Mandatory reporting of medicine shortages

The Pharmacy Guild has welcomed the passing of legislation to make the reporting of essential-medicine shortages mandatory.

The legislation, which comes into effect on January 1, 2019, also provides an opportunity for PBS coverage of alternative medicines when there are shortages.

Medicine shortages have become an increasing problem in recent years, not just in Australia but around the world. A shortage of a critical medicines places patients’ lives at risk, the Guild says.

The move to a mandatory-reporting regime will significantly improve communication around medicine shortages for the benefit of patients and health professionals – something the Guild says it has been advocating for some years.

“Timely communication about medicine shortages and available alternatives is vital to providing the best level of care for patients,” the Guild said.

“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.”

Health Minister Greg Hunt, in announcing the legislation’s passing, thanked the Guild and other organisations that “have worked collaboratively together and with government to design a new approach that will support and protect Australian patients”.

Generic and Biosimilar Medicines Association Chair Sylvain Vigneault says medicine shortages are a global challenge and Australia is showing leadership on such a complex issue.

“This is a significant development that will lead to better protection of our most vulnerable Australians,” he said.

“Now, industry, community pharmacy, hospitals and the government will collaborate more effectively to ensure information about the supply of vital medicines reaches those who need it.

“Patients need certainty and clarity on when there is likely to be a shortage of vital medicines, unintentional or otherwise.

“This will give Australia a more effective system to red-flag potential issues before they impact on patients.”

National Pharmaceutical Services Association Chair Mark Hooper says passage of the Therapeutic Goods Amendment (2018 Measures No 1) Bill 2018 will help doctors and pharmacists minimise the impact on patients in the event of medicine shortages. He adds that more action is needed, however, to extinguish avoidable risks.

“Exclusive-direct supply from manufacturers to pharmacies creates a dangerous dependency on sole distribution for the medicines they carry, with no redundancy of supply,” he said. “If there’s a supply interruption, for whatever reason, then patients would be potentially denied access to their medication.”

The government’s Community Service Obligation (CSO), created to ensure all PBS medicines are available to Australians generally within 24 hours, sets high standards to protect against service disruption.

“If one CSO distributor cannot supply a drug, another is available to meet the shortfall,” Mr Hooper said. “That system works when every PBS medicine is available to every CSO distributor. Pharmacists recognise and value this service.

“It’s in patients’ interests for the government to take the logical next step in managing medicine shortages and plug this regulatory loophole by ensuring all PBS-listed medicines are made available to CSO distributors at equivalent prices.”