Developing and Initiating Validation of a Model Opioid Patient-Prescriber Agreement as a Tool for Patient-Centered Pain Treatment

Background: Opioid treatment agreements generally are used in pain treatment to delineate the terms and consequences of opioid use and abuse. Methods: The US Food and Drug Administration (FDA) Safe Use Initiative convened a multi-disciplinary working group with outside experts to draft a patient-centered, model opioid treatment agreement named the Model Patient-Prescriber Agreement (model PPA). The model PPA was evaluated for readability and usability in two tests that sampled both healthcare professional and non-healthcare professional FDA employees. In a survey sent to FDA employees in the Center for Drug Evaluation and Research (CDER), 209 respondents assessed the quality of the content and the level of difficulty in reading and understanding the model PPA. Ten other FDA employees participated in usability testing to assess the effectiveness of the model PPA as an educational and decision-making tool. Results: The majority of the 209 CDER employee survey respondents indicated the model PPA was neutral in tone (67.5 %) and easy or somewhat easy to understand (90.4 %). Usability study participants generally thought the model PPA would facilitate discussion between patient and prescriber and that the content was informative, thorough, and clear. Conclusions: These studies suggest that the working group was able to develop an opioid PPA that may be acceptable and usable among a diverse population of stakeholders. A follow-up pilot study using the model PPA in medical facilities in the USA with patients is underway and will facilitate this determination.