‘Who takes responsibility for errors?’


pharmacist holding script, medicine

RACGP shares concern over pharmacist metformin substitution plan, saying substitution without prescriber knowledge “leaves gaps in continuity of care”

With current shortages for multiple brands of metformin modified-release 500mg tablets expected to continue until at least 5 June, the TGA has issued the first Serious Shortage Medicine Substitution Notice for the drug.

The notice, which applies from 13 May to 31 July 2020, specifies substitutions that pharmacists may make for patients with a script for this product.

In this first case, it permits metformin modified-release 500 mg to be replaced with either immediate-release metformin 500mg or metformin modified-release 1000mg, depending on the prescribed dose.

Leading pharmacy groups now await all state and territories to adopt the notice, with confirmation that the notice has been enabled in the ACT, NSW, Northern Territory and Queensland to date.

Meanwhile a RACGP representative has taken issue with the substitution notices, complaining that the TGA did not make enough effort to inform GPs and other prescribers.

“Passive communication is not optimal; no GP reads the TGA website and substitution without prescriber knowledge leaves gaps in continuity of care,” Dr Gary Deed, Chair of the RACGP Specific Interests Diabetes network, told newsGP.

“Who takes responsibility for errors that could have been avoided? My concern is that [without] an agreed communication strategy, many GPs would remain unaware of these changes and not manage this issue proactively for the best interest of their patients.”

Dr Deed said he was concerned that the notice allows pharmacists to use their  “professional and clinical judgement” to determine whether it is suitable to substitute a patient’s prescribed medicine.

He also shared concerns about what he believes is potential to increase patient confusion and possible loss of adherence to usual regimens.

A TGA spokesperson told newsGP that the scope of substitution is “limited” and safety issues should not be expected if the substitution occurs “in accordance with the protocol”.

The spokesperson also said patients must consent to the substitution and that pharmacists should notify the prescriber of the substitution “as soon as possible”.

However PSA and the Pharmacy Guild have both taken issue with the limitations of serious medicines shortages notice, arguing that pharmacists are competent to make such substitutions without the need for issuing serious medicines shortages notices at all.

 “PSA still maintains that pharmacists are highly skilled medicine experts and competent to make such substitutions without the need for the issuing of a serious medicines shortages notice,” said national president Chris Freeman.

The Pharmacy Guild agrees: “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,” said a Guild spokesperson said.

“The Pharmacy Guild cannot support a complicated system where the TGA needs to publish a Serious Shortage Medicine Substitution Notice 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.”

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