- November 23, 2020
- Posted by: Manoj Swaminathan
Medicinal products that are authorised for use in animals are called Veterinary Medical Products (VMP). Medicated feed is a mixture of animal food and veterinary medicinal product produced under controlled conditions. This has the purpose of treating or controlling disease in farmed animals, aquaculture species and pets. By far, medicated feed is the most effective medicine delivery to animals.
Like human beings, animals too can experience an adverse reaction. There is quite a lot of similarity between the Pharmacovigilance requirements for VMP as against those meant for human use. If a human being experiences an adverse event with a VMP, it is termed a Human Adverse Reaction, and one may need to expedite such reports within 15 calendar days, even if non-serious.
The concept of ICSR may or may not be relevant in the case of Veterinary Pharmacovigilance, where one can consider grouped case reports when a particular set of species experiences the same event and probably at the same time.
Traditional safety databases may not support managing data for VMP. However, there are Vet safety databases available in the market. One may consider these only if the data cannot be managed in excel or in case the ADE volumes are huge.
Countrywise Veterinary Pharmacovigilance Requirements – Click Here
In EU/EEA, the VGVP Modules are referred to for Pharmacovigilance purposes, while in US, CFR 514.80 is referred to.
The following concepts may still be applicable in the case of Pharmacovigilance for VMPs, depending on the local requirements:
1. QPPV and Back-up
2. Pharmacovigilance System Master File
3. PSUR, Signal Management, Risk Management
4. Literature Monitoring
5. Safety Variations and Urgent Safety Restrictions
6. Safety Data Exchange Agreements (including distributor audits)
Reporting Case Reports
One may consider using a gateway for reporting Vet Cases. There is an EVVet portal in EU/EEA and a Safety Reporting Portal in Safety Reporting Portal in Safety Reporting Portal in Safety Reporting Portal in Safety Reporting Portal in the US.
Causality assessment for VMPs is slightly different. This follows the ABON System.
Category A: Probable.
Category B: Possible.
Category O: Unclassifiable/Unassessable (events where insufficient information was available to draw any conclusion).
Category O1: Inconclusive (events where other factors prevented a conclusion being drawn, but a product association could not be discounted).
Category N: Unlikely to be product related.
Companies that find this complex may consider hiring Vet consultants. Off-Label use is not uncommon in case of VMPs and one can even find overtly caring owners/ caretakers. Product complaints are not uncommon with VMPs. Like human products, one can even expect inspections for VMPs. At times these can even be unannounced/ triggered. Hence one cannot disregard Pharmacovigilance compliance.