Investigating the reporting of adverse drug reactions using electronic healthcare records
7 June 2023
Heather Davies from the University of Liverpool received PetSavers funding for the student research project Exploring recording of adverse drug reaction reporting in veterinary free text clinical narratives. Student Emily Blackwell, whose presentation of her work at BSAVA Congress 2022 won her the PetSavers Clinical Abstract Award, describes the study.
As a 4th year veterinary medicine student from the University of Liverpool, I had the opportunity to undertake a summer research project in collaboration with the team from the Small Animal Surveillance Network (SAVSNET). We were grateful for funding from BSAVA PetSavers to support this work, which explored the recording of suspected adverse drug reactions (ADRs) within free-text clinical narratives of first-opinion veterinary practices participating in the SAVSNET project. I became very interested in research as it was something unique, new, and can have a huge impact on the profession in the future.
Project background, hypothesis and aims
SAVSNET collects free-text consultation notes in near real time from first-opinion veterinary practices in the UK. At the time of writing, over 500 veterinary sites contribute to SAVSNET, and the database contains approximately 10,000,000 clinical narratives.
The aim of the project was to determine how often suspected ADRs are recorded within veterinary consultation notes, and if such events then get reported to the appropriate regulatory authorities. Veterinary professionals and pet owners can report ADRs directly to the Veterinary Medicines Directorate (VMD), who are the regulator of veterinary medicines in the UK, or to the product manufacturer if the product holds a marketing authorization, aka license. Veterinary professionals are encouraged to report by the RCVS Code of Professional Conduct, and we know that the reporting of ADRs is vital to improve the safety profile of drugs that are frequently used in practice. Higher reporting rates allow the VMD and manufacturers to act more quickly to reduce any health risk associated with a particular product.
Based on findings in human healthcare and emerging evidence in the veterinary setting, it was hypothesized that suspected ADRs are vastly underreported.
Methods and results
We used SAVSNET as our database and employed a keyword search technique known as a regular expression to filter out records of interest. The records were then reviewed and classified into various categories, such as:
- Whether the suspected ADR was serious or non-serious
- Whether the reaction was expected or not, based on the literature
- Whether reporting to the VMD or manufacturer was recorded in the clinical notes.
We then cross-referenced a subset of these records against the VMD database to determine if the suspected ADR had been truly reported.
Both the VMD and manufacturers maintain an ADR database; periodically this information is shared. A limitation of the work was that we could only cross reference serious ADRs with the VMD database. The main reason for this was that non-serious events are not immediately shared between the manufacturer and the VMD. During the study period, non-serious events were required to be reported periodically (every few years) as part of a wider safety update report, whereas serious events had to be reported within 15 days of receipt. Time constraints of this study meant that contacting each manufacturer to obtain information regarding non-serious ADRs was not feasible.
This work was the first to directly document significant underreporting within the veterinary setting and was presented at BSAVA Congress 2022.
Relevance of the study findings
The recognition of high levels of underreporting within the veterinary sector is a call to action to improve ADR reporting rates and support more rapid mitigations against the harms caused by ADRs. SAVSNET is already evaluating the potential to use technology that makes it easier to report directly from a patient’s electronic health record. A recent survey also suggested that many veterinary professionals are interested to learn more about their role in this area. This is something that could be fed into both general practice and referral settings as all veterinary professionals have the responsibility to drive the necessary change. Improved reporting will not only benefit our patients and clients but will also lead to safer prescribed drugs and more information to give to owners about the risk of drug side effects.
Two significant challenges of achieving better reporting rates include the engagement of veterinary professionals and practices, and establishing a common understanding of what should be reported. Technically, any untoward effect that occurs after a drug is administered is reportable (as detailed in the RCVS Code of Professional Conduct), but this is an impractical ideal. For example, polyuria/polydipsia is very commonly associated with the administration of corticosteroids and is reportable under the Code but is rarely reported in reality. Enhanced guidance regarding whether veterinary professionals should continue to report all suspected ADRs or rather focus on more significant events such as serious or unexpected ADRs might help overall recording rates.
Following the completion of the summer project, I remain involved with the team and we continue to work with the VMD. Our aim is to publish the findings of our research in full and to raise further awareness of the importance of ADRs and reporting.
Overall, I thoroughly enjoyed doing the project and am very much looking forward to where we go with it next. The financial support from PetSavers allowed me to engage fully with the project and it was nice to have their backing. I would like to thank PetSavers for both their financial support and for giving me the opportunity to be involved in the research.
About the Author
Emily Blackwell is a final year student from the University of Liverpool who completed a summer research project on the reporting of adverse drug reactions. Emily enjoys all areas of veterinary with a particular interest in anaesthesia and pharmacology. Her project highlighted issues in an area that aligns with her interests and hopes to expand on the project in her future career.