Drug shortages law passed
A NEW mandatory reporting scheme for medicines shortages has now become legislation, forcing pharmaceutical companies to report shortages of important medicines within two working days.
The new national system for managing medicines supply will come into effect on 01 Jan 2019 after the Therapeutic Goods Amendment (2018 Measures no. 1) Bill 2018 passed through the Federal Senate on Mon night.
Mandatory reporting will apply to all prescription medicines as well as other vital medicines such as EpiPens and inhalers.
A critical medicine will be deemed to be in shortage if there is not enough, or likely will not be enough, for all Australian patients who take it or may need to take it, at any time in the next six months.
In addition, if a critical drug is being removed from the market, the department must be notified at least 12 months in advance, or “as soon as possible”.
Non-critical drug shortages will need to be reported within 10 working days.
Tough penalties will apply to companies that do not comply with these new laws, including fines of up to $210,000 for each infringement and the possibility of further court action.
Health Minister Greg Hunt said he made “no apologies” for taking a hard-line approach to ensuring patients aren’t kept in the dark about potential shortages.
Earlier this year, Australia was one of several countries hit by a shortage of EpiPens (PD 09 Mar), and without early notification to the Therapeutic Goods Administration, patients and doctors were not alerted in time for them to make alternative arrangements, Hunt said.
Hunt thanked industry bodies including Medicines Australia, the AMA, SHPA, the Pharmacy Guild, ASMI, NPSA, PSA and the GBMA for their involvement in the consultation and design of the new approach.
Society of Hospital Pharmacists of Australia ceo Kristin Michaels said introduction of the new protocol was a big win that would “make a huge impact on the effectiveness of hospital pharmacists in Australia, liberating their time to spend on crucial face-to-face cognitive pharmacy services on the ward, maximising their input into multidisciplinary medical teams”.
The Pharmacy Guild of Australia also welcomed the new legislation, saying “too many times in the past community pharmacists have been affected by shortages with no warning or readily available information.
“This legislation will significantly reduce the likelihood of substandard patient care arising from unforeseen and un-notified medicine shortages,” the Guild said.