Regulatory policies, education and training in veterinary pharmaceutical sciences

Abstract

The responsibility to provide high-quality pharmaceutical care for animal patients challenges pharmacist knowledge regarding indications, dosages and drug administration. The aim of the study is to develop a regulatory and an academic framework in veterinary pharmaceutical sciences. The methodology is divided into two parts. In Part I three questionnaires were developed and disseminated to veterinary surgeons, pharmacists and pet owners to identify the perception of the role of the pharmacist in animal care and challenges of access to medicines. Data generated from the questionnaires was used to design a training programme validated using a modified e-Delphi method, for pharmacists. In Part II the regulatory framework for veterinary medicinal products was analysed by comparing Directive 2001/82/EC, Regulation (EU) 2019/6 and Directive 2001/83/EC. A separate questionnaire to identify the resources required by a National Competent Authority (NCA) to assess veterinary medicinal products, to provide medicines information and to collaborate with other entities was disseminated to EU NCAs that regulate veterinary medicinal products. Respondents from Part I consisted of 21 veterinary surgeons, 92 pharmacists, and 232 pet owners. Seventeen veterinary surgeons prescribed human medicines for use in animals because the veterinary medicinal product needed was not available. Pharmacists were perceived as unprepared to safely dispense and provide advice for medication use in animals by 61 pharmacists, 16 veterinary surgeons and 122 pet owners. Pharmacists (n=68) and veterinary surgeons (n=16) agreed that pharmacists should be trained in veterinary pharmaceutical sciences. Pet owners (n=171) would be more willing to ask a pharmacist for advice if they can be sure that the pharmacist is knowledgeable. The developed validated training programme consists of three main areas, namely veterinary disease states, veterinary pharmacotherapy, and regulation of veterinary medicinal products. In Part II, the analysis of the legal framework showed that the requirements for the dossier for human and veterinary medicinal products are similar. Respondents included ten NCAs. Seven NCAs had a dedicated department, with varying areas of expertise, for veterinary medicines. One NCA indicated that the staff worked in an integrated manner with both veterinary and human medicines. Training for assessors was provided by six NCAs. A proposal for the setup of a support office within a regulatory entity specialised in human medicines to include the assessment of veterinary medicinal products and medicines information in its remit was developed. The trust in the pharmacist taking an active role in animal care could be improved in the fifty-two percent of veterinary surgeons and fifty-three percent of pet-owners who had reservations. Trained pharmacists should strengthen their role with veterinary surgeons and pet owners. Interdisciplinary collaboration provides the best care for animal patients and improves access to safe and effective medicine. The analysis of the regulatory framework and the reflection of the questionnaire for NCAs provides a basis to support the establishment for a support office within an entity specialised in human medicines to include veterinary medicines. Pharmacists should be the drivers to enact change as illustrated in the veterinary-pharmacy bicycle paradigm where trained pharmacists combined with a robust regulatory framework will help in achieving excellence in veterinary services.