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Consultation: Management and communication of medicines shortages

23 April 2018

This consultation closed on 30 April 2018.

The TGA sought comments from interested parties on a proposal that would require medicine sponsors to report all medicines shortages in confidence to the TGA and those medicines shortages classified under a revised medicines shortages protocol as of 'extreme' or 'high' patient impact to be mandatorily published via the Medicines Shortages Information Initiative (MSII) on the TGA website.

This consultation paper seeks input on a number of matters that will shape how the improvements to the management and communication of medicines shortages are implemented.

Consultation documents

How to access a pdf or Word document

Proposed implementation approach

A new protocol

Timetable

Documents released for consultation on Tuesday, 27 March 2018.

Interested parties should respond by close of business Monday, 30 April 2018.

Feedback will be released following consideration of submissions. (see 'What will happen').

About the consultation

This consultation paper is seeking stakeholder feedback on:

  • the definition of a medicine shortage that would trigger mandatory reporting to TGA and subsequent action;
  • the medicines in scope for mandatory reporting;
  • proposed timing and content of mandatory reports;
  • the proposed list of medicines on the 'Medicines Watch List' (a shortage of a product on this list would automatically classify the shortage as of 'extreme' patient impact); and
  • compliance obligations and proposed penalties for non-compliance.

Background

Medicine shortages have become an increasing problem in the past few years for a number of reasons. These include the decrease in local Australian manufacture of prescription medicines and the increasingly globalised nature of the supply chains for medicines. This means that even in cases where several products containing the same active ingredient are registered in Australia, they may be made by the same manufacturer. As a result, a manufacturing problem in any facility may simultaneously affect several Australian sponsors.

Reporting and management of medicine shortages involves all stakeholders - industry, healthcare professionals and State and Territory and Commonwealth governments. The Commonwealth government's role in managing medicine shortages includes having up-to-date and comprehensive information available on medicine shortages, ensuring that this is well-communicated and, where shortages have been identified, to use regulatory measures to enable temporary access to similar foreign-registered medicines.

The MSII was launched in 2014, supported by the MSII Protocol, which sets out how a shortage should be managed by the parties involved. Participation in the MSII is currently voluntary and sponsors provide TGA with information in the form of submitted notifications for publication on the TGA website. These notifications advise health professionals and consumers of current, anticipated and resolved shortages as well as product discontinuations.

However, the MSII has had major failings. Notwithstanding the introduction of the MSII, a significant number of shortages of extreme or high patient impact have not been reported by some sponsors. Instead, the first indication that the TGA received of these medicine shortages has in many cases been from correspondence from members of the community impacted by a shortage and it has been subsequently confirmed after contact with the relevant sponsor. There have also been significant delays in some cases in confirming the existence of a shortage.

Clearly, the reporting of medicines shortages does not in itself prevent the actual shortage occurring. However, timely reporting of all shortages and the timely public communication of those which have a significant clinical impact would enable alternative supplies of the product to be accessed from overseas sources. Also, if a shortage has been notified early the remaining available product in Australia can then be rationed for use in the most serious cases. This also allows relevant groups of health professionals to convene as a matter of urgency to discuss suitable therapeutic alternatives, a critical consideration for ongoing patient care.

Submissions

Enquiries

Any questions relating to submissions should be emailed to PSAB.Communications@tga.gov.au.

What will happen

All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.

Recommendations made by the TGA following consideration of submissions from interested parties will be published on the TGA website as outcomes.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
    • seek feedback about how the consultation was undertaken.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
  • More information on consultations and privacy is included in the submission form and on our website.