Is Australia heading for rationing of critical medicines?
Medicines may be rationed as a last resort once new shortages legislation comes into effect in January.
According to a Department of Health document, sponsors may also work with CSO wholesalers to impose “maximum sale allocations” to prevent stock-piling.
Here are eight key points from the document:
- There is a watch-list of critical medicines that includes select emergency and obstetric drugs, vaccines, anticoagulants, antivenoms, poisoning antidotes and antimicrobial agents. Some OTC medicines, including adrenaline autoinjectors and salbutamol inhalers, are on the list. The sponsor must notify the TGA of a current or anticipated shortage of any of these medicines within two business days.
- Metformin is not on the watch-list. However, TGA representatives will review all shortages and may classify a shortage as being of critical impact even if a medicine is not on the list. Sponsors can also self-assess a shortage as being critically important.
- A Medicines Shortages Action Group may be convened to help co-ordinate the response to a shortage. It would be tasked with coming up with strategies, including rationing and sourcing alternative medicines, to reduce the impact of the shortage.
- Sponsors must notify the PSA, Pharmacy Guild, wholesalers and pharmacies of expected shortages of critical medicines.
- The TGA will contact the PSA and Guild to help raise awareness of critical and medium-impact shortages, and to come up with strategies for mitigating them, such as sourcing alternative products overseas.
- The Department of Health will determine how to pay for medicines temporarily listed on the PBS to help mitigate a shortage.
- Only critical-impact shortages have to be published on the TGA’s medicine shortages website. But the TGA may decide to publish a shortage at its discretion.
- Steps being taken to help reduce the impact of the shortage may be published on the TGA’s medicine shortages website.