RESUMO
PURPOSE: Active surveillance of population-based health networks may improve the timeliness of detection of adverse drug events (ADEs). Active monitoring requires sequential analysis methods. Our objectives were to (1) evaluate the utility of automated healthcare claims data for near real-time drug adverse event surveillance and (2) identify key methodological issues related to the use of healthcare claims data for real-time drug safety surveillance. METHODS: We assessed the ability to detect ADEs using historical data from nine health plans involved in the HMO Research Network's Center for Education and Research on Therapeutics (CERT). Analyses were performed using a maximized sequential probability ratio test (maxSPRT). Five drug-event pairs representing known associations with an ADE and two pairs representing 'negative controls' were analyzed. RESULTS: Statistically significant (p < 0.05) signals of excess risk were found in four of the five drug-event pairs representing known associations; no signals were found for the negative controls. Signals were detected between 13 and 39 months after the start of surveillance. There was substantial variation in the number of exposed and expected events at signal detection. CONCLUSIONS: Prospective, periodic evaluation of routinely collected data can provide population-based estimates of medication-related adverse event rates to support routine, timely post-marketing surveillance for selected ADEs.
Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Vigilância da População/métodos , Vigilância de Produtos Comercializados/métodos , Algoritmos , Celecoxib , Planos Médicos Alternativos/organização & administração , Planos Médicos Alternativos/estatística & dados numéricos , Sistemas Pré-Pagos de Saúde/organização & administração , Sistemas Pré-Pagos de Saúde/estatística & dados numéricos , Humanos , Revisão da Utilização de Seguros/estatística & dados numéricos , Lactonas/efeitos adversos , Lactonas/uso terapêutico , Sistemas Computadorizados de Registros Médicos/estatística & dados numéricos , Infarto do Miocárdio/induzido quimicamente , Infarto do Miocárdio/diagnóstico , Naproxeno/efeitos adversos , Naproxeno/uso terapêutico , Vigilância de Produtos Comercializados/estatística & dados numéricos , Pirazóis/efeitos adversos , Pirazóis/uso terapêutico , Piridinas/efeitos adversos , Piridinas/uso terapêutico , Estudos Retrospectivos , Rabdomiólise/induzido quimicamente , Rabdomiólise/diagnóstico , Sulfonamidas/efeitos adversos , Sulfonamidas/uso terapêutico , Sulfonas/efeitos adversos , Sulfonas/uso terapêutico , Fatores de Tempo , Resultado do Tratamento , Estados UnidosRESUMO
To determine whether treatment with protease inhibitors (PIs) is associated with male sexual dysfunction, we conducted a retrospective, cohort study of 254 adult male PI recipients who received care from the staff-model division of a large managed care organization in New England between 1993 and 1998. After a median of 5.0 years of observation, 80 incident cases of sexual dysfunction were observed. Relative to unexposed individuals, the rate of sexual dysfunction adjusted for confounding was most elevated with use of ritonavir (hazard ratio [HR], 2.83; 95% confidence interval [CI], 1.34-5.97; p =.006) followed by indinavir (HR, 1.69; 95% CI, 0.84-3.37; p =.14), nelfinavir (HR, 1.53; 95% CI, 0.66-3.54; p =.32) and saquinavir (HR, 1.25; 95% CI, 0.53-2.96; p =.60). We conclude that PIs, especially ritonavir, appear to increase the risk of sexual dysfunction.
