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Background
SafeScript was implemented in Victoria in April 2019 as a clinical tool to aid prescribers and pharmacists to make safer clinical decisions by providing real-time access to information about high-risk prescription medicines prescribed or otherwise supplied to patients.
Between April 2019 and April 2020, prescribers and pharmacists were encouraged to use SafeScript to inform their decision making before prescribing or dispensing high-risk medicines as part of their existing obligation to ensure they take all reasonable steps to ensure a therapeutic need exists before prescribing Schedule 4 and 8 monitored medicines.
On 1 April 2020, it became mandatory for prescribers and pharmacists to take all reasonable steps to check SafeScript on each occasion before prescribing or supplying a patient with a monitored medicine (subject to certain limited exceptions). The rationale for implementing mandatory use was based on experiences of Prescription Drug Monitoring Programs in the USA, which found that the systems have greatest potential for reducing harm when fully utilised by health practitioners treating patients under their care.
The case study below highlights the importance of mandatory integration of SafeScript into practice and consequences of non-usage.
Patient details
Patient A was a middle-aged person found deceased in their home by Victoria Police in mid-2021. At the time of their death prescription medications were located in close proximity. The medical cause of death was found to be opioid toxicity (tapentadol and oxycodone).
Past medical history:
- Headaches
- Anxiety
- Gastrointestinal ulcer
- Duodenal ulcer
- Chronic pain
- Deviated septum
- Nasal polyps
- Granulomatosis with polyangiitis.
Medication history:
- Oxycodone
- Diazepam
- Tapentadol
- Methotrexate
- Folic Acid
- Prednisolone
- Pregabalin
- Mirtazapine
- Pizotifen
- Esomeprazole
- Ibuprofen/codeine
- Zolpidem
- Paracetamol/codeine.
A Coronial investigation concluded that on the background of long-term ill-health, Patient A had developed an addiction to prescription medicines and they actively sought out opioid drugs, among others, to satisfy this addiction to prescription medicines.
Between November 2020 and May 2021, a total of 988 tapentadol tablets (on 41 occasions) were prescribed to Patient A in both 50 mg and 100 mg dosage strengths, with clinical directions to take one tablet 3 times daily. Tapentadol was prescribed and dispensed in amounts exceeding the clinical directions.
During this period, a total of 1,785 oxycodone tablets (on 22 occasions) were prescribed to Patient A in 5mg dosage strength with clinical directions to take a total of 8 tablets daily. The total number of oxycodone tablets prescribed and dispensed over the period was the equivalent of almost 10 tablets daily, which exceeded these clinical directions.
Between December 2020 and May 2021, a total of 556 diazepam tablets (on 14 occasions) were prescribed to Patient A in 5 mg strength with clinical directions for most of this period being to take one half to one tablet twice daily. During their last 2 consultations, Patient A was directed to take two 5 mg diazepam tablets 3 times daily. The total number of diazepam prescribed and dispensed over the period was equivalent to a daily dose of 16 mg of diazepam a day.
A total of 9 practitioners were involved in the prescribing of the above medications for Patient A during these periods.
Practitioner case
The Department of Health investigated the 9 practitioners prescribing to Patient A as part of it's regulatory role in ensuring that prescribers check SafeScript on each occasion they prescribed a monitored medication.
One of those prescribers Doctor B, was an experienced general practitioner who graduated in the early 1990s and had been registered with Ahpra for nearly 20 years. Doctor B first registered as a SafeScript user in April 2020. Despite being registered for SafeScript, Doctor B did not access or view any patient profiles on SafeScript when prescribing a monitored medicine prior to Patient A's death.
At the time of Patient A's death, SafeScript had already been compulsory for use for more than a year.
Doctor B also did not hold a Schedule 8 (S8) Treatment Permit to prescribe Schedule 8 medicines for Patient A.
Medications Doctor B prescribed to Patient A between February 2021 and May 2021:
- Tapentadol – prescribed on 7 occasions (total of 8,800 mg)
- Oxycodone – prescribed on 3 occasions (total of 300 mg)
- Diazepam – prescribed on 2 occasions (total of 100 mg).
In all prescribing occasions, Doctor B failed to take all reasonable steps to check SafeScript for records or information in relation to the deceased before prescribing the monitored medicines.
In additional to the prescriptions provided by Doctor B, Patient A received 65 other prescriptions for the same monitored medicines from 8 other practitioners during the 6-month period leading up to their death.
Summary
The outcome
Doctor B was charged with 24 offences for conduct in their treatment of Patient A between February 2021 and May 2021:
- 12 summary offences under section 30F of the Drugs, Poisons and Controlled Substances Act 1981 – those charges relate to a failure to take all reasonable steps to check SafeScript before prescribing a monitored poison (Tapentadol, Oxycodone Hydrochloride and Diazepam); and
- 12 indictable offences under regulation 17(c) of the Drugs Poisons and Controlled Substances Regulations– those charges relate to a failure to ensure a therapeutic need existed before prescribing a monitored poison.
Doctor B was convicted and fined $20,000 in the Magistrates Court and ordered to pay $8,500 in costs. The Magistrate noted that in coming to the sentence imposed, they considered that had Doctor B not pled guilty, they would have ordered an aggregate fine of $50,000 with conviction.
Lessons to be learnt
SafeScript
Had the SafeScript profile of Patient A been accessed and reviewed, Doctor B would have been alerted to a significant history of prescribing of monitored medicines by multiple medical practitioners. This information would have assisted the prescriber in determining whether Patient A:
- had a therapeutic need for the prescribed medicines
- was a drug-dependent person and/or required a Schedule 8 Treatment Permit to be prescribed a Schedule 8 medicine
- might have been using monitored medicines inappropriately and should be managed differently. This may include utilizing additional support services and referral pathways and communicating and with other medical practitioners prescribing monitored medicines for patient A.
In the case of Patient A, SafeScript held records that showed he was receiving prescriptions for monitored medicines at a high frequency and from a total of 9 prescribers. This included records which showed that Patient A:
- had been treated with a Schedule 8 medicine for a period greater than 8 weeks by one or more practitioners
- was prescribed a daily morphine equivalent dose (MED) of opioid analgesics that exceeded 100 mg
- may be a drug-dependent person, given the frequency and quantity of monitored medicines prescribed and dispensed in a short time frame.
Coronial findings concluded that the conduct of each of the medical practitioners, in prescribing tapentadol and oxycodone without taking all reasonable steps to check SafeScript and heeding SafeScript alerts, is connected with Patient A's death.
Schedule 8 Treatment Permits
The requirement for Treatment Permits is intended to limit a patient’s ability to obtain Schedule 8 medicines from multiple prescribers and establishes criteria for when a prescriber requires a Treatment Permit to prescribe Schedule 8 medicines.
Accessing and viewing the profile of a patient in SafeScript provides prescribers with information that informs their assessment of whether a particular patient requires a Treatment Permit or whether a therapeutic need exists for the relevant medicine. SafeScript also provides prescribers with details of other prescribers (including any permit holders) and the dispensing pharmacist(s) to facilitate coordination of treatment between healthcare providers.
Coronial findings concluded that the conduct of Patient's treating medical practitioners who collectively prescribed opioids and other drugs in excess of medical need, contributed to the chain of events leading to the death.
Warning to health practitioners
SafeScript provides an opportunity for prescribers to identify and manage clinical risks associated with monitored medicines, engage patients in the clinical decision-making process, and ultimately reduce the likelihood of harm to patients.
Medical practitioners are reminded of their statutory obligations to take all reasonable steps to check SafeScript before prescribing and supplying a monitored medicine and to obtain S8 Treatment Permits prior to prescribing target medications.
Through prosecutions such as this, the Department of Health is working to minimise the harms associated with the misuse of high-risk prescription medicines. The Department continues to undertake investigations and actions against practitioners that fail to meet their statutory obligations when prescribing high-risk medicines.
Resources
- Schedule 8 permits and notifications – information on Schedule 8 Treatment Permits
- SafeScript for prescribers and pharmacists – SafeScript information for prescribers and pharmacists
- Real-time prescription – clinician resources by the Australian Commission on Safety and Quality in Health Care.
Reviewed 27 November 2024