Open Access Open Access  Restricted Access Subscription or Fee Access

Primary care physician opinion survey on FDA Opioid Risk Evaluation and Mitigation Strategies

Kieran A. Slevin, MD, Michael A. Ashburn, MD, MPH


Introduction: In response to disturbing rises in prescription opioid abuse, the Food and Drug Administration (FDA) has proposed the implementation of aggressive Risk Evaluation and Mitigation Strategies (REMS) that will require prescribers to obtain mandatory education, provide mandatory patient education, register patients into registries, and so forth before prescribing certain opioids. The first opioid to be subject to the new REMS was the recently approved fentanyl buccal soluble film (Onsolis™). The FDA plans to extend mandatory REMS to other opioids, including all rapid-onset formulations and eventually all long-acting opioids, whether or not they already have FDA approval. To assess the likely impact of REMS on opioid prescribing, the authors conducted a survey of how REMS implementation might affect opioid prescribing.
Methods: After obtaining Institutional Review Board’s approval, a survey regarding opioid prescribing was sent via e-mail to 2,800 physician members of the Pennsylvania Academy of Family Physicians. Practicing family practice physicians were asked to respond to questions regarding their current opioid prescribing, and how various components of REMS might alter their future opioid prescribing.
Results: A total of 259 surveys were completed. Of the 259 physicians who responded, 87 percent reported themselves as being primary care practitioners; others identified themselves as specialists. Of all respondents, 96 percent currently prescribe opioids for acute pain, 77 percent for cancer pain, and 83 percent for chronic nonmalignant pain. The respondents were split from 52 percent to 48 percent in terms of being in an urban versus a rural practice setting. Forty-eight percent of all respondents reported their willingness to complete no more than 2 hours of training if it were available locally to be able to continue prescribing opioids. A similar percentage (50 percent) also said that they would encourage patient compliance with education and register their patients on a 6-month basis. However, the following percent of respondents reported that they would discontinue prescribing an opioid product if required to comply with the following REMS requirement: obtain 4-8 hours of training, followed by 2 hours of pain-related continuing medical education every 2 years (13.4 percent); complete mandatory patient education (12.2 percent); document ongoing monitoring of therapy including efficacy, safety, and monitoring for aberrant drug-related behavior (10.4 percent); or register each patient in a patient registry, and have the patient re-registered every 6 months (18.3 percent).
Conclusions: The results suggest that 50 percent of the responding physicians would be willing to comply with the mandatory education component of REMS, including the requirement to provide education to patients. For some REMS components, willingness to continue to prescribe despite the restriction was higher (up to 90 percent). However, this leaves a substantial proportion of physicians who would not be willing to prescribe opioids controlled by the new REMS, which could have the unintended effect of decreasing access to these medications for legitimate medical purposes.


opioids, regulation, breakthrough pain

Full Text:



Leong M, Murnion B, Haber PS: Examination of opioid prescribing in Australia from 1992 to 2007. Intern Med J. 2009; 39: 676-681.

Paulozzi LJ, Budnitz DS, Xi Y: Increasing deaths from opioid analgesics in the United States. Pharmacoepidemiol Drug Saf. 2006; 15: 618-627.

Kuehn BM: Efforts aim to curb opioid deaths, injuries. JAMA. 2009; 301: 1213-1215.

Meyer BM: The Food and Drug Administration Amendments Act of 2007: Drug safety and health-system pharmacy implications. Am J Health Syst Pharm. 2009; 66: S3-S5.

Shane R: Risk evaluation and mitigation strategies: Impact on patients, health care providers, and health systems. Am J Health Syst Pharm. 2009; 66: S6-S12.

FDA Website: Questions and answers about Onsolis (fentanyl buccal soluble film). Available at Accessed July 28, 2009.

Baron RJ: What’s keeping us so busy in primary care? A snapshot from one practice. N Engl J Med. 2010; 362: 1632-1636.

Tompkins DA, Lanier RK, Harrison JA, et al.: Human abuse liability assessment of oxycodone combined with ultra-low-dose naltrexone. Psychopharmacology (Berl). 2010; 210: 471-480.

Butler SF, Black R, Grimes Serrano JM, et al.: Estimating attractiveness for abuse of a not-yet-marketed “abuse-deterrent” prescription opioid formulation. Pain Med. 2010; 11: 81-91.

White AG, Birnbaum HG, Schiller M, et al.: Analytic models to identify patients at risk for prescription opioid abuse. Am J Manag Care. 2009; 15: 897-906.

Wilsey BL, Fishman SM, Casamalhuapa C, et al.: Documenting and improving opioid treatment: The Prescription Opioid Documentation and Surveillance (PODS) System. Pain Med. 2009; 10: 866-877.



  • There are currently no refbacks.