Mastodon REMS education comment period ~ Pallimed

Friday, November 11, 2011

REMS education comment period

The FDA has opened a comment period, closing December 7, on it's just-released draft "Blueprint for Prescriber Continuing Education Program." The accompanying request-for-comment states that "The central component of the Opioid REMS program is an education program for prescribers and patients." If you've missed the previous discussion of opioid REMS, see Drew's blogs here and here and especially Stew Leavitt's extensive analysis last April.

The actual REMS stuff that has come out so far has not been as draconian as some had feared when first announced. The education Blueprint is pretty benign and pretty much (what should be) standard of care for almost any medication: the prescriber should know about the medications' potential negative effects, take them into consideration in prescribing and in teaching/counseling patients, and systematically monitor effects. Naturally, there is a fair amount about managing the risk of intentional misuse. The content outline provided by FDA to educational providers states that education must include information on: (1) weighing the risks & benefits of opioid therapy; (2) choosing patients appropriately; (3) managing and monitoring patients; (4) counseling patients on the safe use of these drugs; (5) information on how to recognize evidence of or the potential for opioid misuse, abuse, and addiction.

There are explicit statements that the educational basics outlined in the Blueprint do not have to be part of required education for licensing of prescribers, although apparently the FDA will approve these basic educational offerings. They estimate the basics can be presented in 2-3 hours. The industry consortioum has submitted suggested supplemental content that could take 10x that amount of time or more. FDA explictly says they will not require nor review supplemental educational content. The other explicit exclusion is Patient-Provider Agreements (these have been called opioid contracts in the past). FDA says content about these as a managment option should be included, but will not be required as a standard for pain practice. Industry is expected to provide grants to CE providers to develop and present these courses free of charge to prescribers. ACCME standards are to be maintained.

My main concern, both viscerally and cognitively, is the generally negative tone. All the emphasis is on negative effects/risks with nothing at all said about how valuable and effective opioids are when prescribed and used as intended. There are statistics presented about the misuse, abuse, and non-medical use of opioids, but nothing at all about the prevalence of pain, as described in (competing?) government publications such as the "Special Feature: Pain" chapter in the CDC report Health, United States, 2006 and the IOM 2011 report Relieving Pain in America. See Stew Leavitt's discussion on the use/misuse of statistics in government publications on the prescription drug abuse "epidemic."

The Blueprint is really not about managing pain--it's about prescribing and monitoring opioid analgesics. The target audience is probably primary care practitioners, but there are plenty of specialists who use opioids poorly, if at all. An educational emphasis on safe prescribing of these agents is probably not a bad thing, although the tone could reinforce the prevalent perspective that these medications are too dangerous to prescribe.

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