Pharmacovigilance: Enhancing Drug Safety Through Technology

Year : 2025 | Volume : 16 | 02 | Page : –
    By

    Kalyani Ghanshyam Patil,

  • Akash S. Jain,

  • Divakar R.Patil,

  • Azam Z. Shaikh,

  • Sameer R. Shaikh,

  • Hitendra S. Chaudhari,

  1. Student, Department of Pharmaceutics, P. S. G. V. P. Mandal’s College of Pharmacy, shahada, Maharashtra, India
  2. Assistant Professor, Department of Pharmaceutical Chemistry, P. S. G. V. P. Mandal’s College of Pharmacy, shahada, Maharashtra, India
  3. Assistant Professor, Department of Pharmaceutical Chemistry, P. S. G. V. P. Mandal’s College of Pharmacy, shahada, Maharashtra, India
  4. Assistant Professor, Department of Pharmaceutical Chemistry, P. S. G. V. P. Mandal’s College of Pharmacy, shahada, Maharashtra, India
  5. Assistant Professor, Department of Pharmaceutical Chemistry, P. S. G. V. P. Mandal’s College of Pharmacy, shahada, Maharashtra, India
  6. Assistant Professor, Department of Pharmaceutical Chemistry, P. S. G. V. P. Mandal’s College of Pharmacy, shahada, Maharashtra, India

Abstract

document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_abs_193004’);});Edit Abstract & Keyword

The research and practices surrounding the identification, evaluation, and avoidance of hazardous medication responses in people are known as pharmacovigilance. Pharmacovigilance has been defined as a kind of ongoing observation of side effects and other safety-related features of medications that have previously been introduced to the market. Pharmacovigilance has been shown to be crucial in promoting the sensible use of medications by disseminating knowledge about the negative effects that pharmaceuticals have on the general public. This article provides a quick overview of the relevance, necessity, operation, function, and significance of pharmacovigilance. To ensure the safety of therapies at every stage of development, pharmacovigilance is crucial. It entails continuously monitoring side effects and other unfavorable outcomes linked to medicinal substances after they hit the market  Pharmacovigilance aims to identify any safety concerns through thorough data collection, analysis, and communication, protecting patients and advancing public health. In order to guarantee the safety of pharmaceutical goods at every stage of their lifespan, pharmacovigilance is essential. It entails continuously monitoring side effects and other unfavorable outcomes linked to medicinal substances after they hit the market. Pharmacovigilance aims to identify any safety concerns through thorough data collection, analysis, and communication, protecting patients and advancing public health.

Keywords: Pharmacovigilance, Drug Safety, Technology, Adverse Event, Reporting Signal Detection.

How to cite this article:
Kalyani Ghanshyam Patil, Akash S. Jain, Divakar R.Patil, Azam Z. Shaikh, Sameer R. Shaikh, Hitendra S. Chaudhari. Pharmacovigilance: Enhancing Drug Safety Through Technology. Research and Reviews: A Journal of Pharmaceutical Science. 2025; 16(02):-.
How to cite this URL:
Kalyani Ghanshyam Patil, Akash S. Jain, Divakar R.Patil, Azam Z. Shaikh, Sameer R. Shaikh, Hitendra S. Chaudhari. Pharmacovigilance: Enhancing Drug Safety Through Technology. Research and Reviews: A Journal of Pharmaceutical Science. 2025; 16(02):-. Available from: https://journals.stmjournals.com/rrjops/article=2025/view=0


document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_ref_193004’);});Edit

References

1. Cioanca O,Hancianu M. Phytotherapy approaches in stress-related disorders. In10th International Pharmaceutical Conference „Science and Practice 2019” 2019 Nov 15 (p. 15). Lithuanian University of Health Sciences.

2. Soni R, Kesari B. A Review on Pharmacovigilance. Int J Pharm Sci Rev Res.; c2014 MayJun;26(2):237- 241

3. Garashi HY, Steinke DT, Schafheutle EI. A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators. Ther. Innov. Regul. Sci. 2022;56:717-743. https://doi.org/10.1007/s43441-022-00415-y

4. WHO. The Importance of Pharmacovigilance: Safety Monitoring of medicinal products. 2002; https://www.who.int/publications/i/item/10665-42493

5. Hamid AAA, Rahim R, Teo SP. Pharmacovigilance and Its Importance for Primary Health Care Professionals. Korean J Fam Med. 2022 Sep;43(5): 290-295. doi: 10.4082/kjfm.21.0193.

6. Sarker A, Ginn R, Nikfarjam A, O’Connor K, Smith K, Jayaraman S, et al. Utilizing social media data for pharmacovigilance: A review. J Biomed Inform. 2015;54:202-212.

7. Beninger P. Pharmacovigilance: An Overview. Clin Ther. 2018 Dec;40(12):1991-2004. doi: 10.1016/j.clinthera.2018.07.012

8. Stagi L, Bocchi I, Bernardini D, Ciappa M, Dellon S, Castiglione GN, Romano S, Fabrizi E, Mattavelli A, Grisoni I, Finizia G, Bonato S. The evolution of the Pharmacovigilance department in the pharmaceutical industry: results of an Italian national survey. Ther Adv Drug Saf. 2024 Nov 4;15:20420986241293296. doi: 10.1177/20420986241293296

9. Jeetu G, Anusha G. Pharmacovigilance: A worldwide master key for drug safety monitoring. J Young Pharm. 2010;2(3):315-320.

10. Bihana K, Lebrun-Vignes B, Funck-Brentano C, Salem JE. Uses of pharmacovigilance databases: An overview. Therapies; c2020. DOI:10.1016/j.therap.2020.02.022.

11. Inácio P, Cavaco A, Airaksinen M. The value of patient Inácio P, Cavaco A, Airaksinen M. The value of patient reporting to the pharmacovigilance system: A systematic review. Br J Clin. Pharmacol. 2017;83:227-246.

12. Caron J, Rochoy M, Gaboriau L, Gautier S. Histoire delapharmacovigilance. Therapie. 2016;71(2):123-128.

13. McBride WG. Thalidomide ancongenitalabnormalities. Lancet. 1961;278(7216):1358.

14. WHO Policy Perspectives on Medicines. Geneva: WHO; 2004. Geneva: World Health Organization. Looking at the Pharmacovigilance: ensuring the safe use of medicines.

15. Fornasier, G., Francescon, S., Leone, R., & Baldo, P. (2018). An historical overview over Pharmacovigilance. International Journal of Clinical Pharmacy, 40(4), 744–747. https://doi.org/10.1007/s11096-018-0657-1.

16. Benyoucef, L., & Grabot, B. (Eds.). (2010). Artificial intelligence techniques for networked manufacturing enterprises management. Springer London.https://doi.org/10.1007/978-1-84996- 119-6.

17. Norwood PK, Sampson AR, A statistical methodology for postmarketing surveillance of adverse drug reaction reports, Stat Med, 1988, 7:1023-1030.

18. Green CF, Mottram DR, Rowe PH, Pirmohamed M. Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting. Br J Clin Pharmacol. 2001;51(1):81–86.

19. Almenoff J, Tonning JM, Gould AL, et al. Perspectives on the use of data mining in pharmacovigilance. Drug Saf. 2005;28:981–1007.

20. Sharma S, Phadnis P, Gajbhiye S, Pharmacovigilance: Its Awareness and Impact Care Teaching Medical College in Central India Impact-Study in a Tertiary care Teaching Medical College in Central India, International Journal ofPharmaceutical Research and Bio- Science (IJPRBS), 2013; 2:234-247.

21. Kennedy, D.L. Spontaneous reporting in the United States. Pharmacoepidemiol., 2000, 149- 174.

22. Descriptive Analysis of COVID19-Related Spontaneous Reports from VigiBase: Interim Results. Last accessed on 2020 Jun 10 Available from: https://www.who.int/medicines/regulation/medicines- safet/ICSRs-COVID19 April-12.pdf?ua=1.

23. Rathi S, Ish P, Kalantri A, Kalantri S Hydroxychloroquine prophylaxis for COVID 19 patients in India. Last accessed on 2020 Jun 19 Available from: https://www.thelancet.com/pdfs/journals/laninf/PIIS1473- 3099(20)30313-3.pdf
24. EU Clinical Trials Register.Lastaccessed on 2020 May 27
Available from: https://www.clinicaltrialsregister.eu/ctr-search/search?que y=covid-19

25. Maiti Bodhisattwa, Nagori B.P., Singh Rambir, Kumar Pragati and Upadhyay Nishant, “Recent Trends in Herbal Drugs: A Review”, International Journal of Drug Research and Technology, 1, 2011, 17-25.

26. Kulkarni M.D., Baig M.S., Chandaliya K.C., Doifode S.M., Razvi S.U., Sidhu N.S., “Knowledge, Attitude and Practice of Pharmacovigilance among Prescribers of Government Medical College and Hospital, Aurangabad (Maharashtra), international journal of pharmacology and therapeutics, 3, 2013, 10- 18.

27. Chakraverty Raja and Banerjee Anindya, “Emerging Issues in Pharmacovigilance of Herbal Medicines in India”,International Journal of Pharmaceutical Sciences Review and Research, 20, May – Jun 2013, 40- 42

28. Lagier G, Vincens M, Castot A, Imputability in drug monitoring: Principles of the balanced drug reaction assessment method and principal errors to avoid. Therapie,1983; 38(3):303-18.

29. Gross FH. The scientific basis of drug safety regulations. InDrug Safety 1982 Jan 1 (pp. 9-18). Pergamon.
30. Domínguez Carrillo, L. G., & Domínguez Gasca, L. G. (2021). Síndrome del tendón Del peroneo largo por lesión del Os peroneum. Acta Médica Grupo Ángeles, 19(1), 128–129. https://doi.org/10.35366/98583

31. Kesharwani, Vipin & Farooqui, Mohd & Kushwaha, Nikhil & Singh, Ravi & Jaiswal, Pankaj. (2018). AN OVERVIEW ON PHARMACOVIGILANCE: A KEY FOR DRUG SAFETY AND
MONITORING. Journal of Drug Delivery and Therapeutics. 8. 130-135. 10.22270/jddt.v8i5.1970

32. Lalita B. Patil, Swapnil S. Patil, Sarika S. Hubale, Rahul U. Mane, (2015). Pharmacovigilance
-a Review, International Journal of scientific Research in Science and Technology; 1(3): 25-29.

33. Velo, G., Moretti, U. Ecopharmacovigilance for Better Health. Drug-Safety 33, 963–968 (2010). https://doi.org/10.2165/11539380-000000000-00000

34. Trifirò G and Crisafulli S (2022) A New Era of Pharmacovigilance: Future Challenges and Opportunities. Front. Drug. Saf. Regul. 2:866898. doi: 10.3389/fdsfr.2022.866898.

35. Pirmohamed M, Park BK (2001) Genetic susceptibility to adverse drug reactions. Trends Pharmacol Sci 22:298–305.

36. Department of CDSCO, Ministry of health & family welfare, Government of India: Protocol for national pharmacovigilance programme, November 2004.

37. WHO Medicines Strategy: Framework for Action in Essential Drugs and Medicines Policy 2000-2003.

38. Blanc S, Leuenberger P, Berger JP, Brooke EM, .Schelling JL, Judgments of trained observers on adverse drug reactions, ClinPharmacol Ther 1999; (25):493-498

39. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Development Safety Update Report E2F. 2010. Available from: http:// www.ich.org/LOB/media/MEDIA4727.pdf. [Accessed on 2010 Dec 10]

40. Maqbool, M., et al. Drug safety and Pharmacovigilance: An overview. J. Drug Deliv. Therap., 2019, 9, 543-548.

41. Rawlins, M.D. Pharmacovigilance: Paradise lost, regained or postponed?: The William Withering Lecture 1994. J. Royal Colle. Physi. London., 1995, 29, 41.

42. Ahmad, A., Patel, I., Balkrishnan, R., Mohanta, G.P. and Manna, P.K. An evaluation of knowledge, attitude and practice of Indian pharmacists towards adverse drug reaction reporting: A pilot study. Persp. Clin. Res., 2013, 4, 204.

43. Kalaiselvan, V., Srivastava, S., Singh, A. and Gupta, S.K. Pharmacovigilance in India: Present scenario and future challenges. Drug safet., 2019, 42, 339-346.

44. Ara, I., Bukhari, B., Ara, N. and Maqbool, M. Present status, standardization and safety issues with herbal drugs. Int. J. Res. Pharm. Sci. Technol., 2020, 1, 95-101

45. Margraff, F. and Bertram, D. Adverse drug reaction reporting by patients: an overview of fifty countries. Drug safet., 2014, 37, 409-41

Ahead of Print Subscription Review Article
Volume 16
02
Received 01/03/2025
Accepted 10/05/2025
Published 16/06/2025
Publication Time 107 Days
96

[first_name] [last_name]

My IP

PlumX Metrics