The association has backed the TGA’s proposed three-part update, which precedes are wider review of medicine labelling.
The AMA has put its weight behind updates to medication labelling proposed by the TGA to improve safety.
Yesterday, the TGA closed its public consultation on proposed changes to medicine safety matters outlined in the Therapeutic Goods Orders 91 and 92.
The consultation revolved around three matters involving medicine labelling, that require action before the labelling rules are reviewed more broadly.
In its submission to the consultation, the AMA said it supported ongoing refinement of the labelling rules and backed changes made so far, which included updates in 2016.
“The AMA supports the scope of the proposed changes, particularly the important safety measures to be addressed ahead of the broader sunsetting review process, and acknowledging the ongoing consultation that contributes to the robustness of review,” said the association.
The first of the three changes asks that clinically relevant quantities for active ingredients in injectable electrolytes be “displayed prominently”.
The AMA fully supported maintaining current requirements and adding mmol equivalents where possible, particularly for potassium chloride.
“The AMA supports the recommendation to require the quantity of potassium chloride to be expressed in mmol, as the most relevant clinical unit,” it said.
“This is an important safety measure given the high-risk nature of this medication if incorrect doses are administered.”
It also supported removing the requirement to include strengths in millimoles/litre, as this was not clinically appropriate.
The group agreed with proposed amendments to the guidance for sponsors, to provide clarity.
“A transition period of two years is reasonable to accommodate suppliers with the implementation of these changes,” it said.
The second change proposed by the TGA recommended that clear instructions on preparation and storage of particular injectables be made available for health professionals in an “appropriate format”, possible by QR code, following changes to the requirements around Product Information last year.
The changes removed the requirement for the PI to be included as a package insert for injectable products administered by health professionals.
While the AMA acknowledged the use of a QR code may limit excess paper use, it expressed concerns over internet being an access barrier, particularly in remote areas.
“The AMA is supportive of a QR code for communicating PI information,” said the AMA.
“However, we recommend continuing with package inserts outlining instructions for preparation as per appendix D.
“Broader consultation could then be undertaken to ascertain the usefulness of the insert and any unindended consequences of moving to a digital-only option.
“The AMA does not see this as a clinically urgent recommendation and so review could be delayed until the sunsetting review period if multiple changes are to be minimised.”
Finally, the consultation suggested improvements for labelling of tablets.
“The AMA is supportive of regulatory changes requiring listed medicines in the form of large dosage units intended for swallowing to be labelled with a warning to provide greater practitioner and patient awareness of potential choking hazards,” the AMA said in its submission.
“Further regulatory changes regarding limits on the size of dosage forms may be appropriate in future to reduce adverse events, particularly considering choking-related adverse events are more likely among aged cohorts, a vulnerable demographic that may benefit from greater regulatory safeguards.”
The association also agreed that proposed labelling requirements only apply to listed medicines and should only apply for certain sized tablets.
“In particular, we support the recommendation to include the word “warning” on the label, and to include medicines where the width only is >9mm.
“Consideration could be given to a standardised 22m length cutoff (rather than 22mm for tablets and 23.3mm for capsules) to aid in regulatory simplicity and sponsor compliance.
“However, the AMA leaves direct feedback on that point to sponsors.”
The AMA reiterated that a two-year transition period was appropriate.