GLOBAL TRENDS IN PHARMACY REGULATION: A COMPARATIVE CRITICAL REVIEW
Main Article Content
Keywords
Pharmacy Regulation, Global Trends, Comparative Analysis, Developed vs Developing Countries, Harmonization, Digital Health, Counterfeit Drugs, International Collaboration, Regulatory Reforms, Global Health
Abstract
The regulatory landscape of pharmacy practice has undergone significant transformations, influenced by global trends, technological advancements, and evolving healthcare needs. This comparative critical review explores the current state of pharmacy regulation across various regions, highlighting the disparities and commonalities in developed and developing countries. Through a systematic examination of regulatory frameworks, the review sheds light on the challenges posed by globalization, such as harmonization of standards, digital health integration, and the fight against counterfeit drugs. Case studies from select nations illustrate innovative regulatory strategies and underscore the complexities inherent in balancing access to medicines with ensuring drug safety and efficacy. The analysis reveals a trend towards greater international collaboration, with implications for future regulatory reforms and the role of pharmacists in global health. The review concludes with a discussion on the need for dynamic regulatory approaches that are adaptable to emerging healthcare paradigms, advocating for a unified effort to elevate pharmacy practice worldwide.
References
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24. Bump, J.B., Johnson, K.G., & Alkenbrack, S. (2019). "The health sector's role in early recovery and peacebuilding: A qualitative assessment in northern Uganda." Health Policy and Planning, 34(3), 166-174.
25. Pharmacy Board of Australia. (2019). "About." [Online]. Available: https://www.pharmacyboard.gov.au/About.aspx
26. Bates, I., John, C., Bruno, A., Fu, P., & Aliabadi, S. (2016). "An analysis of the global pharmacy workforce capacity." Human Resources for Health, 14(1), 61.
27. World Health Organization (WHO). (2011). "Good Pharmacy Practice (GPP) in Developing Countries: Recommendations for Stepwise Implementation." WHO.
28. Mackey, T. K., & Liang, B. A. (2011). "The global counterfeit drug trade: patient safety and public health risks." Journal of Pharmaceutical Sciences, 100(11), 4571-4579.
29. Hogerzeil, H. V., Liberman, J., Wirtz, V. J., Kishore, S. P., Selvaraj, S., Kiddell-Monroe, R., Mwangi-Powell, F. N., & von Schoen-Angerer, T. (2013). "Promoting access to medical technologies and innovation: Intersections between public health, intellectual property and trade." World Health Organization.
30. Aungst, T. D., Patel, R., & Patel, P. (2018). "Telepharmacy: A New Paradigm for Our Profession." Journal of Pharmacy Technology, 34(3), 131-136.
31. Khan, T. M., & Zaidi, S. T. R. (2012). "The need for promoting professionalism in pharmacy education in Pakistan." Archives of Pharmacy Practice, 3(4), 173-175.
32. World Health Organization (WHO). (2011). "Good Pharmacy Practice (GPP) in Developing Countries: Recommendations for Stepwise Implementation." WHO.
33. Aungst, T. D., Patel, R., & Patel, P. (2018). "Telepharmacy: A New Paradigm for Our Profession." Journal of Pharmacy Technology, 34(3), 131-136.
34. Hogerzeil, H. V., Liberman, J., Wirtz, V. J., Kishore, S. P., Selvaraj, S., Kiddell-Monroe, R., Mwangi-Powell, F. N., & von Schoen-Angerer, T. (2013). "Promoting access to medical technologies and innovation: Intersections between public health, intellectual property and trade." World Health Organization.
35. Basheti, I. A., Nassar, R., Barakat, M., Alqudah, R., Abufarha, R., Mukattash, T. L., Saini, B. (2020). "Pharmacists’ Readiness to Deal with the Coronavirus Pandemic: Assessing Awareness and Perception of Roles." Research in Social and Administrative Pharmacy, 17(3), 514-522.
2. International Pharmaceutical Federation (FIP). (2019). Global Pharmacy: Meeting the Challenges to Effective Regulation. Available at: https://www.fip.org/file/4369
3. Pharmacy Council of New Zealand. (2019). Standards for Pharmacy Practice. Available at: https://pharmacycouncil.org.nz/wp-content/uploads/2022/09/Consultation-on-Competence-Standards-and-Guidance-for-Pharmacy-Profession.pdf
4. Bates, I. (2018). "The role of pharmacists in developing countries: The current scenario and future perspectives". International Journal of Pharmacy Practice, 26(5), 418-426.
5. American Pharmacists Association. (2021). Pharmacy and Medically Underserved Areas Enhancement Act. Available at: https://www.pharmacist.com/Advocacy/Issues/Provider-Status
6. Bissell, P. (2005). "The Pharmacy Act of 1868: Setting the Agenda for Pharmacy in Britain." Pharmacy in History, 47(1), 7-23.
7. Mossialos, E., Courtin, E., Naci, H., Benrimoj, S., Bouvy, M., Farris, K., & Sketris, I. (2015). "From "Retailers" to Health Care Providers: Transforming the Role of Community Pharmacists in Chronic Disease Management." Health Policy, 119(5), 628-639.
8. Higby, G. J. (1990). "The Food, Drug, and Cosmetic Act of 1938: Its Legislative History and Its Subsequent Amendments." Pharmacy in History, 32(2), 59-76.
9. World Health Organization (WHO). (2011). "Good Pharmacy Practice (GPP) in Developing Countries: Recommendations for Stepwise Implementation." WHO.
10. International Pharmaceutical Federation (FIP). (2012). "FIP Global Pharmacy: Responding to the Challenge of Poor Regulation." FIP. Available at: https://www.fip.org/files/fip/HaMIS /fip_ipsf_pce_2nd_2012.pdf
11. Accreditation Council for Pharmacy Education (ACPE). (2020). "Accreditation Standards and Key Elements for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree." ACPE.
12. General Pharmaceutical Council (GPhC). (2017). "Standards for Pharmacy Professionals." GPhC. Available at: https://www.pharmacyregulation.org/sites/default/files/standards_for_pharmacy_professionals_may_2017_0.pdf
13. Buerki, R. A., & Vottero, L. D. (2013). "American Pharmacy: An Introduction to Pharmaceutical Techniques and Community Pharmacy Practice." American Institute of the History of Pharmacy.
14. European Association of Faculties of Pharmacy (EAFP). (2016). "Pharmacy Education in Europe: Towards Quality and Innovation." Available at: https://www.eahp.eu/news/EU-monitor/eahp-eu-monitor-21-june-2017-0
15. Mossialos, E., Courtin, E., Naci, H., Benrimoj, S., Bouvy, M., Farris, K., & Sketris, I. (2015). "From 'Retailers' to Health Care Providers: Transforming the Role of Community Pharmacists in Chronic Disease Management." Health Policy, 119(5), 628-639.
16. Wafula, F. N., & Goodman, C. A. (2010). "Are Interventions for Improving the Quality of Services Provided by Specialized Drug Shops Effective in Sub-Saharan Africa? A Systematic Review of the Literature." International Journal for Quality in Health Care, 22(4), 316-323.
17. Binagwaho, A., Pegurri, E., Muita, J., & Bertozzi, S. (2010). "Male Circumcision at Different Ages in Rwanda: A Cost-Effectiveness Study." PLoS Medicine, 7(1), e1000211.
18. Plianbangchang, S. (2007). "Thailand Health System Review." Health Systems in Transition, 9(1), 1-180.
19. FIP (International Pharmaceutical Federation). (2014). "Global Framework for Quality Assurance of Pharmacy Education." Available at: https://www.fip.org/files/fip/PharmacyEducation/Quality_ Assurance/QA_Framework_2nd_Edition_online_version.pdf
20. WHO (World Health Organization). (2019). "Model List of Essential Medicines." Available at: https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2023.02
21. European Commission. (2005). "Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the Recognition of Professional Qualifications." Avilbe at: https://eur-lex.europa.eu/eli/dir/2005/36/oj
22. Food and Drug Administration (FDA). (2018). "Drug Supply Chain Security Act (DSCSA)." [Online]. Available: https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa
23. Binagwaho, A., Kyamanywa, P., Farmer, P.E., Nuthulaganti, T., Umubyeyi, B., Nyemazi, J.P., Mugeni, S.D., Asiimwe, A., Ndagijimana, U., Lamphere McPherson, H., Ngirabega, J. de Dieu, Sliney, A., Uwayezu, A., Rusanganwa, V., Wagner, C.M., Nutt, C.T., Eldon-Edington, M., Cancedda, C., Magaziner, I.C., & Goosby, E. (2010). "The Human Resources for Health Program in Rwanda — A New Partnership." New England Journal of Medicine, 363(25), 2378-2381.
24. Bump, J.B., Johnson, K.G., & Alkenbrack, S. (2019). "The health sector's role in early recovery and peacebuilding: A qualitative assessment in northern Uganda." Health Policy and Planning, 34(3), 166-174.
25. Pharmacy Board of Australia. (2019). "About." [Online]. Available: https://www.pharmacyboard.gov.au/About.aspx
26. Bates, I., John, C., Bruno, A., Fu, P., & Aliabadi, S. (2016). "An analysis of the global pharmacy workforce capacity." Human Resources for Health, 14(1), 61.
27. World Health Organization (WHO). (2011). "Good Pharmacy Practice (GPP) in Developing Countries: Recommendations for Stepwise Implementation." WHO.
28. Mackey, T. K., & Liang, B. A. (2011). "The global counterfeit drug trade: patient safety and public health risks." Journal of Pharmaceutical Sciences, 100(11), 4571-4579.
29. Hogerzeil, H. V., Liberman, J., Wirtz, V. J., Kishore, S. P., Selvaraj, S., Kiddell-Monroe, R., Mwangi-Powell, F. N., & von Schoen-Angerer, T. (2013). "Promoting access to medical technologies and innovation: Intersections between public health, intellectual property and trade." World Health Organization.
30. Aungst, T. D., Patel, R., & Patel, P. (2018). "Telepharmacy: A New Paradigm for Our Profession." Journal of Pharmacy Technology, 34(3), 131-136.
31. Khan, T. M., & Zaidi, S. T. R. (2012). "The need for promoting professionalism in pharmacy education in Pakistan." Archives of Pharmacy Practice, 3(4), 173-175.
32. World Health Organization (WHO). (2011). "Good Pharmacy Practice (GPP) in Developing Countries: Recommendations for Stepwise Implementation." WHO.
33. Aungst, T. D., Patel, R., & Patel, P. (2018). "Telepharmacy: A New Paradigm for Our Profession." Journal of Pharmacy Technology, 34(3), 131-136.
34. Hogerzeil, H. V., Liberman, J., Wirtz, V. J., Kishore, S. P., Selvaraj, S., Kiddell-Monroe, R., Mwangi-Powell, F. N., & von Schoen-Angerer, T. (2013). "Promoting access to medical technologies and innovation: Intersections between public health, intellectual property and trade." World Health Organization.
35. Basheti, I. A., Nassar, R., Barakat, M., Alqudah, R., Abufarha, R., Mukattash, T. L., Saini, B. (2020). "Pharmacists’ Readiness to Deal with the Coronavirus Pandemic: Assessing Awareness and Perception of Roles." Research in Social and Administrative Pharmacy, 17(3), 514-522.
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Published
Nov 20, 2022
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How to Cite
Ajeem Hamed Ajeem Almoutared, Saleh Saud Saleh Alsalem, Melfi Dahen Ziad Alsinan, Hussein Mana Alzmanan, Mohammad Hassan Ali Aldhuwayin, & Lafy Saud Saleh Alsalem. (2022). GLOBAL TRENDS IN PHARMACY REGULATION: A COMPARATIVE CRITICAL REVIEW. Journal of Population Therapeutics and Clinical Pharmacology, 29(04), 1264–1272. https://doi.org/10.53555/jptcp.v29i04.4355
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Author Biographies
Ajeem Hamed Ajeem Almoutared
Ministry of Health
Saleh Saud Saleh Alsalem
Ministry of Health
Melfi Dahen Ziad Alsinan
Ministry of Health
Hussein Mana Alzmanan
Ministry of Health
Mohammad Hassan Ali Aldhuwayin
Ministry of Health
Lafy Saud Saleh Alsalem
Ministry of Health