TGA to permit conditional substitution to ease serious shortages

In response to the COVID-19 pandemic, the Therapeutic Goods Administration (TGA) is implementing Serious Shortage Medicine Substitution Notices. These notices will allow pharmacists to substitute dose strengths, forms and different release-rate forms of specified medicines under certain conditions without prior approval from the prescribing doctor. Substituting medicines in this way will relieve pressure on doctors and allow continued supply of essential medicines for patients.

The TGA has been working closely with health professional peak organisations, state and territory governments and other key stakeholders to urgently develop measures to help ease serious medicine shortages during the COVID-19 pandemic.

The COVID-19 pandemic has seen unprecedented increases in demand for certain medicines. Together with disruptions to manufacturing and logistical operations globally, the increased demand has put pressure on supplies of a number of medicines that Australians rely on for their ongoing health and wellbeing.

Although few products to date have been the subject of national-level shortages, local-level supply disruptions have made it more difficult for some people to obtain their regular medicines.

Serious shortages are normally defined as verified shortages of a particular medicine at a national level. However, the new substitution arrangements may be used to address severe local-level supply disruptions during the COVID-19 pandemic. Serious shortages will be characterised by a high likelihood of significant and immediate negative health consequences for patients who cannot access the medicine at the prescribed intervals.

The changes will allow a pharmacist to dispense different strengths of a product (such as two 20 mg tablets in place of a 40 mg tablet), or a different dose form of the same medicine (such as a capsule instead of a tablet) or a different release formulations (such as extended release instead of immediate release).

Substitution of a medicine with another product containing a different active ingredient will not be permitted under these measures.