Digital Images of Prescriptions for Schedule 4 Medicines fact sheet and FAQ (for Prescribers)
COVID-19 interim arrangements for prescriptions for Schedule 4 medicines in Tasmania: supporting the Commonwealth Special Arrangement
On 7 April 2020 the Commonwealth Department of Health issued the National Health (COVID-19 Supply of Pharmaceutical Benefits) Amendment (Expansion of Telehealth and Telephone Attendances) Special Arrangement 2020 to allow the supply of Pharmaceutical Benefits Scheme (PBS) subsidised medicines to patients via telehealth. The arrangement created an additional method for prescriptions for Schedule 4 medicines to be supplied based on a digital image of the prescription provided to a pharmacist by the PBS prescriber for a limited time. This arrangement ended on 31 March 2022 in a community setting but has been extend by the Commonwealth to apply in limited circumstances in hospitals.
The Tasmanian approval for use of digital image-based prescriptions in a community setting has also ended on 31 March 2022. To complement the Commonwealth’s extension in limited circumstances in hospitals, the Chief Pharmacist of the Department of Health has approved under Regulation 46 of the Poisons Regulations 2018 for prescribers who are authorised to issue prescriptions for Schedule 4 (restricted substances) to electronically issue such prescriptions directly to an approved hospital pharmacy as digital images under certain conditions. The prescriber issuing a prescription via a digital image under this Tasmanian approval must:
- comply with the requirements of regulation 45(5) of the Poisons Regulations 2018, with the exception of the condition that the prescription be handwritten in ink; and
- comply with the requirements of the Tasmanian Electronic Transactions Act 2000; and
- record that the prescription was issued to a pharmacist as a digital image; and
- retain the original prescription for two years; and
- produce the original prescription required to be retained, at the request of a Poisons Inspector appointed under section 23 of the Poisons Act 1971.
- applies only to prescriptions for the supply of restricted substances by pharmacies that are also approved hospital authorities within the meaning of the Australian Government National Health Act 1953; and
- does not apply to the prescribing of Schedule 4 declared restricted medicines (S4Ds) to which Section 36 of the Poisons Act 1971 applies (Poisons (Declared Restricted Substances) Order 2017) and does not apply to the prescribing of Schedule 8 narcotic medicines.
The Tasmanian approval has been issued in response to the COVID-19 pandemic and complements the Commonwealth’s time-limited special arrangement. The approval commenced on 1 April 2022 and continues in force until midnight 30 September 2022 unless revoked earlier.
What does this approval enable for prescribers?
This time-limited approval enables prescribers to send digital images of prescriptions for most Schedule 4 medicines to hospital pharmacies which are approved hospital authorities under section 94 of the National Health Act 1953 (Cth) and for these to be considered legal prescriptions.
The approval has been issued to provide an additional method for prescription supply to support the extension of the Commonwealth special arrangements in Tasmania. All other prescription supply arrangements may still be utilised whilst this approval is in force.
From 1 April 2022, digital image-based prescriptions in the community setting can no longer be legally issued in Tasmania, except in relation to hospitals as noted above. Digital image-based prescriptions issued by a prescriber prior to 1 April 2022 for Schedule 4 medicines (excluding Schedule 4D) will remain valid for 12 months from the date of issue for dispensing at the pharmacy sent the image-based prescription.
How would issuing a prescription to an approved hospital authority pharmacy using a digital image look in a ‘typical’ practice setting?
- A prescriber creates an original prescription including all required details under Regulation 45(5), during a telehealth consultation.
- This prescription must be signed by the prescriber using a valid signature, which may include an electronic signature. Prescriptions that are not signed cannot be dispensed.
- This prescription must be annotated to state that it is a digital image of the prescription. In this case, no original paper prescription is required to be sent by the prescriber to the dispensing approved hospital authority pharmacy
- The prescriber then ensures a clear digital copy of the entire signed prescription (a digital image such as a photo or pdf including the barcode, where applicable) is sent directly to the patient’s nominated approved hospital authority pharmacy.
- The paper prescription and digital image of the prescription must not be supplied to the patient.
- The prescriber must make a record that the digital image of the prescription has been sent directly to the approved hospital authority pharmacy, noting the particulars of the approved hospital authority pharmacy and method of transmission.
- The prescriber must retain the original prescription for a period of two years for audit and legislative compliance purposes.
Why do prescribers need to record that the prescription was issued to a pharmacist as a digital image? How do prescribers do this?
In the event of audit and compliance actions by a Poisons Inspector in either a medical practice or pharmacy, recording that a prescription has been issued to the pharmacist as a digital image is required to verify accountability for the authorisation to supply without the supply of the original paper prescription under this approval. It is recommended that prescribers record on the original prescription and their clinical system, where and how they have transmitted the digital image of the prescription. Failure to annotate a prescription to state that it is a digital image of the prescription signals to a pharmacist that the request is an emergency instruction under Regulation 47 and would require the original paper prescription to be provided to the pharmacist. This process requires a pharmacist to record the supply of the medicine in their clinical dispensing software differently whilst they await supply of the original paper prescription.
What happens at the approved hospital authority pharmacy?
Once the patient’s nominated approved hospital authority pharmacy has received the digital image of the prescription, the pharmacy will supply the prescribed medicine(s) to the patient. Existing obligations for pharmacists to keep records of all supplies of scheduled medicines have not changed. The annotation provided by the prescriber on the prescription noting the digital image is to be used for supply informs a pharmacist that they will not receive a hard copy prescription and enables a pharmacist to record the dispensing event normally.
What about if repeats are authorised on the digital image of the prescription?
If a digital image of a prescription for a Schedule 4 medicine is issued with repeats, the Commonwealth requires that all remaining repeats are retained and supplied at the original dispensing pharmacy.
How does this affect existing paper prescriptions and repeats?
Patients with existing paper prescriptions or repeats who are confined to their homes will not be able to use this method to send a digital copy to the pharmacy in place of the paper prescription.
Do prescribers need to sign prescriptions issued as a digital image?
Yes. Prescriptions must be signed by the prescriber before legal supply can occur. This is a requirement of Regulation 45(5) and provides verifiable confirmation to a pharmacist of a prescriber’s intentions.
How does a pharmacist verify a prescription is authentic?
The introduction of the Commonwealth’s special arrangement has resulted in the reduction of tangible features available on paper prescriptions for pharmacists to verify the authenticity of a prescription. Potentially there are also new practical methods a prescriber may utilise to send a digital image of prescription to a pharmacist. These circumstances may create practice ambiguity for prescribers and pharmacists. Provided the digital image of the prescription meets the requirements of this approval, the method a pharmacist utilises to verify a prescription’s authenticity is a practice issue. It is recommended that pharmacists and prescribers collaborate to establish mutually beneficial communication systems that are secure, effective, and ultimately provide safe ongoing care to patients.
Are there any storage and retrieval requirements for prescribers?
The prescriber will be required to retain the original prescription for a period of two years for audit and legislative compliance purposes.
Does this approval apply to Schedule 8 and Schedule 4D medicines?
No. The use of a digital image of the prescription for these medications is not approved in Tasmania. Medicines classified as Schedule 8 (eg oxycodone, morphine) or Schedule 4D (eg diazepam, Panadeine Forte®) are not included in the approval under Regulation 46. Prescribers are required to use the established legal methods of authorising supply of S8 and S4D medicines to pharmacists in case of emergency (eg phone or fax instruction), followed by the legal requirement for the paper prescription to be sent to the pharmacy within five days of authorising the emergency supply.
The decision to limit this approval to Schedule 4 medicines is due to the absence of a robust Council of Australian Governments endorsed framework which would ensure a secure industry-standard applies to this prescribing method to mitigate the risk of fraudulent activity.
Does this approval allow my prescribing software to electronically transmit prescriptions under the Australian Electronic Prescribing Conformance Framework?
No. Software that has been developed to generate, transmit and receive prescriptions via the Australian Electronic Prescribing Conformance Framework must attain a Conformance ID from the Australian Digital Health Agency (ADHA) and an approval under the Poisons Act 1971 from the Secretary of the Tasmanian Department of Health.
Why does this approval have an expiry of 30 September 2022?
This approval has been issued in response to the COVID-19 pandemic and complements the Commonwealth’s time-limited special arrangement. This approval may be revoked sooner should the COVID-19 pandemic subside or if the Commonwealth instrument is rescinded.
Is sending a digital image of a prescription for Schedule 4 medicine to an approved hospital authority pharmacy available to hospital prescribers?
Yes. The same requirements detailed above apply for storage of the original prescription for two years and a record made that a digital image of the prescription was sent.
For questions regarding the fast tracking of the Australian electronically transmitted prescription system framework or extended special arrangement measures please contact the Commonwealth Department of Health. For questions regarding the Tasmanian poisons legislation please contact Pharmaceutical Services Branch.