Sunday, September 27, 2009

Onsolis and FDA Opioid REMS: Is this the future of opioid prescribing?

:Original raster version: :en::Image:Food and ...Image via Wikipedia
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.
Reblog this post [with Zemanta]