Coronavirus disease (COVID-19) information for pharmacists

This information was last updated Thursday 30 July 2020

 

PSA is committed to keeping members informed throughout the rapidly evolving coronavirus disease (COVID-19) pandemic. Through this webpage, we’ll keep you informed with the latest information as it becomes available. It contains links to up-to-date information, guidance and resources from governments and other trusted sources for pharmacists and their patients.

Latest updates

Face masks and PPE – Find the latest information and resources regarding the use of face masks for pharmacists and consumers. Read more here.

 

Medicine supply limits – Find the latest updates on children’s paracetamol supply limits and limits on the supply of other prescription and OTC medicines. Read more here.

 

Expanded Continued Dispensing – On 1 July 2020 the Australian Government extended the temporary Continued Dispensing (Emergency Measure) to 30 September 2020. Read more here.

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.

Minister Hunt has penned an open letter to the community pharmacy sector thanking them for their dedication and service to the Australian Community. Read the letter here.

 

Stay informed and protected

 

The Australian Government has released a number of official apps to enable all Australians to stay up to data and protected.

 

COVIDSafe app

 

The COVIDSafe app speeds up contacting people exposed to coronavirus (COVID-19). This helps to support you, your friends and your family.

 

PSA is proud to join with 11 other peak health organisations in supporting COVIDSafe as a public health measure, and as a critical tool in helping our nation fight the COVID-19 pandemic.

 

Learn more about the COVIDSafe app, including answers to frequently asked questions here. Find additional COVIDSafe app help here.

The Department of Health has developed a number of useful resources to help promote the COVIDSafe app. Display these posters in your pharmacy and use the social media tiles to spread the word. Additional resources including videos and social media tiles can be downloaded here.

Know faster if you’ve come in contact

Keep your community safe

We need your help

COVIDSafe app – Download today

Coronavirus Australia app

 

Stay up to date with official information and advice about the coronavirus (COVID-19) situation. Check your symptoms and get notified when urgent information and updates are published.

Australian Government WhatsApp channel for COVID-19

 

Join the COVID-19 WhatsApp channel to learn the latest on Australia’s response to coronavirus (COVID-19).

 

If you already use WhatsApp, join the COVID-19 channel by following the directions here.

The TGA is regularly publishing information about medicines and medical devices as they relate to COVID-19. Read the latest TGA advice here.

 

Following media reports on the preliminary findings of the Randomised Evaluation of COVID-19 Therapy (RECOVERY) Trial, the following key messages from the TGA have been issued to support pharmacists and to mitigate against stockpiling:

  • The RECOVERY trial has not yet been published; the results reported are preliminary findings only;
  • The RECOVERY trial reportedly showed benefit only for ventilated or oxygenated COVID-19 patients in hospital, not for mild cases or prophylactic use. There is no evidence to support use of this medicine for COVID-19 in the outpatient setting;
  • There is currently no national shortage of dexamethasone injection or tablets reported to the TGA. Based on information provided to the TGA by sponsors, there is currently sufficient stock of dexamethasone tablets and injection to meet normal demand;
  • Sponsors and wholesalers are closely monitoring the demand for their dexamethasone products and will implement appropriate measures if necessary to mitigate the risk of shortages;
  • Unnecessary stockpiling of dexamethasone tablets and injections is strongly discouraged as it could create supply issues and prevent patients who require treatment with dexamethasone from accessing this medicine.

 

TGA is working closely with sponsors of dexamethasone and wholesalers, to monitor demand and will implement measures to mitigate the risk of shortages, if necessary. There are currently no national shortages of dexamethasone injections or tablets reported to the TGA.

The Australian Government website is regularly updated with the latest COVID-19 news, updates and advice from government agencies across Australia. Read more here.

Ahpra and the National Boards are receiving a range of questions about how they will respond to requests for changes to the way that they register individuals in the context of managing the health sector impacts of COVID-19. They are in the process of considering how regulatory requirements can adapt to emergency health service needs and support continuity of health service delivery, and are planning for different scenarios which may occur.

 

Keep up to date on developments at Pharmacy Board’s website.

Keep up to date on developments at Ahpra’s websites.

We thank all Interns who have provided feedback about issues affecting your intern experience during the rapidly changing  situation with COVID-19.

 

PSA is meeting daily with the Commonwealth Department of Health, Ministers and State Health Departments and this feedback has allowed us to put these important issues forward and to advocate for you.

 

One of the most critical issues being discussed at the moment is how do we support our future pharmacists, our interns, to successfully complete and thrive after your Intern Year.

 

We have been pushing the Australian Pharmacy Council (APC) and Pharmacy Board of Australia (PBA) to change the requirements for this year’s interns, acknowledging the new challenges being faced in pharmacy at the moment. These challenges include, but are not limited to

  • Access to practice sites
  • Availability and time with preceptors
  • Uncertainty around the examination process
  • How a period of isolation or illness will impact on your ability to meet requirements of your Intern year
  • Timeliness of registrations on completion.

 

PSA have been advocating on your behalf to the PBA to ensure that you are not delayed in your journey to general registration due to the impacts of COVID-19. On 30 April 2020, the PBA announced some interim modifications to some of the requirements for general registration and examinations. Find out more here.

 

PSA is commitment to continue to provide updates with all you need to know about your intern year.

 

At PSA we have been rapidly responding to COVID-19 to ensure that you have continued access to your intern training program:

  • Your ITP workshops are being delivered digitally
  • Additional first-aid & CPR courses nationally to support you meet this requirement with additional measures in place to reduce the risk of transmission. Check our events page regularly for updates
  • Additional Markers to ensure speedy return of assignments
  • Extensions on certain practice based assignments
  • a dedicated micro-site on our website which you can also filter by state to keep you up to date with Covid-19 developments and advice.

 

You can access information on the AHPRA website here or contact one of our learner support officers on 1300 369 772 or via e-mail learnersupport@psa.org.au to discuss.

On Wednesday 11 March 2020 the World Health Organization made the assessment that COVID-19 can now be characterised as a pandemic.

 

Access the latest information and guidance from the World Health Organization (WHO).

Face masks and Personal protective equipment

PSA is aware that there is significant confusion and misinformation regarding the use of face masks and personal protective equipment (PPE) in response to the COVID-19 pandemic. Information has been subject to change based on the evolving circumstances of the pandemic and government responses.

 

Face masks: Use by pharmacists and pharmacy staff (3 August 2020)

The current advice to pharmacists and pharmacy staff regarding use of masks varies between locations, depending on risk of exposure to COVID-19:

  • Areas of high community transmission (Victoria): Masks must be worn at all times at work
  • Areas of low to moderate community transmission (NSW): Mask use recommended while at work
  • Areas of no known community transmission (rest of Australia): Masks not currently recommended, but may be used

 

Some workplaces, such as aged care, may adopt more proactive protocols for use of face masks (e.g. aged care).

 

Where pharmacists and pharmacy staff wear face masks, they should be medical grade masks, such as type 1 surgical masks. Cloth masks and reusable masks should not be used.

 

The Australian Government has also updated guidance on the use of face masks and shields by health care workers in areas with significant community transmission.

 

Consumer resources on masks have been prepared by the Australian Commission of Safety and Quality in Health Care:

Wear masks where 1.5m distance between you and patients cannot be guaranteed at all times.

Pharmacists and pharmacy staff should wear surgical masks rather than reusable cloth masks consistent with all health providers

 

Community pharmacy and general practice

For pharmacists and pharmacy staff residing and working in locations with community transmission, you should wear a mask at work. 1.5m physical distancing between other people, including other staff, may be difficult to continuously maintain in most community pharmacies and therefore it cannot be guaranteed.

 

Government directions notices relating to use of face masks in public may extend to pharmacists at work.

 

he routine use of masks by pharmacists and pharmacy staff residing or practising in areas where community transmission is currently low is not actively recommended at this time, but can be worn if desired or directed by management.

 

Face masks are an additional protection against transmission of COVID-19. Physical distancing, hand hygiene and staying home if unwell remain essential at all times to prevent transmission. and should be actively practised at all times in pharmacy workplaces.

 

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 1.5m physical distancing cannot be maintained, where required by government regulation, at preference of the health professional or following a patient request.

 

Face masks are an additional protection against transmission of COVID-19. Physical distancing, hand hygiene and staying home if unwell remain essential at all times to prevent transmission. and should be actively practised at all times.

 

If the patient or a household contact is self-isolating or unwell, consider rescheduling HMR or telehealth consultation.

Pharmacists and pharmacy staff should wear surgical masks rather than reusable cloth masks consistent with all health providers.

A number of reputable resources have been compiled to support you in deciding whether to wear a mask. It is recommended that you adapt this information to your personal and professional circumstances with consideration of the current advice and level of community transmission in your area.

 

The Victorian Department of Health and Human Services has compiled an extensive list of frequently asked questions and resources which answers many of the common queries regarding the use of face masks.

 

The Australian Commission on Safety and Quality in Health Care has also developed a list of frequently asked questions and a useful fact sheet aimed at helping people decide whether to wear a mask, and how to use them safely:

Access the latest advice on the use of face masks from the Commonwealth Department of Health below:

Distribution of PPE from the National Medical Stockpile (NMS) for community pharmacies is being coordinated through the Primary Health Networks (PHNs).

 

Providing PPE is considered a normal cost of business, similar to providing hand sanitiser, hand-washing facilities and maintaining clean premises. However, where commercial supply is not available, pharmacists in primary care can contact PHNs to access free supply of face masks.

 

PSA continues to work with governments to ensure your PHN is providing you access to masks where needed. If you are having difficult accessing masks from your PHN, please email policy@psa.org.au.

 

Generally PHNs will provide one box of 50 masks to each community pharmacy. Depending on stock levels you may receive more provided you can show demonstrated need. These masks must not be sold as commercial stock.

 

The latest information on PPE distribution can be found on the Commonwealth Department of Health website.

Find the details of your local PHN below:

Practical information and advice

Watch a replay of the COVID-19: How to look after yourself webinar recorded on 7 May 2020. PSA members are encouraged to self-record CPD to their CPD plan after viewing this webinar.

Watch a replay of the COVID-19: Your Telehealth Questions Answered webinar recorded on 29 April 2020. PSA members are encouraged to self-record CPD to their CPD plan after viewing this webinar.

Watch a replay of the COVID-19: Pharmacy Layout and Protection webinar recorded on 15 April 2020. PSA members are encouraged to self-record CPD to their CPD plan after viewing this webinar.

Watch a replay of the COVID-19: How to support your immunocompromised patients and staff webinar recorded on 8 April 2020. PSA members are encouraged to self-record CPD to their CPD plan after viewing this webinar.

Watch a replay of the COVID-19: Your Immunisation Questions Answered webinar recorded on 1 April 2020. PSA members are encouraged to self-record CPD to their CPD plan after viewing this webinar.

Watch a replay of the COVID-19: your questions answered webinar recorded on 25 March 2020. PSA members are encouraged to self-record CPD to their CPD plan after viewing this webinar.

PSA has been fielding many member queries seeking practical advice about things like general hygiene precautions and infection control measures. Below are some valuable resources.

The Department of Health has developed this resource explaining the different symptoms you may experience if you have coronavirus (COVID-19), a cold, or the flu.

The Department of Health has developed this COVID-19 infection control training for health workers in all settings, which covers the fundamentals of infection control.

The Therapeutic Goods Administration has issued advice on the association between the use of ibuprofen and worse outcomes in patients with COVID-19.

The following practical, interim guidance for pharmacists has been developed by local health authorities:

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

PSA has been receiving a significant number of questions from members about the delivery of pharmacist vaccinations during the COVID-19 pandemic. The below information has been compiled to support pharmacists in each jurisdiction, with a particular focus on influenza vaccinations given the convergence of COVID-19 and the 2020 influenza season.

 

Australian Technical Advisory Group on Immunisation (ATAGI)

 

ATAGI have issued the following advice to support immunisers to meet the anticipated demand as we enter the 2020 influenza season, acknowledging the convergence with coronavirus. It is recommended that pharmacists be familiar with all of these resources.

ATAGI has published Guiding principles for maintaining immunisation services during the COVID-19 pandemic. These guiding principles highlight the importance of maintaining routine immunisation services, and give immunisation providers advice on adapting their procedures and practices to comply with measures in place to reduce the transmission of COVID-19. Access this document below:

Practical information and resources for pharmacists

 

PSA immunisation training

 

Given the ongoing COVID-19 situation and recent APC announcement around the delivery of immunisation training, PSA have adapted the delivery of our immunisation course to minimise the practical face to face component, where state/territory legislation allows. This was done to ensure the safety of our students, staff and facilitators, give more flexibility in how our students work through and complete the course and prepare pharmacist immunisers for the increased demand for influenza vaccinations in the community.

 

If you would like to find out more about the options available in your state/territory, please call 1300 369 772 to discuss.

2020 Immunisation resources

 

The following resources, updated for 2020, are useful for pharmacist immunisers:

Additional information can be found at the Department of Health’s immunisation website, which can be accessed here.

First Aid and CPR training requirements for pharmacist immunisers

 

PSA has been responding to significant questions regarding:

  • the need to obtain First Aid and CPR certificates prior to undertaking PSA immunisation training
  • whether pharmacists can continue to vaccinate even though their CPR certificate has expired.

 

Pharmacists yet to undertake immunisation training

 

The Australian Pharmacy Council has issued advice on Modification to Standards for the Accreditation of Programs to support Pharmacist Administration of Vaccines during COVID-19 pandemic. This includes the temporary waiving of the requirement for participants to hold a current First Aid certificate and CPR certificate in order to enrol in pharmacist immunisation training.

 

Pharmacists should note that in order to receive their Statement of Attainment upon completion of the training, they must still provide a current First Aid and CPR certificate within 12 months of completion of the training, and must comply with the relevant state and territory requirements with regard to ongoing First Aid and CPR training before commencing the administration of any vaccinations.

 

Pharmacists that have previously completed immunisation training

 

In most states and territories, pharmacists must have a current certificate in both First Aid and CPR, and CPR training must be undertaken annually in order to administer vaccinations. Some jurisdictions however have waived these requirements during the COVID-19 pandemic given current restrictions. A summary of the current requirements can be found below.

 

It is strongly recommended that any pharmacist who is unsure whether they are authorised check with their local authority before administering any vaccinations.

 

First Aid or CPR training requirement Relevant resource/s
ACT During the COVID-19 emergency and for 6 months following the first aid and CPR refresher training requirement for accredited pharmacist immunisers has been temporarily waived.
NSW No change – CPR must be updated annually; First Aid every 3 years
NT No change
QLD During the declared public health emergency related to COVID-19, pharmacists who have completed first aid training since October 2016 and CPR training since October 2018 will be considered to hold a current Australian recognised qualification in first aid.

 

pharmacists who have completed an accredited vaccination training program, but are unable to complete first aid training themselves due to the restrictions related to COVID-19, must ensure that there is at least one other member of staff on the premises who has completed first aid training since October 2016 before undertaking a vaccination.

SA No change
TAS No change
VIC No change
WA To enable safe and lawful practices during the COVID-19 pandemic, when vaccines are being administered (including during the period of post-vaccination monitoring), at least one pharmacist or other staff member, who is currently competent to provide CPR and first aid, must be present and available.

 

If a pharmacist’s certification has recently expired in 2020 and they are unable to renew, they need personally assess whether they will be able to confidently provide CPR/First Aid in the event of a serious medical emergency associated with vaccination.

 

Minimum age for pharmacists delivered influenza vaccinations

ACT NSW NT QLD SA TAS VIC WA
≥ 10 yrs ≥ 10 yrs ≥ 16 yrs ≥ 10 yrs ≥ 10 yrs ≥ 10 yrs ≥ 10 yrs ≥ 10 yrs

 

Pharmacist vaccinations outside of pharmacy

ACT NSW NT QLD SA TAS VIC WA
Yes Yes Hospital Public hospital Yes Yes Hospital, Depot or outreach No

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.

On Wednesday March 18 the Federal Government announced a range of restrictions to aged care with the following people unable to enter any aged care facility:

  • People who have returned from overseas in the last 14 days
  • Those who have been in contact with a confirmed cased of COVID-19 in the last 14 days
  • Those with fever or symptoms or acute respiratory infection and symptoms
  • Those who have not been vaccinated against influenza (from May 1).

 

Facilities must reduce the risk of transmission to residents, including limiting visits to short periods and a maximum of two visitors at one time per day.

 

Visits should be conducted in a resident’s room, outdoors or in a specific area designated by the facility, rather than communal areas where the risk of transmission to other residents is greater.

PSA is aware of member concerns regarding patient signatures on PBS prescriptions and the associated risk of virus transmission to patients and/or 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 judgement 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 that is temporarily in place until 30 September 2020.

Information on programs and regulatory issues
Update on dispensing and supply restrictions

Update 1 July 2020 – Children’s paracetamol liquid returns to front-of-counter, but supply limits remain

 

The TGA medicine shortages taskforce has advised that pharmacies can now 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 S2 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.

 

The TGA has also approved temporary supply of an alternative, unregistered paediatric paracetamol product to support continuing access to children’s paracetamol formulations for Australian consumers. The alternative brand, Tylenol, must be stored behind pharmacy counters as the strength differs from other brands available in Australia. Pharmacists will confirm dosing instructions with parents and caregivers for these products.

 

Dispensing and supply limits for certain other prescription and over-the-counter medicines should also remain in place.

 

Read the full TGA advice here.

 

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 bold decision has been made to start putting a limit on the dispensing and sale of certain medicines.

 

From Thursday 19 March 2020:

  • Pharmacists will be 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 will be strongly encouraged to limit dispensing and sales of all other medicines to one months’ supply or one unit
  • pharmacists are required to place paracetamol paediatric formulations behind the counter to assist in allocating supply equitably
  • Supply of salbutamol inhalers are also subject to additional restrictions, assessment and recording requirements.

 

Full details of the decision can be found below.

To help explain these changes to customers, PSA has developed a sign that can be used in your pharmacy.

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 is effective to 30 June 2020.

 

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.

 

The relevant Commonwealth legislative instrument can can be found here.

 

As of 14 April 2020, all jurisdictions have enacted the necessary regulatory changes to enable Expanded Continued Dispensing. Supply of medicines under the expanded arrangements must be consistent with these regulations in your practising state or territory.

 

On 1 July 2020, the Australian Government extended the temporary Continued Dispensing (Emergency Measures) to 30 September 2020.

To support pharmacist in navigating these 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?

As of 14 April 2020, all jurisdictions have enacted the necessary regulatory changes to enable Expanded Continued Dispensing. 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 also published an addendum to the guidelines to support pharmacists in assisting patients with these continued dispensing arrangements in the context of the COVID-19 pandemic.

What other options should I consider before dispensing a medicine under the Continued Dispensing arrangements?

The Australian Government has recently introduced measures to help reduce the risk of community transmission of COVID-19 and provide protection for patients and health care providers. These include:

  • new temporary MBS telehealth items which are available to providers of bulk billed telehealth services for a wide range of consultations with any Medicare eligible Australians;
  • special arrangements to enable prescribers to provide a pharmacy with a digital image (via fax, email or text message) of a prescription for a vulnerable patient who has had a telehealth consultation, which can be dispensed by the pharmacy. The patient or prescriber would then be required to supply the pharmacy with the paper prescription within 15 days; and
  • the fast-tracking of implementation of electronic prescribing (ePrescribing) for up to 80% of general practices and community pharmacies by May 2020.

 

These 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.

A patient needs her previously supplied medicine, which was for an increased quantity (Authority item). Am I allowed to supply the increased quantity under the expanded Continued Dispensing arrangement without breaching the prescription medicine supply limits introduced on 19 March 2020?

You may supply the increased quantity instead of the standard PBS quantity provided it is permitted by your relevant state or territory legislation. The medicine supply limits introduced on 19 March were to prevent the supply of quantities that are not clinically required for an individual.

Can I supply any medicine through the expanded continued dispensing arrangements?

Medicines listed in the relevant Commonwealth legislation may be supplied provided you are complying with the state or territory legislation relevant to your professional practice. For example, you may not be permitted to supply a Schedule 8 medicine without a valid prescription in your state or territory. Note that medicines supplied under Section 100 Special Supply Arrangements (e.g. HIV medicines available through the Highly Specialised Drugs Program) are not available under the Continued Dispensing arrangements.

A patient in our local area experienced hardship with the January bushfires and has now been confirmed as a positive case of COVID-19. 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 current arrangement. You should discuss with the patient options available to them including other emergency supply provisions.

As part of the Commonwealth Department of Health’s National Health Plan, electronic prescribing is being prioritised with progressive deployment in a steady and managed approach expected by September 2020. Further information on the implementation of electronic prescribing is available here.

 

As an interim arrangement prior to the implementation of ePrescribing, a Special Arrangement has been put in place to support patients to access prescription medicines via telehealth arrangements while confined to their homes during the COVID-19 pandemic.

 

The legislative instruments are National Health (COVID-19 Supply of Pharmaceutical Benefits) Special Arrangement 2020 and National Health (COVID-19 Supply of Pharmaceutical Benefits) Amendment (Expansion of Telehealth and Telephone Attendances) Special Arrangement 2020.

 

Pharmacists should check advice from their specific state or territory health department to determine which aspects of this Commonwealth measure have been incorporated into their local legislation. PSA is continuing to closely work with Commonwealth, state and territory departmental staff and will update this page as information comes to hand.

To support pharmacist in navigating these changes relevant to your practice jurisdiction PSA has prepared a Summary of COVID-19 regulatory changes.

The following fact sheets provide further information and are available for prescribers, dispensers, and consumers.

To support pharmacists with this change, PSA has prepared the following FAQs. These are based the best available information currently available to the organisation.

Why has this Special Arrangement been implemented?

This Special Arrangement has been implemented by the Commonwealth as an immediate and interim option to enable patients to access necessary medicines via telehealth services while they are confined to their homes. Progressive deployment of electronic prescribing in a steady and managed approach is expected by September 2020.

What does this Special Arrangement allow?

Under this Special Arrangement, prescribers can provide a digital image or copy of a person’s prescription following a telehealth consultation to the patient’s pharmacy of choice via fax, email or text message. A digital image should include the prescription barcode where applicable.

Is this Special Arrangement available in every state and territory?

All jurisdictions have enacted the necessary regulatory changes to enable dispensing of prescriptions from a digital image.

 

In all jurisdictions, the supply of medicines under this special arrangement must be consistent with the regulations in your practising state or territory. To support pharmacist in navigating these changes relevant to your practice jurisdiction PSA has prepared a Summary of COVID-19 regulatory changes.

Does the prescriber still need to send the original paper prescription to the pharmacy?

No, when the prescriber has transmitted a telehealth consultation prescription to the pharmacy as a digital image or copy, there is no need for them to send the original paper prescription.

Does the prescriber’s signature still need to be provided on the digital prescription?

The prescription must be signed as normal or using a valid digital signature.

Can a prescriber send a digital image featuring all of the pharmaceutical benefits they are seeking to have dispensed for the patient?

The prescriber must create a clear copy of the entire prescription (a prescription may contain multiple pharmaceutical benefits) and send to the patient’s pharmacy of choice, including the prescription barcode where applicable. Multiple prescriptions cannot be sent in a single digital image.

How do I claim for a prescription that I’ve received as a digital image?

Pharmacists can dispense and claim from the digital image of the prescription sent through by the prescriber.

Do I need to print out a copy of the prescription from the digital image?

Yes, the process for dispensing a telehealth prescription must follow the same process as with a standard paper prescription. This includes having a hard copy of the telehealth prescription to attach the relevant dispensing labels to.

Does the prescriber need to send through an image of both the ‘Pharmacist/patient’ copy and the ‘Medicare/DVA copy’?

Prescribers have been requested to provide an image of both the pharmacist/patient copy and the Medicare/DVA copy to the pharmacy. However, pharmacists can dispense from the image even if they only receive the pharmacist/patient copy if there is sufficient information for dispensing.

Can I defer a supply of a pharmaceutical benefit from a digital image of a prescription?

Yes, a digital image can contain the supply of one or more pharmaceutical benefits and allows an approved supplier (pharmacist) to defer the supply of one or more pharmaceutical benefits on a digital image of a prescription or a copy of a prescription. The words “original supply deferred” must be written/included on the copy of the prescription or print out of the digital image of the prescription.

What do I do with repeat authorisations issued from a prescription received as a digital image?

Pharmacists must create a repeat authorisation and attach it to a printed copy of the digital image. This should be retained in the dispensing pharmacy for subsequent supply of the medicine, and pharmacists are advised to explain this to the patient prior to supply where practical.

What are the audit and compliance requirements under this measure?

The pharmacist is required to retain the following documents for two (2) years from the date of supply for audit and compliance purposes:

  • first and only supply on a prescription (and CTS claim is made) – the digital image, print out of the digital image or the copy of the prescription
  • supply on a repeat authorisation or deferred supply authorisation (and CTS claim is made) – the repeat authorisation or deferred supply authorisation
  • after the supply when there are no remaining supplies – the digital image, print out of the digital image or the copy of the prescription.

 

The prescriber is required to retain the legal paper prescription (or an electronic copy) for a period of two (2) years from the date of the prescription.

Are any medicines excluded from this arrangement?

Yes, medicines in Schedule 8 and medicines in Schedule 4 and Appendix D of the Poisons Standard are not part of this arrangement and must be supplied under the current prescribing arrangements. Pharmacists must also check particular arrangements within their jurisdiction as other medicines may also be excluded.

Is this option only available to prescribers or can patients send their existing paper prescriptions by this method too?

This measure is only available to prescribers. Patients with existing paper prescriptions or repeats will need to ask someone to visit the pharmacy on their behalf with the paper prescription/s. If this is not possible, patients can obtain a new prescription/s from their doctor via a telehealth consultation and ask the doctor to send a digital image of their prescription/s to their chosen pharmacy.

How will the patient receive their medicine if they are in self-isolation?

Pharmacies can either use their existing home delivery service or explore alternate arrangements that have recently been announced. The Home Medicines Service may provide an option for free delivery to eligible patients.

Does the patient need to sign for the receipt of a prescription?

Where practical, patients should continue to sign for receipt of PBS benefits. If it is impractical for the patient to sign the prescription acknowledging receipt of supply, a relaxation of this requirement is in place for the duration of the telehealth measure (currently ceasing on 30 September 2020). All other compliance requirements remain unchanged.

How long is this interim arrangement in place?

These interim arrangements are temporary and will cease in accordance with the National Health Plan telehealth measure which is scheduled to cease on 30 September 2020.

In March 2020, new limits were introduced to the supply of S3 salbutamol inhalers to specify that its supply is limited:

  • 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 State or Territory law to use or supply salbutamol in the practice of their profession (such as medical practitioners), or
  • for use in institutional first aid (e.g. schools and workplaces).

 

The new entry also specifies that supply is limited to one primary pack of salbutamol for each person with evidence of a medically diagnosed lung condition or previous supply from 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.

 

PSA has updated the Guidance for provision of a Pharmacist Only medicine: Short-acting beta2-agonists (salbutamol and terbutaline) to reflect these changes. This can be accessed by members only or is available in the digital version of APF which can be accessed here.

 

To support pharmacists with this change, PSA has prepared the following Q&As.

What legislative changes have come into force for salbutamol?

On 24 March 2020, a new Commonwealth legislative instrument came into force. This has since been incorporated into the Poisons Standard.

What has changed?

The Schedule 3 entry for salbutamol was amended to require pharmacists to confirm that patients requesting salbutamol over-the-counter have evidence of a medically diagnosed lung condition or a record of previous supply from the pharmacist, and to limit the supply to a maximum of one pack per purchase. Salbutamol will continue 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 person.

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 has made these changes to regulate inappropriate supply of salbutamol and to ensure ongoing access for people with diagnosed respiratory conditions. The peak bodies representing pharmacists worked with the government on these urgent measures to ensure people who need the medicines most can access them.

What can be used to confirm a clinical diagnosis?

There are a number of ways a pharmacist could check to ensure the supply of a salbutamol inhaler to a person as a Schedule 3 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, 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 Ventolin inhaler. What advice should I give?

If your doctor has prescribed inhaled corticosteroid controller medication 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 states this has occurred for many years to meet state regulations, and is described in PSA’s short-acting beta agonist guidance document (member only).

 

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
  • Support evidence requirements for future access to salbutamol
  • Providing patients with customised and individualised instructions for use on the label.
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.

On Friday 17 April and Monday 20 April 2020, the Commonwealth Department of Health announced some important changes to the Home Medicines Review (HMR), Residential Medication Management Review (RMMR), Quality Use of Medicines (QUM), MedsCheck and Diabetes MedsCheck programs.

 

Telehealth medication reviews

In response to the current COVID-19 pandemic, pharmacists will temporarily be able to 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.

 

This will enable pharmacists to deliver essential medication management consultations for those in home isolation and vulnerable patients wishing to limit their potential exposure to COVID-19, and also limit the potential exposure of pharmacists to COVID-19.

 

Response to interim report

In response to the Interim Report of the Royal Commission into Aged Care Safety and Quality, a number of changes are being implemented, effective 21 April 2020.

 

Follow up services

HMRs and RMMRs now include the option for pharmacists to conduct follow up services within nine months of the initial patient consultation. Under the updated program rules, up to two follow up services may be conducted if required due to a patient’s clinical status, the need to assess outcomes of the recommendations from an initial medication review report and the implementation of a medication management plan. It is expected that these will follow a similar, but less complex, process to the initial patient consultation.

 

Referrals by non-GP medical practitioners

HMRs and RMMRs will now be able to be referred by other medical practitioners, not just GPs. This change will allow specialists in aged or chronic care to refer for a medication review where a GP may not be available.

 

Services Agreements with multiple service providers

Facilities will now be able to enter into service agreements with multiple RMMR service providers. This will allow for more access and patient choice when receiving medication review services.

 

Guidelines and tools

Access the PSA’s updated Guidelines for Comprehensive Medication Management Reviews and Guidelines for Quality Use of Medicines Services below:

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.

What are the eligibility criteria for conducting a HMR, RMMR MedsCheck or Diabetes MedsCheck via telehealth?

For a HMR, RMMR, MedsCheck or Diabetes MedsCheck to be conducted via telehealth the patient must meet the following eligibility criteria (in addition to the eligibility criteria for the relevant program):

  • Meets 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;
  • people aged over 70;
  • identify as Aboriginal and Torres Strait Islander people aged over 50;
  • people with chronic health conditions or who are immunocompromised; or
  • parents with new babies and people who are pregnant.
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

How many follow up services can I conduct?

If required and clinically necessary, up to TWO follow up services can be conducted after each initial consultation (HMR or RMMR) as follows:

  • A first follow up consultation can be conducted no earlier than one month and no later than nine months after the initial consultation.
  • A second follow up consultation can be conducted no earlier than one month after the first follow up and no later than nine months after the initial consultation.

 

It is expected that these follow up services will follow a similar, but less complex process than the initial patient interview.

 

Refer to the updated Guidelines for Comprehensive Medication Management Reviews for information on clinical indicators and the relevant Program Rules on the Pharmacy Programs Administrator website for information on timing of follow ups.

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.

What if a subsequent HMR or RMMR is conducted before the follow up occurs?

In the event that any subsequent referrals are issued and an additional initial consultation is conducted and claimed, no follow up service(s) can be undertaken on the first HMR/RMMR service.

Can I conduct follow up services on a HMR or RMMR conducted prior to these Program Rules being updated on 21 April 2020?

Yes, any initial service undertaken after 21 September 2019 may be eligible to receive a follow up service. Refer to the updated Guidelines for Comprehensive Medication Management Reviews for information on clinical indicators and the relevant Program Rules on the Pharmacy Programs Administrator website for information on timing of follow ups.

Are follow up services included in my monthly HMR cap?

No, only the initial HMR review is counted towards the monthly cap. Follow up services are considered part of the HMR service and are not counted towards the monthly cap.

What are the fees for conducting follow up services?

Under the HMR program the approved service provider can claim the following payments:

Description Fee (per patient)
Provision of a HMR Service $222.77
First follow up service $111.39
Second follow up service $55.70

Under the RMMR program the approved service provider can claim the following payments:

Description Fee (per patient)
Provision of a RMMR Service $112.65
First follow up service $56.33
Second follow up service $28.16
How do I claim for follow up services?

Follow up services are claimed through the Pharmacy Programs Administrator under either the HMR or RMMR program depending on which type of initial consultation was conducted.

 

As with HMR and RMMR services, claims for follow up services must be submitted by the end of the next calendar month after the follow up was conducted.

The Australian Government is implementing a temporary measure from 1 May 2020 to allow flexibility around PBS restrictions for some medicines to support continued treatment. Prescribers will be able to lodge a request for exemption with Services Australia (Medicare) where they believe a requirement (such as pathology or point-of-care testing) may put patients at increased risks of COVID-19. This request will need to accompany the authority request for continuing therapy.

 

A list of eligible PBS medicines is available here.

 

Pharmacists are encouraged to reassure patients concerned about pathology requirements of available flexibility and refer them on to their treating doctor.

 

The Department of Health advises the temporary measure will be repealed by 30 September 2020.

On Wednesday 11 March 2020, the Australian Government announced a $2.4 billion COVID-19 health package. Included in this package was 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 full details of this measure have now been released. The Australian Government will provide up to $25 million, over six months, 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.

 

More information about the COVID-19 Home Medicines Service, including the program rules, eligibility criteria, FAQs and to access the claiming portal, follow the links below.

UPDATE: From 30 March 2020, pharmacies can offer free delivery of prescriptions after Australia Post launched its Pharmacy Home Delivery Service. The initiative allows vulnerable members of the community to receive medication and other essential supplies (under 500grams) through Australia Post’s Express Post network, once a month, and pharmacies can receive the full cost back through government rebate. The initiative incorporates Australia Post’s contactless delivery in line with current COVID-19 guidelines.

 

See the announcement from Australia post and information on how you can access the service below.

For further information on this service, contact Australia Post on pharmacysupport@auspost.com.au.

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:

  • ethanol 80% v/v (pharmacopoeial grade or food standard grade) in an aqueous solution that may contain a denaturant such as denatonium benzoate (NLT 5ppm), sucrose octaacetate (0.12%w/v) or tertiary butyl alcohol (0.25%v/v) OR isopropyl alcohol 75% v/v (pharmacopoeial grade) in an aqueous solution
  • purified water derived from potable water that has been rendered sterile or otherwise purified by boiling, distillation or other purification process; the purified water must be used as soon as practicable following purification to maintain the acceptable chemical quality, and the acceptable microbiological quality, of the water
  • glycerol 1.45% v/v (pharmacopoeial grade or food standard grade)
  • hydrogen peroxide 0.125% (pharmacopoeial grade).

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:

  • include a business name or logo of the manufacturer/supplier, and a trade name – neither of which may suggest/imply that the goods have been recommended/approved by or on behalf of a government authority
  • include a batch number
  • include an expiry date, not more than 36 months from date of manufacture
  • state that the product is based on the handrub formulation of the World Health Organization
  • include any caution, warning or other marking relating to the safe use, transportation or storage of the product
  • be printed in colour.

 

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.

Regarding self-isolation for interstate travel

 

LocumCo is currently seeking clarification regarding locums travelling between states and the need for isolation. PSA will provide further information here and on social media when it is available.

Clinical information and advice
NPS MedicineWise

NPS MedicineWise has prepared a dedicated website to support both health professionals and patients to be medicinewise during COVID-19.

Information for health professionals

NPS MedicineWise is maintaining a regular update on emerging evidence on hydroxychloroquine and COVID-19.

Information for patients

NPS MedicineWise has also published FAQs for patients on COVID-19 and the use of certain medicines and conditions.

Australian Commission on Safety and Quality in Health Care

The Australian Commission on Safety and Quality in Health Care have released a position statement on COViD-19 medicines management and medicine-related issues. They have also released a document detailing the medicines currently under investigation in the treatment of COVID-19. Access both documents below:

Veterans’ MATES’

The team at Veterans’s MATES have prepared a number of COVID-19 resources to support Veteran’s and the health professionals that provide care to them. Titled Keeping well during COVID-19, these resources can be accessed below:

International Pharmaceutical Federation (FIP)

The International Pharmaceutical Federation (FIP) has published comprehensive COVID-19 guidance for pharmacists.

A National taskforce has been established bringing together peak professional bodies across Australia whose members are providing clinical care to people with COVID-19.

 

They are undertaking 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. The guidelines address questions that are specific to managing COVID-19 and cover the full disease course across mild, moderate, severe and critical illness.

 

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.

On 17 June 2020, the National COVID-19 Clinical Evidence Taskforce issued a statement on the release of results of dexamethasone arm of the UK RECOVERY Trial. Read the full statement here.

Federal Government response to COVID-19

On Thursday 12 March 2020, the Australian Government announced a $17.6 billion economic response to COVID-19. This package has been announced to address the potentially significant economic consequences of COVID-19 and, from a pharmacy perspective, will support vulnerable Australians and the health professionals and staff who support them. A full overview of the economic response can be accessed here.

 

CASH FLOW ASSISTANCE FOR BUSINESSES

The announcement includes grants of up to $25,000 with a minimum payment of $2,000 for small and medium businesses that employ staff with an annual turnover of up to $50 million and will be provided through the tax system, tax free. More information can be accessed here.

 

DELIVERING SUPPORT FOR BUSINESS INVESTMENT

As part of the announcement, the Government has also increased the instant asset write-off threshold from $30,000 to $150,000 and expanded access to include businesses with aggregated annual turnover of less than $500 million (up from $50 million) until 30 June 2020. Businesses with a turnover of less than $500 million will be able to deduct an additional 50 per cent of the asset cost in the year of purchase (through to 30 June 2021). More information can be accessed here.

 

ASSISTANCE FOR SEVERLY AFFECTED REGIONS

The Government has also set aside an initial $1 billion allocation to support those regions and communities that have been disproportionately affected by the economic impacts of the Coronavirus, including those heavily reliant on industries such as tourism, agriculture and education. More information can be accessed here.

Other resources
NPS MedicineWise

NPS MedicineWise has prepared a dedicated website to support both health professionals and patients to be medicinewise during COVID-19

NPS MedicineWise has also published FAQs for patients on COVID-19 and the use of certain medicines and conditions.

Access trusted health information and advice for patients and the community

The Older Persons COVID-19 Support Line (1800 171 866)

 

Some older people are vulnerable to COVID-19 but less connected to the internet and in need of ways to access information for their circumstances. The Older Persons COVID-19 Support Line provides information, support and connection to Older Australians.

 

Older Australians, their families, friends and carers can call the support line if they:

  • would like to talk with someone about the COVID-19 restrictions and its impact on them
  • are feeling lonely or are worried about a loved one
  • are caring for someone and need some information or a listening ear
  • need help or advice about changing the aged care services they are receiving
  • need help to access new care services or essential supplies such as shopping
  • are concerned about themselves, a friend or family member living with Dementia
  • would like to arrange a one-off or regular wellbeing check for themselves, or someone else.

 

The Older Persons COVID-19 Support line is available on 1800 171 866 between 8.30am – 6.00pm AEST weekdays.

 

The Older Persons COVID-19 Support Line is a joint initiative of COTA Australia, Dementia Australia, National Seniors and OPAN, supported by funding from the Australian Government.

Media and communications
From the National President

COVIDSafe app

Tuesday 5 May 2020

Protecting pharmacists from abuse

Tuesday 5 May 2020

Changes to Medicine Review Services

Friday 24 April 2020

Digital Image Prescribing

Friday 24 April 2020

Digital Image Prescribing

Tuesday 21 April 2020

Violence against pharmacists

Tuesday 14 April 2020

Digital Image prescribing and PPE

Tuesday 7 April 2020

Member enquiries

PSA will continue to provide updates as we receive information. To speak with one of our team please call PSA on 1300 369 772 or send us an email.

 

The Australian Government has established a Coronavirus Health Information Line on 1800 020 080 for anyone seeking information on coronavirus.