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Substituting scarce medicines
On occasion a pharmacist may be unable to dispense a prescription medicine because the medicine is affected by a shortage. This often m`eans the patient has to try to source the medicine from other pharmacies or go back to their prescriber for a new prescription for an alternative medicine. Any delay in accessing their medicine risks disrupting the patient’s treatment which could affect their health.
To avoid delays in providing medicines to patients and relieve workload pressure on prescribers and pharmacists Serious Scarcity Substitution Instruments (SSSIs) were introduced to allow community pharmacists to substitute specific medicines without prior approval from the prescriber. Pharmacists are, however, required to notify the prescriber after substitution.
What is a Serious Scarcity Substitution Instrument or SSSI?
When the TGA declares a ‘serious scarcity’ of a medicine, an SSSI is made specifying the substitutable medicine(s) that pharmacists are permitted to dispense in substitution for the scarce medicine. The SSSI also specifies the circumstances in which that substitution is permitted.
SSSIs are made when there is a significant risk of adverse health consequences for Australian patients if those patients are unable to take the scarce medicine, and there is a suitable substitute medicine available. SSSIs are made for a defined period and may be revoked sooner.
What is a serious scarcity of a medicine?
The TGA can declare a serious scarcity of a medicine when there is a supply disruption of a particular medicine and demand cannot be met by the total stock available. The total stock available includes stock levels of all available brands of the medicine or an overseas alternative medicine approved for supply under section 19A of the Therapeutic Goods Act 1989.
A serious scarcity of a medicine can be declared when either or both of the following apply:
- the supply of the medicine in Australia is not currently meeting demand
- there is an imminent risk that supply of the medicine in Australia will not or will not be likely to meet demand
Supply disruptions do not need to affect the whole of Australia for a serious scarcity to be declared.
Identifying the need for an SSSI
We work closely with sponsors, wholesalers and key stakeholders to monitor the ongoing supply of medicines for Australian patients. This enables early identification of potential disruptions to medicine supply.
Once a medicine has been identified as being at risk of serious scarcity, we make an assessment to determine whether an SSSI is a suitable strategy to mitigate the shortage.
We evaluate the appropriateness and availability of potential substitutable medicines, assess the risk of adverse health consequences if access is delayed and identify vulnerable population groups affected by the medicine shortage.
How substitute medicines are determined
When we determine that an SSSI may be a suitable strategy to mitigate the shortage, we assess which medicines might be suitable alternatives and then we check with the sponsors of those medicines if there is enough supply to cover the demand of the scarce medicine. If both suitability and supply of alternatives are sufficient, they are put forward as potential substitute medicines.
An essential aspect of determining substitute medicines is our consultation with various health professional groups. We liaise with TGA medical officers, relevant clinical groups, specialist medical colleges and health professional societies to confirm that the proposed substitutes are suitable. We also confirm the proposed dose regimen and specific conditions.
Substitute* medicines for a scarce medicine will usually be:
- Tablets/capsules of lower or higher strength
- Other dose forms containing the same active ingredient (for example, a capsule instead of a tablet, or a syrup or suspension).
- Where a fixed-dose combination may not be available but the two or three medicines that make up the combination are these medicines can be dispensed individually.
- Dispensing of an immediate-release form in lieu of a sustained/extended-release version and vice versa
- The same active ingredient, but with a different salt.
Only substances included in Schedule 4 to the current Poisons Standard can be considered as a substitute for a scarce medicine.
*Substitute medicines are referred to as ‘substitutable’ medicines in the SSSI.
Communication about SSSIs
Details of the substitution are drafted into a legislative instrument, the SSSI, and published on the Federal Register of Legislation.
We also share information on the TGA website, social media, email alert service and through a wide range of partner organisations including relevant health professional bodies, patient/consumer groups and industry peak bodies.
We continue to monitor the need for and safety of the SSSI. If the serious scarcity is resolved, or safety concerns are identified, we may revoke the SSSI before its end date.
Reporting problems with an SSSI
Consumers and health professionals are encouraged to report problems with medicines or vaccines. The report should mention the problem relates to an SSSI. Your report will contribute to the TGA's monitoring of the safety of the SSSI.
The TGA cannot give advice about an individual's medical condition. We encourage you to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.
Legislative basis for SSSIs
Under section 30EK of the Therapeutic Goods Act 1989 (the Act), under certain conditions, the Minister for Health can make a legislative instrument to:
- declare that there is a serious scarcity of specified medicine (the scarce medicine) across the whole or a specified part or parts of Australia; and
- specify the medicine (the substitutable medicine) that pharmacists are permitted to dispense in substitution for the scarce medicine and specify the circumstances in which that substitution is permitted.
Publication of an SSSI allows pharmacists to dispense the substitutable medicine under the conditions described in the instrument, even if the state or territory legislation would normally prevent this from occurring.
Full details of the substitution provisions are described in sections 30EK and 30EL and subsections 4(1) and 57(10)(AA) of the Act. There are currently no related provisions included in the Therapeutic Goods Regulations 1990.
SSSIs replace the Serious Shortage Substitution Notices published on the TGA website throughout 2020 to ensure fast and consistent implementation across all states and territories.