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What the TGA’s recent opioid changes mean for GPs


John Skerritt


9/11/2020 2:36:16 PM

Adjunct Professor John Skerritt of the Therapeutic Goods Administration outlines why the regulator is making changes to opioid indications and pack sizes.

Opioid pill
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.

TGA-column-article.jpg
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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Dr Urmila Sriskanda   9/11/2020 5:40:26 PM

It seems like the TGA made some changes 5 months
ago and then made further changes last month. I wonder what prompted the TGA to revise the opioid policy again in such a short span of time.


Dr Nicole Lewindon   10/11/2020 7:14:38 AM

One of the biggest barriers to opioid reduction is the cost involved to the patient. Say you are on 40mg OxyContin bd. But to write scripts for 40mg mane 35 mg nocte you need multiple scripts. Which costs the patient more per week. You should be able to just write a dose and it gets dispensed at the same cost. The slower you bring patients down the easier it is for them. I also think they should be sold Webster packed to discourage patients just taking an extra one and getting into the habit of
pill popping.


Dr Nicole Lewindon   10/11/2020 7:15:51 AM

Also the communication about these changes to GPs was woeful


Dr Oliver Frank   10/11/2020 9:21:38 AM

The content of this article appears to have been written before 1/7/2020, but is published only now. If this is correct, I would be interested to know why its publication has been delayed by at least four months.


Dr John Smart   10/11/2020 9:29:56 AM

There is a problem here for aged care providers who often have fairly large numbers of the extreme aged (but non palliative) on low dose opioids. There is a need to provide a prescription renewal every two week. The alternatives to this are cumbersome, time consuming, generally unpaid and and only provide a four week scrip.


Dr Ian Mark Light   10/11/2020 12:36:35 PM

It is important to be very mindful of the mental health of patients and the danger of self destructive behaviours .So there need to be a strong team looking after patients with opioid dependency checking always for suicidal risk .
And there has to be follow up and support for life .


Rural GP   10/11/2020 1:35:42 PM

GP's have been asked to " reflect" or undertake an "e audit".
We were shown a big stick and told to change our ways.
Most of the changes are just obstructive.
Failings Include : no notice of the changes , woeful wait times on the hotline, multiple rejections without identifying the reason ( just a referral to website),
"Lets just make it tough for them"
Speaking with hospital drug and alchohol services, they are now overwhelmed with patients whose GP's have given up on the opaque system ( numbers doubled here).
I break out in a cold sweat everytime I try to negotiate these impractical changes .
This has harmed real patients and caused significant stress.
I cant find the new script easily on Best Practice
Smaller pack sizes : great.
More pain management services: would be helpful
Multiple script rejections and trying to find the new script to read : time wasting .
Is this the job of the TGA?


Dr Peter James Strickland   10/11/2020 5:59:58 PM

How many of these people on the TGA really know anything about pragmatic medicine? Every GP I have known (apart from a few) are very careful with opioid prescriptions. Many patients come out of hospital and pain clinics on opioids, and the addiction that goes with that quite often, and simply because that is the way these clinics and inpatient wards operate ---thus leaving the GP to manage chronic pain. Educating GPs and specialists about opioids use is good; forcing impractical clinical conditions on GPs etc is NOT good, and smells of 'big stick' authorities with poor knowledge of patients needs, costs and welfare. Smaller packs rather than VARIABLE PACKS means more scripts, and a failure of the TGA again in assisting everyone, and including the health costs for government as well as doctors and patients. The TGA do this so often that it needs a thorough review of their authority to interfere continually in good medical management.


Dr Graham James Lovell   10/11/2020 10:12:56 PM

IF our unmentioned State Government Drugs of Dependence units had been effective at dealing with the out of control prescribers in each State we probably wouldn’t be suffering under this unannounced Federal policy , that is obstructive and not working!
Multiple GPs in my local area had up to a hundred unauthorised long term narcotic patients in breech of requirements, but Drugs of Dependence sat on their hands until complaints were made.
Should the State Health Departments now save money and appropriately allow us to suffer under just the one now bigger “Big Brother” ?
Clearly the Federal Government overdose statistics show that having the ridiculous double Approval process for over 2 months narcotic usage has been ineffective...


Dr Alan Graham MacKenzie   10/11/2020 10:55:50 PM

What is the actual definition of an “Unintentional Overdose “ which cause death?


Dr Nicole Gouda   12/11/2020 7:55:57 PM

‘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.’

Reading this makes me feel ill. It implies we ( GPs ) are 'by default' irresponsible prescribers, when the vast majority of us give great thought to prescribing and consider it very carefully. Give us a break.


Dr Maureen Anne Fitzsimon   14/11/2020 11:02:34 PM

Agree with many of the comments. A very narrow approach to this problem is offered as a ridiculously simple solution. It’s all very well to take away opioids from people stable, and managing their lives on them, but to then offer no alternative solution for their pain ,will result in serious disability, mental health issues, and, possibly suicides. The end points of this exercise do not measure these adverse outcomes.


Dr Richard P. Wellm   15/11/2020 11:02:36 AM

I avoid prescribing immediate relief opiates (Endone) in favour of slow release (Targin). I've been taught there is less risk of dependence from this.
Medicare now forces me to prescribe Endone for acute injuries, like fractures, where people are however ongoing in pain.
Moreover I'd be curious about any real life changes of these new rules. My opinion, we were simply forced to learn more admin talk - well done government.
Surely another layer of breaurocracy will fix those GPs.