A 5 year retrospective analysis of pharmacovigilance study, completeness and quality of suspected adverse drug reaction forms at adverse drug reaction monitoring center Port Blair.

Abstract

In India, Adverse Drug Reaction (ADRs) related morbidity and mortality is one of the leading health problem. ADRs result in diminished quality of life, prolonged hospital stay, morbidity and mortality. The present study was planned to scrutinise suspected ADRs forms and evaluate completeness with quality assessment of ADR reports at AMC Port Blair. The study was a 5 year retrospective observational study. The collected data was evaluated based on patients’ demographic, adverse drug reaction and drug characteristics with completeness and quality of reactions. A total of 877 ADRs from 715 offending drugs in 671 patients were reported. In India, 9.5% hospital admissions were because of ADRs. 52% female experienced ADRs which was more than male. The occurrence of ADRs in adult patients was high. Antibiotics (39%) was most commonly prescribed class of drug followed by NSAID (10.9%). Majority of ADRs (45%) were observed in the skin followed by musculoskeletal system (12.7%). In our study, 60.2% of patients recovered in the outcome parameters. 83.6% of drugs withdrew for management of ADRs. Rechallenge was made only in 12.3% patients, 71.6% of patients had non-serious reactions and 71.7% ADRs were probable. We received the highest completeness score in 2020 which was 0.98. ADRs remain as a challenge in modern healthcare. The health system should promote spontaneous reporting of ADRs. The proper documentation and periodic reporting to ADR monitoring centres (AMC) reduce the incidence of new ADRs and maintain the public confidence toward safe use of drugs. This good quality reporting increases the potential for signal generation.

Keywords

• adverse drug reaction,,
• ,،,؛adverse drug monitoring centre,,
• ,،,؛completeness score,,
• ,،,؛pharmacovigilance