PBS Special Arrangement and SA Exemption for supply of medicines using an image based prescription

The Commonwealth Government has made temporary changes to medicines regulation to ensure Australians can continue to access the Pharmaceutical Benefits Scheme (PBS) medicines they need, as the COVID-19 (Coronavirus) pandemic continues. One of these measures relates to the supply of a Schedule 4 (S4) medicine using an image based prescription.

To support this measure, a temporary Exemption has been made in South Australia to enable supply of S4 medicines using an image based prescription.

The notice relating to the Exemption was published in the South Australian Government Gazette on 16 April 2020.

Supply of a Schedule 4 medicine using an image based prescription – the PBS Special Arrangement

The Commonwealth’s National Health (COVID-19 Supply of Pharmaceutical Benefits) Amendment(Expansion of Telehealth and Telephone Attendances) Special Arrangement 2020 (PBS Special Arrangement) in place until 30 September 2020, makes temporary provisions to enable more convenient supply of medicines listed on the Pharmaceutical Benefits Scheme (PBS) to patients prescribed these as the result of a Medicare telehealth attendance, introduced as a temporary measure in response to the impact of risk of human coronavirus (COVID-19).

The PBS Special Arrangement means prescribers can give a prescription to a pharmacist using a digital image of the prescription instead of the original written prescription.

Prescribers must comply with all requirements of the PBS Special Arrangement which include that they must provide the digital image of the prescription directly to the pharmacist and not to the patient, and that the prescriber must keep the original prescription for two years.

The Special Arrangement allows a pharmacist to supply a pharmaceutical benefit without acknowledgment of the patient where it is impractical for them to sign the prescription, for example due to infection control. Pharmacists are still expected to ask patients to acknowledge receipt of the item where practical; however pharmacists are not required to sign on the patient’s behalf.

What does the Exemption allow in South Australia?

In South Australia, there is provision under Regulation 33 (5) of the Controlled Substances (Poisons) Regulations 2011 (Poisons Regulations) for a prescriber to give a prescription to a pharmacist by telephone, fax or by electronic transmission of the paper prescription. However, the Poisons Regulations require the prescriber to forward the original written prescription to the pharmacist if giving a prescription in these ways.

The Exemption temporarily exempts prescribers from the legal requirement to forward the original written prescription for the S4 drug to the pharmacist, provided it has been prescribed in accordance with the PBS Special Arrangement.

The Exemption enables the PBS Special Arrangement to apply in South Australia and also applies to prescribers who give image based prescriptions for non-PBS medicines.

How can prescribers give a prescription under the Special Arrangement?

The PBS Special Arrangement allows prescribers to provide a pharmacist with a digital image of their patient’s prescription via fax, email or text message. For example, the prescription may be sent to the pharmacist via:

• Fax or e-Fax
• Email or text message containing an original photograph of the prescription
• Email or text message containing a PDF of the original prescription.

Prescribers should check with the patient’s pharmacy about how they would like to receive a digital image of the prescription.

Pharmacists are obliged to confirm the bona fides of the prescription including that it has been written and sent by an authorised prescriber.

Which drugs cannot be prescribed under the Special Arrangement?

The Special Arrangement does not apply to drugs listed in Schedule 8 (S8) of the Poisons Standard, which includes opioids, stimulants and medicinal cannabis.

S4 drugs listed in Appendix D of the Poisons Standard are also excluded. S4 drugs listed in Appendix D include clozapine, benzodiazepines and hydroxychloroquine

The authorised prescriber should provide a paper prescription for S8 and S4 Appendix D drugs.

Do prescribers need to sign the prescription?

The legal requirements for what must be included in a prescription in South Australia have not changed and are set out in Regulation 34 of the Poisons Regulations.

The prescription will need to be signed as normal or using a valid digital signature as per the PBS Special Arrangement.

Authority prescriptions

The Special Arrangement applies to authority prescriptions and the usual inclusion of authority codes and notifications apply.

Repeat prescriptions

The pharmacist may create a repeat authorisation and attach it to a print out of the digital image to the prescription.  This should be held in the pharmacy for subsequent dispensing.

Can prescribers still give a prescription by fax or telephone where the drug is not included in the PBS Special Arrangement?

There are existing provisions under Regulation 33 (5) of the Poisons Regulations for how a prescription is to be given, which have long been in place in South Australian law.

A prescriber can, if of the opinion that good reason exists for doing so, give a prescription to a pharmacist by telephone or fax. If the prescription is not covered by the PBS Special Arrangement, the usual regulatory provisions apply and the prescriber must forward the written prescription to the pharmacist as soon as practicable, or within 24 hours for prescription for a drug of dependence.

Where a prescriber has given a prescription to a pharmacist by fax, the prescriber is not required to forward the original prescription to the pharmacist, provided the prescriber has endorsed the fax with the name and address of the single pharmacy that may dispense the prescription (Regulation 33(4)).

It is important to note that medicines prescribed outside of the provisions of the PBS Special Arrangement are not subsidised under the PBS.

For Poisons Regulations requirements for how a prescription is to be given in South Australia, refer to Regulation 33.

Further information

For further information about the PBS Special Arrangements refer to the Explanatory Statement and the following guides for prescribers and pharmacists:

• COVID-19 National Health Plan – Electronic Prescribing: A guide for prescribers
• COVID-19 National Health Plan – Electronic Prescribing: A guide for pharmacists

Pharmacists requiring information about PBS requirements under the PBS Special Arrangement should contact the Commonwealth Department of Health via email:pbs@health.gov.au or telephone 132 290.