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Showing posts with label DEA. Show all posts
Showing posts with label DEA. Show all posts

Monday, September 9, 2013

Prescribe Long Acting Opioids? You Must Know About REMS


Here is the simple version:

If you prescribe long acting opioids then you (and all your prescribing co-workers) should sign up for the FREE FDA/DEA mandated REMS training hosted by AAHPM on September 10th (yes, tomorrow!) andOctober 11th.

Here is the (semi-)long version:

The FDA and DEA have noticed the public health risk caused by long acting opioids being used inappropriately.  One part of their remedy is to increase training for prescribers of opioids.  The AAHPM along with 9 other interdisciplinary organizations (Collaborative on REMS Education CO*RE) are working to provide the educational activity.  This training takes place over two days: September 10th and October 8th.

We have covered REMS on Pallimed previously: here, here, and here.

If you are worried that you cannot make these dates for training, you can always look for more live and online training resources from the CO*RE website under Educational Opportunities.

If anyone has taken a CO*RE class we would love to hear feedback.  It will be interesting to see how this does (or does not?) affect the growing challenge of misappropriation and misuse of opioids, which are a powerful and important therapeutic class of medications for hospice and palliative care clinicians to have available.


Don’t forget to register and tell your peers who prescribe, otherwise you might be the only REMS certified prescriber in town, and I don’t think you want to imagine that future.

Monday, September 9, 2013 by Christian Sinclair ·

Thursday, April 21, 2011

Feeling grumpy about opioids

As it's been noted on the blog before, it's safe to say we are in the midst of a transition towards increasing restrictions on our ability to prescribe opioids to our patients, although the nature of these restrictions are really just emerging**.  All of this is, of course, in response to the horrifying epidemic of prescription opioid abuse - see this recent New York Times piece for a bone-chilling description of prescription opioid abuse in Appalachia.

Which is not to say that some of the recent high-profile scholarly publications on the risks of chronic opioid therapy make me very, very grumpy, at least how they are interpreted in the headlines and editorial page.  I've really appreciated Stewart Leavitt's ongoing, critical discussion of these publications (and the larger editorial/media conversation) at his Pain Treatment Topics blog, and I couldn't presume to do a better job analyzing the studies than Stew.  See, for instance, this analysis of two recent high-profile publications purportedly about the dangers of opioid therapy.  I read both the studies he mentions, as well, and thought to myself:  Gee, these studies seem to highlight how safe chronic opioid therapy is.  Read his analysis and the articles and decide for yourself, but I concluded the same thing he did:  while the risk of fatal overdose increases with increasing prescribed dose, the absolute risk of fatal overdose (in these studied populations) was exceedingly low. 

**Yes, I actually wrote those words last night.  Subsequently my inbox gets flooded with notifications that the FDA has announced its long-awaited REMS program for long-acting opioids...kind of.  Press-release here, which discusses, in broad-strokes, a multi-agency strategy (beyond REMS) to help stem the epidemic.  We are told the key elements of the strategy will be:
  • expansion of state-based prescription drug monitoring programs
  • recommending convenient and environmentally responsible ways to remove unused medications from homes
  • supporting education for patients and health care providers
  • reducing the number of “pill mills” and doctor-shopping through law enforcement
 All of this sounds swell of course, but the devil will be in the details, which are still forthcoming, and in part will be defined by manufacturers.  The plans, as far as prescribers are concerned, seem to be mostly about increased education, but nothing along the lines of requiring prescribers to complete and sign off on certain educational materials in order to prescribe certain drugs, etc.  Nods are given to the importance for balancing the needs of patients to receive pain relief and the public health catastrophe diversion and abuse of prescription opioids.  I still think, at the end of the day, that docs aren't detectives, we can't be, and with the exception of a tiny number of completely clueless prescribers and some criminals, targeting prescribers just isn't going to help.

I'd recommend reading Stew Leavitt's analysis for a more knowledgeable discussion of the announcement.

Photo from the FDA's press-release.

Thursday, April 21, 2011 by Drew Rosielle MD ·

Tuesday, January 17, 2006

Prognosis in end-stage HIV AIDS. Supreme court rules on Oregon's PAS law.

The December Journal of AIDS has a paper about predicting prognosis in end-stage HIV-AIDS. It is based in a cohort of 230 patients enrolled in an HIV Palliative Care program in New York. This was a sick cohort--median CD4 count was 39/mm^3; median Karnofsky was 30; and after a median follow up of 4 months 54% had died. After analyzing those who died, only age greater than 65 years and performance status (measured as either Karnofsky score or number of impairments in activities of daily living) independently predicted death. Viral load, CD4 count, and baseline symptom scores were not predictive of death.

This is ongoing evidence that in a multitude of diseases, performance status is the best predictor of mortality. The authors point out that HIV-specific measures (such as viral load, CD4 count, etc.) are good predictors of mortality in healthier people with HIV; however they lose their prognostic power towards the end where pretty much everyone's CD4 counts are in the tubes. It should be noted, of course, that this was a very unique population--a single center's referral population. So the generalizability of this is limited, although it's not the first study to come to this conclusion in HIV.

The Supreme Court ruled in favor of Oregon's physician assisted suicide law today. Specifically, it ruled by a 6-3 margin that the federal government can't use the Controlled Substances Act to crack down on doctors who prescribe drugs to be used in assisted suicide under the Oregon Death with Dignity Act. Chief Justice Roberts dissented, in a block with Justices Thomas and Scalia, in a move that's of interest for those of us who are concerned about the balance of power on the Court. I've noted on this blog before that I'm no fan on assisted suicide, nor am I convinced Oregon's law is the best way of allowing and regulating it. But just because I've yet to be in a situation where PAS seems right--right for a specific patient, in a specific situation, using "close-up" ethics--doesn't mean that I won't someday. And having the DEA scrutinizing decisions, inserting themselves into the doctor-patient relationship at the end of life, is good for no one. See this previous post. I thought NPR's "All Things Considered" coverage today was particularly good.

Tuesday, January 17, 2006 by Drew Rosielle MD ·

Thursday, January 5, 2006

DEA and dying patients

The current New England Journal of Medicine has a perspectives piece by Timothy Quill and Diane Meier about the upcoming Supreme Court decision regarding the Oregon physician assisted suicide law (and whether the DEA or the state medical boards have the power to restrict physicians' use of controlled substances). Their take is that a decision in favor of the DEA will have a chilling affect on physicians' prescribing of controlled substances to dying patients, for fear of scrutiny for being involved in 'assisted suicide.' It is a chilling article and all I can say is that if the Supreme Court rules "against" the Oregon law, I hope Drs. Quill andMeier are wrong. A quote:

This type of DEA involvement in medical practice would adversely affect far more patients than those few who seek assistance with a hastened death in Oregon. If the government thus oversteps its legitimate role and expertise, allowing DEA agents, trained only to combat criminal substance abuse and diversion, to dictate to physicians what constitutes acceptable medical practice for seriously ill and dying persons, it will undermine palliative care and pain management for the much larger number of seriously ill patients in all states.

Free full-text is available.

Thursday, January 5, 2006 by Drew Rosielle MD ·

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