Wednesday, September 11, 2013

FDA Mandates Opioid Label Changes

The FDA yesterday announced that it will require fairly significant changes to the labeling of all extended release and long acting opioid analgesics.  First, the good news:

A drug's "label" is the tool the FDA uses to inform the physician community of the approved uses, risks, and safety concerns of all drugs it approves for use.  Going forward, the labels for all extended release and long acting (ER/LA) opioid analgesics will include the following changes:

1) "ER/LA opioid analgesics are indicated for the management of pain severe enough to require daily, around the clock, long-term opioid treatment and for which alternative treatment options are inadequate." 

This effectively removes the current indication for ER/LA opioid analgesics for moderate pain and focuses the indication for ER/LA opioids on severe pain only.  This may not seem like a big deal (and as you'll read later, it may lead to little change in prescribing behavior), but the FDA has taken a clear stand here - ER/LA opioids are dangerous and should not be used for anything but severe pain

2) "The updated indication further clarifies that, because of the risks of addiction, abuse, and misuse, even at recommended doses, and because of the greater risks of overdose and death, these drugs should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain; ER/LA opioid analgesics are not indicated for as-needed pain relief."

This statement is essentially reflective of the FDA catching up with what we've practically known for some time - these drugs are dangerous at any dose and should only be used to treat patients for whom all other potential treatments have been tried and failed.  Now, however, conversations with prescribing physicians who have not tried alternative treatments can be based, at least in part, on a conversation around why they're prescribing ER/LA opioids "off-label".  While they have every right to do so, this creates an opportunity to educate the physician community about the new FDA label language. 

Finally, the new labeling will also include warnings about the potential for Neonatal Opioid Withdrawal Syndrome (NOWS), one of the saddest consequences of the opioid epidemic.  And FDA is also going to require more post-market safety studies focused on addiction and abuse issues. 

All great news, right?  It's a good sign, but its unlikely to impact prescribing behavior in the short term.

The FDA does not regulate the practice of medicine.  While the new label language will slow down pharmaceutical marketing efforts (albeit temporarily), prescribing physicians are still free to use medications as they see fit, even beyond what the FDA label indicates.

So there's still a great deal of work to do.  But the FDA has used its authority, however limited, to help us fight the battle against prescription drug misuse and abuse.

On Twitter @PRIUM1

Monday, September 9, 2013

Surveys and Guides: Mapping Out Opioids in Work Comp

I just finished reviewing two of the most recent industry pieces on opioids in workers' compensation: first, CompPharma's Tenth Annual Survey on Prescription Drug Management in Workers' Compensation and second, the IAIABC's Policy Guide for Reducing Inappropriate Opioid Use in Treatment of Injured Workers (you have to register to get a copy).

The most significant insight from Joe Paduda's CompPharma survey is that despite the appearance of the industry having drug spend under control, respondents to the survey still see opioids as a "very significant problem, giving it an average of 4.8 [on a scale of 1 to 5].  This remains the highest score for any question in the history of the survey." 

My take: While the most of the PBM drug trend reports and industry trade journals seem to celebrate when opioid spend is flat or slightly declining year over year, the payer community is smart enough to realize that a 2-3% drop in opioid spend isn't nearly sufficient to stem the long term clinical and economic impact of inappropriate utilization.  Letters to physicians, generic conversion programs, and peer reviews aren't enough.  I don't think we'll see that 4.8 score come down until we're seeing opioid utilization dropping by double digits in year over year results.

As the report concludes, "If the industry and individual companies within the insurance and reinsurance industry do not meet this challenge head-on, acknowledge it and develop effective programs to prevent, identify and treat abuse, misuse, addiction and dependency, we will almost
certainly see the bankruptcy of several workers’ comp insurers over the next decade.  It remains to be seen if insurers grasp the seriousness of this issue before it is too late."

Regarding the IAIABC Policy Guide, I have been tough on this organization over the last year due to the fact that the Executive Committee shelved the model legislative and regulatory language it had worked on for a year.  That said, this new policy guide will serve as an a solid conversation starter in state capitals through the country.  Policy recommendations include inter-agency coordination, adoption of treatment guidelines, exploration of pre-authorization and formulary requirements, the necessity of drug tapering, the need for continuing education for physicians, the need for every state to have a functioning prescription drug monitoring program, and a discussion of what a "fast track" dispute resolution process should look like when questions of medical necessity cannot be collegially determined.  The guide also includes many helpful references to specific and successful state programs. 

The IAIABC Policy Guide isn't perfect.  Perhaps out of sheer necessity and obvious resource constraints, the guide glosses over the gritty detail in its examples of certain legislative language and regulatory programs - and as we all know, that's where the success or failure of such things if often determined.  That said, the guide is a great overview of the topics that a state workers' compensation program or legislative body needs to consider and it contains enough detail to inform conversations about how best to deal with the crisis of opioid misuse and abuse within the system. 

On Twitter @PRIUM1