FREQUENCY, TYPES, SEVERITY, PREVENTABILITY AND COSTS OF ADVERSE DRUG REACTIONS AT A TERTIARY CARE HOSPITAL OVER A NINE MONTH PERIOD

Background:

Prior to this study, there were no pharmacovigilance centres or any other ADR monitoring framework available in any of the leading hospitals of the Indian state of Jammu and Kashmir.

Objective/Aim:

To assess the frequency, preventability, types, severity, causality and costs of drug-related adverse effects in Kashmiri patients at a tertiary care hospital.

Methods:

A prospective, observational, cohort, ADR monitoring study was conducted on adult patients admitted in Internal Medicine IPD, presenting to the Internal Medicine OPD and those visiting the Accident and Emergency Department of a tertiary care hospital during a 270 day period. A total of 5482 patients belonging to both the sexes were screened and monitored on a daily basis for the occurrence of any ADRs. WHO definition of ADRs was used and causality of suspected ADRs was determined using Naranjo’s algorithm whereas severity was assessed using modified Hartwig’s Scale and preventability was determined using Hallas methodology. Cost of ADRs was calculated as per the protocols suggested by Lagnaoui et al and Nicholas et al (extension in hospital stay).

Results:

ADRs accounted for 6.23% of adult Kashmiri patients visiting a tertiary care hospital, either for referral or hospitalization, with the majority (81.57%) of these ADRs being preventable; 23.68% of patients had mild ADRs, 69.29% had ADRs of moderate severity, and 7.01% had severe ADRs. The 4 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 total cost to the hospital due to hospitalization of patients presenting with ADRs over the 9-month period in the internal medicine IPD was USD 22469.

Conclusion:

The present work is the maiden pharmacovigilance study conducted on Kashmiri patients, especially at a tertiary care teaching hospital that has provided baseline information about the prevalence of ADRs and their distribution among different age groups, genders, organ systems affected, and therapeutic classes of medicines. The data collected will be useful in future for more extensive ADR monitoring on Kashmiri patients and will also be useful in framing policies toward the rational use of drugs. This study led to the establishment of a full-fledged pharmacovigilance centre and initiation of pharmaceutical care services at the study hospital.