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COVID-19 information for pharmacists

This information was last updated Tuesday 14 September 2021

 

PSA is committed to keeping members informed throughout the COVID-19 pandemic. This page will 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 (Updated 29 August 2021). Find the latest information and resources regarding the use of face masks for pharmacists and consumers. Read more here.

 

Medicine supply limits continue to apply – Find the latest updates on the supply of prescription and non-prescription medicines here.

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.

Australia’s community pharmacy network has been activated to participate in the national COVID-19 vaccine roll-out. On-boarded pharmacies have commenced administering the AstraZeneca COVID-19 vaccine in approximately 2,500 community pharmacies. Community pharmacists will commence administering the Moderna mRNA COVID-19 vaccine from late September (subject to regulatory approvals).

 

The EOI and payment process is being managed by the Pharmacy Programs Administrator (PPA) on behalf of the Department of Health.

 

What vaccines will be administered?

Community pharmacists are expected to initially administer the AstraZeneca vaccine.  It is anticipated other COVID-19 vaccines, such as Moderna’s Novovax, will be administered from late September 2021.

 

What are the service requirements?

The COVID‑19 vaccine will be administered in the community pharmacies by appropriately COVID‑19 vaccine trained, registered pharmacists, nurse practitioners, nurses and Aboriginal Health Workers under the supervision of an Approved Pharmacist.

 

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.  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. Have your Ahpra number handy as you will require this to enrol. 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:

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.

Face masks and personal protective equipment
Current recommendations for pharmacists and the community

 

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. Face shields are considered eye protection. They not an equivalent substitute for surgical masks.

 

Updated 29 August 2021 Is COVID-19 PPE recommended for pharmacists and pharmacy staff? Is use of masks required in the community by public health orders? Further information
ACT Yes Yes Face mask requirements (ACT Health)
NSW Yes – Minimum PPE includes:

  • surgical masks
  • eye protection
Masks must be worn indoors and outdoors, except when exercising

Masks must be carried at all times

NSW Health – Agency for Clinical Information COVID-19 risk monitoring dashboard

NSW Health – face mask rules

Government Gazette 266 – Directions about face coverings

NT No, but surgical masks may be worn if desired Not at this time NT Government: Slowing the spread
QLD Affected areas*: Yes – surgical masks

 

Rest of Queensland: No, but surgical masks may be worn if desired

Affected areas*:

  • Masks must be worn indoors and in some outdoors settings**.
  • You must carry a mask at all times

Rest of Queensland:

  • Not at this time, unless you have been in an affected area in the past 14 days
Queensland Health PPE guidance for healthcare workers

Face masks (Queensland Health)

* Affected areas includes the following local government areas: Brisbane City, Logan, Moreton Bay, Ipswich, Redlands, Sunshine Coast, Gold Coast, Noosa, Somerset, Lockyer Valley and Scenic Rim local government areas.

** Masks do not have to be worn when in a car by yourself/household; outdoors when physical distance can be maintained (masks must be worn at public events); or if eating or drinking.

SA Yes (surgical masks) – high risk setting Masks must be worn in high-risk settings, including most health settings and beauty services. Public Activity directions notices

SA Health – PPE advice for health care workers

TAS No, but surgical masks may be worn if desired Not at this time Face masks – DHHS (Tas)
VIC Yes – Minimum PPE for confirmed COVID-negative people includes:

  • surgical masks
  • eye protection
Masks must be worn indoors and outdoors, except at home or where an exemption applies (e.g. eating/drinking)

You must carry a mask at all times

VicDH PPE guidance for health care workers:

Legal directions:

WA No, but surgical masks may be worn if desired Not at this time Health WA – Face masks

Information aligns with current public health advice and is subject to change.  In addition to the above, all states and territories have introduced mandatory face mask use at airports and on commercial aircraft.

 

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

 

Additional to the requirements in the table above, some people may be required to wear face masks in public or in workplaces to minimise risk following travel in an affected region in the previous 14 days.

 

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

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 where masks use is recommended or required by public health directions, you must wear a medical grade face mask at work (Level 1 or above).

 

Where public health advice requires masks use when physical distancing cannot be maintained, medical masks should be worn as 1.5m physical distancing between other people, including other staff, may be difficult to continuously maintain in nearly all community pharmacies and therefore cannot be guaranteed.

 

The routine use of medical masks by pharmacists and pharmacy staff residing above and beyond public heath advice is not actively recommended, but can be adopted 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 required or recommended by government authorities, 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, reschedule HMR or provide telehealth consultation as appropriate.

Pharmacists and pharmacy staff should wear surgical masks rather than reusable cloth masks consistent with relevant health department guidance for all health care workers.  Health department guidelines require masks providing greater protection when caring for patients who are confirmed COVID-19 positive or COVID-19 probable.

 

Use of non-surgical masks and/or incorrectly work surgical masks increase the risk of being deemed a close contact (including 14-day isolation requirement)  following exposure to a person with COVID-19 infection.

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) and is subject to declaration of a COVID-19 hotspot under the Commonwealth definition.

 

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.

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 when there is sustained community transmission of COVID-19.

 

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.

Contact tracing requirements

Contact tracing requirements, while broadly consistent, vary between jurisdictions. It is now generally mandatory for all people to log their attendance at any public venue or workplace in any Australian jurisdiction regardless of duration of visit.

 

Locations and people who must record attendance for contact tracing

The below table describes the obligations as they are likely to affect pharmacists in their practice:

 

Updated 26 July 2021 Community pharmacy Hospitals Aged Care visitors/staff Accepted contact registers Written register permitted? More information
ACT Yes Check In CBR Only if not possible to use the app due to technical issues. Business Profile function should be used for persons without phones. Information for businesses

Public Health (Check In Requirements) Emergency Direction 2021

Staff must take all reasonable steps to ensure people >16year age record attendance.

Staff may deny entry to persons who refuse to use the Check In CBR app.

NSW Yes Yes*~ Yes Services NSW app If it is not possible for a person to check in using their device, an occupier must have an alternate sign-in method. Businesses must register those contact details with Service NSW within 12 hours Mandatory electronic check-in

* Alternative check-in systems permitted in hospitals.

~ Patients are not required to check-in to health facilities (other than community pharmacies)

NT Yes, if on premises for >15 mins~ The Territory Check In app

Pen/paper

Alternate QR registers

Yes, all businesses encouraged to provide paper for people who do not have phones. The Territory check-in app: Business information

~Customers do not have to check in if they are collecting a prescription or undertaking retail purchase. Customers must sign in if they are attending for longer >15 mins (e.g. vaccination)

QLD Yes Visitors, volunteers and contractors: Yes Yes Check In Qld Only for unexpected circumstances, a risk of safety issues or because the business is located in a place that does not have mobile internet data connection QR Code must be displayed at every entry, preferably in colour

QLD CHO Direction

Hospital Visitors Direction

SA Yes Yes Yes COVID SAfe Check-In via mySA GOV app Yes, only as a back-up for people who don’t have a smart phone COVID SAfe Check-In
TAS Yes* Yes* Check In TAS Only in the event of no internet access or device malfunction Check in TAS: Information for businesses

If a person refuses to check in, the operator of the premises or event must refuse entry as per the Direction Under Section 16 (Contact Tracing – No. 5) of the Public Health Act 1997

* Mandatory from 31 July

VIC Yes* Attendance must be recorded, although Services Vic QR app not mandatory Anyone other than residents: Yes.

 

Residents: Must be recorded, although Services Vic app not mandatory

Services Victoria No, kiosk mode of the Services Victoria app must be used for people who do not have a mobile phone. Checking in with QR Codes

*limited exceptions including (i) alcohol & drug services and; (ii) click and collect if not entering premises

Staff must ask every patron to check-in (i) at point-of-service if <2000m.sq; or (ii) at entry to premise if >2000m.sq

WA Yes Yes, for visitors only – including persons visiting patients or attending meetings/lectures, couriers, and contractors SafeWA (preferred)

Pen/paper

Alternate QR systems

A paper-based contact register must also be made available SafeWA app

 

Unless stated, the above includes all people who visit the location every time they enter. This includes all patients, carers, third-parties, staff, contractors (e.g. delivery drivers, external security personnel).

Practical information and advice

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.

2021 Immunisation resources

 

Below are links to resources and advice from the Commonwealth Department of Health and the Australian Technical Advisory Group on Immunisation (ATAGI). These resources have been updated to reflect the most up-to-date information available for the 2021 influenza season:

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.

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 18 March 2020 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 with the current influenza season vaccine

 

These restrictions have been maintained.  During periods of enhanced local restrictions (e.g. lockdowns) further limits on visitors may be imposed. 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.

 

On 2 July 2021, National Cabinet announced they had endorsed the decision of the Australian Health Protection Principal Committee to make COVID-19 vaccination mandatory for all residential aged care workers by mid-September 2021, when they are required to have at least a first dose of a COVID-19 vaccine.

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 September 2021.

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.

Information on pharmacy programs and regulatory issues
Limits on dispensing and sales of prescription and over-the-counter medicines

PSA is aware of member concerns that patients 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 was made in March 2020 to limit the dispensing and sale of certain medicines.

 

These mitigation measures introduced last year, including purchasing limits and labelling requirements for over-the-counter supplies of salbutamol, remain in place. The current COVID-19 situation in Australia is continuously evolving, and PSA has been advised the TGA continues to actively review the need for these requirements.

 

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 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 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.

 

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.

 

 

 

Read the full TGA advice here.

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

Update March 2021 – Continued Dispensing emergency arrangements to continue until 31 December 2021.

 

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 to 31 March 2021.

 

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 be found here.

 

All jurisdictions have enacted the necessary regulatory changes to enable Expanded Continued Dispensing. In all cases supply of medicines under the expanded arrangements must be consistent with these 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.

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 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.

Update 1 April 2021 – Digital Image Prescriptions to continue until 31 September 2021

 

As an interim arrangement prior to the widespread 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. This enables supply of certain PBS medicines to be made based on an image of the prescription provided to the pharmacist by the prescriber.

 

This updated instrument also includes a waiver for a patient signature acknowledging receipt if it is impractical to obtain, and includes waiver for the pharmacist’s signature on prescription record forms as long as the record is not handwritten.

 

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.

More information can be found here

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. Electronic prescriptions are expected to entirely replace digital image prescriptions described in this Special Arrangement later in 2021.

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 must 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 until 31 September 2021. All other compliance requirements remain unchanged.

How long is this interim arrangement in place?

This interim arrangement was extended in September 2020 and will now cease on 31 March 2021.

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.

 

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) will shortly be updated to reflect these changes. This can be accessed by PSA members only or is available in the digital version of APF which can be accessed here.

 

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).

 

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.

 

The use of ivermectin for the treatment of COVID-19 has not been proven. The Cochrane Review published on 28 July 2021 included that:

There is uncertainty about the efficacy and safety of ivermectin used to treat or prevent COVID-19, although the evidence base is limited. Evaluation is continuing in 31 ongoing studies. At this time there is no evidence to support the use of ivermectin for treating or preventing COVID-19 infection.

 

 

Implications for pharmacist practice

Current Australian advice includes the following:

 

  • The National COVID-19 Clinical Evidence Taskforce has issued a high priority recommendationDo not use ivermectin for the treatment of COVID-19 outside of randomised trials with appropriate ethical approval.
  • 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.

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.

Update 23 March 2021 – Home Medicines Service to continue until 31 December 2021

 

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 will provide funding until 31 December 2021, 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.

 

As of September 2020, more than 1.1 million deliveries have been made by more than 4,600 pharmacies through this service.

Update 25 September 2020 – Australia Post’s Pharmacy Home Delivery Service also to continue until 31 March 2021

 

Australia Post has announced the extension of its Pharmacy Home Delivery Service until 31 March 2021. 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 announcements 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

 

Interstate border closures and intrastate travel restrictions aimed at limiting the spread of COVID-19 during community transmission outbreaks presents challenges for provision of locum services. Restrictions may be applied at short notice, including requirements to stay-in-place or isolate during and/or after travel. Pharmacists are advised to review border restrictions and discuss contingencies for self-isolation or hotel quarantine directions when undertaking practice related travel.

For more information contact PSA at membership@psa.org.au

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.

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.

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.

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.

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).

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.

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.

 

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