New rules on serious scarcity


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New legislation has been passed to allow pharmacists to substitute medicines that have been declared to be in serious scarcity

The TGA said in a statement on Thursday that the change formalises the Serious Shortages Substitution Notices, which have been in operation since May 2020.

It removes the need for each SSSN to be recognised in individual state and territory legislation before pharmacists can make the substitution.

“Under the new laws, a new legislative instrument will be registered each time a substitute medicine is needed to address a serious scarcity,” the TGA said.

“These instruments will provide details of medicines that pharmacists are permitted to dispense as a substitute and any conditions that apply.

“Each one will be developed in the same way SSSNs have been created to date.”

Seeking input from health professionals and clinical groups remains an important part of the process, says the TGA.

“Allowing pharmacists to substitute specific medicines without prior approval from the prescriber relieves pressure on doctors and helps patients get faster access to alternative medicines when there is a serious scarcity.”

The TGA advised that pharmacists should continue their usual practice and contact prescribers to notify them as soon as possible following the substitution.

“Any state and territory legislation relevant to the substitution must still be followed.

“Patients will continue to decide whether they wish to accept the substitute medicine from their pharmacist.”

The Pharmacy Guild welcomed the move, saying it allows for faster and more consistent implementation. 

The National President of the Guild, George Tambassis, said the legislation was a commonsense move which ensured continuity of care for patients irrespective of where they lived, while also recognising pharmacists as being medicine experts.

“Medicine shortages has been a long-term problem, exacerbated over the past 12 months by COVID-related disruptions,” he said.

“Allowing pharmacists to substitute specific medicines without prior approval from the prescriber will go a long way in helping to ease pressure on doctors and help patients get faster access to alternative medicines when there is a serious scarcity.

“The TGA has recognised this as one management strategy for medicine shortages and with the Guild’s support and advocacy, has led on having this implemented permanently through legislation.

“The next step is for the Government to allow the substituted medicines to be dispensed as pharmaceutical benefits so patients are not adversely affected by costs.

“It is also critical that serious shortages are identified as early as possible so this process can be activated and the impact on patients minimised.”

Guild representatives have several times flagged the fact that substitution of an unavailable medication may leave patients out of pocket, without the PBS subsidy. 

Mr Tambassis said pharmacists should continue their usual practice and for prescribers to be promptly notified following the substitution. 

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