"In early 2018, Australia was hit by a shortage of EpiPens, which provide lifesaving adrenalin for people who have had an acute allergic response. In this and a number of other cases, shortages were not reported in advance to the TGA and as a result, patients and doctors were not alerted in time for them to make alternative arrangements."
A new law requires drug sponsors to notify the federal Department of Health about expected medicine shortages & discontinuations in Australia.
Passed by the Senate, this new law comes into effect on the 1st January, 2019. Sponsors will have two working days to notify the department about expected shortages of a critical-impact medicine. This is a summary of the new requirements:
Sponsors will have 10 working days to report shortages of non-critical medicines. In case of non-possibility of Sponsors reporting the TGA 12 months’ notice before discontinuation of critical-impact medicine, it needs to be done as soon as practical after the decision is made. The discontinuation notice for all other medicines must be submitted six months in advance.
Failing to comply with the new laws, Sponsors will be exposed on the TGA website as a last resort.
There will be a watch-list of critical-impact prescription and non-prescription medicines. It will include medicines where a shortage could lead to patient death or morbidity. Medicines will also be considered critical-impact if there are no current alternatives or not enough substitutes to meet demand.
The department will be given more power to request information about shortages and discontinuations.
Shortages will exist if supply won’t meet (or is unlikely to meet) all patient demands at any time in the next six months.
Mandatory reporting won’t stop medicine shortages; it will assist health professionals to be better prepared when shortages occur, said Gregory Andrew Hunt, the Minister for Health. Sponsors who fail to comply with the new regulations can face penalties of up to $210K and the possibility of court action.
This hard approach had to be implemented as medicine shortages have become an increasing problem where companies have failed to comply with the current voluntary reporting scheme.