Q&A - Opioid prescribing – TGA changes, the PBS and the Law

This is an important point. There is individual State and Territory jurisdiction for prescribing legislation requirements. These fall under the respective State Department of Health and are known as the Drugs & Poison Units or the like. They can vary in requirements and is imperative that you understand the rules in your local jurisdiction where you are to practice.

Further information about the TGA and State /Territory roles and contact information can be found at:  State and Territory medicines poisons regulation unit

This may be within the opioid indication changes/PBS criteria subject to clinical judgement as exceptional circumstances (as suggested by the need for adjunct therapy and specialist involvement). A neurologist opinion confirming the need to adjust the therapy would likely be sufficient for second opinion. This is required for increased quantities or repeats. This is appropriate if considered clinically exceptional circumstances criteria and they are met.

The regulatory changes have carefully considered the need to maintain access in the palliative care space and were not intended to change this space. It is important such patients receive the care they require and needs are met. The new additions will help and ensure continuity of drugs. Opioids can continue to be used subject to clinical judgement of the prescriber and clinically appropriate, noting the need to justify dosages.

Prescribers still choose the pack size they prescribe(10 or 20) as clinically indicated and as per clinical judgement . The smaller packs are now additional, they are not replacing larger packs. They were introduced for acute periods of pain and so in some situations there is no left over medication. There is considerable evidence the acute pain does not last  longer than 3 days , and so the smaller packs may be warranted. Practitioners should reflect on the prescribing of these smaller pack.

Our TGA and Department of Health guests are unable to provide clinical advice and prescribers should refer to clinical guidelines. This does however indicate the independent nature of our healthcare system. This can be a challenging scenario in the same way a GP accepts a discharged patients with an opioid medication, with limited discharge information. Ideally one should talk to the specialist and seek an understanding of the clinical rationale  A properly conducted opioid trial  may be appropriate.

These again can be difficult and challenging practice settings. There are on occasions sub optimal clinical handovers. The recent changes however in no way prevent or stop the prescribing of opioids in this practice setting, subject to clinical judgement and the usual indications and local requirements. Telehealth prescribing of opioids is currently allowable.

As a general rule reflect on clinical appropriateness, taking into the risks of hazardous and harmful use, before prescribing. Well intentioned prescribing may be problematic. Take a judicious and considered approach, especially for new patients. Acknowledge that opioids don’t always work for chronic pain and actively look at other medications and consider weaning trial.  When prescribing, use the smallest amount for the smallest time possible and review.

From the regulatory perspective there has been extensive consultation including with RACGP and AMA over the last 2 years – however the changes were competing this year with the COVID-19 news cycle which means that some messaging may not have cut through. PBS changes went through normal process, but similarly may have only been noticed by some prescribers when software changed. Education continues to be provided to health care professionals directly and through Colleges, professional associations and medical defence organisations.

MIPS sees such complaints on a consistent basis and will provide members with assistance including legal representation in the event of an AHPRA complaint. It is up to the prescriber to make decisions of clinical judgement. Always consider in a judicious and considered manner based on clinical indications and legislative requirements of your jurisdiction.  MIPS is not aware of any successful litigation based on such a premise. As always document your consultation findings of history, investigations and advice appropriately. In most cases, these types of AHPRA complaints have been determined to have no basis and there are usually no adverse findings against practitioners.