Prescription medicine labellingAdoption of TGO 91

Adam Mortimer

Evaluator

Pharmaceutical Chemistry Section, Scientific Evaluation Branch

Medicines Regulation Division

28 November 2017

Overview

• Why we need labels

• History of regulation

• Creation of TGO 91and TGO 92

• Common prescription labelling

issues

1

Updating medicine labels

Responding to internal and external stakeholder needs:

• Medicine labels and quality use of

medicines (QUM)

• Addressing technical inadequacies

• Clearer labelling requirements

• Need for international alignment

2

Labelling Reform Consistent location of important health information

Improved readability of important health information

Improved safety and quality use of

medicines for consumers

Reduce medication errors

3

Two labelling Orders

When one

Becomes two

TGO 91 – Prescription and related medicines

TGO 92 – Non-prescription medicines

4

Nothing is perfect …

First round of amendments

• Multiple ‘declarable substance’

statements

• Clarity and consistency in Na and K

statements

• New name for re-made TGO 69

5

6

Top prescription labelling issues

Prominence of active ingredient

• Larger and clearer text

• Consistent location of

information – cohesive unit

• Easier identification of active

ingredient name and quantity

information

7

Name of the medicine

• As appears on Certificate of Registration

• With some potential exceptions

– Name of active ingredient

– Strength

– Dosage form

– Name of sponsor/ distributor

8

Example

Before

After

9

ExampleBefore

• Name not on 3 non-opposing

sides

• Can have more than 1 main

label

*Images shown are not actual medicines or brands

10

Example

AfterProduct name displayed on

3 non-opposing sides

Clearly identified

dispensing label space11

Example

Before

After

• 10mL not part of name

of medicine on

registration certificate

*Images shown are not actual

medicines or brands

12

Schedule 1

• New requirement for prescription

medicines

• Detection limits

• Multiple warnings

• Reference to Consumer Medicine

Information (CMI)

• Substances that are not ingredients

13

Use of colour

• New colour contrast

requirement

• Check guidance

• Search for Vision

Australia colour contrast

analyser

14

Other common issues

• Warning statements from Poisons

Standard

• Dosage unit on ARTG

• Batch and expiry prefixes

15

Batch and expiry prefix

Before After

16

Guidance

• Mandatory and Best Practice

information

• Former best practice guidance for

prescription medicines

• Updates with clarifications

• Prominence of active ingredient

information

• Schedule 117

We all use medicine labels

• Frequent enquiries from consumers

and industry – interest level is high!

• New webpage for consumers

• New webpage for health professionals

• Input to newsletters

• Social media

• Specific guidance for industry??

– let us know18

Questions?

19