A RETROSPECTIVE PHARMACOVIGILANCE ANALYSIS AT TERTIARY CARE HOSPITAL: AN OBSERVATIONAL STUDY
DOI:
https://doi.org/10.22159/ajpcr.2022.v15i8.45019Keywords:
Adverse drug monitoring, Pharmacovigilance, Medicine information OPDAbstract
Objective: Pharmacovigilance Program of India is a robust program extending from government hospitals to non-government hospital for implementation of policy of safe and rational use of drugs and early signal generation for adverse effects of drugs. Department of Pharmacology, Institute of Medical Sciences, Banaras Hindu University is part of this program since 2004. Retrospective analysis of adverse drug reaction (ADR) reported to the adverse drug monitoring center at tertiary Care Hospital.
Methods: The study site was Sir Sundar Lal Hospital, Institute of Medical Sciences Banaras Hindu University, Varanasi. The study was performed after the approval of the Institutional Ethics Committee, letter number: Dean/2020/EC/2153. It was a retrospective observational study. Data collected through VigiFlow software in standard IPC Pharmacovigilance Program of India prescribed suspected ADR form, from March 2020 to June 2021 were analyzed. Causality assessment was done using a World Health Organization Uppsala Monitoring Center scale.
Results: In the present study, the percentage of male patients affected is 58% and 42% female patient got suffered from adverse drug effects. About 64% of adverse effect are in possible category followed by probable, that is, 36%. The majority of adverse effects are due to antimicrobials, that is, Cephalosporins and Antitubercular group of drugs. About 20.1% adverse events show gastrointestinal symptoms. In the present study, we also observed that 5.17% adverse effects are due to hydroxychloroquine account for gastritis, headache, lethargy, and vomiting which were prescribed as prophylactic drug for COVID-19.
Conclusion: Medicine information OPD in every medical college is the need of the hour to increase awareness regarding adverse events. It is important to spread importance of reporting adverse events by spontaneous reporting under Pharmacovigilance Program of India to detect rare and unusual side effects.
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References
Nagaich U. Era of pharmacovigilance: Revolution in healthcare. J Adv Pharm Technol Res 2015;6:87.
Lihite RJ, Lahkar M. An update on the pharmacovigilance programme of India. Front Pharmacol 2015;6:194. doi: 10.3389/fphar.2015.00194, PMID 26441651.
Kalaiselvan V, Thota P, Singh GN, Pharmacovigilance Programme of India. Recent developments and future perspectives. Ind J Pharmacol 2016;48:624-8.
Rawlins MD. Spontaneous reporting of adverse drug reactions. I: The data. Br J Clin Pharmacol 1988;26:1-5. doi: 10.1111/j.1365-2125.1988. tb03356.x, PMID 3203052.
Vallano A, Cereza G, Pedròs C, Agustí A, Danés I, Aguilera C, et al. Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital. Br J Clin Pharmacol 2005;60:653-8. doi: 10.1111/j.1365-2125.2005.02504.x, PMID 16305591.
Alvarez-Requejo A, Carvajal A, Bégaud B, Moride Y, Vega T, Arias LH. Under-reporting of adverse drug reactions estimate based on a spontaneous reporting scheme and a sentinel system. Eur J Clin Pharmacol 1998;54:483-8. doi: 10.1007/s002280050498, PMID 9776440.
World Health Organization. Safety of Medicines. Geneva: World Health Organization. Available from: https://www.who.int›issues›WHO_ DI_32-1_safetymedicines
World Health Organization. Safety of medicines: Pharmacovigilance programme of India. WHO Drug Inf 2018;32:10-7.
Sood A, Sood V, Prajapati H, Sharma A, Bansal R, Mahajan V. Pharmacovigilance analysis in a rural tertiary care hospital in North India: A retrospective study. Int J Basic Clin Pharmacol 2016;5:1425-31. doi: 10.18203/2319-2003.ijbcp20162447.
Sen M, Singh A, Misra M. Retrospective analysis of adverse drug reactions reported at ADR monitoring centre under PvPI in a tertiary care hospital. Int J Basic Clin Pharmacol 2018;7:303-8. doi: 10.18203/2319- 2003.ijbcp20180103.
Pugi A, Bonaiuti R, Maggini V, Moschini M, Tuccori M, Leone R, et al. Safety profile of antiviral medications: A pharmacovigilance study using the Italian spontaneous-reporting database. Am J Health Syst Pharm 2013;70:1039-46. doi: 10.2146/ajhp120665, PMID 23719881.
Kalaiselvan V, Thota P, Singh GN, Pharmacovigilance Programme of India. Pharmacovigilance programme of India: Recent developments and future perspectives. Indian J Pharmacol 2016;48:624-8. doi: 10.4103/0253-7613.194855, PMID 28066097.
Agrawal V, Shrivastava TP, Adusumilli PK, Vivekanandan K, Thota P, Bhushan S. Pivotal role of pharmacovigilance programme of india in containment of antimicrobial resistance in India. Perspect Clin Res 2019;10:140-4. doi: 10.4103/picr.PICR_29_18, PMID 31404182.
Tandon VR, Mahajan V, Khajuria V, Gillani Z. Under-reporting of adverse drug reactions: A challenge for pharmacovigilance in India. Indian J Pharmacol 2015;47:65-71. doi: 10.4103/0253-7613.150344, PMID 25821314.
Gor AP, Desai SV. Adverse drug reactions (ADR) in the inpatients of medicine department of a rural tertiary care teaching hospital and influence of pharmacovigilance in reporting ADR. Indian J Pharmacol 2008;40:37-40. doi: 10.4103/0253-7613.40488, PMID 21264160.
Zhao Y, Sun S, Li X, Ma X, Tang H, Sun L, et al. Drug-induced anaphylaxis in China: A 10 year retrospective analysis of the Beijing pharmacovigilance database. Int J Clin Pharm 2018;40:1349-58. doi: 10.1007/s11096-017-0535-2, PMID 29086147.
Singh H, Dulhani N, Kumar B, Singh P, Tewari P, Nayak K. A pharmacovigilance study in medicine department of tertiary care hospital in Chhattisgarh (Jagdalpur), India. J Young Pharm 2010;2:95-100. doi: 10.4103/0975-1483.62222, PMID 21331200.
Singh AP, Tousif S, Umbarkar P, Lal H. A pharmacovigilance study of hydroxychloroquine cardiac safety profile: Potential implication in COVID-19 mitigation. J Clin Med 2020;9:1867. doi: 10.3390/ jcm9061867, PMID 32549293.
Montastruc JL, Rousseau V, Durrieu G, Bagheri H. Serious adverse drug reactions with hydroxychloroquine: A pharmacovigilance study in Vigibase®. Eur J Clin Pharmacol 2020;76:1479-80. doi: 10.1007/ s00228-020-02920-1, PMID 32506216.
Hugman B. The Erice declaration: The critical role of communication in drug safety. Drug Saf 2006;29:91-3. doi: 10.2165/00002018- 200629010-00007, PMID 16454537.
Meher BR. Vaccine pharmacovigilance in India: current context and future perspective. Indian J Pharmacol 2019;51:243-7. doi: 10.4103/ijp. IJP_53_19, PMID 31571710.
Mei PA, Montenegro MA, Guerreiro MM, Guerreiro CA. Pharmacovigilance in epileptic patients using antiepileptic drugs. Arq Neuro Psiquiatr 2006;64:198-201. doi: 10.1590/s0004- 282x2006000200005, PMID 16791355.
Revet A, Montastruc F, Roussin A, Raynaud JP, Lapeyre-Mestre M, Nguyen TT. Antidepressants and movement disorders: A postmarketing study in the world pharmacovigilance database. BMC Psychiatry 2020;20:308. doi: 10.1186/s12888-020-02711-z, PMID 32546134.
Hosohata K, Inada A, Oyama S, Niinomi I, Wakabayashi T, Iwanaga K. Adverse cutaneous drug reactions associated with old- and new-generation antiepileptic drugs using the Japanese pharmacovigilance database. Clin Drug Investig 2019;39:363-8. doi: 10.1007/s40261-019- 00754-z, PMID 30689189.
Tarapués M, Cereza G, Figueras A. Association of musculoskeletal complaints and gliptin use: Review of spontaneous reports. Pharmacoepidemiol Drug Saf 2013;22:1115-8. doi: 10.1002/pds.3503, PMID 23960039.
Giri KR, Pathak S, Giri RR, Palandurkar K, Totade S, Jha R, et al. Need of medicines information OPD in tertiary health care settings: A cross sectional study. Int J Med Sci Public Health 2012;1:121-6. doi: 10.5455/ijmsph.2012.1.121-126.
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Copyright (c) 2022 Dr. Kiran Giri, Dr. Kamlesh M.Palandurkar, Dr. Reena Giri, Udit Agrawal
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