Adverse drug reaction reporting in a tertiary care teaching hospital in eastern India: a retrospective study

Abstract

Background: Adverse drug reactions (ADRs) are one of the prime causes of morbidity and mortality, increase in hospital stay and socioeconomic burden on the patients. Periodic monitoring aids in formulating methods for safe usage of medicines in hospitals. This study was undertaken to study the patterns, assessment of causality, severity, preventability, body systems affected from ADRs received by the Pharmacovigilance cell, Department of Pharmacology between April 2018 to June 2019.Methods: The present study is an observational, retrospective, non-interventional analysis of voluntarily reported ADRs. Demography of patients, causative drugs, reactions, outcome, and severity are recorded. Data were analysed and expressed in numbers, percentages.Results: A total of 180 ADRs were spontaneously reported. Dermatology (42.8%), psychiatry (23.9%) and general medicine (18.3%) are the major departments reporting ADRs in our hospital. 60.6% reports were in males. The body system with maximum reactions is dermatological (51.1%). Drug class most commonly affected is anti-microbials (36.1%). Paracetamol (8.9%) is the most common drug with reactions. Causality assessment stated that 41.7% ADRs are probable and 58.3% were possible. Severity assessment showed 86.7% as mild and 13.3% as moderate. Preventability assessment stated that 93.3% ADRs not preventable, 5.6% probably preventable and 1.1% definitely preventable.Conclusions: The study provides a valuable insight with regards to the pattern of ADRs in our hospital. This will be useful in initiating a reporting culture, increase awareness, reducing under-reporting of ADR in our set up.

A Prospective, Observational Study of the Spontaneous Reporting Patterns of Adverse Drug Reactions in a Tertiary Care Teaching Hospital

“…Female preponderance (60.5%) was noted among the cases, similar to a study by James and Rani 10 (60%) and Godbharle and Padwal 11 showing that females may have more risk of developing ADRs. In our study, the adult age group (31–45 years) reported the majority of ADRs (27.2%), which was comparable to a study by Misra et al 5 (42.8%).…”

“…In our study, the frequently affected organ system was found to be the dermatological (68.4%) with a predominance of cutaneous manifestations (itching and rashes) (29.8%), similar to studies by James and Rani (75%), 10 Godbharle and Padwal (34.4%) 11 and Misra et al (51.1%), 5 but a study by Venkatasubbaiah et al 1 and Joseph and Badyal, 12 showed the most commonly affected system was gastrointestinal system followed by skin.…”

“…Hence, there is a necessity to boost health care professionals’ responsiveness to the prevention, identification and reporting of ADRs. 5…”

A study of reporting pattern of adverse drug reactions in a tertiary care teaching hospital

“…This result was somewhat in concordance with some previous studies. 12 Adverse drug reactions have been reported to occur mainly in young and middle-aged adults. Reason could be that the patients of this age group are more prone to diseases, are often on multiple drug therapy and frequently visits the outpatient department for their regular check-ups.…”

“…This finding was similar to findings of numerous previous studies. 12,[16][17][18][19] The reason could be that antimicrobials are the most common class of drugs to be used in hospital settings. So, the chances of ADRs being reported due to them are also high.…”