The therapeutic substitution arrangements in their proposed form are “not workable” and ultimately “unacceptable”, says pharmacy body
A few weeks ago the Federal Government announced it would implement changes to allow pharmacists to substitute dose strengths or forms of medicines without prior approval from the prescribing doctor, if a medicine is unavailable at the time of dispensing.
“These changes will relieve pressure on busy doctors and allow patients to receive their medicines from their pharmacist without delay,” said Health Minister Greg Hunt.
“The changes will allow, for example, a pharmacist to dispense different strengths of a product (such as two 20mg tablets in place of a 40mg tablet), or a different dose form of the same medicine (such as a capsule instead of a tablet).
“The changes will be implemented through the Scheduling Policy Framework and Poisons Standard, with implementation by States and Territories and the Government through the TGA.
“The Australian Government continues to consult on the implementation and the potential expansion of these substitution measures.”
However the PSA is not pleased with how these measures are developing.
“I am frustrated to report that work on the therapeutic substitution arrangements recently foreshadowed by the Health Minister are not progressing well,” national president Chris Freeman said this week.
“The Australian Government’s current proposed model involves a protocol being issued by the TGA to instruct pharmacists on how they should respond to every shortage.”
Pharmacists would be expected to follow the protocol as well as fill out multiple forms in the process, he explained.
“This is not workable and is unacceptable to us. Being able to substitute strength and dose is well within a pharmacists’ skills and knowledge,” said Associate Professor Freeman.
“In fact, it treats pharmacists with contempt at the time when we are providing vital healthcare to our communities.
“In a profession where we are accountable for making complex medicine safety decisions, it is inconceivable that the Government would see the need to advise pharmacists that 2 X 20 mg tablet equals one 40mg tablet,” he said.
“This is well within the scope of practice for a pharmacist, it is a very sensible solution to the medicines shortages issue and we are working now to make sure the implementation of this is done in a way which doesn’t add to the workload of the already busy pharmacy workforce.”
On the initial announcement of the arrangements, Pharmacy Guild Queensland branch president Trent Twomey called for less red tape and said the Guild had proposed to enable “full therapeutic substitution”, for example, where salbutamol MDIs are unavailable, to substitute for the next closest thing.
“So the Government needs to immediately move on removing the red tape that prohibits us from ensuring continuity of care,” said Mr Twomey.
The Pharmacy Guild of Australia declined to further comment on how the therapeutic substitution arrangements are developing, except to say that the Federal and State health authorities are working through these arrangements now.
However along with the PSA it welcomed the original announcement that the Government was implementing the changes.
NSW branch president David Heffernan told AJP earlier in the week that the Guild has been working daily with both the Federal and State governments on trying to “advance” the arrangements.
“We’re working hard on progressing that,” said Mr Heffernan. He added that his branch was working daily with the [NSW] chief medical officer and chief pharmacist “trying to alleviate any other issues coronavirus throws as up at us”.
Meanwhile PSA re-iterated its call for a chief pharmacist to be located within the Federal Department of Health to “fight for the role of pharmacists”.
“We will again make this call, so we know that pharmacists will have a voice, and that medicines policy advice comes from medicines experts – pharmacists,” said Associate Professor Freeman.