Pattern of adverse drug effects reported by patients being treated in a tertiary healthcare institution in North India: A retrospective observational study

Abstract

: Patient safety and well-being is favored by reporting adverse drug effects timely and precisely. Pharmacovigilance contributes to post-marketing surveillance and ensures that necessary changes may be done to the drug labels accordingly.: The study was aimed at observing, analyzing and reporting various adverse effects due to prescribed drug intake for patient conditions and disease being treated at our tertiary healthcare institution.: Study was conducted at Dr. RPGMC, Kangra at Tanda, which is a multi-specialty tertiary healthcare hospital with 700 beds and an ADR monitoring Centre situated in the lap of western Himalayas in North India. Pattern of ADRs reported by the volunteers receiving drug therapy from January to December 2021 was assessed. Data pertaining to age, gender, drug intake, types of ADRs, treatment and outcome of the reactions was collected. Individual assessment was done for each patient. WHO scale was used for causality assessment. ADR profiling was carried out based on site, onset, organ system affected, duration, whether urgent referral was required or not and resolution of signs & symptoms.The data was analyzed using Microsoft excel 2019 and expressed as mean ± standard deviation & percentages.: A total of 83 patients reported ADRs (adverse drug reactions). These were reported to IPC, Ghaziabad through our AMC (Adverse Drug Reaction Monitoring Centre) from 1 January 2021 to 31 December 2021. Gastro-intestinal system related adverse effects (35%) were most common followed by skin (22.9%) and CNS (12%) adverse effects. GI adverse effects included anorexia, dyspepsia, diarrhoea, oral ulcers, nausea, vomiting, weight-loss and raised liver function tests.: ADRs occur commonly but are often undetected. Even if detected they remain underreported as most of the health care professionals are unaware about pharmacovigilance. Therefore, mass sensitization and reward to those who report ADRs vigilantly is the need of the hour to promote patient safety.