INTENSIVE HOSPITAL-BASED ADVERSE DRUG REACTION MONITORING STUDIES ON 5482 PATIENTS OF KASHMIRI ORIGIN AT A TERTIARY CARE HOSPITAL

Problem Statement: Prior to this study there was no provision for monitoring drugs for their adverse effects in any of the leading hospitals of Kashmir division of the J&K state.

Objectives: Present study was undertaken to assess the prevalence, preventability, category, costs and severity of drug-related adverse effects in Kashmiri patients at a Srinagar-based tertiary care hospital.

Design: Prospective, observational, cohort study with follow-up

Setting: All adult patients admitted in Internal Medicine IPD, presenting to the Internal Medicine OPD and those visiting the Accident and Emergency Department of the study hospital, over a 270 day period were included in the study.

Study Population: A total of 5482 patients, of both sexes were screened and monitored on a daily basis for the occurrence of any ADRs.

Intervention: Data was recorded using structured forms and then scrutinized for various assessment parameters by a multi-disciplinary medical team of a senior consultant in medicine, a clinical pharmacologist and a pharmacist. Interventions relating to detection and management of ADRs were undertaken on case-to-case basis. Study led to the establishment of a full-fledged Pharmacovigilance Centre in the hospital.

Policies: No hospital drug policy or ADR monitoring policy/framework was available in the study hospital at the time of this study.

Outcome Measures: Causality assessment, severity assessment, preventability assessment, extension of hospital stay and cost due to ADRs.

Results: ADRs account for 6.23% Kashmiri patients visiting a tertiary care hospital, either for referral or hospitalization and a majority (81.57%) of these ADRs were preventable. 23.68% patients had mild ADRs while 69.29% patients had ADRs of moderate severity and 7.01% patients had severe ADRs. The four classes of drugs most frequently suspected in admissions due to ADRs were anti-infective agents (40.92%) including anti-tubercular drugs (13.15%), steroids (14.03%), anti-coagulants (8.77%) and NSAIDs (7.89%). Increasing age and female gender were identified as risk factors. The organ-systems most commonly affected were gastrointestinal (81%), dermatological (43%), central nervous (40%), hematological (34%), metabolic (33%), cardiovascular (22%), urinary (18%), ENT (18%), immunological (11%) and respiratory (10%) systems. The total cost to the hospital due to hospitalization of patients presenting with ADRs over the 9 month period in the IPD of Internal Medicine at the study hospital was USD 22469.

Conclusion: Present work is the maiden pharmacovigilance study conducted on Kashmiri patients, moreso at a tertiary care teaching hospital that has provided base line information about the prevalence of ADRs and their distribution amongst different age groups, genders, organ systems affected and therapeutic classes of medicines. The data collected will be useful in future for long term and more extensive ADR monitoring on Kashmiri patients and will also be useful in framing policies towards the rational use of drugs.