COVID-19 practice advice and regulatory issues
This information was last updated Friday 15 September 2023
- Face masks and PPE: Pharmacists should continue to wear medical grade face-masks in public/patient-facing roles.
- Medicine supply limits apply ongoing: Find the latest updates on the supply of prescription and non-prescription medicines.
- Spikevax, (Moderna) mRNA COVID-19 vaccine:
- Omicron BA.4-5 COVID-19 vaccine – From March 2023
- Comirnaty, Pfizer mRNA COVID-19 vaccine:
- Omicron BA.4-5 COVID-19 vaccine – From March 2023
- Pfizer 5-11 years (orange cap), paediatric COVID-19
- Nuvaxovid, Novavax’s protein-based COVID-19 vaccine
The following COVID-19 vaccines are no longer available:
- Vaxzevria, AstraZeneca COVID-19 vaccine
- Bivalent Omicron COVID-19 vaccine
- Comirnaty (Pfizer) mRNA COVID-19 vaccine original formulation – no longer available from June 2023
- Omicron BA.1 COVID-19 vaccine – From December 2022 to March 2023
- Spikevax, (Moderna) mRNA COVID-19 vaccine original formulation – no longer available from November 2022
Not all community pharmacies are administering all vaccines. Most pharmacies are limiting services to specific clinic times or dates.
The vaccine roll-out has been extended until 31 December 2023 as part of Australia’s 2023 COVID-19 national management plan.
The EOI and payment process is managed by the Pharmacy Programs Administrator (PPA) on behalf of the Department of Health (Australian Government).
Until 30 September 2023, pharmacist vaccinators must undergo specific training in the COVID-19 vaccines, which will be the same for all health care workers administering COVID-19 vaccines. Vaccinators are expected to complete the relevant module before administering each different vaccine – including the new bivalent formulations. Vaccinators are also expected to revise each module after each update. This is in addition to meeting the requirements of being a pharmacist vaccinator in your state/territory.
Pharmacists seeking to become vaccinators can undertake pharmacist vaccinator training offered by PSA which is recognised by state and territory governments.
Pharmacists who wish to do additional training to familiarise themselves with multi-dose vials can request to undertake vaccine refresher training at PSA Vaccine Face-to-Face immunisation workshops
Information about COVID-19 vaccines has been translated into over 60 languages. Help your patients access information in their language.
Links for specialist information services for every state/territory. These services provide specialised immunisation advice and care to clinicians and families. These services have specialised nursing and medical staff to provide clinical advice on immunisation for patients with complex or unusual medical backgrounds or who have had an adverse event following immunisation.
Face masks and personal protective equipment
Face masks remain recommended in health settings by health departments in some jurisdictions. Recommendations may vary depending on practice setting. Some workplaces, such as hospitals and aged care, are subject to additional PPE obligations or may introduce additional PPE requirements as controls to mitigate risk.
Pharmacists and pharmacy staff should wear face masks which are at least medical grade masks, such as type 1 surgical masks. Correctly fitted P2/N95 masks offer additional protection for the person wearing the masks and their contacts.
Cloth masks and reusable masks should not be used. Face shields are considered eye protection. They not an equivalent substitute for surgical masks.
Pharmacists and pharmacy staff should wear surgical masks rather than reusable cloth masks consistent with all health providers
Community pharmacy and general practice
Pharmacists and pharmacy staff should wear a medical grade face mask at work (Level 1 or above) due to risk of exposure to COVID-19 in the workplace and care role in supporting vulnerable people. Correctly fitted P2/N95 masks offer greater protection than surgical masks.
Hospital pharmacy and aged care
Adhere to advice provided by your health department, state government directions notices and/or employer as applicable.
Home medicine reviews
Where interviews are conducted in person, face masks should be worn where required or recommended. Where possible, well ventilated or outdoor locations should be chosen for the interview to reduce transmission risk.
Pharmacists and pharmacy staff should wear surgical masks rather than reusable cloth masks consistent with relevant health department guidance for all health care workers. N95/P2 masks, where available, offer greater protection to the person wearing the mask and to people the person wearing the mask comes into contact with.
Eye protection is an enhanced precaution which has been recommended in various locations during COVID-19 to protect health care workers against risk of transmission. It is generally recommended in routine care of people who may have respiratory infections.
Where eye protection is recommended for health workers, it is of greatest protective value where there is a risk of droplet transmission. PSA considers this to apply to the following:
- Point-of-care tests including blood pressure, blood glucose monitoring
- CPAP services (e.g. mask-fitting)
- Provision of first aid
- Wound care
- Some consultation services
- Any other service where there is a risk of contact with body fluids
Pharmacists may also wish to wear eye protection in other situations where there is a risk of contact with body fluids is a risk. When recommended, PSA suggests pharmacists should minimise exposure risk by erring on the side of caution; citing that if staff are directly interacting with the public eye protection is required.
Notes for using eye protection
- Some face shields are single-use only, while others can be reused
- Reusable googles and face shields must be removed, cleaned and disinfected between use according to manufacturer’s instructions
- Eye protection is additional to the requirement for use of face masks and other infection control measures such as physical distancing, hand hygiene and staying home if sick.
Higher levels of precaution are needed where there is contact with a person who is known or suspected to have COVID-19. This may include protective gowns and/or P2/N95 masks (which may include fit testing). Pharmacists working in higher risk environments must be familiar with local directives and PPE guidance.
Information on pharmacy programs and regulatory issues
Limits on dispensing and sales of prescription and over-the-counter medicines
PSA is aware of member concerns that patients sometimes pressure pharmacists to dispense unsafe amounts of medicines. Together with the Government, the Pharmacy Guild of Australia and the National Pharmaceutical Services Association, the decision was made in March 2020 to limit the dispensing and sale of certain medicines.
Mitigation measures introduced in 2020, included purchasing limits, should continue to be applied consistent with product availability and professional practice guidance. Disruptions to global supply challenges and fluctuating demand continue to affect stability of medicines availability. The TGA continues to monitor these requirements in consultation with stakeholders and medicine sponsors.
From 1 October 2023, the SUSMP listing of salbutamol removes some restrictions introduced in 2020. Professional expectations regarding appropriate supply of salbutamol as a Pharmacist Only Medicine are contained in the Australian Pharmaceutical Handbook and Formulary (APF).
From 1 July 2020, the TGA medicine shortages taskforce advised that pharmacies could return children’s paracetamol liquid formulations to front-of-counter, as demand for these products has eased. (Note: The requirement in WA and QLD to store Pharmacy Medicines in a place that prevents physical/direct access by the public (‘behind the counter’) remains unchanged.)
Current TGA medicine shortages statement can be found on the TGA website
PBS Continued Dispensing emergency arrangements ended on 30 June 2022.
New permanent PBS Continued Dispensing arrangements commenced on 1 July 2022.
On 31 March 2020, the Federal Health Minister announced a temporary expansion of the PBS Continued Dispensing initiative to support continuity of essential medicine therapy for Australians during the COVID-19 pandemic. The extension has been extended multiple times and will end on 30 June 2022.
From 1 July 2022, the formulary of medicines permanently able to be supplied under the PBS through Continued Dispensing reflects a list endorsed by PBAC in November 2021. This list incudes a range of medicines used in the management of stable, chronic health conditions, such as medicines used to treat diabetes, hypertension, asthma and HIV.
Other eligibility changes to PBS Continued Dispensing also changed at this time:
- the PBS medicine must have been supplied in the previous 3 months (currently 6 months)
- the regular prescriber must be unable to be contacted
Continued dispensing allows consumers to access standard PBS pack sizes of essential medicines in an emergency where there is an immediate therapeutic need and accessing a prescription is not practical. Under PBS Continued Dispensing, there is no requirement for a person to obtain a prescription to cover the supply or PBS subsidy of medicines supplied under this provision.
Most jurisdictions only permit Continued Dispensing in accordance with the National Health (Continued Dispensing) Determination 2022.
For the latest advice on continued dispensing regulations in each state/territory, review the PSA Regulation Hub.
The PBS special arrangement for digital image prescribing ended on 31 March 2022 (except within hospitals).
Transition arrangements were in place for prescriptions which were written before 31 March 2022, including repeats.
In NSW, digital image prescriptions continued to be permissible for non-PBS prescriptions until 30 September 2022.
In March 2020, new limits were introduced to the supply of salbutamol inhalers, including changes to the Schedule 3 entry for salbutamol. The TGA subsequently made minor amendments to the Schedule 3 salbutamol listing effective 1 October 2020. These permanent changes to the Poisons Standard continue to apply.
Salbutamol inhalers may be supplied as a Pharmacist Only Medicine:
- for the relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease, or
- for acute prophylaxis against exercise-induced asthma and other stimuli known to induce bronchospasm, or
- for the treatment of a person with a record of previous supply from a pharmacy, or
- to persons authorised under State or Territory law to use or supply salbutamol in the practice of their profession (e.g. medical practitioners), or
- for use in institutional first aid (e.g. schools, workplaces).
The entry specifies supply is limited to one primary pack of salbutamol for each person being treated by the pharmacist.
These changes to the Poisons Standard are designed to ensure availability of salbutamol inhalers for patients with a genuine need for their asthma condition and have been revised following feedback that restrictions implemented in March 2020 had impeded access to those with an urgent therapeutic need.
PSA’s Guidance for provision of a Pharmacist Only medicine: Short-acting beta2-agonists (salbutamol and terbutaline) supports pharmacists in supplying these medicines. This can be accessed by PSA members only or is available in the digital version of APF.
To support pharmacists with this change, PSA has updated the following Q&As.
What legislative changes have come into force for salbutamol?
On 1 October 2020, the Poisons Standard was updated to amend the Schedule 3 entry for salbutamol.
What has changed?
The Schedule 3 entry for salbutamol has been amended to permit pharmacists to supply salbutamol inhalers:
- for the relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease, or
- for acute prophylaxis against exercise-induced asthma and other stimuli known to induce bronchospasm
- for the treatment of a person with a record of previous supply from a pharmacy.
Supply is limited to a maximum of one pack per patient.
Salbutamol continues to be allowed to be supplied by pharmacists for use in institutional first aid (e.g. schools, workplaces) or to persons who are authorised under State or Territory law to possess it or supply it under lawful practice of their profession (e.g. medical practitioners) without the limit of one pack per patient.
How do I respond to patients and carers who ask why the supply of salbutamol inhalers is being limited even though they have been using this medicine for many years?
The Australian Government made changes to regulate inappropriate supply of salbutamol and to ensure ongoing access for people with diagnosed respiratory conditions. The earlier changes have since been reviewed to allow less restricted access to all people with a reasonable therapeutic need. The peak bodies representing pharmacists worked with the Government on reviewing these measures to ensure people who need the medicines most can access them.
What can be used to confirm a patient meets the requirements to supply?
There are a number of ways a pharmacist could check to ensure the supply of a salbutamol inhaler to a person as a Pharmacist Only Medicine meets the requirements stipulated. For example:
- previous supply is confirmed through the person’s dispensing history or My Health Record
- confirmation that the person has a current asthma management plan
- patient description of symptoms is consistent with bronchospasm for people living with asthma or COPD
- observation of patient experiencing bronchospasm
- observing via photo or in person a physical inhaler or asthma medicine dispensed in their name.
A person says they have heard that they should now avoid using their corticosteroid inhaler, and want to just rely on using their salbutamol (Ventolin/Asmol) inhaler. What advice should I give?
If your doctor has prescribed inhaled corticosteroid controller medicine for your asthma, you should continue to use it (as prescribed) during the COVID-19 pandemic.
Does the supply of salbutamol need to be recorded?
Yes. To support ongoing availability of salbutamol to those who need it, the PSA, Department of Health, pharmacy wholesalers and the Pharmacy Guild of Australia jointly endorsed additional controls on the supply of salbutamol, including a requirement that supply is recorded. In some jurisdictions this has been a regulatory requirement for many years, and is described in PSA’s short-acting beta agonist guidance document (PSA member-only access).
PSA’s Guidance for provision of a Pharmacist Only medicine: Short-acting beta2-agonists (salbutamol and terbutaline) describes the pharmacists should reoutinely record supply of salbutamol in patient records, such as via dispensing software.
In addition to supporting the ongoing availability of salbutamol, recording supply supports patients through:
- creating a record at the pharmacy, and accessible via My Health Record (where available) to inform clinical decisions across healthcare teams
- supporting evidence requirements for future access to salbutamol
- providing patients with customised and individualised instructions for use on the label.
Do the 1 October 2020 changes mean pharmacists no longer need to verify a medical diagnosis of a respiratory condition?
Pharmacists have an obligation to establish a therapeutic need for all Pharmacist Only Medicines supplied to patients. While the scheduling criteria have been modified for salbutamol, many of the ways that pharmacists confirmed medical diagnosis between March–September 2020 remain useful in establishing therapeutic need.
A patient’s description of bronchospasm symptoms or a pharmacist’s observation of breathing difficulties also satisfy the scheduling criteria and can be used as evidence to establish therapeutic need.
Updated TGA advice regarding hydroxychloroquine use in treating COVID-19
On 27 May 2020, the TGA updated their advice based on the latest international data. At this time the use of hydroxychloroquine to treat COVID-19 is strongly discouraged, including in hospital in patients. The only exception should be patients who are enrolled in a clinical trial with appropriate safety monitoring protocols in place and oversight by a Human Research Ethics Committee. This advice is in the context of the number of currently hospitalised COVID-19 patients in Australia being very low.
Information on the hydroxychloroquine scheduling change
Effective 24 March 2020, restrictions were been placed on the prescribing of hydroxychloroquine. These amendments were incorporated into the Poisons Standard.
Initial treatment of a patient with hydroxychloroquine is now restricted to specialists in any of the following specialties:
- intensive care medicine
- paediatrics and child health
- emergency medicine
- dental practitioners registered as a specialist in oral medicine
PSA and the Guild advocated for this change in an open letter to prescribers on 21 March 2020.
Adjustments to the PBS listing for hydroxychloroquine
Changes were also been made to the PBS listing for hydroxychloroquine to help minimise the risk of PBS prescriptions being supplied to patients accessing the medicine for unapproved uses. The streamlined authority requirement has now been removed.
Implications for pharmacist practice
Current Australian advice includes the following:
- The National COVID-19 Clinical Evidence Taskforce has issued the recommendation: “Do not use hydroxychloroquine for the treatment of COVID-19.”
On 11 September 2021, based on the advice of the Advisory Committee on Medicines Scheduling, the TGA placed restrictions on the prescribing of oral ivermectin (tablet dosage form) by general practitioners through a new listing in Appendix D of the Poisons Standard. This restriction were removed on 1 June 2023.
Ivermectin is not approved for use in prevention or treatment of COVID-19 in Australia.
Stromectol (ivermectin 3mg tablets) is TGA-approved for the treatment of onchocerciasis (river blindness), intestinal strongyloidiasis (threadworm of the intestines) and scabies. All medical practitioners can continue to prescribe oral ivermectin for the approved indications. However, prescribing for non-approved indications (e.g. rare parasitic conditions) have not been limited to specialists from 1 June 2023.
As with all dispensing activities, pharmacists presented with prescriptions for ivermectin need to be satisfied a medicine is safe and therapeutically appropriate prior to supply of the medicine (Professional Practice Standards, 2023).
Further information regarding the scheduling change is available at:
Evidence for use of ivermectin
The approved indications in Australia for ivermectin are for the treatment of roundworm infections, scabies and inflammatory rosacea.
Implications for pharmacist practice
Current Australian advice includes the following:
- The National COVID-19 Clinical Evidence Taskforce has issued the recommendation: “Do not use ivermectin for the treatment of COVID-19.”
- Advice has also been issued by the TGA that ivermectin has not been approved in Australia (or other OECD countries) to prevent or treat COVID-19 disease, and should not be imported for this indication.
Some doctors may decide to prescribe ivermectin for off-label use taking into account potential risks and benefits and with appropriate informed consent. However, given the lack of evidence to support use of ivermectin for COVID-19, it would be difficult for a pharmacist to professionally justify off-label supply of ivermectin for COVID-19 outside of a well-designed clinical trial.
Therefore, PSA recommends that pharmacists do not supply ivermectin for the treatment or prevention of COVID-19. Should pharmacists be unable to establish intended use of an ivermectin prescription, supply should also be declined.
In response to the COVID-19 pandemic, pharmacists were temporarily able to deliver medication reviews to eligible patients via telehealth arrangements from 21 April 2020. This included Home Medicines Reviews, Residential Medication Management Reviews, MedsChecks and Diabetes MedsChecks.
These telehealth arrangements ceased on 31 December 2022.
The Australian Government implemented a temporary measure from 1 May 2020 to 30 June 2022 to allow flexibility around PBS restrictions for some medicines to support continued treatment. Prescribers were able to lodge a request for exemption with Services Australia (Medicare) where they believed a requirement (such as pathology or point-of-care testing) may have put patients at increased risks of COVID-19.
The Home Medicines Service ended on 30 June 2022
On Wednesday 11 March 2020, the Australian Government announced the COVID-19 Home Medicines Service enabling 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.
The Australian Government provided funding to support and protect the most vulnerable members of our community from potential exposure to COVID-19 by way of a fee per delivery payable to pharmacies for the home delivery of PBS and RPBS medicines, thereby removing the need for a patient to visit a pharmacy.
As of September 2020, more than 1.1 million deliveries had been made by more than 4,600 pharmacies through this service.
In response to the increased demand for hand sanitisers and subsequent shortages in 2020, PSA made representations to the TGA to ensure pharmacists were able to provide hand sanitisers to Australian consumers and patients. As a result, certain hand sanitisers with specific requirements were excluded from the operation of the Therapeutic Goods Act 1989 (the ‘Act’).
The TGA prepared further advice for pharmacists on hand sanitiser manufacture, supply and advertising, and advice for consumers on buying and using hand sanitisers. This information can be accessed below:
These exemptions no longer exist. There are adequate supplies of hand sanitiser commercially available, so these products should not be compounded.
Details of the expired temporary regulatory changes are summarised through the Q&As below.
What legislative changes were in force?
In late March, the following two Commonwealth legislative instruments came into force – Therapeutic Goods (Excluded Goods – Hand Sanitisers) Determination 2020 and Therapeutic Goods Amendment (Excluded Goods – Hand Sanitisers) Determination 2020.
In May 2020, the Therapeutic Goods Amendment (Excluded Goods – Hand Sanitisers) Determination (No. 2) 2020 came into force. These amendments are intended to further safeguard public health.
These determinations are no longer in force.
Can I manufacture and supply other types of hand sanitisers or hand rubs?
Hand sanitisers are regulated either as cosmetics (general consumer products) or therapeutic goods depending on what they contain, what they claim to do and how they are used. Further information is available here.
PSA is aware of member concerns regarding the need to obtain patient signatures on PBS prescriptions and the associated risk of virus transmission to patients and/or pharmacy staff.
The Commonwealth Department of Health advises the following for pharmaceutical benefits. Pharmacists should:
- still ask the patient or agent to acknowledge receipt of supply where practical
- use their professional judgment and implement processes to manage risks, particularly for vulnerable people.
When a signature is not practical, pharmacists will not need to certify the prescription. This is an interim arrangement was extended in March 2023 until 31 March 2024.
During the COVID-19 pandemic, Services Australia applied a temporary waiver on the requirement for a patient to sign their Prescription Record Forms (PRFs) and PBS Safety Net applications where there were concerns of virus transmission to patients and/or pharmacy staff.
This is an interim arrangement ended in early 2023.
Clinical information and advice
A national taskforce has broughttogether peak professional bodies across Australia whose members are providing clinical care to people with COVID-19.
They undertake continuous evidence surveillance to identify and rapidly synthesise emerging research in order to provide national, evidence-based guidelines for the clinical care of people with COVID-19, post-COVID syndrome (long COVID), as well as other emerging conditions, such as mpox.
These are ‘living’ guidelines, updated with new research in near real-time in order to give reliable, up-to-the minute advice to clinicians providing frontline care in this unprecedented global health crisis.
PSA will continue to provide updates as we receive information. To speak with one of our team, including the member-only Pharmacist-to-Pharmacist advice line, please call PSA on 1300 369 772 or send us an email.