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New legislation grants access to substitute medicines amid shortage


Anastasia Tsirtsakis


16/08/2021 4:57:05 PM

In the event a patient’s usual medicine is deemed to be in serious scarcity, pharmacists will now be able to supply a PBS-listed alternative.

Pharmacist scanning a script
Current SSSIs include tocilizumab and progynova, ensuring patients have access to a PBS-listed alternative and that they do not face significant out-of-pocket costs.

The new arrangements come with patients and prescribing doctors having already faced months of ongoing medicine shortages, as the COVID-19 pandemic continues to disrupt supply chains.
 
As per the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021, pharmacists can now supply a patient that has been prescribed a medication issued a Serious Scarcity Substitution Instrument (SSSI) by the Therapeutic Goods Administration (TGA) with a substitute listed under the Pharmaceutical Benefits Scheme (PBS).
 
The new agreement allows a pharmacist to:

  • dispense different strengths of a medicine (eg two 20 mg tablets in place of a 40 mg tablet)
  • dispense a different dose form of the same medicine (eg a capsule instead of a tablet, or as one transdermal patch for another transdermal patch)
  • substitute a product that is an extended/sustained-release variant of a prescribed immediate-release medicine, or vice-versa.
As long as the alternative medicine is supplied by the pharmacist in accordance with the specifications of the SSSI, the patient is not required to return to the prescribing doctor for a new or amended prescription.
 
The pharmacist does, however, have an obligation to seek the patient’s consent to substitute the prescribed medicine before supplying a substitute benefit, and to inform the prescribing doctor in writing within 72 hours.
 
According to the PBS website, the new arrangement is in place to ensure patients get timely access to a prescribed medicine – and at no additional cost – where it is not practicable to obtain a PBS prescription for the substitute item.
 
‘These changes aim to ensure consumers continue to have access to medicines, are able to make an informed choice, and are not financially disadvantaged during periods of PBS medicine shortages,’ the website states.
 
‘By enabling the pharmacist to substitute an alternative PBS item for the medicine described on the consumer’s script, continuity of treatment can more easily be maintained.
 
‘These changes will also relieve pressure on prescribers and allow consumers to receive their medicines from their pharmacist sooner.’
 
According to the PBS website, serious scarcity of a medicine will be characterised by:
 
  • strong evidence of an imminent (within coming weeks) gap in supply, and
  • the expectation of significant and immediate negative health consequences for patients were they not to take the relevant medication at the prescribed intervals.
Medicines listed under the SSSI will be decided by the Minister for Health, while the choice of the substitute item will be determined through strict clinical considerations based on expert professional advice.
 
As well as addressing national-level medicine shortages, an SSSI can also be issued when there is a significant local-level disruption to the supply of a medicine and patient access will be affected before supply can be restored in that region.
 
However, ‘in all cases, an SSSI will apply Australia-wide’, according to the PBS website.
 
As of 16 August, the TGA has issued two SSSIs, including tocilizumab and for all strengths of progynova estradiol valerate tablets.
 
All medicines identified for substitution will be communicated on the TGA website, including information about how long the shortage is expected to last.
 
The PBS website also makes clear that the arrangement is not dependent on the pandemic’s timeline.
 
‘The changes have been put in place to manage serious medicine shortages, regardless of the reason for the shortage,’ the website states.
 
‘The COVID-19 pandemic presents a situation where a medicines shortage may occur, as supply may be disrupted as a result of transport restrictions affecting the distribution of medicines.
 
‘However, as other situations disrupting the supply of medicines may occur in the future, these changes are being introduced to ensure that patient access to affordable medicines is maintained in such cases.’
 
Prescribing doctors can find a list of the substituted medicines that are eligible for dispensing under the PBS on the PBS website.  
 
The TGA also has a medicine shortage database that includes both current and anticipated shortages.
 
Answers to frequently asked questions about pharmacist substitution of PBS medicines during shortages is available on the PBS website.
 
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