Utilizing Medicare claims data for real-time drug safety evaluations: is it feasible?,

Author:

Hartzema Abraham G.1,Racoosin Judith A.2,MaCurdy Thomas E.34,Gibbs Jonathan M.4,Kelman Jeffrey A.5

Affiliation:

1. University of Florida; Gainesville FL USA

2. Food and Drug Administration; Silver Spring MD USA

3. Stanford University; Stanford CA USA

4. Acumen LLC; Burlingame CA USA

5. Center for Beneficiary Choices; Office of the Administrator; Center for Medicare & Medicaid Services; Washington DC USA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference4 articles.

1. FDA MedWatch: the FDA safety information and adverse event reporting program 2010 http://www.fda.gov/Safety/MedWatch/default.htm

2. FDA Postmarketing clinical trials 2009 http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/Phase4Trials/default.htm

3. Estimating the Extent of Reporting to FDA: a case study of statin-associated rhabdomyolysis;McAdams;Pharmacoepidemiol Drug Saf,2008

4. CMS Medicare Claims Processing Manual 2010 http://www.cms.gov/manuals/downloads/clm104c01.pdf

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