ABSTRACT
Background: Adverse drug reactions (ADRs) have become frequent cause for hospitalization and are coming up as an economic burden on health systems. Identification of ADRs and their reporting pattern can provide useful information for their management.Methods: This was an observational and prospective study. ADR reports of 130 patients were collected of the inpatient department of various clinical departments of Sanjay Gandhi Memorial Hospital, Rewa, Madhya Pradesh (M.P.) The ADRs were collected during October 2014-September 2015, with ADR reporting form of Central Drugs Standard Control Organization (CDSCO), New Delhi. ADRs were assessed for their causality, severity, and preventability as per the standard scales. Data was analysed using descriptive statistics and expresses in percentages.Results: Overall occurrence of ADRs was slightly more in males (55%). Maximum (26%) suspected ADR reported during study period was skin rash. Skin (44%) was the most commonly affected organ system. Antimicrobials (68%) were the drug group most commonly involved in ADRs. Most of the suspected ADRs were probable in causality assessment, moderate in severity and probably preventable.Conclusions: The study results revealed opportunities for interventions in ADR management to ensure safer drug use.
ABSTRACT
Background: Adverse drug reactions (ADRs) are a major concern in present day clinical practice. They are inevitable consequences of drug therapy; as no pharmacotherapeutic agent is completely free from noxious and unintended effects. They are major contributors for morbidity, mortality and hospitalization of the patients increasing the economic burden on the society and uncertainty in clinical outcomes.Methods: This was a retrospective observational study, extending over 6 months (September 2016 to February 2017). A total of 290 cases were studied, excluding the geriatric age group. The data was collected using CDSCO ADR reporting form. A comparison of ADR between males and females was made; based on the organ system affected and the category of drug using “proportion test”.Results: The study showed the ADR incidence was equal in both sexes (?50%). It was observed that majority ADRs were from gastro intestinal system (39%) followed by CNS (20%) and skin and soft tissue (14%). Constipation was found to be the most common of the reported ADRs (18%) followed by vomiting (9%) and diarrhoea (8%).Conclusions: ADRs are a major cause of morbidity worldwide. Several studies; including the present one, has shown GIT to be the most common system affected. Frequency of ADRs can be reduced by careful follow up and a robust hospital based pharmacovigilance setup.