Government releases details on proposed pharmacist medicine substitution process, but concerns are raised that it’s “too complex, too slow”
The Therapeutic Goods Administration (TGA) has released details on the Federal Government’s plan to allow community pharmacists to substitute specific medicines without prior approval from the prescribing doctor.
However, the PSA has said it is “disappointed with the proposed model”, with its national president, Associate Professor Chris Freeman, saying the proposed model is “too complex” and “too slow”.
The substitution will apply in “certain situations where a medicine is unavailable at the time of dispensing”.
“The changes will allow a pharmacist to dispense different strengths of a product (such as two 20 mg tablets in place of a 40 mg tablet) or a different dose form of the same medicine (such as a capsule instead of a tablet),” the TGA advice states.
“It will also allow a medicine that is prescribed as an extended/sustained release medicine to be substituted for an immediate release medicine, or vice versa.
Substitution of a medicine with another product containing a different active ingredient is not considered”.
Medicines identified for substitution will be communicated in a Serious Shortage Substitution Notice on the TGA website. Notices will tell the pharmacist which medicines are allowed to be substituted. Click here to see a proposed template for the notice.
Serious shortages would be characterised by:
- strong evidence of an imminent (within coming weeks) gap in supply; and
- the expectation of significant and immediate negative health consequences if patients went without the relevant medication at the prescribed intervals.
During the COVID-19 pandemic, when domestic transport services are more limited, in some cases a Serious Shortage Medicine Substitution Notice may be declared when there is a significant local-level supply disruption of medicine (not a national-level shortage) and its supply cannot be replenished in that region before patient access is affected, the TGA stipulated.
In all cases, notices will apply Australia-wide.
PSA had previously expressed concerns about the therapeutic substitution proposals, and they remain concerned about the model now more detail has been revealed.
“This system will not work. It is too complex, too slow, and won’t be invoked for the majority of medicine shortages our supply chains experience,” A/Prof Freeman said.
“Put simply, it will not achieve its intended benefit of maintaining therapy for patients and taking pressure off doctors and pharmacists”.
“This is not the model PSA and the Pharmacy Guild supported and took to the TGA Medicine Shortages Working Group. PSA cannot support the need for the TGA to publish a notice before allowing pharmacists to substitute medicines, particularly straightforward substitutions such as the dose and quantity of a tablet,” he said.
“It is not in the public interest. It is not in the profession’s interest, and we can not see how this is in the Government’s interest in responding to the challenges from COVID-19”.
“Arrangements for supply of substituted medicines under the PBS has not yet been announced and changes at the state and territory level show implementation will further be limited by red tape, such as the requirement in NSW for gazettal of the substitution notice by the Secretary”.
The TGA emphasised that the measures may not just apply for the duration of the current pandemic.
“With the ongoing impact of medicines shortages, it will be important to consider the feasibility of there being certain pharmacist substitution powers on an ongoing basis,” the information said.
“In many cases, the current arrangements by states and territories only apply for the duration of the COVID-19 pandemic, but over the coming months the Commonwealth and states and territories will consider whether different, longer-term approaches for substitution (including Pharmaceutical Benefits Scheme [PBS] dispensing) are appropriate”.
The information page also covers information about which records the pharmacist needs to keep, whether it is mandatory to dispense medicines against a Serious Shortage Substitution Notice and otehr regulatory issues.