A STUDY ON IMPACT AND OUTCOMES OF PHARMACOVIGILANCE AND ITS IMPLICATIONS, PRACTICES OVER ADR IDENTIFICATION, REPORTING AND MONITORING IN PROMOTION OF RATIONAL DRUG USAGE.

Mekkanti Manasa Rekha

Abstract

The present study reports on impact of pharmacovigilance and drug safety monitoring practices in promotion of rational drug usage in General Medicine Department of ESI hospital with an objective of identification and reporting of adverse drug reactions. It is a prospective, observational study & was conducted for a period period of 8 months from Jan 2022 to Aug 2022. A sample size of 126 patients were randomly opted for this study, out of which 58 (sample size) were analysed for potential drug interactions and were also selected for comparison of results. The details of patient’s medication therapy were collected from patients through personal interview, case sheets, treatment charts and data collection forms. Data collected during the study included demographics of the patients who encountered the ADRs, diagnosis, co- morbidities, treatment, information regarding previous allergies and other medicines taken by the patient. During the study period, a total of 58 ADRs were reported by CPs, out of which, the most common organ system affected was GIT 23(39.64), Therapeutic drug class most implicated to cause ADRs was Antihypertensives 12(20.68%), As per the Rawlins and Thompson classification of ADRs out of 58 reported ADRs 43(74.13%) are type A reactions and 15(25.86%) are type B reactions. The most commonly reported ADR was Acidity 8(13.79%). On evaluation of severity of reported ADRs using Hartwig’s severity scale, majority of ADRs 43(74.13%) were mild in nature. Upon causality assessment of reported ADRs using WHO probability scale, majority of ADRs 22(37.93%) were rated as ‘Possible’ and as per the Naranjo scale, majority of reported ADRs 35(60.34%) were rated as ‘Possible’. The Present Study concludes that Detection of adverse drug reaction, the harmful effects of drugs to the patient were prevented and minimized byproviding the Physician and other, Healthcare Professionals with the information’s regarding identified problems and reporting them to respected authorities.