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What the TGA’s recent opioid changes mean for GPs
Adjunct Professor John Skerritt of the Therapeutic Goods Administration outlines why the regulator is making changes to opioid indications and pack sizes.
Rising opioid use in Australia is behind recent regulatory changes.
While opioids have been used to treat pain for millennia, the rise of powerful synthetic opioids in recent decades has added new dimensions to their clinical use as well as new risks of harm.
Recent clinical evidence has also shifted what is regarded as best practice in opioid prescribing.
In response, Australia’s regulatory environment is changing to reduce potential harms and reflect the latest evidence base.
Research commissioned by the Therapeutic Goods Administration (TGA) has found that prescribers are a critical, trusted source of information and advice for patients, but that the complex nature of patient presentations and variable patient health literacy mean barriers to best practice opioid prescribing still exist. The TGA has set out to put in place tools to help prescribers tackle these challenges.
I will outline these regulatory changes, as well as some of the resources available for GPs to help adapt to them. But first I will explain why the TGA needed to act.
Why do we need regulatory change?
The TGA undertakes the review of medicines, medical devices, cell and tissue and blood products prior to their marketing in Australia, as well as the continued monitoring of product safety once goods are on the market.
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.
Prescription opioids are currently responsible for more deaths and hospitalisations in Australia than illegal opioids such as heroin. Opioids were the drug group most commonly identified in unintentional overdose deaths in 2018 (involved in 900 deaths), followed by benzodiazepines (648 deaths).
For very many people with chronic non-cancer pain, opioids do not provide clinically significant improvement in pain or function compared with placebo. In contrast, they carry significant risk of harm, even when used as prescribed.
The key regulatory challenges
Targeted consultations with healthcare professionals and patient groups, workshops and a public consultation led to the establishment of the Opioid Regulatory Advisory Group, which met over an 18-month period from late 2018 to early 2020. This group, which included the RACGP, advised the TGA on the design and implementation of a number of reforms including:
- aligning opioid indications and clarifying that opioids are not indicated for chronic non-cancer pain unless in exceptional circumstances
- requiring additional warnings in all opioid information for health professionals and consumers
- encouraging pharmaceutical companies to register additional smaller pack sizes for immediate release prescription opioids for treatment of trauma or acute postoperative pain
- extensive education programs for health professionals and consumers underpinned by nationwide research into behaviours and attitudes.
The changes support safe and best practice opioid use while maintaining access for Australian patients who need these medicines.
Where clinically appropriate, and with patient consent, some patient cohorts may be safely tapered off prescription opioids in a staged and medically supervised manner.
The new indications
The new indications listed in the Product Information reinforce that opioids should only be used when other analgesics are not suitable or have proven not to be effective.
For immediate-release products, the new indication emphasises they are for short-term management of severe pain.
Modified-release products should also only be used where the pain is opioid-responsive and the patient requires daily, continuous, long-term treatment.
Modified-release opioids are not indicated to treat chronic non-cancer pain (other than in exceptional circumstances), or to be used for ‘as-needed’ (PRN) pain relief. In addition, hydromorphone and fentanyl modified-release products, because of their potency, should not be used in opioid naïve patients.
‘Exceptional circumstances’ was deliberately not defined by the Opioid Regulatory Advisory Group or the TGA as it is acknowledged there may be a range of potential situations where they might apply to an individual patient, subject to the clinical judgment of the prescriber.
However, the impact of the indication changes is to narrow the circumstances in which opioids are prescribed for chronic non-cancer pain and for prescribers to be very strongly encouraged to rule out other potential treatment modalities (including non-pharmacological options) before determining whether ‘exceptional circumstances’ apply.
Pharmaceutical companies (known as sponsors) recently completed their updates to the indications in the Product Information for all of the ‘innovator’ (ie first to be marketed) opioids and the sponsors of equivalent generics will now have to update their own information to align with the innovators.
Changes to the Consumer Medicines Information documents for patients and carers will flow on from changes to the Product Information.
Smaller pack sizes
The TGA has contacted all sponsors of immediate-release opioids requesting them to register smaller pack sizes in addition to their current range.
The aim is to provide more options for health professionals to be able to prescribe smaller amounts for short-term use without requiring community pharmacists to break packets, reducing the amount of unused opioids in the community and lessening the likelihood of use following injury or surgery progressing into the longer term.
Several sponsors have indicated they intend to market smaller pack sizes alongside the currently available pack sizes. Prescribers are, of course, already able to prescribe reduced quantities when a whole pack is not needed.
The TGA has asked all sponsors of immediate-release opioids to register smaller pack sizes.
Recent Pharmaceutical Benefits Scheme (PBS) changes have introduced restricted benefit listings for reduced quantities of immediate-release opioids, making it simpler to prescribe appropriate quantities for acute severe pain when an opioid is warranted.
Additional warnings on opioid information
Prominent ‘boxed warnings’ and class statements are being added to the Product Information as product indications are changed across the range of opioids.
The boxed warnings highlight limitations of use and a range of risks:
- hazardous and harmful use
- life-threatening respiratory depression
- concomitant use of benzodiazepines and other central nervous system depressants, including alcohol.
The Required Precautions and Warnings Class Statement includes the key advice: ‘Opioid therapy for chronic non-cancer pain should be initiated as a trial in accordance with clinical guidelines and after a comprehensive biopsychosocial assessment has established a cause for the pain and the appropriateness of opioid therapy for the patient.’
Breaking down barriers for consumers
While our research found that prescribers are a critical, trusted source of information and advice for patients, the information they are providing may not be registering or ‘cutting through’ with some patients.
In many cases the pain being treated, or the stress it causes, may make the patient less able to process information during the consultation. Other forms of information provision such as handouts, Consumer Medicines Information and labelling may assist with messaging.
Given this gap in effective provision and receipt of information, the research identified a need to reach consumers directly via an education/communication campaign.
The campaign will encourage consumers to take an active role in their pain management and to be receptive to prescribers when discussing new treatment pathways.
PBS changes
To support the TGA’s regulatory changes, the Pharmaceutical Benefits Advisory Committee recommended a number of changes to PBS listings. These changes were implemented on 1 June 2020 and included:
- new listings for reduced pack sizes
- changes to the indications
- changes to the authority process that doctors must follow to prescribe opioids to be subsidised under the PBS.
The changes do not reduce access to opioid prescription medicine for patients with cancer-related pain or those in palliative care. However, additional requirements aim to ensure the safe and effective prescribing and use of opioids while maintaining access for patients who need them.
Prescribing of opioids to patients with chronic non-cancer pain can likewise occur, subject to the PBS requirements being satisfied.
Resources for prescribers
The TGA maintains an
opioids resources hub, which includes a dedicated
resources page with a wide range of materials for both health professionals and consumers.
We have also funded a range of additional Continuing Professional Development (CPD) and other resources specifically for prescribers to use free-of-charge:
- Better pain prescribing: Clarity and confidence in opioid management. Specialist pain management clinicians from the Australian and New Zealand College of Anaesthetists and Faculty of Pain Management developed this eLearning package to help you develop sustainable techniques that reduce both opioid dependence and patient harm.
- Clinical e-Audit developed by NPS Medicinewise: ‘Review your prescribing of opioids for patients with chronic non-cancer pain’.
- Reducing opioid harm in rural and remote Australia. This webinar series is just one of the resources available via the Rural Doctors Association of Australia.
GPs and the way forward
I encourage you to make use of these CPD resources and also take a look at the wider range of information and tools available via the TGA’s opioids resources hub.
In acknowledging the clinical challenges in changing prescribing practice, a focus of these resources is to help GPs and other health professionals be confident in being able to initiate and sustain potentially difficult conversations with patients regarding their opioid use in accordance with best practice.
The consumer campaign will aim to alert your patients to the overall issue of opioid risks and assist the discussion on changes to their treatment, if required.
The regulatory changes are well underway and as they roll out, all GPs will have to reflect how their opioid prescribing represents best practice for each patient’s individual circumstances.
Skilled GPs are the most important group of people in Australia to tackle the issue of opioid harm and ensuring opioids are used as effectively and safely as possible in the Australian community.
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