Pharmacoepidemiology and pharmacovigilance for safety and efficacy in older people

Abstract

At the time of drug product approval, there is limited data on drug safety and efficacy in older patients. In old age there is an increased prevalence of chronic disease and of medication utilization resulting in multimorbidity and polypharmacy. While older people have potential for significant benefit from medicines, they are also susceptible to adverse drug events. Pharmacoepidemiology and pharmacovigilance studies provide real-world evidence on drug utilization and safety, and limited information on efficacy and effectiveness of drugs in older people. The reliability and validity of pharmacoepidemiologic studies have improved with advances in and standardization of study design and reporting, as well as development of objective measures to capture key aspects of geriatric medicine. Pharmacoepidemiologic studies now inform both clinical practice and medicines policy.