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Upcoming changes to reduce harm

5 November 2019

Pharmaceutical opioids are now responsible for far more deaths and poisoning hospitalisations in Australia than illegal opioids such as heroin.

Every day in Australia, nearly 150 hospitalisations and 14 emergency department admissions involve opioid harm, and three people die from drug-induced deaths involving opioid use.

These figures are too high, and the Australian Government has asked the Therapeutic Goods Administration (TGA) to play a role in tackling the problem. To help reduce the harm, we conducted a public consultation on prescription opioids in 2018. A summary of the submissions received and consultation outcomes has been published at Prescription strong (Schedule 8) opioid use and misuse in Australia - options for a regulatory response. A total of 98 submissions were received with feedback indicating strong and consistent support from all stakeholders for a regulatory response.

Following the initial consultation, the TGA established the Opioid Regulatory Advisory Group (ORAG), which includes representatives from a range of health professional and consumer organisations, to provide independent, expert advice. ORAG has strongly supported the proposed options and provided advice on how best to implement them.

Throughout the process, it has been recognised that opioids play an important role in providing pain relief for many people and there has been a focus on ensuring appropriate and safe access is maintained.

Several reviews and activities arose from the consultation. As a result:

  • Smaller pack sizes will be available for immediate-release prescription opioid products. For example, following a minor procedure you may currently be given a packet containing a week's worth of opioids when you would usually only need to take them for two or three days. The unused opioids subsequently circulating in the community may be used in harmful or hazardous ways, either inadvertently or deliberately, or become targets for theft.
  • We will require that sponsors include boxed warnings and class statements in the Product Information (PI) documents for all prescription opioids in relation to their potential for harmful and hazardous use. These documents provide information for health professionals about medicines and their appropriate use.
  • We will work with sponsors to ensure that safety information, including the relevant warnings, is prominently displayed in the Consumer Medicines Information (CMI) to ensure consistency of language and information across all classes of prescription opioids. These documents provide important information for consumers about medicines.
  • The indications (the appropriate circumstances for use of a medicine) in the PI documents for prescription opioids will reinforce that opioids should only be used when other analgesics have proven not to be effective.
  • Fentanyl is one of the strongest opioids available in Australia. In recognition of the increased potential for harmful and hazardous use, the indication for fentanyl patches will be updated to state they should only be prescribed to treat pain in patients with cancer, patients in palliative care and those with exceptional circumstances.
  • We will be communicating the changes to both prescribers and consumers using a range of channels to ensure health professionals follow best prescribing practice and consumers are fully informed how best to use opioids. We have already begun to encourage consumers to return unwanted opioids to pharmacies for destruction by distributing prescription covers with relevant messaging to every pharmacy in Australia as well as via various social media activities.

These measures will align with broader Australian Government initiatives to improve appropriate pain management, particularly the National Strategic Action Plan for Pain Management. This strategic plan will address issues of pain management holistically and will ensure the appropriate support is available for areas of need. The need to maintain appropriate access to opioids, particularly in regional and remote areas, has been a consideration at all times in the TGA's regulatory response. See below for consumer and health professional resources.

The measures have been carefully considered to ensure that they support and maintain the safe and clinically appropriate use of opioids without restricting prescribers from accessing them for their patients when needed. These actions are also similar to activities that have been undertaken in other countries, for example the United States and Canada.

Q&A

A: Prescription opioids such as fentanyl, codeine, hydromorphone, oxycodone, morphine, tramadol, tapentadol, buprenorphine and methadone are affected.

A: Over the past decade, countries such as the United States have experienced an 'opioid crisis' of misuse of pharmaceutical opioids. Hazardous and harmful use in Australia has been rising.

Every day in Australia, nearly 150 hospitalisations and 14 emergency department admissions involve opioid harm, and three people die from drug-induced deaths involving opioid use.

Smaller pack sizes will provide a more appropriate option for short-term pain relief, for example after surgery or injury, and reduce the risk of harm from unused opioids.

The additional boxed warnings and class statements will remind prescribers of the appropriate circumstances for opioid use and discourage inappropriate prescribing.

The various improvements to information for prescribers and patients will encourage best-practice prescribing and help consumers to be better informed about the potential risks and how to mitigate them.

The updated fentanyl indication will help reduce the inappropriate use of this powerful opioid in patient groups where the risks outweigh the benefits. Fentanyl is also a major target for diversion and harmful and hazardous use, and the changes will help reduce these undesirable outcomes.

A: It is recognised that opioids play an important role in providing pain relief for many people. It is vital that appropriate and safe access is maintained.

Those who require long-term pain relief from opioids, such as people with cancer and those in palliative care, will continue to receive the same opioid medications they need in the same way, with the same pack sizes as they do now.

Although there is the potential for harmful and hazardous use of all opioid products, the main focus of these changes are for opioids that are mostly used by consumers in an outpatient setting, that is, outside of hospital or other acute care settings. This is due to the higher risk of misuse and diversion involving opioids circulating in the community. Opioids such as the injectable forms used in hospitals and ambulances will continue to be accessed as they are now.

As always, the decision as to whether or not to prescribe a particular product will be subject to the clinical judgement of the individual prescriber who is responsible for obtaining informed consent from their patient. However, if you require opioids for short-term relief you will be likely to receive smaller, more appropriate pack sizes, reducing the amount of unused opioids after you no longer need to use them.

The Product Information and CMI updates will remind prescribers and consumers of current best-practice in opioid prescribing and discourage inappropriate prescribing and consumer expectations. For example, current prescribing guidelines recommend that opioids should not be prescribed for lower back pain although they are currently widely used for this condition. In many cases the use of non-opioid treatment for either acute or chronic pain is safer and more appropriate and prescribers may choose to explore alternative pain management options with their patients.

The tightening of the indication for fentanyl patches is because of the harmful and hazardous use of this product in patients who have not previously been prescribed an opioid (opioid naïve). Fentanyl is a very powerful opioid and therefore overdose is more likely to occur in those patients that have not been prescribed an opioid before being prescribed fentanyl.

If you have been prescribed fentanyl for acute pain or non-cancer pain your doctor may recommend moving to other opioids or analgesics.

A: No. You should continue to take your pain medication but you should talk to your prescriber about whether the treatment remains appropriate. Stopping opioids suddenly can lead to withdrawal symptoms so stopping them should be under the direction of you healthcare professional.

If you have any questions about your treatment you should always discuss these with your doctor or pharmacist.

It is anticipated that the first of the smaller pack sizes will be registered from January 2020. The fentanyl indication changes will come into effect in the first half of 2020. Due to the large number of opioid products on the Australian market the other changes will be phased in.

A: You should return unused opioids to your local pharmacy. The TGA website has more information about Safe disposal of unwanted medicines.

A: You should initially discuss pain issues with your treating doctor or pharmacist. In some cases, they may be able to refer you to one of the specialist pain management services available in your area.

A: A good place to start is to talk to your doctor or pharmacist.

You can also search for Consumer Medicines Information online via the TGA portal.

For mobile devices the latest medicines information is available through the TGA's MedSearch app.

NPS MedicineWise has lots of information on its website, or you can talk to one of their pharmacists by telephoning 1300 633 424 during office hours.

A: The TGA's team of doctors, pharmacists and other medicines specialists received advice from the Opioid Regulatory Advisory Group (ORAG).

Organisations represented on ORAG included: Australian and New Zealand Society of Palliative Medicine, PainAustralia, the Australian and New Zealand College of Anaesthetists Faculty of Pain Medicine, Royal Melbourne Hospital, the Australian Medical Association, Palliative Care Australia, University of Western Australia, the Royal Australasian College of Physicians, Australian Commission on Safety and Quality in Health Care, Tasmanian Health Services, Society of Hospital Pharmacists of Australia, Pharmaceutical Society of Australia, and the Royal Australian College of General Practitioners.

Resources for consumers

Resources for health professionals

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NPS MedicineWise

  • Book a one-on-one educational visit, virtual visit by video call or small group meeting, facilitated by an NPS MedicineWise Educational Visitor.
  • This MedicineWise News article presents the latest evidence on the limited role of opioids in chronic non-cancer pain. There is an emphasis on non-pharmacological therapies and active self-management as the preferred approach to improving function and quality of life for people living with chronic non-cancer pain.
  • Action plan to use with patients (pdf,1.25Mb)*: NPS MedicineWise has teamed up with painaustralia and the NSW Agency for Clinical Innovation to develop a resource that supports conversations between health professionals and consumers about the benefits of reducing or stopping their opioid dose. It clarifies what's involved in the process and helps to agree a planned approach.
  • This conversation starter resource (pdf,205kb) offers useful information for health professionals to discuss tapering with patients.
  • Pharmacy Practice Review: CPD activity for pharmacists. Opioids: reducing harms from long term use focuses on the important role pharmacists play to ensure the safe use of opioids for chronic non-cancer pain and to identify patients who may be at risk of harm from long-term use. Participants receive a counselling checklist and practice tips for starting conversations with patients about opioid tapering.

painaustralia

Faculty of Pain Medicine of the Australian and New Zealand College of Anaesthetists (ANZCA)

  • The Faculty of Pain Medicine's opioid calculator is designed to simplify the calculation of equianalgesic dose by expressing it as total oral Morphine Equivalent Daily Dose (oMEDD). It uses a "traffic light" dose warning system as a clear, simple way to indicate the risk of dose-related harm. Download the free smartphone app:
  • Better Pain Management: A professional, high quality online education program for specialist and general medical practitioners, medical students, nurses and allied health practitioners engaged in the care of patients with persistent pain.

Pain Management Network

National Drug & Alcohol Research Centre

  • Screening for dependence: the Routine Opioid Outcomes Monitoring (ROOM) Tool is a screening tool for prescription opioid dependence, developed specifically to use in primary care settings.

National Centre for Education and Training on Addiction

Palliative Care Australia

Guidelines and position statements