Purdue Pharma is apparently working on an tamper-resistant formulation for stand-alone hydrocodone that may bump Zogenix's new extended release hydrocodone formulation, Zohydro, from the market. Purdue's drug has been through final stage trials and the drug company is now pushing for expedited FDA review. Zogenix is also working on an abuse-deterrent formulation, but that drug won't be ready for FDA review until 2016.
So is this good news? One of the most significant concerns about Zohydro is its lack of abuse-deterrent formulation. Is Purdue going to save the day?
Not from my perspective.
I wish to be perfectly clear on this point: I am 100% supportive of abuse-deterrent formulations of prescription opioids. These formulations are effective in combating abuse and diversion (at least in the short-term - it seems drug addicts often find a way to crack the code of each newly formulated medication. But that doesn't mean we should stop trying, nor does it mean we should eliminate the economic incentive for the pharmaceutical companies to develop such technology).
To me, though, this conversation is a distraction. While eliminating abuse and diversion would be great for the work comp system, these aberrant behaviors are not driving the bulk of the problem. The vast majority of cases in which PRIUM intervenes involve legitimate prescriptions being taken as prescribed. Very little pill crushing. Very little intravenous injections. Very little drug dealing.
The problem as we see it is lack of medical necessity. In most cases, it doesn't matter if the patient's opioid is abuse-deterrent or not. If it's medically unnecessary, if it's leading to loss of function, if it's leading to dependence and addiction... it needs to go away. The doctor will be better educated. The patient will get better. The cost of care will go down. Everyone wins.
Abuse deterrent technology is great, but if we focus on technology over medical necessity, we will have missed the mark and the crisis will continue.
Michael
On Twitter @PRIUM1
I couldn't agree more. I have been a work comp case manager for over 20 years and I see the problem with prescription narcotic addiction daily. I think some doctors prescribe because it gets the patient out of the office faster to give them what they want and some prescribe because they may believe the surgery they did made the pain worse and they feel responsible for the pain. If there was a truly objective way to measure pain, I think a lot of the prescriptions would stop. Short of that, the physician really does need to be educated on the effects of the patient and their family when they become addicted.
ReplyDeleteAgreed. Until there is some accountability on the physicians part for writing some of these scripts, it doesn't matter what new and improved drug comes along.
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