Medicine shortages have become an increasing problem in the past few years for a number of reasons. Under the current medicine shortage management scheme launched in 2014 sponsors voluntarily report shortages to TGA; although a significant number of shortages of extreme or high patient impact have not been reported by some sponsors. Timely reporting of shortages and public communication of those which have a significant clinical impact enables alternative supplies of the product to be accessed or remaining available product to be rationed. This presentation covers changes being made to improve the management and communication of medicines shortages in Australia.

1. Medicine Shortages
Changes to the Communication and Management of Medicine
Shortages in Australia
Dr Tony Gill
Director
Medicine Shortages Section, Pharmacovigilance and Special Access Branch
ARCS Annual Conference
23 August 2018

2. Background
• Medicine shortages are a global public health issue affecting rich and poor countries alike
• Complex issue where there is a lack of a universally accepted definition of a “medicine shortage”
• Varying degrees of patient impact
– e.g. a shortage of a generic amoxicillin 250 mg oral product = LOW IMPACT
– e.g. unexpected batch failure of heparin-based products which has NO therapeutic alternative = CRITICAL
IMPACT
• Medicine shortages are unavoidable and cannot be prevented in most cases
• However the timely communication of medicine shortages informs:
- The development of mitigation strategies
- Healthcare professionals in the management of their patient’s treatment

3. Causes of shortages
• Disruption to manufacturing processes
• Unavailability of raw materials
• Manufacturing/Quality related issues
• Diversity of regulatory requirements
• Changes in product formulation
• Changes in product manufacturer
• Commercial decision by sponsors
• Unexpected fluctuations in demand
• Lack of timely communication regarding supply/demand

4. How shortages have been managed until now
• Previously no consistent and co-ordinated approach to the communication and management of
medicine shortages in Australia
• Healthcare professionals and consumers left uninformed
• Subsequent decision to have an organised approach
• Joint initiative established
• Medicine Shortages Information Initiative (MSII) webpage was launched on 26 May 2014.
• http://apps.tga.gov.au/prod/MSI/search/

5. Joint Initiative

6. Australian protocol
• Founded on a commitment to improve the communication and management of medicine
shortages in Australia
• Key document highlighting the roles and responsibilities of all stakeholders in the event of
a medicine shortage and the subsequent actions required
• Based on voluntary notifications from sponsors
• Medicine Shortages Information Initiative Protocol is available on the TGA website
• http://www.tga.gov.au/publication/medicine-shortages-information-protocol

8. Benefits of a medicine shortage database
• Consolidated
“source of truth”
• Confidence of
updates
• Information to
support continuity
of care
Health professionals
• Information to
support discussions
with HCP
Consumers
• Role clarity
• Efficient
Mechanisms to
“close the loop”
• Standardised
assessment/
Consistent
responses
Sponsors
• Role clarity
• Streamlined
systems
TGA

9. MSII website
http://apps.tga.gov.au/prod/MSI/search

10. Information available on the website
• Sponsor name and contact details
• Product active ingredient and trade name, strength, dose form and ARTG number
• Reason for shortage (provided by sponsor from drop down menu)
• Estimated duration of the shortage
• Shortage type – anticipated, current, resolved, discontinuation
• Additional supply details about the medicine as appropriate
• Information about substitute medicines or therapeutic alternatives as appropriate and available

11. Limitations
• Voluntary scheme vs FDA and Health Canada where reporting of shortages is mandatory
• Not all shortages notified and reasons for which include:
– Perceived commercial risk with future contracts
– Perceived commercial risk that lose share of markets if generic products available
• Timelines
– Variable timeliness of notification – tend to hear from other sources and then speak to sponsor to request
notification
– Accuracy of information
 shortage commenced but not notified and available on MSII
 duration of expected shortage under estimated
 Information integrity– sponsors forget to update current information once published

12. Statistics
• In 2017 224 notifications to the TGA
– Commercial changes – 5
– Discontinuations – 26
– Manufacturing issues – 103
– Unexpected increase in demand – 36
– Other - 54
• As of 22 August 2018 Australia had 214 current
notifications on the MSII and 428 notifications
in total (includes current, anticipated, resolved
and discontinued notifications)
• Society of Hospital Pharmacists of Australia in June 2017
reported on a survey of medicine shortages on a
particular day in hospitals across Australia.
– 1577 medicines
– 154 substances/API
– 14.8% on MSII website

13. Statistics – 2015, 2016 & 2017
Commercial
Changes
2%
Discontinuation
12%
Manufacturing
46%
Other
24%
Unexpected
Increase in
Demand
16%
Shortage Reasons 2017
• Discontinuations are classified as permanent shortages

14. Breakdown of notifications
• Notifications are classified by high level descriptors
• Various contains all notifications resulting from the shortages of allergens
0 5 10 15 20 25 30 35 40
Alimentary tract and metabolism
Cardiovascular system
Genito-urinary system and sex hormones
Antiinfectives for systemic use
Musculo-skeletal system
Respiratory system
Various
Notifications by ATC Code 2016

15. 0 5 10 15 20 25 30 35 40
45
50
Alimentary tract and metabolism
Blood and blood forming organs
Cardiovascular system
Dermatologicals
Genito-urinary system and sex hormones
Systemic hormonal preparations, excluding sex hormones and insulins
Antiinfectives for systemic use
Antineoplastic and immunomodulating agents
Musculo-skeletal system
Nervous system
Respiratory system
Sensory organs
Various
Notifications by ATC Code 2017

16. Changes to how shortages will be communicated and
managed in Australia
• Public consultation held from 28 March to 30 April
• All stakeholders acknowledged the need for a better system
• Issues under consideration included: the definition of a medicine shortage, the reporting obligations and
timeframes for sponsors, introduction of the “Medicines Watch List” (MWL) and penalties for non-compliance
• Definition of a medicine shortage: if the supply of that medicine in Australia will not, or will not be likely to
meet the demand for the medicine at any time in the next 6 months for all patients in Australia who take, or
who may need to take, the medicine
• The Bill has been introduced into Parliament and subject to the passage of legislation, the introduction of
mandatory reporting for all “reportable medicine” shortages to the TGA will commence from 1 January 2019

17. Changes to how shortages will be communicated and
managed in Australia (contd)
• “Reportable medicines” include all S4, S8 and some S3 medicines
• Mandatory publication on the MSII website for medicine shortages assessed to be of Critical Impact
• Critical Impact medicine shortages include instances where there are no reasonable substitutes available or if
the shortage has the potential to have a life threatening impact on patients who need or may need to take it
• Medicines Watch List: a subset of medicines identified to assist in simplifying and speeding up decision-
making when deciding if a medicine shortage has critical patient impact
• Sponsors will have to report critical impact medicine shortages within 2 working days of becoming aware of
the shortage with certain information including: name of the sponsor, product and estimated duration of
shortage. All other required information to be reported within the following 3 working days

18. Changes to how shortages will be communicated and
managed in Australia (cont.)
• All other shortages to be reported within 10 days of becoming aware of the shortage
• Discontinuations will also have to be reported
• Critical impact medicine discontinuation- 12 months notice required or as soon as the sponsor is made aware
of the decision to discontinue
• All other discontinuations- 6 months notice required or as soon as the sponsor is made aware of the decision
to discontinue
• TGA takes a graduated, risk-based approach to compliance and will assess reports of non-compliance on a
cases by case basis

19. Changes to how shortages will be communicated and
managed in Australia (cont.)
• Penalties for demonstrated and deliberate non-compliance will include civil penalties (fines) with a
maximum of 100 penalty units for an individual and 1000 penalty units for a sponsor
• TGA will also publish the names of sponsors who have been non-compliant on the MSII
• Further stakeholder engagement and communication activities planned for 2018 to ensure all
stakeholders are aware of their roles and responsibilities (including the publication of a revised
protocol)

20. Requirements when reporting - post 1 January 2019
• The information required when reporting remains the same with two additional fields:
– availability i.e. unavailable, limited availability, only available on NIP, and Emergency supply only; and
– date when was the shortage known to the sponsor
• The impact rating and the shortage type/status i.e. anticipated, current, resolved or discontinued will be
brought to the beginning of the form to inform which route the notification should take
• Critical impact shortages will be able to be submitted with reduced mandatory fields in the first instance only
• Some options have been removed e.g. “Unknown at this time”. Sponsors will be required to provide actual data
when estimating:
– demand volumes,
– percentage share and
– stock levels, to enable a more accurate assessment of the current situation
• The sponsor website address is not mandatory. Websites that have information relating to the management of
the medicine shortage should be included

21. Requirements when reporting - post 1 Jan 2019 (cont.)
The following fields will be required when submitting a medicine shortage notification:
• ARTG Product name and number
• Sponsor details and primary contact (prepopulate
from login ID)
• Shortage type/status
• Shortage patient impact ranking
• When was the shortage known to the sponsor (new)
• Estimated From and To dates of shortage
• Aust. Telephone Number for public contact purposes
• Medical Information Email for public contact purposes
• The ATC Descriptor
• All pack sizes for this ARTG entry affected
• Is this ARTG entry listed in the PBS
• The Shortage Reason
• Availability (new)
• Is this shortage specific to Australia
• Is this shortage related to other medicines within the same
Therapeutic Class
• Estimated Normal Demand Volumes for Australia
• Estimated Percentage Share of the Australian Market
• Estimated Current Stock at Sponsor / Manufacturing Level in
Australia (zero will now be a valid response)
• Estimated Current Stock at Wholesaler / Distributor Level in
Australia (zero will now be a valid response)
• Are there therapeutic alternatives on the Australian market
• Do any specific population groups use this product
• At least one Communication Activity
• At least one Supply Management Action
• Publication date on the medicine shortage page
Red = mandatory fields for an initial notification of a critical impact shortage. The remaining fields must be submitted within 5 days of becoming aware of the medicine shortage.

22. Section 19A approvals
• Allows a sponsor to import and supply a medicine not on the Australian Register of Therapeutic Goods (ARTG) because:
– The Australian registered medicine is in shortage or unavailable
– The medicine is needed in the interest of public health
• Approvals are granted for a specified period of time
• Subject to any relevant conditions (eg packaging in English or identifiable in English; Dear Health Care Professional Letter,
label with name and address of the sponsor to ensure that adverse events can be reported)
• It is the sponsor’s responsibility to source an alternative product under s19A
• The TGA is not involved in the pricing of s19A products
• Information is at http://www.tga.gov.au/accessing-medicines-during-medicines-shortage

23. Section 19A database http://www.tga.gov.au/ws-s19a-index

24. Questions?