The document discusses several initiatives by the Therapeutic Goods Administration (TGA) to improve patient care, including levels of evidence for complementary medicines, adverse event reporting, and information resources. It describes the TGA's role in regulating medicines, medical devices, and other products. It also explains the two-tiered regulatory system for medicines, requirements for listed complementary medicines, and efforts to make adverse event reporting easier for consumers and pharmacists.

1. Access all areas – empowering patient care
using TGA initiatives
Dr Tony Hobbs
Principal Medical Adviser
Therapeutic Goods Administration
Pharmacy Australia Congress, October 2014

2. Topics covered in this session:
• Introduction to TGA
• Levels of evidence linked to complementary
medicines
• Adverse Event Reporting system
• Medicine Shortages Information Initiative
• TGA information – a one stop shop
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3. About the TGA – what do we regulate:
Medicines and blood products
• prescription medicines
• over the counter medicines
• complementary medicines
• blood, blood components and plasma derivatives
Medical devices
• implants (artificial hips, breast implants)
• in-vitro diagnostics (pregnancy tests, blood glucose monitors)
• low risk medical devices (bandages, tongue depressors,
condoms)
Biologicals
• human stem cells
• tissue-based products (skin and bone)
• cell-based products
2

4. A broad overview of our approach to regulation
As Australia’s regulator, we:
• ensure manufacturers meet standards
for producing goods
• authorise supply for therapeutic goods
• monitor products once they are on the
market and take action if there are
problems
• identify illegal activities like
counterfeiting and take action to stop
these occurring.
3

5. Did you know that we:
• Review the manufacturing information for every batch of every
vaccine
• Test the first five batches of most biological medicines
• Perform targeted investigations of medicines for suspected non-compliance
• Seek advice from experts on our advisory committees
• Test devices for sterility and when they have been involved in
adverse events
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6. Levels of evidence linked
to complementary medicines
5

7. Complementary Medicines
Medicinal products containing designated active ingredients, such as:
• herbal materials
• vitamins, minerals, amino acids
• essential oils
• certain nutritional substances
• certain animal derived materials
e.g. fish oil, bee pollen
• homoeopathic preparations.
Regulated as medicines under the Therapeutic Goods Act 1989.
6

8. Risk based regulation of medicines
Australia has a risk-based approach with a two-tiered system for
the regulation of all medicines, including complementary medicines.
The majority of complementary medicines fall into the lower risk
category.
Lower risk medicines
• listed on the Australian Register of Therapeutic Goods (ARTG)
• AUST L
Higher risk medicines
• registered on the ARTG
• AUST R
AUST
L
AUST
R
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9. Listed vs registered medicines
Registered medicines (AUST R) are assessed by the TGA for
quality, safety and efficacy
Registered medicines include:
• all prescription medicines
• most over-the-counter medicines
• some complementary medicines.
Listed medicines (AUST L) are assessed by the TGA for quality and
safety but not efficacy. There is no individual premarket evaluation of
each product
Listed medicines include:
• some over-the-counter medicines
• most complementary medicines. 8

10. Requirements for listed medicines
To be a listed medicine on the ARTG, the medicine must:
• only contain low risk, pre-approved ingredients
• not make indications (therapeutic use) for the treatment of a
disease or condition
• be manufactured in accordance with Good Manufacturing
Practice (GMP) principles.
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11. Application for a listed medicine
• Listed medicines are included on the ARTG via a streamlined
electronic listing facility which is part of the TGA’s business framework
• After applying a listed medicine can generally supply their product in
Australia within 48 hours
• Medicines listed on the ARTG are assigned their unique AUST L
number, which must be displayed on the medicine label
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12. Legislative requirements for a listed medicine
At the time of submitting an application for a listed medicine, the sponsor
must certify that the goods meet all of the legislative requirements of
section 26A of the Therapeutic Goods Act 1989. This includes the
requirement that:
• the sponsor holds evidence to support all indications and claims
made for the medicine
• the medicine conforms with all advertising requirements
• the medicine conforms to every standard.
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13. Evidence for listed medicines
• Although the TGA does not evaluate any evidence for a medicine
before it is included in the ARTG, The sponsor must certify that they
hold evidence to support all indications and claims
• Complementary medicines may have traditional or scientific indications
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14. Traditional indications
Traditional indications present factual statements of a health benefit
relating to a historical record of use within a traditional paradigm:
• for example “Traditionally used in Western herbal medicine to
support a healthy digestive function”
• to claim evidence of traditional use, a sponsor must ensure that
their medicine or ingredient is an established part of a tradition of
medicinal use within a particular paradigm or culture for over
three generations
• traditional indications cannot make a scientific claim of efficacy
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15. Scientific indications
• Scientific indications require supportive scientific evidence.
• Scientific evidence refers to quantifiable data and includes:
– clinical trials in humans
– epidemiological evidence
– animal studies, and
– other evidence of
biological activity.
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16. Ensuring compliance
• On average, there are
approximately 1800 new
complementary medicines listed
on the ARTG each year. As the
TGA cannot review all listed
complementary medicines, a risk
management approach is used to
set priorities for listed medicine
compliance reviews.
• Reviews are random or targeted.
Targeted
Random
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17. Random and targeted reviews
Random reviews:
• a percentage of new medicines randomly selected, based on a
mathematical model
• standard set of information reviewed.
Target reviews:
• may be triggered by a complaint or risk profiling
• may be brought to the TGA’s attention by a number of sources,
including the public, media, health care professionals or other external
sources
• specific information reviewed
• may include comprehensive evidence review.
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18. Further information
Further information regarding the
requirement to hold evidence is
included in TGA Guidance
material: Guidelines on the
Evidence Required to Support
Indications and Claims for Listed
Complementary Medicines.
This information can be accessed
on the TGA website.
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19. Adverse Event
Reporting system
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20. How does TGA define an Adverse Event?
Adverse Event
For both medicines and medical
devices: an event that resulted in, or
could have resulted in, serious
injury, illness or death
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21. What should you report?
The TGA is particularly interested in:
• serious or unexpected reactions to
medicines
• serious medicine interactions
• faults or problems with medical devices
that have resulted, or could have
resulted, in adverse events
• serious and unexpected reactions are
distinct from well known side effects. For
example, we would not expect reports of:
– tiredness after taking an opiate based
painkiller
– nausea or diarrhoea after taking
certain antibiotics. 20

22. There are many ways you can report
 online: www.tga.gov.au/hp/problem.htm
 via the GuildLink web service
You can also report:
• via telephone: 1800 044 114
• by post to: Therapeutic Goods Administration, PO Box 100, Woden,
ACT 2606, Australia (please include the type of report in the address
block)
• via email: adr.reports@tga.gov.au
• via fax: +61 2 6232 8392.
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23. Making it easier to report
• It is generally acknowledged that adverse events are under-reported
around the world, with estimates that 90-95% of adverse events are
not reported to regulators
• We want to make it easier to report and have recently introduced a
new online reporting form to be used by patients
• In recent years evidence has emerged that adverse event reports from
consumers contain information that is useful for monitoring the safety
of therapeutic products, but there is low awareness of available
reporting systems
The TGA’s new online reporting form is easy
for your patients to use:
http://www.tga.gov.au/safety/consumer-side-effect-report.htm
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24. Improving reporting for pharmacists
As well as the new Adverse Event reporting form on our website, there
are further initiatives that TGA has been involved in to increase reporting.
Earlier this year GuildLink was the first company to provide an integrated
link to the TGA's adverse event reporting web service.
• GuildLink supplies Australian community pharmacy software that
supports the delivery of professional health services
• GuildLink's use of the web service makes it easier for community
pharmacists to report and contribute to the ongoing safety of medicines
and vaccines in Australia
• The web service is available to any company providing software to
health professionals - including general practitioners, hospital and
community pharmacists, specialists and nurses - at no cost.
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25. Reports following introduction of GuildLink
2014 (up to 3 October)
Sponsors - 51%
S & T Health Departments - 17%
Hospitals (including hospital pharmacists) - 13%
Community pharmacists - 8%
General Practitioners - 4%
Consumers - 3%
Other - 3%
So far in 2014, there are almost as many reports from community
pharmacists as there were for the entire year in 2013. 24

26. Why is reporting important?
Not all risks can be identified before registration. In some cases, a handful
of reports can uncover previously unknown safety issues.
The TGA received eight reports of serious liver injury
associated with the use of lumiracoxib (an anti-inflammatory
used to treat osteoarthritis) including two fatalities, two liver
transplants, severe jaundice and acute hepatitis without liver
failure.
The TGA investigated the reports and received expert advice
that the apparent rate of severe liver injury with lumiracoxib
appeared greater than for other similar medicines.
The TGA immediately cancelled the registration of all forms of
lumiracoxib in Australia, on the grounds that failure to do so
would create an imminent risk of death, serious illness or
serious injury. 25

27. Medicine Shortages
Information Initiative
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28. Background
• Before 26 May 2014 there was no
central, timely, consistent, coordinated
communication channel about
prescription medicine shortages
• Individual patient care may have been
compromised and the work of health
professionals affected
• The Medicine Shortages Information
Initiative was developed under a
partnership between the TGA, Medicines
Australia and Generic Medicines Industry
Association – with a view to improving
the management and communication of
prescription medicine shortages in
Australia 27

29. About the initiative
The TGA and companies undertake:
• timely notification about changes in supply
into the Australian market
• structured assessments of the likely impact of
these changes
• coordinated responses and communication
Information is based on the voluntary
notification by companies to the TGA.
The timely delivery of this information via a
searchable website assists health professionals
and consumers make informed decisions about
medicines that may be in short supply. 28

30. How it works
29

31. Assessing shortages
Shortages are assessed depending on their
level of potential impact, and 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
This provides a mechanism for assessing
the potential impact of a shortage and
assists companies to manage it
appropriately.
There is a graduated set of
required response activities,
depending on whether the
impact of the shortage is high,
medium or low
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32. Shared assessment framework
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33. Subscribe and search medicine shortages
The website provides health professionals
and consumers with information about
prescription medicines registered on the
ARTG.
By subscribing to the alert service, you
can elect to receive email or RSS feed
notification of new and updated medicine
shortages information.
The site includes reference to the status
of the shortage by:
• current shortages
• anticipated
• resolved
• discontinued products.
608 subscribers to
email alert service
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34. Website demonstration
http://www.tga.gov.au/hp/information-msi.htm
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35. Benefits
Health
professionals
• Consolidated
‘source of
truth’
• Confidence of
updates
• Information to
support
continuity of
care
Consumers
• Information to
support
discussions
with health
professionals
Companies and
manufacturers
• Role clarity
• Efficient
mechanisms
to ‘close the
loop’
• Standardised
assessment/
Consistent
responses
TGA
• Role clarity
• Streamlined
systems
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36. TGA information
– a one stop shop!
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37. TGA databases – ARTG and Prescribing in pregnancy
There is a range of information about medicines available on our
website that you can access:
• Search the Australian Register of Therapeutic Goods (ARTG):
– http://www.tga.gov.au/industry/artg.htm
– provides information about therapeutic goods that can be lawfully
supplied in Australia
– where available, results will also include the Product Information
and Consumer Medicines Information
• Search the Prescribing medicines in pregnancy database:
– http://www.tga.gov.au/hp/medicines-pregnancy.htm
– provides information to health professionals planning the medical
management of pregnant patients or patients intending to become
pregnant. It is not presented as medical advice to health
professionals or the public. 36

38. TGA databases – adverse events and recalls
• Database of Adverse Events Notifications (DAEN):
– http://www.tga.gov.au/safety/daen.htm
– DAEN – medicines: provides information about
adverse events related to medicines and vaccines
used in Australia
– DAEN - medical devices: provides information
about adverse events related to medical devices
used in Australia
• System for Australian Recall Actions (SARA):
– http://www.tga.gov.au/safety/sara.htm
– provides information about recall actions occurring
in Australia for therapeutic goods. The Database
holds information on recall actions that have been
undertaken in Australia since 1 July 2012
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39. Questions
38

40. Contact TGA:
www.tga.gov.au
info@tga.gov.au
1800 020 653
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