It seems no amount of evidence can make political leaders disabuse themselves of the misguided notion that the nation’s opioid overdose crisis is caused by doctors getting patients hooked on prescription opioids. A group of eight senators unveiled the CARA(Comprehensive Addiction and Recovery Act) 2.0 Act on February 27, targeting the opioid crisis. It would impose a 3-day limit on all opioid prescribing for patients in acute and outpatient postoperative pain.
But the movement to restrict prescriptions is not evidence-based, as prominent experts have pointed out. The politicians base their proposal on the 2016 opioid guidelines put out by the Centers for Disease Control and Prevention. The guidelines stated:
When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.
The guidelines pointed out that the above recommendations were based on “Type 4” evidence:
Type 4 evidence indicates that one has very little confidence in the effect estimate, and the true effect is likely to be substantially different from the estimate of the effect.
It further described Type 4 evidence as being based upon “clinical experience and observations, observational studies with important limitations, or randomized clinical trials with several major limitations.”
In their introductory comments, the guidelines stated:
Clinical decision making should be based on a relationship between the clinician and patient, and an understanding of the patient’s clinical situation, functioning, and life context. The recommendations in the guideline are voluntary, rather than prescriptive standards. They are based on emerging evidence, including observational studies or randomized clinical trials with notable limitations. Clinicians should consider the circumstances and unique needs of each patient when providing care.
When health care providers read and interpret these guidelines, they understand them to be informational, nonbinding, and inconclusive. But that’s not how politicians “do science.”
It doesn’t seem to matter that studies have shown the addiction potential of opioids prescribed for acute pain to be extremely low, including a January 2018 study published in BMJ of more than 568,000 postoperative patients receiving opioids between 2008 and 2016 who were found to have a “misuse” rate (using all “misuse” diagnostic codes) of 0.6%. It doesn’t matter that Cochrane systematic studies in 2010 and 2012 demonstrated a roughly 1% addiction rate in chronic non-cancer pain patients.
The National Survey on Drug Use and Health reports that less than 25% of nonmedical opioid users received a doctor’s prescription, and a November 2017 study found that heroin was the gateway drug in 33.3% of opioid addicts entering rehab in 2015 (as opposed to 8.7% in 2005).
There has been a 41% drop in high-dose opioid prescriptions since 2010, yet overdose rates continue a steady climb, with more than 60% due to heroin and fentanyl. In fact, the CDC notes the fentanyl overdose rate has been increasing at a clip of 88% per year since 2013; the heroin overdose rate has gone up 33% per from 2010–2014, and 19% per year since 2014. Meanwhile the prescription overdose rate has been increasing at a stable rate of 3% per year since 2009. With the advent of abuse-deterrent prescription opioids (ADFs) in 2010, opioids diverted to the black market have become increasingly useless to nonmedical users.
All the evidence points to the overdose crisis being primarily the result of nonmedical users accessing drugs in the black market. The restrictive, supply-side approach of present-day opioid policy has driven these users to more dangerous, but cheaper and readily available, fentanyl and heroin. And the majority of opioid overdoses involve multiple drugs. New York City recently reported that 75% of the overdoses in 2016 were due to heroin and fentanyl, and 97% of overdoses involved multiple drugs—46% of the time it involved cocaine. This is not an opioid crisis—it’s a fentanyl and heroin crisis. And the deaths are due to drug prohibition: the result of nonmedical users accessing drugs in a black market.
If CARA 2.0 passes as written, look for more patients to suffer in agony. As a surgeon who prescribes postoperative opioids to my patients for pain control, I will no longer be able to individualize my prescriptions to my patients. This will probably mean I will have to see many of my patients for their postoperative visit 3 days after surgery, rather than the 10–14 days that is usually the case, so that I can prescribe a refill of their pain prescription. And because I am being surveilled by my state’s Prescription Drug Monitoring Program, the pressure will be on me to limit those refills.
Meanwhile, not one intravenous heroin user will be moved to pull the needle out of their arm as a result of this policy.
To its credit, CARA 2.0 has provisions to liberalize the prescription of buprenorphine which, like methadone, is a form of medication-assisted treatment, a proven type of harm reduction. And it provides increased funding in order to make the overdose antidote naloxone more available. But it doesn’t go far enough: naloxone should be available over-the-counter.
The damage and death resulting from drug abuse will continue unabated as long as drug prohibition continues unabated. Meanwhile, policymakers should drop their focus on doctors treating patients in pain and place their efforts squarely on reducing harm. Medication-assisted treatment, syringe services programs, and naloxone distribution are good places to start. The current restrictive approach will only further drive up the death rate.