Main Article Content

Abstract

In order to guarantee medication safety, enhance clinical procedures, and safeguard the public's health, pharmacovigilance is essential in identifying and controlling adverse drug reactions (ADRs). Expert systems are crucial for quickly detecting safety issues and averting product withdrawals because to the increasing amount of ADR data. Complex, cross-border safety issues can be better managed by implementing independent review methods and fortifying the worldwide pharmacovigilance network, such as through the Uppsala Monitoring Center. The creation of pharmacovigilance centers around the world has strengthened medication safety monitoring, despite ongoing issues including underreporting and data quality. Initiatives since the year 2000 have concentrated on enhancing drug safety systems, encouraging cooperation between researchers, healthcare providers, and regulatory bodies, and extensively sharing safety data. Pharmacovigilance developments have changed the strategy from changing from reactive to proactive, filling in the gaps, and enhancing medication safety. Along with lowering patient harm and promoting sensible prescription usage, these advancements have also increased confidence in healthcare systems around the world. Pharmacovigilance is becoming a vital instrument for public health protection.

Keywords

Pharmacovigilance, Drug safety, Adverse Drug Reactions, Public health, Safety

Article Details

How to Cite
Asha Nandabaram, Deepika Nadiminti, Namitha Naluvala, Manogna Nanded, Rachana Nangunoori, & Panjala Saikiran Goud. (2025). A Comprehensive Overview On Pharmacovigilance Ensuring Drug Safety. International Journal of Research in Pharmacology & Pharmacotherapeutics, 14(1), 216-226. Retrieved from https://ijrpp.com/ijrpp/article/view/640

References

  1. 1. 1.Geneva: World Health Organization. Looking at the Pharmacovigilance: ensuring the safe use of medicines. WHO Policy Perspectives on Medicines. Geneva: WHO; 2004. Available from: http://www.whqlibdoc.who.int/ hq/2004/WHO_EDM_2004.8.pdf. [cited on 2009 Dec 15].
  2. 2. Bégaud B, Chaslerie A, Haramburu F. 1994. Organization and results of drug vigilance in France. Rev Epidemiol Sante Publique. 42, 416-23. PubMed
  3. 3. Harmark L, van Grootheest AC. Pharmacovigilance: Methods, recent developments and future perspectives. Eur J Clin Pharmacol 2008;64:743-52.
  4. 4. WHO. The Importance of Pharmacovigilance, Safety Monitoring of medicinal products. World Health Organization 2002.
  5. 5. Biswas P, Biswas A. Setting standards for proactive pharmacovigilance in India: The way forward. Indian J Pharmacol 2007;39:124-8
  6. 6. Report E. Effective communications in Pharmacovigilance. International Conference on Developing Effective Communications in Pharmacovigilance, Erice, Sicily 1997; 24-27.
  7. 7. Shuka SS, Gidwani B, Pandey R, Rao SP, Singh V, et al. 2012. Importance of Pharmacovigilance in Indian Pharmaceutical Industry. Asian J. Res. Pharm. Sci. 2, 4-8.
  8. 8. Hornbuckle K, Wu H-H, Fung MC. 1999. Evaluation of spontaneous adverse event reports by primary reporter - a 15-year review (1983 to 1997). Drug Inf J. 33, 1117-24
  9. 9. WHO. 2000. Consumer reporting of ADRs. WHO Drug Information. 14, 211-15
  10. 10. Egberts GPG, Smulderes M, De Konig FHP, et al. 1996. Can adverse drug reactions be detected earlier?: a comparison of reports by patients and professionals. BMJ. 313, 530-31. PubMed http://dx.doi.org/10.1136/bmj.313.7056.530
  11. 11. 11.Norwood PK, Sampson AR. 1988. A statistical methodology for postmarketing surveillance of adverse drug reaction reports. Stat Med. 7, 1023-30. PubMed http://dx.doi.org/10.1002/sim.4780071004
  12. 12. 12.whqlibdoc.who.int [homepage on the Internet]. Geneva: World Health Organization. 1973. Handbook of resolutions and decisions of the World Health Assembly and Executive Board. Available from: http://whqlibdoc. who.int/wha_eb_handbooks/9241652063_Vol2.pdf. [Last cited on 2009 Dec 26].
  13. 13. Lared NL. Pharmacists’ role in reporting adverse drug reactions in an international perspective. 2003. Available from: http://www.lareb.nl/ documents/pds2004_1291.pdf. [last cited on 2010 Jan 28].
  14. 14. WHO. Immunization safety surveillance: Guidelines for managers of immunization programmes on reporting and investigating adverse events following immunization. Immunization Focus: WHO Regional Office for the Western Pacific. Manila 1999.
  15. 15. WHO. Global programme for vaccines and immunization: Expanded Programme on Immunization. Surveillance of adverse events following immunization: Field guide formanagers of immunization programmes. Geneva 1997.
  16. 16. Simonsen L, Kane A, Lloyd J, Zaffran M, Kane M. 1999. Unsafe injections in the developing world and transmission of bloodborne pathogens: a review. Bull World Health Organ. 77, 789-800. PubMed
  17. 17. Moore N. The role of the clinical pharmacologist in the management of ADRs. Drug Saf 2001;24:1-7.
  18. 18. 18.. Strom BL. Overview of automated databases in pharmacoepidemiology (ed). Pharmacoepidemiology Chichester. UK, John Wiley & Sons. 2005;p.219–22.
  19. 19. Butlen S, Ducuing F. 2010. European medicines agency support mechanisms fostering orphan drug development. Drug News Perspect. 23, 71-81. PubMed http://dx.doi.org/10.1358/dnp.2010.23.1.1437303
  20. 20. 20.. Giezen TJ. 2009. Evaluation of post-authorization safety studies in the first cohort of EU risk management plans at time of regulatory approval. Drug Saf. 32, 1175-87. PubMed http://dx.doi.org/10.2165/11318980-000000000-00000
  21. 21. Herret E. 2010. Validation and validity of diagnoses in the general practice research database. J Clin Pharmacol. 69, 4-14. PubMed http://dx.doi.org/10.1111/j.1365- 2125.2009.03537.x
  22. 22. Abenhaim L. 1996. Appetite-suppressant drugs and the risk of primary pulmonary hypertension. N Engl J Med. 335, 609-16. PubMed http://dx.doi.org/10.1056/NEJM199608293350901
  23. 23. Kaufman DW. 2001. Signal generation and clarification: Use of case-control data. Pharmacoepidemiol Drug Saf. 10, 197-203. PubMed http://dx.doi.org/10.1002/pds.571
  24. 24. Greene W. The Emergence of India’s Pharmaceutical Industry and Implications for the U.S. Generic Drug Market. U.S. International Trade Commission 2007.
  25. 25. Iskander J. 2005. Monitoring vaccine safety during an influenza pandemic. Yale J Biol Med. 78, 265-75. PubMed
  26. 26. Stefano F, Tokars J. 2010. H1N1 vaccine safety monitoring: Beyond background rates. Lancet. 375, 1146-47. PubMed http://dx.doi.org/10.1016/S0140-6736(09)61917-6
  27. 27. Chen RT. 2000. The vaccine safety datalink: Immunization research in health maintenance organizations in the USA. Bull World Health Organ. 78, 186-94. PubMed
  28. 28. Vander H, Stichele R. 2004. European Surveillance of Antimicrobial Consumption (ESAC): Data collection performance and methodological approach. Br J Clin Pharmacol. 58, 419- 28. PubMed http://dx.doi.org/10.1111/j.1365-2125.2004.02164.x
  29. 29. 29.. Martirosyan LA. 2010. Systematic literature review: Prescribing indicators related to type 2 diabetes mellitus and cardiovascular risk management. Pharmacoepidemiol Drug Saf. 19, 319-34. PubMed
  30. 30. Cioms CH. Geneva. Benefit-risk balance for marketed drugs. Evaluating safety signals: Report of CIOMS working group IV. CIOMS, Geneva. 1998. Available from: http://www.cioms.ch/publications/g4-benefit-risk. pdf. [last cited on 2010 Jan 15].
  31. 31. McClure DL. 2009. Improving Drug Safety: Active Surveillance Systems Should be Paramount. Pharmaceutical Medicine. 23, 127-30. http://dx.doi.org/10.1007/BF03256760
  32. 32. Shibata A, Hauben M. Pharmacovigilance, signal detection and signal intelligence overview. Proceedings of the 14th International Conference on Information Fusion (FUSION-2011). Chicago, IL. 2011; pp. 1-7.
  33. 33. 33.. Lopes P, Nunes T, Campos D, Furlong LI, Bauer-Mehren A, et al. 2013. Gathering and Exploring Scientific Knowledge in Pharmacovigilance. PLoS ONE. 8(12), e83016. PubMed http://dx.doi.org/10.1371/journal.pone.0083016
  34. 34. Stahl M, Edwards IR, Bowring G, Kiuru A, Lindquist M. 2003. Assessing the Impact of Drug Safety Signals from the WHO Database Presented inSIGNAL': Results from a Questionnaire of National Pharmacovigilance Centres. Drug Saf. 26, 721-27. PubMed
  35. 35. 35.. Lazarou J, Pomeranz BH, Corey PN. 1998. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 279, 1200-05. PubMed http://dx.doi.org/10.1001/jama.279.15.1200
  36. 36. 36.. Meyboom RHB, Lindquist M, Egberts ACG, Edwards IR. 2002. Signal Selection and Follow-Up in Pharmacovigilance. Drug Saf. 25, 459-65. PubMed http://dx.doi.org/10.2165/00002018-200225060-00011
  37. 37. De Bruin ML, Van Puijenbroek EP, Egberts AC, Hoes AW, Leufkens HG. 2002. Nonsedating antihistamine drugs and cardiac arrhythmias– biased risk estimates from spontaneous reporting systems? Br J Clin Pharmacol. 53, 370-74. PubMed http://dx.doi.org/10.1046/j.1365-2125.2002.01569.x
  38. 38. Coloma PM, Schuemie MJ, Trifirò G, Gini R, Herings R, et al. 2011. Combining electronic healthcare databases in Europe to allow for largescale drug safety monitoring: the EU-ADR Project. Pharmacoepidemiol Drug Saf. 20, 1-11. PubMed http://dx.doi.org/10.1002/pds.2053
  39. 39. Härmark L, van Grootheest AC. 2008. Pharmacovigilance: methods, recent developments and future perspectives. Eur J Clin Pharmacol. 64, 743-52. PubMed http://dx.doi.org/10.1007/s00228-008-0475-9
  40. 40. Lazarou J, Pomeranz BH, Corey PN. Incidence of ADRs in hospitalized patients: A meta-analysis of prospective studies. J Am Med Assoc 1998;279:1200-5.
  41. 41. Ioannidis JP, Lau J. Completeness of safety reporting in randomized trials: An evaluation of 7 medical areas. JAMA 2001;285:437-43.
  42. 42. Pandemic pharmacovigilance weekly update Status. 2009. Available from: http://www.ema.europa.eu/pdfs/influenza/78468109en.pdf. [last cited on 2010 Jan 12].
  43. 43. Kane A, Lloyd J, Zaffran M, Simonsen L, Kane M. Transmission of hepatitis B, hepatitis C, and human immunodeficiency virus through safe injections in the developing world: mode-based regional estimates. Bull World Health Organ 1999;78:801-7.
  44. 44. Sleath B, Svarstad B, Roter D. Physician motivation for non-scientific drug prescribing. Soc Sci Med 1997;44:541-8.
  45. 45. Kurz X. 2010. The Eudra Vigilance database of spontaneous adverse reactions as a tool for H1N1 vaccine safety monitoring. Pharmacoepidemiol Drug Saf. 19, 330-31.
  46. 46. Bapna JS, Tripathi CD, Tekur U. Drug utilization patterns in the third world. Pharmacoeconomics 1996;9:286-94
  47. 47. ICH. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Final Concept Paper- E2F-Development Safety Update Report 2006. Available from: http://www.ich.org/LOB/media/MEDIA 3302.pdf.
  48. 48. Biswas P. 2013. Pharmacovigilance in Asia. J Pharmacol Pharmacother. 4, S7-19. PubMed http://dx.doi.org/10.4103/0976-500X.120941
  49. 49. Meslin EM. 1990. Protecting human subjects from harm through improved risk judgments. IRB. 12, 7-10. PubMed http://dx.doi.org/10.2307/3563683
  50. 50. Robb MA, Racoosin JA, Sherman RE, Gross TP, Ball R, et al. 2012. The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety. Pharmacoepidemiol Drug Saf. 21, 9-11. PubMed http://dx.doi.org/10.1002/pds.2311
  51. 51. Edwards LD, Fox AW, Stonier PD. Principles and Practice of Pharmaceutical Medicine. 3rd Edition, Wiley-Blackwell 2011
  52. 52. Andrews EB, Moore N. Mann's Pharmacovigilance. Third Edition, Wiley Blackwell. 2014; pp 287–88.