The Adverse Experience Reporting Program (AERP)

Industrial and domestic chemicals – NICNAS (National Industrial Chemicals Notification and Assessment Scheme) Human medicines – TGA (Therapeutic Goods Administration) Agricultural and veterinary chemicals – The ‘National Registration Scheme’ including the APVMA Storage, transport (“dangerous goods) and occupational health and safety (“hazardous substances”) – Australian Government and States Australian Pesticides and Veterinary Medicines Authority Chemical Regulation in Australia

APVMA regulates veterinary medicines and pesticides (up to and including the point of retail sale) State/Territory government agencies regulate actual use of chemicals (control of use) Work cooperatively to deliver the National Registration Scheme Australian Pesticides and Veterinary Medicines Authority Agvet Chemical Management in Australia

Feedback loops Adverse Experience Reporting Program (AERP - APVMA) – Reports on unintended and unexpected effects of Agricultural or Veterinary chemicals on animals, people and the environment Chemical Review (APVMA) – Reconsiders registration of chemical products where new concerns are raised Australian Total Dietary Survey (FSANZ) – Screens food prepared to table-ready state Residue Testing Programs (Various) – Monitors chemical residues in raw food and fibre commodities

Compliance Activities Has the law been broken? Chemical Review Activities New information on the toxicity of an existing active constituent is available. This may relate to: –Human health and safety –Environmental toxicity –New Residues Data –Adverse Experience Reports Adverse Experience Reporting Program (AERP) Did things go as expected? What does “post registration” mean?

Legislative basis for AERP An interested person Anyone with a commercial interest in the production or registration of a chemical Becomes aware of relevant information Anything that contradicts previous information given to the APVMA Indicates there may be undue hazard to people including residues, harmful to animals, plants or the environment. Shows that use according to label may be dangerous or prove product is ineffective Process defined in Section 161 of the AgVet Code Act (1994)*

Who can report an Adverse Experience? ANYONE People affected Owners of animals or land affected Bystanders Government organisations Registrants (obliged to tell us)

Serious incidents – notify us within 7 working days – Death of human, deaths in small/companion animal and production species – Hospitalisation of human, small or companion animals – Medical treatment of human – Multiple medical visits for animals – Welfare implications – When you have a concern All other incidents can be submitted as Periodic Summary Updates (PSUs). Industry Obligations

Tell us about… On or Off label? Yes please! To help ensure labelling is clear and effective Deliberate or accidental? These reports will add to our understanding what is happening Side effects Were the side effects experienced not warned on the label? Lack of effect or residues Is the chemical achieving its claims Human health Privacy is maintained Environment Looking after the birds and the bees and the trees also.

What do we need to know? We need a product or active to consider AND Contact details for the reporting person AND A description of what happened and what went wrong.

Short adverse experience reporting form

Poor Kitty! – a case study The scenario – a dog product containing permethrin The problem – used on cats The result – cats get very sick and some die The product is toxic to cats. The label states ‘Do not use on cats” but clients either ignore this or think that is a marketing ploy. What has AERP done in this situation? We have negotiated with companies who make these products, the new recommendation for the labels are:- Keep cats separated from recently treated dogs. – There are reports of toxic effects in cats which groom or contact dogs treated 48 hours earlier. – Toxic effects include behaviour changes, drooling, tremors and death. – Seek veterinary advice immediately if you suspect toxicity in a cat.

Possible outcomes of an AER We collect data Watch for trends Identify recurring events over time Label changes Especially considering older labels. Recommend chemicals to Chemical Review Program for their consideration. Ongoing feedback to the Registration and Compliance arms of the APVMA

Contact details Phone: FreeCall: (within Australia) - charges apply for calls made from mobile phones Fax: Write PO Box 6182 Kingston ACT 2604 Webapvma.gov.au/aerp