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New law to ensure reporting of medicine shortages

pharmacyThe Pharmacy Guild of Australia has welcomed new legislation to make reporting of essential-medicine shortages mandatory.

Medicine shortages have become an increasing problem worldwide in recent years. A shortage of critical medicine places patients’ lives at risk, the Guild says.

The legislation, which comes into effect on January 1, provides an opportunity for Pharmaceutical Benefits Scheme (PBS) coverage of alternative medicines when there are shortages.

The move to a mandatory-reporting regime will significantly improve communication around medicine shortages for the benefit of patients and health professionals.

“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.”

In announcing the legislation’s passing, Heath Minister Greg Hunt 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.

“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,” he said

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.”


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