Introduction

As part of an effort to address the abuse and misuse of prescription drugs, the US Food and Drug Administration (FDA) approved in July 2012 a risk evaluation and mitigation strategy (REMS) for extended release (ER) and long-acting (LA) opioid analgesics. The REMS states that training for healthcare providers on responsible opioid prescribing should be made available by all ER/LA opioid manufacturers. Though it is “strongly encouraged” by the FDA that providers undergo such training, it is currently a voluntary measure. The Obama administration, as part of its 2011 Prescription Drug Abuse Prevention Plan (“2011 Prevention Plan”), has endorsed making the REMS-specified training mandatory. According to the FDA, the White House is currently pursuing the legislative reform necessary to enact the 2011 Prevention Plan.

Background

ER/LA opioid analgesics are highly potent, highly addictive drugs for  treatment of moderate to severe pain. According to the National Institute of Drug Abuse, approximately 1.9 million people in the United States are addicted to or dependent on prescription opioids. Unintentional drug overdose deaths involving prescription opioids quadrupled between 1999 and 2008 to 12 000 deaths annually; this vastly outnumbers the annual unintentional overdose deaths from heroin and cocaine combined.

Physicians who wish to prescribe controlled substances, including ER/LA opioids, must first register with the Drug Enforcement Administration (DEA). As recommended in the 2011 Prevention Plan, completing a mandatory training program would be a precondition to gaining authorization by the DEA to prescribe controlled substances.

The training program endorsed in the 2011 Prevention Plan and described in the REMS is based on the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics (“FDA Blueprint”). The FDA Blueprint outlines several elements that should be included in an opioid prescribing educational program, including risk assessment, dose selection, adherence monitoring, adverse event management, and patient/caregiver counseling on the safe use of opioid analgesics.

Issue

Should practitioners authorized to write prescriptions for controlled substances be required to take an opioid prescription training program?

Rule

Practitioners should be required to take an opioid prescription training course if the following statements hold true:

1. There exists reliable data indicating a gap between current opioid prescribing practices and evidence-based best practices,

AND

2. Instating the mandatory training program for all authorized practitioners will not burden physicians to the point of negatively affecting patient care.

Analysis

Evidence for gaps between current and recommended opioid prescribing practices

A 2012 survey of medical toxicologists in the United States showed that 25% of the medical toxicologists were not aware of Prescription Drug Monitoring Programs (PDMPs), statewide electronic databases of controlled substance prescription information. PDMPs are one way in which physicians may be able to identify individuals who are abusing prescription drugs, and the system is included in the FDA Blueprint as one element that should be covered in all opioid prescribing training programs.

A survey of physicians in Wisconsin, conducted in 2005, also found gaps in knowledge relevant to opioid treatment. Physicians generally had a poor understanding of symptoms of addiction and of state and federal controlled substance prescription regulations, both areas that are to be covered in opioid prescription training programs.

The above studies indicate that there are significant gaps in knowledge and practice that would be addressed by the FDA-outlined training programs. Focus groups of healthcare providers in New York City identified a lack of education as a major barrier to prescribing opioids for chronic pain, providing further evidence for the potential benefit of a mandatory educational program.

Evidence for burdens of mandatory training on physicians

The American Medical Association (AMA) and other major doctor groups believe mandatory training would be burdensome and could reduce the number of doctors who treat patients for pain, according to an article in the New York Times. Actual data on this potential consequence is limited, but 13.4% of surveyed primary care physicians in Pennsylvania stated that they would stop prescribing opioids if the training program was required.

A working group representing ER/LA opioid manufacturers agreed that making training mandatory would result in fewer doctors opting to obtain authorization to prescribe pain medications and thereby reduce patient access to pain treatment, especially in rural and underserved areas. However, it should be noted that ER/LA opioid manufacturers are required by the REMS to provide funding for training programs, and may therefore have financial incentive to reject a mandatory training policy.

On the other hand, most of a 10-member expert panel assembled by the FDA took the stance that training on responsible opioid prescribing practices should be required, not voluntary as suggested in the REMS. There are also doctor groups, such as the American Society of Interventional Pain Specialists, that support the proposed mandatory training policy.

The medical community is divided on the issue of whether or not mandatory training would place significant burden on healthcare providers. Because reputable groups such as AMA believe that instating mandatory training could ultimately be detrimental for patients with pain, it may be wise to maintain the voluntary training policy, at least until more conclusive data is made available.

Conclusion

There are significant gaps in the knowledge and performance of healthcare providers regarding responsible opioid prescribing, but a mandatory training program could be burdensome on physicians, thereby negatively affecting patient care. Unless this potential consequence can be eliminated as a valid concern, opioid prescribing training should remain voluntary.