Why REMS for Extended-Release/Long-Acting Opioids May NOT Matter
JANUARY 14, 2013
B. Eliot Cole, MD, MPA
The regulators of Canada have decided to allow generic OxyContin to be sold in Canada. Canadians now may obtain Extended-Release/Long-Acting (ER/LA) oxycodone in several formulations: one that is easily tampered with; one that has been created to resist common forms of manipulation; and one containing naloxone to make intravenous use ineffective and opioid withdrawal-provoking. This decision in Canada will pit “hardened” OxyNEO (the name for reformulated OxyContin in Canada) and Targin (oxycodone with naloxone) against the old formulation that was easily defeated by chewing, crushing, snorting, and injecting intravenously. The return of the original formulation of OxyContin in Canada raises the distinct possibility that ER/LA-opioid REMS education in the US will be unable to stop cross-border movement of the old formulation, further worsening oxycodone-related abuse, misuse, diversion, overdose, and death.
The FDA will similarly consider allowing generic old formulation OxyContin in the US in 2013. Should they decide to allow the sale of the generic old formulation, it will join generic Opana ER (having just been “hardened” in the summer of 2012) and lead to more opioid-linked problems in the US. It will be the proverbial “one step forward and two steps back” situation.
Having both old and new formulations of similar medications in the marketplace will create unique prescribing challenges. For the first time, prescribers will have to carefully and deliberately consider which formulation to prescribe. For those patients with no clear personal or family history of substance abuse or mental illness, and those judged by opioid risk tools to be at low risk of abuse, it will be possible to offer potential cost advantages with generic medications. For patients with known mental illness and/or substance abuse histories, or determined to be at high risk of abuse by opioid risk tools, it will be safer to prescribe “hardened” and “tamper- or abuse-resistant” medications. If there is any doubt about a patient’s risk for opioid abuse, it would likely be preferable to err on the side of caution and only prescribing “hardened” and “tamper- or abuse-resistant” medications.
However, it is equally likely that insurers will demand Prior Authorization Requests (PARs) for more costly “safer” medications, and that they will steer their customers to less expensive generic medications whenever feasible. This pressure to deliver treatment less expensively will create additional burdens for prescribers, who will be left holding the bag if they give in to insurers’ requests/demands.
Related Coverage >>>