26 Apr 2024
Analysis – believed to be the first of its kind – of more than 10,000 SAVSNET records by academics at the University of Liverpool identified around 800 individual incidents.
Allister Webb
Job Title
Image: © Onchira / Adobe Stock
Researchers have issued a “call to arms” after a new study indicated around 90% of suspected adverse drug reactions (sADRs) in animals currently go unreported.
The finding is based on analysis – believed to be the first of its kind – of more than 10,000 SAVSNET records by academics at the University of Liverpool, which identified around 800 individual incidents.
Around 70% of the identified reactions in the paper, published in the Journal of Small Animal Practice, were said to be “expected”, while almost three-quarters (74%) related to dogs.
But the researchers believe the findings should be the basis for greater vigilance by both clinicians and regulators.
Lead author Heather Davies said: “It has long been thought that adverse drug reactions are under-reported.
“This work used real world evidence from first opinion practice to be the first publication that confirms this suspicion.
“As adverse drug reaction reporting rate is directly linked to the regulators’ ability to mitigate safety issues, this paper is a call to arms encouraging all veterinary professionals to report suspected adverse drug reactions and regulators to make reporting quicker and easier.
“It also the highlights the promise that big real-world data sets hold in enhancing drug safety monitoring processes.”
The study, which received funding from BSAVA Petsavers, the Veterinary Medicines Directorate (VMD) and the Wellcome Trust, examined incidents recorded over a period of more than seven years, between April 2014 and July 2021.
Out of 827 sADRs identified in the paper, 41 (5%) were classed as severe, although veterinary professionals were only said to have reporting incidents in 39 (4.7%) of the cases.
In a further 54 instances (6.5%), veterinary professionals recorded an intention to submit an sADR report or a direction for a colleague or the pet owner themselves to do so, leading to a minimum non-reporting level of 89.8%.
Known reporting levels were found to increase to 7.8% and 7.3% respectively where reactions were classed as either unexpected or severe respectively, and the paper suggested overall non-reporting rates were of a similar level to those previously found in research on the issue within human health care.
But it also found that none of the reactions described as “side effects” were reported – a trend that the researchers suggested showed “a general acceptance that some sADRs are inevitable”.
They added: “There is a clear requirement for measures that improve the reporting of sADRs and AEs [adverse events] in veterinary medicine.
“Initial steps that could be taken towards this would be to improve the education surrounding pharmacovigilance and understanding of impact that it has.
“This is particularly true in the case of ‘expected’ sADRs whereby continuous monitoring can aid the detection of certain predispositions.”
Another avenue for reform lies in the revised Veterinary Medicines Regulations (VMRs), which were laid before Parliament last month and most recently debated in the House of Lords on 18 April.
The updated rules include a new requirement for all adverse events to be reported within 30 days. The previous regulations only required serious incidents to be reported within 15 days.
Co-author David Killick said improved definitions and terminology in the revised rules “will help support professional guidance on reporting activity”. Prof Killick added that work to deploy informatics, including AI, to identify adverse events in veterinary records also has significant potential to expand current activity.
