EUROPEAN COMMUNITY PHARMACY BLUEPRINT

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1 EUROPEAN COMMUNITY PHARMACY BLUEPRINT for optimisation of health outcomes to individual patients and value for health systems across Europe Pharmaceutical Group of European Union Groupement Pharmaceutique de l Union Européenne

2 EXECUTIVE SUMMARY The European Community Pharmacy Blueprint reflects the desire among European community pharmacists to advance the pharmacy profession and community pharmacy practice in order to meet patients needs and current challenges in healthcare. European governments are seeking to optimise the use of medicines, achieve better value from pharmacotherapy of patients, and reduce the overall cost of health care. Making better use of the competences of European pharmacists can help them achieve these goals. To enhance the contribution of community pharmacies to the effectiveness and efficiency of health systems, community pharmacists need to play an active role in the primary healthcare team, use of ehealth solutions in the community pharmacy should be supported, and national medicine management strategies need to be developed. The unique asset that is the community pharmacy network needs to be better exploited. Community pharmacy, alongside other social and health partners and national governments, is committed to finding new ways to improve the health of the public and the quality and efficiency of the health sector, within the framework of national competences in health. TO OPTIMISE HEALTH OUTCOMES TO INDIVIDUAL PATIENTS AND ADD VALUE FOR HEALTH SYSTEMS ACROSS EUROPE, WE MUST: ENHANCE MEDICINE SAFETY AND ACCESS TO MEDICINES 1. Further strengthen the medicines supply chain to prevent falsified medicines reaching hands of European patients; 2. Work with other stakeholders and governments to prevent medicine shortages; 3. Make more hospital-only medicines available via community pharmacies; 4. Deliver medicines to care homes and the patients homes and assist patients of our pharmacies who have complex treatment regimes in managing their medication, by providing pharmacy services such as individual singledosage systems for our patients in the pharmacy; 5. Have the possibility to dispense prescription only medicines without a medical prescription in emergencies, under strict conditions and in collaboration with physicians; Isabelle Adenot PGEU President,

3 IMPROVE TREATMENT OUTCOMES OF INDIVIDUAL PATIENTS 1. Manage medication while further empowering patients to self-manage their condition; 2. Maximise our patient care interventions through gaining access to the patient s health record where appropriate according to national data protection rules and with the patient s consent; 3. Engage in collaborative care, e.g. while assisting in detecting and managing chronic disease or bringing our expertise in medicines to specialised care networks; 4. Ensure the continuity of pharmaceutical care during the patient s transition between acute care settings and home; 5. Build a community pharmacy research strategy to support the development of services; 2. Improve adverse drug reactions reporting; 3. Participate in the setting up and development of future or existing national ehealth systems 4. Use our network better to spread public health messages and manage public health crises; 5. Develop screening programmes and further contribute to immunisation strategies; 6. Develop a pharmacy-based holistic public health service package and make it available to the community according to the local needs; CONTRIBUTE TO THE EFFICIENCY AND QUALITY OF THE HEALTH SYSTEM 1. Deliver pharmacy services aiming to improve adherence and rationalise care of polymedicated patients; 2. Continue to promote and facilitate greater use of cheaper medicines via appropriate substitution when suitable; 3. Encourage services such as dispensing repeat prescriptions and monitoring pharmacotherapy of individual patients, recommending dosage adjustments when appropriate. IMPROVE PUBLIC HEALTH 1. Support safe and effective self-care and self-medication when providing health advice, responding to symptoms and/or offering services that promote healthy living and disease prevention; 3

4 EUROPEAN COMMUNITY PHARMACY KEY FACTS AND FIGURES Approximately 98% of EU citizens can reach their nearest community pharmacy within 30 minutes, while 58% of citizens indicate that their closest community pharmacy is within 5 minutes reach from their work or home 2. Pharmacies in the majority EU countries are required to ensure that premises have access for people with disabilities. Community pharmacists in the EU are highly qualified healthcare professionals. Community pharmacies across EU employ pharmacists, as well as over other pharmacy support staff and provide training sites for pharmacy students. For many years pharmacists have been in the top 10 of the most trusted professions according to consumer surveys 3. There are community pharmacies in the EU 1. Pharmacies are the most widely distributed healthcare facility in Europe. Community pharmacists complete at least 5 years of university based education (equivalent to a Master degree according to Bologna system), including 6 months training in the pharmacy. Computerisation of pharmacies is 99.99%. 4

5 According to the World Health Organization WHO, the cost of adverse drug reactions (ADRs), including hospitalisations, surgery and lost productivity, exceeds the cost of medicines in some countries 7. The use of multiple medications, known as polypharmacy, is recognized as an increasingly serious problem in the current healthcare systems. Community pharmacies are accessible to over 500 million EU citizens. Among the 23 million people who visit a community pharmacy everyday are the most vulnerable and those with the least means. Over 9,5 billion prescription only medicine packs are dispensed in Europe annually 5. The great majority of medicines are prescribed in primary care setting and therefore dispensed in the community pharmacy. In general pharmacies have longer opening hours than other health care settings and through extended opening hours, rota and night services ensure patients can access their services 24/ deaths a year in the EU are due to miss dose and non-adherence of prescribed medication. Nonadherence is estimated to cost the European Union 125 billion annually 8. More than medicines are licensed in the EU 4. In addition, community pharmacists acquire specific competencies and develop expert professional practice for the field of community pharmacy and are required continuously to update their knowledge and skills to make sure they are fit for practice. Continuing professional development or lifelong learning is a professional and ethical obligation of community pharmacists and is being reinforced in many EU countries. On average, the medicines budget is 17% of the total health budgets 6. 5

6 INTRODUCTION Moving Forward: Advancing Community Pharmacy Practice in Challenging Times Health systems do not stand still. The organisational environment in which pharmacy operates constantly changes and evolves. Healthcare systems are currently facing several significant challenges: DEMOGRAPHIC CHALLENGE: growing life expectancy combined with falling birth rates has resulted in a steady rise in the proportion of older persons in EU countries. Translating this into active and healthy life years for those over 65 remains a challenge with direct impact on the sustainability of health systems. RISK FACTORS TO HEALTH HAVE CHANGED as a result of rising living and educational standards, lifestyles as well as technology. The rate of obesity has more than doubled over the past 20 years in most EU countries. The prevalence of diabetes, chronic obstructive pulmonary disease (COPD) and other chronic conditions has increased and is a growing burden on health systems. However, only an average of 3% of current health expenditure is spent on prevention and public health programmes by EU countries 9. HEALTH WORKFORCE: by 2020 there will be a shortage of health professionals in the EU 10. Shortages of some health professionals, such as general practitioners and nurses, are already reported in some EU countries and are expected to increase. PATIENT-CENTRED CARE: the healthcare pathway has become more complex and fragmented, for example with the increasing role of non-clinical practitioners, carers and patients themselves. Additionally, the focus of health systems is shifting from treatment to prevention. ECONOMIC PRESSURE: In times of economic crisis, all health budgets are under severe pressure. Effectiveness and efficiency are key considerations. According to OECD figures, health expenditure has risen in all European countries, often increasing at a faster rate than economic growth, resulting in a rising share of GDP allocated to health 9. Despite the constant pressure for change, the ultimate goal of modern health care as well as pharmacy practice should always be to provide patients with the best and most cost-effective care possible. In the context of national competences in healthcare policy 11, the community pharmacy network is ready to play a significant role in helping national health systems to meet today s and tomorrow s challenges. 6

7 4 CLUSTERS OF MODERN COMMUNITY PHARMACY PRACTICE Modern community pharmacy practice is increasingly complex and relies on the expertise of the community pharmacists, the unique community pharmacy setting and the available technology. We believe that daily activities of the community pharmacy can be classified under four clusters: ENHANCING MEDICINES SAFETY AND ACCESS TO MEDICINES, IMPROVING OUTCOMES OF INDIVIDUAL PATIENTS, IMPROVING PUBLIC HEALTH, CONTRIBUTING TO SYSTEM EFFICIENCY. The following chapters describe these clusters of activities in detail, and identify areas where we want to deliver better care to the public we serve while addressing patients needs and expectations. 7

8 ENHANCING MEDICINE SAFETY AND ACCESS TO MEDICINES Medicines are the most frequently used intervention within the modern health system, and their importance will only grow as the population ages and pharmaceutical innovation advances. Used appropriately, medicines can bring about a remarkable improvement n a patient s condition or result in cure. Making sure that the right patient gets the right medicine, at the right time, followed by the appropriate advice is the corner stone of pharmacy practice. CORE PHARMACY ACTIVITIES INCLUDE: Sourcing and securing pharmacy stock After purchasing medicines from an authorised wholesaler, community pharmacies assume responsibility for their safe and appropriate storage. A very wide range of medicines and medical devices, including those requiring special storage conditions, such as cold chain products, are traditionally distributed in the pharmacy. The community pharmacy is often obliged to keep certain categories in stock at all times. Ensuring quality of medicines In order to ensure integrity and high quality of medicines, pharmacies comply with complex regulatory requirements. Community pharmacy, as the last point of the supply chain before medicines reach the hands of patients, is a key factor in effective medicines recall processes. Recalls take place on a weekly basis in some European countries. Pharmaceutical preparation Pharmaceutical preparation remains one of the core services of community pharmacies in many European countries. Some medicines are not available in the right dose, for example for newly born and young children. Community pharmacists fill this gap and provide patients with custom-made medicines prepared according to a prescribed formulation. In addition, in several European countries community pharmacists prepare individual single-dosage systems for their patients in the pharmacy with complex treatment regimes. Emergency supply Community pharmacists are the most accessible health care professionals, seeing patients without prior appointment and during extended opening hours. In addition they offer an emergency service 24 hours a day 365 days a year. To ensure timely access to medicines for patients, in several Member States governments already recognise the need to allow dispensing medication by community pharmacist normally subject to prescription in emergency circumstances. Dispensing vs. supply Finally it is important to understand that pharmacists do not have simply a logistical role in handing the patient a box of medicines. Dispensing medication is a professional pharmacist s activity. When dispensing medication pharmacists will supplement medication supply with information about medicine 8

9 such as side effects, pharmacological action, instructions how to take medication as well as checking for medicines-medicines or medicines-patient interaction, based on the available information. This helps the patient to maximize the benefits of medicines therapy. HOW CAN WE DO MORE TO IMPROVE ACCESS TO MEDICINES? In order to better respond to changing needs of patients and health systems, we must: 1. Work together with European policy makers, national authorities, manufacturers and other stakeholders to further strengthen the medicines supply chain in order to prevent falsified medicines reaching hands of European patients and ensure the continuity of medicines supply when eliminating medicines shortages. 2. Make more hospital-only medicines available via community pharmacies to ensure that patients in need can access those medicines close to their home or place of work. 3. Deliver medicines to care homes and the patients homes (as already happens in some Member States) and assist patients of our pharmacies who have complex treatment regimes in managing their medication, for example by preparing individual single-dosage systems for our patients in the pharmacy. Community pharmacies should be remunerated for these pharmaceutical services. 4. Have the possibility to dispense medication normally subject to prescription in emergency circumstances. Those circumstances in which such dispensing could take place are highly specific to national situations, and are subject to support and collaboration with other stakeholders such as physicians. 9

10 IMPROVING TREATMENT OUTCOMES OF INDIVIDUAL PATIENTS Overall, community pharmacy practice is about managing patient care and ensuring that appropriate therapeutic outcomes are achieved when medicines are prescribed and dispensed 1. Managing the medication use process in order to improve outcomes, including the patients quality of life, is at the core of our profession. COMMUNITY PHARMACISTS ARE ALREADY PLAYING THEIR PART IN IMPROVING PATIENT OUTCOMES AND ADHERENCE TO MEDICATION WHEN: Providing information Community pharmacists provide expert information about medicines, medical devices and other pharmacy products for example relating to side-effects, pharmacological action and instructions on how to take the medicines. They also check for medicines-medicines or medicines-patient interaction, based on available information. In addition, when performing generic substitution pharmacists explain to the patient bio equivalence, packaging differences, etc. to avoid medicine error and improve adherence. Managing medication The community pharmacist not only provides information to the 1 An activity that has become known as pharmaceutical care. patient on how to take medication, but will also contact the prescriber where a prescribing error is detected or more suitable medication is available 12. Ultimately, the pharmacist has a right to refuse to dispense medication if he/she thinks harm can arise from using it or there are ethical or professional concerns. The management of medication by pharmacists maximises the benefits and minimises the risk inherent in the use of medicines by patients through better selection, optimisation and utilisation 13. A good example of a successful and effective intervention to optimise patient outcomes is the community pharmacist-conducted medication review 14,15. It is a patient-care service provided by a pharmacist through an individual appointment during which the patient and pharmacist identify all medications that the patient is taking, discuss how the medications are best taken and medication related problems. The medication review service improves patient knowledge, adherence and use of medicines when establishing use and understanding, resolving ineffective medicine use, identifying side effects/drug interactions, improving clinical and cost effectiveness, and reducing waste. Ultimately, the community pharmacist will report medication related problems to the physician, so that he/she may, in turn, adjust medication therapy at an early stage. Chronic disease management People with chronic diseases managed by medication visit their community pharmacists more frequently than any other healthcare professional. Patients with for example, asthma, diabetes or a heart condition see their community pharmacist every time they get a prescription filled. Also, patients with undiagnosed chronic conditions will often be frequent visitors to the pharmacy. This 10

11 places community pharmacists in an ideal position to detect early changes in a condition, assist patients in self-management of their disease and direct more serious or new cases to a physician. There are opportunities for health screening, medicines management, health promotion and education, and ultimately enhanced selfmanagement. Contributing to the patient s medication journey Community pharmacists deliver patient care services in different stages of the medication journey. For instance, we: Perform a patient s needs assessment; Initiate, adjust, or discontinue treatment upon consultation with the prescriber when necessary; In many countries, manage diseases, maximize outcomes of pharmacotherapy through services such as medication use review and deliver medication management services; In some countries, perform, interpret, and monitor laboratory test results; Provide follow up services to support patients in for example, chronic condition management. A major challenge for pharmacists remains the delivery of effective, patient-centred and efficient services in collaboration with other healthcare professionals. Community pharmacists often work with no direct contact to other healthcare professionals working in the community. It is important to support the professional interchange with all parties involved in the care of the patient in both secondary and primary care. HOW CAN WE DO MORE FOR OUR PATIENTS? In order to better respond to changing needs of patients and health systems, we must: 1. Manage medication and take more control and responsibility for the people in our care. Educate patients about their treatment and empower them to self manage their condition. 2. In order to consider all relevant information when checking a patient s medication, we should have access to patient s health information and the list of medication he/she is taking, while respecting national data protection and privacy rules. This is essential to maximise the benefits of the community pharmacist s intervention in patient care. 3. Cooperate with other members of the healthcare team in the detection and management of chronic diseases, and bring our expertise in medicines to specialised care networks tackling a specific pathology. Overall, the collaborative care model should allow healthcare professionals to work together in a way which maximises their competences within the healthcare team. 4. Ensure the continuity of pharmaceutical care during the patient s transition between acute care settings and home. For example, reconciliation of medicines between acute and primary sector should be undertaken systematically in Europe. 5. Build a community pharmacy research strategy to support the future development of services. 11

12 IMPROVING PUBLIC HEALTH The public health mission of community pharmacists goes far beyond the use of medicines. It is part of a broader public health strategy focusing on the population, and aims to improve the health status and quality of life of the communities we serve. Community pharmacists are at the heart of healthcare, providing a wide range of professional services to citizens of EU Member States, aiming to improve their health and wellbeing. As a consequence of the way in which community pharmacies are distributed, often through deliberate planning, the vast majority of people have convenient access to at least one pharmacy and often two or more, near to where they live and work. We know that frequency of pharmacy visits is more than double that of physician visits. This makes the community pharmacist the most frequently visited health care professional, and puts community pharmacy in a unique position in supporting patients and helping improve public health. COMMUNITY PHARMACISTS ARE HANDS-ON PUBLIC HEALTH PRACTITIONERS AND CONTRIBUTE TO IMPROVING PUBLIC HEALTH IN MANY WAYS: Supporting self care Community pharmacists offer advice on common complaints, such as coughs and colds, pain, skin conditions and digestive problems, and are the primary source of advice on medicines available without prescription. They offer a broad spectrum of services to help patients tackle obesity (weight management programmes), smoking, drinking or misuse of drugs and other addictive substances. They are ideally placed to promote safe sexual health and family planning, including dispensing of emergency hormonal contraception. Community pharmacists play an essential role in health education and ultimately ensure effective and safe self care. Contributing to pharmacovigilance Medicines are not without risk. Only when a medicine is available to a large population unexpected adverse events can be identified. Pharmacists report such adverse reactions to national medicines agencies. In doing so, we contribute to the safety of patients and thus improve the quality of care in terms of efficiency and tolerance. Detecting threats to public health and managing crises Frequently, community pharmacists act as radars for threats to the public health. Pharmacists are in a unique position in the community to detect emerging public health problems. Moreover, community pharmacists have a significant role to play in national strategies in response to crises. The community pharmacy network often serves as an information point to citizens, and can readily be adapted to offer necessary pharmaceutical services. Spreading public health information In all European countries, community pharmacies participate in health campaigns developed by community pharmacists themselves and/or in collaboration with public authorities or other public health partners. The accessibility of the community pharmacy network improves outreach of public health campaigns, addressing such issues as antibiotic awareness, cancer screening, healthier lifestyles, and nutrition. 12

13 Participating in disease control, early detection and prevention Many pharmacies are equipped to carry out health checks and contribute to early detection of diseases especially among people who are not frequent users of other health services. When community pharmacists observe abnormal measurements or conditions which cannot be treated with a non-prescription medicine, they will refer patients to the most appropriate health professional or health service. They are a unique gateway for signposting, accessing and providing services and information on health issues to a broad spectrum of the population. Community pharmacists are also important actors in national vaccination strategies. Their involvement varies from participation in immunisation awareness activities to administration of vaccines by trained pharmacy staff in some Member States. Environmental health and safety Appropriate handling of expired or unwanted medicines or medical devices is important for environmental health and safety. Community pharmacists advise patients about appropriate handling of medicines and medical devices. HOW CAN WE FURTHER CONTRIBUTE TO PUBLIC HEALTH? In order to better respond to changing needs of patients and health systems, we must: 1. Play an active role in supporting self-care and selfmedication when providing health advice, responding to symptoms or offering services that promote healthy living and disease prevention. 2. Further strengthen adverse drug reactions reporting. 3. Participate in the setting up and development of the future or existing national ehealth systems. 4. Better deploy community pharmacy network to spread public health messages as well as offer their expertise and communication skills to manage public health crises. 5. Develop screening programmes and further contribute to immunisation strategies. 6. Offer a holistic public health service package and make it available to the community according to the local needs. While the public health approach is very much focused on single issues such as alcohol, obesity or sexual health, it is essential to have a holistic assessment of each individual at a given stage of their life and to support a necessary behaviour change. 13

14 Independent information and decision regarding medicines CONTRIBUTING TO THE EFFICIENCY AND QUALITY OF THE HEALTH SYSTEM In times of economic crisis, when health budgets are under severe pressure, effectiveness and efficiency are the key considerations for national governments. Each Member State seeks to offer its population an efficient, high quality health care system that fulfils the needs of its population. Improving availability and accessibility of services Community pharmacies are the most accessible health care facility to the general public often without prior appointment during extended opening hours. Many consultations that are dealt within the pharmacy would otherwise put an extra burden to frontline health services and general practice physicians 16,17. In this way the physicians practice is freed-up to deal with more complex cases. In addition, pharmacies are accessible to the most vulnerable and those with the least means, including those who do not have a family physician and those that have not yet entered a healthcare pathway. Community pharmacy is very often the first contact point with a health system for EU citizens. Accessibility and availability together with familiar environment of community pharmacies play a significant role in ensuring that health system is more accessible, patientcentred and focused on the needs of the community. As experts in medicines, pharmacists are known as an accessible and trusted source of advice and treatment, subject to common training standards across Europe and to professional and ethical obligations. As health professionals, they are first committed to act in the public interest rather than with a purely economic objective. Therefore it is important to ensure that certain safeguards are in place, so pharmacists can act independently. Cost effectiveness of the services and financial stability of the health care system As described above, pharmacies help to reduce the burden on other healthcare services, by providing a range of services, and contributing to public health. In addition, community pharmacists play an important role in improving the cost of health care, for example when promoting greater use of generic medicines where it is appropriate to do so. Pharmacists will also detect and prevent potential harm (like contraindications, adverse drug reactions, prescribing errors, etc) before dispensing any medicine. Thus not only do they save money to health budgets when offering a cheaper alternative medicine where appropriate, but they also prevent unnecessary high treatment or follow-up costs associated with complications that may arise if medicines are not taken properly. Being a part of the health ecosystem" Community pharmacists, from their own resources, pre-finance prescribed medicines and medical devices. In this way, patients do not need to prepay for their medicines or have to pay only their copayment share. In addition, community pharmacies facilitate billing 14

15 and payment for medicines by patients or the health system. Community pharmacy is an integral part of today s health and social eco-system. Some measures currently under discussion at national level, including increasing commercialisation in the sector, may have a negative impact on the sustainability of the pharmacy network and therefore overall health systems quality. This will ultimately increase costs. HOW CAN WE FURTHER CONTRIBUTE TO EFFICIENCY OF HEALTH SYSTEMS? In order to better respond to changing needs of patients and health systems, we must: 1. Provide more assistance in detecting and managing chronic diseases, in cooperation with other members of the healthcare team. Community pharmacists should deliver more services that target non-adherence or irrational polymedication, such as, for example medicines review. 2. Continue to promote and facilitate greater use of cheaper medicines via appropriate substitution when suitable. 3. Encourage such services as dispensing repeat prescriptions, which allows controlled patients to receive their medication for a defined period of time from their community pharmacist without the need to re-consult their prescriber too soon. This already exists in some Member States. Moreover dosage adjustments on repeat prescriptions could be allowed under predefined circumstances and with the prior consent from the prescribing physician. 15

16 OUR VISION The way in which healthcare is organised is changing. Community pharmacies, as an essential part of health systems, cannot be exempt from this process. The fact that community pharmacy is very often the first and last point of the patient s interaction with health system, uniquely positions the community pharmacy network. Safeguarding the professional independence of pharmacists, keeping them free from commercial pressure, is essential for the further development of pharmacy practice. We are ready to embrace change. We support continuity and integration of patient-centred care aiming at more system efficiency and further improvement of the quality of care. In order to embrace current and future challenges, we want to create a future where services offered at European community pharmacies, at the heart of the communities by highly qualified and independent healthcare professionals community pharmacists further support individual patients, public health and the healthcare system. 16

17 REFERENCES: is the number of community pharmacies in EU27 and candidate country Croatia. Source: PGEU database Survey of Chain of Trust Project, under EC Public Health Programme (Grant Agreement N ) 3. PGEU Database European Medicines Agency s Data for 21 EU Member States, IMS 2010 data. 6. OECD Health Data World Health Organization (2008) Fact sheet No293. Medicines: Safety of medicines adverse drug reactions. Geneva: World Health Organization. 8. Medi-Voice project TION=D&DOC=3019&CAT=PROJ&QUERY= &RCN= OECD (2010), Health at a Glance: Europe 2010, OECD Publishing. en 10. Commission Staff Working Document on an Action Plan for the EU Health Workforce. SWD (2012) 93 final. _healthcare_workforce_en.pdf 11. Under the EU treaties health policy and management of health systems is substantially a matter of the Member States. 12. A pharmacist-led information technology intervention for medication errors (PINCER): a multicentre, cluster randomised, controlled trial and cost-effectiveness analysis. Avery A.J., et al. The Lancet, Volume 379, Issue 9823, Pages , 7 April 2012 doi: /S (11) Tuesca-Molina R, Guallar-Castillón P, Banegas-Banegas JR, Graciani-Perez Regadera A. Determinants of therapeutic compliance in elderly over 60 years old in Spain. Gac Sanit 2006; 20(3): NICE, National Costing Statement: Medicines Adherence, Preventing hospital admissions by reviewing medication (PHARM) in primary care: design of the cluster randomised, controlled, multi-centre PHARM-study. Leendertse AJ et al. BMC Health Serv Res, Study on Assessment of health interventions at the Community Pharmacies in Spain, CGCOF Advice from pharmacies saves hundreds of millions. A survey by PricewaterhouseCoopers and The Association of Finnish Pharmacies.

18 Pharmaceutical Group of European Union 2012 Groupement Pharmaceutique de l Union Européenne 2012 Rue du Luxembourg Brussels Belgium 1