COVID-19 information for pharmacists
This information was last updated Tuesday 21 March 2023
- PBS Continued Dispensing transitioned to permanent arrangements on 1 July 2022: Check the requirements in your state/territory
- Digital image prescribing has ended: Transition arrangements in place.
- Face masks and PPE: Pharmacists should continue to wear medical grade face-masks in all public/patient-facing roles.
- Medicine supply limits continue to apply, including for non-prescription analgesics – Find the latest updates on the supply of prescription and non-prescription medicines.
COVID-19 vaccine roll out: community pharmacy
For information regarding COVID-19 vaccine regulations, how to access your COVID-19 vaccine and top resources can be found on our COVID-19 vaccine information for pharmacists page.
- Vaxzevria, AstraZeneca COVID-19 vaccine
- Spikevax, (Moderna) mRNA COVID-19 vaccine:
- Original formulation – no longer available from November 2022
- Bivalent Omicron COVID-19 vaccine – from October 2022
- Comirnaty, Pfizer mRNA COVID-19 vaccine:
- Original formulation no longer available – December 2022
- Omicron BA.1 COVID-19 vaccine – From December 2022 to March 2023
- 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
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).
Training
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.
This training is hosted on the Department’s online platform and can be accessed here. The training is being provided free to all authorised COVID-19 vaccination providers.
If you are not already a pharmacist vaccinator, you will need to meet the requirements of becoming a pharmacist vaccinator in your state/territory, including completing an accredited vaccination course.
Pharmacists who wish to do additional training to familiarise themselves with multi-dose vials may find the following resources useful:
- Vaccine refresher training at PSA Vaccine Face-to-Face immunisation workshops
- Training from the Melbourne Vaccine Education Centre
- Multi-dose vial masterclass video
Other vaccination settings
Pharmacists are able to be employed in other care settings (such as in a general practice medical centre or at a Commonwealth Clinic) for both the Primary Care EOI and the Surge Workforce arrangements, some of which are currently undergoing active recruitment. Further detail is available in the Australian COVID-19 Vaccine National Roll-out Strategy.
The Commonwealth Department of Health’s COVID-19 vaccination training program provides free and accredited training modules for pharmacists involved in the administration of COVID-19 vaccines.
Upon successful completion of this mandatory training, you will receive a certificate of completion which can be used to manually record this training in your CPD plan. The information below will assist you in recording the correct information simply and accurately.
Information you will need to record this activity
Self-recording CPD in your PSA CPD Plan is easy, and there’s a short video available here which walks you through the process. If you still require assistance our friendly member services team area available on 1300 369 772.
Accreditation code: G2021007
CPD credits: This activity has been accredited for up to 5.0 hours of Group 1 CPD (or up to 5.0 CPD credits) suitable for inclusion in an individual pharmacist’s CPD plan, which can be converted to up to 5.0 hours of Group 2 CPD (or up to 10 CPD credits) upon successful completion of relevant assessment activities.
The number of CPD credits that you can record will be determined by the time that it took you to complete the activity and which modules you completed. CPD can be recorded at a rate of 1 Group 1 CPD credit, or 2 Group 2 CPD credits per hour of activity. For more information refer to the Pharmacy Board of Australia’s Guidelines on Continuing Professional Development which are available here.
The available modules including their estimated duration are provided below. Ensure that you review which modules you completed and estimate the time it took to complete each module when recording these activities in your CPD plan.
Core training modules:
- Module 1: COVID-19: An introduction (25 minutes)
- Module 2: Handling and storage (40 minutes)
- Module 3: Communication and purpose (40 minutes)
- Module 4: Multi-dose vial (MDV) training and delivery (25 minutes)
- Module 5: Documentation and reporting (25 minutes)
- Module 6: Safety, surveillance and reporting for adverse events following COVID-19 vaccination (30 minutes)
Additional training modules:
- Additional module 1: Pfizer-BioNTech vaccine (30 minutes)
- Additional module 2: AstraZeneca vaccine (30 minutes)
- Additional module 3: Moderna vaccine (30 minutes)
Competency Standards: This activity meets the following competency standards as set out in the National Competency Standards Framework for Pharmacists in Australia (2016): 1.3, 2.1, 2.3, 3.1, 3.2, 3.5, 4.5.
Current recommendations for pharmacists and the community
AHPPC and state governments continue to strongly recommend mask use in health settings. This includes all settings pharmacists work. Some workplaces, such as 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.
Distribution of PPE from the National Medical Stockpile (NMS) for community pharmacies is being coordinated through the Primary Health Networks (PHNs) until 31 December 2022.
Providing PPE is generally considered a normal cost of business, similar to providing hand sanitiser, hand-washing facilities and maintaining clean premises. However, supply from the NMS may be available when caring for people diagnosed with COVID-19, when administering COVID-19 vaccines or where commercial supply is not available.
Find the details of your local PHN below:
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
- Vaccination
- 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.
The following resources are available for pharmacists to display in their pharmacy, or share on social media.
Certain Department of Health resources have also been translated in other languages. See the full range of translated resources here.
PSA resources
COVIDSafe app resources
Department of Health general resources
Australian Commission on Safety and Quality in Health Care resources
During COVID-19, pharmacists have been subject to unacceptable abuse and aggression from patients when declining supply of medicines to enforce supply limits and new restrictions aimed at maintaining the integrity of the supply chain and supporting the safe use of medicines. Difficulty in sourcing adequate stock of influenza vaccines and managing patient expectations has also proven challenging.
PDL has provided advice which supports guidance provided by PSA in relation to declining requests for salbutamol, hydroxychloroquine and influenza vaccines where supply is not appropriate or legal, or stock availability is limited.
Following notifications, PDL has recently provided practice advice to help pharmacists responding to requests for medicines affected by recent regulatory changes:
- inform patients of the regulatory changes during the supply process
- explain the reasons for these changes and the limitations the changes place on pharmacists
- discuss with patients the factors which led to your decision to agree to or decline supply
- provide recommendations to facilitate continuity of care (e.g. seeking medical review for consideration of bronchospasm in a person not diagnosed with asthma).
In the case of pharmacists responding to requests for influenza vaccines:
- If stock is not specifically allocated then dispensing of a valid prescription for the vaccine should occur. Declining to supply may be considered unethical.
- If the vaccine is unavailable, this should be communicated clearly to ensure no misunderstanding (e.g. “there is no stock available for dispensing at the moment”)
- The client could be asked if they would like to be contacted once a vaccine becomes available
- It is inappropriate to advise clients that unallocated vaccines are being prioritised for those clients vaccinated within the pharmacy.
While recognising this may take additional time, PDL has emphasised the importance of good communication in reducing the likelihood of confusion of allegations of discrimination. PSA joins with PDL in strongly urging all pharmacists to document any decision to decline supply of medicines on any occasion.
PSA acknowledges the important work that pharmacists are doing on the front line. It is important during events such as the current COVID-19 pandemic that pharmacists take time to care for themselves and debrief with colleagues. To support you through this critical time we’ve collated some valuable COVID-19-related resources to keep you healthy, strong and resilient.
Pharmacists’ Support Service offer support related to the many demands of being a pharmacist in Australia. If you require support, contact the Pharmacists’ Support Service on 1300 244 910 (8.00 am to 11.00 pm AEST).
On 30 March 2020, the Pharmacists’ Support Service announce the availability of grants to support the mental health and well-being of Australian pharmacists and pharmacy staff who having been impacted by bushfires and are now facing the double whammy of COVID-19. Read more here.
This Way Up has provided access to free online tools and practical ways to protect your mental health through the COVID-19 pandemic. They have developed guided workbooks with practical tips and strategies, a ‘Staying on Track’ audio guide and resource pack, and are currently offering free access to their self-paced online courses.
Services and resources
Head to Health is the Australian Government’s digital mental health gateway bringing together information, apps, online programs, online programs and phone services from Australia’s most trusted mental health organisations.
MindSpot is the Australian Government’s free online mental health clinic for Australian adults who are experiencing difficulties with anxiety, stress, depression and low mood.
Beyond Blue is dedicated to promoting good mental health, creating change to protect everyone’s mental health and improve the lives of individuals, families and communities affected by anxiety, depression and suicide.
Black Dog Institute is dedicated to understanding, preventing and treating mental illness, creating a world where mental illness is treated with the same level of concern, immediacy and seriousness as physical illness.
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 temporarily in place and expected to cease on 31 March 2023.
PSA is aware of member concerns regarding the need to obtain patient signatures on Prescription Record Forms (PRFs) and PBS Safety Net applications where there may be associated risk of virus transmission to patients and/or pharmacy staff.
Services Australia has advised that when obtaining a signature from the applicant or agent is not practical, they will accept and continue to process these types of claims during the pandemic.
This is an interim arrangement that is temporarily in place until 30 September 2020, and will be reassessed thereafter.
Limits on dispensing and sales of prescription and over-the-counter medicines
PSA is aware of member concerns that patients are pressuring them to dispense unsafe amounts of medicines. This is unacceptable, and we are dedicated to protecting frontline pharmacists doing their best in these challenging times.
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.
These mitigation measures introduced in 2020, including purchasing limits and labelling requirements for over-the-counter supplies of salbutamol, remain in place. Disruptions to global supply challenges and fluctuating demand continue to affect stability of medicines availability. The TGA continues to actively review the need for these requirements in consultation with stakeholders and medicine sponsors.
Since Thursday 19 March 2020:
- Pharmacists have been required to limit dispensing of certain prescription products to 1 months’ supply at the prescribed dose, and sales of certain over-the-counter medicines to a maximum of one unit per purchase
- In addition, pharmacists have been strongly encouraged to limit dispensing and sales of all other medicines to one months’ supply or one unit
- Supply of salbutamol inhalers is subject to additional restrictions, assessment and recording requirements.
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.) However, one unit limits on sales remain in place and pharmacists are encouraged to use signage to indicate to customers that purchases of these products will be limited to one unit.
To help explain these changes to customers, PSA has developed a sign that can be used in your pharmacy.
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.
Some states continue to allow Expanded Continued Dispensing for a larger range of Prescription Only Medicines as non-PBS supply. Other jurisdictions only permit Continued Dispensing in accordance with the National Health (Continued Dispesning) Determination 2022.
PSA has collated information on what is/is not permitted in each state and territory since 1 July 2022. This information is published on the PSA COVID-19 Regulatory Changes microsite.
To support pharmacist in navigating pandemic-driven regulation changes relevant to your practice jurisdiction PSA has prepared a Summary of COVID-19 regulatory changes.
The following resources also provide helpful support for pharmacists:
The Department of Health has prepared a series of FAQs for pharmacist, patients and prescribers
Services Australia provides an Education guide on the Continued Dispensing initiative
To further support pharmacists, PSA has prepared the following FAQs:
Does this arrangement apply in my state or territory?
All jurisdictions have enacted the necessary regulatory changes to enable Continued Dispensing. However, arrangements differ between jurisdictions. Detailed information and supporting resources for each jurisdiction can be found in the summary tables here.
Are there guidelines that support me to appropriately supply medicines under this initiative?
PSA’s Guidelines for the continued dispensing of eligible prescribed medicines by pharmacists provide support to pharmacists on how to appropriately supply medicines under this initiative and pharmacists must be familiar with and adhere to these requirements when supplying PBS medicines under this temporary emergency measure. PSA has updated the addendum to the guidelines to reflect the changes which occurred on 1 July 2022.
What other options should I consider before dispensing a medicine under the Continued Dispensing arrangements?
Alternative arrangements for obtaining a valid script and other options as outlined in PSA’s guidelines should be considered before using the Continued Dispensing arrangements. This should at least include attempting to contact the prescriber for an electronic prescription.
A patient needs her previously supplied medicine, which was for an increased quantity (Authority item). Am I allowed to supply the increased quantity under PBS Continued Dispensing?
No. From 1 July 2022, only the standard PBS quantity can be supplied (where permitted by your relevant state or territory legislation).
Can I supply any medicine through continued dispensing arrangements?
For PBS Continued Dispensing, only medicines listed in the National Health (Continued Dispensing) Determination 2022 can be supplied.
Some jurisdictions currently permit a wider range of medicines to be supplied in an emergency under authorities issued during the pandemic, sometimes referred to as ‘Expanded Emergency Supply’ or ‘Non-PBS Continued Dispensing’. See PSA’s COVID-19 Regulatory Changes page for more information.
All jurisdictions exclude Controlled Drugs (S8) from emergency supply measures.
A patient in our local area has been subject to multiple isolation periods during the COVID-19 pandemic. Can the patient continue to access their medicines through this expanded continued dispensing arrangement?
If the patient obtained a medicine through continued dispensing arrangements in the last 12 months, they will not be eligible under the Continued Dispensing arrangement.
The patient may be eligible for private (non-PBS) supply in some jurisdictions, subject to state and territory regulations and professional obligations being met.
You should discuss with the patient options available to them including other emergency supply provisions or prescribing via telehealth services or other pandemic primary care pathways.
The PBS special arrangement for digital image prescribing ended on 31 March 2022 (except within hospitals).
Transition arrangements are 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.
Further details of transition arrangements and legal requirements for prescriptions written before 31 March 2022 are available on our regulation microsite:
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, new restrictions have been placed on the prescribing of hydroxychloroquine. These amendments have now been incorporated into the Poisons Standard.
Initial treatment of a patient with hydroxychloroquine is now restricted to specialists in any of the following specialties:
- dermatology
- intensive care medicine
- paediatrics and child health
- physician
- emergency medicine
- dental practitioners registered as a specialist in oral medicine*
*Dental practitioner specialists in oral medicine may prescribe hydroxychloroquine in the treatment of conditions such as ulcerative oral lichen planus.
This amendment is intended to support the continued availability of hydroxychloroquine during the public health emergency due to COVID-19 and to prevent its inappropriate use in Australia.
PSA and the Guild advocated for this change in an open letter to prescribers on 21 March 2020. Read more about the new restrictions on the prescribing of hydroxychloroquine from the TGA here.
Adjustments to the PBS listing for hydroxychloroquine
Changes have 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. This is also intended to ensure continued access for patients who rely on this medicine for approved uses.
From 1 May 2020, the general unrestricted benefits listing was split into separate initial and continuing treatment listings for the TGA-approved uses of malaria and autoimmune disorders. Under both listings, the prescribing health professional is required to seek PBS authority (streamlined). Under the initial PBS listing, initial therapy must be authorised by a medical practitioner of any of the specialities defined in the clinical criteria as specified in the Poisons Standard.
This change means that pharmacists will be required to ensure that any relevant prescriptions that they dispense have a valid streamlined authority code, which must be valid at the date of prescribing.
More information on these changes can be accessed on the PBS and TGA websites.
To support pharmacists with this change, PSA has prepared the following FAQs.
What legislative changes have come into force for hydroxychloroquine?
On 24 March 2020, and 3 April 2020, new Commonwealth legislative instruments came into force. These amendments have now been incorporated into the Poisons Standard.
What has changed?
Additional Appendix D controls are now included in the Poisons Standard and apply to the prescribing of hydroxychloroquine. These specify that initial treatment of a patient with hydroxychloroquine must be authorised by:
- a medical practitioner specialist in any of the following specialties: dermatology, intensive care medicine, paediatrics and child health, physician, and emergency medicine.
- a dental practitioner specialist in the speciality field of oral medicine (this field is concerned with the diagnosis, prevention and predominantly non-surgical management of medically-related disorders and conditions affecting the oral and maxillofacial region, in particular oral mucosal disease and orofacial pain as well as the oral health care of medically complex patients .
Does that mean general practitioners cannot prescribe hydroxychloroquine?
GPs cannot initiate treatment with hydroxychloroquine for a patient. However, GPs can authorise (prescribe) continuing supply of hydroxychloroquine for a patient (after specialist initiation).
A patient presents a new prescription for hydroxychloroquine. How do I know if I can dispense it?
Pharmacists should confirm whether the prescriber is a specialist. Calling the prescriber or using the AHPRA register are possible ways to verify that the prescriber is recognised in one of the listed specialties outlined in Appendix D.
What happens if a patient presents a new prescription for hydroxychloroquine from their GP?
Pharmacists should consider information from the patient’s dispensing history or My Health Record for prior dispensing of hydroxychloroquine. In the absence of any dispensing history, pharmacists should ascertain with the patient whether the medicine is for ongoing therapy.
What if a patient presents a repeat prescription for hydroxychloroquine?
A pharmacist can dispense a valid repeat prescription for hydroxychloroquine.
Does this change apply in every state and territory?
PSA understands these changes are being adopted by every jurisdiction.
Why were these changes necessary?
Hydroxychloroquine has been used for prevention and treatment of certain types of malaria, rheumatoid arthritis and other conditions. Dental practitioner specialists in oral medicine may prescribe hydroxychloroquine in the treatment of conditions such as ulcerative oral lichen planus. Recent studies indicated hydroxychloroquine may have potential in the treatment of COVID-19. Pharmacists also reported increased prescribing of hydroxychloroquine, and this raised concerns of a potential shortage of these medicines in Australia. This legislative outcome is to ensure availability of supply of hydroxychloroquine for those patients who need it and to prevent inappropriate use.
What specialties fall in the category of Physician?
The Medical Board of Australia refers to ‘Physician’ as any of the following specialties:
- Cardiology
- Clinical genetics
- Clinical pharmacology
- Endocrinology
- Gastroenterology and hepatology
- General medicine
- Geriatric medicine
- Haemotology
- Immunology and allergy
- infectious diseases
- Medical oncology
- Nephrology
- Neurology
- Nuclear medicine
- Respiratory and sleep medicine
- Rhuematology.
What has changed with the PBS listing for hydroxychloroquine?
On 1 May 2020 the PBS listing for hydroxychloroquine was amended to help minimise the risk of PBS prescriptions being supplied to patients accessing the medicine for unapproved uses and to ensure continued access for patients who rely on this medicine for approved uses.
As part of this change, the general unrestricted benefits listing was split into separate initial and continuing treatment listings for the TGA-approved uses of malaria and autoimmune disorders. Under both listings, the prescribing health professional is required to seek PBS authority (streamlined). Under the initial PBS listing, initial therapy must be authorised by a medical practitioner of any of the specialities defined in the clinical criteria as specified in the Poisons Standard.
PSA is aware that some pharmacists have experienced an increase in presentations of prescriptions for ivermectin, including where the patient is unwilling or unable to discuss what they are being used for. In response to these concerns, pharmacists should consider the following when presented with prescriptions for ivermectin.
Change to scheduling of ivermectin
Effective 11 September 2021, based on the advice of the Advisory Committee on Medicines Scheduling, the TGA has 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.
Ivermectin is not approved for use in prevention or treatment of COVID-19 in Australia. There have been recent cases of significant harm resulting from people taking ivermectin in high doses or for extended periods.
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) is now limited to specialists in the following specialties or fields of specialty practice, if they believe it is appropriate for a particular patient:
- dermatology
- gastroenterology and hepatology
- infectious diseases
- paediatric gastroenterology and hepatology
- paediatric infectious diseases.
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, subject to the scheduling restrictions described above. 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 current COVID-19 pandemic, pharmacists cantemporarily deliver medication reviews to eligible patients via telehealth arrangements from 21 April 2020. This includes Home Medicines Reviews, Residential Medication Management Reviews, MedsChecks and Diabetes MedsChecks.
These telehealth arrangements will cease on 31 December 2022.
Access the Pharmacy Program Administrators website to see the latest program rules and other information relevant to these programs below:
The Department of Health has partnered with PSA in developing resources for pharmacists conducting medication reviews via telehealth. These resources are for pharmacists conducting service via telehealth, and to assist patients receiving these service. Access the tools below:
To provide further details, and to support pharmacists with these changes, PSA has prepared the following FAQs:
Am I now able to conduct all HMRs, RMMRs, MedsChecks and Diabetes MedsChecks via telehealth?
Not exactly. This temporary arrangement has been put in place in response to the COVID-19 pandemic to enable pharmacists to conduct HMRs, RMMRs and MedsChecks via telehealth arrangements for any patient/s that meet the relevant eligibility criteria.
Telehealth consultations for these services will not be funded beyond 31 December 2022.
Are telehealth medication reviews only able to be conducted using video?
Medication reviews by video are the preferred approach for substituting face-to-face consultations. However, if video is not available, audio-only medication reviews can be conducted via telephone.
What video platforms can be used to conduct telehealth consultations?
The Program Rules and relevant professional guidelines do not contain an approved list of telehealth platforms. AHPRA and the Department of Health have reminded health professionals delivering telehealth services that many free platforms do not have adequate encryption for delivery of health services and paid subscriptions to these services may be needed.
The Department of Health notes telehealth can be provided through video calling apps and software such as Zoom, Skype, FaceTime, Duo, GoToMeeting and others
Do I need a separate referral to conduct a follow-up service for a HMR or RMMR?
No, the HMR or RMMR service consists of the initial patient interview, clinical assessment, initial medication management report and up to two follow up services where required.
An indication of whether or not a follow up is recommended should be included in the original medication management report provided to the referrer, and the decision on whether a follow-up is required should be made by the accredited pharmacist in collaboration with the referrer.
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 that will enable 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 have been made by more than 4,600 pharmacies through this service.
In response to the increased demand for hand sanitisers and subsequent shortages, 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 have been excluded from the operation of the Therapeutic Goods Act 1989 (the ‘Act’).
The TGA has 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:
Details of regulatory changes are summarised through the Q&As below.
What legislative changes have come into 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.
What has changed?
Specific hand sanitisers have been excluded from TGA regulation with strict requirements specified on:
- ingredients in the final formulation
- manufacturing practices
- advertisement, and
- presentation of goods for supply.
What are the requirements that need to be met?
| Ingredients | Final formulation must only contain:
Must not contain any other active or inactive ingredients, including colours, fragrances or emollients. |
| Concentration | Concentration of ethanol / isopropyl alcohol must be verified by testing samples of each batch using gas chromatography, alcoholmeter, hydrometer, or other chemical analysis of equivalent or greater accuracy. |
| Manufacture | Must be manufactured under sanitary conditions using equipment that is well maintained and fit for purpose. |
| Record keeping | Must keep records of the manufacture with regards to each of the items above. |
| Labels | The final hand sanitiser product can only be presented for supply using front and back labels as shown below, which may be combined or co-located (text in square brackets needs to be finalised by the pharmacist/manufacturer) with exceptions that the label may:
Hand sanitisers must not be presented for supply in a way that it is likely to be mistaken for or confused with food or beverages (e.g. must not use inappropriate containers such as foil sachets, pouches with a spout or those with a pop top lid).
Front label
Back label
A copy of this label can be downloaded here. |
| Advertising | The products may be advertised in a manner consistent with information contained on the labels, and including information on where the product may be purchased, and the associated price. |
Do I have to comply with PSA’s Professional Practice Standard on Compounding?
No, manufacture of the specified products is not considered compounding. However, the specific requirements and conditions outlined in the table must be met.
Does this mean these products are unregulated?
No, the goods specified in the Determination are excluded for the purposes of the Act but will continue to be regulated as consumer goods under Australian Consumer Law by the Australian Competition and Consumer Commission. This arrangement may be revisited in the future as circumstances change.
Who can these hand sanitisers be supplied to?
Provided the exact ingredients and quantities in the final formulation and other requirements are followed, the formulation is permitted for use in healthcare facilities as well as for consumer use.
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.
If adequate supply of hand sanitisers is available, is it now the preferred option for good hand hygiene?
No, washing hands with soap is still considered to be the most effective hand hygiene practice, however, hand sanitisers also play an important role in helping to reduce the spread of microorganisms.
Locum register
Australia’s two leading Pharmacist Recruitment Specialists have come together to support pharmacists through provision of a locum hotline service:
Raven’s Locum Recruitment
Phone: 1800 429 829 (business hours) 0419 600 434 (after hours)
Email: info@ravensrecruitment.com.au
Website: www.ravensrecruitment.com.au
LocumCo
Phone: 1800 357 001 (business hours and after hours)
Email: jobs@locumco.com.au
Website: www.locumco.com.au
Both businesses will have dedicated experienced recruitment consultants ready to advise you on how you can assist and also provide you with the latest information regarding any work-related practices.
Emergency Locum Service
The Emergency Locum Service supports community pharmacies in rural and remote areas through direct access to pharmacist locums in emergency situations. The program rules have been updated with changes related to COVID-19.
In the event that a pharmacist is:
- isolating themselves at home on the advice of a medical practitioner, for confirmed COVID-19; or
- meeting the current national triage protocol criteria for suspected COVID-19 infection after consultation with either the national COVID-19 hotline, state COVID-19 hotlines, a registered medical or nursing practitioner or COVID-19 trained health clinic triage staff.
The maximum placement duration has also been extended to fourteen consecutive days. Find out more below.
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.
The Commonwealth Department of Health continue to publish and update a variety of information and resources for health professionals and patients on the evolving COVID-19 situation.
Member enquiries
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.