In Australia, opioids account for just over three deaths per day and nearly 150 hospitalisations and 14 emergency department presentations involve opioid harm1.
The majority of these opioid-induced deaths were unintentional and involved pharmaceutical opioids, often in the presence of other substances2. According to the Australian Bureau of Statistics, out of the 1,740 registered drug-induced deaths in 2018, opioids were present in close to two-thirds and pharmaceutical opioids present in over 70 per cent of opioid-induced deaths.
TGA’s regulatory reforms
From January 2020, the Therapeutic Goods Administration has instituted a number of new measures, including manufacturing smaller pack sizes. The aim of this is to allow doctors to prescribe smaller quantities of opioids, which will be appropriate for short-term pain relief and reduce the risk of harm from surplus opioids.
Updated instructions for prescribing fentanyl patches, safety warnings and product information on all opioids will also be phased in through the first half of 2020. These instructions will outline that fentanyl patches should only be used to treat pain in patients with cancer, patients in palliative care and patients in exceptional circumstances.
New warnings and tighter indications in the Product Information will be updated across all opioids, highlighting their potential for harmful and hazardous use. There will also be tighter restrictions for certain immediate release and modified release products used to treat severe pain.
SafeScript becomes mandatory in VIC from April 2020
From April 2020, it has become mandatory for doctors in Victoria to check a patient’s prescription history in SafeScript before prescribing a ‘monitored medicine’. According to the Victoria State Government, this follows worldwide best practice, which is mandatory in many other countries and has been proven to reduce harm and enables doctors to make safer decisions about prescribing high-risk prescription medicines.3
Since SafeScript’s initial state-wide rollout in late 2018, healthcare professionals in Victoria have had considerable time to register and become familiar with the new monitoring system, before it became mandatory in April 2020. Reports show that it has been a success and there has already been a 25% reduction in patients taking a high-risk opioid between April to October of last year4.
What is SafeScript and why we need it
The introduction of real-time prescription monitoring has revolutionised the way in which medical practitioners are able to monitor the use of drugs of dependence. SafeScript is a real-time prescription database which provides prescribers with important information in relation to specific high-risk medications. This includes Schedule 8 medications as well as Schedule 4 drugs of dependence; a list of the medicines monitored can be found here.
It has now been integrated into clinical software in many practices, however practitioners can also access this information online through a secure login. SafeScript provides detailed information to doctors and pharmacists regarding a patient’s prescribing and dispensing history of the monitored high-risk medications. SafeScript automatically obtains prescription records from the Prescription Exchange Services (PES) through an electronic transfer, when a prescription is issued or dispensed by a medical clinic or pharmacy.
Not only will the prescribing GP be notified of the patient’s history, but the pharmacist dispensing the drug will also be made aware of the patient’s individual scripts. While SafeScript allows healthcare professionals to be informed of high-risk patients and their circumstances, it doesn’t prevent them from prescribing medicine if they feel it is necessary.
SafeScript is compulsory in Victoria and Queensland is in the process of rolling out QScript, which is a system based on the SafeScript model. A similar system has been trialled and is available in Tasmania, which will be accessible to all doctors at a future date.
In states where real-time prescription monitoring has not been formally implemented, it is important to use Medicare’s Prescription Shopping Programme (PSP) as they remain a key tool to help identify a ‘doctor shopper’.
How to spot ‘doctor shopping’ behaviours
A ‘doctor shopper’ can be defined as someone who has obtained or who is attempting to obtain Schedule 8 prescriptions from three or more doctors from different practices over a three-month period.
Patients with doctor shopping behaviours may include:
- patients with a history of clinical issues and repeated doses may lead to dependence
- drug-dependent patients who are overusing or misusing
- patients in financial need who may try to sell their medications
- patients who suffer from mental health issues, lack social support, and may be at risk of self-harm or suicide.
PSP identifies patients who obtain more Pharmaceutical Benefits Scheme (PBS) subsidised medicines than they need. If you are a general practitioner and you have registered for the programme, you can contact this service 24 hours a day, seven days a week to receive information about a suspected doctor shopper.
A patient will have met the PSP criteria if they have received:
- any PBS items prescribed by six or more different prescribers
- a total of 25 or more PBS target items
- a total of 50 or more PBS items, both target and non-target.
How to deal with a suspected doctor shopper
Here are several clinical assessments and fact-checking exercises that may help in dealing with a potential doctor shopper:
- Have a sign in your waiting room saying: "No drugs of addiction will be provided on the first appointment". This does not mean you cannot provide drugs of addiction on the first appointment if the situation requires, but it might limit drug-seeking behaviour.
- Confirm the patient’s identity and attempt to consult databases, such as PSP, to check their history.
- Consider time-limited trials, supervised dosing, prescribing small amounts, and implement a follow-up regime.
Avant’s push for key regulatory changes
Avant provided a consultation paper to the TGA on a regulatory response to the potential misuse of prescribed Schedule 8 (S8) opioids in Australia.
Many practitioners face challenges dealing with patients who are drug-dependent. As a result, there has been a rise in patients who should not be receiving drugs of dependence and hesitation to prescribe to patients that require it.
Avant has championed measures which change prescribing behaviour, including:
- the implementation of a national real-time monitoring system
- the development of clinical support tools within clinical information systems to support doctors at the point of prescribing
- national harmonisation of legislation and regulation (including consistent terminology and clear definitions)
- continued and further education and guidelines about the legal and clinical aspects of prescribing S8 drugs.
Urgent need for national drug monitoring system
While there have been discussions that a national real-time monitoring system would be delivered soon, individual funding and planning is required from each state. The Federal Government rolled out the National Data Exchange (NDE) component in 2018, which will receive and distribute dispensing information across all states and territories but requires all states and territories to integrate with the NDE.
States are allowed to build their own real-time prescription monitoring systems, as long as they are interoperable with a national system. Pending the results of SafeScript in Victoria, it should set a benchmark for how the new system would work and evidently reduce drug-induced deaths involving opioid use.
If you need medico-legal advice regarding opioid prescribing, please email us at firstname.lastname@example.org or call 1800 128 268, 24/7 in emergencies.
- TGA's prescription opiods hub
- The Australian Bureau of Statistics: Opioid-Induced Deaths in Australia
- Safescript FAQs for health professionals
- AJP article: It's already making a big difference