This content is current only at the time of printing. This document was printed on 23 June 2021. A current copy is located at http://www.plural-consulting.com/node/86336
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Adverse Experience Reporting Program
The Adverse Experience Reporting Program (AERP) is a post-registration program that assesses reports of adverse experiences associated with the use of a registered chemical product?(or those on permit). Reports of adverse experiences are closely monitored by the Australian Pesticides and Veterinary Medicines Authority (APVMA).
It is vital to record, assess and classify adverse experiences to detect uncommon events not evident during the initial registration process of a product.
Problems reported with chemical products may result in further regulatory action in accordance with the legislation, for instance, through compliance action or chemical review. If the issue reported is related to control of use, or is otherwise outside the jurisdiction of the APVMA, the information may be referred to the appropriate authority.
2. Definition of a serious adverse experience
Any adverse experience that results in death, is life-threatening, results in persistent or significant disability or incapacity, prolonged duration of serious signs or is a congenital abnormality or birth defect in animals.
A serious adverse experience in humans is one that requires medical treatment or involves death.
A serious or urgent adverse experience is expected to be reported promptly to the APVMA by the product registration holder. If there is any doubt about the seriousness of a suspected adverse experience, the incident must be treated as a serious adverse experience and reported by the registration holder to the APVMA as soon as possible.
The following provides a quick guide to determine if an adverse experience involving a veterinary chemical product is to be regarded as serious.
- Medical treatment required
- Farm, domestic and/or native animal deaths
- Hospitalisation or more than one veterinary visit
- Welfare implications
- More than 10% morbidity in livestock (more than 5% increase in base mortality for poultry)
- Significant off-target environmental damage, including fish kills and water quality issues
- Crop and plant damage (for example, plant death, severe stunting or significant yield loss)
2.4. Efficacy and trade
- A lack of efficacy
- Residue detections
- Contaminated chemical products
- Labelling issues
- Product, chemistry, or manufacturing quality?
3. Assessing an adverse experience
A standard method of assessment is used to determine whether the adverse experience may have been related to the use of the product, including use of the Causality Assessment Algorithm.
3.1. Classifying an adverse experience
The APVMA classifies the relationship between exposure to or use of a registered product and a reported adverse experience that is considered 'related to'?agricultural or veterinary chemical products.
A ‘probable’ classification is given when all the following criteria are met:
- There is a reasonable association between exposure to or the use of a product and the onset and duration of the reported adverse experience.
- The description of the presenting signs is consistent with (or at least plausible, given) the known pharmacology and toxicology of the product.
- There are no other equally plausible explanations for (or contributing factors to) the adverse experience.
When any of these criteria cannot be satisfied (due to lack of sufficient information or conflicting data) the APVMA cannot classify the relationship as ‘probable’.
A ‘possible’ classification is given when there is a reasonable association between the exposure to the product and the onset of the reported adverse experience. Therefore, it is reasonable to include the adverse reaction as a differential diagnosis, and it is one of the possible explanations for the adverse experience (for example the use of concurrent medication etc.), or the association is reasonable but does not meet the criteria for a probable classification.
3.2. Classification of reports not considered 'related to'
3.2.1. Probable or possible off-label
This classification is given as per the classifications of ‘probable’ or ‘possible’, but where clear evidence of off-label use also exists (including when used under the prescribing rights of a veterinarian, use in species not listed on the product label, overdosing or underdosing).
An ‘unlikely’ classification is given when sufficient information exists to establish that the adverse experience was not likely to have been associated with how a product was used, or when other more plausible explanations exist for the adverse experience.
An ‘unknown’ classification applies when reliable data are unavailable or are insufficient to make an assessment of an adverse experience.
4. How to report
Anyone can report a problem with a chemical product.
Holders are required to report relevant information to the APVMA, in accordance with the legislation.
The AERP is not intended to replace a consumer’s right or responsibility to complain to the registration holder or manufacturer about an adverse experience involving an agricultural or veterinary chemical product.
4.1. Periodic Summary Updates Reports (PSURs)
Registration holders of products that were registered at some time during the reporting period are requested to provide the APVMA with an annual summary of adverse experiences by no later than 30 September each year for the preceding financial year. The APVMA encourages submission of more frequent PSURs, on a quarterly or biannual basis.
The annual summary can be submitted using a variety of formats –?.CSV or spreadsheet files are preferred. Should you require a form to facilitate the submission of PSURs, please visit the forms page?on our website or?contact the AERP.
5. More information
Contact details for specific areas of the APVMA are available online.
5.1. Privacy statement
Your personal information is protected by law, including through the Privacy Act 1988 and the Australian Privacy Principles (APPs).
Personal information (within the meaning of the Privacy Act 1988) in these reports are collected for the purpose of providing feedback to the APVMA?about the safety, quality and effectiveness of agricultural chemicals and veterinary medicines (agvet?chemicals). All reports are retained by the APVMA electronically.
The APVMA will limit the collection, use and disclosure of personal information for what is necessary to undertake the APVMA’s functions. Individuals providing information to the APVMA have the option to do so anonymously or by using a pseudonym unless the APVMA is required or authorised by or under an Australian law, to deal with individuals who have identified themselves. Without the collection of certain information, the APVMA may be unable to assess the safety, quality and effectiveness of relevant agvet chemicals, and whether the adverse effect is associated with the use of a registered chemical product.
The APVMA is required by law to publish certain information about adverse experience reports, including annual reports. No personal information is included in these publications.
The APVMA may disclose your report to Australian, state or territory government agencies, the holder of the product(s) registration or active constituent approval, or any other relevant third party (for example, expert witnesses) contracted to provide advice or comments to the APVMA. These entities must not use this information for any other purpose. The APVMA is unlikely to disclose personal information to overseas recipients.
Personal information will only be disclosed where required by, or authorised under an Australian law. Information provided to the APVMA in this report is subject to the Freedom of Information Act 1982 (FOI Act) and the APVMA may be required to disclose such information in accordance with the provisions of the Act.
For queries in relation to privacy matters, you can contact the APVMA Privacy Team by email at firstname.lastname@example.org.
5.2. Annual Reports
Under regulation 1A.3(e-g) of the Agricultural and Veterinary Chemicals (Administration) Regulations 1995, the APVMA is required to publish in the Annual Report the number of adverse experience reports received; the number of adverse experience reports determined to be related to human, animal, or crop health; environment, or efficacy; and, a summary of action taken by the APVMA in relation to reports of adverse experiences. Historical summary data is available on our website.