Original Research Article
Year: 2017 | Month: November | Volume: 7 | Issue: 11 | Pages: 111-117
Adverse Drug Reaction Monitoring of Commonly Prescribed Medicines in Gynaecology Patients in a Tertiary Care Hospital in North India
Ruchi Mangla1, Savita Verma2, M.C.Gupta3, Savita Singhal4
1Post-graduate, 2Professor, 3Senior Professor and Head,
Department of Pharmacology, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana
4Senior Professor& Unit Head of Obstetrics and Gynaecology, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana
Corresponding Author: Ruchi Mangla
Introduction: The prevalence of gynecological disorders is quite high which warrants more number of prescribed drugs. Females are also at an increased risk of developing ADRs as compared to men. Present study focuses on the Adverse Drug Reactions (ADRs) monitoring of drugs commonly prescribed to gynaecological patients.
Materials and Methods: Gynaecological patients who were on drugs for various gynaecological disorders were observed prospectively in a cross-sectional, non-interventional manner and ADRs were collected by spontaneous/solicited monitoring. ADRs were coded according to the MedDRA classification, were assessed for their seriousness, severity, causality and preventability and were managed accordingly. The seriousness of adverse events was assessed according to the type of outcome as mentioned in the CDSCO ADR proforma. Severity was assessed using modified Hartwig scale, causality assessment was done using WHO-UMC scale and preventability of ADRs was done by using modified Schumock and Thornton criteria.
Results: 235 patients, who were being treated for various gynaecological disorders, were observed of whom 163 patients reported ADRs. A total of 181 ADRs were collected and eighteen patients reported more than one ADR. Antibiotics were the most common group of drugs implicated in the causation of ADRs. The most commonly affected organ class was the gastrointestinal system. Majority of the reactions (81.77%) were ‘mild’ in nature and no serious reactions were reported. Causality assessment by WHO-UMC scale revealed most of the reactions as ‘probable’ (72.93%) while 27.07% were classified as possible. Preventability assessment determined that 47.51% of ADRs were ‘not preventable’ and only 7.74% were labelled as definitely preventable. Majority (59.68%) of the ADRs were managed by withdrawing the suspected drug.
Conclusion: Overall, drugs for gynaecological disorders appear to be a safe option for patients but they still have potential to cause ADRs, so for better patient safety, probability of ADR should be kept in mind before prescribing any drug.
Key words: Gynaecology, Adverse Drug Reactions, WHO UMC, MedDRA