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Medicine shortages reforms guidance and resources

21 December 2018

Update - TBS resources for sponsors

21 December 2018

Mandatory reporting of shortages from 1 January 2019

23 November 2018

Mandatory reporting of medicines shortages will commence on 1 January 2019. These changes will facilitate more proactive, timely and transparent management and communication about medicine shortages for the benefit of Australian consumers and health professionals.

From the beginning of next year, sponsors of prescription and some over-the-counter (OTC) medicines will be required to report all medicine shortages (including those arising from discontinuations or recall actions) within specified timeframes.

The Therapeutic Goods Administration (TGA) will then automatically and prominently publish information about all current and anticipated shortages of critical patient impact through its Medicines Shortages Information Initiative webpage. Sponsors will also be strongly encouraged to publish information about current shortages with low or medium patient impact.

Guidance and legislative instruments

To assist stakeholders to prepare for these changes and ensure that medicine sponsors are able to easily and effectively comply with the new reporting requirements, the TGA is now releasing Management and communication of medicine shortages and discontinuations in Australia - Guidance for sponsors and other stakeholder bodies

Products on the Medicines Watch List (medicines for which shortages have been predetermined as having critical patient impact) and on the list of reportable OTC medicines (OTC medicines that are considered critical for public health) will be included in two legislative instruments and are listed in Appendix 1 and Appendix 2 of Management and communication of medicine shortages and discontinuations in Australia - Guidance for sponsors and other stakeholder bodies

The above guidance document and lists have been developed in close consultation with stakeholders, including industry and health professional organisations.

Webinar

The TGA is also hosting a webinar regarding the medicine shortages mandatory reporting at 5pm-6pm Wednesday 28 November 2018. Sponsors are invited to participate free of charge and are invited to submit questions beforehand. If you are unable to attend, a video of the webinar will be available on the TGA website after the event.

Frequently asked questions

In addition to the Medicine Shortages Information: Questions and answers already available on the TGA website, the TGA has developed responses to frequently asked questions specifically related to mandatory reporting.

These responses will be incorporated into the above resource on 1 January 2019, once mandatory reporting takes effect. In the meantime, they are provided below for your information.

From 1 January 2019, sponsors of prescription medicines and some OTC medicines are required to report all shortages of those products to the TGA.

Shortages of reportable medicines with a critical patient impact 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.

It is acknowledged that sponsors may require time to determine whether a particular circumstance will result in a shortage. Sponsors should undertake investigations as soon as possible to enable prompt reporting.

The TGA will then mandatorily publish information about all shortages that have been assessed as having critical patient impact.

A reportable medicine is one that must be reported to the TGA if the medicine experiences a medicine shortage.

Principally, these are:

  • prescription medicines (schedule 4 and schedule 8)
  • other medicines determined in a legislative instrument by the Minister, provided the Minister is satisfied that they are critical to the health of Australian patients or that the reporting of any shortage or permanent discontinuation of them would be in the interests of public health (for example, ventolin inhalers or adrenaline auto-injectors).

A shortage of a reportable medicine is automatically considered to have a critical patient impact if it is included in the Medicines Watch List, or if either of the following applies:

  • at the time of the shortage or decision to permanently discontinue, there are no registered goods that could reasonably be used as a substitute for the medicine in question or, if there are, they would likely not be available in sufficient quantities to meet demand; or
  • the shortage or discontinuation has the potential to have a life-threatening impact on, or a serious impact on the physical or mental health or functioning of, persons who take or who may need to take, the medicine in question.

The Medicines Watch List is a legislative instrument setting out a list of known critical medicine ingredients. It will help sponsors and the TGA to simplify and speed decision-making when deciding if a medicine shortage or permanent discontinuation may have a critical patient impact. Only ingredients from medicines that are included in the Australian Register of Therapeutic Goods (ARTG) are considered for the list.

The list of ingredients included in the Medicines Watch List has been derived from a consensus review of existing state hospital Emergency and Life Saving Drug Lists and the World Health Organizations' Model List of Essential Medicines that are contained in the ARTG.

Yes. 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 the guidance to determine whether or not a shortage needs to be reported within 2 working days. That impact assessment will be reviewed by the TGA to confirm the status and determine what actions then should be taken (in accordance with the guidance).

Yes. As a legislative instrument, the Medicines Watch List could be amended by the Minister or a delegate of the Minister in the Department of Health. This would in most instances only occur after appropriate consultation has been undertaken. The TGA has also undertaken to review the Medicines Watch List on an annual basis to ensure it remains current and appropriate.

Known medicine shortages of critical patient impact 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 (those of low or medium patient impact) need to be reported in full within 10 working days.

Mandatory reporting shortages (including those arising from discontinuation of products), will facilitate more proactive, timely and transparent management and communication about medicine shortages for the benefit of Australian consumers and health professionals, as well as for medicine sponsors.

Medicine shortages have become an increasing problem in Australia, and the previous voluntary scheme for reporting shortages proved ineffective. Many shortages of critical patient impact were not reported to the TGA, which meant valuable information could not be shared with consumers and health professionals. This caused delays to the effective management of medicine shortages.

Improved communication will help consumers to be aware of medicine shortages that may affect them sooner, which will enable them to obtain timely advice and support from a health professional. In some situations, their health professional may be able to recommend alternative treatments or arrange supply of an alternative product.

It is important to note that sometimes disruptions to supply of a medicine cannot be avoided. The problem of medicine shortages is not unique to Australia. Mandatory reporting of medicine shortages will not prevent these disruptions, but early identification and notification will benefit consumers and health professionals.

All shortages of critical patient impact will be published on the TGA website in the Medicine Shortages Information Initiative section. They will be listed under one of the following sub-categories: current, anticipated or discontinued. There will also be a list of resolved critical shortages.

In certain cases, further information may be published on the TGA website, including information on alternative products where appropriate. Links to other websites (sponsor, State and Territory, clinical college) will also be provided. Information on products approved to be imported under section 19A as alternative products to Australian-registered medicines that are experiencing a shortage are also available on the TGA website.

While not mandatory, sponsors will be strongly encouraged to publish other (medium/low patient impact) shortages on the Medicines Shortage Information Initiative website in a consolidated list of notifications.

These notifications can be searched using either brand (trade) name or by active ingredient name.

Compliance measures in relation to these reporting obligations will be in accordance with the TGA's Regulatory Compliance Framework.

The TGA takes a risk-based approach to compliance and will develop appropriate strategies to prevent non-compliance. This will include activities to raise awareness and understanding of the new scheme, which will allow the TGA to respond proportionally to the varied types of non-compliant behaviour.

New regulatory measures available to the TGA under the Act can be used to address breaches. These measures range from publishing the names of sponsors who do not comply with the new requirements (in accordance with s61 of the Therapeutic Goods Act 1989), to issuing infringement notices and, in the most serious cases or where there is repeated non-compliance, initiating civil penalty proceedings. Civil penalties can result in maximum fines of 100 penalty units for an individual and 1000 penalty units for a body corporate.

In most cases, civil penalty action would only be used where other steps, such as awareness raising and warnings, have previously been used and there is a history of repeated non-compliance.

Additional resources and further information

Additional resources are still being developed. These include updated instructions for sponsors on how to submit medicine shortage notifications through the TGA's Business Services (eBS) portal and related video presentations, which are expected to be made available in December 2018.

If you require further information you can contact the TGA's Medicine Shortages Section via: