RESUMEN
The current study was undertaken to analyze the profile of adverse drug reaction (ADR) contributed by fixed drug combinations (FDC). A cross-sectional, retrospective study was conducted over a period of 2 years to evaluate the profile of ADR contributed by FDC using suspected ADR data collection form used under Pharmacovigiliance Programme of India (PvPI). A total number of 2242 ADRs were reported during the study period of two years out of which drug combinations responsible for ADRs were 589 (26.27%). Fixed drug combinations (FDC) contributing to ADRs were 88(3.9%). As per latest WHO essential drug list, irrational FDC were responsible for 83 (3.70%) accounting 94.3% of the total FDC. Whereas, only 5(0.2%) of rational FDC contributed to the total pool of ADRs. Most frequent drug combination contributing to ADR was of anticancer drugs leading to vomiting and alopecia, where as most common irrational FDC was aceclofenac plus thiocolchicoside and ofloxacin plus ornidazole leading insomnia & rash respectively. Levodopa plus carbidopa and trimethoprim plus sulphamethoxazole were two common rational FDC contributing to ADRs. The above results underscores that drug combinations and FDC as well as irrational FDC substantially contribute towards the pool of total ADRs.
RESUMEN
The current retrospective cross sectional study was undertaken using suspected ADR data collection form used under Pharmacovigiliance Programme of India (PvPI). A total of 2586 ADR events were recorded in 3years out of which 392(15.15%) were because of antimicrobials. males constituted 253 patients (64.54%) and females constituted 139 patients (35.45%) with male: female ratio as 1.8:1. Adults were more commonly affected followed by geriatric and pediatric population in both the groups. I.V route followed by oral route of drug administration accounted maximum ADR in similar way in both the genders. Monotherapy was responsible for 81.81% for males and 82.01% for females. Among combinations 78.26% in males and 64% in females were irrational as per latest WHO13th essential drug list. Majority of ADR, 88.14% and 92.80% were of moderate severity among males and females respectively. Maximum ADR were latent, type-A, probable in nature as per Naranjo and WHO-UMC scale. Inj.ceftriaxone followed by tab. azithromycin, tab.ofloxacin-ornidazole were the commonest antimicrobials responsible for ADRs in both the genders. The most common system involved was dermatological followed by GI in both males and females. On statistical comparison, no significant differences were observed among both the genders in any of the parameters except causality assessment scale (P<0.5). The current study suggests the ADRs due to antimicrobials are a significant health problem. No major gender related differences were observed in ADR profile of our study cohort.