By John Fitzgerald, Ph.D., LPC, CAS and author of Addiction Management
I bet that when you see the acronym REMS you think about sleep, yes? Why the Food & Drug Administration (FDA) decided to call risk management plans for medications REMS (Risk Evaluation and Mitigation Strategy) is beyond me, but they did. I will also bet that you likely have never heard of the FDA REMS unless you happen to be a prescriber of medications, and even then, chances are still good you have never heard about it. Yet we all should at least be somewhat aware of what it is, and why it is important.
Where it All Began: Drug Overdose Deaths
Our story begins back in the late 1990s when prescription drug abuse first started registering as a public health problem. If you study the graph below, you can quickly understand our problem today. While cocaine and heroin are still around, deaths from opioid analgesics – pain medications – have skyrocketed in just over a decade. In fact in many states, drug overdose deaths are now greater than motor vehicle deaths.
The graph explains why the FDA needed to do something, and they did, in 2007. A new law gave the agency the ability to require REMS of manufacturers of medications – particularly those with an abuse liability – in hopes that this upgraded risk management plan would curb the overdose deaths. But what exactly is in a REMS? The FDA’s Brief Overview of REMS is a good place to start, with the specific components of REMS detailed on slide 7. The cliff-notes version is that REMS boils down to educating prescribers and patients about the risks of medicines, so care can be taken to assure that the benefits of the medicines outweigh the risks. If you want to see a list of drugs and specific REMS, the FDA keeps an updated list. But our story is far from over…
ACT II: The Class REMS
While the new law gave FDA authority to issues REMS, it also said that REMS should not become a burden to prescribers working in the healthcare system. So while companies were scrambling to understand and create REMS for products mandated by FDA, it was not long before the powers that be, realized that prescribers did not have the time to review individual REMS for as many drugs that needed them. So the solution was to create a Class REMS for products with the greatest risk, which the FDA believed to be extended-release and long-acting pain medications. This led to the historic collaboration of about 20 pharmaceutical companies banding together to develop and implement the FDA’s plan of a Class REMS. While there are many details to this plan, the big idea was to educate the prescribers of the extended-release medications on an outline the FDA created called the Blueprint for Prescriber Education. While much of the information in this document prescribers should already know, the FDA believed many needed a refresher (and that this would ultimately lower the OD rate). If you spend just a few minutes studying this document, you will see there is a lot there!
To get the job done, the pharma companies elicited the help of accredited continuing medical education (CME) companies to develop educational programs based specifically on the FDA Blueprint. A competitive bid process was established and the best proposals won funding (supported by pharma). And off to the educational races we went….
ACT III: A Fly in the Ointment
Historic efforts to educate prescribers on the Blueprint continue at this very moment, and all involved deserve credit for doing their best to intervene on a serious public health problem. But there is a fly in the ointment!
What if we take a closer look at the overdose deaths and ask:
What opioid medications are involved in the deaths?
Where do those who die get the medications from?
It turns out getting answers to these questions is not so hard, there are plenty of data sources that when reviewed, lead to the following summary of factors related to pain medication overdose deaths:
It does not take a rocket scientist to see that reducing overdose deaths by focusing on educating prescribers of extended-release long-acting (ER/LA) pain medicines is a narrow slice of the pie – about 10 percent. It’s true that if we include methadone, there is the potential to influence a bigger slice, but go back and review the FDA Blueprint and see how much emphasis is placed on methadone. As an aside, the methadone deaths are primarily from pain patients, not those using methadone in addiction treatment programs. It should also be clear that when those who die get their pain medicine from illicit or diverted sources, they are not interfacing with an ER/LA opioid prescriber who can educate them about the risks of what they are taking (or abusing).
The Final ACT: An Uncertain Future
Complex problems never have simple answers. While educating prescribers about the risks of ER/LA pain medicines will have some impact on overdose deaths, to truly take a bite out of this pie we need to do a lot more. Fortunately, a lot is being done, but not necessarily in a coordinated way.
- Law enforcement: Most agencies throughout the US will say combating Rx drug abuse is among their top priorities, and significant resources have been directed at reducing pill diversion. While I am no fan of the war on drugs, I also believe law enforcement deserve a lot of credit for playing a critical role in reducing abuse and overdose death.
- Pharmacists: Most pharmacists now employ prescription drug monitoring systems to combat diversion, and rightfully so. These programs work and play an important role in reducing overdose death.
- Pharmaceutical companies: In the not so distant future, most pain medicines will likely be required to employ some type of abuse-deterrent technology designed to reduce abuse and overdose death. Unfortunately, while reducing risks for pharmaceutical companies, such formulations push abusers to other more easily abused products, or to illicit drugs like heroin.
While many other stakeholders have skin in this public health nightmare, a lack of coordination has made it challenging to measure progress and know exactly what intervention ingredients are making an impact. What we do know is that people continue to die every day, and those who are struggling for their life, or doing their best to keep a loved one alive, need help right now.