title: Estimating post-marketing exposure to pharmaceutical products using ex-factory distribution data.
abstract: The pharmaceutical industry has an obligation to identify adverse reactions to drug products during all phases of drug development, including the post-marketing period. Estimates of population exposure to pharmaceutical products are important to the post-marketing surveillance of drugs, and provide a context for assessing the various risks and benefits, including drug safety, associated with drug treatment. This paper describes a systematic approach to estimating post-marketing drug exposure using ex-factory shipment data to estimate the quantity of medication available, and dosage information (stratified by indication or other factors as appropriate) to convert the quantity of medication to person time of exposure. Unlike the non-standardized methods often used to estimate exposure, this approach provides estimates whose calculations are explicit, documented, and consistent across products and over time. The methods can readily be carried out by an individual or small group specializing in this function, and lend themselves to automation. The present estimation approach is practical and relatively uncomplicated to implement. We believe it is a useful innovation.
authors.affiliation: Johnson & Johnson Pharmaceutical Research and Development, Benefit-Risk Management Department, Epidemiology Division, Titusville, NJ 08560, USA.
authors.forename: Tamara
authors.initials: T
authors.lastname: Telfair
authors.forename: Aparna K
authors.initials: AK
authors.lastname: Mohan
authors.forename: Shalini
authors.initials: S
authors.lastname: Shahani
authors.forename: Stephen
authors.initials: S
authors.lastname: Klincewicz
authors.forename: Willem Jan
authors.initials: WJ
authors.lastname: Atsma
authors.forename: Adrian
authors.initials: A
authors.lastname: Thomas
authors.forename: Daniel
authors.initials: D
authors.lastname: Fife
mesh_terms: D000465:Algorithms; D004345:Drug Industry; D011307:Drug Prescriptions; D006801:Humans; D017891:Pharmacoepidemiology / Q000379:methods; D010601:Pharmacology, Clinical / Q000379:methods; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000706:statistics & numerical data; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors