Presentation: GP’s role in quality use of medicines in Australia

TGA presentations given at: RACGP (GP17) conference, 26-28 October 2017

13 November 2017


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  • Presented by: Dr Jane Cook
  • Presented at: GP17 RACGP Conference
  • Presentation date: 27 October 2017
  • Presentation summary: Presentation regarding the quality use of medicines in Australia and enhancements to Australia’s medicines vigilance scheme.


GPs’ role in quality use of medicines in Australia

Dr Jane Cook
Pharmacovigilance and Special Access Branch
Medicines Regulation Division, Therapeutic Goods Administration

GP17 RACGP Conference, 27 October 2017

Slide 1 - Overview

  • How are medicines made available for use in Australia?
  • Why do we want to monitor the safety of medicines once registered?
  • How can GPs help ensure Quality Use of Medicines and why would they want to?
  • You need information to be informed
  • What do patients expect from GPs when they prescribe a medicine – what information do they want?
  • What’s new?

Slide 2 - How are medicines made available for use in Australia?

TGA assesses safety, efficacy and safety…

… PBAC assesses cost effectiveness

Slide 3 - Why do we want to monitor medicines’ safety once registered?

Slide 4 - Post-market monitoring identifies …

  • New adverse events or a change in the rates of known adverse events.
  • Production and other quality issues.

Slide 5 - Post-market monitoring identifies …

photographic image of the defects of thalidomide on an infant

The birth defects caused by thalidomide caused governments around the world to strengthen their monitoring and regulation of medicines safety.

Slide 6 - Response to the thalidomide tragedy

Providing the best healthcare requires information to flow various ways, including:

  • from patient to doctor
  • from doctor to patient
  • from TGA to doctor
  • from doctor to TGA.

Slide 7 - Consumer Medicine Information (CMI) and Product Information (PI)GPs should consider:

CMI and PI can be downloaded via or in widely available clinical software.

Slide 8 - Information from doctor to patient: CMIs

  • Provide the CMI to the patient or advise them how they can obtain the CMI from their pharmacist.
  • The CMI provides important information about the symptoms that patients may have when they use the medicine you have prescribed.
  • Providing a CMI improves compliance

Slide 9 - Information from TGA & sponsor to doctor: PI

  • A product information (PI) document has been written by the pharmaceutical company responsible for the medicine and approved by the TGA.
  • A PI provides objective information about the quality, safety and effectiveness of the medicine.
  • This information is intended to assist health professionals in prescribing and dispensing

Find PIs via:, the Medsearch app or widely available clinical software

Slide 10 - Product Information reformatting

The Product Information (PI) is being reformatted to:

  • improve its usability for health professionals, by bringing critical clinical information to the front of the PI
    • indications, dosage and administration, contraindications, precautions, adverse events
    • align format with other countries
  • Transition to the new format will be over three years
  • All PIs in the market will be in the new format by the end of 2020

Slide 11 - Other sources of information from TGA

The TGA publishes a range of other information relevant to GPs including:

  • Medicines Safety Update (MSU) and Medical Devices Safety Update (MDSU)
  • Safety alerts
  • Recalls
  • Monitoring communications
  • Medicines shortages notifications

Subscribe at

Slide 12 - Information flowing from doctors to TGA please report your adverse events

  • GPs are among those best-placed to provide the most useful adverse event reports.
  • Analysis of adverse event reports is a major tool used in monitoring medicine safety in Australia.
  • The easiest way to report is online via our website.

Slide 13 - Black Triangle Scheme

  • Identifies new medicines and those being used in new ways
  • Encourages the reporting of adverse events associated with their use
  • The symbol and text will appear on the PI and CMI, and TGA-related materials

PI: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events

CMI: This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get.

Access to medicinal cannabis products: steps to using access schemes

Slide 14 - Triangle Scheme – inclusion criteria

  • All new medicines, except:
    • biosimilars
    • seasonal influenza vaccines
  • Medicines with a provisional extension of indications
  • Extensions of indication into significantly different conditions or patient groups may be included
    • e.g. for an oncology to rheumatology indication

Slide 15 - Black Triangle Scheme – implementation

  • Scheme starts in January 2018
  • 5 year duration for standard registration and then lapses
  • Provisional registration period
  • Inclusion automatically lapses at the end of the agreed period

Slide 16 - Black Triangle Scheme – more information

  • We will conduct information campaigns for both health professionals and consumers in coming months using a range of channels.
  • Keep an eye on your professional bodies’ journals and newsletters.
  • More information is also available on the TGA website.


Slide 17 – New Provisional Approval pathway

A new Provisional Pathway will allow certain medicines to be provisionally registered on the ARTG:

  • Some medicines will be able to reach Australian patients up to two years earlier
  • An option where the potential benefit of earlier availability outweighs the risk that additional data are still required.

The TGA particularly encourages adverse event reports for these medicines.

Slide 18 – Other monitoring

  • AusVaxSafety – A national collaborative active vaccine safety surveillance initiative
    • SmartVax and Vaxtracker – Software programs run by GPs and immunisation clinics that send an SMS or email to patients or carers following vaccination
    • STARSS – Study evaluating the use of SMS and telephone follow-up after vaccination
  • We are trialing combining and monitoring de-identified information from various sources to detect safety signals.
  • We will be able to use data from ‘My Health Record’ when the program is up-and-running.

Slide 19 – Your role as a health professional

GPs can play an important role by reporting any suspected adverse events to the TGA.

We are particularly interested in:

    • suspected reactions involving new medicines (this is where Black Triangle comes in!)
    • serious or unexpected reactions to medicines
    • serious medicine interactions
  • You don't need to be certain, just suspicious!
  • Reports can be made online, or by phone, fax or email
  • Visit the TGA website for more information:

Slide 20 – Codeine Rescheduling

Up-scheduling of codeine to Schedule 4 (Prescription Only)

  • From 1 February 2018, medicines containing codeine will no longer be available without a prescription
  • The rescheduling decision was made on the grounds of public safety and potential for abuse
  • Research shows that over-the-counter low-dose codeine can cause:
    • opioid tolerance
    • dependence
    • addiction
    • poisoning
    • death
  • Addiction as a result of regular use can occur without the patient realising
  • Visit the TGA website ( for resources on codeine access or visit the TGA exhibition space for more information

Slide 21 – Therapeutic Goods Evaluation Panel

Would you like to evaluate for the TGA as an External Evaluator?

  • The TGA is currently looking to appoint suitably qualified and experienced individuals and organisations with expertise in various scientific and medical fields to the Therapeutic Goods Evaluation Panel.
  • Evaluation services in the areas of clinical medicines and technologies, nonclinical sciences and quality of pharmaceutical therapeutic goods.
  • Request for Tender open on AusTender
  • Industry briefings/information sessions in November 2017

TGA tenders (

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