Opioid Patient-Prescriber Agreement

A Tool for Shared Decision-Making in the Treatment of Pain

As part of a pain treatment regimen, patients may be prescribed opioid analgesics. Opioids, like all drugs, have risks. Prescribing errors and inappropriate use of opioid analgesics increase risk and can lead to serious harm, including death. This harm is preventable.

In April 2011, FDA Safe Use Initiative convened a multidisciplinary working group, including pain specialists, addiction specialists, and primary care providers; research institutes; professional organizations; government agencies; plain language and health literacy experts; and patients and patient advocacy groups. The working group’s charge is to develop tools for patients and prescribers to use when they are considering opioids for the treatment of pain. In 2012, the working group developed a model Opioid Patient-Prescriber Agreement (PPA) that is patient-focused. This tool can replace the variety of opioid treatment contracts or agreements currently in use in some healthcare settings. The list of working group organizations appears at the bottom of this page.

The Opioid Patient-Prescriber Agreement is intended to:

• Replace the currently-used opioid treatment agreement documents with a model document that provides consistent and accurate information regarding the use of opioids to treat pain
• Facilitate an open dialogue between the prescriber and patient around the choice to use prescription opioid analgesics to treat pain
• Increase prescriber and patient awareness of the nature of the drugs they choose to treat pain
• Address both the risks and benefits of using opioid analgesics
• Highlight the responsibilities of the patient and prescriber in the management of opioid analgesics as part of pain treatment

Updates from 2012:

• Opioid PPA  completed by the working group
• Opioid PPA Survey completed by FDA employees
• Pilot documents developed by the working group

In November 2012, a survey was sent to FDA CDER employees using SurveyMonkey.™  The survey asked questions regarding the readability of the document, the balance of risks and benefits, and length of time needed to read the PPA.

Updates from 2013:

• Opioid PPA Usability testing by FDA employees completed
• New York University volunteered to lead the pilot effort for the Opioid PPA working group
• New York University began recruitment of providers and piloting in October

In June 2013, FDA Safe Use Initiative conducted a usability test (an evaluation of the document by sample users) with FDA employees of varying ages and education levels.

New York University (NYU), under the Practitioners Engaged in Applied Research and Learning Network (PEARL), is leading the pilot of the Opioid PPA for the working group.  NYU received Institutional Review Board (IRB) approval to conduct the study, and recruitment of prescribers and piloting of the PPA began in October 2013.

Next steps:

• Revise the PPA based on the results of the pilot testing
• Post the final model PPA on FDA website
• Working group members disseminate the model PPA more broadly to their professional audiences and others
• Define outcomes for future Safe Use opioid project plans to measure how use of the document influences opioid prescribing practices and overall patient understanding.   

If you or your organization is interested in testing this Opioid PPA, we welcome your collaboration.

Please contact Mary Ghods: