The facts and figures about the opioid crisis in the U.S. are well-known. They’ve been widely disseminated through a variety of media, government, and third-party sources over the past two years. Without repeating a string of statistics, we’ll briefly sum up the situation and how we got here:
- In the late 90s, pharmaceutical companies introduced new, extended release variations of opioid medications. They encouraged physicians to prescribe these new medications with claims the new formulations were less addictive than previous opioid medications.
- The number of opioid prescriptions skyrocketed between 1999 – 2014. During that period, instances of prescription opioid misuse, addiction, and overdose deaths related to prescription opioids increased at alarming rates. For the stats on these trends, read the CDC summary here.
- Between 2007 and 2016, instances of heroin use and heroin overdose deaths also increased.
- Between 2009 and 2016, there was an increase in instances of fentanyl overdose
- In 2016, the Centers for Disease Control (CDC) released the report CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016.
- In 2017, seventeen state legislatures passed and implemented laws governing the prescription of opioid medication based on the guidelines suggested in the CDC report.
- Insurance providers, physicians, and pharmacists also began using the CDC guidelines as a standard of care for prescribing opioid medication.
But there’s a catch.
The CDC didn’t write their report to create a standard of care or set of best practices for physicians or other medical professionals prescribing opioid medications. Unfortunately, though, that’s how many lawmakers, insurers, and physicians viewed them. Though guided by the best intention – helping victims of the opioid crisis – this misinterpretation led to unintended negative consequences for several groups of individuals, most notably those who’d previously been on long-term opioid treatment to manage chronic pain.
What the CDC Report Says
The CDC makes the goal of their report clear in the opening summary:
“The guideline is intended to ensure that clinicians and patients consider safer and more effective treatment, improve patient outcomes such as reduced pain and improved function, and reduce the number of persons who develop opioid use disorder, overdose, or experience other adverse events related to these drugs.”
These are noble goals, clearly in the public interest. No one who knows anything about the opioid crisis would ever criticize them. However, qualifying statements like these also fill the introductory paragraphs:
“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.”
The report continues:
“Some of the recommendations might be relevant for acute care settings or other specialists, such as emergency physicians or dentists, but use in these settings or by other specialists is not the focus of this guideline.”
Despite these disclaimers, state legislatures, prescribing physicians, and pharmacists implemented the CDC recommendations virtually word for word. They adopted the voluntary guidelines as prescriptive standards. Even though the CDC makes clear – reread the wording above – that establishing a standard of care for prescribing opioids was never their intention.
Changes in Practice: The Consequences
In addition to creating prescribing guidelines, states implemented prescription drug monitoring programs that included provisions to identify both over-prescribing physicians and over-using patients. Taken together, the changes in policy and practice led to an overall reduction in opioid prescriptions by physicians. These reductions, though, while an important step in the right direction, led to the following unintended outcomes, as documented by this article published in the American Journal of Public Health:
- Many physicians reduced or discontinued opioid prescriptions for patients with documented chronic pain.
- In some cases, the changes were instituted “literally overnight.”
- Pharmacies and insurance providers began refusing refills and reimbursements for opioid prescriptions that fell outside the new CDC recommendations
- Chronic pain patients often had no effective alternatives for pain control
- Chronic pain patients found themselves:
- In constant pain
- In withdrawal from opioids
- Unable to access substance use disorder treatment programs
- Many of these chronic pain patients turned to black market opioids. The switch to fentanyl, or illegal street drugs, such heroin, resulted in:
- Higher rates of addiction
- Increase cases of HIV/AIDS and hepatitis from IV drug use
Once it became clear that physicians, insurers, and large pharmacy chains had instituted CDC guidelines as a de facto standard of care and a new set of best practices, concerned physicians realized they needed to weigh in on the new guidelines.
The American Medical Association (AMA) Response
The AMA reacted quickly – for a large organization – and formed an official response to the new CDC guidelines. In November, 2018, the organization adopted Resolution 235, “Inappropriate Use of CDC Guidelines for Prescribing Opioids.” In the resolution, the AMA supported the CDC in its efforts to combat the opioid crisis, but took strong positions against:
- Blanket proscription against filling prescriptions that exceed numerical thresholds without considering diagnosis, previous patient response, and clinical nuance
- Misapplication of CDC guidelines by pharmacists, insurers, pharmacy benefit managers, and public or private legislative/regulatory bodies that prevent or limit medical access to opioids.
AMA Resolution 235 also took strong positions for:
- Recognizing that some patients benefit from taking opioid pain medications at doses greater than the CDC guidelines
- Recognizing that prescriptions at doses greater than the CDC guidelines may be medically necessary and appropriate in some cases
- Advocating that no entity should use CDC guidelines as anything more than guidance
- Advocating that physicians should not be subject to prosecution for prescribing opioids above levels identified by the CDC if the prescriptions fall within standards of medical necessity and quality patient care
It’s important to note that the AMA is committed to solving the opioid crisis. They want to help anyone struggling with an opioid use disorder live a life free from addiction. At the same time, they recognize this crucial statistic: people who are addicted to prescription opioids are forty times more likely to become addicted to heroin. Their resolution acts on two levels. First, it seeks to maintain an appropriate level of care for patients for whom opioid medication is effective. Second, it seeks to advise regulatory bodies to temper their eagerness to enact stricter controls around prescription opioids with caution, deliberation, and reason.
Do No Harm
There is good news inside all of this. Those in a position to have a significant impact on the opioid crisis are listening. Both the medical and legislative establishments, often slow to react to contemporary issues, have taken action. They’veenacted initiatives to expand care and reduce barriers to treatment/insurance reimbursement for treatment. Many states have eased restrictions on Medication-Assisted Treatment (MAT) for opioid use disorders.
We can hope that – just as quickly – additional state legislators, regulatory bodies, pharmacies, and insurers will listen to the AMA. We can hope they’ll revisit the decision to make mandatory a set of guidelines that were originally intended to be voluntary rather than prescriptive. In the rush to take action on the opioid crisis, the near-arbitrary application of the new CDC guidelines has driven some patients from the prescription opioids upon which they depended to black market opioids or heroin, which, in the end, exacerbates the very problem the CDC designed their guidelines to alleviate.
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