The US Department of Health and Human Services (HHS) released in October a Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics.¹ In the new document, HHS emphasizes that “Opioids should not be tapered rapidly or discontinued suddenly due to the risks of significant opioid withdrawal.” National media portrayed the new guideline as a “reverse course on strict restrictions^”2 from the federal government—but does this guidance really reflect such a massive shift? How do the new recommendations interact with pre-existing laws?

The new HHS guideline makes clear that, while there are many instances in which opioid tapering is recommended, rapid tapering or sudden discontinuation of opioids can lead to acute withdrawal symptoms, increased pain, serious psychological distress, and suicidal thoughts. Sudden discontinuation may also increase the chance that a patient will seek out illicit opioids in an effort to manage pain and withdrawal symptoms.

Therefore, in the absence of a life-threatening issue, the agency does not recommend abrupt opioid dose reduction or discontinuation.

Many have questioned why the HHS issued a new guideline given its alignment with the CDC and FDA communications on opioid tapering and discontinuation. (Image: iStock)

Where the HHS and CDC Align

The CDC’s Guideline for Prescribing Opioids for Chronic Pain,³ treated as the gold standard of opioid prescribing guidelines since its release in 2016, made a number of recommendations related to opioid tapering. In nearly every way, the CDC’s recommendations are mirrored by the new HHS guidance. Both federal agencies agree that tapering or discontinuation of opioid therapy should:

• be considered when pain and function are not meaningfully improved as compared to pain and function prior to opioid use
• be considered when the benefits of opioid use no longer outweigh the risks, but should not be considered when the benefits of opioids continue to outweigh the risks
• be done safely and slowly enough to minimize opioid withdrawal symptoms and signs (eg, drug craving, anxiety, insomnia, abdominal pain, vomiting, diarrhea, diaphoresis, mydriasis, tremor, tachycardia)
• be done with appropriate expertise and care in the case of pregnancy, as opioid withdrawal is dangerous for the patient and the fetus, including an increased risk of spontaneous abortion and premature labor.

Given the agreement between the two documents, it’s easy to question why the HHS Guide was even developed. The answer? To resolve misconceptions regarding tapering and discontinuation that have existed since the release of the CDC’s original guidance.

Within the CDC opioid prescribing guideline, recommendations related to tapering and discontinuation represented a very small part of the document. In large part, the CDC focused on initiating opioid therapy, establishing treatment goals, opioid selection, dosage, dura­tion, and follow-up. Perhaps most notably, and most at-play when it comes to miscon­ceptions that have result­ed in unwarranted opioid tapers, is the CDC’s rec­ommendation to avoid increasing dosage to ≥ 90 MME/day.

Mis­application of “90 MME/day” recommendation has been so prolific that both the FDA, as well as the CDC, recently addressed the issue. In early 2019, the FDA issued a Drug Safety Communication⁴ stating that it had received reports of serious harm in patients who were physically dependent on opioid pain medicines suddenly having their medicines discontinued or the dose rapidly decreased, going so far as to caution against abrupt discontinuation. Not long after, the CDC re­leased its own media statement⁵ in which it emphasized that 90 MME/day is not a hard limit, and that its dosage recommendation does not suggest discontinuation of opioids already pre­scribed at higher dosages.

Further, the CDC made it clear that its guideline does not support abrupt tapering or sudden discontinuation of opioids. They went so far as to say that, “…policies that mandate hard limits conflict with the Guideline’s emphasis on individualized assessment of the benefits and risks of opioids given the specific circumstances and unique needs of each patient.”

HHS Guide Supports State Policies—With One Possible Exception

In recent years, most states have adopted their own laws, rules, and guidelines related to opioid prescribing, and a number of those policies have sections related to tapering and discontinuation. In Arizona, for example, in regard to Workers’ Compensation, a patient’s treatment plan must include the criteria and procedures for tapering and discontinuing opioid use.⁶ In South Carolina and West Virginia, among other states, guidance states that if opioid therapy is discontinued, a patient who has become physically dependent should be provided with a safely structured tapering and withdrawal regimen.^7,8 In all of these cases, state recommendations and requirements may easily be followed while still working within the federal recommendations from HHS.

While the new guidance from HHS aligns with state policies in nearly all cases, there is one state in which clinicians may feel a certain amount of confusion and unease when trying to reconcile local mandates with federal guidance: Kentucky.

The Kentucky Board of Medical Licensure has a rule which states that, when a drug screen or other available information indicates that a patient is non-compliant, the physician shall: do a controlled taper; stop prescribing or dispensing the controlled substance immediately, or refer the patient to an appropriate specialist.⁹ While this requirement does not completely conflict with federal guidance, in that the “or” statement allows for referral to a specialist rather than tapering or discontinuation, it would be easy for a clinician to assume that they must taper or immediately discontinue—particularly if they intend to keep treating the patient themselves.

It is worth noting that Oregon-based clinicians may also feel a disconnect between state and federal policies, as Oregon’s Medicare program previously had a strict tapering mandate for certain patients, but this mandate has recently been relaxed to allow for individualized tapering plans.¹⁰

What about Individualizing Care?

For clinicians that have been operating under both real and perceived pressure to reduce and/or discontinue their patients’ opioid prescriptions, it may feel as if the new HHS guidance is a huge shift in federal policy. Upon closer inspection, however, the new guidance supports nearly all pre-existing federal and state guidance in regard to opioid tapering. What the guidance does differently is to rephrase and clarify opioid tapering recommendations in order to help clinicians avoid the many misperceptions and misapplications that have been associated with the opioid prescribing policies released in recent years at the federal, state, and even local levels.

Who Has the Final Say?

If your state currently has, or later implements, a policy related to opioid tapering that conflicts with a federal policy, which policy is controlling?

• If a federal law or rule directly conflicts with a state policy (whether a law, rule, or guideline), the federal law will be controlling. This scenario should not apply at this time, as federal policy related to opioid tapering is currently guidance, not law.
• If federal guidance or recommendations conflict with a state law or rule, the state requirements will be controlling since they have the force and effect of law, while the federal guidance does not. This scenario would occur, for example, if your state implemented a rule that mandated immediate discontinuation based on certain factors—something that federal policy currently recommends against.
• If federal guidance or recommendations conflict with state guidance or recommendations, clinicians must carefully use their best judgment to weigh both sets of recommendations against the risks and benefits of opioid therapy to their particular patient’s situation. In cases where a clinician feels their judgment may be questioned because they’ve opted to take the advice of one set of recommendations over another, it is strongly recommended that the clinician clearly document their thought process and ultimate decision in the patient’s medical record.

So, what is the bottom line for your practice and patients? As with all medical decisions, opioid tapering and discontinuation should be based on the individual patient’s circumstances. There is no one-size-fits-all approach and in every case the clinician needs to weigh the risks and benefits of the current therapy, develop an individualized care plan with their patient, and re-evaluate and adjust that plan regularly.

Practical Takeaways with Jennifer P. Schneider, MD, PhD,

Based on direct quotes from the CDC and HHS opioid guidelines discussed in this column, here are some practical takeaways for clinicians to consider:

• The guidelines are intended for treatment of chronic non-cancer pain; not acute, cancer, or end-of-life pain.
• “Decisions to continue or reduce opioids for pain should be based on individual patient needs.”
• The guidelines do not ban prescribing >90 MME/day but rather to “carefully justify this decision.”
• “If the current opioid regimen does not put the patient at imminent risk, tapering does not need to occur immediately”…If a taper is indicated, ensure a “multimodal approach including mental health support if needed is in place prior to initiating taper.”
• “At times tapers might have to be paused and restarted again when the patient is ready.”
• “Slower tapers (eg, 10% per month or slower) are often better tolerated than more rapid tapers, especially after opioid use for >1 year.”
• “Closely monitor patients who are unable or unwilling to taper and who continue on high-dose or otherwise high-risk opioid regimens.”

Thus, these guidelines clearly recognize that some patients with chronic pain benefit from opioid treatment, including those who may benefit, or are benefitting, from >90 MME/ day. They do not advocate: never initiating opioids above a specific dose; reducing every patient on opioids to a dose below that dose; tapering all patients off opioids; or avoiding starting any chronic pain patient on opioids. Instead, clinicians are encouraged to carry out careful initial and ongoing assessments that address function, behavioral health, red flags (eg, addiction risk, misuse, noncompliance), and other modalities.

Once again the DEA seems to be MIA… so what if they decide that they are perfectly happy with the original CDC guidelines and ignore these clarification(s) and revisions and continue to raid/shut down practitioners’ offices based on their previous interpretations of the CDC guidelines. Because what is the DEA going to do… go after the various CARTELS that it is claimed generated > 100 billion/yr and are heavily armed and tend not to take kindly to anyone who tries to interfere with their business plan.

we have had 115 LEO deaths in 2019 https://www.odmp.org/search/year        including 5 who work at the FEDERAL LEVEL ..https://www.odmp.org/search?state=U.S.%20Government&from=2019&to=2019&filter=nok9  none labeled as working for the DEA. Does this suggest that anyone working for the DEA has the lowest risk of anyone in law enforcement to be killed while on duty ?