Comparative Profile of Adverse Drug Reactions with Antimicrobials:Women Vs Men

Female gender, advancing age, paediatric age, multiple drug usage, smoking, alcohol, inappropriate drug usage and irrational drug combination have been documented as important risk factors for adverse drug reactions (ADRs). (1-4) Women experience more adverse reactions with therapeutic drugs than men and often they are more serious than men. (5) However, there are contrary reports also which suggest that no major genderrelated differences exist for ADR patterns. (6, 7) Due to high prevalence of infectious diseases in developing countries antibiotic are commonly prescribed group of drugs. Antimicrobials have also the potential for being misused both by patients and doctors which can result into increase prevalence of adverse drug events among users. Though, the data on gender related differences in ADR's profile exists in volumes for other group of drugs. (5-7) To best of our knowledge, there exist no study exclusively analyzing the gender related differences in ADR's trends and patterns related to antibiotics in Indian population. Hence to best of our knowledge, the current study is the first study of its kind conducted to evaluate gender related differences in ADR profile of antimicrobials. Material and Methods A three year retrospective observational crosssectional analysis was carried out to evaluate the profile of adverse drug events related to antimicrobials in ADRM Centre, working under PvPI in a tertiary care teaching hospital from north India using suspected drug reactions monitoring data collection form used under PvPI. Information about patient, suspected ADR, suspected medication, reporter, date of reaction, date of recovery and presentation of problem were recorded. Under suspected medication, name of drug, brand of Introduction Abstract 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 WHO13 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.