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Current Drug Safety

Editor-in-Chief

ISSN (Print): 1574-8863
ISSN (Online): 2212-3911

Clinical Implications of Patient-Provider Agreements in Opioid Prescribing

Author(s): Carl N. Kraus, Alan T. Baldwin, Frederick A. Curro and R. G. McAllister

Volume 10, Issue 2, 2015

Page: [159 - 164] Pages: 6

DOI: 10.2174/1574886309666140922095844

Price: $65

Abstract

In June, 2012 the United States Food and Drug Administration (FDA) developed a “blueprint” for prescriber education as a means of directing Certified Medical Education (CME) activities that included content which would meet the regulatory requirements of the class-wide, longacting/ extended-release (LA-ER) opioid Risk Evaluation Mitigation Strategies (REMS). Within the blueprint is the suggested adoption of Patient-Provider Agreements (PPAs) to be used in association with opioid prescribing, but, to our knowledge, there have been no reported evaluations of the role played by opioid-agent PPAs in clinical practice, or of the perceptions of this regulatory mandate by clinicians. Therefore, we conducted a survey regarding PPA perceptions by opioid prescribers that was posted for five weeks on a well-trafficked online CME service provider (Medscape). Of the 1,232 respondents (reflecting a 99.5% completion rate), 52.4% treat acute or chronic pain with opioids. The survey identified an improvement of opioid safe-use education (21% of respondents) as the most frequently selected beneficial element of PPAs. Conversely, the challenges to adoption included time constraints (21% of physicians) as well as lack of evidence that PPAs will reduce drug misuse, and the lack of a uniform, patient-friendly PPA. Based on our survey, clinicians consider the PPA of potential value, but data regarding the utility of such an instrument are lacking.

Keywords: Food and Drug Administration Amendments Act (FDAAA), opioids, patient-provider agreement, risk management, pain management, US FDA.


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