Medicine shortages in Australia regulated by the TGA

The Australian Government Department of Health Therapeutic Goods Administration (TGA) has announced there is a medicine shortage in Australia.

A medicine shortage occurs in Australia when there are insufficient amounts of a prescription available to those who require it.

From January 2019, the TGA introduced mandatory regulations where suppliers must report shortages of prescription medicines and some over-the-counter medicines.

Using the data on supply shortages provided by sponsors, the TGA mandatorily releases information on medicine shortages that have critical patient impact.

The Medicine Shortages Reports Database on the TGA website publishes detailed information on specific single product medicine supply shortages, usually a consumer will find there are alternative medical brands, strengths, and doses available after consulting with their doctor or pharmacist.

The aim of the Medicine Shortages Reports Database is to provide consumers with timely notifications so they can plan during a medicine shortage and seek advice from their doctor on potential alternative treatments.

Causes for a medicine shortage in Australia are often due to the discontinuation of products, product recalls from consumer, manufacturer and wholesaler complaints, product defect correction, hazard alerts, and the impact from COVID-19 panic buying and stockpiling.

The TGA provides access to medicine pathways for health professionals and consumers during a shortage by providing advice on alternative medicine solutions.

A pharmacist will instruct if there is more than one brand of medicine available, if there is a medicine shortage and no alternative brands, a doctor can advise on a substitute treatment and they might be able to arrange a medicine replacement from overseas through one of the TGA’s access schemes.

A consumer should first check the TGA Medicine Shortage Reports Database for detailed information on how long the shortage is expected to last, even if there is a national shortage, a patient can consult with their pharmacist to ascertain if they can order some medicine through their wholesaler or sponsor.

If the TGA lists the medicine as being in a critical shortage, consumers can pursue a variety of medicine access options, these include seeking an alternative medicine in another country, finding an unregistered alternative medicine, taking a different strength or dose instructed by a pharmacist, obtaining a personal alternative product, or asking your doctor to prescribe a different medicine.

Medicines not on the Australian Register of Therapeutic Goods (ARTG) can be approved for import and supply in Australia through the database of Section 19A if there is a medicine shortage and the medication is required for public health.

Medicines approved for import through the Section 19A database initiative are subject to TGA conditions.

The Special Access Scheme (SAS) allows health practitioners to apply to access therapeutic goods for a single patient such as: medicines, medical devices, and biologicals, which are not on the ARTG.

Individual patients need to discuss the implications of using ‘unapproved’ therapeutic goods with a health professional and the practitioner must assess the evidence and risks to support the consumer accessing an ‘unapproved’ therapeutic product.

The Australian Government is implementing A Serious Shortage Substitution Notice (SSSN) initiative that will allow community pharmacists to substitute certain medicines without requiring approval from a doctor in some situations where a medicine is unavailable.

The aim of the SSSN is to allow patients to receive medications from a pharmacist without delay and to minimise the stress on doctors.

Through the SSSN a pharmacist will be allowed to distribute different strengths of a product, for example two 20mg tablets instead of one 40mg tablet, or a different dose of the same medicine, a capsule instead of a tablet, medicines identified for substitution will be listed in the SSSN on the TGA website.

The Personal Importation Scheme is a medicine pathway where consumers can legally import therapeutic goods for their own treatment or immediate family, if they do not sell or give the medication to any other person.

Through the Personal Importation Scheme, without requiring approval from the TGA, an individual can import up to three months’ supply at one time of unapproved therapeutic goods if they follow the importation guidelines.

Alternative medicine access pathways can incur increased cost to consumers, medications accessed through the SAS are not subsidised under the Pharmaceutical Benefits Scheme (PBS), section 19A products can receive a PBS subsidy if the ARTG product is already subsidised or the sponsor applies for a subsidy, although the TGA cannot instruct the sponsor to apply.

Consumers and health professionals can always keep regularly informed on medicine shortages, availability, impact, and expected supply dates by accessing the TGA Medicine Shortage Reports Database.