In our interconnected world, animals serve more than just companionship. They are vital in our food production, scientific research, and ecological balance. It is a moral obligation and an essential requirement to ensure their well-being through veterinary pharmacovigilance. This field protects the health and happiness of our beloved pets and contributes to the broader mission of sustaining a healthy planet and safeguarding human health. Not in vain, the inaugural EMA Veterinary Awareness Day aims to disseminate information about these crucial activities to a broader audience. However, the inspiration for this article comes from an intriguing case involving an adverse reaction to a medication in a cat. During our literature review, we stumbled upon a report detailing a skin problem resulting from the subcutaneous administration of furosemide. Hence, the subject of literature monitoring within the field of veterinary pharmacovigilance piqued our curiosity.
Case description: a cat’s journey
A 2-year-old cat with heart issues received hospital treatment, including oxygen, intravenous furosemide, and clopidogrel. Upon discharge from the hospital, the medical team transitioned the cat’s furosemide treatment from intravenous to oral. However, the cat experienced two episodes of lung edema recurrence within two weeks. In response, the dosage of furosemide was increased, and the method of administration was changed to subcutaneous injections. Remarkably, after two weeks of subcutaneous injections, the cat developed skin problems with ulcers and hair loss at the injection sites. These unusual skin issues were suspected to be a rare side effect of furosemide, which had not been previously observed in cats but had been documented in dogs and humans. They altered the furosemide brand to address this concern while maintaining the exact dosage and injection technique. The skin ulcers resolved within a month, and the cat experienced no further skin issues.
Annual expedition: literature monitoring in veterinary pharmacovigilance
So, what steps should be taken when encountering such a case documented in the literature? Let’s refer to the Veterinary Good Pharmacovigilance Practices (VGVP) guideline. According to VGVP, Marketing Authorization Holders (MAH) should ensure that procedures are in place to monitor publications in relevant peer-reviewed scientific journals. If the MAH becomes aware of publications in non-peer-reviewed local journals, the suspected adverse events identified in these publications should also be reported. This review should be conducted annually and, if necessary, more frequently based on a risk-based approach. Furthermore, MAH must promptly record any suspected adverse event reports identified in the scientific literature. Ensure timely reporting to the Union pharmacovigilance database by registering this information within 30 days of receipt.
Unveiling literature monitoring in UK veterinary pharmacovigilance
Per the Veterinary Medicines Directorate (VMD) guidelines, MAH must routinely scan scientific literature for any adverse events related to their products that necessitate reporting. To maintain ongoing surveillance and signal detection, MAHs should perform regular literature searches at least once a year. Initiate the search based on the active substance and narrow it down to the individual product rather than commencing with a product-specific search. While searching for ‘adverse events,’ it’s essential not to use overly restrictive search terms. Consider using alternate terms such as ‘adverse reaction,’ ‘side effect,’ ‘toxicity,’ and ‘idiosyncratic effect.’
Furthermore, it is preferred to cast a wide net by utilizing a variety of databases and search engines. Examples include CAB Abstracts, Google Scholar, Medline, PubMed, and Scopus. The MAH can tailor the choice of databases and search engines according to their discretion.
Optimizing veterinary pharmacovigilance: challenges and prospects
Regularly conducting literature searches stands as a fundamental practice in pharmacovigilance. It involves systematically searching for information on medicinal products and active pharmaceutical ingredients in published literature. Human pharmacovigilance entails monitoring the literature for each drug every week. However, in veterinary pharmacovigilance, the requirement is to perform literature monitoring at least once a year. In this context, thoroughly examine both peer-reviewed global and non-peer-reviewed literature. It’s worth noting that veterinary pharmacovigilance often faces resource limitations compared to its human medicine counterparts, making the collection and analysis of data more challenging. Nonetheless, we should anticipate its continued growth, which will likely involve increasing automation, especially in literature monitoring.