The Drug Enforcement Agency has published its final rule on HCPs - hydrocodone containing products - which will be rescheduled (from schedule III to schedule II) beginning on October 6.
The two areas that appear to be of greatest concern in the market regarding this move are:
1) The impact on pharmacies which will now be required to handle, store, and dispense these drugs with greater restrictions going forward, undoubtedly increasing costs for pharmacy operations; and
2) The impact on patient access. Will patients in pain still be able to get these drugs?
On the first issue, we should all acknowledge the reality of retail pharmacy operations. This will cause changes and those changes will lead to increased costs. While I would argue the clinical and public health benefits of the rescheduling of HCPs outweigh those costs, I'm not running a retail pharmacy. My hope is that these costs trend down over time as pharmacy operators adapt to the new routines required.
To the second issue regarding patient access, let's keep in mind that a rescheduling of a drug may not necessarily impact prescribing patterns. Yes, schedule II drugs cannot be written for more than a 30 day supply and each prescription requires an office visit. This will inconvenience some patients in chronic pain. That said, there are "work arounds". At the Georgia Workers' Compensation Education Conference here in Atlanta yesterday, I moderated a panel regarding medication usage for the treatment of chronic pain. A suggestion was made that some doctors may just write two 30 days scripts with a "do not fill before" date on the second script. Voila! 60 day supply.
Most troubling, though, is the sentiment I've heard from several workers' compensation professionals that goes something like "if a patient really wants the drug - and they will still want HCPs - they'll jump through whatever hoops necessary to get it." On the one hand, I get it. It's not as if cynicism in our industry doesn't have obvious and ubiquitous roots. On the other hand, we cannot allow patient directed care to dictate appropriate treatment pathways for injured workers. The rescheduling of HCPs should signal to physicians that the drugs are potentially more dangerous than we originally thought. Doctors, not patients, should therefore be engaged in differential decision making. If patients are going to be involved in that decision at all (and they certainly should be), the discussion should surround the significant risks and limited long term benefits of opioid use - not figuring out what hoops they have to jump through to continue getting it.
Bottom line: The rescheduling of HCPs is more symbolic than anything else. After 15 years of debate and discussion, the DEA, FDA, and clinical community have finally decided that virtually all opioid analgesics should be scheduled the same way (on schedule II, indicating high potential for abuse).
But don't expect to see a huge drop in HCP scripts in work comp. Our expectations of what's possible are far too low for that to happen.
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