The first medicine has been added to the TGA’s new Serious Medicine Shortage List for therapeutic substitution by pharmacists – but is the new process fit for purpose?
The TGA says it has been notified of current shortages for multiple brands of metformin modified-release 500mg tablets, which are expected to continue until at least the 5th of June 2020.
In response, it has issued the first Serious Shortage Medicine Substitution Notice, for metformin modified-release 500mg, specifying substitutions that pharmacists may make for patients with a script for this product.
These notices allow pharmacists to make certain substitutions for the item in shortage, which could relate to strength, dose form, fixed-dose combinations or controlled release medicine substitutions.
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.
The notice applies from 13 May 2020 until 31 July 2020.
But the PSA and the Pharmacy Guild have pointed out that the process for therapeutic substitution to address such shortages is not what they had proposed, highlighting what they consider to be significant shortcomings with the new system – including that substituted products are not subsidised under the PBS.
Associate Professor Chris Freeman, national president of the Pharmaceutical Society of Australia said that PSA welcomed the first notice being issued.
However he warned that, “While this does help those taking this particular medication in principle, given the substitution will not be PBS subsidised it may increase out-of-pocket costs for patients”.
The Guild spokesperson noted that, “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.
“If not covered, patients are faced with additional costs which are unacceptable.”
Another issue is that currently, not all pharmacists across the country will be able to make such substitutions: as stated by the TGA, the notice must be given effect under State or Territory law before pharmacists can supply according to the specified substitution.
A spokesperson for the Pharmacy Guild told the AJP that the organisation has had confirmation that the notice has been enabled in the ACT, Northern Territory and Queensland to date.
“Guild Branches will be checking with their State authorities regarding local arrangements and timing,” the spokesperson said.
“Most jurisdictions require legislative amendments on a case by case basis in response to the publication of a TGA notice and only as part of the response to a public health emergency.”
A/Prof Freeman said that, “Currently, pharmacists will need to wait for state health departments to adopt this notice with reference to the TGA serious medicines shortages notice, and currently some states and territories at this stage have done this”.
“We will inform our members when this has been enacted at each state level through our PSA microsite,” he said.
“It does raise the risk of confusion for pharmacists, doctors and patients because of variability in the timeframe for implementation.”
The Guild spokesperson told the AJP that the issuing of the Serious Shortage Notice 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 and patients may not be able to afford the options”.
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 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.”
A/Prof Freeman said that the PSA feels similarly. “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,” he said.
The Pharmacy Guild is now calling on the Commonwealth Department of Health to implement a number of changes, including the removal of the requirement for a restrictive Serious Shortage Medicine Substitution Notice to enable substitutions in a supply shortage – “particularly for straightforward dose and form substitutions”.
The Guild also wants the Department to automate reciprocal and consequential regulatory processes, such as enabling PBS eligibility for any medicine where there is a serious supply shortage; and to include all medicines for which there is a serious local or national supply shortage that is affecting patient access to these medicines.
The Guild is also calling on all State and Territory Governments to introduce standard regulatory arrangements which are not limited to public health emergencies and that automatically permit pharmacists to substitute a medicine recognised to be in serious shortage by the TGA; and to annotate the change on the existing prescription for immediate and future dispensing.
Both groups say they will continue to observe the situation and offer feedback.
“The Guild will continue to work with the TGA and Commonwealth and State health authorities to see these changes implemented effectively in the most practical manner for the benefit of people increasingly affected by medicine shortages,” the Guild spokesperson said.
And A/Prof Freeman said that the PSA will, “monitor the implementation of this measure, and will report feedback should there be challenges through to the TGA and the Commonwealth Department of Health, as well as state departments of health”.