The COVID-19 pandemic continues to disrupt many aspects of everyday life, and there are increasing reports worldwide shortages of medicines which may be used, or are potential candidate for use, in the fight against COVID-19. The pandemic has also given rise to concerns about shortages of essential medicines which are manufactured in, or require ingredients supplied by, countries affected by business closures and other operational delays.

The regulator and peak industry bodies have already taken some steps to manage potentially critical shortages of these medicines, and further action is likely to follow. Organisations involved in the pharmaceuticals supply chain - from manufacturers and distributors, to healthcare providers, pharmacists and consumers, should be aware of these potential shortages and how they are being managed in Australia so they are prepared to respond.

Essential medicine shortages in Australia

Peak industry bodies Medicines Australia and the Generic and Biosimilars Medicines Association have identified that maintaining the supply of essential medicines to patients is one of their critical priorities during the pandemic. The industry bodies are reportedly working closely with governments and healthcare providers to respond to an 'unprecedented surge in demand' for essential medicines, in circumstances where 70% of Australia's most commonly used medicines are produced in India and 80% of active pharmaceutical ingredients are manufactured in China.

On 19 March, the Pharmaceutical Society of Australia and the Pharmacy Guild of Australia issued an open letter to their members requiring that community pharmacies comply with dispensing limits in order to manage several 'local-level out-of-stocks' arising from a significant increase in demand. Those limits mean that community pharmacists can only dispense one months’ supply of certain prescription products, and only sell or supply one unit per purchase of certain over-the-counter medicines. Pharmacists were also encouraged to limit the dispensing and sale of all other medicines to one months' supply or one unit. The

Therapeutic Goods Administration (TGA) has also taken steps to manage potentially critical shortages of hydroxychloroquine and salbutamol.

Hydroxychloroquine is an anti-malarial drug which is currently being tested in a number of clinical trials worldwide for efficacy against COVID-19. The drug received publicity after US President Donald Trump promoted the promising results of a small French trial. The President's post on Twitter was followed shortly thereafter by reports of stockpiling and concerns about an Australian shortage, notwithstanding that at least one subsequent trial did not have positive results, and misuse of a related medicine, chloroquine, led to the death of at least one person in the US.

Salbutamol, supplied as Ventolin by GSK, is used to treat asthma and related conditions, including exercise-induced bronchoconstriction, and chronic obstructive pulmonary disease. Although confident that it presently has sufficient stock, GSK has said 'We are currently seeing unprecedented and unpredictable high consumer demand for Ventolin (salbutamol) inhalers across Australia.'

To address the potential for an irrecoverable depletion in stock of either drug, amendments were made to the Poisons Standard on 24 March to impose restrictions on the use and dispensing of hydroxychloroquine (by limiting the medical practitioners who can prescribed it) and salbutamol (by limiting the classes of persons to whom it can be dispensed).

However, it is not yet clear what measures are going to be required to address the already accumulating number of shortages of other medicines across the country. Since January 2019, sponsors have been required to report all shortages of specified 'reportable' medicines to the TGA (a shortage is considered to occur when supply of the medicine will not, or will not be likely to, meet the demand for the medicine at any time in the next six months).

The TGA publishes information about any shortage that may have a critical patient impact, as well as other shortages if the sponsor agrees or the TGA determines that it is in the interest of public health. There are currently 61 critical shortages, and 7 anticipated shortages, for medicines that include oral and IV antibiotics, several brands of water for injections and adrenaline (epinephrine) acid tartrate products which are used for the emergency treatment of anaphylaxis.

The regulatory response for medicines that may be used to treat COVID-19

Ordinarily, all medicines which are supplied in Australia are required to be entered in the Australian Register of Therapeutic Goods (ARTG). With increasing shortages, however, the TGA has recognised that alternative, unapproved products may be required to meet demand. Under section 18A of the Therapeutic Goods Act 1989, the Federal Health Minister may exempt some medicines from being entered in the ARTG if he is satisfied that, in the national interest the exemption should be made:

• So that the goods may be stockpiled as quickly as possible, in order to deal with a potential threat to public health that may be caused by a possible future emergency; or
• So that the goods can be made available urgently in Australia in order to deal with an actual threat to public health caused by an emergency that has occurred.    

This is the same power which the Minister used to authorise the distribution of unapproved diagnostic tests for the detection of COVID-19 to accredited pathology laboratories. On 2 April 2020, several medicines which are currently under investigation in clinical trials were exempted from the ordinary regulatory requirements when supplied:

• By, or under an agreement with, the Federal Department of Health; and
• For the prevention, treatment or alleviation of COVID-19.

The exemptions include medicines which contain chloroquine or hydroxychloroquine, remdesivir or lopinavir, and ritanovir. From a practical perspective, health professionals will also play an important role in managing further shortages of medicines, especially prescription medicines and medicines that are, or may be, effective in treating COVID-19.

All healthcare professionals are required to only prescribe medicines that are clinically appropriate. This is particularly significant when prescribing a medicine for ‘off-label’ use; that is, for a purpose for which the medicine has not been approved by the TGA. Off-label use is only permitted if the prescribing medical practitioner considers the use of the medicine to be appropriate and necessary in their reasonable clinical judgment.

Presently, no medicines have been approved in Australia for the treatment of COVID-19. Therefore, any medicine prescribed for that purpose would be ‘off label’ use. By only prescribing medicines for which there is a genuine clinical need, medical practitioners can help in preserving the availability of prescription medicines and preventing any unnecessary shortages. Of course a healthcare professional who prescribes any medication in the absence of genuine clinical need is also at risk of serious penalties under the Health Practitioner Regulation National Law, including the potential suspension or cancellation of their registration in serious cases.

If you have questions about how you or your business may be affected by medicine shortages, or what you can do to prepare or respond to such a scenario, please don't hesitate to contact us.