Medicines Management during COVID-19

On 9 June 2021, registered pharmacists and intern pharmacists in the ACT were authorised to administer a vaccine for COVID 19 included on the Australian Register of Therapeutic Goods, in accordance with the ACT Pharmacist Vaccination Standards (Vaccination Standards).

The Vaccination Standards included a condition that pharmacists were only able to administer the COVID-19 (chadox1-s) (AstraZeneca) vaccine to people aged 50 years or older in accordance with the Australian Technical Advisory Group on Immunisation (ATAGI) at that time when the Pfizer (Comirnaty) COVID-19 vaccine was preferred over the AstraZeneca vaccine for people aged under 50 years.

As of 10 August 2021, the Vaccination Standards have been updated to remove this condition on pharmacists. Pharmacists may now administer the AstraZeneca vaccine to persons aged 18 years and over with informed consent.

Pharmacists must administer the AstraZeneca vaccine in accordance with the most recent ATAGI clinical guidance on use of COVID-19 vaccine in Australia as it relates to patient age. The most recent ATAGI clinical guidance dated 17 June 2021 is that that the Cominarty (Pfizer) vaccine is preferred over the AstraZeneca vaccine for people aged less than 60 years. This means that pharmacists may administer the AstraZeneca vaccine to persons aged 18 to 59 years, but only after preferential consideration of the Pfizer vaccine for that person and with written informed consent from the patient. Pharmacists should explain the risks and benefits of the AstraZeneca vaccine to patients prior to obtaining informed consent.

The Australian Government has published Information for health care providers to help consumers make informed decisions about the COVID-19 AstraZeneca vaccine. Pharmacists should refer to this resource when explaining the risks and benefits of the AstraZeneca vaccine and are encouraged to use the Australian Government Consent form for COVID-19 vaccination when obtaining patient consent.

As of 10 August 2021, the Vaccination Standards have also been updated to enable pharmacists to administer COVID-19 vaccines in accordance with minimum patient age limits provisionally approved by the Therapeutic Goods Administration.

Currently, the minimum patient age provisionally approved by the TGA for use of COVID-19 vaccines is as follows:

• AstraZeneca vaccine – 18 years
• Pfizer vaccine – 12 years
• Moderna vaccine – 12 years.

If any of these COVID-19 vaccines become approved for use in children younger than 10 years of age, pharmacists will only be authorised to administer the vaccine to patients aged 10 years or over.

For all COVID-19 vaccines, a pharmacist must be able to demonstrate evidence of successful completion of the Australian Government COVID-19 Vaccination Training Program. All dealings with a COVID-19 vaccine must be in accordance with the Australian Government COVID-19 Vaccination Program.

A pharmacist should administer a COVID-19 vaccine in accordance with the Australian Technical Advisory Group on Immunisation (ATAGI) Clinical guidance on use of COVID-19 vaccine in Australia (current online version).

Pharmacists must electronically record all vaccination events (including non-COVID-19 vaccines) on the Australian Immunisation Register (AIR) as soon as possible following administration.

The COVID-19 (chadox1-s) (AstraZeneca) vaccine will become available at participating pharmacies as part of the Australian Government COVID-19 Vaccination Program when stocks are made available.

For further information please visit the Pharmacist Vaccinations page or contact the Pharmaceutical Services Section of the Health Protection Service on pss@act.gov.au or (02) 5124 9208.

The Australian Government COVID-19 National Health Plan package enables vulnerable people and people in self-isolation to order their PBS and RPBS prescriptions remotely and have their medicines home delivered to reduce their potential exposure to COVID-19. All community pharmacies will be eligible to participate if they can support online dispensing of medicine and provide home delivery services.

Home medicines services are enabled by ACT legislation1

Further information about the Australian Government COVID-19 National Health Plan - Home Medicines Services package may be found here.

As of 14 October 2022, mandatory isolation requirements were lifted in the ACT for individuals who test positive to COVID-19. The continued safe delivery of opioid maintenance treatment (OMT) for ACT patients during COVID-19 remains a priority for ACT Government.

The Chief Health Officer Controlled Medicines approvals framework under ACT legislation provides options to support prescribers and their patients during COVID-19.

Patients who test positive to COVID-19 have the option to attend their usual dosing point, arrange for personal collection or nominate an agent to collect and deliver their OMT on their behalf. The ACT Health Directorate has updated information for patients who test positive to COVID-19.

The ACT Health Directorate has updated the contingency guidelines for OMT clients who test positive to COVID-19. Additional updated information includes:

• Prescriber Information and;
• Information for pharmacists and nurses providing OMT.

If you are a prescriber or pharmacist and have any questions about managing OMT for your patients who test positive to COVID-19, please contact the Health Protection Service 02 5124 9208 or hps@act.gov.au.

For general information on OMT contingency arrangements contact AODPolicy@act.gov.au.

The Australian Government Therapeutic Goods Administration (TGA) has made updates to scheduling of some medicines during the COVID-19 emergency. The key changes include:

Salbutamol

The schedule 3 (pharmacist only medicine) entry for salbutamol has been changed to limit supply:

- to persons with evidence of a medically diagnosed lung condition; or

- to persons with a record of previous supply from the pharmacist; or

- to persons authorised under a law of a State or Territory to use or supply salbutamol in the practice of their profession; or

- for use in institutional first aid; and

Supply is also restricted to one primary pack of salbutamol per person (with evidence of a medically diagnosed lung condition or previous supply from the pharmacist).

The scheduling change for salbutamol is automatically adopted in ACT legislation1.

The Australian Government has made these changes to regulate inappropriate supply of salbutamol and to ensure ongoing access for people with diagnosed respiratory conditions.

Hydroxychloroquine

Hydroxychloroquine is approved for use as a treatment for malaria and certain autoimmune diseases, including rheumatoid arthritis.

Recently there has been considerable focus on hydroxychloroquine as a potential treatment for COVID-19, leading to increased off-label prescribing.  This has the potential to create a shortage of hydroxychloroquine for patients who need it for treatment of an auto-immune condition.

Given the limited evidence for effect against COVID-19, as well as the risk of significant adverse effects, the TGA strongly discourages the use of hydroxychloroquine outside of its current indications at this time other than in a clinical trial setting or in a controlled environment in the treatment of severely ill patients in hospital.

To regulate off-label prescribing and ensure continued access for patients who require this medicine, the Australian Government has listed hydroxychloroquine as an Appendix D medicine in the Poisons Standard. Appendix D medicines are those where additional controls apply on their possession or supply.

The Appendix D entry restricts the initial prescribing of hydroxychloroquine to the following specialists from 24 March 2020:

1. dermatology;
2. intensive care medicine;
3. paediatrics and child health;
4. physician;
5. emergency medicine.

From 3 April 2020, the Appendix D entry also applies to Australian Dental Board registered oral medicine specialists.

Further information on the new restrictions on prescribing hydroxychloroquine can be found on the Therapeutic Goods Administration website.

The Appendix D entry for hydroxychloroquine is automatically adopted in ACT legislation1.

This means that from 24 March 2020 offences apply for prescribing of hydroxychloroquine by unauthorised prescribers in the ACT.

Appendix D medicines cannot be self-prescribed in the ACT.

The Therapeutic Goods Administration (TGA), in consultation with state and territory health departments and national stakeholders, has developed a national protocol for enabling pharmacists to substitute medicines during serious medicines shortages.

In the event of a serious medicines shortage, the TGA will coordinate stakeholder advice on whether a pharmacy-level substitution is warranted. The decision to confirm a serious medicines shortage and allow substitution would be made by the TGA and will be published as a Serious Shortage Medicine Substitution notice (Notice) on the TGA website.

There is a range of situations where substitution by a pharmacist could be undertaken by a Notice, such as dispensing tablets of:

• a lower or higher strength of a product, 
• another dose form of the same medicine, 
• a combination of individual medicines when a fixed dose combination is not available, or 
• an immediate release form in lieu of a sustained/ extended release version or vice versa. 

Under the TGA protocol, substitution will not be permitted for another product containing a different active ingredient or for Schedule 8 (controlled) medicines, such as strong opioids. 

A pharmacist is not required to check with the patient’s prescriber before substitution in accordance with a TGA Notice, however they should advise the prescriber as soon as practicable.

To enable pharmacist substitution under a TGA Notice in the ACT, on 1 May 2020, Dr Kerryn Coleman, ACT Chief Health Officer issued a temporary Standing Order for the supply of medicines during a public health emergency under the Medicines, Poisons and Therapeutic Goods Regulation 2008. 

This decision has been made to reduce the impact of a serious medicines shortage in the ACT and prevent or mitigate any resulting public health harms. 

The Standing Order automatically enables pharmacist substitution of any medicine in accordance with a TGA Notice in the ACT. The Standing Order is in force for the duration of the ACT declared public health emergency, unless revoked earlier. ACT Health Directorate will consider options to adopt the TGA scheme in the longer term. 

More information about the TGA Serious Medicine Shortage Substitution protocol, including Questions and Answers, is available on the TGA website.

The Australian Government is fast-tracking implementation of electronic prescribing (ePrescribing) as part of its COVID-19 National Health Plan.

ACT legislation supports electronic prescribing. Practitioners who are ready and using conformant software may commence use of electronic prescriptions for their patients.

Further information about electronic prescriptions is available here.

The Australian Government has enabled the dispensing and claiming of pharmaceutical benefits using a digital image (photo, scanned copy or pdf) of the prescription as an interim measure to support telehealth services.

Under the Australian Government interim arrangements[2], the dispensing and claiming of pharmaceutical benefits using a digital image are allowed, including:

• A digital image (photo, scanned copy or pdf) of the entire prescription sent to the patient’s pharmacy of choice directly from the prescriber via email or text message (Digital Image Prescriptions), or
• A copy of the entire prescription sent to the patient’s pharmacy of choice directly from the prescriber via fax (Faxed Prescriptions).

Digital image and faxed prescriptions are enabled by ACT legislation [1]. Further information about these types of prescriptions is listed below.

Telephone (verbal) prescriptions are also enabled by ACT legislation[1]. An original written prescription must be sent to the pharmacy within 24 hours of being given verbally. Written includes in electronic form. Telephone prescriptions are not claimable under the Australian Government interim arrangements.

The supply of schedule 4 (prescription only) Appendix D and schedule 8 (controlled) medicines using electronic, digital image, fax or telephone prescriptions is enabled under ACT legislation[1].

It is critical that prescribers send prescriptions directly to the patient’s pharmacy and have the necessary ACT standing or Chief Health Officer approval in place in order to mitigate risk of diversion or duplicate dispensing of Appendix D or schedule 8 medicines that may be subject to abuse or misuse.

Prescribers and pharmacists are also reminded to use the DORA real time prescription monitoring website to support patient care for those requiring treatment with a controlled medicine. Further information about ACT DORA is available here.

Digital Image Prescriptions

Digital image prescriptions transmitted electronically are enabled by ACT legislation[1].

A digital image prescription must be sent from the prescriber directly to the patient’s pharmacy of choice. Digital image prescriptions should never be given directly to the patient.

You can search for your patient’s preferred pharmacy and their contact details using the Healthdirect Find a health service website.

Under ACT and Australian Government interim arrangements, prescribers are not required to send a printed paper prescription to the pharmacy. The Australian Government interim arrangements require a prescriber to retain the prescription for at least 2 years.

Prescribers should also obtain and record patient’s consent to send the prescriptions electronically.

Please note that the PBS and RPBS interim arrangements are only for prescriptions written as a result of telehealth attendance or phone attendance provided on or after 20 March 2020. The PBS and RPBS interim arrangements are temporary and will cease in accordance with the COVID-19 National Health Plan which is currently scheduled to cease on 31 March 2022.

Faxed Prescriptions

The PBS and RPBS interim arrangements and ordinary arrangements[3] allow pharmacists to supply pharmaceutical benefits from a copy of prescription sent via fax.

Faxed prescriptions are also enabled by ACT legislation[1]. ACT pharmacists may claim for pharmaceutical benefits supplied on a faxed prescription according to the PBS and RPBS interim arrangements.

Under the Australian Government interim arrangements, a prescriber is required to retain the original of a faxed prescription for at least 2 years, which is permitted by ACT legislation.

Pharmacists are required to confirm that the faxed prescription was written as part of a telehealth consultation in order to meet the ACT record keeping requirements and should make a record of this.

Verbal advice from the prescriber or patient is considered sufficient for this purpose. Prescribers can also confirm this in writing on the faxed prescription.

If a faxed prescription was not written as part of a telehealth consultation, ACT legislation requires:

• the prescribers to send the original prescription to the pharmacy within 7 days of sending it via fax[4].
• the pharmacists to notify the Pharmaceutical Services Section of the Health Protection Service (on behalf of the Chief Health Officer), in writing, if they fail to receive the original prescription of a faxed prescription within 14 days of dispensing [5]. Notifications may be sent to pss@act.gov.au or via fax 02 5124 9309.

ACT Health Directorate has worked with key medical and pharmacy stakeholder and developed the following FAQs to assist with Telehealth Prescribing.

Further information about the Australian Government interim prescribing arrangements for prescribers and pharmacists are available via these links.

Further information on requirements for Digital image prescriptions and Faxed prescriptions in the ACT is available here.

Further information about prescribing via telehealth for your patients is available on the telehealth prescriptions FAQ page.

Contact details of  community pharmacies are available at the Healthdirect Find a health service website.

[1 Medicines, Poisons and Therapeutic Goods Act 2008]

[2 National Health (COVID-19 Supply of Pharmaceutical Benefits) Special Arrangement 2020]

[3 National Health (Pharmaceutical Benefits) Regulations 2017]

[4 Section 31 of Medicines, Poisons and Therapeutic Goods Regulation 2008]

[5 Section 120(g) of Medicines, Poisons and Therapeutic Goods Regulation 2008]

The Australian Government’s Continued Dispensing – Emergency Measures have been extended for the COVID-19 emergency. 

The Continued Dispensing arrangements enable a pharmacist to supply a Pharmaceutical Benefits Scheme (PBS) or Repatriation Pharmaceutical Benefits Scheme (RPBS) medicine to a patient when there is an immediate need and they cannot obtain a prescription. 

Continued Dispensing is fully enabled under the ACT Medicines, Poisons and Therapeutic Goods Act 2008 and has immediate effect in the ACT. More information about Continued Dispensing is available on the PBS website.

In addition, on 1 April 2020, Dr Kerryn Coleman, ACT Chief Health Officer issued the Medicines, Poisons and Therapeutic Goods (Temporary Authority – Supply by pharmacists of designated Schedule 4 medicines without prescription) CHO Standing Order 2020 (No 2) to enable the emergency supply of a standard pack size of private designated (non-PBS) prescription only medicines by pharmacists without a prescription during the COVID 19 emergency. 

Prescribers and pharmacists are encouraged to read this Information sheet.

Further information about novel coronavirus is also available on our website.