Probing the in-depth analysis of Serious Adverse Drug Reactions in a tertiary care hospital of Central India.

Background: Serious Adverse Drug Reactions (ADRs) represent a critical challenge in contemporary healthcare, necessitating comprehensive investigation and analysis. Within Central India, where healthcare systems grapple with unique demographic, epidemiological, and infrastructural dynamics, understanding the landscape of serious ADRs is paramount.

Objective: This study aimed to evaluate serious ADRs related to age, gender, most implicated class of drugs & single drug, hospital admission, most affected system organ classes, causality and outcome of reactions and fatalities.

Methods: This retrospective study analysed serious individual case safety reports (ICSRs) recorded from January 2016 to December 2019 at the Department of Pharmacology, Pt. JNM Medical College, Raipur (ADR monitoring centre), and submitted to the Pharmacovigilance Programme of India database using VigiFlow® for further process. ADRs were collected from Dr. BRAM Hospital and DKS Hospital and recorded using the standard suspected ADR reporting form (version 1.4). Cases were classified as serious if they met at least one criterion from the WHO-UMC scale, with some cases meeting multiple criteria. Causality was assessed using the WHO-UMC scale, ensuring patient and reporter confidentiality. Descriptive statistics such as number and frequency were used to analyse serious ADRs.

Results: A total of 762 ICSRs were entered into VigiFlow® during the study period, of which 239 (31.36 %) were classified as serious ADRs. The demographic distribution revealed a slight preponderance of females 125 (52.30 %) over males 113 (47.28 %). The hospital admissions due to ADRs were 57 (23.84 %). Antibiotics were the most commonly associated drug class (52.30 %), followed by Non-Steroidal Anti-Inflammatory Drugs (11.29 %). Among individual drugs, ceftriaxone and phenytoin were the most common drugs involved in serious ADRs. Adults were the most affected, 185 (77.40 %) compared to other age groups. The skin and subcutaneous tissue disorders, system organ class (SOC)155 (46.55 %) was highly affected, while erythematous and maculopapular rashes were the most common. Eleven Stevens-Johnson syndrome cases and three toxic epidermal necrolysis cases, like specific ADRs, were also obtained. The most ADRs were probable 121 (50.60 %) and possible 100 (41.84 %) category.

Conclusion: This study highlights the significant burden of serious ADRs within Central India, emphasising the need for heightened pharmacovigilance and targeted interventions, especially among adults. The prevalence of serious ADRs in females and adults and the impact on hospitalisations emphasise the need for cautious drug use, especially in inpatient settings. Limited understanding and reporting exist regarding the profile of serious ADRs in resource-limited countries. The findings will contribute to developing strategies for shaping future policies to promote the safer use of medicines. The under-reporting of ADRs in our setting and low-income countries is also a concern. Therefore, it is imperative to raise awareness about ADR reporting by healthcare professionals as well as patients to promote the safe utilisation of drugs.