COVID-19: Your questions answered

Expanded Continued Dispensing 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.

Digital image prescriptions and ePrescribing FAQs
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.

Schedule 3 salbutamol (scheduling change) FAQs
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.
Hydroxychloroquine (scheduling change) 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.

Medication management programs 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.

Hand sanitiser manufacture FAQs
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.