New ACOEM Opioid Guidelines: I Hope You're Sitting Down

Reed Group has published revised ACOEM Opioid Guidelines.  I hope you’re sitting down. 

These new guidelines are comprehensive, impressive, and should change the way you think about opioid use.  The question is no longer whether or not the medical evidence supports the view that long term opioid use is rarely appropriate.  The question now is: will your claims organization have the courage and wherewithal to use these guidelines to ensure patient safety and improve clinical outcomes?

A few highlights: 

Remember all of the discussion, education, and effort your claims organization went through to understand the concept of morphine equivalent dosage (MED) and the threshold of 120 mg MED daily, above which the risk of negative health consequences (like, for instance, death) rose significantly?  Well, after reviewing 960 references and 157 separate studies with 27 external peer reviewers, ACOEM has given us a new threshold…

50 mg daily MED. 

And they’re right.  The 120 mg MED threshold often comes too late in the treatment process to make meaningful impact and the clinical risks are observable at much lower dosage.   Here’s the proof (in laymen’s terms, the hazard ratio is the comparative or relative risk associated with a certain treatment vs. the control group.  In this case, MED at 50 mg/day suggests a death rate 3-5 times that of the control group). 

Remember how I’m always going on about the fact that there are no studies that support the long term use of opioids for non-malignant chronic pain management?  It’s nice to put some data around that statement:  the longest placebo-controlled trial lasted only…

4 months.

Specifically, of the 67 high-to-moderate quality placebo-controlled clinical trials addressing opioid use for chronic pain, 52% lasted a single month, 12% lasted 1-2 months, and 34% lasted 3 months.  There was a single trial that lasted longer than three months (and it lasted only 4 months). 

You know the pharmaceutical commercials that list all of the adverse side effects one might experience while on the medication?  The new ACOEM guidelines provide a list of those side effects in relation to long term opioid use.  Ready?

Heart attack or sudden death

Fainting on standing up
Sudden death
Nausea, abdominal pain, early satiety
Constipation, bowel obstruction
Abdominal pain
Urinary retention
Impotence or reduced sex drive and erectile dysfunction, osteoporosis, feminization, reduction of muscle mass, reduced strength
Reduced or abnormal menstrual periods
Fatigue, low blood pressure, electrolyte changes
Hastening of death if cancer is present
Rash, shortness of breath, itchy skin, edema
Outbursts, inappropriate behavior, limit testing, violence, reduced impulse control
Alterations in executive function, emotional response
Slight to severe impairments if an overdose occurs
Problems thinking clearly
Headache
Increased pain sensitivity, increasing doses of opioids/dose escalation
Reduced pleasure in eating, weight loss
Seizures
Increased accident risks and unclear thoughts
Crash risk and reduced functioning
Unsafe operation of machinery, motor vehicles, motor vehicle crashes
Unsafe operation of machinery, falls
Mistaken judgment, changed interactions with other people
Altered mood, depressed feelings,
Suicidal feelings
Birth defects, miscarriage
Newborn babies of mothers on opioids go through opioid withdrawal
Reduced ability to breath during sleep; daytime sleepiness
New or increased problems with obstructive sleep apnea; daytime sleepiness
Pneumonia
Worsening asthma and chronic obstructive pulmonary disease (COPD)

I think I better understand why opioid manufacturers don’t advertise on television. 

Michael
On Twitter @PRIUM1

Abuse-Deterrent Zohydro is NOT the Answer

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