Drug safety and Pharmacovigilance: An overview
Adverse drug reactions (ADRs) have a major impact on public health, reducing patient’s quality of life and imposing a considerable financial burden on the health care systems at a time when many health care systems are under considerable financial strain. All healthcare providers have roles to play in maintaining a balance between a medicine's benefits and risks. Once a drug is available to the public, making a determination about its safety is the shared responsibility of all who are part of the prescribing process, including patients. The role of healthcare professionals is vital in recording and reporting suspected ADRs in order that regulatory agencies are alerted of emerging safety concerns and thereby facilitating timely and appropriate action. Pharmacovigilance is an important exercise for monitoring of drug related issues after marketed in “real world setting”. Pharmacovigilance and all drug related issues are important for everyone whose life is being impacted any way by medical interventions. The evolution of Pharmacovigilance in recent years has growing importance as a science critical to effective clinical practice and public health science. The national Pharmacovigilance centers have become a significant influence on the drug regulatory authorities, at a time when drug safety concerns have become increasingly important in public health and clinical practice. This paper unfolds the basics of drug safety and other important aspects of Pharmacovigilance.
Keywords: Adverse drug reactions, Pharmacovigilance, Drug regulation.
2. Laurence D, John C. A Dictionary of Pharmacology and Clinical Drug Evaluation, 1994.
3. The Importance of Pharmacovigilance, World Health Organization, 2002.
4. Pirmohamed M, Atuah KN, Dodoo ANO and Winstanley P. Pharmacovigilance in developing countries: Requires collaboration between stakeholders to develop novel models of funding. British Medical Journal, 2007; 335:462.
5. Meyboom RH, Egberts AC, Gribnau FW, Hekster YA. Pharmaco vigilance in perspective Drug Safety, 1999; 21(6):429-47.
6. WHO. The Importance of Pharmacovigilance, Safety Monitoring of medical products. WHO Geneva 2002.
7. Gupta R, Sheikh A, Strachan D, Anderson HR. Increasing hospital admissions for systemic allergic disorders in England: analysis of national admissions data. BMJ 2003; 327(7424): 1142-3.
8. A short history of involvement in drug safety monitoring by World Health Organization. The importance of Pharmaco vigilance, Safety monitoring of medicinal products. WHO bulletin; 2002.
9. Amery WK; ISPE, "Why there is a need for Pharmacovignance'' Pharmacoepidemiology and Drug Safety, 1999; 8(l):61-4.
10. http://apps.who.int/medicinedocs/en/d/Js6164e/2.html, accessed on 30th November 2018.
11. WHO (2002a) Safety of Medicines: A guide to detecting and reporting adverse drug reactions; why health professionals need to take action. World Health Organization. [cited 12/010/2018]. Available from: http://whqlibdoc.who.int/hq/2002/WHO_EDM_QSM_2002.2.pd
12. Beard K and Lee A. Introduction. In: Adverse drug reactions. London:Pharmaceutical Press, 2006; 1(2):1-22.
13. Pitt B. Drug safety: who is responsible? International Journal of Clinical Practice, 2007; 61 (2):182-183.
14. Van G, Berg, L. Patients' role in reporting adverse drug reactions. Expert Opinion on Drug Safety, 2004; 3 (4):363-368.
15. Morrison G, Walley TJ, Park B K, Breckenridge AM. and Pirmohamed M. Reporting of adverse drug reactions by nurses, The Lancet, 2003; 361 (9366):1347-1348.
16. Ulfvarson J, Mejyr S. and Bergman U. Nurses are increasingly involved in pharmacovigilance in Sweden. Pharmaco epidemiology and Drug Safety, 2007; 16 (5): 532-537.
17. Conforti A, Opri S., Dlncau P, Sottosanti L, Moretti U, Ferrazin, F. Adverse drug reaction reporting by nurses: analysis of Italian pharmacovigilance database. Pharmaco epidemiology and Drug Safety, 2012; 21 (6):597-602.
18. Fortnum H, Lee A J, Rupnik B, Avery A. Survey to assess public awareness of patient reporting of adverse drug reactions in Great Britain. Journal of Clinical Pharmacy and Therapeutics, 2011; 37 (2):161-165.
19. McLernon DJ, Bond C M, Lee A J, Watson M C, Hannaford PC, Fortnum H. (2011) Patient views and experiences of making adverse drug reaction reports to the Yellow Card Scheme in the UK. Pharmacoepidemiology and Drug Safety, 2011; 20(5):523-531.
20. Anderson C, Krska J, Murphy E, Avery A. Assessing the usability of methods of public reporting of adverse drug reactions to the UK Yellow Card Scheme. Health Expectations. British Journal of Clinical Pharmacology, 2011; 72 (5):806-822.
21. Hughes ML, Whittlesea CM, Luscombe DK. Review of national spontaneous reporting schemes: strengths and weaknesses. Advances in Drug Reactions and Toxicology Review, 2002; 21 (4):231-41.
22. Roden S. An introduction to drug safety surveillance. In Research international Drug Surveillance Depertment (IDSD) Glaxo Group, ed. Drug safety: a shared responsibility, 199; 1-10.
23. WHO-UMC. Being a member of the WHO Programme for International Drug Monitoring, 2009. [cited 19/1/2019]. Available from: http://who-umc.org/graphics/25642.pdf
24. WHO-UMC WHO Programme, WHO Programme for International Drug Monitoring, 2009. [cited 19/1/2019]. Available: http://www.who-umc.org/DynPage.aspx?id=13140#1.
25. WHO (2012) Safety, efficacy and utilization (Pharmaco vigilance). World Health Organization. Cited 19/1/19]. Availablefrom:http://www.who.int/medicines/areas/quality_safety/safety_efficacy/en/index.l.
26. Safety of medicines in public health programmers: Pharmacovigilance an essential tool, World Health Organization, 2006.
27. Strom BL. Pharmacoepidemiology John Wiley and Sons, Ltd, New York; 2005; 1(4):23.
28. Schulz K, Grimes D. The Lancet Handbook of Essential Concepts in clinical research. Elsevier publications; 2006: 45-47.
29. A practical handbook on the pharmacovigilance of anti-retroviral medicines. World Health Organization; 2009; 19-20
30. Task force on risk management. Managing the risks from medical product use: Creating a risk management framework. Part 3.How does FDA conduct post marketing surveillance and risk assessment. Report to the FDA commissioner; 1999.
31. Mehta U, Durrheim DN, Blumberg L, Donohue S, Hansford F, Mabuza A. Malaria deaths as sentinel events to monitor healthcare delivery and antimalarial drug safety. Trop. Med. Int. Health. 2007; 12(5):617-28.
32. A practical handbook on the pharmacovigilance of antiretroviral medicines. World Health Organization; 2009; 7.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (SeeÂ The Effect of Open Access).