Pattern of adverse drug reactions to antibiotics commonly prescribed in department of medicine and pediatrics in a tertiary care teaching hospital, Ghaziabad.

Adverse Drug Reactions (ADRs) are an important cause of mortality and morbidity and constitute an enormous burden on the society. Many studies have implicated that the antibiotics are among the major group of drugs, which cause adverse drug reactions (ADRs). This Retrospective, non- interventional study was undertaken in Medicine and Pediatrics unit from November 2013 to April 2014 to monitor the adverse drug reactions of antibiotics prescribed by physicians and pediatricians in a tertiary care hospital, Ghaziabad, to establish ten most common antibiotics which caused ADRs, to determine most commonly affected organ system and assess their causality. A total of 126 ADRs were identified in 80 patients, out of which 42(52.5%) occurred in male patients and 38(47.5%) in female patients. The age wise distribution revealed that adult patients showed more incidence of ADRs 46(57.5%), followed by children 26(32.5%) and Geriatrics 8(10%). GIT 28(22.2%) was the most affected organ system by Adverse Drug Reactions due to antibiotics followed by the Respiratory system 26 (20.63%), Skin 23(18.25%), CVS 17 (13.5%), CNS 12(9.52%), Musculo-skeletal system 10(7.93%), Urinary System 8 (6.35%) and Haemopoietic Disorders 2 (1.58%). Maximum ADRs were reported with Beta-Lactams class 51 (40.4%) followed by Aminoglycosides 29(23.01%), Quinolones 20(15.8%), Others 16 (12.69%) and Macrolides 10(7.93%), . Antibiotics comprise the major volume of the drug family and inpatient prescriptions and thus are the most irrationally prescribed. So implementation of antibiotic guideline policy for the hospitals and strict adherence to it should be ensured to promote their rational and safe use. Also health system needs to promote spontaneous reporting of ADRs detected in clinical practice to Regional Pharmacovigilance centers.

To monitor the adverse drug reactions and safety of medicines commonly prescribed at obstetrics and gynaecology unit in a tertiary care hospital.

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.