Opioid rules tightened


codeine tabsules spill from orange pill bottle

New restrictions on opioids provide an excellent opportunity for pharmacists to raise awareness about dependence, naloxone and pain management, say stakeholders

Commencing Monday, 1 June 2020, the PBS listings for opioid medicines will change, the TGA has advised.

In response to concerns about deaths and hospitalisations due to prescription opioids, the PBAC recommended changes as part of a broader suite of measures, which are intended to support appropriate use of opioids, including education and awareness campaigns, changes to clinical guidelines and ongoing prescription and compliance monitoring.

Opioid medications will now be available in smaller quantities with no repeats for the treatment of non-chronic pain.

“To be eligible for treatment with opioids, patients will need to be unresponsive or intolerant, or have achieved inadequate relief of their acute pain, to maximum tolerated doses of non-opioid treatments,” the TGA says.

“Patients who require long-term treatment of chronic pain with opioids will still be able to access larger pack sizes and prescribers will be able to prescribe repeats where they meet the new restrictions requirements.

“For chronic pain, increased quantities and/or repeats may be authorised by Services Australia where the patient meets the restriction requirements.

“Increased quantities to extend treatment up to one month may be requested via telephone/electronic authority request, and up to three months’ supply (up to one-month quantity and up to two repeats) may be requested via an electronic/written authority request.

“To be eligible for treatment with high strength opioids such as morphine and fentanyl, patients will need to be unresponsive or intolerant, or have achieved inadequate relief of their acute pain, following maximum tolerated doses of other lower strength opioid treatments.

“These new arrangements apply to all PBS listings for opioid medications and therefore there will also be amendments to the tramadol and paracetamol/codeine restriction requirements.”

For pharmacists, this means that from 1 June 2020, some opioid listings will become Authority Required (Streamlined).

As a result, pharmacists will have to ensure any relevant dispensed scripts have a valid streamlined authority code, which needs to be valid at the date of prescribing.

“Pharmacists are also required to ensure prescribers have correctly requested increased quantities or repeats for chronic pain through telephone/electronic authority for up to one month’s treatment or electronic/written authority for up to three months’ treatment,” says the TGA.

Clinical Pharmacy Lecturer at La Trobe University, Pene Wood told the AJP that she thinks the change is “great – it’s something that I’ve advocated for”.

Dr Wood, who sees a lot of patients with pain management issues, often with complex needs who are taking opioids, in her work in a GP clinic, said that she sees a great deal of inappropriately prescribed fentanyl in particular.

“This is a good opportunity to have a conversation with [patients] and talk about why we need to change them off,” she said.

“The change creates awareness that these medicines aren’t designed to be used long-term, but in the short term for acute pain. If we’re only giving you 10, then after five days you shouldn’t need them any more.

“It also encourages people to go back to the doctor and seek feedback about the problem.”

She encouraged pharmacists to talk to patients who come in with scripts for opioids about the risks associated with their use, particularly in the long term.

She also encouraged them to discuss naloxone, saying that if the discussion is worded sensitively patients are more likely to be receptive to having the medicine on hand.

“Particularly if they’re on fentanyl, it’s something we can always offer to any patient, but in particular those on high-risk opioids, or opioids and sleeping tablets, or opioids and smoking, or with a respiratory condition,” she said.

“I have this conversation with most patients: I don’t use the word ‘overdose,’ I use the phrase, ‘opioid toxicity,’ and talk about how this medication can slow down your breathing, so that if you get the flu or use certain other medicines it could result in a bad outcome.

“I haven’t had one person knock it back yet.”

She also encouraged pharmacists to discuss naloxone with doctors – “We can ring them up, and say, ‘Have you thought about this?’”

Spokespeople for the Royal Australian College of General Practitioners also welcomed the TGA’s changes.

Chair of the RACGP Addiction Medicine network Dr Hester Wilson said that, “Limiting quantities and repeats is only one step towards reducing the harms that can result from opioids”.

“Unfortunately, I fear some people who have their opioid prescriptions limited will find it hard to give up and some may turn to black market alternatives.

“We need to be alert to that and government must ensure that there are enough treatment services available in as many locations as possible because substance use affects all communities

“I also think that we need to be much more proactive in helping patients with alcohol and other drug problems, including prescription drugs and illicit drugs.”

This includes GPs doing more to get naloxone into the hands of people who need it most, she said.

“Expanding access to opioid pharmacotherapy options such as methadone and buprenorphine is also really important.

“This can prove decisive in weaning people off opioid drugs. But again there is the factor of cost and some health professionals not having much knowledge or awareness of how beneficial this form of treatment can be.

“There is a certain stigma that still surrounds alcohol and other drug treatment and management and this needs to change. Problematic opioid use can affect anyone, it could be your mum or dad, a brother, a friend, a colleague, a neighbour – no one is immune.”

More information is available from the TGA here.

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7 Comments

  1. Joyce McSwan
    30/05/2020

    I would please urge pharmacists to support their patients if there are any abrupt cessation or forced withdrawals due to these changes. Abrupt cessation due to these PBS changes is not supported by any evidence based practice nor any guidelines. I would also urge pharmacists to be up-to-date with their own clinical practice in supporting local prescribers with these changes and to patiently explain to patients these changes to avoid any panic that may arise. This has come during an environment high in ambient stress already, thus this is an opportunity for the pharmacist to conduct medication reviews (MedsCheck, HMRs etc) via Telehealth if appropriate to ensure that patients are getting reviewed and validated with the opportunity to increase literacy of the role of opioids. Supportive deprescribing can occur though in reality a complete cessation may or may not be possible depending on the case at hand and will take time. However at all times a patient-centered approach is essential to minimise issues of medical negligence or inadvertent panic resulting in mental health consequence or resorting to illicit means of opioid purchase. All of which are not necessary events for the vulnerable patient if well supported. Unfortunately there are not sufficient publicly available services to cater for these needs, thus it will come back to those in the primary health care space to work with each other. Most certainly a role we can all play in. There is much to do. Kindly familiarise also with this – http://fpm.anzca.edu.au/FPM/media/FPM-Images/PS01(PM)-Foreground-paper-FINAL-20200511.pdf And am more than happy to support any pharmacist clinically on this: info@painwise.com.au

    • Jarrod McMaugh
      30/05/2020

      Well said Joyce

      In addition, please refer people who are subject to sudden cessation of opioids to Chronic Pain Australia so we can advocate for their rights

    • Evan Ackermann
      31/05/2020

      The new TGA recommendations do not advocate, nor should they cause any abrupt cessation in opioids. The regulatory changes will not lead to a ban on prescribing opioids in any category of patient, if ongoing use is considered to be clinically appropriate.

      Put simply, the new changes -:

      1. Involve *smaller maximum quantities of immediate release opioids*, (with no increased quantities or repeats), for patients requiring short-term relief of acute severe pain.

      2. Change in the *indications* for opioids in the management of chronic non-cancer pain
      (rules concerning quantities have not changed)

      If there is confusion, discussion with the prescriber is advised.

      • Jarrod McMaugh
        01/06/2020

        I agree with you on this Evan

        There is a lot of sense to the changes, yet there is a history to consider.

        Recently when the chief health officer sent letters to the “top” prescribers of opioids, people did experience sudden cessation.

        Not ideal, not the intent, yet it occurred (with some individuals experiencing severe outcomes).

        The approach to these changes is being handled with more care, including TGA convening a communications committee to discuss how to deliver these messages, yet despite this, there are still risks…. especially since it is now June, and understanding of these change by health care consumers, prescribers, and pharmacists, is still not “wide spread” yet.

        I personally have some concerns around the messaging that is being discussed in this committee; we’ll see if these concerns influence the outcome or not, but the TGA seems to have been receptive to them so far.

        Ultimately, we want to see people managed effectively, without being exposed to opioids when it isn’t going to be of benefit, yet not exposed to sudden cessation for those already experiencing tolerance. At the same time, other segments of the health department need to consider the messaging about “non-medical” options of treatment, and deciding on how they will effectively fund these options if they are truly considered an alternative or the primary means of managing pain.

  2. Lee Ridsdale
    10/06/2020

    As a chronic pain sufferer, who has had several inpatient rehabilitation services, lumbar and cervical spinal surgery, have ongoing nerve damage effecting not just my back and legs but urinary, bowel and sexual functions, but continue living my life and studying nursing full time, am angry and frustrated that I was unable to get a prescription for my SR Tramadol today. I was offered morphine patches and endone niether of which have any theraputic effect on me. I long for the day those advocating for these changes are debilitated with a chronic condition. The only people you are hurting are the genuine sufferers. Drug seekers will always find a way to get what they want. I am extremely lucky to have a excellent relationship with my surgical team who will do all they can to ensure their patients are not shafted by those who have no idea.

    • Sarah Edwards
      27/06/2020

      I completely agree; it’s astounding that these changes can be initiated without consultation or consideration of genuine chronic pain sufferers. You’re prescribed these drugs and become reliant and all of a sudden they limit them and make it much more difficult to access which in turn causes more distress and pain!

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