Publishing a notification form
The MSII website has been redesigned to open on a page dedicated to shortages of medicines with critical patient impact. From this page users can navigate to another web page that will hold a consolidated list of medicines shortages. This consolidated webpage will contain a list of all medicines shortage notifications that have been notified to TGA and where publishing has been agreed with the sponsor i.e. shortages and discontinuations of low, medium and critical patient impact. In the interests of transparency and to assist in maintenance of patient care, sponsors of low and medium patient impact are strongly encouraged to allow publishing of the information relating to these shortages on the MSII website.
The initial landing page will hold information relating to any shortage or discontinuation that is of critical patient impact. For critical shortages the TGA will have identified shortage management action(s). These will be published under a separate heading 'TGA Shortage Management Actions'. These will be available by opening the drop-down arrow on the actual medicine shortage page and will provide proposed management action(s) and the progress of these action(s). The TGA management action information will be updated by TGA separately from the 'Notification' form. This information will be identified on the MSII webpage for the individual product as TGA-provided information in the form of 'TGA Management Action'. This will not be visible on the opening page but is accessed by clicking on the medicine ingredient.
What is published?
Information relating to critical impact medicine shortages will be mandatorily published and will appear on both the critical impact medicines shortages list and on the consolidated medicine shortages list. The information that will be published can include:
- sponsor's name
- sponsor's nominated public contact details
- sponsor's nominated website details *
- ARTG number
- ARTG name of medicine (includes name, active ingredient(s), strength, dosage form and container)
- active ingredient(s)
- therapeutic class description
- nature of the shortage
- impact of the shortage
- availability
- reason for the shortage
- estimated shortage dates for current or anticipated shortages
- deletion from market date for discontinued products
- supply information where appropriate.
*Sponsor website details will only be published if they contain information that relates to the management of the medicine shortage.
For medium and low impact medicine shortages, publication is not mandatory but is strongly encouraged to assist health professionals in the management of their patients and to allow consumers access to information relating to their own health.
By choosing 'Yes' to publishing in the notification form for medium and low impact medicine shortages, consent is given to the TGA for some of the information contained within the notification to be published on the MSII website. The information that can be published is the same as above for critical impact medicine shortages.
If the sponsor chooses not to publish the medicine shortages information they will not have to provide a date of publication in the notification form. It is important to note that the TGA does have the power to publish medicine shortage information in the interest of public health even when the sponsor has chosen 'no' to publication. If this should happen, the TGA will contact the sponsor involved and advise that TGA intends to publish the medicine shortage information on the MSII website. This will not be an automatic process without the knowledge of the sponsor. The information that would be published would be the same as above for critical impact medicine shortages.
The TGA can also add information not supplied in the notification form. This will be included in the 'TGA Management Action' field and relates to the management of the shortage rather than the information provided by the sponsor, which relates to the medicine or the reason for the shortage.
When is it published?
The TGA will publish the information on the MSII website as soon as is practicable for medicine shortages that will have a critical patient impact. In other cases (medium and low patient impact shortages) the TGA will publish in alignment with the sponsor's commencement of supply chain communication. This is the date provided by the sponsor on the notification form in the 'Details' tab to the question 'Proposed date of publication on the TGA Medicine Shortages website'.
Has it published?
This information is provided on the 'Medicine Shortages' list of notifications that has been TGA assessed, located on the TBS Navigator under the 'Your TGA Information' link.
Legislative basis for publication
The information published to the MSII website and the date this occurs is intended to occur with the full consent of the sponsor. It is recognised that there may be situations where consent is not given to the TGA or is not possible. In cases where it is in the interest of public health that the information be released the TGA has the option to publish without this consent under section 61(5C) of the Therapeutic Goods Act 1989.