Chapter 3Performance management report

Strategy 4: Seek and use stakeholder feedback to inform regulatory activities

The APVMA encourages feedback about the quality and performance of registered pesticides and veterinary medicines in the field where they may have had an adverse affect on people, animals, the environment, or trade in produce from crops or animals treated with these chemicals.

The Adverse Experience Reporting Program (AERP) is the main mechanism for the APVMA to receive and consider stakeholder feedback on adverse experiences relating to the use of registered pesticides (agricultural chemicals—AERP Ag) and veterinary medicines (AERP Vet). These two programs provide post-registration surveillance loops that help facilitate responsible marketing and management of registered pesticides and veterinary medicines throughout their life.

The objectives of AERP Ag and AERP Vet are to provide the APVMA with feedback about the quality, safety and efficacy of registered pesticides and veterinary medicines in the field. This information helps to ensure that the APVMA’s registration decisions are appropriate. The programs help promote and maintain public confidence in the National Registration Scheme.

The AERP considers adverse experience reports relating to:

  • animal health issues, including both domestic and native animals
  • damage to crops and plants
  • human health issues, where people are exposed to pesticides or veterinary medicines
  • lack of efficacy
  • residue issues
  • environmental damage.

Adverse experience reports are often considered with the consultation of various operational areas within the APVMA as well as with other relevant Australian, state and territory government departments, product registrants, monitoring agencies in other countries and recognised subject experts.

During 2010–11, the APVMA assessed and classified 2764 reports of suspected adverse experience related to pesticides and veterinary medicines. This is 38 per cent more than the adverse reports processed and classified in the previous year. This year, 72 per cent of reports were finalised within 90 days from the date of their receipt. The AERP continued to provide surveillance feedback to various areas of the APVMA in order to assist in making compliance, registration, review and licensing decisions.

AERP Vet

AERP Vet is widely used by veterinary surgeons, owners, members of the public and product registrants to report suspected adverse experiences involving veterinary medicines. During 2010–11, of the adverse experience reports assessed and classified, 2686 involved veterinary medicines. Numerous enquiries were also received from veterinarians and members of the public. Of the veterinary adverse experience reports, 76 per cent involved animal safety, 21 per cent involved lack of efficacy, and 3 per cent involved human health issues (Figure 5).

Figure 5: Percentage of various types of adverse reports involving veterinary medicines—processed and classified by the Adverse Experience Reporting Program, 2010–11

Figure 5: Percentage of various types of adverse reports involving veterinary medicines—processed and classified by the Adverse Experience Reporting Program, 2010–11

Permethrin toxicity in cats

Permethrin spot-ons are registered as flea treatments for use only on dogs. A cooperative project between the APVMA, the Australian Veterinary Association, and product registrants has led to the development of new label warnings that clearly indicate that permethrin spot-on treatments are safe to use on dogs but toxic to cats. The label warnings were developed following industry-funded market research, which aimed to better understand consumer attitudes to permethrin spot-on products and to test more effective warning messages for inclusion on all permethrin spot-on products. Registrants are currently in the process of updating their labels to include the new label warnings. Participants in this initiative are now looking into developing a consumer awareness and educational campaign designed to focus attention on the new warning labels as they become available.

An article describing this initiative was published in the Australian Veterinary Journal (January/February 2011 issue: ‘World-first initiative tackles permethrin toxicosis in Australian cats’).

A registrant of an injectable veterinary antibiotic voluntarily withdrew the product from the market in view of a number of adverse experience reports resulting from the use of the product. AERP Vet coordinated this withdrawal by assessing and classifying the reported adverse experiences.

AERP Ag

In 2010–11, the APVMA assessed and classified 78 adverse experience reports related to agricultural chemicals. The APVMA also responded to enquiries received from members of the public. Adverse experience reports involving effects on crops or target areas accounted for approximately 63 per cent, lack of effect for 6 per cent, environmental or non-target effects for 1 per cent, and human adverse experiences for 30 per cent of the reports (Figure 6).

Figure 6: Percentage of various types of adverse reports involving agricultural chemicals—processed and classified by the Adverse Experience Reporting Program, 2010–11

Figure 6: Percentage of various types of adverse reports involving agricultural chemicals—processed and classified by the Adverse Experience Reporting Program, 2010–11

Several suspected environmental, human and animal health adverse events have been considered with assistance from state and territory authorities. Specific chemicals could not be identified in a number of off-target spray cases. The environmental reports related to off-target spray drift are considered as part of the APVMA’s Spray Drift Review program to consider regulatory control for a range of chemicals that are applied by spraying.

Noosa Fish Health Investigation Task Force

The Noosa Fish Health Investigation Taskforce was established by the Queensland Minister for Primary Industries and Fisheries in January 2009 to investigate problems with fish health at a private fish hatchery near Noosa. The Taskforce published its report in June 2011. The report contains five recommendations for the APVMA. The APVMA is currently considering the report’s recommendations.

Review of registrant reporting component of AERP Ag

The report of the review of the registrant component of the Adverse Experience Reporting Program for agricultural chemicals (AERP Ag) was finalised and published in December 2010. This work was undertaken to address a commitment made by the APVMA in the regulatory impact statement, which was prepared at the initiation of AERP Ag.

Initiative—focused communication with stakeholders improving reporting quality

The AERP undertook focused communication to encourage reporting individuals to report suspected adverse experiences using AERP’s newly released reporting form. One of the aims of introducing this simplified reporting form is to receive reports containing clear and relevant information. Moreover, during the year, the product registrants were also provided with detailed advice on how to improve the quality of information provided in the annual summaries submitted to the AERP and how minimising redundancy will help to augment the accuracy of record keeping.

As a result of this multifaceted campaign, less than 30 per cent of adverse experience reports required subsequent clarification from the reporting persons or entities.

Information publication activities

For public awareness, the AERP published the Report of Adverse Experiences for Veterinary Medicines and Agricultural Chemicals 2009 in December 2010. Subsequently, a number of internal and external enquires in relation to the publication were answered.

An article about AERP Vet and a reporting form were also published in MIMS IVS Annual (2011). The inclusion of this information in this widely used reference therapeutic listing is a key initiative to improve awareness of practicing veterinarians about the AERP.

Participating in international regulatory efforts

This year, the AERP hosted and provided training to a staff member of the Malaysian National Pharmaceutical Control Bureau to assist the Malaysian Adverse Drug Reactions Advisory Committee with its new program of post-market monitoring of registered veterinary medicines.

The AERP also liaised with a range of international regulatory agencies of the European Union, the United Kingdom, the United States and New Zealand to ensure that the adverse information published by the APVMA is optimal and comparable to these agencies.

Promotional activities

The AERP aimed to further promote and improve the visibility of the program as a useful feedback mechanism to monitor APVMA’s regulatory decisions. To achieve this, AERP staff participated in field days, attended relevant conferences, presented an informational session to a group of visiting university students and continued to strengthen networks with appropriate business representatives, academic and health professionals.

The APVMA also continued to encourage adverse reporting and enhance public awareness through the networks of members of the APVMA’s Community Consultative Committee (CCC). A member of the APVMA’s CCC undertook a range of activities to promote the AERP to rural audiences including students, agricultural workforce and employees of various organisations.

To undertake one of the operational objectives to engage with the training sector, the AERP liaised with the relevant academics of a number of university programs in veterinary sciences. This activity aimed to enhance the curriculum content pertaining to reporting adverse experiences in Australia.

The AERP staff augmented their skills and knowledge by completing courses in 2010–11.

During the year, the AERP also made progress on a number of other important projects. Examples are,

  • compiling an in-house AERP staff training manual
  • developing a guide to undertake reporting incidence analysis
  • initiating a periodic AERP newsletter
  • streamlining in-house AERP query requisition processes.

These projects could not be completed due to resource constraints and are therefore ongoing.

Consultative committees

The APVMA has a number of consultative committees representing the community, government, rural industries and the chemical industry. Further information on the activities of these committees is provided in Appendix C.

Initiative—implement processes for regular performance reviews of consultative and liaison committees

During 2010–11, the APVMA worked with the Community Consultative Committee, the Industry Liaison Committee and the Registration Liaison Committee to develop and implement a process for regular performance review as relevant to the terms of reference and objectives of the committees.

Public consultation policy implemented

An interim public consultation policy was developed to streamline and formalise how the APVMA conducts consultations. The policy recognises that there is no one-size-fits-all approach to public consultations and that each opportunity should be considered on a case-by-case basis. The policy governs the timeframe for consultations, where consultation opportunities should be published, and how to communicate with affected and interested stakeholders.

Ninety per cent of public consultations have been undertaken in line with the policy since its implementation on 1 January 2011. A final public consultation policy is scheduled for completion in 2011–12.

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