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Management and communication of medicine shortages and discontinuations in Australia
Guidance for sponsors and other stakeholder bodies
Scope and definitions
This guidance provides information to sponsors and other stakeholder organisations regarding the management and communication of medicine shortages and discontinuations in Australia. It applies to the handling of all Australian registered prescription medicine shortages, not just those medicines available under the Pharmaceutical Benefits Scheme (PBS). This includes medicines for hospital use and prescription medicines, both PBS and non-PBS, available from community pharmacies. Shortages of some over-the-counter (OTC) medicines are also subject to mandatory reporting requirements.
This guidance also applies to any shortage that may occur as a result of a recall action of a medicine by a sponsor in accordance with the Uniform Recall Procedure for Therapeutic Goods.
From January 2019, medicine sponsors are required to report all medicine shortages to the TGA. We then mandatorily publish information about all shortages that have been assessed as having critical patient impact.
We have worked closely with industry and peak health organisations to develop these reforms and have produced this guidance and other resources to help sponsors ensure they remain compliant with these requirements. The protocols set out in this guidance document have been developed through a joint initiative of the Medicines Partnership of Australia (comprising the National Pharmaceutical Services Association, Generic and Biosimilar Medicines Association, Pharmacy Guild, Pharmaceutical Society of Australia, Australian Self Medication Industry and Medicines Australia), the Australian Government Department of Health (including the TGA), the Society of Hospital Pharmacists of Australia and the Australian Medical Association.
Through this initiative, the TGA has:
- established agreement on what constitutes a medicine shortage
- developed an improved process for communication and action regarding medicine shortages that will have potential material impacts on patients, including a national coordination and management approach for the management of shortages
- clarified the roles and responsibilities of sponsors, distributors, dispensers and government
- reached consensus on reporting requirements for current* and anticipated** shortages (and communication of information about verified shortages).
'Current shortage' means a shortage of a medicine that has commenced and is ongoing.
'Anticipated shortage' means a shortage of a medicine that is anticipated to commence at a future date.
The Medicines Watch List is a Legislative Instrument that has been established to identify medicines that have been predetermined as having critical patient impact. Known shortages of these medicines must be reported to the TGA within 2 working days. At this time the sponsor provides at least the minimum mandatory information about the shortage. The sponsor then has another 3 working days in which to provide the remaining required information on the shortage. All non-critical shortages need to be reported in full within 10 working days. The Medicines Watch List will be reviewed by the TGA on an annual basis.
Shortages of medicines that are not on the Medicines Watch List can still be assessed as critical by the TGA. Sponsors are also required to self-assess according to these protocols to determine whether or not a shortage needs to be reported within 2 working days.
While information about current and anticipated critical medicine shortages will always be published, publication of information about non-critical (low and medium impact) shortages through the Medicines Shortage Information Initiative is not mandatory, but is strongly encouraged in the interest of public health (see Table 3).
Early and timely engagement with health care practitioners is a priority to ensure impacts are accurately identified. Assessing the potential impacts of a particular shortage will be aided by expertise within medical (colleges and professional organisations) and pharmacy bodies (for example, Society of Hospital Pharmacists of Australia Specialty Practice Groups) when required. State and Territory Chief Health Officers and Chief Pharmacists may also be involved in management of shortages of medicines of major importance in public health systems.
Similarly, early identification of an alternative medicine in cases of a shortage of critical patient impact is paramount. The medicine could be an alternative medicine already registered in Australia or another therapeutic alternative. It may also involve identification of suitable overseas registered products for importation and use under special provisions (for example, section 19A of the Act or the TGA's Special Access Scheme).
It is highly recommended that medicine sponsors develop effective internal procedures to ensure that they can comply with the mandatory reporting requirements, including reporting timeframes.
The internal process within the wider Department of Health for triage and coordination in response to information received by the TGA about shortages is also documented in this guidance.
Figure 1 - Response to a reportable medicine shortage schematically outlines the response to a medicine shortage.
What constitutes a medicine shortage/discontinuation?
A medicine shortage is defined in the Act as:
a shortage of a medicine in Australia at a particular time if, at any time in the 6 months after that particular time, the supply of that medicine in Australia will not, or will not be likely to, meet the demand for the medicine for all of the patients in Australia who take, or who may need to take, the medicine.
A shortage of a reportable medicine must be reported to the TGA within legislated timeframes.
The discontinuation of the supply of a medicine (a permanent shortage) must also be notified to the TGA as outlined in the legislation:
- if the discontinuation is likely to be of critical impact:
- at least 12 months before the discontinuation is proposed to occur; or
- if the person is unable to comply with subparagraph (i) - as soon as practicable after the decision is made; or
- in any other case:
- at least 6 months before the discontinuation is proposed to occur; or
- if the person is unable to comply with subparagraph (i) - as soon as practicable after the decision is made.
A discontinuation refers to a medicine no longer being available in the marketplace; it does not refer to the cancellation of the Australian Register of Therapeutic Goods (ARTG) entry from the Register. Information about discontinuations will be visible on the Medicines Shortage Information Initiative website for a limited time period (12 months from the deletion from market date provided by the sponsor).
What are reportable medicines?
Mandatory reporting requirements apply to all Australian registered prescription medicine shortages, and a limited number of OTC medicines that are listed in the relevant legislative instrument.
They also apply to any shortage that may arise as a result of a recall action of a medicine by a sponsor in accordance with the Uniform Recall Procedure for Therapeutic Goods.
Reportable medicines are defined in the legislation as:
- For the purposes of this Act, registered goods are a reportable medicine if:
- the goods are medicine; and
- the medicine contains one or more substances included in Schedule4 or 8 to the current Poisons Standard; or
- the medicine is determined in an instrument under subsection (2).
- The Minister may, by legislative instrument, determine medicine for the purposes of subparagraph (1)(b)(ii).
The criteria for inclusion of a non-prescription medicine are:
- the medicine is critical to the ongoing health of the patient (for example, salbutamol inhalers for asthma)
- inclusion of the medicines is critical for public health (for example, naloxone injections for opioid overdose).
The current list of reportable OTC medicines is available in the relevant legislative instrument.
Products currently on the Medicines Watch List are being included in a legislative instrument and are listed in Appendix 1 of this document.
The current list of reportable OTC medicines is being included in another legislative instrument and is listed in Appendix 2 of this document.
The process for obtaining access to alternative medicines during shortages (for medicines that are not registered in Australia) outside the Special Access Scheme has also been made more transparent and flexible. The Act has been amended to enable alternatives to medicines in short supply to be sourced from a wider range of countries.
To assist applicants (usually pharmaceutical companies or specialist suppliers) wishing to import alternative products in the context of a shortage, information, guidance and an application form have been published on the TGA website. The TGA website also includes information current section 19a approvals.