Abstract
Ongoing discussions about how best to prevent prescription opioid analgesic (POA) misuse and abuse have generated a number of public policy proposals at both the federal and state levels. One type of proposal focuses on encouraging, and in some cases requiring, increased use of abuse-deterrent formulations (ADFs) of POAs. Political and media deliberations personifying ADFs as the panacea for squelching POA abuse reached a fever pitch following the US Food and Drug Administration's (FDA) approval of a non-ADF extended-release (ER) single-agent hydrocodone product (Zohydro™ ER), with several states attempting to ban the product from the market, either through executive order (since overturned by a federal judge) [1] or through legislation [2,3]. Congress, too, has gotten into the act, with bills in both houses [4,5]. Yet, until this recent media and political blitz, relatively no attention was paid to non-ADF products such as generic oxymorphone ER, Nucynta ER, or any of the other several branded or generic ER morphine formulations. In addition to legislation specifically aimed at one medication, at least five states have introduced legislation designed to increase use of ADFs, either by mandating automatic substitution to an ADF of the same drug at the same dose [6,7], by preventing automatic substitution of a non-ADF if an ADF is prescribed [8], or by allowing the prescriber to request prior authorization if he or she believes an ADF is indicated for a particular patient [9]. Federal legislation has been introduced to incentivize the further development of ADF products [10], and both the US …
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