PHARMACOEPIDEMIOLOGY OF ADVERSE DRUG-REACTIONS IN HOSPITALIZED-PATIENTS WITH HUMAN-IMMUNODEFICIENCY-VIRUS DISEASE

To evaluate the incidence, characteristics, and risk factors of advers e drug reactions (ADRs) in patients with human immunodeficiency virus (HIV) disease, we conducted was a prospective observational study of i npatients with HIV disease. The study was conducted in a public teachi ng hospital affiliated with the University of California, San Francisc o. We reviewed daily the hospital records of all eligible inpatients t hroughout their hospitalization for potential ADRs. Potential ADRs wer e independently evaluated by two of the authors with regard to the ext ent of their causal association(s) with implicated drug(s) using a pre viously validated algorithm. Type (A, augmented; B, bizarre) and sever ity (mild, moderate, severe) were also evaluated. Among 495 patient ad missions involving 390 eligible patients, 173 potential ADRs were iden tified, of which 118 (68.2%) had a probable or definite causal relatio nship to the implicated drugs. These probable or definite ADRs occurre d among 79 (20%) eligible patients; 82 ADRs (69.5%) were classified as augmented (type A) and 36 (30.5%) were classified as bizarre (type B) reactions. Skin rash was the most frequent (17%) ADR encountered. Of the medications causing ADRs, 70% were antimicrobial drugs. Significan t independent risk factors for developing ADRs included advanced stage of HIV disease, intake of a greater number of medications, and longer hospital stay. A high percentage of patients with HIV disease develop ed ADRs. Skin rash was the single most common kind of ADR. Advanced st age of illness and prolonged drug exposure were the only risk factors for ADRs.