The Role of Drug Regulatory Authority in Ethical Promotion of Pharmaceuticals in Pakistan: A Grounded Theory Study
Abstract
This paper elucidates on the current achievements of Drug Regulatory Authority of Pakistan (DRAP) in ethical promotion of medicines. The old orthodoxy of maximizing shareholders wealth has no significance in contemporary businesses where prominence is given to fair, transparent and ethical behaviors. Ethical and moral behaviors in product promotion are linchpins for pharmaceutical industry. Pharmaceuticals reduce illness of mankind and their appropriate promotion further boosts the wellbeing and reduces sufferings of patients. Nevertheless, Pharmaceutical marketing has an unswerving and unwavering impact on human lives, so this entails regularization and legalization of the discipline through an authentic statutory body. This study conducted open ended interviews from 12 respondents which consist of DRAP employees, sales managers from industry, and pharmacists. After analysis and findings of data, a theme explicitly emerged which shows that the current performance of DRAP is unjustifiable and not up to the mark in governing the sales and use of controlled drugs. The categories are poor enforcement, failure to implement Drug Act 1976 and lack of power to mitigate the malpractices of drugstores. Inescapably, the sales of drugs over-the-counter are common which leads to drug overuse and misuse and subsequently increase the chances of drug related side effects, particularly antibiotic resistance. This is an emerging global challenge for all stakeholders. The study suggests some recommendations for improving the current performance of DRAP within the existing resources.
References
Alexander, Larry, & Moore, Michael. (2007). Deontological ethics.
Allan, George. (2003). A critique of using grounded theory as a research method. Electronic journal of business research methods, 2(1), 1-10.
Amaeshi, Kenneth, Nnodim, Paul, & Onyeka, Osuji. (2013). Corporate social responsibility, entrepreneurship, and innovation: Routledge.
Arias, Cesar A., & Murray, Barbara E. (2009). Antibiotic-Resistant Bugs in the 21st Century — A Clinical Super-Challenge. New England Journal of Medicine, 360(5), 439-443. doi: 10.1056/NEJMp0804651
Atif, Muhammad, Ahmad, Mahmood, Saleem, Quratulain, Curley, Louise, Qamar-uz-Zaman, Muhammad, & Babar, Zaheer-Ud-Din. (2017). Pharmaceutical Policy in Pakistan. In Z.-U.-D. Babar (Ed.), Pharmaceutical Policy in Countries with Developing Healthcare Systems (pp. 25-44). Cham: Springer International Publishing.
Babchuk. (1997). The rediscovery of grounded theory: Strategies for qualitative research in adult education.
Barlam, ., Fishman, Neil O., Hamilton, Cindy W., Jenkins, Timothy C., Lipsett, Pamela A., Malani, Preeti N., . . . Falck-Ytter, Yngve T. (2016). Implementing an Antibiotic Stewardship Program: Guidelines by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. Clinical Infectious Diseases, 62(10), e51-e77. doi: 10.1093/cid/ciw118
Bauchner, Howard, Pelton, Stephen I, & Klein, Jerome O. (1999). Parents, physicians, and antibiotic use. Pediatrics, 103(2), 395-401.
Bowie, Norman E. (2002). A Kantian approach to business ethics. A companion to business ethics, 3-16.
Bryant, Antony, & Charmaz, Kathy. (2007). The Sage handbook of grounded theory: Sage.
Carpenter, Daniel P. (2004). The political economy of FDA drug review: processing, politics, and lessons for policy. Health Affairs, 23(1), 52-63.
Charmaz, Kathy. (2000). Grounded theory: Objectivist and constructivist methods. Handbook of qualitative research, 2, 509-535.
Charmaz, Kathy. (2006a). Constructing grounded theory: A practical guide through qualitative analysis (Introducing Qualitative Methods Series).
Charmaz, Kathy. (2006b). Constructing grounded theory: A practical guide through qualitative research. SagePublications Ltd, London.
Charmaz, Kathy. (2012). The power and potential of grounded theory. Medical Sociology Online, 6(3), 2-15.
Charmaz, Kathy. (2014). Constructing grounded theory: Sage.
Charmaz, Kathy, & Belgrave, Linda Liska. (2007). Grounded theory. The Blackwell encyclopedia of sociology.
Chren, Landefeld, & Murray. (1989). Doctors, drug companies, and gifts. Jama, 262(24), 3448-3451.
Coyle, S. L., for the, Ethics, Human Rights, Committee, & American College of Physicians–American Society of Internal, Medicine. (2002). Physician–industry relations. part 1: Individual physicians. Annals of Internal Medicine, 136(5), 396-402. doi: 10.7326/0003-4819-136-5-200203050-00014
Francer, Jeffrey, Izquierdo, Jose Zamarriego, Music, Tamara, Narsai, Kirti, Nikidis, Chrisoula, Simmonds, Heather, & Woods, Paul. (2014). Ethical pharmaceutical promotion and communications worldwide: codes and regulations. Philosophy, Ethics, and Humanities in Medicine, 9(1), 7.
Ghafur, AK. (2010). An obituary—on the death of antibiotics. J Assoc Physician India, 58(3), 143-144.
Gibson, Kevin. (2000). The moral basis of stakeholder theory. Journal of business ethics, 26(3), 245-257.
Giske, Tove, & Artinian, Barbara. (2007). A Personal Experience of Working with Classical Grounded Theory: From Beginner to Experienced Grounded Theorist. International Journal of Qualitative Methods, 6(4), 67-80. doi: 10.1177/160940690700600405
Glaser. (1978). Theoretical sensitivity: Advances in the methodology of grounded theory: Sociology Pr.
Glaser, & Holton, Judith. (2004). Remodeling grounded theory. Paper presented at the Forum Qualitative Sozialforschung/Forum: Qualitative Social Research.
Goulding, Christina. (2005). Grounded theory, ethnography and phenomenology: A comparative analysis of three qualitative strategies for marketing research. European Journal of Marketing, 39(3/4), 294-308. doi: doi:10.1108/03090560510581782
Gunn, Veronica L, Taha, Samina H, Liebelt, Erica L, & Serwint, Janet R. (2001). Toxicity of over-the-counter cough and cold medications. Pediatrics, 108(3), e52-e52.
Gupta, Madhur, Shridhar, Manisha, Singh, GN, & Khadem, Alireza. (2017). Regulatory systems in India. WHO Drug Information, 31(3), 387-401.
Hoffman, Steven J, & Outterson, Kevin. (2015). What will it take to address the global threat of antibiotic resistance? The Journal of Law, Medicine & Ethics, 43(2), 363-368.
Holton, J. (2010). The coding process and its challenges. The Grounded Theory Review, 9 (1), 21–40.
Hubbard, Jason E. (2007). The dangers of detailing: how pharmaceutical marketing threatens health care.
Hutt, Peter Barton. (1973). Philosophy of Regulation Under the Federal Food, Drug and Cosmetic Act. Food Drug Cosm. LJ, 28, 177.
Jones, & Alony, Irit. (2011). Guiding the use of Grounded Theory in Doctoral studies–an example from the Australian film industry.
Kamat, Vinay R., & Nichter, Mark. (1998). Pharmacies, self-medication and pharmaceutical marketing in Bombay, India. Social Science & Medicine, 47(6), 779-794. doi: https://doi.org/10.1016/S0277-9536(98)00134-8
Kenny, MГ©abh, & Fourie, Robert. (2015). Contrasting classic, Straussian, and constructivist grounded theory: methodological and philosophical conflicts. The Qualitative Report, 20(8), 1270-1289.
KLP. (2012). The Kuala Lumpur Principles Medical Device Sector Codes of Ethics.
Krause, Gerard, Borchert, Matthias, Benzler, J, HeinmГјller, R, Kaba, I, Savadogo, M, . . . Diesfeld, HJ. (1999). Rationality of drug prescriptions in rural health centres in Burkina Faso. Health policy and planning, 14(3), 291-298.
Laxminarayan, Duse, Adriano, Wattal, Chand, Zaidi, Anita K. M., Wertheim, Heiman F. L., Sumpradit, Nithima, . . . Cars, Otto. (2013). Antibiotic resistance—the need for global solutions. The Lancet Infectious Diseases, 13(12), 1057-1098. doi: https://doi.org/10.1016/S1473-3099(13)70318-9
Lichtenberg, Frank R, & Brown, CC. (2002). The economic benefits of new drugs. Economic Realities in Health Care Policy, 2(2), 14-19.
Mappes, Thomas A, & Zembaty, Jane S. (1981). Biomedical ethics: Citeseer.
Moghaddam, Alireza. (2006). Coding issues in grounded theory. Issues in educational research, 16(1), 52-66.
Nerlich, Brigitte, & James, Richard. (2009). “The post-antibiotic apocalypse” and the “war on superbugs”: catastrophe discourse in microbiology, its rhetorical form and political function. Public Understanding of Science, 18(5), 574-590.
Pecoul, Bernard, Chirac, Pierre, Trouiller, Patrice, & Pinel, Jacques. (1999). Access to essential drugs in poor countries: a lost battle? Jama, 281(4), 361-367.
Rägo, Lembit, & Santoso, Budiono. (2008). Drug regulation: history, present and future. Drug benefits and risks: International textbook of clinical pharmacology, 2, 65-77.
Rashid, Hira. (2015). Impact of the drug regulatory authorityPakistan: An evaluation. New Visions for Public Affairs, 7, 50-61.
Regmi, Pramod, Van Teijlingen, Edwin, Hundley, Vanora, Simkhada, Padam, Sharma, Sheetal, & Mahato, Preeti K. (2016). Sustainable Development Goals: relevance to maternal and child health in Nepal. Health Prospect: Journal of Public Health, 15(1), 9-10.
Robinson, T. P., Bu, D. P., Carrique-Mas, J., FГЁvre, E. M., Gilbert, M., Grace, D., . . . Woolhouse, M. E. J. (2016). Antibiotic resistance is the quintessential One Health issue. Transactions of The Royal Society of Tropical Medicine and Hygiene, 110(7), 377-380. doi: 10.1093/trstmh/trw048
Sen, Amartya. (2000). Consequential evaluation and practical reason. The Journal of Philosophy, 97(9), 477-502.
Starks, Helene, & Brown, Trinidad. (2007). Choose Your Method: A Comparison of Phenomenology, Discourse Analysis, and Grounded Theory. Qualitative Health Research, 17(10), 1372-1380. doi: 10.1177/1049732307307031
Strauss, & Corbin. (1989). Grounded theory's applicability to nursing diagnostic research. Research Methods for Validating Nursing Diagnoses. Palm Springs. NANDA, 4-24.
Strauss, & Corbin. (1998). Basics of qualitative research techniques: Sage publications Thousand Oaks, CA.
Valdez, Marcelino P. (2016). Efficiency Performance of Firms Under Pharmaceutical and Healthcare Association of the Philippines (PHAP) 2010 to 2014. University of Santo Tomas.
Vangay, Pajau, Ward, Tonya, Gerber, Jeffrey S, & Knights, Dan. (2015). Antibiotics, pediatric dysbiosis, and disease. Cell host & microbe, 17(5), 553-564.
Verma, SK. (2004). Physician-pharmaceutical industry interaction: Changing dimensions and ethics. Indian pediatrics, 41(1), 29-36.
WHO. (2002). Promoting rational use of medicines: core components: Geneva: World Health Organization.
WHO. (2015). The Rational use of drugs: report of the conference of experts, Nairobi, 25–29 November 1985. 1987: Geneva.
WHO. (2016). SDG 3: ensure healthy lives and promote wellbeing for all at all ages. Geneva: World Health Organization.
Yu, Xuan, Li, Cheng, Shi, Yuhua, & Yu, Min. (2010). Pharmaceutical supply chain in China: current issues and implications for health system reform. Health policy, 97(1), 8-15.
Zoghbi, William A, Duncan, Tony, Antman, Elliott, Barbosa, Marcia, Champagne, Beatriz, Chen, Deborah, . . . Komajda, Michel. (2014). Sustainable development goals and the future of cardiovascular health: a statement from the Global Cardiovascular Disease Taskforce: Journal of the American College of Cardiology.
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