COVID-19: medicine access
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.
In this section:
- Medicine shortages, patient stockpiling and panic buying
- Regulation 49 prescriptions
- Pharmacy supply and dispensing
- Pharmacy home delivery services
- Continued dispensing
- Serious Shortage Medicine Substitution Notices
- Hydroxychloroquine/ chloroquine
- Electronic prescriptions and interim arrangements
- Pharmaceutical Benefits Scheme (PBS)
- PBS Authority approval telephone line
- 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.
- 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,
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.
- Intensive care medicine
- Paediatrics and child health
- Emergency medicine
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.
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.
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