No conflict of interest was declared. Ethics: The information used in this manuscript did not violate any ethics regulations.
Estimating post-marketing exposure to pharmaceutical products using ex-factory distribution data†
Version of Record online: 7 JUN 2006
Copyright © 2006 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 15, Issue 10, pages 749–753, October 2006
How to Cite
Telfair, T., Mohan, A. K., Shahani, S., Klincewicz, S., Atsma, W. J., Thomas, A. and Fife, D. (2006), Estimating post-marketing exposure to pharmaceutical products using ex-factory distribution data. Pharmacoepidem. Drug Safe., 15: 749–753. doi: 10.1002/pds.1264
- Issue online: 21 SEP 2006
- Version of Record online: 7 JUN 2006
- Manuscript Accepted: 17 APR 2006
- Manuscript Revised: 31 MAR 2006
- Manuscript Received: 21 NOV 2005
- exposure estimation;
- exposure estimation algorithm;
- pharmaceutical products;
- post-marketing surveillance;
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. Copyright © 2006 John Wiley & Sons, Ltd.