PHARMACOVIGILANCE/REPORTING ADVERSE DRUG REACTIONS: AN APPROACH TO ENHANCE HEALTH SURVEILLANCE AND EXTENDING MARKET SHARE BY MINIMIZING THE CHANCES OF DRUG WITHDRAWALS
Any unintended response of a drug which; apart from the doses that cover therapy of a disease; includes lack of efficacy, overdose and its misuse can be termed as an adverse drug reaction. In this scenario, adverse effects of drugs are mostly shown which result in the withdrawals of block buster's molecules and finally lead to the sharp decline of the market share. So there is an immense need to keep a hawk eye on these suspected adverse reactions to enhance health surveillance as well as minimizing the chances of drug withdrawals from the market. Thus the whole exercise of reporting adverse drug reactions is administered through implementation of pharmacovigilance program that deals with timely identification of ADR and it's monitoring-i.e. Collecting data, assessment, and follow up action. The importance of Pharmacovigilance has been on the rise because the frequency of ADRs and the percentage of hospital admissions have been increasing day by day, which finally have led to decline the global market share of blockbuster drugs by numeral instances of the cases of recalls and in some more severity have resulted in drug related mortality and morbidity of patients forcing the companies to ultimately withdraw the drug. The article highlights the different approaches of reporting the adverse drug reactions for enhancing the health surveillance and strategic consent for the pharmaceutical industry to generate long term revenues by reducing the chances of drug withdrawals with special emphasis on the consequences of reporting and non-reporting of ADRs and due examples of drug reported ADRs & their recalls. The article also highlights the Pharmacovigilance program in the European Union, United States and India, strategies for reducing the ADRs and future aspect of Pharmacovigilance.
2. Kumar Sahu R, Yadav R, Prasad P, Roy A, Chandrakar S. Adverse drug reactions monitoring: prospects and impending challenges for pharmacovigilance. Springer Plus 2014;695:1-9.
3. Ghosh AK. Current problems and future aspects of pharmacovigilance in india. Int J Pharm Biol Sci 2011;2(1):15-28.
4. Kumar S, Baldi A. Pharmacovigilance in India: perspectives and prospects. J Drug Delivery Ther 2013;3(4):237-46.
5. http://www.fda.gov/Safety/Recalls/ucm165546.htm [Last accessed on 12 Apr 2015].
6. Glossary of terms used in pharmacovigilance. Available from: URL: http://who-umc.org/graphics/28401.pdf [Last accessed on 15 Apr 2015].
7. Begum SS, Mansoor Md, Sandeep A, Mahadevamma L, Krishnagoudar BS. Tools to improve reporting of adverse drug reactionsâ€“a review. Int J Pharm Sci Rev Res 2013;23(1):262-5.
8. Dhikav V, Singh S, Anand KS. Adverse drug reaction monitoring in india. J Indian Acad Clin Med 2004;5(1):27-33.
9. Singh G. Do no harmâ€“But first we need to know more: the case of adverse drug reactions with antiepileptic drugs. Neurol India 2011;59(1):53-8.
10. Michelle Putzeist. Marketing authorisation of new medicines in the EU: towardsevidence-based improvement; 2013. p. 9-24. Available from: URL: http://apps.who.int/medicinedocs/ documents/ s21298en/s21298en.pdf [Last accessed on 10 Apr 2015].
11. John Talbot, Jeffrey K. Aronson Stephensâ€™ detection and evaluation of adverse drug reactions principles and practice. 6th edition; 2012. p. 5-6.
12. Khurana A, Rastogi R, Gamper LHJ. A new era of drug safetyâ€“New EU pharmacovigilance legislation and comparison of PV in EU, US and India. Int J Pharm Pharm Sci 2014;6(7):15-21.
13. European medicines agency and heads of medicines agencies. Guideline on Good Pharmacovigilance Practices. Available from: URL: http://www.ema.europa.eu/ema/ index.jsp? curl=pages/regulation/document_listing/document_listing_000345.jsp [Last accessed on 16 Apr 2105].
14. The new EU pharmacovigilance legislation: Directive 2010/84/EU and Regulation No. 1235/2010 Guidance for Patient Organisations. Available from: URL: http://www.eu-patient.eu/globalassets/policy/pharmaceuticalpackage/epf-guidance-pharmacovigilance-for-patient-organisations.pdf [Lasr accessed on 16 Apr 2105].
15. Comparison of EU-Pharmacovigilance System Master File with US System. Available from: http://dgra.de/media/pdf/ studium/masterthesis/master_sheikholeslam_a.pdf [Last accessed 18 Apr 2105].
16. YK Gupta. Pharmacovigilance programme for India; 2010. Available from: URL: http://www.rmlh.nic.in/ writereaddata/ linkimages/7286947352.pdf [Last accessed on 11 Apr 2105].
17. Joe C Mathew. Govt sets up NPAC to launch pharmacovigilance programme network. Available from: URL: http:// www.pharmabiz.com/NewsDetails.aspx?aid=23480&sid=2 [Last accessed on 13 Apr 2105].
18. The Value of a Letter: The Importance of Dear Doctor Letters Last Updated: February 6 2014 Meta C. Danzey. Available from: URL: http://www.mondaq.com/unitedstates/x/291138/ Healthcare/The+Value+Of+A+Letter+The+Importance+Of+Dear+Doctor+Letters [Last accessed on 16 Apr 2105].
19. From vision to decision Pharma 2020. Available from: URL: https://www.pwc.es/es_ES/es/publicaciones/pharma/assets/pharma-2020-de-la-vision-a-la-decision.pdf [Last accessed on 15 Apr 2105].
20. Michelle Putzeist. Marketing authorisation of new medicines in the EU: towards evidence-based improvement; 2013. p. 9-24. Available from: URL: http://apps.who.int/ medicinedocs/ documents/ s21298en/s21298en.pdf [Last accessed on 16 Apr 2105].