The presentation was given by the TGA at the 2014 ARCS Scientific Congress, and covers TGA's implementation of the Medicine Shortages Information Initiative

1. Medicine Shortages
Information Initiative
Thursday 11 Sept 2014
Dr Tony Hobbs

2. Background
• Before 26 May 2014 there was no
central, timely, consistent,
coordinated communication channel
about medicine shortages.
• Individual patient care may have
been compromised and the work of
health professionals affected.

3. A partnership approach
Communicate
and manage the
effects of
medicine
shortages
Therapeutic Goods
Administration
Medicines Australia and
their member companies
Generic Medicines Industry
Association and their member
companies

4. The Initiative
Delivers:
• Timely notification about changes in supply
• Structured assessments of the likely impact of
these changes
• Coordinated responses and communication

5. The Protocol
• Sets out the arrangements for the
Medicine Shortages Information website
• Hosted by the TGA, it is the key tool for delivering
consolidated information to support health
professionals and consumers when there is a
medicine shortage
Presentation title 4

6. The Assessment Framework
Shortages will be assessed depending on their level
of potential impact, and will be managed
consistently with the assessed impact level.
The level of potential impact is based on the:
• medical condition and unique concerns of the
patient population
• availability and conditions of registration of
substitute medicines or therapeutic alternatives
High
Medium
Low

7. Shared Assessment Framework
Substitute Medicines or Therapeutic Alternatives Ranking
 Registered for use for the indication in Australian market?
 Available in adequate quantities to meet demand?
Exact Similar Appropriate Possible None
Patient Population
Ranking
 Medical condition?
 Unique population
concerns?
Mild Low Low Medium Medium High
Moderate Low Medium Medium High High
Severe Low Medium High High High

8. 15/09/2014
7
Website demonstration:
http://www.tga.gov.au/hp/information-msi.htm

9. Feedback
• 3 months since the
launch
• Feedback received
mainly from Sponsors

10. Search medicine shortages
• 30 Current shortages
• 0 Anticipated
• 2 resolved
• 27 Discontinued products
557 subscribers to email alert service
Presentation title 9

11. You can help by notifying us
The TGA eBS website provides a simple
streamlined tool for you to notify the TGA
of medicine shortages:
https://www.ebs.tga.gov.au/

14. Early learning
• Some parts of the Notification form
require further clarification
• Not all medicine shortages
published
• IT system
• More sponsor and healthcare
professional and consumer
education needed
Presentation title 13

15. Evaluation
• Website
- Layout is causing
some confusion
• Notification form
- Sponsor feedback that
some of the fields are
confusing
Presentation title 14

16. Evaluation
• Initial Evaluation (3 months)
• Sponsors found training valuable
• 90% Notification forms received
published within 5 days
• 12 months Evaluation plan
• To review the realisation of benefits pursued
under the Medicine Shortages Information
Initiative
• To recommend areas and strategies for
improvement
• Survey to commence 9 months after release
of V2
• Reporting in August 2015
Presentation title 15

17. Find out more:
www.tga.gov.au/hp/information-msi.htm
1800 020 653
medicine.shortages@tga.gov.au