Pharmacovigilance: Present Scenario and Future Goals

Pharmacovigilance: Present Scenario and Future Goals

Assistant Professor, faculty of Pharmacy, World University of Bangladesh

 International Journal of Hospital Pharmacy

Melon Pharmacovigilance is the science and activity relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Pharmacovigilance basically targets safety of medicine. Pharmacists have crucial role in health systems to maintain the rational and safe use of medicine for they are drug experts who are specifically trained in this field. The perspective of pharmacy students on pharmacovigilance and ADR reporting has also been discussed with an aim to highlight the need to improve content related to ADR reporting and pharmacovigilance in undergraduate pharmacy curriculum. Globally, although the role of pharmacists within national pharmacovigilance systems varies, it is very well recognized. Incorporation of ADR reporting concepts in education curriculum, training of pharmacists and voluntary participation of pharmacists in ADR reporting is very crucial in achieving the safety goals and safeguarding public health. Also, these knowledge gaps can be fulfilled through continuous professional development programs and reinforcing theoretical and practical knowledge in undergraduate pharmacy curriculums. Without adequately identifying and fulfilling training needs of pharmacists and other health care professionals, the efficiency of national pharmacovigilance systems is unlikely to improve which may compromise patient’s safety.

Keywords: Prevention; Monitoring; Pharmacists; ADR; Safety; Medicine

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How to cite this article:
AK Mohiuddin, Pharmacovigilance: Present Scenario and Future Goals. International Journal of Hospital Pharmacy, 2019,4:23.


1. Öztürk AB, Özyiğit LP, Şener Ü, et al. Reporting Adverse Drug Reactions in a Tertiary Care Hospital in İstanbul. Turk Thorac J. 2018;19(4):237-239.
2. Ribeiro MR, Motta AA, Marcondes-Fonseca LA, Kalil-Filho J, Giavina-Bianchi P. Increase of 10% in the Rate of Adverse Drug Reactions for Each Drug Administered in Hospitalized Patients. Clinics (Sao Paulo). 2018;73:e185.
3. Parameswaran Nair N, Chalmers L, Peterson GM, Bereznicki BJ, Castelino RL, Bereznicki LR. Hospitalization in older patients due to adverse drug reactions -the need for a prediction tool. Clin Interv Aging. 2016;11:497-505. Published 2016 May 2. doi:10.2147/CIA.S99097
4. Ruscin JM, Linnebur SA. Aging and Drugs. Merck Manual Consumer Version. © 2018 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA
5. Chopra D, Rehan HS, Sharma V, Mishra R. Chemotherapy-induced adverse drug reactions in oncology patients: A prospective observational survey. Indian J Med Paediatr Oncol. 2016 Jan-Mar;37(1):42-6. doi: 10.4103/0971-5851.177015. PubMed PMID: 27051157
6. Inácio P, Cavaco A, Airaksinen M. The value of patient reporting to the pharmacovigilance system: a systematic review. Br J Clin Pharmacol. 2016;83(2):227-246.
7. Al Dweik R, Stacey D, Kohen D, Yaya S. Factors affecting patient reporting of adverse drug reactions: a systematic review. Br J Clin Pharmacol. 2016;83(4):875-883.
8. Gurmesa LT, Dedefo MG. Factors Affecting Adverse Drug Reaction Reporting of Healthcare Professionals and Their Knowledge, Attitude, and Practice towards ADR Reporting in Nekemte Town, West Ethiopia. Biomed Res Int. 2016;2016:5728462.
9. Avong YK, Jatau B, Gurumnaan R, et al. Addressing the under-reporting of adverse drug reactions in public health programs controlling HIV/AIDS, Tuberculosis and Malaria: A prospective cohort study. PLoS One. 2018;13(8):e0200810. Published 2018 Aug 22. doi:10.1371/journal.pone.0200810
10. O’Callaghan J, Griffin BT, Morris JM, Bermingham M. Knowledge of Adverse Drug Reaction Reporting and the Pharmacovigilance of Biological Medicines: A Survey of Healthcare Professionals in Ireland. BioDrugs. 2018;32(3):267-280.
11. Hohl CM, Small SS, Peddie D, Badke K, Bailey C, Balka E. Why Clinicians Don’t Report Adverse Drug Events: Qualitative Study. JMIR Public Health Surveill. 2018;4(1):e21. Published 2018 Feb 27. doi:10.2196/publichealth.9282
12. Gifford ML, Anderson JE. Barriers and motivating factors in reporting incidents of assault in mental health care. J Am Psychiatr Nurses Assoc. 2010 Sep;16(5):288-98. doi: 10.1177/1078390310384862. PubMed PMID: 21659279.
13. Ferner RE, Easton C, Cox AR. Deaths from Medicines: A Systematic Analysis of Coroners’ Reports to Prevent Future Deaths. Drug Saf. 2018 Jan;41(1):103-110. doi: 10.1007/s40264-017-0588-0. PubMed PMID: 28808959
14. Giardina C, Cutroneo PM, Mocciaro E, et al. Adverse Drug Reactions in Hospitalized Patients: Results of the FORWARD (Facilitation of Reporting in Hospital Ward) Study. Front Pharmacol. 2018;9:350. Published 2018 Apr 11. doi:10.3389/fphar.2018.00350
15. Chu DK, Kim LH, Young PJ, Zamiri N, Almenawer SA, Jaeschke R, Szczeklik W, Schünemann HJ, Neary JD, Alhazzani W. Mortality and morbidity in acutely ill adults treated with liberal versus conservative oxygen therapy (IOTA): a systematic review and meta-analysis. Lancet. 2018 Apr 28;391(10131):1693 1705. doi: 10.1016/S0140-6736(18)30479-3. Epub 2018 Apr 26. Review. PubMed PMID:29726345.
16. Wilke RA, Lin DW, Roden DM, et al. Identifying genetic risk factors for serious adverse drug reactions: current progress and challenges. Nat Rev Drug Discov. 2007;6(11):904-16.
17. Angiji A. Adverse Drug Reactions related to mortality and morbidity: Drug – drug interactions and overdoses. Available From:
18. Hillman D, Mitchell S, Streatfeild J, Burns C, Bruck D, Pezzullo L. The economic cost of inadequate sleep. Sleep. 2018 Aug 1;41(8). doi: 10.1093/sleep/zsy083. PubMed PMID: 29868785.
19. Hartman J, Härmark L, van Puijenbroek E. A global view of undergraduate education in pharmacovigilance. Eur J Clin Pharmacol. 2017;73:891–899. doi: 10.1007/s00228-017-2237-z.
20. Abubakar AR, Haque M. Pharmacovigilance practice: the current challenges and the gaps in the medical students’ curriculum. J App Pharm Sci. 2016;6(05):210–2015. doi: 10.7324/JAPS.2016.60532.
21. Gavaza P, Bui B. Pharmacy students’ attitudes toward reporting serious adverse drug events. Am J Pharm Educ. 2012;76(10):194. doi: 10.5688/ajpe7610194.
22. De Angelis A, Colaceci S, Giusti A, Vellone E, Alvaro R. Factors that condition the spontaneous reporting of adverse drug reactions among nurses: an integrative review. J Nurs Manag. 2015;23(4):1–13p.
23. Pagotto C, Varallo F, Mastroianni P. Impact of educational interventions on adverse drug events reporting. Int J Technol Assess Health Care. 2013;29(4):410–417. doi: 10.1017/S0266462313000457.
24. Rutter P, Brown D, Howard J, Randall C. Pharmacists in pharmacovigilance: can increased diagnostic opportunity in community settings translate to better vigilance? Drug Saf. 2014;37(7):465–469. doi: 10.1007/s40264-014-0191-6.
25. Gonzalez-Gonzalez C, Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Strategies to improve adverse drug reaction reporting: a critical and systematic review. Drug Saf. 2013;36(5):317–328. doi: 10.1007/s40264-013-0058-2.
26. Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2009;32(1):19–31. doi: 10.2165/00002018-200932010-00002.
27. WH I Attitudes to adverse drug reaction reporting. Br J Clin Pharmacol. 1996;41(5):434–435.
28. Alessia De Angelis SC, Giusti A, Vellone E, Alvaro R (2015) Factors that condition the spontaneous reporting of adverse drug reactions among nurses: an integrative review. J Nurs Manag 24(2)
29. Herdeiro MT, Ribeiro-Vaz I, Ferreira M, Polnia J, Falco A, Figueiras A. Workshop-and telephone-based interventions to improve adverse drug reaction reporting: a cluster-randomized trial in Portugal. Drug Saf. 2012;35(8):655–665. doi: 10.1007/BF03261962.
30. Johansson-Pajala RM, Martin L, Fastbom J, Blomgren KJ. Nurses’ self-reported medication competence in relation to their pharmacovigilant activities in clinical practice. J Eval Clin Pract. 2015;21(1):145–152. doi: 10.1111/jep.12263.
31. Ribeiro-Vaz I, Santos CC, Cruz-Correia R. Promoting adverse drug reaction reporting: comparison of different approaches. Rev Saude Publica. 2016;50:14. doi: 10.1590/S1518-8787.2016050006122.
32. Ribeiro-Vaz IH, T M, Polonia J, Figueiras A. Strategies to increase the sensitivity of pharmacovigilance in Portugal. Rev Saude Publica. 2011;45(1):129–135. doi: 10.1590/S0034-89102010005000050.
33. Talbot JC, Nilsson BS. Pharmacovigilance in the pharmaceutical industry. Br J Clin Pharmacol. 1998;45(5):427-31.
34. WHO Medicines Strategy: Framework for Action in Essential Drugs and Medicines Policy 2000-2003.
35. Olsson S. The role of the WHO Programme for International Drug Monitoring in coordinating worldwide drug safety efforts. Drug Saf. 1998;19:1–10.
36. Coulter DM. The New Zealand intensive medicines monitoring programme in proactive safety surveillance. Pharmacoepidemiol Drug Saf. 2000;9:273–80.
37. Moore N. The role of the clinical pharmacologist in the management of ADRs. Drug Saf. 2001;24:1–7.
38. Hornbuckle K, Wu HH, Fung MC. Evaluation of spontaneous adverse event reports by primary reporter: A 15-year review (1983 to 1997) Drug Inf J. 1999;33:1117–24.
39. Mahmood KT, Amin F, Tahir M, Haq IUl. Pharmacovigilance—a need for best patient care in Pakistan. A review. Pharm Sci Res. 2011;3(11):1566–1584.
40. Uppsala Monitoring Centre (UMC) Web. WHO Collaborating Centres November 13, 2017
41. WHO Web. The Importance of Pharmacovigilance – Safety Monitoring of Medicinal Products 2002. Essential Medicines and Health Products Information Portal A World Health Organization resource.
42. Peabody J, Acelajado MC, Robert T, et al. Drug-Drug Interaction Assessment and Identification in the Primary Care Setting. J Clin Med Res. 2018;10(11):806-814.
43. Ansari J. Drug interaction and pharmacist. J Young Pharm. 2010;2(3):326-31.
44. Yeh YT, Hsu MH, Chen CY, Lo YS, Liu CT. Detection of potential drug-drug interactions for outpatients across hospitals. Int J Environ Res Public Health. 2014;11(2):1369-83. Published 2014 Jan 27. doi:10.3390/ijerph110201369
45. Shah RR. Importance of Publishing Adverse Drug Reaction Case Reports: Promoting Public Health and Advancing Pharmacology and Therapeutics. Drug Saf Case Rep. 2017;4(1):11. Published 2017 Sep 20. doi:10.1007/s40800-017-0053-0
46. Bowles GC., Jr Adverse drug reaction reporting urged as factor in accreditation. Mod Hosp. 1964;103:120.
47. Latif A, Helen P, Boardmana F. The contribution of the Medicines Use Review (MUR) consultation to counseling practice in community pharmacies. Patient Education and Counseling Volume 83, Issue 3, June 2011, Pages 336-344.
48. van Grootheest AC, de Jong-van den Berg LT. The role of hospital and community pharmacists in pharmacovigilance. Res Social Adm Pharm. 2005 Mar;1(1):126-33. Review. PubMed PMID: 17138470.
49. APhA. Principles of Practice for Pharmaceutical Care. © Copyright 2018, American Pharmacists Association. Available From:
50. Mohiuddin AK (2018) Patient Compliance: An Untold Story or a Fairy Tale? Pharmaceut Reg Affairs 7: 207. doi: 10.4172/2167-7689.1000207
51. Brajesh Kumar et al. / Professional scopes and roles of community pharmacists in various health care services: An updated review. Journal of Pharmacy Research 2011,4(5),1331-1335
52. Bhaskaran S. A vision of Indian pharmacist in 2020. December 16, 2010.
53. Toklu HZ, Mensah E. Why do we need pharmacists in pharmacovigilance systems?. Online J Public Health Inform. 2016;8(2):e193. Published 2016 Sep 15. doi:10.5210/ojphi.v8i2.6802
54. Management Sciences for Health ( chapter 33. Encouraging appropriate medicine use by consumers. Available From:

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