Adapting pharmacoeconomic data and methods to extend the postpublication utility of analyses

Alan Lyles

doi:10.1016/j.clinthera.2009.01.008

Adapting pharmacoeconomic data and methods to extend the postpublication utility of analyses

Alan Lyles

Research output: Contribution to journal › Editorial › peer-review

Original language	English (US)
Pages (from-to)	192-193
Number of pages	2
Journal	Clinical therapeutics
Volume	31
Issue number	1
DOIs	https://doi.org/10.1016/j.clinthera.2009.01.008
State	Published - Jan 2009
Externally published	Yes

ASJC Scopus subject areas

Pharmacology
Pharmacology (medical)

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10.1016/j.clinthera.2009.01.008

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title = "Adapting pharmacoeconomic data and methods to extend the postpublication utility of analyses",

author = "Alan Lyles",

note = "Funding Information: The US Food and Drug Administration (FDA) MedWatch Safety Information and Adverse Event Reporting Program6 suffers from having to rely on voluntary-and hence infrequent-reporting by physicians and other health professionals. A new private-sector initiative funded by Pfizer Inc. in association with the Massachusetts General Hospital and the Brigham and Women's Hospital aims to improve the detection and reporting of adverse effects? When a change in pharmacotherapy is entered in the patient's electronic medical record, the software prompts the clinician to add the reason(s) for the change; changes resulting from adverse effects are reported to the FDA through an independent party. A critical determinant of this project's success will be whether it reduces the administrative burden by embedding reporting in routine practice. The project will not create another information silo, as adverse effects are reported directly to the FDA. Under the Food and Drug Administration Amendments Act of 2007, Section 915, postmarketing information on drug safety is now aggregated and linked on a single FDA Web site to improve transparency and communication to patients and health care providers.8 Under Section 921, this comprehensive Web site for drug safety information also contains quarterly reports on potential signals of serious risks and new safety information identified by the Adverse Event Reporting System.",

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JO - Clinical therapeutics

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Adapting pharmacoeconomic data and methods to extend the postpublication utility of analyses

ASJC Scopus subject areas

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