Adverse event (AE) reporting is a cornerstone of veterinary pharmacovigilance, playing a vital role in safeguarding animal health, public safety, and regulatory compliance. However, while the value of AE reporting in human medicine is widely recognized and supported by robust systems, the veterinary sector still grapples with significant hurdles. These challenges impede timely, accurate, and comprehensive adverse event data collection, limiting the industry’s ability to act on emerging safety concerns.
This thought leadership article explores the core challenges veterinarians face when reporting adverse events and outlines strategies—spanning regulatory reform, digital innovation, and educational outreach—that can streamline and strengthen AE reporting practices in veterinary medicine.
Despite regulatory mandates in many regions, many practicing veterinarians remain unaware of the importance and requirements of adverse event reporting. Unlike the human healthcare sector, where pharmacovigilance training is often integrated into clinical education, veterinary curricula may not always emphasize AE reporting protocols or legal obligations.
Solution:
Enhancing awareness through continuous professional education (CPE) programs, webinars, and workshops sponsored by regulatory authorities and veterinary associations can improve reporting compliance. Additionally, embedding AE reporting modules in veterinary school curricula and certification programs will ensure that early-career professionals recognize its importance from the outset.
Veterinarians often work in fast-paced environments where urgent clinical care takes precedence. Completing detailed AE reports can be time-consuming, particularly when documentation tools are paper-based or disjointed from clinical systems. This leads to underreporting, especially of non-serious or ambiguous events.
Solution:
Adopting digital tools that integrate seamlessly with practice management systems can reduce reporting friction. For instance, electronic AE reporting platforms or mobile apps that auto-populate clinical and product data can streamline submissions, making the process quicker and less burdensome for busy practitioners.
Veterinary AEs are often more complex to define due to the variability in species response, off-label use of medications, and limited comparative data. Veterinarians may hesitate to report when the causal link between treatment and outcome is uncertain or the event seems insignificant.
Solution:
Clearer regulatory definitions and consistent guidance from agencies such as the FDA Center for Veterinary Medicine (CVM), EMA, or Health Canada can alleviate this ambiguity. Decision trees, real-world reporting examples, and AI-driven decision support tools embedded in digital systems can guide practitioners on when and how to report.
AE reporting requirements vary significantly by region. In some countries, it is mandatory for veterinarians; in others, it is encouraged but not enforced. This inconsistency not only confuses multinational veterinary organizations but also fragments global safety data.
Solution:
Harmonizing global reporting standards—guided by organizations like the World Organisation for Animal Health (WOAH/OIE) or VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products)—would standardize expectations and facilitate better cross-border data analysis and regulatory collaboration.
Many veterinarians express frustration over the lack of acknowledgment or follow-up after submitting AE reports. Without feedback, clinicians may feel their efforts are not valued, leading to disengagement over time.
Solution:
Creating a transparent feedback loop can motivate consistent reporting. Regulatory bodies and manufacturers can implement automated acknowledgment systems, dashboards showing aggregated data trends, or newsletters summarizing pharmacovigilance actions based on real-world AE reports. This fosters a sense of contribution to broader animal safety efforts.
Many current AE systems are siloed, requiring manual data entry into separate portals, which can lead to duplicate reporting, data loss, or inconsistencies. There is also a lack of real-time analytics to identify emerging signals promptly.
Solution:
Modernizing veterinary pharmacovigilance systems through cloud-based platforms with built-in analytics, species-specific coding, and real-time data visualization can enhance data quality and early signal detection. Integration with IoT devices and animal health trackers may further enrich data capture.
Some veterinarians fear legal liability or reputational damage from reporting adverse events, particularly when outcomes are severe or involve off-label drug use. Others worry about relationships with pharmaceutical reps or client trust.
Solution:
Ensuring confidentiality and offering legal protection for good-faith reporting—similar to “whistleblower” protections in other sectors—can ease these fears. Transparent policies from regulatory authorities and pharmaceutical companies that clarify non-punitive responses to AE reporting are essential.
Overcoming the challenges of adverse event reporting in veterinary medicine requires a multifaceted approach. From modernizing reporting infrastructure and harmonizing regulations to educating veterinarians and fostering a transparent feedback culture, progress must be collaborative and proactive.
As veterinary pharmacovigilance continues to evolve, leveraging digital innovation and global partnerships will be key to ensuring that every adverse event—no matter how minor—is an opportunity to improve safety outcomes for animals, humans, and ecosystems alike.
Cloudbyz offers a unified, cloud-based veterinary vigilance platform built on Salesforce to enable automated AE intake, real-time signal detection, and global compliance. Our solution helps veterinarians, manufacturers, and regulators streamline pharmacovigilance workflows, reduce underreporting, and make evidence-based decisions that protect animal health. Learn more at Cloudbyz Veterinary Vigilance.