Bottle full of medicineEnding prescription drug abuse is not easy. It’s a complex problem, and solving it is going to take a complex solution made up of many components. One such component capturing the spotlight recently is the development and marketing of so-called “abuse-deterrent formulations” (ADFs) of extended-release/long-acting (ER/LA) opioid pain relievers. Policymakers are touting these medications as being so important that they are willing to consider legislation requiring that ADFs be used for all ER/LA opioid prescriptions. What many of those policymakers apparently haven’t considered, however, is how much this is going to cost, and who is going to bear that cost.

First, let me just say this about the term “abuse-deterrent”: it’s a misnomer. Currently approved ADFs are designed either to make it hard for people to crush, cut or otherwise alter the pills obtained from the pharmacy (e.g., OxyContin®, Hysingla®) or with a sequestered opioid antagonist that is released if the product is altered, rendering the opioid totally ineffective if it is ingested (e.g., Targiniq®, Embeda®). Other ADF mechanisms are envisioned in the draft guidance issued by the U.S. Food and Drug Administration (FDA) in 2013, but the common theme for all of them is an attempt to discourage people from altering the medication to snort, inject, smoke or otherwise ingest it by an unintended route. Doing this with an ER/LA opioid is dangerous because the medication in it is intended to be released over 12 to 24 hours, but when altered and taken by another route, the entire dose of the drug hits the bloodstream immediately, increasing the risk of overdose exponentially. ADFs deter this kind of abuse; but what they don’t deter is the most common form of abuse: swallowing more of the intact medication than is intended. In a sense, the “ADF” acronym really ought to stand for “alteration-deterrent formulation.”

Altering ER/LA opioids is a behavior most often seen among those who have a long history of abusing drugs. It is a behavior that is very rarely seen in people with pain who are prescribed these medications by their healthcare providers. As one panelist observed at a recent FDA meeting about ADFs, it’s a little odd that we’re designing these medications to protect people who shouldn’t be using them in the first place, rather than designing them to benefit those who SHOULD be using them. Requiring universal use of ADFs, which is the track on which the policy train is currently gathering speed, unquestionably would benefit the public health and reduce fatal overdoses involving prescription opioids. From that standpoint, such policies make a great deal of sense, and should be supported.

Unfortunately, it’s not that easy. Because these are new medications, the companies who make them have development costs to recoup, which is why the government grants them patent protection to exclusively market these new ADFs for several years. Like all such monopolistic situations, the result is a new product with a much higher price tag than the older products being replaced. This leads to another consideration: If the vast majority of people who are prescribed ER/LA opioids don’t alter them, why should they have to pay considerably more for medications designed to protect someone else? And, if some of these medications have older (cheaper) non-ADF versions on the market, why shouldn’t they be able to use these and save some money?

Clearly, if we want to encourage wide-spread adoption of ADF opioid pain relievers (and I think we certainly do), we need to take the necessary steps to make them affordable. That is why many pain management advocates support legislation that requires the use of ADFs in most instances, but only when coupled with a provision that third-party payers (insurance companies, Medicare, Medicaid, etc.) cover them so that patients’ out-of-pocket cost is as low as possible. Massachusetts did just that in a law it passed last year, and we at the Academy are advocating for similar provisions in bills that are now popping up in many state legislatures.

As is the case with every policy addressing prescription drug abuse, ADFs are not THE solution to the problem, but they are A solution – another vital piece in the policy puzzle we have to put together to end this complex public health crisis and save precious lives.

Bob TwillmanBob Twillman, Ph.D., FAPM
Executive Director
American Academy of Pain Management

 

 

Sources:

http://www.aapainmanage.org
http://sppan.aapainmanage.org/abusedeterrent
http://www.fda.gov/Drugs/NewsEvents/ucm408607.htm