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“Without documentation of adverse reactions we perpetuate the myth that these events are rare. In reality, however, adverse reactions to vaccines, microchip implants and other veterinary products are not rare. Adverse reactions are often misdiagnosed, they are grossly covered up, and they are rarely reported.

Please be a part of the solution -- please take the time to accurately record and report all adverse reactions, and all suspected adverse reactions.” Reporting Léon's Adverse Reaction - Lingering Questions

AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY (APVMA):

“Recording and investigating reports of adverse experiences is an important step in detecting unusual or rare conditions that were not evident in clinical or field trials and as a result, could not be assessed during the product registration process.”

www.apvma.gov.au - “Adverse Experience Reporting For Veterinary Medicines”

AUSTRALIAN VETERINARY ASSOCIATION (AVA):

“There have been sporadic reports of microchips that could not be scanned correctly or that have caused problems. Traditionally, these ‘adverse reactions’ have been reported to the company / manufacturer concerned. However, the AVA feels that this information should be collated and coordinated by the AVA as independent body.”

www.ava.com.au - “Microchip adverse reactions reporting scheme”


HEALTH CANADA:

“Health Canada monitors health and safety risks related to the sale and use of chemicals, drugs and vaccines, food, pesticides, medical devices and certain consumer products.”

www.hc-sc.gc.ca - “Adverse Reaction Reporting”

VETERINARY DRUGS DIRECTORATE (VDD):

“Once new veterinary drugs are authorized for sale in Canada, it is important to monitor these drugs and their effects while they are in more widespread use. To meet this need, Health Canada's Veterinary Drugs Directorate (VDD) formalized its pharmacovigilance program.”

www.hc-sc.gc.ca - “Adverse Drug Reactions (Pharmacovigilance)”
www.hc-sc.gc.ca - “Drug Adverse Reaction Reporting”
www.hc-sc.gc.ca - “For Your Information: Pharmacovigilance”

CANADIAN FOOD INSPECTION AGENCY (CFIA) - VETERINARY BIOLOGIC SECTION (VBS):

“The Veterinary Biologic Section (VBS) of the Animal Health and Production Division, Canadian Food Inspection Agency (CFIA) is responsible for licensing veterinary biologics in Canada.”

www.inspection.gc.ca - “Veterinary Biologics”
www.inspection.gc.ca - “Guideline for Reporting Suspected Adverse Events to Veterinary Biologics”

PEST MANAGEMENT REGULATORY AGENCY (PMRA):

“Although all pesticides are carefully tested for safety before they are registered, some adverse effects may not become evident until the general population uses a product under ‘real-life’ circumstances. By submitting a suspected incident report, you are contributing to the ongoing collection of information on pesticides after they have been registered.”

www.pmra-arla.gc.ca - “Pesticide Incident Reporting”
www.pmra-arla.gc.ca - “Fact Sheet on Reporting Pesticide Incidents”


EUROPEAN MEDICINES AGENCY (EMEA):

“The European Medicines Agency (EMEA) is a decentralised body of the European Union with headquarters in London … Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.”

emea.europa.eu - “European Medicines Agency (EMEA)”

EUDRAVIGILANCE:

“EudraVigilance Veterinary is the European data-processing network and database management system for the exchange, processing and evaluation of Suspected Adverse Reaction Reports (SARs) related to veterinary medicinal products authorised in the European Economic Area (EEA).”

eudravigilance.emea.eu.int - “Info To Public”
eudravigilance.emea.eu.int - “How to Report”
eudravigilance.emea.eu.int - “Questions And Answers On Pharmacovigilance And Eudravigilance”


AGRICULTURAL COMPOUNDS AND VETERINARY MEDICINES (ACVM) GROUP:

“The Agricultural Compounds & Veterinary Medicines (ACVM) Group is responsible for the registration of agricultural compounds and veterinary medicines, and monitoring their importation, manufacture, sale and use.”

www.nzfsa.govt.nz - “ACVM Group Overview”
www.nzfsa.govt.nz - “Reporting Adverse Events”


VETERINARY MEDICINES DIRECTORATE (VMD):

“The Suspected Adverse Reaction Surveillance Scheme (SARSS) is a national surveillance scheme run by the Veterinary Medicines Directorate (VMD). The scheme aims to record and monitor reports of suspected adverse reactions to veterinary medicines in both animals (any species) and humans.”

www.vmd.gov.uk - “Adverse Reactions”
www.vmd.gov.uk - “Adverse Reactions – Frequently Asked Questions”

BRITISH SMALL ANIMAL VETERINARY ASSOCIATION (BSAVA):

“Members of the BSAVA Microchip Advisory Group would encourage everyone to complete forms whenever problems are identified with implanted microchips in any species.”

www.bsava.com - Microchip Advisory Group (MAG)


U.S. FOOD AND DRUG ADMINISTRATION (FDA):

“The testing that helps to establish the safety of products, such as drugs and medical devices, is typically conducted on small groups before FDA approves the products for sale. Some problems can remain unknown, only to be discovered when a product is used by a large number of people.”

www.fda.gov - “How to Report Problems With Products Regulated by FDA”

CENTER FOR VETERINARY MEDICINE (CVM):

“The primary purpose for maintaining the FDA/Center for Veterinary Medicine Adverse Drug Experiences (ADE) database is to provide an early warning or signaling system to the Center for adverse effects not detected during pre-market testing of FDA-approved animal drugs and for monitoring the performance of drugs not approved for use in animals.”

www.fda.gov - “ADE Report Description”
www.fda.gov - “How To Report An Adverse Drug Experience”
www.fda.gov - “FAQs About Adverse Veterinary Drug Experiences”
www.fda.gov - “Cumulative Veterinary Adverse Drug Experience (ADE) Reports”
www.fda.gov - “Freedom of Information”

U.S. DEPARTMENT OF AGRICULTURE (USDA) - ANIMAL AND PLANT HEALTH INSPECTION SERVICE (APHIS):

“APHIS regulates veterinary biologics (vaccines, bacterins, antisera, diagnostic kits, and other products of biological origin) to ensure that the veterinary biologics available for the diagnosis, prevention, and treatment of animal diseases are pure, safe, potent, and effective. This work is done by APHIS’ Center for Veterinary Biologics (CVB) and is centered around enforcement of the Virus Serum Toxin Act.”

www.aphis.usda.gov - “Veterinary Biologics”

“An adverse event is any undesirable occurrence after the use of an immunobiological product, including illness or reaction, whether or not the event was caused by the product. For products intended to diagnose disease, adverse events refer to anything that hinders discovery of the correct diagnosis.”

www.aphis.usda.gov - “Adverse Event Reporting”
www.aphis.usda.gov - “Common Questions about Pharmacovigilance”
www.aphis.usda.gov - “Common Questions About Veterinary Biologics”
www.aphis.usda.gov - “Biologics Program Links”
www.usdoj.gov - “Freedom of Information Act (FOIA)”

U.S. ENVIRONMENTAL PROTECTION AGENCY (EPA):

“EPA is responsible for assuring that all pesticides sold in the United States do not cause unreasonable risks when they are used according to label directions and precautions.”

www.epa.gov - “Protecting Pets”

U.S. PHARMACOPEIA (USP):

“The United States Pharmacopeia has advised the AVMA it will terminate its Veterinary Practitioners' Reporting Program.”

www.avma.org - “U.S. Pharmacopeia to close Veterinary Practitioners' Reporting Program.”

Last Updated: August 2007