Pharmacy Daily | Complex substitution model starts

PHARMACISTS in the ACT, Northern Territory and Queensland are set to be able to substitute prescriptions for type-2 diabetes medication, metformin modified-release 500 mg tablets, under the Therapeutic Goods Administration's (TGA) new Serious Medicine Shortage list protocols.

However, pharmacists in other parts of the country will have to wait for state governments to issue authorisations permitting therapeutic substitution, under what the Pharmacy Guild of Australia has described as a "complex process", which was not in line with proposals from the Guild and Pharmaceutical Society of Australia (PSA).

Under the TGA notice issued on Wed, pharmacists will be able to replace metformin modified-release 500 mg with either immediate-release metformin 500 mg or metformin modified-release 1,000 mg, depending on the prescribed dose, without approval from the prescriber, until 31 Jul.

"Under the process that has now been implemented, the TGA publishes a Serious Shortage Medicine Substitution Notice (SSMSN) to tell pharmacists what substitutions are, and are not permitted, when medicines are out of stock," a Guild spokesperson said.

The Guild has been advised that each notice will likely require separate consideration of how the Pharmaceutical Benefits Scheme will allow for medicines substituted under the serious shortage initiative to be eligible as a pharmaceutical benefit.

"The TGA notice of a SSMSN for metformin has highlighted that this is an overly complicated process which may place patients at harm, as pharmacists are not able to work to their full capacity to support their patients when there is a serious medicine shortage.

"This inflexible policy places an inordinate amount of additional pressure on pharmacists to address patient needs due to a medicine shortage, irrespective of a public health emergency status.

"Pharmacists are medicines experts, and the straightforward dose and form substitutions these notices will allow are within the competence of every pharmacist in Australia to manage individually with their patients.

"The Guild cannot support a complicated system where the TGA needs to publish a SSMSN that must then be recognised under State and Territory law before pharmacists can make dose and form substitutions without the need to consult the prescriber and that is only permitted during a declared emergency."