Reporting Adverse Drug Events in Veterinary Practice

Ashley M. Bell, PharmD, FSVHP, DICVP, North Carolina State University

ArticleLast Updated August 20234 min readPeer Reviewed
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Pharmacovigilance refers to the science of and activities relating to the detection, assessment, understanding, and prevention of adverse drug effects or other drug-related problems.1 Because veterinary health care professionals treat a variety of species, pharmacovigilance can help ensure the safety and efficacy of drugs used in a diverse population of animals; however, finding evidence to support causality during a drug-associated adverse event in a specific species can be challenging.  

How are reportable adverse drug events defined?  

The FDA defines an adverse drug experience/event (ADE) as any adverse event (regardless of whether the event is drug related) associated with use of a veterinary drug (regardless of whether the drug was used in accordance with FDA-approved labels; see Examples of Reportable Adverse Drug Events).2 Adverse drug reactions are a subset of ADEs in which harm is caused directly by a drug, despite appropriate use. 

Is reporting adverse drug events required? 

Clinicians are not mandated by US law or the FDA Center for Veterinary Medicine to report a suspected ADE; however, the AAHA considers ADE reporting an accreditation standard, and the AVMA strongly encourages reporting an ADE. In addition, at the time of publication, the FDA recommends mandatory reporting of ADEs associated with compounded medications.3 

What is the impact of not reporting adverse drug events? 

Reporting ADEs can help provide a comprehensive understanding of these events, enhance patient care, and improve patient outcomes; however, ADEs in veterinary patients are significantly underreported. For veterinary-specific products, data outside safety studies and pre-approval clinical trials are limited, and even less information about human medications administered to veterinary patients is available. Clinical trial data are also limited due to small patient populations, short duration of the trial, or drug use in specific conditions.  

Voluntary postapproval reports are used to identify ADEs (including those that are rare or unexpected) not detected during premarket testing, manufacturing issues, and/or problems related to incorrect use.4 Information from these reports can also be used to monitor for emerging trends, investigate whether a drug can be attributed to the event, and take corrective measures (eg, necessary changes to product labels).5 Reporting medication errors can help determine the incidence and severity of these errors and identify methods to reduce future errors.6,7 

Who can report adverse drug events? 

Direct electronic report submissions to the FDA are not yet available, and completing the correct form (see Suggested Reading) can be time-consuming; however, any veterinary staff member with access to the necessary information can submit a report to the manufacturer or the FDA.   

Although reports should ideally be made by a health care professional, pet owners can also submit ADE reports using the same process as veterinary staff. 

The FDA considers all reported patient and client information private and protected by law.8 

How should adverse drug events be reported? 

The regulatory body (eg, FDA, Environmental Protection Agency [EPA]) for the drug product should be determined before an ADE is reported. As much information as possible should be provided.  

Reporting FDA-Approved Veterinary Drugs 

For FDA-approved veterinary drugs or indexed products (ie, unapproved veterinary drugs with legal marketing status [see Suggested Reading]), ADE reports should be submitted to the manufacturer. Drug manufacturers are legally required to forward these reports to the FDA. 

Reporting Unapproved Drugs 

For unapproved drugs (eg, compounded products, human products used extra-label in veterinary patients), ADE reports can be submitted via FDA form 1932a (see Suggested Reading). Reporting ADEs to the drug manufacturer or compounding pharmacy from which the product was obtained is also important to ensure the safety of compounded products. 

Reporting Biological Products

For biological products (eg, vaccines), ADE reports should be sent to the US Department of Agriculture Center for Veterinary Biologics (see Suggested Reading).  

Reporting Environmental Protection Agency-Regulated Products

For products regulated by the EPA (eg, flea and tick products), ADE reports can be submitted to the EPA. Products regulated by the EPA have an EPA registration number on the back of the package (see Suggested Reading). 

How can submitted data be accessed?   

The FDA Center for Veterinary Medicine provides quarterly reports related to veterinary drugs and devices (see Suggested Reading); however, finding applicable reports can be a challenge. The manufacturer can provide insight into previous reports while current reports are being submitted.  

The Adverse Veterinary Events website, which queries the FDA database, can provide an easy method of searching for ADE reports.9