A study on pattern of adverse drug reaction in an adverse drug reaction monitoring centre of a tertiary care hospital in South Kerala, India

Abstract

Background: Adverse drug reactions (ADR) are rated as fifth leading cause of death and accounts for approximately 5% of all hospital admissions. Under reporting of ADR from healthcare professional is considered as the contributing factor for increased morbidity and mortality. India has taken well appreciated step to launch Pharmacovigilance Programme of India (PvPI) to safeguard heath care of Indian population. This study looks into the detailed analysis of ADR reported to adverse drug reaction monitoring centre (AMC), Government Medical College, Trivandrum to assess its pattern, causality, severity and seriousness of ADR. Primary objectives of this study are the pattern of adverse drug reactions reported to ADR monitoring centre (AMC) and secondary objective is to assess causality, severity.Methods: A record based descriptive study was conducted in the ADR monitoring centre of government medical college, Trivandrum, Kerala from September 1st 2016 to February 2017(6 months). The data were collected from the all reported case records/ ADR report form of CDSCO. The details of the various adverse drug reactions were identified and analysed to find the pattern of adverse drug reactions including distribution of age, gender, causal drug group, system organ class. Also, an attempt is made to do causality assessment using WHO UMC scale and severity by using Heart wig Seigel Scale.Results: Out of 320 ADR cases, majority of reports were due to cutaneous manifestations. Most common ADRs were erythema, induration, and rash, itching. Females were 56% and males were 44%. Majority cases were of adult age group. Causality 91.88% were probably related, 75.6% were mild reaction. 25% of cases were serious. 77.5% were recovered. Antibacterial implicated 25(7.8%) followed by anti-epileptics 24 (7.5%) ADR.Conclusions: The pattern of adverse drug reactions reported to this AMC is comparable to the studies done in other parts of country. A strong need for streamlining of ADR monitoring system and reporting reemphasized by this study, which will promote the ADR reporting in healthcare professionals.

Analysis of spontaneous individual case safety reports reported at adverse drug reaction monitoring centre: tertiary care teaching hospital in South India

“…ADR/AE could be considered as a differential diagnosis of heterogenetic conditions, as it is difficult to diagnose. 12 In general practice unexpected hospital admissions around 6% and consultations around 3% and were found to be due to ADRs/AEs. 13 In the present study we have encouraged all the HCPs and direct consumer or patient caretakers for reporting ADRs/AEs in order to strengthen the patient safety contribution from each individual which plays a major role.…”

“…5,7,18,24,25 Considering the outcome parameter the end result of the reported cases in the indexed period are mostly recovered followed by recovering, not recovered and fortunately only one case of fatal was reported which where compared with similar to study conducted in India while studies done by Sneha et al and Hemavathy G et al reported cases with recovering outcome parameter were higher then recovered. 5,7,12,26,27 In regards to the causality assessment it is to determine the relatedness or the likelihood of the drug (s) with reaction (s) establishing the reasonable time relationship and considering the comorbid factors. In the present study there is no much significant difference was observed between probable and possible criteria.…”