ANALYSIS OF ADVERSE DRUG EVENTS REPORTED AT PERIPHERAL ADR MONITORING CENTRE IN GUJARAT

  • RHYTHM Department of Pharmacology, Pramukhswami Medical College, Karamsad, Gujarat, India, 388325
  • ALPA PRAGNESH GOR Department of Pharmacology, Pramukhswami Medical College, Karamsad, Gujarat, India, 388325
  • BHARAT GAJJAR Department of Pharmacology, Pramukhswami Medical College, Karamsad, Gujarat, India, 388325
  • ZALAK DALWADI Department of Pharmacology, Pramukhswami Medical College, Karamsad, Gujarat, India, 388325
  • ANJALI GOYAL Department of Pharmacology, Pramukhswami Medical College, Karamsad, Gujarat, India, 388325

Abstract

Objective: Hospital-based ADR (Adverse drug reaction) monitoring and reporting programmes are useful for identifying and minimizing preventable ADRs and may enhance the ability of prescribers to manage ADRs more effectively. The objective of this study was to evaluate and analyze the spontaneously reported adverse drug events from various departments of Shree Krishna Hospital, Karamsad.


Methods: This was a retrospective study and data was analyzed for adverse drug events reported during the period of April 2018 to March 2019 from various departments of Shree Krishna Hospital, Karamsad. Analysis was done on the basis of the demographic profile of patients, health care professionals who have reported and drugs causing ADRs, with their causality assessment using WHO probability scale.


Results: Out of 36 patients, 20 (55.55%) were males and 16 (44.44%) were females. Antibiotics were the most common culprit group of drugs for reported ADRs in 21 patients. The number of ADRS related to the skin was 21 (58.33%) followed by GIT 11 (30.55%), cardiovascular 2(5.55%) and neuronal 2(5.55%). According to WHO causality assessment scale 01 (2.77%) of the suspected ADR was certain, 27(75%) were probable and 8 (22.22%) were possible.


Conclusion: Our study concluded that the most commonly reported ADRs were dermatological reactions like itching and rashes. Antimicrobials were the most common drug group involved in causing ADRs. Even though there were continuous efforts for adverse drug event reporting awareness, still there is need to sensitize health care professionals to improve reporting.

Keywords: Adverse Drug reaction monitoring, Causality Assessment, Health Care Professional

Downloads

Download data is not yet available.

References

1. Giardina C, Cutroneo P, Mocciaro E, Russo G, Mandraffino G, Basile G, et al. Adverse drug reactions in hospitalized patients: results of the forward (Facilitation of Reporting in Hospital Ward) study. Front Pharmacol 2018;9:350.
2. Prajapati K, Desai M, Shah S, Panchal J, Kapadia J, Dikshit R. An analysis of serious adverse drug reactions at a tertiary care teaching hospital. Perspect Clin Res 2016;7:181?6.
3. Pharmacovigilance Programme of India [Internet]; 2020. Available from: http://www.ipc.gov.in/PvPI/about.html [Last accessed on 11 Apr 2020]
4. Lobo M, Pinheiro S, Castro J, Momente V, Pranchevicius M. Adverse drug reaction monitoring: support for pharmacovigilance at a tertiary care hospital in Northern Brazil. BMC Pharmacol Toxicol 2013;14:5.
5. Venkatasubbaiah M, Dwarakanadha Reddy P, Satyanarayana S. Analysis and reporting of adverse drug reactions at a tertiary care teaching hospital. Alexandria J Med 2018;54:597-603.
6. Lihite R, Lahkar M, Das S, Hazarika D, Kotni M, Maqbool M, et al. A study on adverse drug reactions in a tertiary care hospital of Northeast India. Alexandria J Med 2016;53:151-6.
7. Lucca JM, Ramesh M, Ram D. Gender differences in the occurrences and pattern of adverse drug reactions in psychiatric patients: a prospective observational study. Trop J Med Res 2017;20:84-90.
8. Patil S, Raikar S, Janardhan M, Rao Y, NB, Vahila N. A profile of adverse drug reactions in a rural tertiary care hospital. Natl J Physiol Pharm Pharmacol 2016;6:559-62.
9. Bhabhor P, Patel T, Vahora R, Patel P, Desai N. Adverse drug reactions in a tertiary care teaching hospital in India: analysis of spontaneously reported cases. Int J Basic Clin Pharmacol 2014;3:1078-85.
10. James J, Rani J. A prospective study of adverse drug reactions in a tertiary care hospital in South India. Asian J Pharm Clin Res 2019;13:89-92.
11. Ingale A, Nadig P, Chakraborty A. Analysis of the adverse drug reactions collected through active surveillance in the pharmacovigilance unit of a tertiary care hospital. Asian J Pharm Clin Res 2018;11:383-7.
12. Kharb P, Mittal N, Gupta M. An evaluation of adverse drug reactions monitoring at a pharmacovigilance unit under pharmacovigilance program of India in a tertiary care hospital of Haryana. Int J Basic Clin Pharmacol 2015;4:556-60.
13. Sen M, Singh A, Misra M. Retrospective analysis of adverse drug reactions reported at ADR monitoring center under PvPI in a tertiary care hospital. Int J Basic Clin Pharmacol 2018;7:303-8.
14. Patidar D, Rajput M, Nirmal N, Savitri W. Implementation and evaluation of adverse drug reaction monitoring system in a tertiary care teaching hospital in Mumbai, India. Interdiscip Toxicol 2013;6:41-6.
15. The use of the WHO-UMC system for standardized case causality assessment [Internet]. who.int; 2020. Available from: https://www.who.int/medicines/areas/quality_safety/safety_efficacy. [Last accessed on 11 Apr 2020].
Statistics
237 Views | 185 Downloads
Citatons
How to Cite
RHYTHM, A. P. GOR, B. GAJJAR, Z. DALWADI, and A. GOYAL. “ANALYSIS OF ADVERSE DRUG EVENTS REPORTED AT PERIPHERAL ADR MONITORING CENTRE IN GUJARAT”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 12, no. 6, May 2020, pp. 72-75, doi:10.22159/ijpps.2020v12i6.37771.
Section
Original Article(s)