The Senate has passed legislation which will require pharmaceutical companies to report shortages of important medicines as they occur
Based on the new legislation, medicine companies will have to report shortages of important medicines as soon as they occur, with tough penalties to apply to companies that do not comply.
Additionally if a critical drug is being removed from the market, the Department of Health must be notified by the manufacturer at least 12 months in advance, or as soon as possible.
Following a second reading of the Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018 on Monday, senators discussed the importance of the new legislation, with one referring to input from the Pharmacy Guild’s Anthony Tassone.
Tasmanian Labor Senator Helen Polley outlined some of the challenges facing patients whose medicines go into shortage.
“If we don’t know about a shortage ahead of time, patients will simply turn up to a pharmacy to find out that their medicine is not available,” she said.
“They might then end up travelling from pharmacy to pharmacy in a futile search, only to find later that the shortage is widespread. This might be even worse for a patient with a mental health condition.
“Anthony Tassone from the Pharmacy Guild of Australia said: ‘When you have a medication that is used to treat a mental health condition become in short supply, some patients become anxious, which is the last thing they need’.
“Mr Tassone is absolutely right. The shortages will impact disproportionately on people who have a mental health condition.
“However, any person who suffers from a serious or life-threatening illness that requires medication is likely to be very concerned when they suddenly and unexpectedly find that they cannot obtain their medicine.”
Senator Polley and others also highlighted the example of the EpiPen shortage.
Western Australian Liberal Senator Slade Brockman explained that under the current voluntary system, the TGA is only made aware of shortages if the manufacturer chooses to notify it.
This scheme has proven to be ineffective, he said, with the EpiPen shortage a good example.
“Often the first indication of a shortage is through correspondence from a member of the public impacted by it, and the situation then has to be confirmed with the sponsor,” he said.
After the Bill was passed, Health Minister Greg Hunt said that the new law would both protect patients who rely on vital medicines, and give the community, pharma companies and patients the opportunity to mitigate against shortages.
“Mandatory reporting will apply to all prescription medicines as well as other medicines which are vital for public health, such as EpiPens and inhalers,” Mr Hunt said.
“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.
“I make no apologies for taking a hard-line approach to ensuring patients aren’t kept in the dark about a potential medicine shortage.”
Under the new legislation a shortage that will severely impact on patients must be notified to the Therapeutic Goods Administration (TGA) as soon as possible, and no later than two working days after the medicine company knows or should know of the shortage.
“Under the new law, a critical medicine is deemed to be in shortage if there is not enough, or likely will not be enough, for all patients in Australia who take it or may need to take it, at any time in the next six months,” Mr Hunt said.
“Shortages cannot always be avoided but, when they do occur, this mandatory reporting scheme will help Australian patients and health professionals to be more prepared.
“Responses to a shortage could include re-directing the available supplies to patients who need them most, nominating alternative treatments and providing Pharmaceutical Benefits Scheme coverage for the alternatives.
“Medicine companies must also notify my Department of shortages that will not have a severe impact on patients. They will have up to 10 working days to do so.”
Pharmacy groups including the SHPA and Guild welcomed the new legislation.
“Introduction of the new protocol is a big win for our members and will 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,” said its chief executive, Kristin Michaels.
The Pharmacy Guild responded to the legislation’s passage saying that “Medicine shortages have become an increasing problem in recent years not just in Australia but around the world. A shortage of a critical medicine places patients’ lives at risk”.
“The move to a mandatory reporting regime will significantly improve communication around medicine shortages for the benefit of patients and health professionals – something we have been advocating for some years.
“Timely communication about medicine shortages and available alternatives is vital to providing the best level of care for patients.
“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 sub-standard patient care arising from unforeseen and un-notified medicine shortages.”