REPORT OF ADVERSE EXPERIENCES 1999 Executive Summary, Introduction

Executive summary

This is the fourth Annual Report for the National Registration Authority's (NRA) Adverse Experience Reporting Program (AERP) for veterinary chemicals.

A total of 107 voluntary reports were submitted to the NRA during 1999. Of these 28 were submitted by veterinarians, 11 by members of the public, 64 via manufacturers and four from other sources (eg Department of Natural Resources and Environment Victoria and NSW Agriculture).

Sixty-eight reports were treated as animal adverse experiences to veterinary chemical products, 22 human adverse experience reports, ten suspected lack of efficacy reports and seven suspected adverse experiences of crops to agricultural chemical products. No reports involving environmental damage were received involving veterinary chemical products in 1999.  

Throughout 1999 a number of issues relating to currently registered veterinary chemical products were identified by the AERP and were acted on swiftly. As a result of reports received during 1999 regulatory action was taken in a number of cases, which included:

• label changes,
• publication of articles in the veterinary literature to inform the profession on better use practices,
• investigation findings were forwarded on to the NRA's Existing Chemical Review Program (ECRP) for inclusion in review processes, and
• identification of manufacturing processes that required improvement.

A full list of all the outcomes of the program since 1995 is included in Section 1.

Of the reports involving animal reactions, the number of reports by species is outlined in Table 1.

Table 1 - The total number of adverse experience reports received by animal species

Production animals	No. reports for 1999		Companion animals	No. reports for 1999
	Animal reactions	Lack of efficacy		Animal reactions	Lack of efficacy
Cattle	19	2	Birds	3	0
Pigs	2	1	Cats	7	0
Sheep	5	0	Dogs	24	7
			Horses	3	0
			Rabbits	5	0
Total	26	3	Total	42	7

As with previous years, the majority of reports received concerned dogs and cattle, the most commonly kept domestic animals in Australia both privately and commercially.

Many of the suspected human adverse experiences were as a result of accidental exposure to products being applied to or administered to animals. See Section 1 for details of regulatory action taken as a result of these reported human adverse experiences.

INTRODUCTION 

i. Program Outline

The National Registration Authority for Agricultural and Veterinary Chemicals (NRA) is the Australian agency responsible for regulating agricultural and veterinary chemicals up to and including the point of retail sale.

Under the National Registration Scheme, the NRA evaluates and registers agricultural and veterinary chemicals and manages quality assurance programs that monitor ongoing safety and performance of registered products.

The NRA's Adverse Experience Reporting Program (AERP) is a quality assurance program that was established in January 1995 to provide a national mechanism for reporting, recording and analysing adverse experiences with veterinary chemical products, with a view to developing better use practices, preventing avoidable side-effects and aiding continuous improvement to manufacturing practices.

An adverse experience is defined as 'an unintended or unexpected effect on animals, human beings or the environment, including injury, toxicity, sensitivity reactions or lack of efficacy associated with the clinical use of a drug'. In general, adverse experiences refer to abnormalities that occur when a drug is administered at an appropriate dose rate for the purpose intended. However, often in veterinary medicine, drugs may be used that are primarily intended for use in humans or species not listed on the product labels. Limited or no information may be available on appropriate dose rates and adverse reactions in such species. For this reason the NRA also considers reports of such adverse experiences.

ii.  Reporting/ Evaluation Procedures

Procedures for dealing with adverse experience reports are as follows:

• The NRA receives adverse experience reports from veterinarians, farmers, and other users of veterinary chemical products. In the first instance, each report is referred to the product registrant (or manufacturer) for investigation and comment.
• Registrants are required to report their investigation findings and comments directly back to the AERP Coordinator.
•  In considering the submitted reports, the AERP Coordinator also:

1. researches the available scientific literature (eg. worldwide veterinary, medical and toxicological databases); and
2. examines published information from pharmacovigilance agencies in other countries (eg. the Food and Drug Administration website).

• A decision on whether the adverse experience is product-related or not (see below) is made by an in-house panel of veterinary clinicians and pharmacologists.

• Possible actions stemming from this decision may include:

1. recommendations made to the Registrant regarding certain aspects of the product (such as a label change);
2. review of the chemical under the NRA's Existing Chemical Review Program;
3. education of the veterinary profession, farming community or wider public on issues relating to use of products.

iii.  Classification of Adverse Experiences

On the basis of available information, each reported adverse experience is classified by the NRA as one of the following:

• Product related: where the NRA is satisfied that the adverse reaction, whether expected or unexpected, is related to the use of the product. Included in this group are those reactions where it is probable or almost certain that the adverse experience is related to the use of the product.

• Possibly product related: where the NRA is not satisfied that the product was responsible for the reaction but the possibility that the product was implicated cannot be excluded.

• Not product related: where the NRA is satisfied that the reaction is definitely not related to the use of the product, or there was not enough information to allow classification.

• Caused by not using the product according to label directions: where there is clear evidence of incorrect dosing or incorrect route of administration and other such causes. This category includes reactions reported after off-label use of products by veterinarians exercising their professional right to prescribe an appropriate treatment.

iv.  Report Structure

This report only discusses suspected adverse experience reports that were classified as product-related or possibly product-related.

The report is arranged into the following sections:

1. The first section of this report is a new addition since previous publications and is an overview of the program in terms of the number of reports received their sources and resulting outcomes since inception of the AERP. The section also identifies some strategies for promoting the profile of the AERP.
2. The second section contains eight tables arranged alphabetically by species. Each table shows the number of voluntary reports received during 1999 (that have been classified) for each class of product; the number of animals involved in the reports and the final classification given to the reports by the NRA. A brief discussion of the adverse experiences, by product categories, follows each species table.
3. The third section contains a table and discussion of adverse experience reports received during 1999 regarding human reactions.
4. The fourth section contains a summary table with details of all individual reports of adverse animal reactions and their final classification since publication of the 1997/98 report. The table lists each animal species in alphabetical order and is divided into sections that show for each of the products identified by active constituent, the number of animals involved, a brief description of each adverse reaction and the NRA classification of the incident.
5. The fifth section provides a summary table of all reports of alleged lack of efficacy received during the 1999 reporting period.

v. For further information

For information about the Adverse Experience Reporting Program please contact:

Peter Dagg BVSc
Phone:  (02) 6272 3651
Fax:      (02) 6271 6442
E-mail: