HCPLive Network

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

 
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.
 


Further Reading
Citing a “public health epidemic” of death and addiction related to use of prescription opioids, the American Academy of Neurology (AAN) calls for a multi-pronged approach to curbing prescriptions. But the group stresses that finding ways to help patients in chronic pain is worthwhile and difficult.
A patient at Texas Health Presbyterian Hospital has tested positive for the deadly virus.
Kevin Skole, MD is a board-certified gastroenterologist practicing in central New Jersey, part of the gastroenterology division of Princeton Healthcare Affiliated Physicians, a multi-specialty medical practice based out of the University Medical Center of Princeton at Plainsboro (see www.princetonhcs.org). He discusses the increased incidence, risk factors, and prevention of Clostridium Difficile (C. diff) infection.
There is a wide variety of evidence to support benefits of low-fat diets versus low carbohydrate diets and vice versa. As of today, no one can tell us with certainty whether the well-worn dictum "calories in calories out" is really true. The National Weight Control Registry data give us some confidence in recommending that to lose weight most people need to alter their diet to reduce calories, and need to exercise on a near-daily basis.
Cannabis users who acknowledge their problem and report withdrawal symptoms are likely to increase abstinence over a 12-month period, according to research published in the Journal of Addiction Medicine.
Device therapy eligibility requirements are underestimated using 2D echocardiography compared to cardiac magnetic resonance imaging, according to a study from the Netherlands Heart Journal.
Omega-3 supplementation can help reduce behavioral issues in adolescents who may be particularly prone to oxytocin receptor gene methylation.
More Reading