The Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018 has passed the Senate and will come into effect on 1st January 2019. The main focus of this bill concerns the communication of medicine shortages.
Reporting of medicine shortages and anticipated shortages to the Therapeutic Goods Administration (TGA) is currently voluntary. The following changes will occur under the new legislation:
- Mandatory reporting of shortages affecting higher-risk medications (i.e. all prescription medicines as well as medicines deemed vital for public health such as salbutamol inhalers and adrenaline autoinjectors);
- Shortages of critical patient impact must be reported to the TGA as soon as possible, but no later than two working days after the sponsor becomes aware or should have reasonably been aware;
- Shortages that are not of critical impact must be reported to the TGA no later than ten working days after the sponsor becomes aware; and
- Sponsors must notify the TGA at least six months prior to a planned discontinuation (12 months prior for critical medicines), or as soon as practicable.
A Medicines Watch List will be created to document medicines considered to be critical. Medicines will be included on this list if the Health Minister reasons that a shortage or discontinuation could cause significant morbidity or death for patients in Australia, or if there are no clinically appropriate alternatives available to meet the demand.
Companies that fail to comply with these new requirements face fines of up to 1,000 penalty units (one penalty unit is currently $210).
This amendment is intended to improve the communication of medication shortages within Australia and allow healthcare professionals to manage shortages better. Management options that could be considered during a medicine shortage include rationing medications for patients in greatest clinical need, utilising the Special Access Scheme, and considering therapeutic alternatives.
HPS and our network of HPS Approved Pharmacies will also continue to keep our clients informed of medicine shortages via our DrugAlert notifications.
- Department of Health. Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018: Explanatory Memorandum. Canberra: Australian Government; 2018.