New legislation has been passed to allow pharmacists to substitute a different medicine when a patient's usual medicine has been declared to be in 'serious scarcity'.
This formalises the Serious Shortages Substitution Notices (SSSNs) that have been in operation since May 2020 and removes the need for each SSSN to be recognised in individual state and territory legislation before pharmacists can make the substitution.
Under the new laws, a new legislative instrument will be registered each time a substitute medicine is needed to address a serious scarcity. These instruments will provide details of medicines that pharmacists are permitted to dispense as a substitute and any conditions that apply. Each one will be developed in the same way SSSNs have been created to date. Seeking input from health professionals and clinical groups remains an important part of this process.
Allowing pharmacists to substitute specific medicines without prior approval from the prescriber relieves pressure on doctors and helps patients get faster access to alternative medicines when there is a serious scarcity.
Pharmacists should continue their usual practice and contact prescribers to notify them as soon as possible following the substitution. Any state and territory legislation relevant to the substitution must still be followed. Patients will continue to decide whether they wish to accept the substitute medicine from their pharmacist.
The introduction of the new legislation does not affect the existing SSSNs published on the TGA website. New processes are being developed with input from key stakeholders to help a smooth transition to the new arrangements.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.