Pharmacoepidemiology in Safety Evaluations of Newly Approved Medications
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Pharmacoepidemiology in Safety Evaluations of Newly Approved Medications
96 6 5 j Elane M. Gutterman, PhD Senior Research Scientist, Health Data Analytics. Princeton Junction. New Jersey
Key Words Pharmacoepidemiology; Prescription Drug User Fee Act (PDUFA); Drug safety; Risk management; Postapproval surveillance Correspondence Address Elane M. Gutterman, PhD. Health Data Analytics. 35 Arnold Drive, Princeton Junction. NJ 08550 (e-mail: [email protected]).
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In the recent extension of the Prescription Drug User Fee Act, the risk management programs that are to befunded by additional user fees combine ascertainment of risks in the initial postapproval phase with activities to confront these risks. Better recognition of risks, a prerequisitefor success in managing risks, will require strategies to supplement the present system of spontaneous event reporting. This overview considers the merits of Dharmacoepidemiology studies in examining gaps in drug safety resulting from the inherent limitaI
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Many aspects of drug safety cannot be adequately assessed prior to regulatory approval. Widespread use in the initial years following regulatory approval may provide the first opportunity to identify rare but serious health risks. Recent amendments to the Prescription Drug User Fee Act (PDUFA) that took effect October 1,2002 have authorized the Food and Drug Administration (FDA) to use almost $71 million in corporate fees to augment drug safety activities over the next five years. The program calls for the voluntary development of a risk management program to be submitted along with the drug sponsor’s New Drug Application that would address strategies for monitoring, assessing, and controlling risk during the initial two or, in some cases, three, years after drug approval (1). Although pharmacoepidemiology approaches have been considered a critical component in assessing risks in the postapproval phase (2), there is insufficient understanding of their potential contributions and limitations. As conceptualized by the FDA, risk management programs require an integrated and dynamic approach that combines ascertainment of risks with activities to confront these risks (3), including:
tions of clinical trials. After drugs become widely used following regulatory approval, many health outcomes potentially related to drug exposures can be studied in large health insurance claims databases using pharmacoepidemiology designs tailored to this venue. We clarifi types of safety investigations particularly suited to examination in a large claims database, as well as the benefits and caveats of expanding postapproval follow-up through Prescription Drug User Fee Act funding.
Implementing activities to eliminate or minimize risks, Communicating risk information, and Monitoring and evaluating the outcomes of interventions and communications.
Nevertheless, a crucial component in successful risk management will be generating the necessary data to clarify and inform profiles of risk. In this paper, we address the following questions: Wha
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