Electronically transmitted prescriptions fact sheet (for software vendors)

The advent of electronically transmitted prescriptions in Australia has the potential to improve the Quality Use of Medicines by prescribers, pharmacists and patients. This fact sheet provides information for software vendors regarding electronically transmitted prescriptions in Tasmania.

What are electronically transmitted prescriptions?

Electronically transmitted prescriptions are an electronically transmitted and digitally signed legal order authorising the supply of a scheduled substance. An electronically transmitted prescription is issued by a prescriber and transmitted securely for dispensing by a pharmacist, through approved software without production of a paper prescription.

Electronic Transfer of Prescriptions (ETP) involving the use of barcodes on paper prescriptions are not electronically transmitted prescriptions, as the legal order is the original paper prescription.

Paper prescriptions and electronically transmitted prescriptions are separate formats and are not interchangeable. A prescription is issued in either a paper or an electronic format, and that format will remain the same for the life of that prescription. A prescription cannot be converted from one format to the other.

What is changing?

From 1 November 2019, the Commonwealth Government introduced legislative amendments to the National Health Act 1953 (Cth). These amendments enable electronically transmitted prescriptions for scheduled substances listed on the Pharmaceutical Benefit Scheme (PBS) to be claimable for subsidy, in the same way as paper prescriptions.

As a result of the Commonwealth legislative changes, it is anticipated the uptake of electronically transmitted prescriptions will increase. Paper prescriptions and electronically transmitted prescriptions will co-exist, allowing patients to choose their preferred format where available. Software systems are required to obtain a Conformance Identification (ID) from the Australian Digital Health Agency (ADHA) after self-attestation that their system conforms with the ADHA Electronic Prescribing Technical Framework (ADHA Framework).

There is significant change and adoption work being co-ordinated by the ADHA, engaging both software vendors and professional organisations regarding the implementation of electronically transmitted prescriptions.

The Tasmanian poisons legislation was amended in 2008 to allow for electronically transmitted prescriptions where approved by the Tasmanian Secretary for Health. The relevant provisions are Regulations 21 and 46 of the Poisons Regulations 2018. Any software system used in Tasmania to prescribe, transmit, or dispense electronically transmitted prescriptions requires approval in writing from the Secretary for Health.

What is required by software vendors for implementation of electronically transmitted prescriptions in Tasmania?

Step 1 - Australian Digital Health Agency self-attestation process

Software vendors will need to obtain a Conformance ID by submitting a Declaration of Conformance to the ADHA. This requires software vendors to self-attest that their software system conform with the ADHA Framework, state and territory legislative requirements, and national privacy and security principles. The self-attestation model does not include active assessment or quality assurance of a software system by the ADHA. Once issued by the ADHA, the system Conformance ID will be added to the Register of Conformance on the ADHA website.

Software vendors with questions relating to the ADHA Framework or Conformance ID should contact the ADHA.

Step 2 - Tasmanian poisons legislation approval process

Software vendors must apply for approval under Regulations 21 and 46 of the Poisons Regulations 2018 for use of their software system(s) in Tasmanian. The active assessment of applications for approval in Tasmania safeguards that software systems meet the Tasmania legislative requirements. The assessment of software systems includes consideration of authentication (login), authorisation (signing), security, record keeping (storage of data), reporting and auditability features.

To do this software vendors must download the Application for Approval of Electronic Prescription Systems from the Tasmanian Department of Health website and email the completed form to the Chief Pharmacist.

Each application will be assessed on a case-by-case basis and the Department will work with the applicant as part of the approval process. Applicants will be required to provide documentation or demonstration of the system to show the software meets requirements. Additional details may be required depending upon the software application including technical and security information, access procedures and reporting capabilities. The Department may require assessment of the system against relevant industry or quality standards. Any approval will be subject to conditions.

Prior to requesting approval under the Tasmanian poisons legislation, software vendors must:

1. Demonstrate a Conformance ID is listed on the Australian Digital Health Agency Electronic Prescribing Register of Conformance.
2. Demonstrate how the record of the authorised health professional prescribing or dispensing is permanently linked to a prescription, and retained and retrievable upon demand by a Poisons Inspector.
3. Demonstrate how a digital copy of an electronically transmitted prescription is retained and retrievable upon demand by a Poisons Inspector.
4. Demonstrate how a prescriber must reauthenticate prior to issue of a prescription for a Schedule 8 substance.
5. Demonstrate how a repeat interval is electronically endorsed by a prescriber or electronically annotated by a pharmacist for a Schedule 8 or Schedule 4D substance; and demonstrate there is no arbitrary default value for the repeat interval.
6. Demonstrate how the part of a prescription that refers to an unusual dosage is underlined, or by some other means emphasised, by the prescriber and displayed to the pharmacist.
7. Demonstrate reports, including but not limited to:
   • Compliance and audit reporting of prescription details to a Poisons Inspector - showing minimum of:
     • Human readable format
     • Available on demand
     • Indication of paper or electronic format
     • Global unique identifier
     • Date of prescribing and/or dispensing
     • Patient full name and DOB
     • Prescriber and/or dispenser
     • Medication name, strength, form, quantity
     • Exportable format eg CSV or Excel®.
8. Demonstrate how the prescriber or dispenser can maintain control of the prescription token where required under Tasmanian legislation for patient and public safety purposes, eg Section 59E authorisations.
9. Confirm the record of the dispensing of a relevant substance can be provided to the Tasmanian Department of Health database of relevant substances, including the required information for that acquisition or disposal as close to immediately as practicable.
10. Comply with the provisions of the Poisons Act 1971 and Poisons Regulations 2018 in relation to the supply of the scheduled substances.

Required information for prescribers and pharmacists?

Software vendors will need to provide prescribers and pharmacists with confirmation that approval from the Secretary for Health has been granted under the Poisons Regulations 2018.

Prescribers or pharmacists with questions about system integration, practical implementation or technical support for electronically transmitted prescriptions are being directed to contact their software vendors, and the ADHA.

More information

For electronically transmitted prescription system integration, practical implementation and technical support, please contact your software vendor.

For information on the ADHA Framework for electronically transmitted prescriptions, please contact the Australian Digital Health Agency:

Web:    www.digitalhealth.gov.au

Phone: 1300 901 001

Email:   [email protected]

 

For questions regarding the poisons legislation in Tasmania please contact Pharmaceutical Services Branch on:

Phone:  (03) 6166 0400

Email:   [email protected]