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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.

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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.

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The FDA has approved Roxane Laboratories to make concentrated (20mg/ml) morphine liquid for the administration in opioid tolerant patients with moderate to severe acute and chronic pain. 

Others have covered this story including GeriPal, NHPCO (Member-protected link - Why?), and CAPC.  Obviously the hospice and palliative care online communities are welcoming this news given liquid concentrated morphine is an essential tool in good symptom control, especially for patients in the last few weeks of life when swallowing becomes more difficult.

Interestingly, the FDA Press Release says at the end:
"For this formulation of morphine, the manufacturer had to develop a safety program prior to approval to address the known risks of morphine misuse, abuse and overdose."

But there is no link on the FDA site or Roxane to give more information about the safety program.  Given the past concerns about REMS, it would be interesting to see the details of these plans and how they might impact daily hospice care.

And for how the FDA actually reversed course from nearly taking concentrated liquid morphine off the market, you Pallimed readers along with other social media platforms were part of the grass roots support that helped give support to the larger organizations. 

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Thank goodness I get The Pain Medicine News.  I used to think of it as a throwaway industry newspaper but lately it has been a great source of information about the FDA's plans toward the future of opioid prescribing and the Risk Evaluation and Mitigation Strategy (REMS) plans that are coming down the pipeline.  This week's issue discusses the Pain Medicine communities trepidation towards the REMS for Onsolis. (article behind membership wall)

Some background first: If you have not heard about Onsolis yet, it is a film containing fentanyl applied to the buccal (inside cheek) surface to dissolve for immediate pain relief.  If you are thinking "Haven't I heard of something like that before?" you may be recalling it with:

Fentora - Fentanyl buccal tablet made by Cephalon
Actiq - Oral transmucosal fentanyl citrate (on a stick but don't call it a lollipop!) made by Cephalon

Onsolis is made by BDSI and in the Summer of 2009 received FDA approval.  And it got a parting gift from the FDA, the first opioid to be subject to REMS.  I won't spend this post talking about the relative merits or risks of prescribing Onsolis but instead will focus on the REMS as it has a huge potential to affect good pain relief.

So here is the REMS process for Onsolis called FOCUS:

• Each patient, prescriber, distributor, and pharmacy enrolls in FOCUS
• Prescriber faxes the initial prescription information to FOCUS
• Prescriber sends the original, hardcopy prescription to a FOCUS pharmacy via courier using the supplied shipping label
• Patient receives a counseling call
  
• While the hardcopy prescription is in transit the FOCUS pharmacy confirms that the patient and prescriber are active in the FOCUS Program database, the patient counseling call has been successfully completed and schedules Onsolis delivery to the patient.
• Upon receipt of the original, hardcopy prescription, the FOCUS pharmacy dispenses Onsolis and delivers the medication directly to the patient via a secure, traceable courier (with adult signature required) (Apparently within 24 hours, and at most 5 business days)
  

So we can now add bureaucracy to the possible barriers to prescribing opioids.  I am not sure how these steps reduce any risk with opioids with overdose and diversion being the two big ones I would assume the FDA is trying to reduce.  I think the goal is laudable and one I think the hospice and palliative care community has not given the full attention I think it deserves, but the method to me just seems to add red tape without effect.  Has the FDA tested this in opioids in a RCT to see if it reduces any risks?  It would be nice to see an evidence based approach to this important problem.  Thank goodness the law that gave the FDA this power also stipulates review of the REMS program for each drug at 18 months, 3 years and 7 years.

But if the FDA trials it with one drug, I doubt anyone is going to prescribe it when there are viable non-REMS options for immediate relief pain control.  The Pain Medicine News article quotes BDSI staff diminishing the REMS effect on sales, but I think the REMS provide a really tough barrier to prescribing unless you have really run out of other options.  The American Pain Society president wrote the FDA a letter stating they were "surprised and disappointed" the Onsolis REMS were "in stark contrast to many of the stakeholder suggestions made."  The article also highlighted the special needs of the hospice and palliative medicine community although I do not know if anyone in our community was directly involved in any of these discussions.


The FDA has a pretty detailed FAQ on the Onsolis FOCUS REMS program here.  The FDA does not expect the Onsolis REMS will be the REMS for long acting opioids. Here is a list of opioids they expect to fall under REMS in the future.  The InVivo Blog has some more info on the FDA's strategy towards REMS.  And here is BDSI's slide deck about Onsolis which I may tease apart more in the future.

And the cost of the medication is unknown at this time.  I knew you were thinking that.  Are you planning on enrolling in the FOCUS program?  I will ask to enroll if only to tell you all about it.