Ending 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 Other ADF mechanisms are envisioned in the draft guidance issued by the U.S. Food and Drug Administration (FDA) in 2013, but the common theme for all of them is an attempt to discourage people from altering the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.”