Concerns over substitution by pharmacists

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Mixed views over medicine substitution by pharmacists as Parliament debates TGA amendment bill

There have been divergences of opinions expressed in Federal Parliament about the substitution of medicines by pharmacists when the original medicine is impacted by a shortage.

The House of Representatives has this week debated the Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020 which, among other changes allows pharmacists to substitute a different medicine from the one that has been prescribed for a person, without approval from the prescriber, if there is a serious shortage of the prescribed medicine.

Dr Katie Allen, Liberal MP for Higgins, Vic said the substitution measure would “help guarantee the availability of prescription medicine” and would be “particularly helpful in regional and remote areas of Australia.” 

“Importantly, it would only be permitted under the act when the minister is satisfied there is a serious scarcity of a specified medicine. This will help improve the availability of prescription medication during medicine shortages.”

“A pharmacist can provide two 10 milligram tablets instead of a 20 milligram tablet, if that is not available, for instance. I have to say that a frequent occurrence in daily practice is a pharmacist having to resend a script because they have a short-term shortage of 20 milligram tablets instead of 10 milligram tablets,” she said.

“A pharmacist can now provide a capsule rather than a tablet, or a topical cream rather than a skin patch, if there is indeed a serious shortage of a vital medicine. These are practical and safe alternatives that help ensure vital medicines are supplied to patients in serious need”.

However, Dr Mike Freedlander, ALP MP for Macarthur, NSW, and a paediatrician, said he had “some concerns” about the pharmacist substitution measure. 

“This new bill will also allow pharmacists to substitute medicines where certain shortages arise. It will allow the minister to declare a serious shortage of a particular medicine, and a substitute medicine can then be dispensed by pharmacists in circumstances in which substitution is permitted,” he said.

“As a prescribing doctor, I do have some concerns about this… I have major concerns about some aspects of it. There are no details about how pharmacists are going to be able to change medications, and unless this government does something about the supply chains there will be shortages in the future; that’s for sure”.

Another NSW ALP MP, pharmacist Emma McBride was more supportive of the bill, saying the measure was originally proposed by the PSA and other industry bodies and “advocated for by the profession”. 

“This is a commonsense change and the PSA ‘welcomes the willingness and efforts of regulators to implement solutions to help address medicine shortages for patients and to implement changes to allow pharmacists to substitute a medicine in a shortage without prior approval from the prescriber’,” Ms McBride said.

“Having worked as a mental health pharmacist for many years in acute adult in-patient units, I
understand the very real impact that shortages of antidepressants and other commonly prescribed medicines can have on patient care,” she said.

“When someone has finally found a medication that works for them, that is effective, whose side-effects they can tolerate and that gives them good results and benefits it is very distressing to patients and
their families and carers when that medication isn’t available and there is a risk of disruption to their care”.




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