First International Opioid Deprescribing Guidelines Published

The University of Sydney in Australia recently worked with international experts and consumers to develop the first ever guidelines for opioid deprescribing which aim to minimize harm from inappropriate and abrupt discontinuation while maximizing benefits of reducing opioids for appropriate patients. The guidelines emphasize individualized treatment planning and shared decision-making.

Physicians are generally trained on how to prescribe drugs, but rarely receive any guidance on how to take patients off medication that is no longer needed, having unacceptable side effects, posing unacceptable risks or not working. This is especially important when the drugs, like opioids, cause withdrawal effects when discontinued. Significant harm has been caused by forced rapid tapering, abrupt cessation or inappropriate denial of prescription opioids. Significant harm has also been caused when effective replacement pain treatment has not been provided. These guidelines seek to correct these deficiencies.

The guidelines were originally published in the Medical Journal of Australia (MJA). I've included a copy of the news release describing the guidelines as well as the detailed recommendations below;

Guidelines to help clinicians on safer opioid deprescribing:

Evidence based guidelines to help avoid unintended harms

NEWS RELEASE 25-JUN-2023

Australian and international experts have released 11 recommendations on when, how, and in what situation it may be appropriate for clinicians to reduce opioid use, by placing the patient at the centre of the equation.

The University of Sydney led guidelines recommend that clinicians develop personalised deprescribing plans from the beginning for any patient being prescribed opioids.

The guidelines also advise clinicians against abruptly stopping opioid treatment without gradually reducing the dose or transitioning to different treatments, saying it could increase risk of withdrawal symptoms. This includes people with severe opioid use disorder, as doing so without giving them access to opioid substitution therapies can lead to a higher rise of overdose related harms.

Recommendations also advise clinicians not to deprescribe opioids for people nearing end-of life unless there are side effects.

The recommendations and summary of the guidelines are published in the Medical Journal of Australia. The guidelines were led by 17 experts which includes general practitioners, pain specialists, addiction specialists, pharmacists, registered nurses, consumers, and physiotherapists.

The Evidence-based Guidelines for Deprescribing Opioid Analgesics is the first international guideline focussed on helping general practitioners to safely reduce opioid use for adults with pain, and aims to improve quality of care for patients.

Opioids are commonly prescribed to manage pain, with over 1.9 million adults starting opioid therapies each year in Australia. Approximately five percent of patients who fill an opioid prescription transition to long-term use.

Senior author Associate Professor Danijela Gnjidic from the School of Pharmacy says opioid deprescribing may not be appropriate for every single person with emerging evidence that abruptly deprescribing opioids in patients, without support or pain management plans is associated with overdose related harms and death.

“It is possible to reduce opioid use and harms without worsening pain, whilst maintaining or even improving quality of life. However, pain management should not be one-dimensional,” says Associate Professor Gnjidic.

“Before the release of the guidelines, in Australia, clinical guidelines have focused on pain management and prescribing of opioids. We needed evidenced-based guidelines focused on safely reducing or stopping prescribed opioids, and individualised care for patients.”

Pain management should not be ‘one size fits all’

“Opioids can be effective in pain management. However, over the longer-term, the risk of harms may outweigh the benefits,” says fellow senior author Associate Professor Carl Schneider from the School of Pharmacy.

“Reducing the dose or discontinuing (deprescribing) opioids can be challenging, with additional complexity for Aboriginal and Torres Strait Islander Peoples and culturally and linguistically diverse communities. We received strong feedback on the need for specific resources for those communities on how to seek advice from healthcare professionals and be actively involved in decisions.”

Lead author Dr Aili Langford says the best available evidence that was interpreted and informed by expert opinion, and refined following extensive public consultation with healthcare professionals, organisations, policymakers and people who take opioids for pain.

“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,” says Dr Langford, who worked on the report during her doctorate at the University of Sydney and is now based at Monash University.

Pain management a national and international priority

Pain and pain-related conditions are a leading cause of disability and disease burden globally. In Australia one in five adults report having chronic pain.

Escalating opioid use and subsequent harm has been recognised as an international public health concern. The World Health Organization has set a global goal of reducing severe avoidable medication related harms. In 2020, Australia responded by identifying opioids as one of the four medicines of focus in the country.

The guidelines complement the national Opioid Analgesic Stewardship in Acute Pain Clinical Care Standard, released last year by the Australian Commission on Safety and Quality in Health Care, which aims to stop inappropriate prescribing of opioids to treat acute pain in hospitals.

“It is incredibly important that we prescribe opioids safely and appropriately so that we don’t compromise the future health of Australians,” says Associate Professor Liz Marles, Clinical Director at the Commission and a general practitioner.

“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.

“Shared decision-making and ensuring that patients have ways to manage their pain are essential when a deprescribing plan is being discussed. Ultimately, we are all working to reduce the number of Australians at risk of harm from long-term opioid use, which will have broad societal benefits,” says Marles.

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Here are the full texts of the guideline recommendations:

Recommendation	Recommendation classification (certainty of evidence)22, 24	Key practice points
1. We suggest developing and implementing a deprescribing plan for persons being prescribed opioids at the point of opioid initiation.	Consensus recommendation	An opioid deprescribing plan should form part of an agreed pain management plan which incorporates non-opioid treatment modalities and/or non-pharmacological pain management strategies. Optimisation of appropriate non-opioid pharmacotherapy may improve pain management and may have an opioid-sparing effect. Consider the use of evidence-based non-opioid pharmacotherapy where appropriate. Avoid sole reliance on opioids. Optimisation of appropriate non-pharmacological therapy may improve pain management and may have an opioid-sparing effect. Consider the use of evidence-based non-pharmacological strategies for pain management and referral to allied health care professionals where appropriate. When initiating opioids, assess and discuss the expected duration of therapy. Advise the person that it will be a time-limited course of therapy, generally limited from days to weeks. Provide relevant information to the person regarding the safe use, safe storage, and safe discarding of opioids. Avoid repeat prescribing for acute, or acute-on-chronic, pain conditions. Discuss naloxone when prescribing opioids.
2. We suggest initiating deprescribing for persons taking opioids for chronic non-cancer pain if (any of the following): there is a lack of overall and clinically meaningful improvement from baseline in function, quality of life, or pain; there is a lack of progress towards meeting agreed therapeutic goals; or the person is experiencing serious or intolerable opioid-related adverse effects in the physical, psychological or social domains.	Conditional recommendation for (very low certainty evidence)	The use of an opioid deprescribing conversation guide (eg, Communication techniques for opioid analgesic tapering conversations27) may assist in assessing the willingness and readiness of a person taking opioids to engage in deprescribing. The guide may be used to structure conversations relating to the potential benefits and harms of deprescribing in the context of the person's values, goals and preferences. A deprescribing plan, agreed upon by the person taking opioids and their health care professional, may facilitate person-centred medication dose reduction or cessation. Baseline function can be determined by both the person taking opioids and their health care professional. This may be aided by the use of validated tools (see Recommendation 9).
3. We suggest initiating deprescribing for persons taking opioids for chronic cancer-survivor pain if (any of the following): there is a lack of overall and clinically meaningful improvement from baseline in function, quality of life, or pain; there is a lack of progress towards meeting agreed therapeutic goals; or the person is experiencing serious or intolerable opioid-related adverse effects in the physical, psychological or social domains.	Consensus recommendation	Cancer-survivor populations may be at risk for recurrent disease or second malignancies and, therefore, new or worsening pain should be carefully evaluated. The use of an opioid deprescribing conversation guide (eg, Communication techniques for opioid analgesic tapering conversations27) may assist in assessing the willingness and readiness of a person taking opioids to engage in deprescribing. The guide may be used to structure conversations relating to the potential benefits and harms of deprescribing in the context of the person's values, goals and preferences. A deprescribing plan, agreed upon by the person taking opioids and their health care professional, may facilitate person-centred medication dose reduction or cessation. Baseline function can be determined by both the person taking opioids and their health care professional. This may be aided by the use of validated tools (see Recommendation 9).
4. We suggest considering deprescribing for persons taking opioids for chronic pain with one or more of the following clinical characteristics: comorbidities that may increase risk of opioid-related harms (eg, sleep-disordered breathing or sleep apnoea, chronic obstructive pulmonary disease); concomitant use of medicines or substances with sedating effects (eg, benzodiazepines, alcohol, gabapentinoids, antipsychotics, and sedating antidepressants); high doses of prescribed opioids.	Consensus recommendation	Health care professionals need to consider clinical outcomes when making decisions about the appropriateness of opioid deprescribing in populations at increased risk of opioid-related harms. This includes considering the person's response to opioids in terms of their function, quality of life, pain, and adverse effects (see Recommendation 2). Optimisation of medical management of comorbid conditions and the overall medication regimen is required. This may involve reducing or stopping other substances such as benzodiazepines or alcohol in addition to, or instead of, opioid deprescribing. Liaising with other health care professionals, particularly those trained in mental health conditions, may assist in deducing the reasoning behind the use of concomitant medications and any other concerns worth noting. When deprescribing opioids for a person taking concomitant medicines, ensure that opioid deprescribing does not result in increased use of other substances with detrimental effect. Consider generating a referral for a pharmacist to conduct a Home Medicines Review (HMR). HMRs may improve the person's understanding of their medicines and inform the development of a medication management plan and/or deprescribing plan.
5. We suggest avoiding deprescribing for persons taking opioids for pain or dyspnoea who are nearing the end of life.	Consensus recommendation	Persons taking opioids and their carers should be educated about opioid safety and how to monitor for opioid-related harms. There may be specific circumstances where prescribers identify reasons to deprescribe opioids for people who are nearing the end of life. These may include unwanted confusion, opioid hyperalgesia, unmanageable constipation, dry mouth, sweating and itching, and/or organ deterioration. This approach to deprescribing should be discussed with the person taking opioids and/or their family/carer and monitored over time.
6. We suggest avoiding opioid deprescribing for persons taking opioids with a severe opioid use disorder and suggest that evidence-based care, such as transition to, or referral for, medication-assisted treatment of opioid use disorder is provided.	Conditional recommendation against (moderate certainty evidence)	General practitioners can offer, or arrange, evidence-based treatments for people with an opioid use disorder. This may include medication-assisted treatment with buprenorphine or methadone and associated strategies in combination with behavioural therapies. Depending on the skills and experience of the health care professional, this may occur in the general practice setting in collaboration with a pharmacist, through an addiction medicine specialist or psychiatrist, a tertiary drug treatment service, or a combination. Specialist advice or referral may be appropriate for people with chronic pain and opioid dependence or an opioid use disorder. This is due to the potential complexity of managing both conditions. Health care professionals should continue to use non-pharmacological and non-opioid pharmacological pain treatments, as appropriate, and consider consulting a pain or addiction specialist if required. In some Australian states and territories, Schedule 8 medications cannot be prescribed for persons who meet specified criteria related to drug dependence, without a permit or an appropriate approval from the relevant state or territory medicines regulatory area. Please refer to specific state and territory regulations and guidelines for more information. Many states and territories in Australia have a Drug and Alcohol Specialist Advisory Service that prescribers can contact for advice.
7. We recommend gradual tapering of opioids. Abrupt cessation of opioids without prior dose reduction may increase risks of harm.	Recommendation for (low certainty evidence)	A deprescribing plan agreed upon by the person taking opioids and the health care professional may facilitate person-centred medication dose reduction or cessation. There is limited evidence to inform a preferred protocol for opioid deprescribing. Local guidance for gradual dose reduction strategies may be used. For people who have been receiving long term opioid therapy (ie, for years) or taking high doses, the rate of reduction may need to be slower to prevent withdrawal symptoms. Alternatively, more rapid tapers or cessation might be needed for patient safety under certain circumstances (eg, for people who have experienced overdose on their current dosage). In these circumstances, consider the provision of naloxone. If a person has been using opioids short term (eg, less than one week) or has been using opioids infrequently, opioids may be discontinued without gradual tapering. Instructions should be provided to the individual and/or carer/family on what to look out for and what to do if symptoms occur during deprescribing, particularly the possible risk of withdrawal effects (see Recommendation 9).
8. We recommend tailoring the deprescribing plan based on the person's clinical characteristics, goals, and preferences.	Recommendation for (very low certainty evidence)	The use of an opioid deprescribing conversation guide (eg, Communication techniques for opioid analgesic tapering conversations27) may assist in assessing the willingness and readiness of a person taking opioids to engage in deprescribing. The guide may be used to structure conversations relating to the potential benefits and harms of deprescribing in the context of the person's values, goals and preferences. A deprescribing plan, agreed upon by the person taking opioids and their health care professional may facilitate person-centred medication dose reduction or cessation. Where possible, opioid deprescribing should be voluntary in nature, with the deprescribing plan mutually agreed upon by the person taking the medication and the health care professional to facilitate person-centred deprescribing. This may involve discussions around which medications will be decreased first, the rate of taper, and timing of doses. The plan may be adjusted over time to meet the person's ongoing needs. Opioid deprescribing should involve consideration of a person's starting dose and the available opioid dosage forms (eg, immediate release or modified release formulations, oral or transdermal opioids), the total daily dose in 24 hours, and the pharmacokinetic profile (absorption and elimination) of the opioid. Based on these factors, plans may involve gradually reducing the total daily dose of the medication to the next available dose through to the smallest available unit dosage. Small reductions in doses initially may help to cultivate trust between the health care professional and the person taking opioids, minimise fears about withdrawals, and enhance self-efficacy to engage in opioid deprescribing. Characteristics of the person may influence the deprescribing approach, such as previous response to opioids, previous deprescribing attempts and experiences, age, body mass index, liver and renal function, comorbidities and mental health conditions, concomitant medications, and psychosocial factors. Individualisation of the rate and approach of opioid deprescribing may require additional monitoring and input from health care professionals. At times, deprescribing might have to be slowed (eg, once a person reaches a low dosage) or may have to be paused and restarted again when the person is ready. See Recommendation 9 for further details on monitoring. If a person has noticeable decline in function, quality of life or pain control after dose reduction/cessation (after exclusion of other causes), then the medication should be restarted at the previous minimum effective dose. Where opioid deprescribing results in significant withdrawal symptoms or a noticeable decline in function, quality of life, or pain control, consider pausing the taper to stabilise and re-evaluate the person's pain status, diagnosis, overall clinical status, coping mechanisms, and psychosocial factors before resuming deprescribing. When resuming deprescribing, consider slowing down both the amount and frequency of the opioid reduction. Opioid deprescribing may not always be unidirectional and opioid dose increases may be necessary.
9. We suggest conducting regular monitoring and review of a person taking opioids throughout the opioid deprescribing process. Response against agreed therapeutic goals contained in a deprescribing plan should be regularly assessed.	Consensus recommendation	The success of opioid deprescribing may be measured by assessing progress in relation to goals contained within the deprescribing plan. The benefits of opioid deprescribing may not be observed immediately, and assessing response against set goals in the deprescribing plan may be useful. Monitor and document cognitive and functional status, behavioural and psychological symptoms, and how these have changed over the follow-up period. Health care professionals should monitor parameters including function, pain, sleep, mood, withdrawal effects, and dependence. Validated tools to assist monitoring are linked in the full guideline. The person engaging in opioid deprescribing should be provided with information and support to ensure they are aware of common opioid withdrawal symptoms, the likely severity and duration of the symptoms they may experience with each dose reduction, and who to contact if additional advice or support is required. Education and support may assist the person to self-monitor and implement strategies to manage the emergence of these symptoms as their dose is reduced. Consider providing both verbal and written communication that considers the person's health literacy. Establish and document a plan for when and how follow-up is going to occur. Monitoring should be conducted by the prescriber during each clinical review (at a minimum), but a person may receive support from other health care professionals such as pharmacists in between reviews. Practically, monthly reviews may be appropriate, but more frequent monitoring may be required at the beginning and end of the deprescribing process, or if there is concern about managing a person's health condition. Where opioid deprescribing results in significant withdrawal symptoms or a noticeable decline in function, quality of life or pain control, consider pausing the taper to stabilise and re-evaluate the person's overall clinical status, diagnosis, coping mechanisms and psychosocial factors before resuming deprescribing. When resuming deprescribing, consider slowing down both the amount and frequency of the opioid reduction. Opioid deprescribing may not always be unidirectional and opioid dose increases may be necessary in the short term. If complicated withdrawal symptoms are experienced, we suggest discussion with or referral to a pain or addiction medicine specialist. Health care professionals should consider the potential harms of opioid continuation or deprescribing for people receiving high dose chronic opioid treatment and monitor specifically for suicidal thoughts, mental health issues, and illicit opioid use. We suggest discussion with or referral to a psychiatrist where appropriate. Health care professionals should discuss the increased risk for overdose on abrupt return to a previously prescribed higher dose after deprescribing and may consider the provision of naloxone.
10. When available, we suggest the use of interdisciplinary or multidisciplinary care, or a multimodal approach that emphasises non-pharmacological and self-management strategies to deprescribe opioids.	Conditional recommendation for (low certainty evidence)	Interdisciplinary or multidisciplinary care programs provide multimodal treatment, with coordinated contributions by health care professionals from different disciplines typically organised around a biopsychosocial model of chronic pain. While recognising the cost of formal interdisciplinary opioid reduction programs and their current limited availability/capacity, an alternative is a coordinated multidisciplinary collaboration that includes several individual health care professionals whom the person taking opioids can access (eg, nurse, pharmacist, occupational therapist, physiotherapist, addiction medicine specialist, psychiatrist, psychologist). Another alternative is for prescribers to implement a multimodal approach.
11. We suggest the consideration of evidence-based co-interventions to support opioid deprescribing.	Conditional recommendation for (very low certainty evidence)	The appropriateness of co-interventions for opioid deprescribing must be discussed between the health care professional and the person taking opioids, taking into consideration the person's clinical status, preferences, lived experience, values and costs of alternative treatments for the person.