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08 Apr 2020

COVID-19: medicine access

The Australian Government has approved a number of temporary changes to medicines regulation to ensure Australians can continue to access the Pharmaceutical Benefits Scheme (PBS) medicines they need, as the COVID-19 (Coronavirus) outbreak unfolds.

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In this section:


Medicine shortages, patient stockpiling and panic buying

The Therapeutic Goods Administration (TGA) has not received reports of medicine shortages as a result of COVID-19. However, local shortages have occurred due to a spike in demand from patients.
 
Stockpiling medicines is not necessary.
 
It is essential that the public does not stockpile medicines to ensure there is equitable access for everyone. It is vital that people can obtain the medication that they need to stay well and to prevent significant health complications. In some cases, patients who cannot access the medications they need may risk death. If individuals stockpile medicine, there is a risk that the unused medication will become out of date and therefore cannot be used.
 
For more information, see the TGA’s media release, here

Regulation 49 prescriptions

Doctors have an important role to ensure their patients understand the risks of stockpiling and its impacts on the community. It is likely that doctors will receive requests from their patients to be able to receive higher quantities of medications.
 
Regulation 49 (previously regulation 24) prescriptions allow a PBS medication’s original and repeat to be supplied at the same time (i.e. higher quantities of medication are received by the patient in one transaction). Regulation 49 prescriptions can only be prescribed if the treating medical practitioner, midwife, or nurse practitioner has satisfied all the following conditions:
 
  • the maximum PBS quantity is insufficient for the patient's treatment; AND
  • the patient has a chronic illness or lives in a remote area where access to PBS supplies is limited; AND
  • the patient would suffer great hardship trying to get the pharmaceutical benefit on separate occasions.
More information on Regulation 49 prescriptions is available at the Department of Health PBS website – Prescribing Medicines – Information for PBS Prescribers, here
 
The AMA is calling on all members and the wider profession to ensure that only those patients who are eligible and meet the criteria are provided with Regulation 49 prescriptions.

Pharmacy supply and dispensing

A number of restrictions on medication supply were announced on 19 March 2020 as a result of patient stockpiling and demand during the COVID-19 crisis.
 
Pharmacists will be required to:
  • limit particular prescription products to one month’s supply (at the prescribed dose),
  • limit a maximum of one unit per purchase for particular over the counter medications,
Pharmacists are strongly encouraged to limit dispensing and sales of all other medicines to one month’s supply or one unit.
 
Salbutamol inhalers supplied over the counter are limited to one per customer and will require confirmation of the patient’s diagnosis, the supply recorded and the inhaler labelled with the patient’s name.
 
Paracetamol paediatric formulations are limited to one per customer and will be placed behind the counter to assist in supply.
 
A full list of the medicines, including more detail on the restrictions, are available on the TGA’s website, here

Continued dispensing

Continued dispensing arrangements that were implemented as an emergency measure through the bushfire season has been extended until 30 June 2020.
 
Patients can be supplied with their usual medicines if they cannot get a prescription from their doctor. Patients will be able to receive up to one month’s supply. The patient must have been previously prescribed the medication and the pharmacist must be satisfied that there is an urgent need for the prescription to be filled.

Serious Shortage Medicine Substitution Notices 

The Therapeutic Goods Administration (TGA) has released its first Serious Shortage Medicine Substitution Notice (Notice) for Metformin modified-release 500mg tablets. 

Notices were introduced under consultation with the TGA’s COVID-19 Medicine Shortages Working Group, in which the AMA is a member. The changes aim to “relieve pressure on doctors and allow patients to receive their medicines from their pharmacist without delay” during the COVID-19 pandemic. 

A Notice allows pharmacists to substitute a strength, dose form, or extended/sustained /immediate-release form, of medication without first contacting the prescriber. It is the pharmacist’s professional practice requirement to contact the prescriber as soon as practicable when a substitution has occurred.  

Substitution can only occur when the Notice has been published by the TGA. Pharmacists cannot substitute medications within the same therapeutic class.  

The Notice for metformin outlines protocols the pharmacist must follow, including specific medications that are approved to be supplied as a substitute for the modified-release 500mg tablets, and when to contact the prescriber.  

For more information visit the TGA website here.


Pharmacy home delivery services

The Government has provided funding to allow pharmacists to deliver medicines to patients’ homes if they meet the eligibility criteria. The announcement is available here

Hydroxychloroquine/ chloroquine

Hydroxychloroquine is a medication that is used to treat malaria and some autoimmune conditions such as rheumatoid arthritis and lupus.
 
Recently, there have been media reports of hydroxychloroquine being used as a potential treatment for COVID-19. Clinical trials are being conducted on an international level, however, at the moment, there is not enough evidence to use this medication on a wider scale.
 
Hydroxychloroquine can have significant adverse effects. For example, cardiac toxicity (which may lead to heart attack), irreversible eye damage, and severe depletion of blood sugar (which may result in a coma).
 
Everyone has a responsibility to make sure hydroxychloroquine is available to those who need it as determined by their medical condition.
 
Hydroxychloroquine/chloroquine restrictions
As of 24 March 2020, there are new restrictions for prescribing hydroxychloroquine. Initial treatment of hydroxychloroquine must be authorised by a medical practitioner under the following specialties:
  • Dermatology
  • Intensive care medicine
  • Paediatrics and child health
  • Physician
  • Emergency medicine
General practitioners and other medical practitioners (e.g. hospital Resident Medical Officers and doctors in training) are still able to prescribe repeats for patients with a clinical need if the medication was prescribed before 24 March 2020. On and after 24 March 2020, GPs and Doctors in Training can only prescribe these medications when initial treatment was authorised by a medical practitioner under one of the specialties listed above.
 
More information on hydroxychloroquine and COVID-19 are available on the TGA website, here

Electronic prescriptions and interim arrangements

The Government has announced that it will be fast-tracking the implementation of electronic prescriptions (ePrescriptions). These prescriptions enable patients to share their prescription electronically with the pharmacy. The AMA is working with the Government throughout this process.
 
While ePrescriptions are not yet available, to reduce the risk of COVID-19 transmission, a number of special arrangements have been implemented to complement telehealth services.
 
Prescribers will still write a paper-based prescription, however, a digital image can now be created to send via email, text, or fax. This can be sent directly to a pharmacy of the patient’s choosing. Ask the patient if they would like to receive a paper prescription which will need to be sent via mail. The prescriber must keep the paper prescription on file for two years for audit and compliance purposes. 
 
Pharmaceutical benefits under Schedule 8 and under Schedule 4Appendix D in the Poisons Standard are not covered under the Special Arrangement. Requirements change according to State and Territory legislation. Please contact your local health department for advice and visit this page for each jurisdiction’s requirements.

Pharmaceutical Benefits Scheme (PBS) 

From 1 May 2020, temporary measures were introduced regarding PBS restriction leniency for eligible PBS medicines to reduce barriers for continued patient treatment during the COVID-19 crisis.  

Treating medical practitioners can request an exemption with Services Australia if they consider that a patient taking an eligible PBS medicine should be exempt from any specific Authority Required PBS restriction requirement. For example, the requirement may increase the risk of the patient contracting COVID-19 or cannot be completed due to social distancing or isolation requirements. The request for exemption must be included with the authority request through the normal process.  

This measure only applies to continuing prescriptions of the eligible PBS medicine. All other PBS restriction criteria not affected by the COVID-19 pandemic still applies 

As a legal requirement, the prescriber must state the reasons for the proposed exemption and how it relates to the COVID-19 pandemic.  

The measure will be repealed by 30 September 2020.  

More information, and a list of eligible PBS medicines is available here. 


PBS Authority approval telephone line

The PBS Authority Approval Telephone Line has experienced an increased number of calls throughout the COVID-19 pandemic. When required, an emergency protocol will be implemented on the Approval Line. The following advice is provided by Services Australia  

 The COVID-19 emergency protocol will allow prescribing and supply of the quantities and/or repeats required clinically and allowed within PBS limitations. For PBS listings that allow increased quantities and/or repeats, the provision of increased quantities and repeats on authority PBS prescriptions is intended to provide approximately one month's therapy which may be repeated (if clinically appropriate) to provide 6 months' therapy in total.  

 Prescribers must continue to call 1800 888 333 to seek telephone authority approval and to listen to the necessary emergency message when enacted. The emergency message will provide a new COVID-19 emergency approval number that must be annotated on the prescription, with the date and time of the prescriber’s call. The emergency approval number must also be submitted in the pharmacy claim. This number replaces the existing emergency approval number and is for use only during the COVID-19 period.  It is important that the correct approval number is utilised.  

 Following the COVID-19 period, we will return to the current emergency arrangements. 

 Please note this arrangement does not apply to PBS medicines that require authority approval from Services Australia ‘Complex Drugs’ team. Prescribers must follow existing processes to request authority approvals for these medicines.  


Dexamethasone and COVID-19 management 

The World Health Organization has welcomed news that the University of Oxford’s RECOVERY trial has reported positive preliminary results for the use of dexamethasone on patients who are critically ill from COVID-19.  

Dexamethasone is a prescription-only corticosteroid that is used as an anti-inflammatory and immunosuppressant. The results of the trial have produced significant interest as dexamethasone is readily available and affordable in many countries.  

Doctors are reminded that this news may result in an increase of patients asking for the medication, as was seen with media reports of premature promising results for the use of hydroxychloroquine on COVID-19 patients. The TGA have provided the following points that doctors should consider if faced with requests for dexamethasone: 

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

An article from NPS MedicineWise explores the available evidence for dexamethasone and COVID-19 management, available here 


Published: 08 Apr 2020