Australian Guideline Calls for Safer Opioid Tapering

By Pat Anson, PNN Editor

Public health experts in Australia have released what is being called the first international guideline to help primary care doctors safely reduce or stop prescribing opioids to adults with chronic non-cancer pain.

The Guideline for Deprescribing Opioid Analgesics contains 11 recommendations developed by a panel of general practitioners, pain specialists, addiction specialists, pharmacists, nurses and physiotherapists. The guideline emphasizes slow and individualized tapering for patients when long-term opioid use does not improve their pain and quality of life or when they experience adverse side effects. Tapering is not recommended for anyone nearing the end-of-life.

“Internationally, we were seeing significant harms from opioids, but also significant harms from unsolicited and abrupt opioid cessation. It was clear that recommendations to support safe and person-centred opioid deprescribing were required,” said lead author Aili Langford, PhD, a pharmacist and Research Fellow at Centre for Medicine Use and Safety, Monash University.

Millions of pain patients in the U.S. were tapered or cut off cold turkey after the CDC released its 2016 opioid prescribing guideline. Both the American Medical Association and the FDA warned that rapid tapering was causing “serious harm” to patients, including withdrawal, uncontrolled pain, substance abuse and suicide.

In response to that criticism, the revised 2022 CDC guideline took a more cautious approach to tapering, recommending a dose reduction of just 10% a month, a much slower rate than the 10% a week that the agency previously recommended.

The U.S. Department of Veterans Affairs and Department of Defense (VA/DoD) also modified their approach to tapering, which at one time called for tapers of up to 20% every four weeks.  The updated VA/DoD guideline says there is “insufficient evidence to recommend for or against any specific tapering strategies.”

The Australian guideline doesn’t get caught up in fractions or percentages. It simply calls for “gradual tapering” that is tailored to each patient’s needs and preferences. A key recommendation is to discuss tapering as early as possible with patients, to develop a plan when they are first prescribed opioids.  

“Shared decision-making and ensuring that patients have ways to manage their pain are essential when a deprescribing plan is being discussed,” said Liz Marles, MD, a general practitioner and clinical director at the Australian Commission on Safety and Quality in Health Care.  

“These new guidelines further support appropriate use of opioid analgesics and how to safely prescribe and stop prescribing them. They ask clinicians to consider reducing or stopping opioids when the risk of harm outweighs the benefits for the individual.”

One in five adults in Australia have chronic pain, but few actually wind up taking opioids long-term. The guideline authors estimate that only 5% of opioid “naive” patients become long-term users, well below misleading claims by anti-opioid activists that over 25% of pain patients develop opioid dependence or opioid use disorder.

“I am curious to know how many people who are on chronic opioid therapy feel a need to be tapered,” said Lynn Webster, MD, a pain management expert and Senior Fellow at the Center for U.S. Policy.  “Only 5% of opioid-naïve patients remain on opioids for 3 months or longer. Considering the fact that about 10% of the population has severe enough pain to affect quality of life, this statistic argues against the theory that just being exposed to an opioid leads to chronic opioid use.”

Webster says most of the recommendations in the Australian guideline are practical, but he’s concerned that some of the evidence used to support them is “misunderstood and misleading.”

“They make it abundantly clear that tapering should not be forced and that there are serious consequences to forced tapering. But they also use the common yet flawed statement that there is little evidence that opioids are effective for chronic non-cancer pain. Of course, the lack of evidence is not evidence,” Webster said.

Although opioids have been used for thousands of years for pain relief, the clinical evidence for or against their use remains thin. Most of the evidence used to support the Australian guideline was deemed by the authors to be insufficient, unclear or weak. Only one of the 11 tapering recommendations was supported by evidence of “moderate certainty.”

Forced Opioid Tapering Is Risky and Unethical

By Roger Chriss, PNN Columnist

Prescription opioid use has come way down from its peak in 2012. Fewer people receive an initial opioid prescription, pill counts have been lowered, and more people are being taken off opioids.  The American Medical Association recently reported that there was a 37% decrease in opioid prescribing from 2014 to 2019.

The goal of this was to reduce the harms associated with opioid pain medication amid an ongoing drug overdose crisis. But there is no justification for forced opioid tapers. As PNN reported last year, outcomes for patients taken off opioids are not necessarily good. And despite an ongoing focus on reducing prescription opioid use, there is still no established deprescribing strategy or method.

A new study looked at a dozen randomized controlled trials for deprescribing opioids for chronic non-cancer pain. Researchers found that reducing or discontinuing treatment did not reduce opioid use in the intermediate term. It also didn’t increase the number of patients who stopped taking opioids.

After looking at the evidence, the authors of the systematic review concluded that the were unable to draw “firm conclusions to recommend any one opioid-analgesic-deprescribing strategy in patients with chronic pain."

Ethically Unjustified

But even if we knew how to taper patients on prescription opioids, it would still not be ethical to do so. Forced tapers offer relatively few benefits for the patient and may carry serious harms. Policies promoting opioid tapering have nonetheless proliferated in recent years, including one in Oregon that was tabled after a public outcry.

In a recent paper in The Journal of Law, Medicine & Ethics, physicians Stefan Kertesz, Ajay Manhapra, and Adam Gordon argued against the forced tapering policies being promoted by public agencies.

“Neither the 2016 Guideline issued by the Centers for Disease Control and Prevention nor clinical evidence can justify or promote such policies as safe or effective,” they said.

Specifically, Kertesz and his colleagues said “the provider is trained never to treat a patient as merely a means to an end.” In other words, involuntary tapers with the goal of satisfying prescribing metrics or state-mandated statistics are unethical.

A more detailed analysis of the ethics of deprescribing is taken up by Travis Rieder, PhD, author of the book, “In Pain: A Bioethicist’s Personal Struggle with Opioids.” In a new commentary in the AMA Journal of Ethics, Rieder concludes that nonconsensual tapering is “clinically and ethically wrong” because it exposes so-called legacy patients who are dependent on opioids to uncontrolled pain and withdrawal.

“Forcibly tapering otherwise stable patients off high-dose, chronic opioid therapy reveals that this practice might have an effect that is the opposite of what public health is calling for: it may be a harm expanding intervention, exposing those who have long received opioid medications variously to worsened pain, withdrawal, social instability amidst untreated dependence, or loss of medical care relationships,” Rieder said.

“Taking such risks into account, continuing to prescribe high-dose opioid therapy for a legacy patient does not clearly constitute ethical or legal misprescribing.”

‘Large-Scale Social and Medical Experiment’

There is little doubt that prescription opioids involve serious risks and lead to harm for some patients. In some urgent cases, a forced taper may be justifiable in light of specific risks to an individual. But in general, forced tapers not only introduce new risks and create new harms, but they also damage the doctor-patient relationship and deny the patient’s status as an individual.

Stanford pain psychologist Beth Darnall, PhD, calls forced tapering a “large-scale social and medical experiment” being conducted without sufficient evidence on how to do it the right way.

“You may have a patient that has been on a stable dose of opioids for 10 years, and then you start de-prescribing. We are now exposing them to new risks for opioid overdose, for suicidality, for actual suicide, for withdrawal symptoms, for increased pain,” Darnall told The Guardian.

It's worth noting that both Darnall and Rieder were recently named to a new CDC panel that will advise the agency as it prepares to update its 2016 opioid prescribing guideline.

Physicians already have a wide variety of tools to reduce risk and improve outcomes without resorting to the ethically unjustifiable approach of forced tapers. It’s time to emphasize those tools and underscore the ethical importance of patient outcomes.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.