Sunday, April 5, 2009

FDA: Opioids need Risk Evaluation and Mitigation Strategy (REMS)

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The first time I heard about the FDA's Risk Evaluation and Mitigation Strategy (REMS) program for opioids was during Paice's closing plenary at the AAHPM in March 2009. So when REMS for opioid was a headline on the front page of Pain Medicine News (reg required), it immediately grabbed my attention.

After last week's announcement by the FDA regarding the loss of different concentrations of opioids, this seems to be the year of increased opioid scrutiny. The REMS program has already been implemented with Accutane and Thalidomide and is apparently developed and implemented by the pharmaceutical manufacturers with oversight from the FDA.

The Pain Medicine News article states the FDA has already met with key stakeholders to discuss the program, but it does not say if palliative medicine organizations or clinicians were involved. I wonder if they only included pain specialists/anesthesiologists in addition to pharmaceutical companies. The main focus will be on 24 extended release products, as opposed to the immediate release program.

The REMS will likely include a Risk Minimization Action Plan (RiskMAP) which will likely require 'registries for prescribers, pharmacists, and patients.' The reason the FDA is doing this is to 'ensure that the benefits of a drug outweigh the risks.'

There are quotes in the article that the FDA is concerned the general public and practioners are not aware of the risks of extended release opioids. Frankly many patients and family members I talk to are very reluctant to take opioids, and I am sure many hospice or palliative medicine professionals spend a great deal of time educating others that opioids can have benefits that outweigh the manageable risks.

I have told students and residents rotating through that 'opioids need to be respected not feared.' With more experience and good training prescribers can become more confident, safe and skilled in opioid prescriptions. My fear with the FDA REMS program is that it may have an unintended consequence of limiting the number of prescribers who will prescribe opioids, and much of this may fall on the pain specialists or palliative medicine specialists. And then you put the onus of lawyers suing for not adequately controlling pain, and we have a classic Catch-22.

No mention in the article about an exemption or how this may impact hospice patients. I am not sure how I would feel about a complete exemption for hospice patients as this could actually cause different problems, and if hospice patients and opioids in homes are part of the diversion problem we should not be afraid to be part of a well thought out solution that does not limit access for patients needing pain relief.

What do you think about REMS? Should hospice and palliative medicine work to define standards for opioid education before someone else defines them for us?
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