Not Dead Yet Comments on Centers for Disease Control and Prevention
Draft Updated Clinical Practice Guideline for Prescribing Opioids
Docket Number CDC-2022-0024
April 11, 2022
Not Dead Yet, a national disability rights organization, formed in 1996 and focused on public policy issues often described as “end of life” as well as related healthcare topics. In this context, effective treatment of pain is a critical concern. Thank you for the opportunity to respond to the Centers for Disease Control’s (CDC) February 10, 2022 request for comment on the Proposed 2022 CDC Clinical Practice Guideline For Prescribing Opioids. (1)
Many people with disabilities deal with chronic pain and may have bouts of acute pain. Disabled people and others with chronic pain rarely abuse prescribed opioids (2) but they are often faced with having to deal with severe pain without access to opioid medications that would make this pain more tolerable. To put it simply, use of prescribed opioids may enhance the ability of some individuals to better manage their lives, hold jobs and participate in their families and communities.
It is the view of the Academy of Integrative Pain Medicine that “For some patients, access to opioid medications to manage their daily pain is necessary; for others, nonpharmacological methods alone provide sufficient relief; and, for many, it’s a combination of both.” (3) Doctors must be allowed to do a reasonable risk/benefit analysis of the various options and tailor treatment to the individual patient.
We recognize the importance of combating what is called the opioid epidemic but the “one size fits all” approach of the 2116 Guideline doesn’t work. It devalues patients and has caused tremendous suffering. We agree with the National Council on Independent Living (NCIL) that Congressional hearings are needed to inform policymakers, healthcare providers, insurers and the public about the scope and extent of the harms caused by the previous Guideline and potential solutions to address the complex concerns involved.
We also agree with NCIL that the updated Guideline being proposed is a significant improvement over the 2016 Guideline. The new Guideline emphasizes individualized treatment and recognizes the importance of treating pain. It also makes clear that the Guideline is not intended to be applied as a set of inflexible standards across patients or systems. Moreover, it acknowledges the harm that has resulted from the 2016 Guideline and makes specific changes to address it, abandoning strict day and dose limits and cautioning against rapid tapers and abrupt discontinuation of opioid medications. We are glad that the CDC realizes the need to take a nuanced approach regarding the prescription of opioids to control pain.
We also agree with NCIL that there are still areas of concern in the updated Guideline and that changes and clarifications must be made. (4)
Exceptions. The new Guideline continues the exceptions for pain in sickle cell anemia and cancer, and for palliative care. We understand that the CDC’s rationale is that there are different guidelines for these categories. However, unexplained exceptions can create bias. This can be expected to be an even greater risk when many of the individuals falling within these categories are already subject to health care disparities. In other words, exceptions are often misapplied, making it harder for persons to access effective and individualized pain management treatment. Pain severity can vary both depending on the condition and within conditions. All patients in pain deserve to be taken seriously and receive appropriate medical relief. We urge that the Guideline include appropriate clarification on this point.
Use of the term “preferred”. Recommendation #2 begins by stating that “non-opioid therapy is preferred for subacute and chronic pain.” This is an overly broad statement that is at odds with the focus on individualized care. It could also lead to payer denials of prescribed opioids on the basis that it is a “non-preferred” treatment. We urge that the sentence be changed to “non-opioid therapy is often effective for subacute and chronic pain.”
Dosage. We are glad that references to dose amounts measured by morphine milligram equivalents (MME) have been removed from the recommendations which now emphasize a case-by-case risk/benefit approach (see Recommendation #4). However, in the commentary, there are references to 50 MME as a point of caution. This may suggest to some policymakers that any dose of 50 MME is suspect regardless of circumstances. Instead of using specific dosage amounts as “red flags”, the commentary should encourage clinicians to use the lowest effective dose and to do a risk/benefit analysis when considering increasing doses.
Tapering. Although Recommendation #5 adequately warns against sudden or quick tapering, there is language in the commentary that creates bias against reversing tapers. Again, this is at odds with the focus on individualized care. Clinicians should be advised to consider judiciously reversing a taper if the patient is not responding well to it. We also urge that the document include citations for all recent tapering studies. People trying to educate themselves on a subject do consult references.
Poor Quality of Evidence. Advocacy organizations have noted that much of the evidence used in the Guideline is of poor or questionable quality and there are some places where the Guideline states there is evidence to support a proposition and then states that there isn’t. (5) This undermines public trust in the Guideline and, by extension, the CDC. There is, for example, little acknowledgement of the limits of the evidence used, e.g. that most pain studies involve people with mild or moderate pain rather than people with severe pain or pain arising from multiple sources, the omission of studies on long term opioid use that lasts more than a year, and the equating of limited evidence with evidence of limited effectiveness. The drafters should seek to increase the range of the studies they consider. Moreover, on issues where the available evidence is indeed limited, the Guideline should state this clearly.
Opioids vs. Non-Opioids. The Guideline is written in a way that implies people taking medication for pain at any given moment will either be taking opioids or non-opioids. It is not always an either/or scenario. This is another instance where the wording in the Guideline is at odds with the focus on individualized care. Many patients are prescribed a combination of medications for a period of time (6) and the Guideline should clearly recognize this possibility.
Communications and Training. We must stress that in order to undo the harm that the 2116 Guideline has done, the CDC must do more that update the Guideline. The CDC must focus on flexibility and individualized care in its communications and training modules on pain management. It must engage patients and patient advocacy groups in provider training and public education. It must also work with policymakers and other parties including insurers, quality metric providers and law enforcement so that they also move away from policies using strict supply and dosing thresholds. (7)
Reasonable Accommodations. Lastly, we encourage the CDC to make it a priority to do what it can so that reasonable accommodations are made during office visits and pain management discussions so as to ensure that a patient with a disability is fully informed and involved in the process and that communication with all interested parties is enhanced. Otherwise, the Guideline’s goal of true collaboration between the patient and provider in developing a patient’s pain management plan may not be realized.
These accommodations may include providing, among other things, sign language interpreters and accessible digital and print materials for patients and families. Reasonable modifications should also encompass ensuring that a patient has the necessary support services to comply with dosing instructions and the taking of medication at the frequency prescribed. For example, some patients may need in-home aide services or support in grouping pills together. It should be emphasized yet again that all patients are individuals. Needs may differ as will the ways in which these needs should be met.
Please contact us with any questions you may have. Thank you for your time and attention.
Sincerely,
Diane Coleman, JD, President/CEO
Lisa Blumberg, JD, Consultant
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