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Management and communication of medicine shortages and discontinuations in Australia
Guidance for sponsors and other stakeholder bodies
Roles of different stakeholder groups
TGA and Department of Health
The TGA, which is part of the Department of Health and manages the Medicines Shortage Information Initiative website, has an important role in the management and reporting of medicines shortages, but is not the sole 'manager' in these situations.
The TGA must be notified of all current and anticipated medicines shortages and of all discontinuations by sponsors once they are identified by the sponsor.
The TGA will review the sponsor's initial risk assessment of the shortage in conjunction and, as needed, convene other stakeholders (possibly a Medicine Shortage Action Group) to further consider the impact status of the shortage and communicate the shortage as needed.
The TGA can approve the temporary supply of a substitute medicine or therapeutic alternative during a medicine shortage.
The TGA may undertake additional communication activity in relation to particular medicine shortages where there are anticipated to be significant public health impacts. The TGA also consults with sponsors to streamline the notification of medicine shortages, and to enable consistent communication and management. This may include:
- escalation to a public health response, such as advice from the Chief Medical Officer and advice from/ communications with State and Territory Health Departments of cases assessed as critical impact level medicine shortages and shortages of vaccines
- provision of an additional communication channel to inform health professionals and consumers about the details of the shortage (via the website)
- coordination of expert advice and information about substitute medicines and therapeutic alternatives where appropriate
- the publication of information about a medicine shortage in the public interest.
Where there are significant public health impacts the Chief Medical Officer will also have a role in coordinating responses and communication.
The Technology Assessment and Access Division, which has responsibility for the PBS, has described the obligations under the National Health Act 1953 of sponsors of PBS-listed medicines during a shortage above.
It is a condition of listing on the PBS that sponsors have stock available across the supply chain, and they must report any supply disruption with a PBS-listed medicine to the Department of Health (see Appendix 4: PBS medicine supply guarantee). There are legislative requirements whereby manufacturers must guarantee supply of certain medicines for up to 24 months after listing. They must notify the Technology Assessment and Access Division if they are unable to supply within this period. There are criminal penalties for non-compliance.
Where a sponsor has failed to meet their obligations under the National Health Act 1953, the Minister has discretion (under section 99AEH) to: delist the relevant brand, delist any of the supplier's other PBS listed brands or refuse to list a new brand from that supplier.
When a temporary supply has been granted by the TGA (section 19A), the Department is able to negotiate a price for a temporary product to ensure that it can be listed on the PBS while the registered product is in short supply or unavailable.
The reporting requirements protocol is not intended to replace the 'Guarantee of Supply' form, to be used when a 'Responsible Person' wishes to advise a failure to supply a brand of an item listed on the PBS, or a belief that a supply disruption has, or is likely to occur. Sponsors are still required to complete this form and report to the Technology Assessment and Access Division.
The Technology Assessment and Access Division will be consulted during the determination of alternative sponsors as they have information on which sponsors are supplying particular products under the PBS. During confirmed medicine shortages they will also be in communication with PBS sponsors, in particular if short-term changes to listings are required due to a shortage.
Sponsors maintain continuity of supply for a medicine through various business processes, which may include accurate demand forecasting, maintenance of appropriate levels of safety-stock, and identification of backup supply routes. When a disruption to the supply arrangements for a medicine occurs, sponsors routinely:
- assess supply and demand gaps and develop a response:
- implement contingency planning to reduce the supply disruption
- assess the supply disruption to determine if and when the supply is reasonably likely to impact on consumers
- implement management activities to secure supply including applying to the TGA for the supply of substitute medicines or therapeutic alternatives
- implement communication activities to the supply chain that are proportionate to the impact on consumers, which may include:
- publishing of information on sponsor websites
- activating public/health professional information hotlines
- communicating directly with:
- prescribers and pharmacists (for example 'Dear Health Professional' letters)
- the Australian Government Department of Health/State and Territory Health Departments
- State medicine information hotlines
- clinical colleges and health professional peak bodies (for example to discuss therapeutic options)
- health professional media, public media channels.
State and Territory Health Departments
State and Territory Health Departments are also involved in ensuring timely access to medicines through, for example, contractual purchasing and other procurement arrangements, and in providing advice on alternatives through therapeutics committees for hospital networks. They also have a role in coordinating responses to medicine shortages where there is a significant public health impact within their jurisdictions.
Health professionals and professional organisations
Health professionals perform roles as prescribers or dispensers across various healthcare settings including primary care and hospitals.
Health professionals can also notify the TGA of suspected medicine shortages (by email - email@example.com or phone - 02 6232 8850).
Often it is the pharmacist who is first aware of a shortage, rather than the prescriber, as they are involved in the supply of medicine to the consumer and generally the prescriber is not. Health professionals receive medicine supply information via a range of channels, including notices from the wholesaler, letters from sponsors, newsletter articles in professional media, colleagues and consumers.
When a medicine shortage occurs, health professionals are often required to identify substitute medicines or therapeutic alternatives for their patients. The dispenser has the knowledge and expertise to substitute an item that is considered to be bioequivalent. However, they will need to refer to the prescriber for non-identical substitute items and changes to therapy. There may also be high risk cases when it is not reasonable for the dispenser or the prescriber to know about substitute medicines or therapeutic alternatives and additional information is required. In these cases, medical colleges and clinical guidelines experts may become involved in providing advice on the appropriate treatment regimens.
Health professionals are then responsible for passing on information to the consumer, in an easily understood manner. With accurate information about medicine shortages, health professionals will also work to assist the consumer to manage potential problems that arise with the quality use of medicines, for example, the safety and compliance considerations needed when a substitute of different dose forms or strength is used.
Pharmaceutical Wholesalers distribute most medicines to retail pharmacies and hospitals.
In the case of localised or regionalised out-of-stocks or short-term shortages of PBS subsidised medicines, this is usually resolved within 24 hours due to Community Service Obligation delivery guarantee requirements, whereby Community Service Obligation Wholesalers are required to hold supply redundancy, and/or coordinate with alternative Community Service Obligation Wholesalers who may have supply immediately available in that location or region.
Exclusive-direct suppliers or distributors who are not party to the Government's Community Service Obligation do not have any formal delivery guarantee requirements, stock supply redundancy obligations or responsibilities with the Department of Health.
In the cases where shortages have the potential to be of a longer duration, sponsors may work with Community Service Obligation Wholesalers to coordinate the imposition of maximum sale allocations on medicines that are experiencing a supply shortage, to limit the impact of possible spikes in demand driven by knowledge of a shortage.
It should be noted that the therapeutic goods legislation does not extend to the TGA having control over distributors or the distribution of medicines.
Consumers, patients and their carers require information to support their access to and quality use of their medicines from their health professional and other sources. In the case of a medicine shortage, consumer organisations, particularly disease-specific consumer groups, may have a role in supporting consumers with information and/or advising medical experts of considerations when alternative regimens or considering substitute medicines or therapeutic alternatives.