Since Onsolis, as with all opioids, may be misused or abused, it is subject to the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program, requiring the drugmaker to have a plan for managing risks. The FDA claims there are special risks with transmucosal fentanyl products, although they have not provided data to fully explain this. Nevertheless, this new product will only be available through a restricted-distribution program called FOCUS (Full Ongoing Commitment to User Safety). Complying with the FOCUS Program includes: [also see Onsolis Q&A]
- Each prescriber and patient must complete an enrollment process for the FOCUS Program. Prescribers must become trained and pass a qualifying test of competency. Patients must study provided educational materials. Qualified prescribers and patients are entered into a database at a FOCUS program support center.
- Registered prescribers fax prescriptions for Onsolis to the FOCUS support center to start the verification process and also send via courier an original, hardcopy prescription for Onsolis to a FOCUS-authorized pharmacy. There will be a limited number of participating pharmacies in each part of the country (not community pharmacies).
- Meanwhile, the patient receives a followup counseling call from the FOCUS support center to be certain the patient is properly qualified and all educational materials and instructions were understood.
- The FOCUS pharmacy must confirm that the patient and prescriber are active in the FOCUS program database and the patient-counseling call has been successfully completed. If everything is in order, and the original, hardcopy prescription has been received, the FOCUS pharmacy dispenses Onsolis and ships the medication directly to the patient’s home via a secure courier. The whole process is expected to take no more than 5-days. (Inpatient facilities — hospitals, nursing homes, hospices — cannot participate.)
During a hastily-called conference call, not announced to the general public, FDA representatives conceded that the FOCUS program was not field tested in advance. So, it is completely unknown if the program will work and how many prescribers, patients, or pharmacies might be willing to overcome the obstacles of time and inconvenience to qualify — or whether it will actually minimize drug misuse and abuse. The sponsor of Onsolis has been charged with the burden of gathering necessary data to assess and justify the program’s effectiveness.
An added barrier may be cost. The FDA does not seem to concern itself with costs; however, there surely will be much added expense to the drug’s sponsor and the entire healthcare system for the FOCUS program, which no doubt will be passed along to consumers. Will insurance plans pay the price? Or, will Onsolis be a product for elite patients who can qualify and afford it?
And, according to the FDA, similar REMS programs will be extended to the two other approved transmucosal fentanyl formulations — Actiq® and Fentora®. The agency hopes, but cannot demand, that the individual manufacturers will cooperate in a unified approach to avoid 3 separate (and incompatible?) REMS programs.
Is this a harbinger of what lies ahead for a REMS under consideration by the FDA that will cover extended-release opioids? The FDA claims that, since Onsolis is much different than extended-release opioids, they do not foresee the FOCUS program setting a precedent for other types of opioids. They also have stated in the past that their objective with REMS is to reduce opioid medication misuse, abuse, overdose, and addiction while maintaining access to opioid analgesics for all patients with pain who need them. However, the FOCUS program may be indicative of the lengths to which the FDA is willing to go, a mindset of sorts, to achieve their REMS mission. And, to some, this may be viewed as tantamount to limiting access, as well as adding much pain to pain relief in America.
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5 comments:
This scares me as a patient more than anything in the world. I take both transdermal fentanyl and methadone and both are on the "hit list" for the REMS proposal. If this is what is the plan is going to be, it scares me if I need to switch medications (for whatever reason).
And on top of this, in this case, they are asking the manufacturers of the different makers of the drug to work together? What are the real chances of this happening? And most of all, does anyone think their Medicare Part D plan will pay for the outrageous cost this drug will have (with the extra administration and limited-site pharmacy availability).
This looks like it might just become a total nightmare for everyone: patients, caregivers, pharmacies, and healthcare providers alike.
This REM and others proposed by the FDA should scare the pants off anyone who is currently taking and may need prescription medications for pain control.The collusion between the FDA and the DEA has already driven thousands of pain management doctors from the field;what effect will these new restrictions have on the accessibility/availability of pain relieving medications to those who need them in order to function? What seems to totally missing in all the government's rush to protect the public is the basic truth that those who abuse drugs of any kind will find a way to continue to do so-regardless of all the REMs,etc. that are enacted.Where is the purported "patient rights" in all this? I agree with the previous poster-this will be a nightmare of bureaucracy for all-patients, providers, pharmacies-in the final analysis, the pain patient is the one who loses. The various agencies have made obtaining pain relief difficult enough as it is-we are made to feel almost like criminals when we present a prescription for opioids now. WE are not the problem-the ABUSERS are the problem.Perhaps the FDA and the DEA need to re-define their mission-and do THEIR jobs more efficiently without penalizing those of us who have done nothing illegal or untoward -we merely try to mitigate the pain we experience on a daily basis in order to continue to remain functioning members of society.I,and everyone,should be outraged at the extent our government attempts to control all aspects of our lives. This and all proposed similar legislation will accomplish nothing other than to make it even more difficult for those who are suffering to find any kind of relief.I am terrified.
I resent efforts that make my lifesaving drug (Fentanyl) and my breakthrough medication (Percocet) more difficult to obtain.
Less than 5% of all patients using narcotic medication for chronic pain become addcited. Tolerance and dependence are minor issues for those of us who live with intracible pain day after day, week after week and year after year.
Without Fentanyl, I would decide not to live. Yes, that is the extent of my chronic pain and the power of Fentanyl. With it, I am a productive citizen, able to manage my pain and enjoy a rewarding life.
It seems inappropriate to punish the vast majority of chronic pain patients because of the behavior of those few individuals who abuse or sell narcotics.
We don't expect you to comprehend what it feels like to be in constant severe pain. All that we ask is a little compassion.
These are nothing but pencil pushing bean counting bureaucrats who think they can control the misuse of drugs. They are stupid per their usual quest, to control everything. This will curtail abuse or misuse of a drug which is chiefly done by drug abusers .
Any misuse by patients is usually done so not out of intent but desperation in an attempt to get relief from pain which they have probably had for years and have already jumped through hoops to get what pain relief they have now. If the government namely the Da-- DEA would stay out of the medical business and the FDA would do their real job they could stop more deaths from that than any of this REMS crap or what ever stupid name they want to give it. People killed by guns buying drugs is who they lazy but unable DEA should be after but can't stop or are paid off. The FDA and all the poor food they let enter this country they could be stopping innocent children and adults from dying. It seems to me none of our government wants to do their own darn job anymore but wants to be someone one they are not.
It is a sad day for the PEOPLE WHO SUFFER CHRONIC PAIN, just more added hoops.
I am also concerned about the "wasting" of unused portions into the toilet which ultimately ends up in the water supply.
As most things go, the FDA intention is honorable but the outcome is cumbersome, expensive and unsustainable long-term. The abusers and pushers seem to always be two steps ahead of the good guys.
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