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A Study and Report on Impact of Pharmacovigilance and Drug Safety Monitoring Practices in Promotion of Rational Drug Usage in General Medicine Departments of Hospital

Mekkanti Manasa Rekha, Siva Kumar, Ganesh Deb, Rinku Mathappan


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 Drug Related Problems. It is a prospective observational study & conducted for a period of six months from November 2020 to April 2021. A sample size of 120 patients were randomly opted for this study, out of which 82 (sample size) were analysed for potential drug interactions and were also selected for comparison of results. The details of patients’ 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 82 ADRs were reported by 8(80%) CPs, out of which, [68(82.93%)] were found in adults (19-59 years of age) and [14(17.07%)] in geriatrics (≥60 years of age). Out of 82 ADRs, [50(60.98%)] were seen in male and [32(39.02%)] were seen in female patients. Therapeutic drug class most implicated to cause ADRs was Antihypertensives 22(26.83%) and the most common organ system affected was GIT 30(36.58%). Adults were most affected by ADRs [68(82.93%)] and [50(60.98%)] were seen in male patients. The most commonly reported ADR was Acidity 10(12.019%). On evaluation of severity of reported ADRs using Hartwig’s severity scale, majority of ADRs 60(73.17%) were mild in nature. Using Modified Shumock and Thorton criteria for evaluating preventability of ADRs, majority of ADRs 66(80.49%) were ‘Probably Preventable’. Upon causality assessment of reported ADRs using WHO probability scale, majority of ADRs 28(34.15%) were rated as ‘Possible’ and as per the Naranjo scale, majority of reported ADRs 46(56.10%) were rated as ‘Possible’. The Present Study concludes that Detection of Drug Related Problems, the harmful effects of drugs to the patient were prevented and minimized by providing the Physician and other, Healthcare Professionals with the information’s regarding identified problems and reporting them to respected authorities.


Drug Related Problems, Pharmacovigilance, ADR Reporting, Adverse Drug Reaction.

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