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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