MINISTRY OF HIGHER EDUCATION UNIVERSITY OF HAIL COLLEGE OF PHARMACY

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1 MINISTRY OF HIGHER EDUCATION UNIVERSITY OF HAIL COLLEGE OF PHARMACY Academic Reference Standards of Pharm.-D Program College of Pharmacy-University of Hail May

2 The Major shift in the health-care system in providing safer and cost-effective health services mandate pharmacists to require general and specific knowledge and skills, namely pharmacists with Pharm.-D degree. The five years program comprising 174 credit hours is consistent with the mission and vision of Hail University and proposed to gain accreditation from national and international agencies. In addition, Pharm.-D holders usually demonstrate a positive impact on improving patient education and knowledge of their health related quality of life, which will be reflected in better health service and improved Hail society health in particular and the Kingdom in general. 1

3 Table of Contents Topic Pages Introduction 3 Acknowledgment 4 Methodology 5 Characteristic of the Pharm.-D Graduates 6 Learning outcomes 7-11 Glossary Abbreviations 14 Bibliography 15 2

4 Introduction After the establishment of University of Hail (UoH) in 2005, approval was issued primarily in the Royal s Meeting of the Council of Higher Education No. 62 in January 2011 to establish the College of Pharmacy. The college directly developed framework for vocational educational program "Doctor of Pharmacy (Pharm.-D)" with an intent to deliver outstanding professional services in the fields of pharmaceutical science and clinical practice. The program has been designed taking into account the national and the international standards for accreditation in the pharmaceutical field. The National Commission for Academic Accreditation and Assessment (NCAAA) was established to encourage, support, and evaluate the quality of post secondary institutions and the programs they offer to ensure they are equivalent to high national and international standards. Although UOH is newly established institution, it delivers great attention to education quality and development that appears in its vision and mission with continuous support of the University leadership. In this regard, the faculty members are preparing academic reference standards for the Pharm.-D program to comply with the NCAAA requirements to a clear reach academic accreditation. These standards serve as guidelines to design, develop, and review the Pharm.-d. program curriculum. 3

5 Acknowledgment The College of Pharmacy (CoP) at UoH acknowledges all the faculty members, students, and community for the exerted effort to establish the academic reference standards for Pharm.-d. program. First and foremost, the College expresses deepest gratitude to his Excellency the University Rector, and the Deanship of Quality and Development for their continuous support regarding the quality and development work. The College also acknowledges the College Dean, vice-dean for Academic Affairs, and vice-dean for Quality and Development for their continuous support to establish this document. Finally, the CoP at UoH would like to express special thanks to both internal, and external auditors in addition all members worked on this document to come out into the light, at last but not least the College is thankful for this document committee members whose efforts was invaluable. 4

6 Methodology This document was prepared after thorough discussions during which the following steps were proceeded as follows: 1. Brain Storming Sessions and Discussions The committee during these sessions and discussions designed the general framework and the elements that should be included in Pharm.-D ARS document. 2. Reviewing of International Academic Standards Committee members have reviewed the academic standards of carefully chosen accreditation institutions and standards applied by corresponding colleges in different countries to have access to the global level taking into consideration the need to preserve the Saudi Arabian Kingdom identity. 3. Reviewing the Regional and National Academic Standards The committee has reviewed the national academic standards of NCAAA concerning Pharm.-D program and standards that applied by outstanding Saudi Pharmacy Colleges. In addition, the committee has reviewed the academic standards of some regional accreditation institutions and standards applied by some Colleges of leading Universities in the Middle East. 4. Stakeholders Approval Upon completion of this document draft and after internal and external auditing, it will be presented to the Faculty and community and their feedback will be considered. Finally, it will be approved by the College committee. 5

7 Characteristic of the Pharm.-D Graduates Upon successful completion of the program, the graduate should be able to : Provide patient centered pharmaceutical care and be a valuable member of a health-care team, formulate, prepare pharmaceutical products from different sources and participate in systems for dispensing, storage and distribution of medications, manage pharmacy operations in hospitals, community pharmacies, and industrial settings, perform different types of quantitative and qualitative analysis related to drugs, food, and water, perform and encourage scientific research on the basis of the actual needs of KSA especially in Hail region, perform responsibilities in accordance with legal, ethical and professional rules, cooperate with government agencies and community organizations to provide consulting services and providing the necessary information and consultancy as a professional in the fields of health care to foreigners and citizens of Hail as well as The Kingdom in general. 6

8 Learning Outcomes Upon the College program completion, the graduate should be able to: A) Knowledge A-1. A-2. A-3. A-4. A-5. A-6. A-7. A-8. Describe human body structure, organs locations and functions in health and disease states, demonstrate knowledge of theoretical principles of isolation, synthesis, purification, identification of pharmaceutical compounds, describe the principles to determine the contents, content uniformity, limit of content the drugs and additives masses relating the stability of drugs in their various formulations, as well as determination of stability indication based on GLP, QC and QA, describe relationships between chemical structure of compounds of pharmaceutical and medicinal interest and biological activity, recognize the basic principles of thermodynamics and kinetics and their role in defining chemical processes, recognize basic knowledge of evidence based herbal medicine and complementary therapies, define basic principles of drug: target identification, design, informatics, and mechanisms of action. demonstrate knowledge on drug: physiochemical properties, available formulations, route of administration, and its therapeutic indications, A-9. outline the basic principles of pharmacokinetic and pharmacodynamic aspects of commonly prescribed drugs and their impact in clinical setting, A-10. demonstrate knowledge of basic principles of biopharmaceuticals and pharmaceutical biotechnology, A-11. outline principles of clinical pharmacology, therapeutics and pharmacovigilance, 7

9 A-12. demonstrate knowledge of toxicity profiles of drugs and other xenobiotics including source identification, symptoms, management control, and first aid measures, A-13. describe the fundamental concepts and practical considerations needed in QC, QA of pharmaceutical products in various formulations, A-14. outline principles of various instrumentation and techniques used in formulation, manufacturing, packaging, labeling, sampling, storing and distribution processes in pharmaceutical industry according to GPMP, GLP, GSP and GDP, A-15. outline fundamental principles of public health issues including sources and control of microbial contamination as well as sanitation, disinfection, sterilization methods and microbiological QC of pharmaceutical products, A-16. demonstrate knowledge of the basis of drug addiction and abuse, and identify basic principles for drug-drug and drug-food interactions, A-17. recognize the relevance of molecular biology, biochemistry, immunology, and pharmacogenomics to disease states, diagnosis and therapeutics, A-18. identify national and international pharmacy profession regulatory bodies, pharmacy law, and professional ethics, A-19. recognize theoretical basis and concepts of marketing and pharmacy managements, A-20. recognize etiology, epidemiology, pathogens and virulence factors, laboratory diagnosis and clinical features of different diseases. B) Cognitive Skills B-1. B-2. B-3. B-4. construct patient-centered pharmaceutical care, promote health improvement and disease prevention, develop and implement population-specific disease management programs and protocols based upon analysis of epidemiologic, pharmacoeconomic data, medication use criteria, medication use review, and risk reduction strategies, retrieve, analyze, and interpret scientific literature to provide drug information to patients, their families, and other health care providers, 8

10 B-5. B-6. B-7. B-8. B-9. obtain and evaluate relevant patients information from their charts, medication history, physical assessments, diagnostic tests, caregivers and other health care professionals to determine appropriate medication therapy, design risk reduction strategies to ensure patient safety and prevent medication errors, harmful drug interaction, and adverse drug effects, assess patients ability to take/use/administer medications and design to implement strategies to improve adherence and compliance, manage human, physical, medical, informational, and technological resources, obtain complex medication information and integrate it into reports and proposals for colleagues and other health care professionals, B-10. apply problem solving and research skills to enhance their own practice-related activities, B-11. utilize literature, research design, statistics as well as scientific thinking/writing in research and practices. C) Interpersonal Skills and Responsibility C-1. C-2. C-3. C-4. C-5. C-6. have the ability to take an active role in professional and community organizations and promote advocacy for key healthcare and professional initiatives, have the ability for effective self management in terms of time, planning, motivation, and personal initiative, show professionalism through sound judgment, ethical behavior, adherence to legal guidelines and socioeconomic principles, differentiate the roles of various healthcare professionals in multiple healthcare environments with the ability to adapt to changes, participate in team efforts according to his/her role within pharmacy and healthcare groups, maintain their competence to practice pharmacy through lifelong learning, 9

11 C-7. C-8. C-9. participate actively in quality assurance and improvement programs, deal with complex professional and ethical issues, in particular where issues are not adequately dealt with in current ethical codes of practice or regulation in order to make informed, fair, and valid judgments on the basis of sound principles and values, use interpersonal skills of effective listening, negotiating, persuasion and presentation, C-10. demonstrate self-reflection, self awareness, openness and sensitivity to diversity in terms of people, cultures, religions, business and management issues. D) Communication, Information Technology and Numerical Skills D-1. D-2. D-3. D-4. D-5. D-6. D-7. D-8. present results of investigations and inquiries in appropriate forms with succinctly effective communication with various audience using several information and communications technologies, perform patient interviews to obtain medication history and identify drug-related issues and problems, document recommendations and interventions while assuring patient confidentiality, provide appropriate patient education/counseling regarding the safe and effective use of prescription and non prescription drugs and devices, communicate and collaborate with prescribers, patients, care givers, and other health care providers aiming to improve the health outcomes for patient, communicate information to colleagues, other healthcare practitioners, and the general public, regarding drug therapy and related topics, use information systems and computer softwares in order to enhance the delivery of pharmaceutical care, perform mathematical calculations with regard to drug dosing and clinical pharmacokinetics, and analyses relevant to pharmaceutical practice. 10

12 E) Psychomotor skills E-1. E-2. E-3. E-4. E-5. E-6. E-7. apply techniques used in analytical, biological, and microbiological testing, handle and dispose chemicals and pharmaceutical preparations safely, safe use, handle and treat experimental animals effectively and ethically, apply techniques used in operating pharmaceutical equipment and instruments, compound, dispense, label, store and distribute medicines effectively and safely, extract, isolate, synthesize, purify, identify, and/or standardize active substances from different origins, carry out patient physical assessment. 11

13 Glossary Academic Accreditation (AA); it is a quality assurance process under which postsecondary educational institutes or their offered programs are assessed by independent external bodies to see if applicable standards are met. This assessment could be national, regional, or international. Academic Program (AP); is defined as any combination of courses and/or requirements offered by academic institution and leading to academic degree and/or professional qualification. Academic Reference Standards (ARS); are the standards adopted and prepared by an institute or program along the lines of benchmarks. Benchmarking; is the process of comparing an academic program reference standards to bests or best practices from other institutions or to an accredited program nationally, regionally or internationally. Intended Learning outcomes (ILOs): are statements that describe skills a learner will be able to do as a result of teaching and learning. According to the National Commission for Academic Assessment and Accreditation (NCAAA) they fall into five categories: a) Knowledge skills: include the ability to recall, understand, and present information necessary to perform specified functions, i.e. knowledge of facts, concepts, principles and theories, and procedures. b) Cognitive skills: include the ability to apply knowledge skills in similar situations, analyze information, evaluate decisions, and create new ideas, procedures or product to solve problems of unanticipated situations. c) Interpersonal skills and responsibilities: include both the ability and predisposition to act ethically, be responsible for self continuing education and professional development, work effectively in group and exercise leadership when appropriate. 12

14 d) Communication, information technology and numerical skills: include the abilities to communicate effectively in verbal and written forms, use information and communication technology, and use basic mathematical and statistical techniques. d) Psychomotor skills: include the mental capacity to manage physical behavior with precision and skill. National Academic Reference Standards (NARS): are the standards for academic programs developed by national accreditation bodies, these standards represent the minimum requirement for a program to be accredited by these bodies. In the Kingdom of Saudi Arabia (KSA), they are NCAAA standards. Program Accreditation (PA): when an academic program is accredited it means this program comply with assessed standards. In KSA, NCAAA is the accreditation body. 13

15 Abbreviations AACP ACPE ARS CAPE CoP GCP GDP GLP GPMP GSP ILOs IT KSA NAQAAE NARSE NCAAA Pharm.-D QA QC UoH American Association for Colleges of Pharmacy, USA Accreditation Council for Pharmacy Education, USA Academic reference Standards Center for the Advancement of Pharmacy Education, USA College of Pharmacy Good Clinical Practice Good Distribution Practice Good Laboratory Practice Good Pharmaceutical Manufacturing Practice Good Storage Practice Intended Learning Outcomes Information Technology Kingdom of Saudi Arabia National Authority for Quality Assurance and Accreditation of Education, Egypt National Academic reference Standards of Education, Egypt National Commission for Academic Accreditation & Assessment, KSA Doctor of Pharmacy Quality Assurance Quality control University of Hail 14

16 Bibliography 1. Accreditation Standards and Guidelines for The Professional Program In Pharmacy Leading To The Doctor Of Pharmacy Degree; ACPE, Chicago (USA), Educational Outcomes; CAPE & AACP, USA, National Academic Reference Standards; NAQAAE, Egypt, Pharm.-d. Program Assessment Plan; Purdue University Faculty of Pharmacy, Indiana (USA), Pharm.-d. Program Specification; King Saud University Faculty of Pharmacy, KSA, Program Learning Outcomes Guidelines for Program Development and Review; NCAAA, KSA,

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