Health Law Advocate Comments on Current Approaches to Abuse, Misuse, Diversion of Opioids

In an article released earlier this week by the O'Neill Institute for National and Global Health Law at Georgetown University, Fernanda Alonso, LLM, outlined some of the hazards attendant in the FDA’s current guidance on, and advocacy for, abuse-deterrent formulations as a response to the crisis of opioid abuse and overdose. The core problem, Alonso contends, is that the focus on abuse-deterrent opioids seeks to impact the supply side of opioid use, a move that could prove ineffective as abusers simply take more of the medication, or supplant one opioid with another. Further, some recent cases demonstrate that abuse-deterrent opioids have dangerous unintended consequences. Alonso cites the 2012 reformulation of Endo Pharmaceuticals’ Opana ER® as a crush-resistant pill to discourage ingestion by snorting. Instead, abusers are removing the coating and injecting the drug, a more dangerous route of administration, and the likely source of a 2015 HIV outbreak in Indiana triggered by shared needles.

Many prescribers also have a “false sense of security” about abuse-deterrent formulations, according to the article. A 2014 survey conducted by Johns Hopkins University found that 33% thought abuse occurred by means other than ingestion, and one-half thought that abuse-deterrent formulations were inherently less addictive, both of which are untrue. Caleb Alexander, MD, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness commented “…there’s no evidence to suggest that abuse-deterrent formulations are going to fundamentally change the shape of the opioid epidemic. The two most important things that we can do to address the opioid epidemic are to prescribe fewer opioids, and to get patients with opioid addiction into treatment.”

Read more about abuse deterrents, here.

Read the complete article by Dr. Alonso here.


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