To monitor the adverse drug reactions and safety of medicines commonly prescribed at obstetrics and gynaecology unit in a tertiary care hospital.
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Date
2014-07
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Abstract
Adverse drug reactions are the recognized hazards of drug therapy and they can occur with any class of
drugs. Any substance that is capable of producing a therapeutic effect can also produce unwanted or
adverse effects. Adverse Drug Reactions result in increased healthcare cost due to the need of some
interventions and increased hospital stay. The study was undertaken to monitor the adverse drug
reactions to medicines commonly prescribed at obstetrics and gynaecology unit in a tertiary care
hospital, to establish ten most commonly prescribed medicines in this unit that gave maximum adverse
drug reactions and to determine the list of commonly affected organ systems and assess their causality.
In this Retrospective, non-interventional study a total of 63 adverse drug reaction reports were collected
from 249 patients. The most common medicine that caused maximum ADRs was Oxytocin 10
(15.87%). Other frequently used drugs were Amikacin, Methylergometrine, Mifepristone+Misoprostol,
Levonorgestrel+Ethinylestradiol, Cefotaxim+sulbactam, Cefixime+Ofloxacin, Mifepristone alone,
Clomifene citrate, Tramadol. The most commonly affected organ system was cardio-vascular system 12
(19.04%).The assessment by Naranjo’s scale showed that out of 63 ADRs, 41 (65.07%) ADRs were
probably related to drugs, 21 (33.33%) ADRs were possibly related to drugs and 1 (1.58%) ADR was
doubtful. WHO causality assessment scale revealed that out of 63 ADRs, 51(80.95%) ADRs were
probable or likely, 12(19.04%) ADRs were possible. It was observed that safe medicines were
prescribed in obstetrics and gynaecology department as per FDA category A with no banned drugs
.However, there is a need to sensitize the doctors to prescribe rationally and emphasize this aspect in
under and post graduate medical teaching as well. The health system needs to promote spontaneous
reporting of Adverse Drug Reactions from all health care professionals and the public at large in a well
structured programme to build synergies for monitoring ADR in the country. Also proper documentation
and periodic reporting to regional pharmacovigilance centres should be encouraged to arrive at
meaningful conclusion on safety issue of medicines and thereby reduce considerably social and
economic consequences of ADRs.
Description
Keywords
Adverse drug reactions, Pharmacovigilance, Naranjo Scale, WHO scale
Citation
Dhar Kavita, Chauhan Shalu, Sharma Jyotsna, Gaur Preeti, Chopra V S, Bajaj Umakant. To monitor the adverse drug reactions and safety of medicines commonly prescribed at obstetrics and gynaecology unit in a tertiary care hospital. Indian Journal of Pharmaceutical & Biological Research. 2014 Jul-Sept ; 2 (3): 112-119.