US FDA Wants To Know What Doctors Know About Abuse-Deterrent Opioids

Healthcare professionals will be asked about their knowledge of abuse-deterrent opioid formulations along with their views on prescription drug promotions.

The US FDA is tossing in questions about awareness of abuse-deterrent opioid products in its new survey of healthcare professionals.

The agency provides details about the proposed survey in a Federal Register notice to be published March 15. The survey is one of six new research projects FDA's Office of Prescription Drug Promotion (OPDP) has in the works. (Also see "Rx Drug Ads: New US FDA Studies Target Accelerated Approval Information" - Pink Sheet, 12 Mar, 2018.)

While geared towards marketing issues, the survey results seem like they could help inform FDA's assessment of the training materials for healthcare professionals use as part of the risk management plan for opioids. Whether – and how – to mandate such training is among the key issues regulators are assessing as they address the opioid abuse crisis.  (Also see "US FDA Chief Gottlieb Envisions Tiered Mandates For Opioid Training System" - Pink Sheet, 19 Feb, 2018.)

In addition to getting the views of healthcare professionals, FDA also just announced plans to get patient views on treatment of opioid use disorder. The patient-focused drug development meeting planned for April 17 asks many of the standard questions for such events – such as how patients think treatment success should be measured, and how the condition has affected their lives – which can be seen as part of agency's efforts to destigmatize addiction treatment.  (Also see " Addiction Recovery Medications' 'Stigma' Needs To Be Eliminated, Gottlieb Says" - Pink Sheet, 25 Oct, 2017.)

OPDP's Golden Survey

The agency plans to survey 700 primary care physicians, 600 specialists, 350 nurse practitioners and 350 physician assistants, who will be recruited online through WebMD's Medscape subscriber network.

In addition to asking about opioids, the survey will ask:

• What methods and/or channels are used to disseminate prescription drug promotional information to healthcare professionals/prescribers?
• How knowledgeable and interested are HCPs in clinical trial data and its presence in prescription drug promotion?
• How familiar are HCPs with the FDA approval of prescription drugs and how does this translate into practice?

This is OPDP's third survey of healthcare professionals. While the previous surveys focused on direct-to-consumer advertising and promotion, the new survey will focus on Rx drug promotions directed to HCPs.

The cost of the project, "Health Care Professional Survey of Professional Prescription Drug Promotion," is $642,813. Comments on the study are due 60 days from publication of the Federal Register notice.

FDA notes that in 2012, pharmaceutical companies spent more than $24bn on marketing to physicians. The agency says that like most people, healthcare professionals (HCPs) may have cognitive biases in the type of information they pay attention to at any given time.

"They may be persuaded by strong statements and may not have the time to ascertain accuracy of such information," the notice states. "The proposed survey will provide further insights about how professionally targeted prescription drug promotion might influence healthcare professionals' decision-making processes and practices and how information may be communicated more effectively."

The new round of proposed projects brings the total number of OPDP studies of direct-to-consumer and professional drug promotions to 50. Of these, 27 have been completed, four are pending peer review and publication and 19 are in progress.