Draft Federal Report SLAMS CDC Opioid Policies

Buried deep in a new federal inter-agency task force report, which recommends a new national pain management policy, is a stinging rebuke of the 2016 Centers for Disease Control (CDC) opioid prescription guidelines.

The report also calls for major improvements in the 50 widely varied state prescription drug management programs (PDMPs).

Titled “Draft Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations,” the report, released by the Department of Health and Human Services (HHS), expressed concern that the wide acceptance of the CDC guideline as a de facto rule may have led to a spike in suicides by patients cut off from opioid painkillers.

(https://www.hhs.gov/ash/advisory-committees/pain/reports/2018-12-draft-report-on-updates-gaps-inconsistencies-recommendations/index.html)

The report was written by a 29-member Pain Management Best Practices Inter-Agency Task Force, set up by the Comprehensive Addiction and Recovery Act (CARA) of 2016. It is to be sent to Congress after a public comment period which runs until April 1.

The section of the lengthy report on the CDC guideline begins with damningly faint praise, saying, “The CDC guideline provides useful general guidance for prescribing opioids.” Then, it adds:

“A commentary by Busse et al.identified several limitations to the CDC guideline related to expert selection, evidence inclusion criteria, method of evidence quality grading, support of recommendations with low-quality evidence, and instances of vague recommendations,” the new draft report says. The cited Busse commentary ripped into the CDC for allowing its guideline to be designed solely by individuals who had already spoken up critically of opioids, and for leaving pain-suffering patients entirely out of the process for developing the guideline.

The report also accuses the CDC of illogically condemning opioid painkillers: “In addition, the CDC used the criterion of a lack of clinical trials with a duration of one year or longer as lack of evidence for the clinical effectiveness of opioids, whereas Tayeb et al.found that that was true for all common medication and behavioral therapy studies.“

The task force also criticized the CDC for saying new opioid prescriptions should be limited to three days or fewer and that more than a seven-day supply is rarely necessary. “A more even-handed approach would balance addressing opioid overuse with the need to protect the patient-provider relationship by preserving access to medically necessary drug regimens and reducing the potential for unintended consequences.”

Chronic Pain and Suicide Worries

The task force also expressed concern that the CDC guideline, which was supposedly aimed only at new prescriptions for opioids, has been routinely used to boot chronic pain sufferers from, or taper down, long-term opioid prescriptions while offering no alternatives.

The task force noted that CDC’s own studies, before the 2016 guideline was issued, showed that “the percentage of people who died by suicide who also had evidence of chronic pain increased from 7.4% in 2003 to 10.2% in 2014.”

That finding “leads to the rising concern that a recent trend of health care professionals opting out of treating pain has contributed to an existing shortage of pain management specialists and is leaving some patients without adequate access to care.”

“An unintended consequence of the guideline is the forced tapering or patient abandonment that many patients with chronic pain on stable long-term doses of opioids have experienced. The Task Force received public comments indicating that many patients have experienced access issues related to provider fears and concerns with how the guideline would be interpreted and have caused some to consider obtaining opioids from illicit sources or suicide.”

The report says physicians and other caregivers cited the CDC guideline, “along with concern about undue burdens of investigation and prosecution by drug enforcement…when deciding to limit or not to provide pain treatment.”

More Study, More Flexibility Called For

“Given that chronic pain has many different underlying conditions, with great patient variability in metabolism, risk for abuse and medical conditions, further studies are needed to assess the value of long-term opioids when other measures have failed to relieve a patient’s pain, coupled with risk assessment and periodic reevaluation,” the draft report says, recommending studies and clinical trials to drill down into pain and pain management problems scientifically.

PDMP Change Recommendations

The report strongly supports PDMPs but says most have a long way to go as modern computer systems.

It cites a 2010 Ohio study saying that when a PDMP was used in an emergency department, 41% of all opioid prescriptions were changed. Of that 41%, 61% of patients ended up receiving no or smaller opioid doses based on PDMP data, and 39% received more because prescribers were able to determine that the patient didn’t have a recent history of controlled substance abuse.

The report notes that PDMPs work well only when the data is real-time, and issued nine recommendations for improving them, including integrating the activity of checking the PDMP into the workflow in the electronic health record (EHR).