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Study Finds Noncompliance with Drug Black Box Warnings is Common
PA PSRS Patient Saf Advis 2005 Dec;2(4):17.     
 

A large, nationwide study of prescribing patterns for drugs with black box warnings (FDA’s strongest labeling requirement) found that these high-risk medications are prescribed frequently—often in a way that does not comply with the label warnings.

Over the 30-month study period, more than 40% of patients in the health plans studied received at least one drug with a black box warning that could apply to them. The most frequent type of non­compliance identified in the study was a failure to get a baseline laboratory test before initiating ther­apy with drugs where monitoring is recommended.

The study was conducted by retrospective review of automated claims data from 10 geographically diverse health plans throughout the US with more than 929,000 enrollees. It was released electroni­cally on November 18 and will appear in an up­coming issue of Pharmacoepidemiology and Drug Safety.
 
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Study Finds Noncompliance with Drug Black Box Warnings is Common



THE PENNSYLVANIA PATIENT SAFETY AUTHORITY AND ITS CONTRACTORS  
PSA LOGO The Pennsylvania Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI Institute, as contractor for the Authority, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the Pennsylvania Patient Safety Authority, see the Authority’s Web site at www.patientsafetyauthority.org .      
ECRI LOGO ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for more than 40 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, and healthcare processes, devices, procedures and drug technology.      

ISMP Logo The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP’s efforts are built on a nonpunitive approach and systems-based solutions.      
 
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