-readable coding. Laminar airflow hoods for preparation of sterile medicines are not available and they are prepared in or near patient care areas. The same is the situation with the safety cabinets for preparation of sterile and hazardous drugs, which are available in small number of hospital pharmacies. In addition, CPOE system is required not only for expediting the transmittal of medication orders, enhancing efficiency of the dispensing, reducing prescribing and administration error rates, time from ordering until administration, but also by incorporating of chemotherapy protocols to reduce the risk for chemotherapy prescribing errors. In most large central hospital pharmacies, i.v. solutions are not prepared and in those involved in production, the production lines have to be modernized. No hospital pharmacy has capacity to prepare and sell i.v. solutions to other hospitals in the RoM, which could be a serious problem in medicines shortage. This situation described above calls for urgent and large investments in the structure of the community and hospital pharmacy settings, both public- and private-owned. Opening hours Pharmacies have the obligation to inform local governance, health authorities and patients for the opening hours deciding on behalf of the needs of their community, and they have to be consistent with them. It is the decision of the owner and in almost all cases it is market/ business-driven. It is evident that there are not mechanisms by the authorities (i.e. duties on a rota basis) to guarantee access to medicinal products, as it is the decision of the owner not to work night shifts or on-call services. There are lot complaints from the patients/customers regarding this issue. Considering hospital pharmacies, most of them, even central hospital pharmacies, are not open in the second and night shift and during the weekends, which restricts access to the medicines. Therefore, availability of the 24-hour pharmacy services and mechanisms for providing dispensing and preparation services when the pharmacy is closed should be provided, especially in large hospitals, or a mechanism for retrospective review of new medication orders while the pharmacy is closed should be introduced. Twenty-four hour pharmacy services should be employed in all hospitals with clinical programs that require intensive medication therapy (e.g., transplant programs, open-heart surgery programs, neonatal intensive care units, and trauma centers). When 24-hour pharmacy services are not feasible, a pharmacist should be available on an on-call basis. Remote medication order processing may be employed (permitted by law and regulation) but not as a substitute for an on-call pharmacist. Automated drug dispensing equipment and computer databases could help, but they are not a substitute for a pharmacist and should not be considered as alternatives to 24-hour pharmacy services. In the absence of 24-hour pharmacy services, access to a limited and determined supply of medications, properly monitored and documented, should only be available to authorized, licensed health care professionals for use in carrying out urgent medication orders. Access to medications should be limited 59

60 to cases in which the clinical benefit for the medication outweighs the potential risks of making the medication accessible. Policies and procedures for access to medications by (non)pharmacists should be developed. Economic framework Pricing and remuneration regulation Total health expenditure in the RoM as a percentage of GDP amounted from 6.8% in 2002 to 6.9% in 2009, which is significantly lower figure than that of the most of the other EU countries. The expenditure for investment in the health sector should increase considering that actual 0.7% is insufficient for sustained and qualitative health-care services 7. In the LMMD 11, medicines are classified according to the place and manner of dispensing as: (i) medicines dispensed with a prescription only (PoMs), (ii) medicines dispensed without a prescription (NPoMs) and (iii) medicines dispensed in a healthcare institution only. The prices of the PoMs are strictly regulated 23, while it is not the case for the prices of NPoMs. The prices of the medicines dispensed only in health institutions are subject to public tendering. Pursuant to this Law, the Rule Book on the method of dispensation of prescription medicines 67 was enacted. This Rule Book regulates the method of prescribing and dispensing of medicines. It is strictly forbidden to dispense PoMs without a prescription in pharmacies. Individual community pharmacy income varies according to the mix of NPoMs business and the volume of prescriptions dispensed. The average pharmacy (excluding very large high street pharmacies and supermarket pharmacies, as already mentioned do not exist in RoM) earns app. 50% of its income from the HIF. There is no actual price competition in the RoM for the PoMs refunded by the fund in primary care settings and for the medicinal products for hospital needs. The Act titled Methodology for establishing medication prices 24, adopted by the Government in October, 2011, strictly defines the establishment of drug prices, on the basis of comparative study conducted in 12 countries (in the region, EU, including Russia and Turkey). The Law on Health Insurance 9 (up-date 2000) incorporates medicines in the list of basic services covered by the HIF, in accordance with the list of medicines which is determined by a general Act enacted by the HIF and agreed by the Minister of Health/Government of the RoM. The HIF is a purchaser of health services on behalf of the insured persons and, depending on the need for healthcare services and the allocated funds for that purpose in the budget of the Fund, it signs or terminates contracts with healthcare institutions, including pharmacies All pharmacies are allowed to sign the contract with the HIF after obtaining the license for established pharmacy by the MoH. Most of the pharmacies in the RoM have signed the contracts with the HIF. The reimbursement of the drugs is on the basis of referent prices 21-23, established for the drugs in the primary care and hospital. At present, the HIF reimburses pharmaceuticals on the positive list (by generic names) taking insufficient account of the pharmacists overhead costs. Currently, the Fund pays to the pharmacies only for the service of supplying and dispensing of medicines and community pharmacists usually offer these services. In limited number of pharmacies, other services are offered (weight measurement, glucose measurement, etc.), in a manner of added value to the pharmacy, and 60

61 they are usually for free or for very low price. According the patient needs, the monthly budget allocated by the HIF is sufficient only for half of the community pharmacies, but in most of the community pharmacies the reimbursed drugs are available every day. The HIF is paying for the medicaments plus fix margin according to the scale based on referent price of the medicine, lower fee for lower referent price, higher fee for higher referent price (lower is 0,2 euro, higher is 3,33 euro). Community pharmacy contractors may not claim additional fees, including fees for extemporaneously dispensing (items manufactured or mixed together in the pharmacy), measuring and fitting hosiery and trusses, and dispensing controlled drugs. Contractors who exceed a specified volume threshold receive an establishment payment. This payment is based on the volume of prescription items submitted by the pharmacy contractor and processed for payment by the HIF for that month. No practice payments are received, such as the contribution for the provision of auxiliary aids for disabled people. Also, there is no annual repeat dispensing payment because this service is not recognized/provided. At the time of writing this paper, the HIF is proposing changes in the Rule Book for determining the monthly budget that the pharmacy can obtain for dispensed prescription medicines. The main criteria for determination of the budget would be the total value of realized volume of prescription. This excludes the criteria for the structure of the pharmacy in the manner of the number of pharmacists and pharmaceutical technicians per pharmacy, which used to be very important criteria so far. The criteria that the budget for the medicines depends on the pharmaceutical team in the pharmacy have had positive impact on employment structure, as pharmacy owners were motivated to employ pharmacists in order to get higher monthly budget, and provide better medicine supply for their patients. In addition, the HIF is proposing an abolishment of monthly budget in a step-by-step process by the end of 2015, which at this moment would mean decreasing of the budget month by month. Public hospital pharmacies operate within an economic environment in which government play a major role directly in the strategic management of health care delivery. Therefore, the hospital pharmacies services are calculated according to the DRG system. Drug budget overspending is a common problem due to the increasing costs for health care in general and constant innovation in the drug sector in particular. Establishing clinical pharmacy services in the hospital pharmacies is of paramount importance having in regard the pharmacists role at this specialty level i.e. providing information in the forecasting of drug budgetary spend and helping to develop strategies to control annual expenditures. Services related to pharmaceutical care are not widely recognized nor provided in both community and hospital pharmacies and much efforts and evidences must be put to change this status and persuade the Government, HIF and the public for health and economic benefits of providing these services. It is recommended a new contractual framework for community and hospital pharmacies to be introduced and besides essential (e.g. dispensing, support for self-care, etc.), advanced (e.g. medicines use review, prescription intervention, reconciliation, etc.) and enhanced (e.g. weight, blood pressure, blood glucose, total cholesterol and triglycerides measurements, smoking cessation, supervised consumption of substitute medication, advice to care homes, immunization, emergency contraception and pregnancy tests, homecare, etc.) services in the framework to be recognized. Even essential services should be amended by additional which are not currently recognized, such as the repeat dispensing, disposal of unwanted medicines, promotion of healthy lifestyles, etc. All these services should be provided under a clinical governance framework including clinical audit and information governance requirements. Written documents describing the scope of pharmacy services should be maintained and considering hospital pharmacies, these services should be consistent with the hospitals scope of services and applied throughout the hospitals in all practice sites. The mission, goals, and scope of services have to be clearly communicated to everyone involved in their provision, including pharmacists, residents, 61

62 students, technicians, and support staff. Details of remuneration for different types of services should be discussed. In addition, pharmacies have not a validated compliant electronic prescription service system. Once this system established, a monthly payment should be received as reimbursement for the spine connectivity service charge. Since the majority of GP practices have been allocated a monthly budget by the HIF, the reimbursement prices of medicines significantly affect prescribing costs within a practice. Community pharmacists are able to offer advice to GP practices on all aspects of the drug tariff, to support the practice to achieve safe and cost effective prescribing policies, but this role is not recognized by the GPs and society in general. The situation described above clearly shows the need for increasing the budget for the medicines and recognition of more pharmacy services and their reimbursement realizing the PCs added value for the society. Pilot (res earch) programs driven by the pharmacists, MAP and the PCoM which would be (financially) supported by the Government (DB) and the HIF may provide such evidences and in the same time educate the critical number of pharmacists/ pharmacies to provide advanced and enhanced services. Additional strategies to reduce the costs of the drugs used in primary, secondary and tertiary care should be developed, whilst ensuring safe and effective prescribing policies, such as the generic switching programmes, effective communication between the general practices and pharmacies, etc. Overall, investments in clinical competencies, pharmacy premises, staff training and qualifications, together with an enhanced IT infrastructure are needed since they all together are firm foundation on which community and hospital pharmacies could mainstay and grow. Workforce framework Pharmacists education and training in the RoM Accredited high educational institutions (HEIs) for pharmaceutical education in the RoM are the Faculty of Pharmacy at the University Ss Cyril and Methodius (FF-UKIM) in Skopje, Department of Pharmacy at the Faculty of Medicine, University Goce Delcev in Stip (DPFM -UGD) and the Department of Pharmacy at the University Tetovo (DPUT) in Tetovo. The number of the s tudents enrolled in the first year is around 110, 70 and 60, accordingly, which is more than sufficient considering the needs of the country for pharmacists in all areas of pharmaceutical activity. Every year, app. 70% succeeds to graduate regularly after five years of study. Criteria for enrolment in the 1st and 2nd level integrated pharmacy study programs include 4-year secondary education (gymnasium or secondary medical school) and state exam. At these HEIs, the students are enrolled as regular full-time students and their education is financed or co-financed by the State. The pharmacy study programs at all HEIs last 10 semesters (1st and 2nd cycle integrated, 300 ECTS -credits according to Bologna). Integrated MPharm study program leads pharmacists directly to Doctoral level program(s) and other continuing education options. At the DPFM-UGD and DPUT only study programs in pharmacy at 1 st and 2 nd integrated level (300 ECTScredits according to Bologna) are conducted, while at the FF-UKIM, study programs at all three levels according to Bologna are offered 74. Types of study programs offered at the FF-UKIM includes academic and professional (health specialist) study programs. In 2009/2010, in collaboration with the PCoM, the 62

63 new academic pharmacy study program (1st and 2nd cycle integrated, 5 yrs, 300 ECTS-credits) according to Bologna was introduced 75, which was harmonized with the study programs of several Faculties of Pharmacy in Europe (e.g. Faculty of Pharmaceutical Sciences, University of Copenhagen) and with the Directive 2005/36 on recognition of professional qualifications 76. In the last, 10 th semester, a professional practice is provided in community and hospital pharmacies. In the practical teaching and training, health professionals from the university clinical centers and hospital and community pharmacists are included. Case-, project- and problem-based learning as well as experiential learning are the teaching methods which prepare the students for the pharmacy practice after graduation and/or for continuing their professional and scientific development in this area. In the period , new academic study programs at 2 nd level were also introduced at the FF- UKIM and the existing ones modernized. Study programs at this level which develop knowledge and practical skills in certain fields of community and pharmacy practice are the specialist and master study programs in health management & pharmacoeconomy, and phytotherapy and academic specialist study program in pharmaceutical regulatory affairs 77. Accredited pharmacists, after one year working experience, may also apply for health specialist study programs in adequate fields of health practice according to the Law on health protection 19 and the Rule Book for health specialist and subspecialist studies of health practitioners 39. System of mentorship and educators was introduced and the responsibilities of the health institutions where training is conducted, in respect to quality, agreement protocols and planning are regulated. The FF-UKIM in Skopje is the only designated HEI for organizing health specialty studies for the pharmacists in the RoM. The structure, process and outcome indicators point that so far the interest of the pharmacists is below the capacity of the FF-UKIM for accepting the students. Curricula in different health specialist fields were (re)designed in 2011 and the duration of the education/training and the conditions that the institutions must fulfill in respect to space, equipment and personnel defined and regulated as well as the tools and methods for monitoring the procedures and interventions during the traineeship and for evaluation of the acquired competences 39. The health specialist programs that were redesigned in 2011 are in the fields of clinical pharmacy, pharmacoinformatics, toxicological chemistry, medicinal biochemistry, drug quality control, pharmaceutical technology, sanitary chemistry and pharmacognosy, while the programs for pharmacy practice and laboratory medicinal genetics were introduced for the first time. The duration of the education/traineeship depends on the individual efficiency, with minimum between 2 yrs (Pharmacy practice) and 4 yrs (Medicinal laboratory genetics). All of these study programs and specially in clinical pharmacy, pharmacoinformatics, pharmacy practice and medicinal laboratory genetics give an opportunity to the pharmacists to enhance significantly their basic and specialist competencies in the community and hospital pharmacy practice and the titles obtained are adequately recognized as professional qualifications required for providing specific pharmacy services and activities 78. In the time of writing this report (end of 2012), no call for application for health specialty studies was initiated and this is under authorization of the MoH. The MPharm study program at the FF-UKIM in Skopje is designed according to the needs of the country and in this respect industry, pharmacy practice and research components are almost equally integrated in pharmaceutical education. In comparison with the previous curricula (before 2009), which were more product-oriented, the new one moved more towards clinical pharmacy practice by introducing new compulsory subjects, some of them previously offered as optional (e.g. introduction to clinical pharmacy, clinical pharmacy and therapeutics), and new optional subjects (e.g. clinical pharmacokinetics, PK/PD, drug monitoring and toxicology, drug safety, drug dispensing and communication, advanced systems for drug targeting and delivery, etc.) besides the existing ones (e.g. 63

64 pharmacogenetics, phytotherapy, pharmacoeconomy, pharmacoepidemiology, pharmacoinformatics, etc.). In this respect, the MPharm curriculum of the FF-UKIM offers well education of the pharmacists as future hospital or community pharmacists. However, for the best education, inter-professional training has to be integrated in the existing graduate curriculum. There is a room for inter-professional education and training into the graduate curriculum for pharmacists intended to work in pharmacies, both in basic medical subjects and in pharmacy practice. One can say that there is no communication at all between the pharmacy and medical students and nurses during the graduate studies and this explains partly the barriers and poor communication between them in integrated patient care after graduation during their professional work. For this obstacle to be removed, it is strongly recommended inter-professional education and training to be set as a priority in the forth-coming years. Considering the pharmacy practice in the last semester, there is an impression that there is a big room for improvement besides integrating inter-professional training. Firstly, the credits allocated to the pharmacy practice should be increased from 20 to 30 ECTS-credits like in all of the EU-member countries, which is in accordance with the EU Directive 2005/36. In addition, national Law on recognition of professional qualifications has been created and it will enter into force by integration of the RoM in the EU. For this reason and for the best training of the pharmacists as pharmacy workers, modification of the curriculum in this respect is in procedure. Considering education, emerging innovations in technology-based education resources and technologies to enhance learning and achievement of educational outcomes should be explored and in this respect, video technology (e.g., simulation, virtual patients) would be surely beneficial to improve student s decision making skills in clinical pharmacy. Its application or better to say providing financial resources for its application should be one of the priorities. Providing short-term visits for the students to the hospital and community pharmacies in countries with more developed pharmacy practice is extremely valuable for introducing students with the best pharmacy practice and importance of being (well -educated and trained) pharmacists in pharmacy. In this respect, a positive example is a study visit of the group of students from the FF-UKIM, sponsored by DAAD, to the University medical center Hamburg-Eppendorf, Amalie Sieveking hospital (pharmacy) and DocMorris community pharmacy in Hamburg and University hospital pharmacy in Leipzig, which offered possibility for the students to learn more about the concept of pharmaceutical care and practice in central hospital pharmacies, clinics and departments within the hospitals and community pharmacies in Germany 79. The Faculty should use every opportunity to provide students with this type of education. Considering the structure of the pharmacy practice, the time spent in community and hospital (central and satellite) pharmacies and on the wards should be balanced and training of trainers provided by which their knowledge in teaching methods and communication skills will be enhanced. Trainers have to be motivated to participate fully in training of students by reducing their workload and thus allowing more time for communication with the students. In addition, they could be also financially motivated, but a debate who should provide the financies, academia, Government and/or the hospitals or community pharmacies has to be initiated. It is fact that the Faculty is obliged for creating pharmacists as well-educated health professionals, but well-trained pharmacists in pharmacy practice are equally beneficial for the Government, HIF and the health institutions/pharmacies themselves. In additon, the communication between the pharmacy students and pharmacy managers during the graduate study (pharmacy practice) makes an opportunity for the pharmacy managers to reqruite the best students for working in their pharmacies after graduation. 64

65 The pharmacy students graduate by defending their master thesis, but they obtain license after additional six-month training in community and hospital pharmacies, including National drug information center, and by passing the state exam, which is under jurisdiction of the PCoM (see continuing professional development). So, their license is not integrated with their diploma like in other EU member-countries, as it is regulated by the Directive 2005/36. It is recommended a debate on this issue to be initiated. Considering the postgraduate education, the curricula of the health specialty studies provide solid base for developing basic and specialist competencies and skills of the community and hospital pharmacists. Criteria for accreditation of the mentors and educators have been established 39, however, they should be carefully selected and their educational and training skills regularly evaluated, internally and externally. In accreditation of the health institutions for professional training, structure, process and outcome indicators should be considered. At this level, inter-professional education and training is of paramount importance. At this point, it is worth to mention that in the frame of the FF-UKIM, a Center for biomolecular pharmaceutical analysis exists where pharmacogenetics, PK/PD and TDM services are offered to the patients. The Center has established a good cooperation with the University clinics and general hospitals and as a unique example of Faculty center involved in clinical practice, it might offer high level (inter -professional) training for the future hospital and community pharmacists, for developing their specialist competencies in pharmacogenetic and therapeutic drug monitoring. The accreditation of the trainers and institutions is under jurisdiction of the MoH and it is in procedure. Considering the PhD studies, they are organized at the University level and provide certain level of interprofessional education by giving opportunity for selecting subjects from the University list of subjects created by all Faculty units within the University and by attending educational events that provide interprofessional education. It is recommendable, at this level, the PhD students working in community and hospital pharmacies to be introduced with the health assessment technologies and their research skills to be developed and integrated in their practice and clinical studies. Continuous professional development The CPD concept is widely accepted by the community/hospital pharmacists in the RoM for collecting points, but only in a manner of relicensing process, as they have to obtain certain number of credits to renew their working license 20. The concept is not accepted in its real intend, the responsibility of individual pharmacists for systematic maintenance, development and broadening of knowledge, skills and attitudes in order to ensure continuing competence 80. Pharmacists in the RoM participate in CE activities, but these activities do not necessarily lead to positive changes in professional practice. The concept of CPD as stated in EU Directive on recognition of professional qualifications 2005/36 76, continuous education and training shall ensure that person who have completed their studies and are able to keep abreast of professional development to the extend necessary to maintain safe and effective practice is not widely accepted. By the Law on Health Protection 8 (up-date 2004), the CPD for pharmacists is delegated to PCoM. As a professional association, PCoM has the responsibilities to monitor and facilitate professional training (internship) for graduate pharmacists in licensing process 30,31. The professional training is carried out for 6 months through the mentor/educator system in five areas: community pharmacy, hospital pharmacy, pharmacoinformation, clinical pharmacy and pharmacy legislation. After fulfilling the training period and approval from the mentor, the candidates are eligible for professional examination. The Examination Commission is composed of two specialists in pharmacy practice related fields and one lower with 65

66 knowledge in pharmacy regulatory affairs. The professional exam is performed in 2 parts: (i) practical part in community and hospital pharmacy, where professional practical knowledge about medicines, patient safety and communication skill are assessed using case study model; and (ii) written examination. The candidates that have passed the exam are eligible for obtaining license for practicing in pharmacy areas. The licensed pharmacists are evidenced in the register 33. All community/hospital pharmacists in the RoM have license and are registered at the PCoM. Under the Law on Health Protection 20, the relicensing period is 7 years. During this period, the licensed pharmacists have to meet the standards for CPD. Pharmacists have to define their professional interest for continuous education and collect credits from various forms of CE (140 credits 20 per year). In this respect, PCoM had the responsibility to set standards and criteria for providers of various types of CPD activities for pharmacists and related professionals, to certify that accredited providers are capable of meeting the requirements of the essential areas, to assist providers in continuing improvement of their CPD activities and to relate CPD to pharmaceutical care 38. Accreditation of the CPD activities is considered as the process that leads to formal recognition of knowledge, skills and attitudes and is a basis for issuing license for professional activities of individuals and institutions. According to the criteria for accreditation, the CPD activities have to be continuous and organized, meet the needs of pharmacists, cover all specialty fields, be assessable to every member of the society, be adequately accredited (scored), they have to guarantee good pharmacy practice and good pharmaceutical care. The credits allocation depends on the type, context, duration of the CPD activity and qualification of the trainers. The accredited types of CE include courses, seminars, symposiums, workshops, professional meetings, conferences, trainings (internal and external), presentation of professional news for the pharmaceuticals, congresses, academic and professional qualifications obtained during the (re)licensing period, self-directed learning, educator/mentor/assessor in the professional training and exam, participation in quality assurance programs, participation in projects, publications. In the last 6 years, 205 different forms of educational activities have met the standards for accreditation and have been offered to the pharmacists. The Center for Continuous Education (CCE) at the FF-UKIM has realized the need for offering different types of education activities to the pharmacist and declared its own aims and activities: to popularize the idea of CE, to initiate and realize different types of CPD activities which will meet the criteria and needs of the private and public health sector, to provide capacities, equipment and reference materials for the realization of the CPD activities, to monitor the quality and benefits from the CPD, to create a synergism within the university units and to develop strategy for increasing individual contribution of the academics in CPD of interested persons and institutions, to establish inter-professional academic, scientific and expert cooperation with other institutions in the country and abroad devoted to development of programs for CE and CPD, especially through international projects and programs in area of continuing education. CPD activities are continuously performed at the CCE during the past years and they are regularly accredited by the PCoM and when the educational activities are interprofessional, accreditation is required from the other professional chambers. It is obvious that for the CPD, good relationship between professional associations, governmental bodies and academia has been established. Most of the pharmacists show their commitment to improve their knowledge and skills; however, they are not always relevant to their field of expertise. There is an increased need to shift away from credit collection towards a process of self-accreditation and recording learning and applying it into practice. For this to be achieved, the contents of the continuing education activities have to be determined more by the needs of the participants than interests and expertise of the academic presenters. For this to be achieved, questionnaires for the field of interest of the 66

67 community and hospital pharmacists should be regularly prepared, distributed and analyzed. In this context, the CCE of the FF-UKIM and MAP should offer innovative programs and multiple CPD activities with increased involvement of the information technology. Investments in virtual learning environments for the pharmacy practitioners are required and it is essential for the academics to develop skills to use them more effectively and to design courses which are based on sound educational theory and practice. Concerning PCoM, it should continue to accredit programs that will demonstrate that community and hospital pharmacists develop professionally and that their activities are educationally and cost-effective and improve their practice. One way to achieve this is to encourage development of individual educational portfolios. With portfolios, learning can be planed and recorded, it can be subjected to external review and provide documentary evidence to support relicensing and, if necessary, it can contribute to the assessment of performance. It can also provide identification of personal learning needs and those related to the pharmacies for which the pharmacists work and of managers as well. Standards for good pharmacy practice Considering the legal status of the pharmacies and pharmacists in the RoM, their activities and the services provided for health protection of the population and prevention from diseases, one can say that the GPP concept, as it is setup in the latest joint FIP/WHO Guideline for GPP: Standards for quality of pharmacy services (2011), is not fully established. This Guideline states that when establishing minimum GPP standards, it is important, firstly, to define the roles of the pharmacists, as expected by the patients and the society. Secondly, relevant functions for which pharmacists have direct responsibility and accountability need to be determined within each role. Thirdly, minimum national standards should be established in a set of activities supporting each role. As the Guideline states, the minimum national standards for each activity should be based on the processes that are relevant to the local needs of the pharmacy practice and national profession aspirations. In the next section, deep analysis of each role and function of the pharmacies/pharmacists (if established) is performed, barriers for performing this activity are identified and sets of recommendations for their improvement or establishment are given. Role 1. Prepare, obtain, store, secure, distribute, administer, dispense and dispose of medical products Function A: Preparation of extemporaneous medicine preparations and medical products For adequate performance of this activity, the minimum required standards include appropriate premises and preparation of consistent preparations in accordance with the prescription standards and formulas, quality standards for raw materials, equipment and preparation processes. These requirements have been regulated in the current legislation in the RoM. However, the manufacturing practice is not a usual activity for the community pharmacies in the RoM and most of them do not meet the requirements for appropriate premises, equipment, staff, up-to date policies and SOPs for production of medicinal products. With this position of the community pharmacies towards preparation of extemporaneous medicine preparations and medical products, products with minor, but important variations in dosages, strengths or indications are not accessible to the patients, especially neonates, pediatric and geriatric patients, to satisfy their individual medical needs, to enhance medication adherence and to achieve desired therapeutic outcomes. In addition, compounded veterinarian products are not regulated at all. 67

68 The situation is to certain extent better for the hospital pharmacies, but there is also a big room for improvement. The central hospital pharmacies, not all but those that produce pharmaceuticals meet the space and staff requirements and they dispense the prepared products to the satellite pharmacies or patient care areas or wards. They ensure that the compounded medicines are consistently prepared to comply with national legislation (but not EMA/FDA GMP principles), written formulas and quality standards for raw material and preparation processes including stability studies of the formulation (chemical, physical), sterility tests, non-pyrogenicity testing, analysis of chemical content, purity analysis of raw materials and analysis of the final pharmaceutical products. However, their production lines are not modernized and the premises are not sufficient for the required volume of production. In addition, not all central hospital pharmacies employ sufficient number of pharmacists with specialist competences in pharmaceutical technology and drug quality control. Considering above-mentioned, besides investments in pharmacies premises and equipment, special attention should be paid to the education and training of pharmacists to increase their competences for formulation, development and production of medicines, and knowledge not only in pharmacology and pharmaceutical technology, but also in PK/PD, biopharmacy, biotechnology, genomics and new technologies, such as the nanotechnology. The fact that all compounded products can be viewed more or less as unapproved drugs and this raise concerns about safety and efficacy when altering a formulation or combining multiple ingredients, clinical factors must be also carefully evaluated prior to prescribing i.e. preparation and dispensing. Safety and efficacy are more relevant especially in manufacture-scale compounding where added to the limited scientific proof is the lack of well-defined regulations on compounding and the unclear jurisdictions which the state authorities have over compounding pharmacies. Therefore, differences between compounding and manufacturing must be recognized in the legislative. Practices of compounding must be standardized and regulations stringed and permits (accreditations) allowed according to the differences in the products prepared. For example, the compounded inhalation products fall into a gray area of compounding and these products do not require separate licensing. It is recommended, the sterile compounding requirements to be followed in practice due to the concerns about adverse events associated with non-sterile compounding of these products. Enforceable sets of standards for compounding sterile products should be established, which will detail the procedures and requirements for sterile compounding for all pharmacy practice settings. Because compounding pharmacies are not required to follow current GMP as does manufacturing, consensus about which standards or guidelines to follow in sterile compounding prior to the establishment of the new standards should be reached. Sets of standards should also include special issues, such as the compounding of sterile drug products for home use, safe practices for parenteral nutrition formulations, standards for ambulatory care infusion centres, practice standards for handling cytotoxic and hazardous drugs, on-pharmacy prepared ophthalmic products, etc. The concentrations of sterile products used in the institution to simplify preparation and reduce the risk for error in preparation and administration, especially for high-risk medicines, have to be also standardized. Regulatory issues, such as the product stability and quality control of raw materials and final products should also be reconsidered, while their marketing, especially though Internet, regulated. It is expected, the standards to contribute to a decrease in compounding high-risk preparations, an increase in budgetary allocations and improvements in quality assurance practices in community and hospital pharmacies. The jurisdiction to inspect pharmacies is handed over to the Drug Bureau and the safety of patients and the practice of evidence-based medicine should be kept in mind in making all regulatory decisions. Useful guidelines and protocols on compounding, quality assurance, labeling and dispensing of 68

69 pharmacy-prepared sterile products and handling of hazardous drugs, based on scientific data and accepted pharmacy procedures, could also be prepared by the experts selected by the Commission on Accreditation and have legal implications for pharmacists. These guidelines have to be applicable to pharmaceutical services in various practice settings, including, but not limited to hospitals, community pharmacies, nursing homes, ambulatory care infusion centers and home care institutions. Pharmacists should be urged to use professional judgment in interpreting these guidelines and applying them in practice. Function B: Obtain, store and secure medicine preparations and medical products The foundation for this function is recognized in the Law on Medicines and Medical Devices, but national standards have not been established yet. However, according to the employment structure in the community pharmacies, there are no trained pharmacists with procurement skills, and the transparency, professional and ethical aspects are not always ensured to promote equity and access. It is not always ensured that the procurement is supported by strong quality assurance principles or supported by a reliable information system which provides accurate and accessible information. However, contingency plans for shortage of medicines and for purchasing in emergencies are fully implemented in community/hospital pharmacies in the RoM. Medicines procurement in the public hospital pharmacies involves mainly contracted arrangements with wholesalers (usually not coupled with negotiation) and to low extent, direct supply from manufacturers. National tendering of contracts to suppliers, governed by the MoH or HIF, is not a standard practice, although there are some discussions for involving this practice in the state-owned hospitals (pharmacies) in the future. Therefore, policies and procedures for managing medication acquisition should be developed. They should address such issues as formulary development, competitive bidding, group purchasing, best practices, medication shortages, outsourcing, and cost-effective patient services. It is recommended that hospitals, whenever possible, arrange contracts through cooperative purchasing with other hospitals (which is not a common practice) to secure the best purchasing through consortium arrangements. Criteria for selecting drug product manufacturers and suppliers should be established to ensure the highest quality of and the best price for drug products, while the sole responsibility for ensuring the quality of drug products used in the community and hospital pharmacies should maintained to pharmacists. The regulative related to the procurement of medicines needs to be reconsidered to ensure quality of supply from the point of view of transparency of the supply and avoidance of the entry of substandard, low quality, unapproved, fake, or falsified medicines in the supply system. In this respect, the Directive /EU that regulates this issue should be implemented in the national legislation. In addition, provisions should be enacted that will regulate the information system that will support the roles, functions and activities of the pharmacists. In addition, written policies governing the activities of manufacturers representatives or vendors of drug products and related supplies and devices should be developed and all promotional materials and activities should be reviewed and approved by the pharmacists. The storage conditions in community and hospital pharmacies are at optimum level for all medicinal products and the controlled substances are well segregated from the rest of the pharmaceutical products. However, not all pharmacies are equipped with locks and alarms and appropriate security 69

70 measures to prevent access by unauthorized persons. Policies and procedures for periodical checking of thermometers, use of locks and alarm systems and authorization must be established. Automated medicine storage devices are recommendable, especially for community and decentralized hospital pharmacies and when they implemented in the hospitals, access procedure for pharmacists and nursing staff should be defined. Function C: Distribute medicinal preparation and medicinal products General provision regulating the entities that may distribute medicinal products and minimum conditions required for these activities are grounded in the Law on Medicines and Medical Devices. Community pharmacists ensure that the medicinal products are handled and distributed in the manner that ensures reliability and safety of medicine supply. However, no automated distribution devices/robotics are used and therefore, the pharmacists are not freeing up to provide clinical pharmacy services. Considering the hospital pharmacies, there is also no hospital that uses automated distribution devices/robotics and unit dose/bar-code drug distribution system. Instead, conventional ward stock drug distribution system is in practice where bulk medicines are distributed from the centralized pharmacies to the satellite pharmacies or patient wards and stocked in the patient care areas. Not many decentralized (satellite) pharmacies are managed by the pharmacists and even those who are managed have no policy for pharmacist order review. At the level of centralized pharmacies, medication orders are not efficiently received for review of appropriateness by a (clinical) pharmacist and retrospective review of all or a random sample is not performed as well. Thus, automated medicine storage and distribution technologies and/or robotics in larger hospitals as well as automated prescription-filling systems must be considered for establishing and with proper training of the pharmacy technicians and other supporting staff, the pharmacists will have more time for providing advanced and enhanced services once they established. It is of paramount importance to implement these devices knowing that all facilities are without 24-hour pharmacy services. As Ryozo Oishi states in Current status of preparation and distribution of medicines they should be fully integrated with the medication use process to provide medicines in ready-to-use form and make them available near the time of administration, create an individualized patient medication dossier, allow for pharmacist review of medication orders before dispensing, ensure proper storage conditions, prevent access by unauthorized personnel, allow access in emergencies and meet applicable regulations and standards 81. Therefore, policies and standard operative procedures for effective storage and distribution system need to be established, including procedures for prompt and effective recall of medicines that are known or suspected to be unapproved, fake or falsified. In addition, an access plan between pharmacies-manufacturers-wholesalers-government for uninterrupted supply of essential medicines as part of health strategy for disaster or pandemic preparedness should also be established. Function D: Administration of medicines, vaccines and other injectable medications This function requires appropriate education and training of the pharmacists (especially for pharmacybased i.v. admixture services), suitable premises and procedures, which is not the case for the hospital pharmacies in the RoM. As previously said, ward stock system where nurses order, obtain, prepare and administer medications with no or minimal pharmacy support is in practice. Instead of that, 70

71 decentralization of pharmacists, bar-coded medication administration and pharmacy-preparation and review of i.v. solutions, chemotherapy and pediatric medicinal products should be considered. Guidelines and protocols for patient identification, verifying absence of drug allergies and safe administration of medicines should be established. In addition, standard i.v. concentrations, smart pump-infusion devices that include drug libraries with pre-established dose and rate limits based on standard concentrations as well as bedside scanning have to be implemented to reduce the incidence of wrong concentrations and wrong dose errors. The presence of educated and skilled pharmacists in patient care areas, especially pediatric, chemotherapy and intensive care units is of paramount importance for providing medication safety. For example, a pharmacist trained to provide i.v. admixture services could significantly reduce the risk of error when performing pharmaceutical calculations during compounding and administration of medicines. Education of pharmacists in administration technologies is essential. In this respect, guidelines or recommendations for improving patient safety, minimizing floor stock i.e. concentrated electrolytes, standardizing i.v. medication preparation and preparation policies should be established as well as policies and procedures for preventing wrong-route errors. Oncology pharmacists should be also trained in chemotherapy preparation, evaluation of orders and administration and they should be included in the multidisciplinary teams for multiple independent checks. Guidelines on chemotherapy-error prevention should be also developed or adopted. Function E: Dispense medicinal products The community pharmacists are spending much of their working hours on dispensing and there are appropriate facilities, trained personnel and standard dispensing practices (not always written) for the dispensing of prescribed and non-prescribed medicines, herbal drugs and dietary supplements. The pharmacists are allowed to do the generic substitution and they usually ask/inform the patient before making the substitution. The prescriptions (on printed paper -standardized form as regulatory requirement) are evaluated considering therapeutic and legal aspects, but not always considering the social and economic aspects. Pharmacists routinely provide advice ensuring that the patient receive and understand the oral (not written) information for deriving maximum benefit of the treatment. However, effective evaluation of the patient therapeutic needs, predicting and monitoring of therapeutic outcome and preventing medication errors and adverse drug events cannot be performed without access to the patient data and his/her medication profile. In addition, the pharmacists dispense medications at dispensary area which does not always ensure patient confidentiality and it is necessary to enact policies and operative procedures for providing discretion in the areas where medicines are dispensed and advice given at the time of dispensing, which is also required by the provisions stipulated in the Law on Personal Data 82. In all hospitals, especially state-owned, medication orders are transmitted making a handwritten copy, which is sent to the central or satellite pharmacy by responsible nurses from the patients wards and special patient areas. Bulk medicines are distributed and stored in the patient care areas (i.e. on the wards, intensive care units, etc.) and dispensed and administered by the nurses after previous order and review by the physicians. Administration records listing the prescribed drugs, doses, routes of administration and frequency are placed near/at patient beds and the use of medicines is not limited because there is no unit-dose drug distribution system and bar-code assisted dispensing system. Patients bring their own medicines for use in the hospital, they are allowed to use all of them, but an 71

72 order review make by the physician or the pharmacists is not a standard operative procedure and there is no policy that addresses the use of patient s own medicines. Also, there is no policy for controlling use of herbal or dietary supplements. In fact, no medication orders whether emergency or nonemergency, in all or special hospital areas (e.g. surgery, intensive care, etc.) are reviewed by a pharmacist and this is a common practice in all hospitals in the RoM. To remind, the pharmacists have no direct contact with the patients and no access to usually manually created and maintained in- and out-patients medication profiles. From this position, introducing bar-code assisted dispensing system, creating electronic patient medication profiles, establishing CPOE system with a pharmacy interface, containing sufficient patientspecific data and screening capabilities to detect medication errors as well as employment/training of clinical pharmacists is a matter of urgency. Implementation of these technologies and training of specialists would provide financial benefit (re turn) because of a reduction in dispensing errors and adverse drug events. There is no hospital pharmacy nor community or ambulatory pharmacy within the hospital that dispenses medicines to outpatients. In addition, dispensing of cancer chemotherapy for administration on an outpatient basis is not a common practice. This practice must be changed for economic and safety reasons and a mechanism for dispensing medicines when the hospital or community pharmacy is closed must be established. Policies and procedures must be established to review cancer chemotherapy orders to verify the appropriateness of the ordered medicine, dosage regimen, dilution method, administration route, and premedication and auxiliary medication to treat adverse drug effects. In addition, clinical pharmacists with specialist competences in oncology pharmacy must be employed/trained. Function F: Dispose medicine preparation and medicinal products The pharmacists in both community and hospital pharmacies pay much attention for regular monitoring of the medicines inventory and perform process of at least annual inspection for expiration dates and removal of outdated stock. Recalled medicinal products are stored separately for subsequent disposal thus preventing those medicines being available for further dispensing or distribution. However, not always the patients are encouraged to return their expired or unused/unwanted medicines and a campaign should be initiated by the Government to inform the public on the benefits of this activity. Role 2. Provide effective medication therapy management Function A: Assess patient health status and needs Challenges to which pharmacists are faced and unlimited opportunities available to them as part of the health-care team due to on-going changes in the health-care systems enable the pharmacists to be involved in medication therapy management (MTM), as they have knowledge and skills for medicines and therapy. In addition, they are readily available and easily accessible for the patients, able to identify health-related problems, assure effectiveness of the medicines, prevent harm from medicines and skilled for making responsible use of limited health-care resources. However, in the RoM, this function of the pharmacists is not recognized nor regulated. Pharmacists do not incorporate health management, disease prevention and healthy lifestyles behavior into patient assessment and care process due to lack of specialist education and training and of data for the patients and medications they receive. 72

73 Pharmacists usually acknowledge unique patient considerations such as education level, cultural believes, native language and physical and mental capacity in individual patient assessment. Mostly in community pharmacies, pharmacists try to understand patient habits and culture, but there is no staff trained to communicate with patients with specific needs (deaf, blind patients). The same situation is for the hospital pharmacists, but there the situation is even worse due to the restricted communication between the pharmacists and the patients. Policies and procedures have to be developed that will ensure communication between the patients and the pharmacists, define the essential steps in assessing patient needs and recognize different types of assessment services (e.g. standard medication management assessment, patient assessment in adaption of a prescription, assessment for prescribing in an emergency, assessment for initiating medication therapy or managing ongoing therapy, for prescription renewal, comprehensive annual care plan, etc.). To qualify to provide assessment services, the community and hospital pharmacists must develop specialist competences and communication skills, in this way trying to expand their roles in patient assessment. The Government must recognize the economic and health benefits of these services and provide appropriate reimbursement. Function B: Manage patient medication therapy Community and hospital pharmacists in the RoM do not have a role in educating prescribers on the access to and evidence for optimal and appropriate use of medicines, providing advice or recommendations on medicine therapy, including the selection of appropriate medication or dosage. This situation results from lack of communication between the pharmacists and physicians at all levels of health and pharmaceutical care. Pharmacists have no access to essential patient data and therefore, they are not able to coordinate effective MTM services, especially in hospitals where multiple healthcare practitioners are involved in the patients medication therapy. This function entails access to appropriate evidence data bases related to the safe, rational and costeffective use of medicines such as reference books on medicines and scientific journals and literature. In all pharmacies in the RoM, national medicines formulary and drug catalogues (registers) are available and routinely used by the pharmacists. However, cost-effectiveness is not the component that pharmacists are referring to while obtaining information on medicinal products. The pharmacists do not have access to important databases on biomedical literature, life science journals, online books or their printed editions due to lack of financial resources. All pharmacies are connected with the NDIC, but just for receiving information send to them in the manner of news or information about news concerning use of medicinal products. Therefore, for operating this function, the pharmacists, pharmaceutical associations and/or Government/Drug Bureau must develop MTM service programs for optimizing the benefits of prescribed drugs, improving medication use, reducing the risk of adverse drug events and drug interactions, increasing patient adherence to prescribed regimens and preventing medication-related morbidity and mortality. They should improve collaboration among pharmacists, physicians and other healthcare professionals, enhance communication between patients and their healthcare team and demonstrate positive clinical, economic and humanistic outcomes across diverse patient populations in various patient care settings. MTM service programs could include the following pharmacist-provided services: performing or obtaining necessary assessments of the patient s health status, formulating a medication treatment plan: selecting, initiating, modifying or administering medication therapy; monitoring and evaluating the patient s response to therapy, including safety and effectiveness; 73

74 performing a comprehensive medication review to identify, resolve and prevent medication-related problems, including adverse drug events; documenting the care delivered and communicating essential information to the patient s other primary care providers; providing verbal education and training designed to enhance patient understanding and appropriate use of patient medications; providing information, support services, and resources designed to enhance patient adherence with his or her therapy; and coordinating and integrating medication therapy management services within the broader healthcare-management services being provided to the patient. Any patient who uses prescription and nonprescription medications, herbal products, or other dietary supplements has to benefit from the MTM services. Considering that the MTM program structure and the needs of individual patients may vary, the design of a consistent and recognizable framework for core MTM services is essential. However, MTM services in all patient care settings should include structures supporting the establishment and maintenance of the relationship between the patient and the pharmacist. It is important that system be established so that pharmacist-provided MTM services can focus on reconciling the patient s medications and ensuring the provision of appropriate medication management during transitions of care. In primary care i.e. community pharmacies, the MTM services could be delivered in a confidential or private area, by a pharmacist whose time can be devoted to the patient during this service. In other patient care settings (e.g., acute care, long-term care, home care, etc), the environment may differ because of differences in structure and facilities design. Even so, a consistent approach to the delivery of MTM core services should be maintained. So, the core elements of MTM services have to be determined and they might include medication therapy review, personal medication record, medication-related action plan, intervention and/or referral and documentation and follow-up. Within the MTM core elements, the patient will receive an annual comprehensive medication therapy review, additional medication therapy reviews according to his/her needs and ongoing monitoring by the pharmacist to address new or recurring medication-related problems. State must see improvements in the citizens health and savings on overall healthcare costs by supporting design and reimbursement of MTM services. Public, policy makers and other key decision makers should be educated about the important role that pharmacists play in the ever-evolving healthcare system and considering this issue, the pharmacists and pharmaceutical associations must be more active or better to say proactive. Function C: Monitor patient progress and outcomes Monitoring patient progress and outcomes as an important activity of the community and hospital pharmacists to consider patient response to medicine therapy is not performed in the pharmacies in the RoM. As was previously mentioned, the pharmacists have no access to the patient demographics and subjective and objective observations (electronic patient dossier and medication profile is not generated or stored or accessible in pharmacy settings), no patient assessment is made as well as care plan or transition plan or scheduling of next follow-up visit. In fact, in community settings, the patients are not regulatory or in any other way connected to one pharmacy/pharmacist only and the pharmacists, both community and hospital, do not perform point-of-care testing to monitor and adjust patient therapy if/when needed, as this is recognized as physician function only. Medication therapy monitoring, performed by a pharmacist, should include a proactive assessment of patient problems in respect to assessment of the appropriateness of the medication regimen, dose, route, method and frequency of administration, patient adherence to the prescribed therapy, assessment of medication medication, medication food, medication dietary supplement, medication 74

75 laboratory test and medication disease interactions, assessment of ADRs and other undesired effects, patient medication allergies and sensitivities, clinical and PK laboratory data to evaluate the efficacy and safety of medication therapy and to anticipate toxicity and adverse effects, physical signs and clinical symptoms relevant to the patient s medication therapy, etc. National pharmacovigilence but not medication-error-reporting system has been already established within the NCP in the RoM, understandably connected with the WHO Center in Uppsala only but not with the international networks for medication safety (e.g., Although the NCP was established in 1991 and many educational events for training pharmacists since then were performed, so far no reports for adverse drug events or medication errors from pharmacists were received. Not monitoring and measuring patient progress and outcome does not affect a single patient only but also the health system, which performance cannot be measured since no outcome measures are available (e.g. morbidity, mortality, satis faction with pharmaceutical care). This again implies the necessity of implementing and reimbursing clinical pharmacy services in community and hospital pharmacy settings, interaction with the health care teams (on patient rounds), interviewing patients, reconciling medications, providing patient in-service or discharge education and counseling, and followup. In this way only, the adverse drug events or medication error can be reduced, knowledge and medication adherence improved and hospital visits or length of stay decreased. Number of necessary (clinical) pharmacists per citizens (in community settings) or per occupied beds (in hospital settings) must be determined as well as clinical pharmacy services associated with reduced morbidity, mortality and hospitalizing rates. In this way, cost-saving clinical pharmacy interventions could be determined and prioritized for implementation. The pharmacists must take direct clinical responsibility for the use of specific medicines, work very closely with the patients and health care teams and this has to be regulated. Trigger tool methods to identify and measure adverse drug events, dispensing errors and medicine product defects have to be implemented and through monitoring of patient progress and outcome, medication practice could be continually monitored and evaluated and this has to be integrated in a community and hospital pharmacist s day job. Of course, structural and process indicators would be still necessary for measurement of medication practice within the continuum of pharmacy practice. Function D: Provide of information about medicines and health-related issues Considering the pharmacy premises, as previously said there are no community or hospital pharmacies with specifically dedicated suitable areas for discussing confidential information with the customers and patients. Dispensary in community pharmacies is used for providing information to patients, mostly for medicines, therapy and dosage regimens, ADRs and importance of regular therapeutic drug monitoring, while hospital pharmacists provide this kind of information to health-care providers only upon request. In addition, pharmacy structure and investments in pharmacy structure do not include networking with important data bases and access to medicinal journals and books. The community and hospital pharmacies are via internet connected with the NDIC, however requests for information on medicines and health-related issues for specific patients or medicines are rarely requested and used in providing safe and effective pharmacotherapy. In hospital settings, the Pharmacy and Therapeutics Committees have been recently established with pharmacists as their members. The role of the hospital pharmacists in the Pharmacy and Therapeutics Committees has to be defined and guidelines outlining the processes for formulary system management 75

76 and defining the pharmacist s responsibilities and roles in managing the formulary system in partnership with other health care professionals developed. These guidelines should also provide assistance to pharmacists in the organization and operation of the Pharmacy and Therapeutics Committees, evaluation of medications for formularies, and development and implementation of strategies to manage medication use through the formulary system. Role 3. Maintain and improve professional performance Pharmacists in the RoM realize the need for specialist training and CE as part of their CPD and long-life learning, and they have started to demonstrate evidence of CE and CPD in their every-day practice for improving their clinical knowledge, skills and performance. They well-accept the offered accredited types of CE and these activities are recognized by the pharmacies owners and management of the hospitals. In addition, there is a modest interest of the community and hospital pharmacists for obtaining specialist training in different fields of pharmacy practice (e.g., clinical pharmacy, drug information, etc.). Time pressure, workload and lack of finances are perceived as the main barriers for the bigger interest. Role 4. Contribute to improve effectiveness of health-care system and public health Function A: Disseminate evaluated information about medicines and various aspects of self-care The pharmacists in the RoM should be more active in providing patient-specific drug information and accurate and comprehensive information about medicines and pharmacotherapy to health professionals, patients and patients caregivers. For the time being, patient-specific medicine information requests in the community pharmacies are provided in an accurate and timely manner, but there should be a process for assessing and ensuring the quality of responses. Pharmacists working in community and hospital pharmacies should inform the health care providers, patients and patients caregivers about the use of medications on an ongoing basis not only verbally but also through appropriate publications, presentations, in-service training, (educational) programs and activities. Medicinal product information (e.g. recall notices, labeling changes, changes in product availability, etc.) should be timely disseminated, preferably by electronic communication. Function B: Engage in preventive care activities and services Pharmacists in the RoM, generally, do not participate in preparation and dissemination of educational materials or developing programs or campaigns for health management, health promotion and disease prevention i.e. they are not involved in preventive care activities. This is not addressed or regulated in the RoM unlike other countries where it is one of the most recognized and first defined functions of pharmacists, although sporadic but not systematic approach to this function could be seen in the last years in some of the community pharmacies. There are several barriers that could be identified for not providing these services, such as time pressure and workload, lack of training of pharmacist and their staff, lacking of private areas, no reimbursement for these services, lack of support from the owners/management of hospitals, lack of documentation, etc. As already known, there is a big room for pharmacists to act and considering their relations with the patients, especially in the community pharmacies, they must use and develop their knowledge and skills for improving public health. They could participate and be leading actors in the development of policies, 76

77 procedures and campaigns concerning preventive and post-exposure immunization programs for patients, smoking cessation, healthy eating and lifestyle advice, provision of emergency contraception, infection control and prevention, promoting cardiovascular health and blood pressure control, prevention and management of substance abuse, etc. It is recommended, pharmacists to publish their activities in public health and provide evidence base regarding these roles. The Government must recognize this wide range of roles of the pharmacists, while faculties must put an effort to encourage more practicing pharmacists to take up teaching and research position to help in this direction. Function C: Comply with national professional obligations, guidelines and legislation The community and hospital pharmacists in the RoM, generally, operate in compliance with the provisions in national legislation and all of them fulfill the minimum requirements. As for the national code of ethics, there has not been a single case for complain that the Commission for Ethic Issues at the PCoM has received from patients or other health-care providers, nor from national authorities, so the pharmacists take all necessary steps to ensure compliance with the provisions from the existing acts. Function D: Advocate and support national policies that promote improved health outcomes With respect to this function, there is an impression that the pharmacists in the RoM have to be more active and demanding through their associations or on their own. 77

78 Conclusion Introduction and implementation of good pharmacy practice and qualitative pharmacy services through the implementation of GPP standards in community and hospital settings in the Republic of Macedonia is of essential importance. Present study describes the current status of the PP in the RoM and represents important foundation for defining: the necessary steps for strengthening the regulatory framework; priorities i.e. gaps and rooms for improvement in the structure, process and therefore, outcomes of the pharmaceutical care services; increasing the level of education, knowledge and skills of community/hospital pharmacists and their attitude towards PP, PC and CPD and recommendations for stepwise approach for managing the PP and PC changes. In addition, an assessment tool was established for continuing monitoring and evaluation of PP and quality of PC services. Current legislation concerning pharmacy practice do not support best pharmacy practice and pharmaceutical care services. Provisions in existing regulations need to be strengthened in respect to defining clear criteria for PP (geographic and demographic criteria, ownership criteria, pharmacy structure criteria-room, equipment, staff, mechanism to guarantee continuous medicine access regulating the opening hours etc.) The HIF budget for medicinal products need to be increased, and the contractual framework between the HIF and community/hospital pharmacies need to be revised/improved in respect to recognizing the pharmacy services, as basic and additional ones, in the manner of pharmacy/pharmacists added value for the society as well as in reducing the overall costs of the health system. There is lack of knowledge sufficient for introducing and implementation of PC services. The level of education, knowledge and skills need to be improved by introducing inter-professional education and training for pharmacy practice at graduate as well as at postgraduate level. Pharmacists need to accept the concept of CPD as their individual need for performing the best pharmacy practice in their respective locations. Standards for quality of pharmacy services, pharmacists activities and the services provided for health protection of the population and prevention from diseases are not fully established in pharmacies in the RoM. Pharmacists routinely perform traditional PP services and the procurement practice, storage and securing of medicinal products is in place providing quality access to medicinal products. However, pharmacy is still seen as part of the commercial sector rather than part of the health care system, even by the pharmacists themselves. Services related to providing effective medication therapy management in respect to managing patient medication therapy and monitoring patients progress and outcomes need to be improved and documented. As legislation and other health care providers do not recognize pharmacists as important part of the health care team, pharmacists must strengthen their partnership with other health professionals and national authorities for improving the effectiveness of the health-care system and public health. 78

79 National authorities, professional bodies and pharmacists have to put more efforts for intervention in pharmacy sector and the list of priorities is presented in table 6. Table 6. Priorities for intervention by key national bodies Authority to take action Ministry of health, DB, Government Priorities 1.Establishing Law on Pharmacy Practice 2.Revising criteria for establishing pharmacies 3.Introducing standards for GPP 4.Recognizing the economic and health benefits of PC services NHIF 1.Increasing the investment in the pharmacy sector 2.Recognizing essential, advanced and enhanced PC services and their reimbursement Academia MPA PCoM 1.Modernizing the education in pharmacy practice using information and health assessment technologies 2.Introducing inter-professional training and training of trainers for pharmacy practice 3.Increasing awareness of the necessity of basic and specialist competences 4.Offering more educational, training and innovative programs and multiple CPD activities 5.Promoting pharmacists role in the health care system 6.Encouraging development of individual educational portfolios Pharmacists/ pharmacies 1.Moving from commercial to patient care model 2.Investing in pharmacy structure and processes 3.Raising basic and specialist competences and skills 4.Establishing better relationship with other health care providers 5.Continuing assessment of PP status and quality of PC services 79

80 Recommendations for improving the roles of the pharmacists according to the latest WHO/FIP Guidelines for GPP standards are presented in table 7. Table 7. Recommendations for improving the roles of the pharmacists Roles for pharmacists Recommendations (priorities for intervention) Prepare, obtain, store, secure, distribute, administer, dispense and dispose of medicinal products Investing in premises and equipment Increasing basic competences Establishing written policies and procedures Developing guidelines and protocols Provide effective medication therapy management Investing in premises and equipment Introducing essential, advanced and enhanced PC services Developing specialist competences Establishing written policies and procedures Improving collaboration with patients and other heath-care providers Maintain and improve professional performance Demonstrating CE and CPD in every-day practice Minimizing barriers for improving professional performance Contribute to improve effectiveness of the healthcare system and public health Promoting rational pharmacotherapy Participating in preventive programs and campaigns Advocating and supporting national policies and regulatory bodies 80

81 For achieving the quality PP and PC service in RoM and managing changes, plan of action for step-wise approach is needed informing and involving all interested stakeholders (Table 8). Table 8. Stepwise approach for improving the PP and PC services in community and hospital pharmacies Functions and roles of GPP Starting with Moving towards I. Prepare, obtain, store, secure, distribute, administer, dispense and dispose of medicinal products Minimum national standards EU/USA Standards A Preparation of extemporaneous medicine preparations and medical products - Marketing analysis and feasibility studies - Investing in pharmacy structure (e.g. production areas, equipment, production lines, bar-coding technology, laminar airflow hoods, biological safety cabinets, production lines, etc.) - Establishing SOPs and QA program/ procedures - Developing guidelines and up-to date protocols for aseptic preparation and handling of (hazardous) drugs - Preparation of sterile medicinal products according to the FDA/EU standards of GMP - Preparation of drug formulations, dosage forms, strengths, and packaging for individual patients that are not commercially available B Obtain, store and secure medicine preparations and medical products - Establishing policies and procedures for managing medication acquisition that will address formulary development, P&T committees, competitive bidding, group purchasing, best practices, medication shortages, recalled expired and unusable medicines, - Investing in pharmacy structure (e.g. automated medicine storage devices, cabinets, locks and alarm systems, refrigerators with thermometers, etc.) - Establishing and maintaining an up-to-date inventory information system

82 outsourcing, and cost-effective patient services. - Developing and implementing internal quality assurance systems - Establishing written policies governing the activities of manufacturers representatives or vendors of drug products - Establishing policies and procedures for donations, use of medicine samples and investigational medicines - Establishing appropriate mechanisms to ensure compliance - Establishing procedures for verification of proper medicine storage - Developing pharmacists skills in business and management, information technology, safety and risk management, laws and regulations - Creation of an electronic bidding system - Educating technicians for performing procurement functions C Distribute medicinal preparation and medicinal products - Establishing policies and procedures for distribution of medicinal preparations and appropriate mechanisms to ensure compliance - Establishing policies and procedures for distribution of medicinal preparations for in- and out-patients, accordingly (in hospital pharmacies) - Investing in pharmacy structure (e.g. automated distribution devices, bar-coding equipment - in hospital pharmacies) - Establishing policies, procedures and quality assurance programs regarding automated distribution devices - Establishing unit dose distribution system (in hospital pharmacies) D Administration of medicines, vaccines and other injectable medications - Establishing standards of practice in the domain of medication administration for the ward stock - Introducing pharmacy-based intravenous admixture services - Training community pharmacists - Investing in pharmacy structure (introducing barcoding technology in 82

83 and decentralized systems, accordingly - Developing up-to date protocols for labeling of injectable medicines - Establishing policies, procedures and up-to-date protocols for safe medication administration that will address verification of patient identity, access to patient data, presence of pharmacists in patient care areas, etc. - Establishing policies, procedures and quality assurance programs regarding drug delivery systems and administration devices - Establishing methodology for detecting medication administration errors for vaccine administration medication administration, implementing smart pumpsinfusion devices, etc.) E Dispense medicinal products - Establishing policies and procedures for accurate and efficient communication of medication orders and their review - Providing access to patient data - Establishing policies and procedures for dispensing of medicinal preparations for in- and out-patients, accordingly (in hospital pharmacies) - Providing specialist pharmacists in high-risk areas (oncology, pediatrics, intensive care, etc.) - Establishing policies for controlling use of herbal and dietary supplements - Investing in pharmacy structure (e.g. bar-code assisted dispensing system, automated dispensing devices/cabinets, automated prescription-filling systems, CPOE system, etc.) - Developing clinical courses for preparing pharmacists for prescribing medications - Establishing policies and procedures for team approach in the entire therapeutic decision-making process; moving from passive dispensing to active participation in the therapeutic decision-making process - Establishing procedures for dispensing specific drugs (e.g. chemotherapy) on an outpatient basis - Developing policies and written 83

84 F Dispose medicine preparation and medicinal products procedures for disposing recalled, expired, unused or unwanted medicines Starting with Moving towards II. Provide effective medication therapy management Minimum national standards EU/USA standards A Assess patient health status and needs - Recognizing and establishing policies and procedures for different types of assessment services - Providing and regulating access of the pharmacists to the patient data - Providing and regulating access of the pharmacists to the patients (in hospital pharmacies) - Developing specialist competences and communication skills of the pharmacists - Investing in pharmacy structure (area for confidential communication and counseling, computer software with screening capabilities, standalone or part of CPOE system, computerization of patient information, in hospital pharmacies, interfacing the hospital mainframe computer and the pharmacy computer system, providing access to evidence data bases, etc.) - Recognizing the economic and health benefits of the assessment services and providing appropriate reimbursement B Manage patient medication therapy - Defining the core elements of the MTM services - Recognizing advanced and enhanced MTM services and establishing policies and procedures for their implementation - Developing specialist competences of the pharmacists - Investing in pharmacy structure (e.g. computer software with screening capabilities, standalone or part of CPOE system, computerization of patient information, interfacing the hospital mainframe computer and the pharmacy - Providing MTM services during transition of care - Recognizing the economic and health benefits of MTM services and providing appropriate reimbursement 84

85 computer system (in hospital pharmacies), providing access to evidence data bases) C Monitor patient progress and outcomes - Developing specialist skills in clinical pharmacy and pharmacy practice - Establishing regulatory framework for connecting a patient to one pharmacy/pharmacist (in community pharmacies) - Defining number of (clinical) pharmacists/citizen (for community pharmacies) or per occupied bed (for hospital pharmacies) - Establishing medication-errorreporting system - Investing in pharmacy structure (e.g. computer software with screening capabilities, standalone or part of CPOE system, computerization of patient information, interfacing the hospital mainframe computer and the pharmacy computer system (in hospital pharmacies), providing access to evidence data bases) - Implementing (cost-saving) clinical pharmacy services - Developing trigger tool methods - Recognizing the economic and health benefits of clinical pharmacy services and providing appropriate reimbursement - Regulating clinical responsibility for the medication use - Regulating communication with the patients - Regulating communication with the members of the health care teams D Provide of information about medicines and health-related issues - Developing specialist skills in drug information technologies - Networking with evidence data bases and providing access to medicinal journals and books - Establishing effective cooperation with NDIC - Establishing policies and procedures for providing drug information in an accurate and timely manner - Defining the pharmacists role and responsibilities in managing the formulary system - Developing guidelines for formulary system management and operation of P&T committees Starting with Moving towards 85

86 III. Maintain and improve professional performance Minimum national standards EU/USA Standards A Plan and implement continuing professional development strategies to improve current ad future performance - Participation in CPD activities specifically related to every day practice - Enrollment in specialist education and training in different fields of pharmacy practice - Preparing and following (annual) individual portfolio for CE and CPD - Credit allocation only for the CPD activities related to PP Starting with Moving towards IV. Contribute to improve effectiveness of the health-care system and public health Minimum national standards EU/USA Standards A Disseminate evaluated information about medicines and various aspects of self-care - Establishing policies and procedures for disseminating evaluated information to health professionals and patients - Preparing publications and presentations with patientspecific and comprehensive drug information - Developing in-service training and educational programs for specific patient populations B Engage in preventive care activities and services - Establishing policies for involving pharmacists in preventive care activities - Developing knowledge for improving public health - Developing policies, procedures and campaigns for preventive and post-exposure programs - Documenting, publishing and providing evidence base - Recognizing preventive care activities and services by the regulatory bodies and community 86

87 C Comply with national professional obligations, guidelines and legislation - Establishing mechanisms for complying and improving legislation D Advocate and support national policies that promote improved health outcomes - Taking proactive and demanding role individually and through PCoM and MAP 87

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90 35. Rulebook for issuing, extension, renewing and withdrawn of the pharmacy license, Official Gazette of the Republic of Macedonia No. 04/ Rulebook for the criteria that educators have to fulfill to conduct internship for the pharmacy health professionals, Official Gazette of the Republic of Macedonia No. 90/ Rulebook for the program for additional internship training and assessment of the professional knowledge and skills of the pharmacy health professionals, composition of the assessment commission, Official Gazette of the Republic of Macedonia No. 84/ IBRD loan # 4733 for modernizing licensing process for doctors, dentists and pharmacists in Macedonia, Ministry of Health, Republic of Macedonia 39. Report on fifth visit 3 8 December 2006, IBRD loan # 4733, Judy McKimm, December Rulebook for types of continuing education activities and professional development programs, criteria and credits allocation for continuing education and professional development, Official Gazette of the Republic of Macedonia No. 102/07, 102/ Rulebook for health specialist and subspecialist studies of health practitioners, Official Gazette of Republic of Macedonbia No. 61/ The PHARMINE survey of European HEIs delivering pharmacy education and training - Macedonia, PharmacyPractice available at 07/15/ WHO Resolutions on Medicines Strategy (WHA5411) 46. WHO - Strengthening Health Systems in developing Countries (WHA5413) 47. WHO - Ensuring Accessibility of essential medicines (WHA WHO - Quality of care patient safety (WHA5518) 49. WHO - Health promotion (WHA5716) and Rational Use of Drugs (WHA6016) 50. Hoddinott S. N. Et al.the Dillman Total Design Survey Method. Can Fam Physician, 1986, 32: Statute of the Faculty of Pharmacy, University Ss Cyril and Methodus, Skopje, Macedonia, available at 07/15/ Study programmes of FF-UKIM available at 07/15/ Mills. GLF General Level Framework, ASHP Guidelines on quality assurance for pharmacy prepared sterile products 90

91 55. ISMP Medication Safety Self Assessment for Hospitals, 2011; available at 03/15/ ISMP Medication Safety Self Assessment for Community/Ambulatory Pharmacy; available at 03/15/ The American Society of Health-System Pharmacists (ASHP) questionnaire for self-evaluation. available at 07/15/ Trap B. et al. A new indicator based tool for assessing and reporting on good pharmacy practice, Sothern Med Review, Vol 3, Issue 2, Pharmacy Practice Guidance Manual, A self-audit tool for pharmacists and pharmacy owners, The Pharmaceutical Society of Ireland, May Vogler S. et al. Community Pharmacy in Europe, Lessons from deregulation case studies. PGEU, February 2006, College of Pharamcists of British Columbia Framework of professional practice, Good Pharmacy Practice Manual in South Africa, Fourth edition, Aagaard L. at al., Assessments of community pharmacy systems in selected countries - Identification of literature and experiences, 2011 Pharmakon; 63. Liuch M. Et al. Impact of regulation on community pharmacies on efficiency, access and equity, Evidence from UK and Spain, Health Policy 95 (2010) EAHP Survey Kovaceva M. et al., The Macedonian pharmacovigilance system and involvement of pharmacists, Book of abstracts, FIP, Patceva J. et al. Legal status of the pharmacy practice in the European Union and the Republic of Macedonia, Mac Pharm Bull, 58 (2012), in press 67. Rule Book for dispensing prescription medicines, Offcial Gazette of the Republic of Macedonia, No. 106/ Rule Book for the content, rights and obligations for obligatory health insurance, Official Gazette of the Republic of Macedonia, No. 54/ Тhe Hungarian Parliament Act No. CLXXIII of Rulebook for space, equipment and staff needed for establishment of health institution and perform health practice, Offcial Gazette of the Republic of Macedonia, No. 38/ available at 11/13/

92 72. racticegmpguidelinesinspectionchecklist/default.htm, available at 11/13/ _listing_ jsp&mid=wc0b01ac , available at 11/13/ Pharmacy Education and Training in Macedonia, 2012, PHARMINE, Pharmacy Education in Europe, available at 11/13/ Tempus project JEP Reconstruction of the Pharmacy Education in the Republic of Macedonia 76. Dimovski A. and Mladenovska K., The science and practice in the curricula of the faculty of pharmacy at the university Ss Cyril and Methodius in Skopje, Macedonia, Mac Pharm Bull, 57 (2011) Dimovski A. and Mladenovska K, Postgraduate study programs for specialist pharmacy education and training, Book of Proceedings, EAFP Annual Conference, Utrecht, May, Mladenovska K., Report on the study visit of a group of students from the Faculty of pharmacy, University Ss. Cyril and Methodius in Skopje, Macedonia at the Universities of Hamburg and Leipzig, October FIP statement of professional standards Continuing professional development Directive on recognition of professional qualifications 2005/ Ryozo Oishi, Current status of preparation and distribution of medicines, Am J Health-Syst Pharm, 2009, 66 (Suppl 3): S Law on protection of personal data, Official Gazzete of Republic of Macedonia No. 7/05, 103/08 92

93 ANNEX 1 COMMUNITY PHARMACY 93

94 DEMOGRAPHIC CHARACTERISTICS AND MANGEMENT OF THE COMMUNITY PHARMACY 1. Tick the category that best describes the ownership/institution responsible for establishing pharmacy (only one answer) state governance 2,41% local governance 6,02% independent (owned by the pharmacist itself) 24,1% partnership of pharmacists (owned by two or more pharmacists) 15,61% corporate body owning more than 1 pharmacy (part of pharmacy chain) 53,3% international ownership 0 non-profit making institution 0 other (please specify) 0,60% 2. Tick the category that best describes the location of your pharmacy Rural 3,05% Suburban 7,83% City of town centre 72,3% Out of town 1,2% Health centre (within or near) 16,3% Other 0 3. Tick the category that best describes the number of citizens currently served by the pharmacy 500 6,63% ,8% ,10% ,3% ,70% over ,50% other (please specify) 0 4. Tick the category that best describes the number of patients served by the pharmacy per month up to 500 3,01% ,7% ,3% ,7% ,0% over ,3% other (please specify) 94

95 5. Tick the category that best describes the total number of prescriptions dispensed by the pharmacy per month (reimbursed and not reimbursed by NIF) up to ,2% from 2000 to ,6% from 3000 to ,1% over ,1% 6. The total size of the pharmacy floor is: up to 25m 2 3,01% from 25-45m 2 45,2% from 45-65m 2 26,5% from m 2 17,5% over 100m 2 7,23% 7. The pharmacy setting has: Dispensary 96,4% storage room 94,6% office (administration room) 50,6% manufacturing room 3,61% control laboratory 1,2% other 2,41% 8. The pharmacy is open and available for providing services: 8 h/day 3,01% 12 h/day 95,8% 24 h 1,2% 9. The pharmacy is open and available for providing services (more answers): Monday 100% Tuesday 100% Wednesday 100% Thursday 100% Friday 100% Saturday 99,4% Sunday 67,5% Holidays 76,5% 10. The pharmacy provides 24 h on call service during the whole week? Yes 10,8% No 89,2% 95

96 11. The pharmacy computer software is connected to National Health Insurance Fund (NHIF) 19,3% Ministry of Health 6,02% Other pharmacies 39,2% National PharmacoInformation Center 14,5% 12. Full-time employed personnel in the pharmacy (write the number of the corresponding staff): Pharmacy technicians 2,08 /Pharmacy Pharmacists (Master in pharmacy) 1,63 /Pharmacy Specialists in related fields in community pharmacy 0,01 /Pharmacy Cleaning personnel 0,33 /Pharmacy Administrative staff 0,05/Pharmacy 13. Part-time employed personnel in the pharmacy (write the number of the corresponding staff): Pharmacy technicians Pharmacists (Master in pharmacy) Specialists in related fields in community pharmacy Cleaning personnel Administrative staff 14. Full-time or part-time employed (sub)specialist in (write the number of corresponding specialists!): clinical pharmacy pharmacoinformatics pharmaceutical technology 1% drug quality control community pharmacy regulatory affairs cosmetology herbal drugs nutrition 15. Tasks assigned to pharmacy technicians drug supply 42,2% drug dispensing 89,2% patient counseling 81,9% drug information 78,9% drug preparation and quality control 8,43% drug and medical devices acquisition, storage and distribution 23,5% other 2,41% 96

97 16. The pharmacy purchases medications and medical devices trough: Industry 6,02% Wholesalers 98,2% own production 3,61% other pharmacies 4,22% group purchasing 3,01% 17. The pharmacy purchases medications and medical devices: Daily 77,1% twice a week 17,5% weekly 1,2% monthly 18. The following services are provided in and by the community pharmacy dispensing prescription 93,98% repeat dispensing 88,55 disposal of medicines waste 40,36 Medicines use review 53,61 Blood pressure measurement 22,29 Cholesterol measurement 1,20 Glucose measurement 17,47 Weight measurement 5,42 Pregnancy test 11,45 Smoking cessation 3,01 Diabetes management 16,27 Asthma management 16,27 Hypertension management 19,28 Home care services 1,20 Night services 1,20 Vaccination The pharmacists inform the patients about the services provided in the pharmacy Yes 72,89% no 21,69% 20. Pharmaceutical services are provided for all patient groups 42,17% specific patient groups 9,04% 97

98 21. The pharmaceutical services provided in and by the pharmacy are documented Yes 24,70% no 33,13% 22. The services are offered on the advice of the pharmacist Yes 43,37% no 42,17% 23. The services provided in and by the pharmacy are reimbursed by the NHIF Yes 31,33% no 25,30% 24. The pharmacy has a contract with the National Health Insurance Fund (NHIF) Yes 95,18% No 4,82% 25. The budget for the reimbursed medicines determined by the NHIF is sufficient for supplying medicines according to the patients needs Yes 62,05% No 10,24% 26. The reimbursed medicines are available in the pharmacy each and every day Yes 83,73% No 16,27% 27. The received prescriptions that are reimbursed by NHIF are handwritten on paper in standardized form 5,42% printed on paper in standardized form 92,17% e prescriptions 1,21% 28. The medicine without co-payment (if appropriate) is first offered to the patient Yes 81,33% No 17,03% 29. The evidence about reimbursed medicines is kept separately from the evidence for other medicinal product and its access and evaluation are easy Yes 93,98% No 6,02% 98

99 30. The following activities are performed in the pharmacy data protection in compliance with the provisions of the legislation 90,36% correct annotation/endorsement of prescriptions at each dispensing 85,54% registration of information about dispensed medicines in a prescription book 69,28% documentation of all entries in a chronological order in a prescription book using an appropriate filing system that allows prompt retrieval of each and every prescription dispensed 63,86% management of the Controlled Drug Register (CDR) 37,35% 31. Dispensed prescriptions are retained in the pharmacy for at least five years from the date of last dispensing Yes 64,46% No 35,54% 32. The pharmacy keeps evidence of dispensed medicinal products in the patients records Yes 7,83% No 92,17% 33. The patient gives written consent to the pharmacy for keeping and maintaining his/her record Yes 2,41% No 97,59% 34. The patient s record contains basic patient information demographics, disease state, co-morbidity, allergies 9,64% drug history and actual list of prescribed drugs 12,05% dispensed OTCs, dietary supplements, herbal products, homeopathic and alternative medicines 1,20% laboratory and therapeutic drug monitoring data 2,41% alcohol and tobacco use 1,20% information about dispenser and dispensing 13,86% 35. Patients have access to their records kept in the pharmacy Yes 9,04% No 90,96% 36. The pharmacy services are managed: Internally 43,4% Externally 4,82% Both 53,0% 99

100 37. The pharmacy manager is qualified pharmacists Yes 93,4% no (specify the qualification ) 1,8% 38. The pharmacy manager is responsible to: Nobody 6,02% the pharmacy owner 64,5% the Minister of health 53,0% other 3,01% 39. The pharmacy manager is responsible pharmacist Yes 91,6% no (specify the qualification ) 6,02% 40. The responsible pharmacist is responsible to: Nobody 3,01% the pharmacy manager 72,9% the Minister of health 41,6% other 3,01% 41. Up-to-date policies and SOPs procedures are established for compounding magistral medicines 9,64% personnel education and training and competency evaluation 45,2% product acquisition, storage and handling 64,5% supplies, storage and delivery of products 66,3% use and maintenance of facilities and equipment 35,5% process validation 7,83% preparation technique 5,42% labeling 16,9% documentation 47,6% quality control 8,4% personnel access 43,9% movement of materials 10,8% monitoring environmental conditions 26,5% hygiene procedures 56,0% pest control 57,2% management of disposal of expired stock 61,4% products requiring specialized handling 24,1% medicines recall 53,1% reporting adverse drug reactions 45% 100

101 key holding 44,5% cash management 56,6% contingency in the event no pharmacy is present 33,7% complain handling 56,6% fire safety 62,6% incident management 38,5% 42. The pharmacy provides a pharmacy residency-training program that has been approved by the Pharmaceutical Chamber for licensing: Yes 33,1% How many pharmacy residents do you anticipate in your residency-training program per year up to 5 28,3% 5 to 20 4,2% 20 to 40 0,6% 40 to 50 0 over 50 0 No 44% 43. The pharmacy provides a pharmacy residency-training program that has been approved by the Ministry of Health for pharmacy technicians: Yes 47,2% How many pharmacy residents do you anticipate in your residency-training program per year up to 5 34,4% 5 to 20 2,4% 20 to to 50 0 over 50 0 No 35,5% Answer the following questions by choosing one of the options given below: A - Activity fully applied B - Activity partially applied C - Activity not applied (applicable) D - Activity not applicable 101

102 Statement A B C D I PHARMACY STRUCTURE AND PRACTICE A. PHARMACY STRUCTURE % 1. The premises clearly identify the pharmacy as a 96, healthcare facility 2. The premises are accessible to disabled patients 73,49 21,69 4,22 0,60 3. The service areas of the pharmacy are clearly 83,13 15,66 1,2 0 identifiable 4. Existing areas where medication orders are 90,36 6,02 1,81 1,81 reviewed, medications stored and dispensed are clean, adequately illuminated, free of clutter, distractions, interruptions and noise 5. The pharmacy provides suitable waiting area for 35,54 39,76 19,88 5,02 patients, with adequate seating 6. The pharmacy provides area where a patient may 40,96 43,37 9,64 6,03 have a private conversation with the pharmacist 7. The pharmacy provides patient counseling area, with 26,51 40,96 19,28 13,25 visual barrier to prevent unauthorized sight of patient records, prescriptions or product and suitable sound barriers to prevent any other individuals from overhearing private conversations 8. The pharmacy provides separate area for OTC drugs, 57,23 33,13 6,02 3,62 dietary supplements, herbal products, homeopathic and alternative medicines, which is easily approachable for the patients 9. The pharmacy provides area for health promotion 38,55 31,33 17,47 12, The pharmacy provides separate manufacturing area 11,45 0,60 15,06 72,89 according to the safety policies 11. The dispensing area is suitable in size for the 74,10 10, ,66 prescription volume providing uninterrupted and safe workflow 12. A refrigerator for medicinal products is available 72,29 21,69 3,61 2,41 according to the safety requirements 13. All the equipment in the pharmacy is calibrated and 42,77 12,05 18,67 26,51 checked according the standards 14. The existing computerized system is used for 96,39 1,81 0,60 0 dispensing medicines 15. The existing computerized system is used for 92,77 4,22 2 1,01 recording prescriptions 16. The existing computerized system is used for FEFO 35,54 22,29 24,10 18,07 (first expired first out) 17. The existing computerized system is used for 18,07 6,63 40,96 34,34 labeling 18. The existing computerized system is used for obtaining information on medicines and treatments 66,27 21,08 3,61 9,04 102

103 19. The existing computerized system is used for stock management 20. The existing computerized system is used for generating patient medication profiles 21. The existing computerized system is used for financial management 22. Computerized system is designed to perform alert for e.g. over/sub dose, serious drug interactions, (cross) allergies, contra indications, problematic/ similar drug names, packaging and labels etc. 23. The pharmacy that dispense medicines re-packed from the bulk has a dispensing system with printer producing legible and durable labels 24. There is a bar code scanner in the pharmacy for reading the medicinal products and prescriptions 25. Automatic devices are used for storage, distribution and dispensing of medicinal products 78,92 10,24 8,82 2,02 17,47 16,27 42,17 24,09 60,84 19,88 9,04 10,24 13,86 14,70 34,94 36,50 7,23 6,63 35,54 50,6 96,39 1,20 1,20 1, ,97 59,03 B. SUPPLYING, STORAGE AND STOCK 26. Written procedures are in place for ordering and 57,83 21,69 11,45 9,03 receipt of medicinal products 27. Policies and procedures are established to ensure 51,20 10,84 12,05 25,91 immediate supply of medicinal products (to ensure that a patient receives medication as required) 28. Policies and procedures are established for reception 39,16 3,01 25,30 32,53 and handling of controlled i.e. narcotic drugs 29. Medicinal products are ordered by Telephone 94,58 3,01 2, The stock supply in the pharmacy is always ordered 95,18 2,82 2,0 0 from a reputable distributer or manufacturer to avoid counterfeit drugs 31. The refrigerator used for the storage of medicinal 96,00 2,00 2,00 0 products is adequate for the quantity of product stored, with appropriate monitoring, cleaning, temperature mapping and maximum and minimum temperature recorded and documented 32. The pharmacy performs storage of drugs (shelved 87,35 7,83 2,00 2,82 and stocked) in designated areas in the way to ensure proper sanitation, temperature, light, ventilation, moisture control, segregation, and security 33. Examination of the packages and labels of new drugs 87,35 4,22 2,41 6,02 before use and comparison with other products to identify any potential for confusion is performed in the pharmacy 34. The pharmacy applies segregation of products with similar names and packaging and ensures that they 79,52 12,6 1,20 6,68 103

104 are not stored alphabetically and the place where the products are relocated is clearly marked 35. Use of auxiliary warnings or specific labels on packages and storage bins of drugs with similar names, packages and labels is performed in the pharmacy 36. Labels on the medication container face forward when stored upon shelving 37. Hazardous and flammable substances are stored separately in a manner which minimizes risk in compliance with legislation 38. Pharmacy stocks are reviewed and documented at least annually to determine low usage medications that may be eligible for removal from inventory 39. Expired or returned products awaiting disposal are clearly and securely segregated from the rest of the stock 40. All storage areas for medicinal products are under control of the pharmacist 41. The pharmacy follows policy for maintaining the cold chain 42. The pharmacy follows structured system of stock management 54,82 21,08 14,46 9,64 87,35 4,22 0,6 7,83 87,35 2,41 2,41 7,83 92,17 4,82 1,81 1,20 97,59 1,81 0, , ,05 62,65 7,83 10,84 18,68 59,64 10,84 12,05 17,47 C. DISPENSING 43. Written dispensing procedure exists in the pharmacy 51,81 10,84 14,46 22, The received prescriptions are printed on paper in 93,37 standardized form 45. All prescriptions are checked for legibility and 89,16 6,63 0,6 3,61 reviewed on recipe to check name, address and prescribed therapy 46. All prescriptions are routinely assessed for validity 92,77 0,6 2,41 4,22 and authenticity 47. Relevant patient information are obtained before 92,77 5,42 0 1,81 dispensing the prescription(s) 48. The prescription(s) are evaluated for possible 88,55 8,43 1,2 1,82 problems prior to dispensing 49. The pharmacists contacts the prescriber in cases 52,53 10,84 3,01 33,62 when potential problem with the prescribed medicines is identified 50. There is a record maintained in an easily retrievable 23,13 21,08 30,72 25,07 form when a prescriber is contacted to clarify the prescription 51. The medicines are checked for expired dates in routine management of the dispensary during each and every dispensing process 88,55 11,

105 52. The medicinal products in original packages are additionally labeled by the pharmacists providing information on dosage regimen, date and place of dispensing. 53. Doses that require less than a full dosage unit (e.g. tablet) are repacked in the pharmacy into unit-dose package 54. The products that are prepared in the pharmacy are adequately labeled by the pharmacists 81,33 18,01 0 0,6 15,30 13,86 6,02 64,82 100, D. ACCESS TO DRUG INFORMATION 55. National medicines formulary and Dug catalogues (registers) are available in the pharmacy and used for therapeutic drug management 56. Drug interaction references, guidelines and handbooks are used for medication use reviews 57. Pharmacists and pharmacy technicians have easy access to user-friendly, up-to-date computerized information systems, which include drug information, information on OTC drugs, herbal and alternative medicines, medication devices 58. The pharmacy provides access to important databases of biomedical literature, life science journals, online books (e.g. PuBMeD, MicroMedex, HINARI, ) 59. The pharmacy provides access to relevant legislation concerning pharmacy practice 60. The pharmacy is connected with the national/regional drug information center and/or another pharmacy to obtain up-to-date and accurate information on drugs and medication devices used in therapeutic drug management 93,37 5,42 0,6 0,61 70,48 20,48 3,61 5,43 90,96 6,02 0,6 2,42 18,80 28,31 10,24 42,65 83,13 10,24 1,81 4,82 55,42 17,47 15,06 12,05 II. PATIENT SAFETY - ACCESS TO PATIENT DATA, COMMUNICATION, COUNSELING AND EDUCATION 61. Basic information (patient s first name, last name, address, home telephone number, gender, birth date or age, physicians name) are obtained when dispensing medicines 62. Pharmacists obtain information for drug history for prescription medicines 63. Pharmacists obtain information for drug history for OTC drugs, dietary supplements, herbal products, homeopathic and alternative medicines 64. Basic information on co-morbid and/or chronic conditions (e.g. diabetes, renal or liver, impairment, 72,90 25,17 0 1,93 50,34 37,75 9,93 1,98 41,72 36,42 20,53 1,33 54,30 31,79 10,60 3,31 105

106 hypertension, pregnancy, lactation etc.), allergies, height and weight when patient is initially encountered are obtained when dispensing medicines 65. Pharmacists obtain information on patients social 40,40 31,13 19,87 8,60 and personal habits (dietary regimen, tobacco and alcohol use ) 66. In dispensing process, the pharmacist/dispenser 89,40 10, ascertains the clinical purpose of each prescription to ensure that the prescribed therapy is appropriate for the patient s condition 67. In dispensing process, the pharmacist/dispenser 82,78 11,26 2,65 3,31 considers the need for dose adjustments upon available clinical data 68. In dispensing process, the pharmacist/dispenser 90,73 9, takes steps to communicate effectively with the patients who are visually or hearing impaired 69. In dispensing process, the pharmacist/dispenser 90,73 9,27 0 takes steps to understand the cultural issues and overcome language barriers that may occur when patients are served 70. The pharmacists attempt to identify any drugrelated 98,34 1, problem patients may be experiencing 71. The pharmacist use enough time for patient 100, education and counseling about the medicines and therapy and dosage regimens 72. The pharmacist use enough time for patient 88,74 11, education and counseling about how to recognize ADRs, how to prevent them and how to manage them if they occur 73. The pharmacist use enough time for patient 82,12 17, education and counseling about the importance of regular therapeutic drug monitoring (where and how frequent he/she should check the efficacy and safety parameters of the therapy) 74. The patients are encouraged to ask questions about 92,72 7, the medications they are receiving 75. Pharmacists politely and clearly answer the 100, questions asked by the patients about their pharmacotherapy 76. The patients are encouraged to obtain additional 94,04 4,76 0,6 0,6 information about their medication therapy and have a confidential discussion with the pharmacist 77. The patients are informed about the potential error 80,09 11,97 1,32 6,62 with medicines known to be problematic (e.g. look - alike names, interactions, etc.) 78. The patients are provided with up-to-date, useful, 52,92 14,50 25,30 7,28 106

107 written information about medicines that they are receiving in their primary language 79. Adequate information resources are available to the patients to facilitate proper recognition and use of service for making informed choices 80. A procedure is in place informing the pharmacy staff when to refer a patient exclusively to the pharmacist 81. Regular audit is carried out by the pharmacist to ensure that abuse/misuse of non- prescription medicines is minimized 82. A policy is in place to assist individuals who may be abusing/misusing non-prescription medicines 83. Staff members who are trained to provide advice on the use of non-prescription medicines are visible and approachable 84. The patients are referred to other health care provider(s) when necessary 85. Pharmacists develop and organize educational programs for all or specific patient population groups to improve use of medications 56,22 19,14 22,65 1,99 49,54 13,18 27,28 10,00 11,85 25,83 45,03 17,29 28,74 21,26 25,50 24,50 25,05 23,00 21,95 30,00 54,50 11,50 11,50 22,50 10,46 8,48 54,44 26,62 III. MANUFACTURING PRACTICE AND DRUG QUALITY CONTROL 86. The pharmacy prepares dosage forms for all patients 4,22 0,60 18,67 76, The pharmacy prepares dosage forms for individual 11,45 0,60 15,06 72,89 patients 88. Up-to-date policies and procedures for 7,83 2,41 13,25 76,51 manufacturing of the products are written and available to all personnel involved in these activities 89. The pharmacy staff is trained and competent for 9,04 1,81 13,86 75,29 each step of the manufacturing process 90. The substances are appropriately managed (sourced, 9, ,46 76,50 stored, labeled and maintained) and accompanied by relevant safety data 91. The production of pharmaceuticals complies with 3,61 1,20 13,86 81,33 FDA/EMA standards 92. Appropriate range of containers is available for 9,04 0,60 13,86 76,5 packaging of extemporaneously compounded products 93. The responsible pharmacist verifies that the product 9, ,66 75,30 was compounded accurately with the correct ingredients, quantity of each ingredient, containers,. 94. Records for compounded product are easily 6,02 2,20 18,07 73,71 retrievable and stored in an appropriate manner for at least five years from date of compounding 95. Quality control and analytical procedures are 4, ,66 80,12 107

108 performed in the pharmacy 96. Quality control and analytical procedures are performed in accredited laboratory outside the pharmacy (contract service) 97. Analytical procedures are regularly performed to control the quality of the raw materials and pharmaceutical products 98. Regular audit system is in place to provide ongoing quality control 5, ,66 79,92 4,22 0,60 16,27 78,91 4,82 1,20 16,27 77,71 VI. STAFF - WORK FLOW, COMPETENCY AND PROFESSIONAL DEVELOPMENT A. WORK FLOW 99. Adequate staff is employed for traditional pharmacy 89,76 4,82 5,42 0 activities (e.g. purchasing, dispensing ) 100. Adequate staff is employed for pharmaceutical care 9,76 24,82 15,42 50 services 101. The personnel works 7 hours/day with 30-min break 87,95 4,82 2,41 4, An effective back-up plan is established for days 86,75 7,23 2,41 3,61 when staffing is short (due to e.g. illness, vacations, education, etc.) 103. All staff members are adequately trained and 96,39 2,41 1,2 0 competent to fulfill their duties 104. Pharmacy students/residents are trained and they 58,43 6,63 24,10 10,84 work no more than 8 hours/day 105. All professional activities in the pharmacy are carried out under supervision of a pharmacist at all times 59,88 4,70 1,81 33,61 B. COMPETENCY, CONTINUING EDUCATION AND PROFESSIONAL DEVELOPMENT 106. Pharmacists employed in the pharmacy are registered at the PCoM 107. All employed pharmacists are aware of their professional role and the associated boundaries and accountabilities 108. All staff is educated about new drugs added to the pharmacy inventory (e.g. via messages, package inserts placed in mailbox, written memo or alert, medicine monograph, etc.) and any associated guidelines, restrictions, and special precautions are understood before the medicinal product is dispensed 109. The pharmacist establishes a professional relationship with other health care providers 96,99 1,20 0, ,78 1,81 1,21 0,6 96,39 2,41 0,60 0,6 87,95 6,63 1,20 4,22 108

109 110. The pharmacists have competencies for gathering, analyzing and providing drug information 111. The pharmacists have competencies for patient counseling and education 112. The pharmacists have competencies for monitoring the medicine therapy and evaluation of the outcomes 113. The pharmacists have management competences (organization and communication skills, professionalism, management, legislation, economics, budget setting, self management) 114. the pharmacists accept the concept of CPD as a part of the relicensing process 115. the pharmacists collect credits by attending educational courses, workshops related to their professional practice 116. the pharmacists are supported by the pharmacy management for educational programs 117. the pharmacists are financially supported by the management to attend most of the national and international educational/professional events related to their practice 118. Pharmacists prepare annual portfolio for their own continuing education and professional development 119. The newly-employed pharmacists spend a defined time period for training and evaluation of their competency before they can work independently 120. The training period of the newly-employed pharmacists is individualized and based on an ongoing assessment of their needs 121. Pharmacists are trainers of pharmacy students and residents and they are reimbursed for training of pharmacy students and residents by the authorized institution (e.g. Faculty of Pharmacy, Pharmaceutical Chamber of Macedonia, Ministry of Health, etc.) 122. Pharmacists engaged in training of other pharmacists, pharmacy students or residents have reduced workload 123. The pharmacy manager provides formal teamwork training to all staff incorporating elements of information sharing, conflict management, communication and teamwork skills and clarification of team roles and tasks 83,13 10,85 2,41 3,61 83,13 5,42 10,25 1,20 31,45 10,88 22,25 35,42 56,63 22,89 16,87 3,61 86,14 6,02 7, ,57 1,20 7, ,76 1,81 0,60 7,83 55,66 5,75 18,43 20,66 41,57 27,11 13,25 18,07 77,71 9,04 4,22 9,03 77,11 10,84 2,40 9,65 46,99 13,25 10,84 28,92 15,66 12,65 36,14 35,55 71,08 7,83 7,83 13,26 V. QUALITY ASSURANCE, RISK AND DATA MANAGEMENT A. QUALITY ASSURANCE 109

110 124. The pharmacy has a current, structured, written 50,00 18,07 9,64 22,29 quality assurance program 125. Sufficient personnel is available to perform tasks 79,52 16,27 2,41 1,80 adequately 126. The pharmacy is well supplied with medicines 95,78 3,01 0,60 0,61 according to the patient needs 127. The working hours of the pharmacy are prominently 97,59 2, displayed, together with advice for the provision of after-hour services 128. Up-to-date policies and SOPs are established and 65,66 13,86 6,02 14,46 considered in everyday practice to ensure adequate personnel selection, training, supervision, and evaluation 129. Up-to-date policies and SOPs are established and 62,89 10,84 4, considered in everyday practice to ensure that reasonable workload levels and working hours are established and rarely exceeded 130. Lines of authority and areas of responsibility are 87,35 10,24 1,81 0,6 clearly defined for medication use process 131. Similarly packed products are stored and positioned 89,16 9,04 1,20 0,6 in a manner that minimizes the possibility for mix-up 132. The products with a narrow therapeutic index are 49,28 18,07 6,02 26,63 highlighted 133. The pharmacists perform interventions so that 95,18 4,22 0,6 0 errors that may accure during prescribing and dispensing are avoided 134. Medication errors are thoroughly evaluated in an 83,73 9,64 6,03 0,60 open, non-punitive manner 135. A non-punitive anonymous medication error 45,18 22,89 14,46 17,47 reporting system has been established 136. Medication errors and ADRs are reported to the 44,58 21,08 17,47 16,87 National Pharmacovigilance Center 137. Pharmacist are regularly educated on participating in 48,31 13,25 6,03 32,41 medication error reduction process and understand the importance of reporting medication errors 138. here is a process for product recalls and prompt 64,46 12,05 4,82 18,67 caution-in-use notifications 139. When an event involves human error, an 57,71 7,83 3,01 31,45 investigation is undertaken to detect uncover and pre-existing factors (e.g. staff who did not follow a procedure, task complexity, urgency, fatigue, stress, training, etc.) 140. All medication errors that reach the patient are 57,83 15,66 6,02 20,49 honestly disclosed to patients/relatives in a timely manner 141. Pharmacists involved in serious errors that cause 45,78 16,87 14,46 22,89 110

111 patient harm have professional help and are emotionally supported by their colleagues and manager 142. The medication use process is analyzed at least 51,81 15,66 10,84 21,69 annually to identify risk factors for medication errors (e.g. self-assessment questionnaire) 143. The outside agency assists with the quality 27,11 15,06 22,29 35,54 assurance documentation 144. The patient satisfaction with the services offered is 33,13 23,49 17,47 25,91 monitored, evaluated and documented 145. Patients are informed on the complain procedure 57,83 15,66 9,64 16, The quality assurance program is reviewed regularly 52,4 13,25 9,64 24,71 B. DATA MANAGEMENT WITHIN THE PHARMACY 147. The pharmacy protect in compliance with the provisions of the legislation 148. The pharmacists correctly annotate/endorse prescriptions at each dispensing 149. The pharmacists register information about dispensed medicines in a prescription book 150. The pharmacists document all entries in a chronological order in a prescription book using an appropriate filing system that allows prompt retrieval of each and every prescription dispensed 151. The pharmacy manage the Controlled Drug Register (CDR) 152. Dispensed prescriptions are retained in the pharmacy for at least five years from the date of last dispensing 153. The pharmacy keeps evidence of dispensed medicinal products in the patients records 154. The patient gives written consent to the pharmacy for keeping and maintaining his/her record 155. Patients have access to their records kept in the pharmacy 90,36 4,22 1,81 3,61 85,54 11,45 0,6 2,41 69,28 21, ,62 63,86 20,48 11,45 4,21 39,16 3,01 25,30 32,53 64,46 12,65 11, ,83 19,28 41,57 31,32 2,41 4,22 53,61 39,76 9,04 1,81 33,13 56,02 111

112 ANNEX 2 HOSPITAL PHARMACY 112

113 DEMOGRAPHIC CHARACTERISTICS OF THE HOSPITAL/HOSPITAL PHARMACY 1. Tick the category that best describes the ownership/institution responsible for establishing operational policy in the hospital state governance 88.64% local governance 0% investor-owned (profit making institution) 11.36% non-profit making institution 0% military governance 0% 2. The hospital belongs to a group of hospitals with common ownership and/or governance: Yes 22.73% International ownership/governance Ownership/governance in EU-member country 10% Ownership/governance in non EU-member country 20% Domestic ownership/governance 70% No 77.27% 3. Tick the category that best describes the type of your hospital in respect to services offered to inpatients university clinical centre 2.27% clinical hospital 6.82% general medical (internal medicine) 0% general surgical 6.82% general medical/surgical 36.36% long-term acute care 2.27% cardiology 2.27% oncology 2.27% gynecology and obstetrics 6.82% pediatric 2,27% psychiatric 6.82% gerontology 2.27% orthopedic 4.55% ophthalmology 2.27% pulmonary diseases 11.36% nephrology 2.27% hematology 2.27% 4. Tick the category that best describes the number of citizens currently served by the hospital up to % to % to % to % % over % 113

114 5. Tick the category that best describes the type of patients currently served by your pharmacy In-patients with full hospitalization 32.35% outpatients (ambulatory patients) 5.88% inpatients and outpatients 61.76% 6. Tick the category that best describes the location of your pharmacy Satellite 11.76% Central 88.24% 7. Tick the category that best describes the number of inpatient beds currently served by the hospital pharmacy fewer than 50 beds 11.11% 50 to 99 beds 7.41% 100 to 199 beds 18.52% 200 to 299 beds 3.70% 300 to 399 beds 29.63% 400 to 499 beds 0% 500 to 1000 beds 25.93% over 1000 beds 3.70% 8. Tick the category that best describes the average duration of stay for inpatient per year fewer than 15 days 72.73% 15 to 30 days 13.64% 30 to 60 days 13.64% 60 to 90 days 0% over 90 days 0% 9. Tick the category that best describes the number of outpatients served by the hospital pharmacy per year fewer than % 1000 to % 5000 to % to % over % 10. Tick the category that best describes the type of pharmacy services provided on an aroundthe-clock basis drug and medical devices acquisition, storage and distribution 100% I.V. admixture services 4.54% clinical pharmacy services 21% drug information services 32% education and research 5.9% 114

115 11. The pharmacy is open and available for providing services: 8 h/day every day, incl. weekends 5.88% 8 h/day except weekends 79.41% 12 h/day every day, incl. weekends 5.88% 12 h/day except weekends 2.94% 24 h every day, incl. weekends 2.94% 24 h every day except weekends 2.94% 12. The pharmacy provides 24 h on call service during the whole week? Yes 41.18% No 58.82% 13. Tick the category that points to the hospital pharmacy budget for acquisition of drugs per year of total hospital budget up to 30% 25% 30 to 40% 55% 40 to 60% 15% over 60% 5% 14. Tick the category that points to the overall hospital pharmacy budget per year of total hospital budget up to 30% 13.33% 30 to 50% 60% 50 to 70% 26.67% over 70% 0% 15. Part of the overall hospital pharmacy budget is regularly (annually) allocated to improvement of pharmacy structure Yes 0% no 100% 16. Full-time employed personnel in the pharmacy (write the number of the corresponding staff): Pharmacy technicians 1.68 /Pharmacy Pharmacists (Master in pharmacy) 0.68 /Pharmacy Specialists in related fields in hospital pharmacy 0.57 /Pharmacy Master in pharmacy + specialist 1.25 /Pharmacy Cleaning personnel 0.32 /Pharmacy Administrative staff 0.52 /Pharmacy 115

116 17. Full-time or part-time employed (sub)specialists in (write the number of corresponding specialists!): clinical pharmacy 9 pharmacoinformatics 6 pharmaceutical technology 9 drug quality control 1 oncology pharmacy 0 (par)enteral nutrition Tasks assigned to pharmacists patient counseling 29.41% drug information 55.88% drug preparation and quality control 29.41% drug and medical devices acquisition, storage and distribution 82.35% education and research 3.13% administration 5.69% 19. Tasks assigned to pharmacy technicians patient counseling 0% drug information 5.88% drug preparation and quality control 23.81% drug and medical devices acquisition, storage and distribution 76.19% administration 8.82% 20. The hospital/pharmacy purchases medications and medical devices trough: Industry 61.76% Wholesalers 94.12% own production 20.45% other (hospital) pharmacies 8.82% group purchasing 0% 21. The pharmacy services are managed: Internally 94.12% Externally 5.88% 22. The pharmacy manager is responsible to: nobody 2.94% the hospital director 82.35% the clinical centre director 11.76% the Minister of health 2.94% 23. The pharmacy manager is qualified pharmacists Yes 96.77% No 3.23% 116

117 24. The pharmacy staff participates in hospital committees (e.g. Pharmacy & Therapeutic Drug Committee, etc): Yes 67.86% no 32.14% o If yes, indicate the title of the hospital committee 25. Hospital drug formulary is created and used for therapeutic drug management Yes, own formulary harmonized with the national list of essential drugs 15.91% Yes, own formulary non-harmonized with the national list of essential drugs 0% No, national list of essential drugs only 84.09% 26. Hospital drug formulary is updated every year 85.71% every 2 years 14.29% every 5 years 0% over 5 years 0% 27. (A) Designated pharmacist(s) participate(s)in creation and implementation of hospital drug formulary Yes 42.86% No 57.14% 28. Hospital drug formulary contains: price information 57.14% dosage regimens 42.86% prescribing information 14.29% hospital drug use policy 14.29% antibiotic prescribing protocols 14.29% local antibiotic susceptibility 0% 29. Number of drug products in hospital drug formulary fewer than % % % over % 30. Number of chemical entities in hospital drug formulary fewer than % % % % over % 117

118 31. Standard protocols/guidelines based on evidence are used for therapeutic drug management Yes, own protocols/guidelines 28.57% Yes, national protocols/guidelines 42.86% No 28.57% 32. Up-to-date policies and SOPs are established for compounding sterile products 41.67% personnel education and training and competency evaluation 20.83% product acquisition, storage and handling 66.67% supplies, storage and delivery of final products 45.83% use and maintenance of facilities and equipment 25% appropriate garb and conduct for personnel working in the controlled area 16.67% process validation 37.5% preparation technique 29.17% labeling 33.33% documentation 54.17% drug quality control 25% personnel access into and near the controlled area 12.5% movement of materials into and near the controlled area 29.17% monitoring environmental conditions in the controlled area 25% safe use of sterile products once they are distributed out of pharmacy 4.17% providing drug information 4.17% 33. Sterile/non-sterile pharmaceuticals are prepared for: use in the hospital 100% sell to other hospitals 11.11% for intensive care unit only 0% 34. Sterile/non-sterile pharmaceuticals are prepared for: inpatients 100% outpatients 43,75% homecare patients 0% 35. Quality control and analytical procedures are performed in the pharmacy 44,44% in accredited laboratory outside the pharmacy (contract service) 55,56% 36. Drug quality control includes stability studies of the formulation (chemical, physical) 57.14% sterility tests 100% non-pyrogenicity testing 85.71% chemical content 85.71% purity 71.43% analysis of raw materials 71.43% analysis of packaging materials 71.43% analysis of final pharmaceutical product 100% 118

119 37. The pharmacy has a computer system: integrated with the hospital/ward(s) computer system 32.26% interfaced with the hospital/ward(s) computer system 3.23% not integrated/interfaced with the hospital/ward(s) computer system 64.52% 38. The pharmacy provides a pharmacy residency-training program that has been approved by the University/Faculty Council for Master of Pharmacy and Specialist (in fields of hospital pharmacy) education: Yes 76.47% How many pharmacy residents do you anticipate in your residency-training program per year up to % 5 to % 30 to % 60 to % No 23.53% 39. The pharmacy provides a pharmacy residency-training program that has been approved by the Pharmaceutical Chamber for licensing: Yes 75.76% How many pharmacy residents do you anticipate in your residency-training program per year up to 5 64% 5 to 20 28% 20 to 40 4% 40 to 50 0% over 50 4% No 24.24% 40. The pharmacy provides a pharmacy residency-training program that has been approved by the Secondary school/ministry of Health for pharmacy technicians: Yes 66.67% How many pharmacy residents do you anticipate in your residency-training program per year up to 5 45% 5 to 20 20% 20 to 40 30% 40 to 50 5% No 33.33% Answer the following questions by choosing one of the options given below: A - Activity fully applied B - Activity partially applied C - Activity not applied (applicable) D - Activity not applicable 119

120 Indicator A B C D I PATIENT SAFETY A. PATIENT INFORMATION 1. (Clinical) pharmacist participates in clinician/ward rounds and discuss with the physician(s) about the patient pharmacotherapy 2. (Clinical) pharmacist employed in satellite (decentralized) pharmacy visits the patients at least once daily* 3. (Clinical) pharmacist employed in central pharmacy spends at least 50% of his/her time in his/her ward(s) patient care area(s)** 4. Comprehensive information for inpatients (demographics, disease state, co-morbidity, allergies, recent laboratory and TDM data) is obtained and stored in electronic record (incl. COPE***) 5. Comprehensive information for outpatients and home care patients 1 (demographics, disease state, co-morbidity, allergies, recent laboratory and TDM data) is obtained and available in electronic record (incl. CPOE) 6. Complete drug history and actual list of prescribed drugs and OTC drugs (incl. dosage regimens and routes of administration), vitamins, herbal drugs, illicit drugs, alcohol and tobacco use is obtained upon admission of inpatients and stored in electronic record (incl. CPOE) 7. Complete drug history and actual list of prescribed drugs and OTC drugs (incl. dosage regimens and routes of administration), vitamins, herbal drugs, illicit drugs, alcohol and tobacco use is obtained for outpatients and home care patients**** and stored in electronic record (incl. CPOE) 8. Pharmacist verifies that any patient medication and allergy information is accurately included in patient record 9. Ongoing patient data (demographics, disease state, co-morbidity, medications, allergies, laboratory and TDM data for each episode of care) are maintained for at least 5 years and they are considered by a % *To be answered by pharmacists employed in satellite pharmacy **To be answered by pharmacists employed in centralized pharmacy ***Computer prescribing order entry system ****Do not answer the question if this type of patients is not currently served by your pharmacy 120

121 pharmacist when a patient is readmitted 10. (Clinical) pharmacist can access inpatient information (demographics, disease state, comorbidity, medications, allergies, recent laboratory and TDM data) while working in his/her respective location for therapeutic drug management electronically 11. (Clinical) pharmacist can access outpatient and home care patient information**** (demographics, disease state, co-morbidity, medications, allergies, recent laboratory and TDM data) while working in his/her respective location for therapeutic drug management electronically 12. Pharmacist can access inpatient information (demographics, disease state, co-morbidity, medications, allergies, recent laboratory and TDM data) while working in his/her respective location for dose adjustment of narrow therapeutic index/highly toxic drugs electronically 13. Pharmacist can access outpatient and home care patient 4 information (demographics, disease state, co-morbidity, medications, allergies, recent laboratory and TDM data) while working in his/her respective location for dose adjustment of narrow therapeutic index/ highly toxic drugs electronically 14. Routine medication orders are reviewed by a pharmacist prior to administration of first doses for over 90% of drugs 15. (Clinical) pharmacist is engaged in providing direct inpatient pharmaceutical care at the hospital ward(s) to all patients 16. (Clinical) pharmacists is engaged in providing direct outpatient and home patient pharmaceutical care to all patients 17. (Clinical) pharmacist is engaged in inpatient chart and medication use review of all patients 18. (Clinical) pharmacist is engaged in outpatient and home care patient**** chart and medication use review of all patients 19. (Clinical) pharmacist is engaged in inpatient medication reconciliation of all patients 20. (Clinical) pharmacists is engaged in outpatient and home care patient**** medication reconciliation of all patients 21. Pharmacists review medication orders for appropriateness of the drug dose, frequency and route of administration for patient during surgery

122 22. (Clinical) pharmacists design drug administration schedules for specific groups of patients (e.g. patients with polytherapy, specific lifestyle, etc.) to minimize the risk for decreased efficacy and/or increased toxicity (e.g. adverse drug interactions, non-adherence, etc.) 23. Pharmacists manage pharmacotherapy for home care patients**** with high-risk medication regimens, in collaboration with other members of the health-care team 24. Patient use of their own medicine is allowed only for unusual medicines that are not available in the hospital pharmacy and when suitable alternatives are not available 25. Pharmacist communicates electronically, by mail or phone with the community pharmacist for the individual patient s therapy when he/she discharged from hospital 26. Medications brought by a patient/family member are not administered to the patient until a pharmacist has visually inspected the medication and verify its identity, labeling and packaging 27. Pharmacists document their interventions and outcomes of pharmacotherapy for inpatients in electronic record 28. Pharmacists document their interventions and outcomes of pharmacotherapy for outpatients and home care patients 4 in electronic record B. PATIENT COUNSELING AND EDUCATION 29. Counseling/education for the purpose, efficacy and safety of the recommended pharmacotherapy, prescribed dose, use of medical device(s), etc. is routinely provided by the pharmacists prior and during the therapy to all inpatients and/or outpatients and/or their family members 30. Pharmacists are skilled to provide counseling and education to patients with special needs (deaf patients, blind patients, etc.) 31. Patients/family members are provided with supplementary information important for the outcome of the pharmacotherapy (nutrition, lifehabits, physical activity, etc.) 32. Patients/family members are provided with written information on the drugs that are prescribed in their primary language

123 33. Patients/family members are encouraged to ask questions about the medications they are receiving 34. Pharmacists politely and clearly answer to all questions asked by the patients/family members about the pharmacotherapy 35. Hospital pharmacists develop and organize educational programs for all or specific patient populations to improve use of medications 36. Patients are educated by the (clinical) pharmacist how to recognize ADRs, how to prevent them and how to manage them if they occur 37. Patients are educated by the (clinical) pharmacist about the importance of regular therapeutic drug monitoring, where and how frequent they should check the efficacy and safety parameters of the therapy 38. Patients are educated by the (clinical) pharmacist about the importance of keeping list of all medications they take at home, to carry the list with them and to show the list to the drug prescriber 39. Patients are instructed when and whom to call for questions or drug related problems after discharge II MEDICINES AND MEDICATION DEVICES A. MEDICINE/MEDICATION DEVICE INFORMATION 40. The hospital pharmacy is connected with the national/regional drug information center and/or another hospital to obtain up-to-date and accurate information on drug and medication devices used in therapeutic drug management 41. The pharmacy provides a drug/medication device information service to healthcare givers at the hospital units 42. The pharmacy provides a drug/medication device information service to healthcare givers outside the hospital 43. Specialist in drug information is engaged in providing drug/medication device information services, answers complex clinical questions and educate prescribers about quality use of medicines and medication devices 44. Pharmacists and pharmacy technicians have easy access while working in their respective location to user-friendly, up-to-date, computerized information systems, which include drug %

124 information, information on OTC drugs, herbal and alternative medicines, medication devices 45. The hospital pharmacy provides access to important databases of biomedical literature, life science journals, online books (e.g. PuBMeD, MicroMedex, HINARI, ) 46. Current international and national drug information databases in printed editions are available in hospital pharmacy (e.g. USP DI, Martindale, PDR, Drug register of RoM, etc.) 47. Protocols, standardized dosing guidelines and/or checklists are available in the pharmacy and used by pharmacists for individualization of high-alert and/or narrow-therapeutic index drugs (e.g. chemotherapy, AEDs, anticoagulants, digoxin, opoids, insulin, immunosuppressants, etc.) 48. All internationally developed drug information tools (e.g. pocket references, drug information cards, standard order sets, protocols or checklists, patient education materials) are available in the pharmacy and undergo a formal approval process before use (e.g. review by pharmacist) and annual evaluation 49. Pharmacists are informed about information technology systems (e.g. pharmacy CPOE system, smart pump technology, automated compounding devices, etc.) used to assure adequate drug and dosage regimen 50. CPOE system is available (performs dose range checks and alerts maximum dose limits, adverse drug interactions, allergies/cross allergies, interactions drug-biochemical parameters, contraindications, problematic/similar drug names, packaging and labels 51. Pharmacists are actively involved in the development and implementation of evidencebased drug therapy protocols, hospital drug formularies, guidelines, etc. 52. Before a decision is made to add a drug to the hospital formulary, several parameters are considered (e.g. interactions, price, level of evidence, etc.), and an internal risk assessment is made that includes staff who are involved in TDM and the results of this assessment are documented in the drug monograph submitted to the Pharmacy and Therapeutics committee 53. When high-alert drugs are approved for addition

125 to the hospital formulary, safety enhancements such as standardized order sets, prescribing guidelines, check systems, reminders, administration guidelines, monitoring protocols and/or limitations on use, administration and storage of drugs are established and implemented 54. Ongoing-hospital wide surveillance for at least 6 months is initiated immediately after adding a drug to the hospital formulary 55. A designated pharmacist(s) is/are responsible for providing up-to-date information on medical errors and ADRs reported since formulary approval and undertaking necessary activities for drug removal from the formulary 56. Non-formulary products are used only when no alternative exists (e.g. contraindications, ADEs, shortage of formulary drug, etc.) B. ORDERING COMMUNICATION 57. Medications/medication devices are ordered from the wards by entering orders into CPOE system, which includes decision support and standardized order sets 58. Medications/medication devices are ordered from the wards verbally (face-to-face), by phone, fax, mail only in a case of emergency 59. Medications/medication devices are ordered from the wards by pharmacists 60. Verbal or telephone orders are never accepted for oral or parenteral chemotherapeutic agents, incl. chemotherapeutic agents used for nononcologic indications 61. When verbal or telephone/mail orders must be taken, the orders are immediately transcribed by the pharmacist and then sent to the prescriber for verification 62. Medications are not removed from inpatient unit stock before a pharmacist review the specific patient order and screens/take a copy of order for safety 63. Medications are not removed from outpatient 4 unit stock before a pharmacist review the specific patient order and screens/take a copy of order for safety 64. Medication administration records (MARs), which are used to guide and document medication %

126 administration are electronic 65. MARs are available during the selection/ preparation of the medications and at the patient s bedside 66. IV and epidural infusion/medication doses are standardized in the standard order sets and MARs (e.g. mg/kg, mcg/kg/min, etc.) 67. Preprinted order forms for commonly encountered diseases states, procedures or specific drugs (e.g. NTI drugs, second-line drugs) are used to guide the use of drugs 68. Pharmacy interventions regarding potentially harmful medication order are immediately communicated to the nurses/prescribers to halt the potential administration while awaiting clarifying of the order 69. In non-urgent situations, off-label drug orders and orders for drugs in atypical doses are checked and approved by the pharmacists 70. In urgent situations, there is a formal checking system conducted by the pharmacist for off-label drug orders and orders for drugs in atypical doses 71. Cancer chemotherapy orders are verified by the pharmacist for the appropriateness of the ordered medicine, dose, dilution method, administration route and schedule, premedication and auxiliary medication to treat ADEs associated with chemotherapy 72. Elements of the high-alert drugs (e.g. chemotherapy) orders are evaluated in the context of established protocols and the patient height, BW, BSA and laboratory parameters of renal and liver impairment 73. Time for order verification is consistent and depends on urgency 74. A designated pharmacist, with a postgraduate qualification, is authorized to prescribe any licensed medicine for any medical condition within his/her competence, with exception of controlled drugs 75. A designated pharmacist, with a postgraduate qualification, is authorized to prescribe therapeutic substitution C. SUPPLY, STORAGE, LABELING, DISTRIBUTION AND ADMINISTRATION 76. At a minimum, pharmacists are actively involved % 126

127 in all medications purchasing 77. At a minimum, pharmacists are involved in all medication devices purchasing and replacement decision 78. The pharmaceuticals are supplied via public tendering procedures 79. Pharmacy and Therapeutic committee consisted of one pharmacist at least decides for acquisition of drugs and medication devices 80. An initial risk assessment is performed to determine the various types of medication device, identify the possible difficulties in their utilization and address process changes that need to be made and this assessment is updated prior to the purchase of any new medication device 81. Pharmacists participate in planning of annual budget for acquisition of drugs and medication devices and they are informed about the budget allocated and the dynamic of expenditures 82. All drugs are stored in designated areas within the hospital pharmacy which are sufficient to ensure proper sanitation, temperature, light, ventilation, moisture control, segregation, and security 83. Medicines are stored in and dispensed from automatic storage and distribution devices 84. Alcohol and flammables are stored in areas that meet, at a minimum, basic local building code requirements for the storage of volatiles 85. Pharmacy and/or ward stocks are reviewed at least annually to determine low usage medications that may be eligible for removal from inventory 86. Drugs stocked in wards are carefully selected by considering the needs of each patient care ward and unit stock is reviewed every day 87. Drugs stocked in wards are available in the least number of doses, concentrations, and forms that will meet essential patient needs between replenishment (not to exceed 72 h) 88. Solutions, drugs, supplies and equipment used to prepare or administer sterile products are stored in accordance with the manufacturer or Pharmacopoeia requirements 89. Temperatures in refrigerators and freezers used to store ingredients and finished sterile preparations are monitored and documented daily 90. Electronic systems that document temperature

128 ranges and provide immediate problem notification are used for refrigerators that store critical, temperature-sensitive medications and SOP for how to handle any breach have been developed and followed 91. The packages and labels of new drugs are examined before use and compared to other products to identify any potential for confusion 92. Products with similar names and packaging are segregated and not stored alphabetically and the place where the products are relocated is clearly marked 93. Auxiliary warnings or specific labels are used on packages and storage bins of drugs with similar names, packages and labels 94. Bulk chemicals used in the pharmacy are labeled with contents, the date the product was first opened and the expiration date 95. All large-volume bags and bottles of irrigation solutions, organ storage solutions and sterile water are packed, stored and labeled in a way that clearly differentiates them from solution that are administered parenterally 96. At a minimum, all medication containers taken to the bedside or use (e.g. syringes, vials and ampoules, etc.) are labeled with at least the drug name and strength/concentration 97. Unit oral doses (patient specific oral medications) remain in the original (manufacturer s) packaging up to the point of actual drug administration at the bedside so the drug is checked for compliance with the MAR 98. Doses that require less than a full dosage unit (e.g. tablet) are repacked by the pharmacy into unit-dose package 99. Machine readable codes are used for labeling of commercial drugs and medicinal products prepared in the pharmacy and they are used in the drug distribution system 100. The central pharmacy has unit-dose distribution system 101. The pharmacy uses robotic packaging/ distribution system 102. Oral liquid medications are dispensed from the central pharmacy to patient care units (e.g. for pediatric patients) in ready-to-use patient specific doses ,11 11,11 11,11 66,

129 103. Parenteral medications are dispensed from the central pharmacy to patient care units in readyto-use patient specific doses (e.g. single unit-ofdose syringes) 104. Vials of concentrated electrolytes are distributed to authorized patient care units only and stocked in limited quantities in secure storage areas 105. Before drug administration to ensure patient identification and other essential steps in medication administration barcode readers are used (bar-code-assisted dispensing system) 106. High-alert drugs used within the hospital are identified, error-reduction strategies have been established for these drugs and these have been communicated to all practitioners who prescribe, dispense and administer the products and monitor their effects 107. Double check process before medication administration is a standard practice 108. There is a standardized procedure for dispensing chemotherapy for the same procedure (e.g. dispensing intrathecal chemotherapy on different days or times from other chemotherapy) 109. When using i.v. administration devices, administration rates are regularly calculated and checked 110. When using NTI drugs, dosage regimens are regularly calculated taking into account the individual PK parameters and TDM data 111. Double check when calculations are necessary is a standard practice 112. There is a practice to validate mathematical skills of the pharmacists responsible for calculations (e.g. dosage, concentration, infusion rate, etc.) 113. Electronic infusion control device (EICD) is used for solution delivery and criteria have been established to determine which patient populations, specific medications and infusion rate require EICD Concentrations for infusion of all drugs are standardized, for all patient groups, to a single concentration that is used in at least 90% of the cases 115. Smart pumps that include drug libraries with pre-established dose and rate limits based on standard concentration are implemented in drug administration

130 116. Identification labels on tubing near the insertion site are used to prevent misconnections 117. Specially designed oral syringes are available in the pharmacy and are used for administering oral/enteral liquid medications 118. Enteral feeding catheters that cannot connect with i.v. or other parenteral lines are used 119. Self-administration of drugs by patients is permitted only when specifically authorized by the treating or ordering physician; provided the patient has been educated and trained in the proper manner of self-administration and there is no risk of harm to the patient 120. All patients are routinely provided with all necessary medications when discharged from hospital III MANUFACTURING PRACTICE A. PRODUCTION % 121. The pharmacy prepares dosage forms for the individual patient both sterile and non-sterile 122. Sterile pharmaceuticals are produced using i.v. bag production line 123. The production of pharmaceuticals complies with EU/FDA GMP 124. Hazardous medicines (e.g. cytotoxic anticancer drugs) are prepared in a laminar flow hood/biological safety cabinet 125. Chemotherapy doses are prepared under supervision of pharmacist / in pharmacy department 126. Unit-dose medicines for parenteral administration are prepared in laminar flow hood/using aseptic technique 127. Up-to-date policies and procedures for compounding sterile products are written and available to all personnel involved in these activities 128. Master work and preparation sheets are developed for a batch of each discrete identity and concentration of sterile product to be prepared and they are verified by a responsible pharmacist 129. The pharmacy/staff participates in clinical studies and prepares drugs for clinical studies

131 B. DRUG QUALITY CONTROL 130. Analytical procedures are regularly performed to control the quality of the raw materials and pharmaceutical products 131. The responsible pharmacist verify that the product was compounded accurately with the correct ingredients, quantity of each ingredient, containers and reservoirs 132. The final sterile products are inspected when the products are dispensed 133. Complete documentation for sterile products is prepared 2 * , IV ENVIRONENT, WORKFLOW, STAFF AVAILABILITY AND QUALIFICATIONS A. ENVIRONMENT AND WORKFLOW 134.Existing areas where medication orders are reviewed, medications stored and dispensed have adequate space and they are clean, adequately illuminated, without clutter, distractions, interruptions and noise 135. Pharmacy area has adequate space for drug manufacturing 136. Pharmacists and pharmacy technicians employed are sufficient to perform every-day tasks 24 hours 137. The personnel works 8 hours/day with 30-min break 138. An effective back-up plan is established for days when staffing is short (due to e.g. illness, vacations, education, etc.) 139. Pharmacy students/residents are trained and they work no more than 8 hours/day , ,77 87, , ,93 9,68 B. COMPETENCY, CONTINUING EDUCATION AND PROFESSIONAL DEVELOPMENT % 140. A dedicated pharmacist run drug information center and educate medications prescribers (specialist in drug information) *Complete documentation for sterile products consisted of master work sheet, preparation and sterilization records, quarantine records, end-product evaluation and testing results, training and competency evaluation, refrigerator and freezer temperatures, certification of laminar-airflow workbenches 131

132 141. The pharmacy has adequate trained and dedicated personnel to meet the medicationtechnology requirements (e.g. CPOE, etc.) 142. A dedicated pharmacist offers clinical pharmacy services (specialist in clinical pharmacy) 143. Pharmacists participate in ethical and review committees for clinical studies as full voting members 144. Pharmacists are encouraged to complete postgraduate studies in relevant clinical areas: specialist pharmacists in high-risk areas (e.g. oncology, pediatrics) 145. Pharmacists are encouraged to increase their knowledge in prescribing medications 146. Pharmacists participate in hospital multidisciplinary committees as full voting members 147. Pharmacists control all drug-related logistics in the hospital 148. A dedicated pharmacist runs pharmacoeconomic analyses and provide information on the evidence and pharmacoeconomic issues for each drug (specialist in pharmacoeconomy) 149. Pharmacists are encouraged to extent their knowledge in the field of pharmacy management (specialist in pharmacy management) 150. A dedicated pharmacist is responsible for preparing pharmaceuticals in compliance with the GMP principles (specialist in pharmaceutical technology) 151. A dedicated pharmacist is responsible for drug quality control (specialist in drug quality control) 152. All newly-employed pharmacists spend a defined time period for training and evaluation of their competency before they can work independently 153. The training period of new pharmacists is individualized and based on an ongoing assessment of their needs 154. During training period, pharmacists spend time in patient care areas to become familiar with drug prescribing practices, unit stock storage conditions, medication administration procedures and patient education processes 155. Pharmacists are trainers of pharmacy students and residents 156. Pharmacy and pharmacists are reimbursed for training of pharmacy students and residents by the authorized institution (e.g. Faculty of 35,48 12,90 41,93 9,

133 Pharmacy, Pharmaceutical Chamber of Macedonia, Ministry of Health, etc.) 157. Pharmacists engaged in training of other pharmacists, pharmacy students or residents have reduced workload 158. Pharmacists prepare annual portfolio for their own continuing education and professional development 159. Pharmacists are obliged to collect credits and they are subject to relicensing 160. Pharmacist collect credits by attending educational courses, workshops related to their professional practice only 161. Pharmacists are financially supported by the hospital to attend most of the national and international educational/professional events related to their practice 162. The pharmacy manager provides formal teamwork training to all staff incorporating elements of information sharing, conflict management, communication and clarification of team roles and tasks 163. Pharmacists employed in the pharmacy are registered at the PCoM (licensed pharmacists) , , V QUALITY ASSURANCE & RISK MANAGEMENT 164. Quality assurance policy in the pharmacy is 16,13 25,81 58,06 0 established, implemented and evaluated in accordance with the state provisions for accreditation 165. Up-to-date policies and SOPs are established and 45,16 32,26 22,58 0 considered in every day practice 166. Policies and procedures are developed that 3,22 19,36 58,06 19,36 ensure adequate personnel selection, training, supervision and evaluation 167. Sufficient personnel is available to perform tasks 25,81 54,84 19,35 0 adequately 8 h/day 168. Policies and procedures ensure that reasonable 9,68 32,26 58,06 0 workload levels and working hours are established and rarely exceeded 169. Lines of authority and areas of responsibility are 64,52 35, clearly defined for medication use process 170. A hospital has established a safety plan 38,71 35,48 22,58 3, Hospital plan for the implementation of new medication safety technologies is established and its progress is recorded over time 0 12,9 80,65 6,45 % 133

134 172. Pharmacists are educated about the advantages (and potential pitfalls) of technology and/or evidence-based practices that have been implemented in other organization to improve medication safety 173. A multidisciplinary team (e.g. Hospital s Risk Management Team or Quality Assurance Team or Pharmacy and Therapeutic Committee) has been established for formulating medication safety policies 174. A formal drug use evaluation program is integrated and coordinated within the overall hospital quality improvement program 175. (A) Designated pharmacist(s) is/are responsible for detection of medication errors, oversee analysis of their causes and coordination of effective error-reduction plan 176. Medication errors are thoroughly evaluated in an open, non-punitive manner 177. A non-punitive anonymous medication error reporting system has been established 178. Medication errors and ADRs are reported to the National Pharmacovigilance Center 179. Medication errors are monitored, tracked and evaluated on a routine basis 180. Medication error tracking form has been created and it is used for tracing, collection and systematic categorization of data on medication errors 181. Individual(s) from the multidisciplinary team (e.g. Pharmacy and Therapeutic Committee regularly review(s) the medication error tracking form and are delegated for reporting of summary data 182. When an event involves human error, an investigation is undertaken to detect uncover and preexisting factors (e.g. staff who did not follow a procedure, task complexity, urgency, fatigue, stress, training, etc.) 183. Pharmacist are regularly educated on participating in medication error reduction process and understand the importance of reporting medication errors 184. (Computer) Markers or triggers for selected drug orders are used to enhance detection of potential ADEs (medication errors and ADRs) 185. Based on reports of medication errors, the hospital/hospital pharmacy determines where the majority of serious medication errors occur and 9,68 32,26 54,84 3,22 25,81 12,9 61, ,9 19,36 54,84 12,9 9,68 22,58 61,29 6,45 19,36 19,36 58,06 3, ,58 70,97 6,45 0 3,23 90,32 6,45 0 3,23 90,32 6,45 3,23 9,68 80,65 6,45 3, ,10 9,68 0 6,45 74,19 19,36 0 9,68 70,97 19,35 134

135 the priorities for intervention 186. If particular medication classes are associated with the majority of medication errors, the hospital/hospital pharmacy considers implementation of protocols or practice guidelines for the use of those medications 187. All medication errors that reach the patient are honestly disclosed to patients/relatives in a timely manner 188. Hospital/pharmacy manager rewards individuals who report medication errors and ADRs 189. Practitioners/pharmacists involved in serious errors that cause patient harm have professional help and are emotionally supported by their colleagues and manager 190. The medication use process is analyzed at least annually to identify risk factors for medication errors (e.g. self-assessment questionnaire) 191. Pharmacists are provided with regular feedback about reported errors and error-reduction strategies that are being implemented 9,68 12,9 67,74 9,68 0 9,68 74,19 16,13 0 3,23 90,32 6,45 12,9 25,81 61, ,68 87,10 3,22 0 9,68 83,87 6,45 135