Medicines monitored by SafeScript
Prescription medicines that present the greatest risk of harm to the Victorian community are monitored through SafeScript.
The current list of medicines monitored by SafeScript is tabled below:
|Type of prescription
|Strong opioid painkillers
|Buprenorphine, Codeine, Fentanyl, Hydromorphone, Methadone, Morphine, Oxycodone, Pethidine, Tapentadol.
|Strong medicines for anxiety or sleeping tablets (benzodiazepines)
|Alprazolam, Flunitrazepam, Bromazepam, Clobazam, Clonazepam, Diazepam, Lorazepam, Midazolam, Nitrazepam, Oxazepam, Temazepam.
|Other strong sleeping tablets
|Stimulants for ADHD or narcolespsy
|Dexamphetamine, Lisdexamfetamine, Methylphenidate.
|Other high-risk medicines
|Ketamine, Quetiapine, pregabalin, gabapentin, tramadol
These medicines ware informed by literature reviews commissioned by the Department of Health, conducted by Austin Health.
This encompassed both local and international research. The SafeScript Expert Advisory Group were also consulted on the list of medicines to be monitored in SafeScript following presentation of findings of the literature reviews.
Three literature reviews have been commissioned by the Department of Health and undertaken by Austin Health since 2017. These are outlined below.
2021 Austin Health literature review
In 2021, the Department of Health commissioned Austin Health to review the literature of the evidence of harm caused by pregabalin, gabapentin and tramadol. This followed recommendations made by the Coroners Court of Victoria to include pregabalin in SafeScript.
It aimed to assess whether these medicines should be added to others monitored in SafeScript.
For the dispensing and prescribing data of these medicines to be collected as part of SafeScript a process needs to take place:
1. An amendment to the to Drugs, Poisons and Controlled Substances Regulations 2017 to add these substances in Schedule 5 and Schedule 6 of the regulations.
2. This would then mandate transmission of dispensing records for these medicines to the Prescription Exchange Services from all pharmacies in Victoria with compatible pharmacy dispensing software.
3. Data would then be collected in SafeScript.
Inclusion of these medicines in the regulations would also introduce a requirement for prescribers and pharmacists to take all reasonable steps to check SafeScript prior to prescribing and dispensing these medicines, respectively.
A public consultation process will take place to determine whether the regulations should be amended to include pregabalin, gabapentin and tramadol. A Regulatory Impact Statement will be released during the consultation process and feedback from stakeholders will be given the opportunity to provide feedback. Further information on the public consultation will be provided closer to the date.
A copy of the full Austin Heath report can be found below.
2019 review of medicines monitored in SafeScript, and initial 2017 study
In the lead up to SafeScript becoming mandatory in April 2020, an update of the literature review was commissioned in early 2019 to determine if there was any significant new evidence of harm associated with medicines not currently monitored in SafeScript. These findings were then reviewed by the SafeScript Expert Advisory Group.
Medicines looked at in detail in the updated review included pregabalin (used for neuropathic pain), tramadol (a synthetic opioid pain reliever) and olanzapine (treatment for psychiatric conditions).
The Expert Advisory Group did not recommend any new medicines be added to the list of those currently monitored.
In the case of pregabalin, the literature review found evidence of harm only when pregabalin was used in combination with opioids or benzodiazepines, not when prescribed on its own. Overall, the scale of harm for these medicines considered in the 2019 review was not at the same level compared to medicines currently monitored in SafeScript.
Framework for future recommendations
A framework has been developed to guide future recommendations on the inclusion of additional Schedule 4 medicines in SafeScript. This will enable a consistent, transparent and evidence-based approach to be applied when a medicine is being considered for monitoring in SafeScript.
Copies of the initial literature review, the updated review and the criteria for inclusion of additional medicines in SafeScript are available here:
Reviewed 08 August 2023