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Keeping Prescribers on Board if Certification Becomes Part of REMS

Consequences need to be acknowledged and serious thought given to the full impact that the FDA’s proposed Risk Evaluation and Mitigation Strategies (REMS) plan might have.

As the pain field holds its breath for the arrival of class wide REMS for long-acting opioids, there are still many unknowns. Who will provide over-sight of the facets of these programs? Will there be certification of prescribers, pharmacies, and/or registries for patients? These are some of the ideas currently on the table.

We could highlight the good aspects of REMS —better patient education, for instance—but we have many concerns about the issue of certification. Now we aren’t particularly worried about any ill coming from taking, for example, a special day long class on opioids in chronic pain to enhance understanding of safety issues on the part of prescribers—though we doubt that it will provide enough depth to be truly helpful to prescribers trying to make the many and varied difficult decisions they encounter treating pain on a daily basis. However, we are very concerned about the fact that certification could provide the invitation many prescribers have been looking for to opt out of opioid management. This will undoubtedly happen with some prescribers and the issue becomes how the larger pain community can help to limit this negative impact.

The history lesson regarding isotret-inoin should not be ignored, and indeed deserves to be highlighted as the number of prescriptions and prescribers involved is relatively small compared to the numbers seen with pain management. Last year alone there were 460,000 unique prescribers of OxyContin in the USA. Now we know that the long-acting (LA) opioid marketplace is driven by a small number of high volume prescri-bers, that 20,000-30,000 prescribers write about 85% of all of these prescriptions. This leaves over 400,000 prescribers who wrote a smaller number but probably very important 10-15 prescriptions each per year. What is a reasonable prediction of how many of these 400,000 physicians are likely to opt out? 100,000-200,000? And supposing they do and their former pain patients suffer while some percentage of prescription opioid abuse decreases. Will this be considered a victory for REMS?

Without a doubt, this program will put immense pressure on the pain management community. None of my physician colleagues are eager to become the “opiologists” for their states. They are already overbooked and pressed for time, threatening the quality of their work as expert consultants. If their market share of their long-acting opioids goes up to 95% but they are prescribed in a rushed fashion, who benefits? We already know that there are thousands of patients too many for every pain expert in the country.

Now we could encourage these potential dropouts not to do so by appealing to their better nature. To remind them of how important treating pain is to doing right and good medical care of any kind, especially primary care. Treating pain ain’t like treating acne. It is essential to the health care system and nothing is coming around the bend anytime soon to replace opioids as a cornerstone of pain management for many painful conditions.

But in addition to carrots we need sticks. We already have a huge problem nationally in that pain experts have a hard time getting referring physicians to “take back” their referred patients after they are stabilized by the expert. What if pain experts and our professional organizations took on a policy that we would only do consults on patients referred by certified prescribers? An uncertified referring physician is a guarantee not to resume care of the patient and perhaps we could force them to step up to the plate and get certified with such a policy? In either case, the rule of unintended (or perhaps intended) consequences needs to be acknowledged and serious thought needs to be given to the full impact that the proposed REMS might have.

“Without a doubt, this program will put immense pressure on the pain management community. ...We already know that there are thousands of patients too many for every pain expert in the country.”
Last updated on: February 21, 2011
First published on: October 1, 2009