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Medicine Shortages IT changes from 2 June 2021
Quick Reference Guide for sponsors
On 2 June 2021 we updated the Medicine Shortages IT system to improve the reporting process and make information on the TGA Medicine Shortage Reports Database more accurate, easier to find and understand.
This guide will give you an overview of the differences you will see when submitting Medicine Shortage notifications.
More detailed information is available in:
- Medicine shortages/discontinuations – Electronic notification form – User guide
- Reporting medicine shortages and discontinuations in Australia - Guidance for sponsors
These are the main changes you will see:
TBS Portal → Your TGA Information → Medicine Shortages
When you view your submitted notifications under ‘Your TGA Information’, there are new columns to display additional information. Shortage dates and shortage status (anticipated, current, resolved, discontinued) have been added to help you find and sort your notifications. These fields are also included in the existing export functionality.
- New selections for ‘shortage reason’ and ‘manufacturing site problem’
- ‘Other’ is no longer available as a shortage reason
- A new optional free text field so you can provide more information about any type of shortage
The first time you vary an existing notification you will need to re-enter the reason for the shortage, selecting from the new menu.
To allow us to continually assess the shortage, you will need to enter new data for stock values every time you vary an existing notification for the following fields:
- Estimated current stock at sponsor / manufacturing level in Australia
- Estimated current stock at wholesaler / distributor level in Australia.
Improved validation rules to minimise errors. For example, the form will not accept a future date for commencement of a ‘current’ shortage.
- Changes have been made to reflect the Publication of notified medicine shortages: Updated protocol implemented in September 2020.
- ‘Current shortages’ will be published as soon as we process them and you will no longer be able to select a publication date.
- For ‘Anticipated shortages’ you can request to defer the publication date. The requested date must be more than 2 weeks prior to the expected shortage start date and you must provide a reason for deferral.
- For ‘Discontinuations’ you can request to defer the publication date. The requested date must be more than 6 months prior to the discontinuation start date and you must provide a reason for deferral.
- We will decide on an appropriate publication date, taking into account your request and contact you if we decide against your nominated date.
Changes made when varying a notification
When you vary an existing notification, the changes you make can be viewed under the ‘Changes made’ tab (next to the ‘Supporting documentation’ tab).
These changes are also included at the bottom of your document when you select ‘Print preview’.
You can now download a .csv file of all active entries in the public Medicine Shortage Reports Database.
A new automated reminder email will be sent the day after a notification was due to be updated, in addition to the usual reminder 7 days before the update was required.
Medicine Shortage Reports Database
- To help patients and health professionals, the name of the database has changed from Medicine Shortages Information Initiative (MSII) to Medicine Shortage Reports Database.
- ‘Patient impact rating’ has been changed to ‘shortage impact rating’ to reduce distress and confusion.
- Weekly updates to the Medicine Shortage Reports Database will now be sent on Mondays instead of Thursdays to assist health professionals. You can subscribe to Medicine Shortages emails.
See Medicine shortages: Information for sponsors (suppliers) for updated guidance.