Related Information

APVMA Website Archive

The content on this page and other APVMA Website Archive pages is provided to assist research and may contain references to activities or policies that have no current application.

Use of Atropine for Treatment of Organophosphorus (OP) Poisoning – Amendments to First Aid and Safety Directions (FAISDs) on Labels for OPs and Carbamate

10 February 2009

Atropine tablets are no longer available for sale in Australia. Therefore the Department of Health and Ageing will amend the FAISDs to remove the requirement to obtain an emergency supply of atropine tablets before using OP and carbamate products. Registrants will need to amend their labels to match the FAISD handbook.

Users of these products should be aware that these changes do not indicate that there is any decrease in health hazards from OP and carbamate pesticides and should continue to use products with care, following all safety directions.

Background

Labels for many products containing OP and carbamate pesticides include FAISDs referring to the need to obtain an emergency supply of atropine tablets. Atropine has a range of uses including the treatment of poisoning with OP and carbamate pesticides.

Currently, labels for OP and carbamate pesticide products registered for use in Australia must display a statement directing the user to obtain an emergency supply of atropine tablets as an antidote in case of poisoning (Statement 373 – ‘Obtain an emergency supply of atropine tablets 0.6 mg’). Compliance with label requirements is mandatory under legislation in the various States and Territories. Atropine sulfate tablets with the recommended strength of 0.6 mg were previously manufactured by Fawns & McAllan Pty Ltd but this oral dosage form is no longer available in Australia.

Because this product was also required under a First Aid Instruction (statement “m” - “give atropine if instructed”) in case of poisoning, its lack of availability in prescribed tablet form suggested that the current and future product users would be in breach of workplace health and safety legislation. The First Aid Instruction statement, however, did not specify the form of the product or dose levels to be administered. The First Aid Instruction would provide sufficient flexibility to allow for alternative dose forms of atropine if they became available.

In order to address the lack of availability of a supply of atropine sulfate tablets, the Office of Chemical Safety (OCS) within the Department of Health and Ageing formed a Working Group and prepared a document titled Review of Emergency First-Aid Treatment of Anticholinesterase Pesticide Poisoning in Australia (2008) (external website). The findings and recommendations of this review have been considered and endorsed by the NDPSC and are published in the NDPSC June 2008 Record of Reasons (PDF, 392kb) (external website).

Actions

The OCS will update the FAISD handbook to reflect the recommendations of the Working Group Report. This will occur after the ‘Record of Reasons’ for the October 2008 meeting of the National Drugs and Poisons Scheduling Committee (NDPSC) has been published in November. 

This update will involve deleting Safety Direction ‘373’ from more than 100 FAISD entries –‘Obtain an emergency supply of atropine tablets 0.6mg’. 

The corresponding First-Aid statement ‘m’ will be retained – ‘If swallowed, splashed on skin or in eyes, or inhaled, contact a Poisons Information Centre [Phone eg. Australia 131126; New Zealand 0800 764 766] or a doctor at once. Remove any contaminated clothing and wash skin thoroughly. If swallowed, activated charcoal may be advised. Give atropine if instructed.’

Once the amendments to the FAISD handbook are made, the APVMA will give affected registrants the opportunity to voluntarily choose to amend their labels via a Category 13 application, or will be asked to update their labels as part of their reprinting cycle.

Top