Although the pathway to report adverse events is clear for approved drugs and vaccines, it is less clear for EPA-registered
insecticides and parasiticides (the EPA has a limited role in veterinary adverse event reporting), some biological products,
dietary supplements, diagnostic procedures, and medical devices. In contrast to drugs or vaccines, no federally mandated postmarket
surveillance program exists for these products in veterinary medicine. Further, manufacturers are not compelled to share adverse
event reports collected from practitioners or clients. Thus, adverse event reporting for these products will require practitioner
demand for agencies that not only collect the information but allow its review in a user-friendly fashion by practitioners.
Through emerging molecular biology techniques, the last two decades have enjoyed a stunning improvement in the understanding
of the pathophysiology of diseases in people and animals. Although the one medicine concept is commonly embraced at the molecular
level, the clinical application of such information must be applied to a population of the target species at risk. It is at
the point of clinical application that the one medicine concept begins to fail.
By definition, clinical research must be implemented in the target species, precluding extrapolation of data from other species.
Accordingly, it is practitioners' responsibility to help investigators translate basic research in the clinical arena, whether
through participation in clinical trials or adverse events reporting. It is only through these types of clinical research
that new medical knowledge critical to the maintenance and improvement of high-quality patient care will continue to emerge.
Dawn Merton Boothe, DVM, MS, PhD, DACVIM, DACVCP
Department of Anatomy, Physiology, and Pharmacology
College of Veterinary Medicine
Auburn University, AL 36849
1. Woods D, Thomas E. Frequency, types and severity of preventable adverse events in children. Abstr Acad Health Serv Res Health
Policy Meet, 2002.
2. Gurwitz JH, Field TS, Harrold LR, et al. Incidence and preventability of adverse drug events among older persons in the ambulatory
setting. JAMA 2003;289(9):1107-1116.