1 June 2020
Opioid Regulatory Changes
To minimise the harm caused by opioid prescription medicines to Australians each year, a number of regulatory changes are being implemented. The changes will ensure the safe and effective prescribing and use of opioids while maintaining access for patients who need them.
Why the changes are being made
Over the past decade, Australians have experienced a significant increase in the level of harm and deaths arising from the use of pharmaceutical opioids. Every day in Australia, nearly 150 hospitalisations and 14 emergency department admissions involve issues relating to opioid use, and three people die from the harm that results.
Opioids can be an effective component of the management of short-term and cancer-related pain. However, the evidence shows that for most people with long-term non-cancer pain, opioids do not provide clinically important improvement in pain or function compared with other treatments. Instead, they carry significant risk of harm, even when used as directed.
The regulatory changes aim to reduce the harms from opioids by reducing the number of people who start opioid treatment for short-term pain, for example following injury or surgery, and then continue to use the medicine long-term where the risk of harm outweighs benefit. The changes will also allow doctors (and other health professionals who prescribe opioids, such as nurse practitioners) to implement best-practice opioid prescribing for people living with pain while ensuring adequate pain management.
For people who are gaining little benefit from opioids or who are experiencing harm, doctors will be encouraged to work in partnership with their patients to safely reduce their opioid treatment over time to either stop the opioid medicine or ensure the best dose is found that effectively treats their pain while minimising the risk of side effects.
Many people who reduce or stop their use of opioids find that their lives improve. They can think more clearly and are more alert. Some people find their mobility is better and they are steadier on their feet. Less reliance on medication reduces trips to the pharmacy and may save money.
What changes are being made
The regulatory changes will require opioid ‘sponsors’ (pharmaceutical companies) to:
- register smaller pack sizes for immediate-release opioids that will provide a more appropriate option for short-term pain relief, for example after injury or surgery, and reduce the risk of harm from unused opioids (the existing larger pack sizes will still be available for those who need them)
- add additional warning statements to the approved Product Information for all opioids to remind doctors (and other prescribers such as nurse practitioners) of the appropriate circumstances for opioid prescribing and potential adverse effects
- improve the information available to prescribers and consumers to encourage best-practice prescribing and to be better informed about the potential risks with opioid use and how to minimise them
- update prescribing ‘indications’ (the circumstance/s for use) for opioids to ensure patients are prescribed an opioid only where the benefits outweigh the risks.
There will be various changes to the Pharmaceutical Benefits Scheme (PBS) to support the regulatory changes, for example funding for smaller quantities, changes to the ‘indications’ (conditions for use) that will be funded, and changes to the authority process that doctors must follow for opioids to be subsidised.
Products affected by the regulatory changes
Prescription opioid products that are affected by the regulatory changes include:
When the changes take effect
The regulatory changes have already commenced and will be further phased in during 2020, with some Product Information documents that health professionals use already updated.
Health professional bodies have been working to update their opioid prescribing guidelines during 2020.
Will I still be able to get prescription opioids?
Opioids can be an important component of a pain management plan for many people. It is vital that safe access is maintained for patients requiring opioids when other products that manage pain may not be as effective.
If you require opioid treatment for a long period of time, for example if you have cancer or are receiving palliative care, you will continue to receive the same opioid medications in the same way, with the same pack sizes as you do now.
If you require opioids for short-term pain relief, you will likely receive your medication in smaller pack sizes to reduce the amount of opioids left over when you no longer need them. It is not uncommon for people to believe they must continue to take all of the medication in the package, even if they no longer need it.
Continuing to take opioids when they are no longer needed can lead to a higher risk of developing dependency. Other important issues are misuse and diversion to others who may not be using them wisely.
Will my doctor be prevented from prescribing an opioid for my long-term non-cancer pain?
Your doctors and other prescribers will still be able to prescribe opioids if it is considered clinically effective. However, the changes will prompt doctors to consider whether prescribing an opioid is likely to give you greater benefit than the potential risks or whether there may be other treatment options for you.
Opioids can be used as part of the management of long-term non-cancer pain in circumstances where other medicine-based or non-medicine-based treatments have not been effective. However, a large number of studies have shown evidence of harm and a lack of effectiveness of long-term use of opioids for managing non-cancer pain, especially at high opioid doses.
In some conditions, non-opioid medications such as paracetamol or ibuprofen along with other types of treatment not involving medications, may provide similar pain relief as taking an opioid, without the same risk of harm. Ideally, the best alternative for a person living with long-term non-cancer pain is to enrol in a pain management program. This will explore tailored treatment that best meets the needs of each individual. Such treatment can bring in additional options that do not involve medications, including activities such as graded exercise, mindfulness, yoga, etc.
Should I stop taking my opioids immediately?
No. If you have been taking an opioid for some time you should continue to take it, but you should talk to your treating health professionals about whether the treatment remains the best for you. Stopping opioids suddenly can lead to withdrawal symptoms, so changes to the amount you take should be made with the support of a health professional such as a doctor, nurse practitioner or pharmacist.
If you are concerned about the effects your opioid medication is having on you, talk to a health professional, as you may be able to gradually and safely reduce the amount of medication (known as weaning or tapering) with their assistance.
If you have any questions about your treatment always discuss these with a health professional.
What should I do with prescription opioids that I don’t need anymore?
If you have opioids you no longer need, they should be returned to your local pharmacy. The TGA website has more information at: www.tga.gov.au/safe-disposal-unwanted-medicines
Who should I talk to about my pain management?
If you are experiencing ongoing pain, you may be facing a number of everyday challenges. You may find it difficult or impossible to do your normal work or activities, and your relationships with others may change. It is important that you receive support that considers all of the available therapies and approaches that might help you manage your pain. You should initially discuss any pain issues with your treating health professional. If you need more support, you may be referred to a specialist pain clinic that offers a multi-disciplinary pain management program.
Source: Therapeutic Goods Administration: https://www.tga.gov.au/hubs/prescription-opioids
Where can I access further information about prescription opioids?
- A good place to start is to talk to your doctor or nurse practitioner, who will understand your condition and the reason you have been prescribed opioids. Another good source of information is your pharmacist.
- TGA: email – email@example.com, phone – 1800 020 653 (free call within Australia) or more information and links to a wide range of additional resources can be found on the TGA website.
- Pain Australia has an interactive tool to help you find the nearest available specialist pain services.
- NPS MedicineWise: You can also find information about opioid medicines, chronic pain and withdrawal symptoms at NPS MedicineWise website. Also watch their video below on opioids and non-cancer chronic pain below.
Modified release paracetamol changes
From 1 June 2020, you will be required to speak to a pharmacist before purchasing modified release paracetamol. This is to ensure that consumers receive the appropriate advice on the use of these products.
Modified release paracetamol (sometimes labelled as sustained release, slow release or extend release) is formulated with a higher dose of paracetamol per tablet (665 mg) compared to immediate release paracetamol at 500 mg per tablet. In modified release formulations, paracetamol is released into the body more slowly and has a more convenient 8-hourly dosing regimen compared to the immediate release products (usually taken 4-6-hourly).
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