Why REMS for Extended-Release/Long-Acting Opioids May NOT Matter


The Canadian government's recent decision to allow the sale of a generic version of the original formulation of OxyContin could have serious consequences for efforts to curb opioid abuse, misuse, and diversion in the US.

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.

Because “hardened” medications will have different pharmacokinetic properties from formulations not able to resist common forms of misuse and abuse, it is not likely that the FDA will allow them to be interchangeable (AB substitutability). However, many prescribers will not initially realize that they have to specify “branded” OxyContin (OxyNEO in Canada) if they want the “hardened” form of extended-release oxycodone, and “generic oxycodone extended-release” when they want to issue prescriptions for the generic version. Pharmacists will also need to be very careful about which formulations will replace branded products, perhaps potentially facing direct liability for their failure to do so.

We live in an age of globalization. What happens in Canada now, or in Asia or Latin America next year, will directly impact behavior in the US and the rate of morbidity and mortality associated with opioid abuse, misuse, overdose, and diversion. Due to the efficiency of international carriers such as FedEx, UPS, and DHL what is prescribed and dispensed in one part of the world will be available before 10:30am the next day in the US. With respect to Canada and Mexico, what is prescribed and dispensed will be in the US within a matter of minutes (as long as it takes someone to cross the border).

How will REMS education, a voluntary program to teach 320,000 US prescribers of opioids to do so more carefully within four years, meaningfully address the flood of tamperable, immediate-release opioids hitting the US streets, schools, and homes? Despite having no incentive to receive ER/LA REMS opioid education, will enough US prescribers do so? I believe it is unlikely that most prescribers will obtain REMS training and will only change their prescribing behavior and approach to managing pain when they are legally mandated to do so.

Unknown at this time is the extent of potential increased liability for those prescribers who undergo ER/LA opioid REMS education and then are judged in the future to not prescribe more safely by a regulatory authority. It could come to pass that ER/LA opioid REMS-educated prescribers writing for generic medications will be liable for the fate of those drugs and society at large if they could have written for hardened formulations with less potential for deliberate manipulation. No one knows today, but ER/LA opioid REMS education will begin before March 1, 2013.

If you are prescribing ER/LA opioids for pain control, you must become aware of specific formulations, costs for these products, and best methods to screen for and recognize potential for opioid risk. Modify your treatment approach to reflect the degree of risk involved for each and every individual patient. Don’t be complacent and assume that all products are equal and interchangeable; don’t assume that “hardened” medications can never be abused (remember, patients are able to take as many doses as they wish at one time once they have their prescriptions filled). Maintain a high index of suspicion for opioid misuse, abuse, diversion, and adverse events linked to excessive use. Work with law enforcement, pharmacists, and educators to know if medications easily prone to manipulation are available in your community.

Prescribers will have to stay current, consider alternatives, and weigh benefits against risks when they make opioid prescribing decisions. Less expensive generic opioids are not going to be as safe. Beyond the immediate needs of patients in pain, prescribers must consider the safety of society with each decision to prescribe.

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