Reporting adverse events and lack of efficacy

Davies, Heather; Noble, PJ; Pinchbeck, Gina; Killick, David; Diesel, Gillian

doi:10.1136/vr.m4287

Cited by 4 publications

(4 citation statements)

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“…Historically, electronic reporting via the PMS has not been available in the veterinary setting in the UK. Based on the results of this study, we have developed and launched an ADR reporting button for practices participating in the Small Animal Veterinary Surveillance Network (SAVSNET) project 33 . The ADR reporting button is available to clinicians at the end of every consultation and provides functionalities such as prepopulation of animal and drug information and the option to append clinical notes to the report.…”

Section: Discussionmentioning

confidence: 99%

UK veterinary professionals’ perceptions and experiences of adverse drug reaction reporting

et al. 2022

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Background: Spontaneous reporting of suspected adverse drug reactions (ADRs) is the cornerstone of pharmacovigilance. Despite this, it is believed that there is significant under-reporting in the veterinary setting. Low reporting rates delay marketing authorisation holders (MAHs) and regulators taking mitigating action in the case of safety concerns. Method: We designed a survey to explore the perceptions, attitudes and experiences of UK veterinary professionals towards ADR reporting. The survey was advertised widely through conventional and social media and at several conferences. Results: In total, 260 respondents completed the survey, including 210 veterinary surgeons, 49 veterinary nurses and one suitably qualified person. Respondents generally understood the need to report ADRs. The main barrier to reporting was the suspected ADR being well known, and the most popular potential facilitator identified was the ability to report via the practice management system. Facilitation via education in the form of a pharmacovigilance themed continuing professional development event was particularly popular among veterinary nurses, who reported time as being less of a barrier to reporting than their veterinary surgeon counterparts. Conclusions: Our findings suggest that technological interventions to facilitate reporting and empowerment of veterinary nurses to report through a tailored training event should be explored further.

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Section: Discussionmentioning

confidence: 99%

UK veterinary professionals’ perceptions and experiences of adverse drug reaction reporting

et al. 2022

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“… 1 The Small Animal Veterinary Surveillance Network (SAVSNET) at the University of Liverpool, UK has developed a solution with the Veterinary Medicines Directorate to enable veterinary practices to submit AE reports from their EMR systems. 18 , 19 , 20 There are currently 250 veterinary practices (around 450–500 individual sites) participating in a pilot study in the United Kingdom. This system is limited to participating practices; this saves time and facilitates reporting.…”

Section: Strategies For Improving Adverse Event Reportingmentioning

confidence: 99%

A survey of veterinary professionals in Sweden: Adverse event reporting and access to product safety information

Mount

Sjöström

Arthurson

et al. 2021

Veterinary Record Open

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Background Pharmacovigilance based on spontaneously reported suspected adverse events (AEs) from veterinary professionals is a powerful tool for detecting potential risks of using medicinal products. However, it is heavily dependent on the voluntary participation of veterinary professionals. Estimates suggest that over 90% of suspected AEs remain unreported. This survey was conducted to accumulate information on current practices and attitudes of Swedish veterinary professionals in relation to AE reporting and their perceptions of the accessibility of updated product safety information. Methods Swedish veterinary professionals were surveyed using a web‐based questionnaire prepared by the Swedish Medical Products Agency (SMPA). The survey included three sections with 13 questions and was distributed via several communication channels, including the Swedish Veterinary Association. Results The survey was answered by 412 veterinary professionals, including veterinarians and licensed veterinary nurses. The survey identified that most veterinarians comply with national legislation by reporting directly to the SMPA, but not all observed AEs are reported. Veterinary professionals indicated that it is important to have an easy and efficient reporting system, preferably directly from an electronic medical records system. Feedback is considered important. Veterinary nursing staff could potentially improve the reporting rate of suspected AEs in Sweden. The degree of knowledge relating to the reporting of AEs varies among professionals, thus impacting on reporting frequency. A single source of product safety information is mainly used, and improvements are required to enhance accessibility and distribution of updated product safety information. Conclusions The insight gained from this survey will be used to influence attitudes and facilitate adaptations needed to fulfil the requirements of the European Union regulations. To reduce underreporting of AEs and facilitate access to updated product safety information, various approaches are required including educational interventions, new digital reporting tools and adaption of communication strategies.

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“…Prior research by ourselves and others has suggested that alternative methods for reporting such as a mobile app or reporting directly from the PMS would facilitate reporting by enabling fast and easy reporting of sADRs (Davies et al., 2022; De Briyne et al., 2017; Mount et al., 2021). SAVSNET has developed and launched a functionality for reporting AEs directly to the VMD from the PMS for practices participating in the SAVSNET project (Davies et al., 2020). Information on the report form pre‐populates from the EHR, meaning that veterinary professionals are required to enter less information thereby making reporting more efficient.…”

Section: Discussionmentioning

confidence: 99%

Recording of suspected adverse drug reaction reporting in veterinary free‐text clinical narratives

Davies,

Blackwell,

Fins

et al. 2024

J of Small Animal Practice

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ObjectivesTo use text mining approaches to identify instances of suspected adverse drug reactions recorded in first opinion veterinary free‐text clinical narratives, and to evaluate whether these were also reported to either the Veterinary Medicines Directorate or the relevant Marketing Authorisation holder in order to derive an estimate of the suspected adverse drug reaction (sADR) minimum under‐reporting rate. To characterise sADR reports and explore whether particular features are associated with report submission.Materials and MethodsTwo regular expressions were developed to identify mentions of “adverse drug reactions” and “side effects” in the free‐text clinical narratives of electronic health records contained within the Small Animal Veterinary Surveillance Network database. Consultations containing a match for the developed regular expressions were manually reviewed for inclusion and further classified to determine the suspected product, seriousness and expectedness of the event, and an indication of whether the event had been reported. The associations between event characteristics and reporting were explored using Fisher's exact tests.ResultsA total of 10,565 records were manually reviewed from which 827 sADRs were identified. Approximately 90% of these sADRs were not recorded as reported. Suspected adverse drug reactions that were not considered “expected” were recorded as reported more frequently than “expected” sADRs. However, clinical severity did not appear to impact on whether there was a record of reporting.Clinical SignificanceThis is the first estimate of under reporting sADRs based on real world evidence from veterinary clinical records. The under‐reporting rate implied by this study highlights that further interventions are required to improve reporting rate within the veterinary profession in order to support pharmacovigilance activities and improve drug safety.

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Reporting adverse events and lack of efficacy

Cited by 4 publications

References 0 publications

UK veterinary professionals’ perceptions and experiences of adverse drug reaction reporting

UK veterinary professionals’ perceptions and experiences of adverse drug reaction reporting

A survey of veterinary professionals in Sweden: Adverse event reporting and access to product safety information

Recording of suspected adverse drug reaction reporting in veterinary free‐text clinical narratives

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