Serious Shortage Medicine Substitution Notices

Serious shortages will be normally defined as verified shortages of a particular medicine at a national level where demand cannot be met by the total stocks available of any brands of the product or a Section 19A authorisation.

Serious shortages 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 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.

In all cases, notices will apply Australia-wide.

A medicine for which a Serious Shortage Medicine Substitution Notice is issued does not need to be on the TGA's critical Medicines Watch List.

Depending on the situation, we may rapidly seek expert clinical advice from relevant professional groups on the substitution protocol.

In the presence of a serious medicines shortage, measures will be implemented to permit pharmacist substitution under the following conditions:

• Tablets/capsules of lower or higher strength (with the quantity dispensed made correspondingly higher or lower, so that the total amount of the prescribed drug - for example, in milligrams - is consistent). For example, if a higher strength is dispensed, it is expected that a lower number of tablets would be dispensed. Similarly, Notices can also apply to oral suspensions and syrups.
• 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.

Permitting pharmacist substitution of a medicine with different active ingredients within the same therapeutic class is not proposed by the Australian Government at this time. However, it was recognised that if COVID-related medicine shortages escalate seriously, government may need to consider this option in the future.

Schedule 8 controlled drugs will not be permitted to be supplied under a Serious Shortage Medicines Substitution Notice.

To enable substitution to be nationally consistent, and the 'rules' clear, a Notice will be made on the TGA website specifying what medicines can be substituted and the substitutions permitted.

The Notice would be communicated to state and territory chief pharmacists, the Pharmaceutical Society of Australia, the Society of Hospital Pharmacists of Australia and the Pharmacy Guild of Australia, as well as to prescriber organisations (the Australian Medical Association, the Royal Australian College of General Practitioners and relevant specialist colleges). The Notice would also be communicated to subscribers of the TGA's RSS website feeds and social media channels.

Individual states and territories have identified that during the COVID-19 pandemic they can give effect to each notice shortly after through various powers in their respective legislation.

States and territories are legally responsible for controls on the sale or supply of medicines included in the Poisons Standard, and each has an appropriate legal means by which it could give effect to the TGA protocol or TGA Serious Shortage Medicine Substitution Notice (see Appendix). However, several of these means may only apply during an emergency, such as the COVID-19 pandemic. States and territories may also apply specific conditions to pharmacist substitution, such as recording and prescriber communication requirements.

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. 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.

A Notice, when issued by the TGA and implemented by the relevant state and territory, enables community pharmacists (and if determined by the particular jurisdiction, hospital pharmacists) to supply in accordance with the Notice rather than the specific instructions in a prescription, without going back to the prescriber for instructions prior to dispensing. However, there is the professional practice requirement that the prescriber is to be advised of the substitution as soon as practicable.

Where a higher or lower strength is supplied, the pharmacist must ensure the dosage and total quantity of drug supplied remains according to the prescriber's instructions.

Where there is substitution of immediate release for sustained/extended release dose forms and vice versa, the pharmacist must ensure the total daily dose supplied remains according to the prescriber's instructions.

It is important that compounding pharmacists do not use a medicine shortage as an excuse to compound a medicine rather than supplying an alternative strength or dose form of a commercial, finished product registered on the Australian Register of Therapeutic Goods. The supply of commercial products where available is a requirement in the current Pharmacy Board Guidelines on compounding of medicines.

Please see the Pharmaceutical Benefits Scheme website - external site for information.

No. The pharmacy may have the prescribed medicine in stock despite a national-level or local-level shortage. If not, the pharmacist will need to consider whether it is appropriate to supply the drug to a patient in accordance with the Notice and any corresponding authority of the state/territory. If the patient refuses to accept the alternative, does not fulfil all the criteria set out in the protocol, or, based on the pharmacist's professional judgement, there are reasons why supply under the protocol is not appropriate, the pharmacist must refer the patient back to the prescriber to discuss alternative treatment.

Protocols will not be suitable for all medicines and patients. For example, a Notice substituting a modified release medicine would not be suitable for anti-epileptic treatments. Additionally, patients with complex health needs or those where confusion may result may not be considered suitable for supply under a Notice.

Any Notice would be limited in time and would clearly set out the period for which it has effect.

The pharmacist must record in the dispensing record both the instruction of the prescriber on the prescription and the substitute dose form or strength dispensed. Care must be taken to ensure subsidiary information sources are updated and correct (for example, dose administration aids, patient held medicines lists and so on).