Observations presented to the National Center for Injury Prevention and Control’s Board of Scientific Counselors on behalf of the Opioid Guideline Workgroup – May 2016
This presentation covers many of the problems pain patients and pain doctors have been trying to point out.
Update @11am 4/22/2017: I had thought that our concerns may be reaching the awareness of the CDC, but Richard Lawhern pointed out that this document is from May 2016, just 2 months after the final version of the CDC opioid guideline was released.
It seems to list our concerns merely as issues to be overcome by the “implementation” of the guidelines, which shows they knew all along that the guidelines would be “implemented” as rules for pain patients.
Below, I have extracted the text from the slides of the presentation:
The role of the Workgroup was to provide observations about the:
- Clinical evidence review
- Contextual evidence review
To the Board of Scientific Counselor
Workgroup members met four times by teleconference (January 8, 13, 15, and 18)
Consultants to the Workgroup
Consultant Area / Participation
Pediatrics & Anesthesiology / Ad hoc, not contacted
Occupational Med & Worker’s Comp / Ad hoc, not contacted
Obstetrics & Gynecology / Participated 1/15
GRADE methods & cost effectiveness / Participated 1/8, 1/13, & 1/15
Medical Ethics / Ad hoc, not contacted
Addiction Psychiatry / Participated 1/15
Physical Medicine & Rehabilitation / Participated 1/13
Family member affected by loss of a loved one to opioid overdose / Participated 1/13
The omission of the above-listed consulting areas is a glaring problem since addiction medicine was contacted but pain management (often anesthesiology) and ethics are missing from a guideline that involves these two areas more than any other.
- Support integrated care for people with chronic pain
- Monitoring of Guideline implementation for evidence of impact and unintended consequences and modification when warranted
- Pediatric and adolescent populations should be considered for future updates
- Risks and benefits are areas of active research.
– Contextual evidence review may need to be updated more frequently than the clinical evidence review
– Encourage CDC to work with partners to support additional research
- Strong preference for Guideline Recommendations framed with positive language
- Cost feasibility data are lacking and subject to great variability.
– More research is required
- Concerns about access, cost, and insurance coverage
– GR #1, #6, #7, #8, #9, #10, & #12.
- Systematic changes in payment policies will likely be required to support implementation
- Encourage to support
CDC to work with federal partners congruent payment policies
- Routine patient education throughout therapy – Safe storage and disposal
– Risks and benefits – Treatment goals – Mental health
– Pain and function
- Primary care providers may require additional education on approaches integral to implementation of the Guidelines
– non-pharmacologic and integrated care,
– offering naloxone to patients with chronic pain,
– medication assisted treatment for opioid use disorder.
- Encourage CDC to work with partners to support and/or provide appropriate education.
Observations About Specific
Guideline Recommendation Statements
Guideline Recommendation #1
- All members of the Workgroup agreed with the type and category of evidence for Guideline Recommendation #1.
- Commend the ordering of statements • Clear wording of good messages
– Opioids not routine therapy
– Pain and function are important
- Concerns about access to care, particularly for non-pharmacologic therapies
- Suggest clear preference for integrated care throughout the Guidelines
Guideline Recommendation #2:
- All members of the Workgroup agreed with the type and category of evidence for Guideline Recommendation #2.
- Commend focus on patient-centered goals for improvement of pain and/or function
- Some concern that some providers would interpret the phrasing of “pain and function” to mean that improvements were required in both pain and physical function in order to justify continuation of opioid therapy.
- Mental health concerns
- Encourage evaluation function.
addition of language to include of mood in addition to pain and
Guideline Recommendation #3
- All members of the Workgroup agreed with the type and category of evidence for Guideline Recommendation #3.
- Safety discussions should occur at initiation and continue throughout opioid therapy.
- Information about safe disposal of medication should be included in the tools accompanying the Guidelines.
- Possible risk to household members included in the discussion of risks and benefits with the patient
Guideline Recommendation #4
- All members of the Workgroup agreed with the type and category of evidence for Guideline Recommendation #4.
- Guideline Recommendation #4 is evidence type 4.
- Consistent with best practices and well-deserves Category A designation.
Guideline Recommendation #5
- Significant discussion about content, category, and evidence type
– Six of the nine Workgroup members agreed with the category A and evidence type 3 designation.
– Three felt that the evidence type 3 was appropriate except for the last paragraph of
- Category A and evidence type 3 appropriate if discussion of tapering removed from supporting text
– Two Workgroup members suggested revisions
- Last paragraph of the supporting text does not directly support Guideline Recommendation #5.
- Virtually no studies of long-term benefits or improvement in pain and function with opioid therapy
- Encourage future studies to fill this data gap.
- One member strongly opposes Guideline Recommendation #5 as it is written.
- This member stated repeatedly that the current recommendation clearly suggesting dose limits is
not supported by any data showing a decrease in benefit/risk ratio at these arbitrary numbers.
- This member expresses concern that the current wording of Guideline Recommendation #5 will
undermine support for the entire Guidelines from providers and professional organizations.
- Focus on patient pain and function missing
- Pain or functional improvement should be the impetus for any change in dose
Guideline Recommendation #6
- All members of the Workgroup agreed with the evidence type for Guideline Recommendation #6.
- Considerable discussion about the Category – One member considers this Category B
– Many members support Category A designation only if the statement includes a range for duration
- Many members felt that three days was too limited and preferred a range of values
– Seven days or fewer : 4 members – 3–7 days: 2 members
– 5–7 days: 1 member – 3–5 days: 1 member
– One member was strongly opposed to seven days as “too long”.
- Specific wording suggestion
–“Avoid prescribing more than three days supply, unless circumstances clearly warrant additional opioid therapy.”
- Safe medication storage and disposal
Guideline Recommendation #7
- All members of the Workgroup agreed with the type and category of evidence for Guideline Recommendation #7.
- Should apply to all patients
– Several expressed concern that the wording included only opioid naïve patients.
- Individual members suggested specific edits
- Implies all patients should be at a dose of zero opioids
- Fails to suggest what else providers should do besides eliminating opioids
Guideline Recommendation #8
- All members of the Workgroup agreed with the type and category of evidence for Guideline Recommendation #8.
- Stronger by including depressants or sedatives among the risk factors: 2 members
Guideline Recommendation #9
- All members of the Workgroup agreed with the type and category of evidence for Guideline Recommendation #9.
- Should apply high doses and dangerous combinations, not just multiple provider situations
- PDMP access and utility varies • Data sharing for border areas
- Encourage CDC and federal partners to support PDMP development and operation
- Efficient data access and interfaces
Guideline Recommendation #10
- All members of the Workgroup agreed with the evidence type for Guideline Recommendation #10.
- Majority supported Category A rather than B • Universal recommendation
– More focused on patient safety – Less likely to increase stigma
- Encourage use of simplest appropriate test – Reduce cost
– Improve feasibility
- Educate providers about test interpretation
- Research on risks and benefits of urine drug testing is limited
Guideline Recommendation #11
- All members of the Workgroup agreed with the type and category of evidence for Guideline Recommendation #11.
- Risk mitigation with co-prescription
- Current language
– Presumes appropriate benzodiazepine
– Fails to encourage patient-centered decision making about risks and benefits
- Supporting text
– Importance of pharmacist on care team – Use of PDMP to identify concurrence
- Workgroup members noted that the wording of Guideline Recommendation #11 has changed significantly during the comment and review process.
- Several preferred original wording
- Discussion about AVOID vs USE CAUTION – Several supported AVOID, two strongly
Guideline Recommendation #12
- Disagreement for Category
– One member strongly for Category B – Remaining members Category A
- Suggest evidence type upgrade 3 to 2
- Commend the wording
– Encourage proactive treatment
– Expand buprenorphine prescribing
Review of Supplemental Materials
Clinical Evidence Review, Contextual Evidence Review, and Comments from Stakeholders, Peer-Reviewers, and the Public
- Clinical Evidence Review well-done
- Continued support for future clinical and contextual research on benefits and risks of opioid therapy for chronic pain.
- Future Contextual Evidence Review should seek out specific non-pharmacologic therapies
- Mood should be evaluated with pain and function (GR#2 & GR#5)
- Breadth and variety of positions on the issue of opioid therapy for chronic pain among adults managed in primary care.
- Comments suggest guidelines are needed
- Desire that patient-centered care is enhanced rather than reduced by these Guidelines
- Members felt that the guidelines could be implemented in a manner consistent with patient-centered care