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

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

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.

4

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

5

Levels of evidence linked to complementary medicines

6

Complementary MedicinesMedicinal 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.

7

Risk based regulation of medicinesAustralia 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

R8

Listed vs registered medicinesRegistered 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. 9

Requirements for listed medicinesTo 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.

10

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

11

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.

12

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

13

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

14

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.

15

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

16

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. 17

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.

18

19

Adverse Event Reporting system

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

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.

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.

22

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

24

Improving reporting for pharmacistsAs 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.

Reports following introduction of GuildLink

Sponsors - 51%

S & T Health Departments - 17%

Hospitals (including hospital pharmacists) - 13%

Community pharmacists - 8%

General Practitioners - 4%

Consumers - 3%

Other - 3%

2014 (up to 3 October)

So far in 2014, there are almost as many reports from community pharmacists as there were for the entire year in 2013. 25

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.

Medicine Shortages Information Initiative

27

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

29

About the initiativeThe 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.

30

How it works

31

Assessing shortagesShortages 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

32

Shared assessment framework

33

Subscribe and search medicine shortagesThe 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

34

Website demonstration

http://www.tga.gov.au/hp/information-msi.htm

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

TGA information – a one stop shop!

36

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.

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

39

Questions

40

Contact TGA:

www.tga.gov.au

info@tga.gov.au

1800 020 653