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U.S. Department of Health and Human Services

Animal & Veterinary

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Electronic Adverse Drug Event Reporting Goes Global

By FDA Veterinarian Staff

In May 2010, FDA and the National Institutes of Health (NIH) launched the Safety Reporting Portal, a new Web site that gives consumers and regulated industry a way to electronically report information to the U.S. government.  Ultimately, portal users will be able to report a variety of safety and health information, but one of the first uses is for adverse drug event reporting.

An adverse drug event, also called an adverse drug experience or ADE, is an undesired side effect associated with the use of the drug, or a lack of a desired effect (the drug does not do what it is supposed to do).  A drug company that makes and sells an FDA-approved animal drug is required to report to CVM all adverse events that occur with the drug.  CVM encourages veterinarians and animal owners to also report ADEs to the drug company and to CVM. 

The Beauty of Technology

With the launch of the Safety Reporting Portal, drug companies can now submit ADE reports online.  The portal standardizes the reporting system to ensure that the ADE reports contain enough information presented in a usable format.  The portal also automatically enters incoming data into the ADE database, so CVM analysts no longer have to manually enter the data, a process that can take several months.  Another valuable tool of the Safety Reporting Portal is that it allows users to attach documents, and even images, to more thoroughly describe the reported ADEs. 

Drs. Margarita Brown and Glenn Peterson, both in CVM’s Office of Surveillance & Compliance, helped develop the Safety Reporting Portal.  They note that companies that previously mailed paper ADE reports can now provide this information electronically.  Only Internet access is needed. 

The safety portal helps CVM analysts identify problems with animal drugs faster and with more precision.  This means better protection of animal and human health.   

Global Impact

Pharmacovigilance is the science of detecting, analyzing, and preventing ADEs.  Using pharmacovigilance, CVM officials monitor adverse events reported for animal drugs in the United States and abroad. 

Dr. Lynn Post, director of CVM’s Division of Surveillance, chairs the VICH Pharmacovigilance Expert Working Group.  Drs. Brown and Peterson also represent CVM on the group.  One of the goals of the Expert Working Group is to standardize the process for ADE reporting across member countries. 
 

VICH stands for International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Products.  VICH is a trilateral program of the European Union, Japan, and the United States.  The program, coordinated by the OIE (World Organization for Animal Health), was formed to harmonize the guidelines for animal drug studies among participating countries.

 

In June 2010, the Expert Working Group met in London and approved three guidelines on ADE reporting.  The newly approved guidelines specify:

  • what data are needed for an ADE report (VICH Guideline 42);
  • the terms to describe ADEs, also known as the dictionary (VICH Guideline 30); and
  • the requirements for transmitting data electronically (VICH Guideline 35).

Each member country will review the VICH guidelines for likely adoption.  In the United States, the new process of reporting ADEs through the safety portal will eventually comply with the VICH guidelines, according to Drs. Brown and Peterson.   

When all member countries fully implement the new VICH guidelines on ADE reporting, drug companies and regulatory authorities across the globe will have a faster, more accurate, and easier way to share data about adverse events associated with animal drugs.
 

Members of the VICH Pharmacovigilance Expert Working Group:

  • FDA’s CVM
  • The European Medicines Agency
  • The Animal Health Institute
  • The International Federation of Animal Health
  • The U.S. Department of Agriculture (USDA) Center for Veterinary Biologics
  • Japan Ministry of Agriculture, Forestry, and Fisheries
  • Japan Veterinary Pharmaceutical Association
  • An individual from Australia/New Zealand, as an observer
  • An individual from Health Canada, as an observer