1. Pharmacovigilance updates
Promotion of pharmacovigilance
The HPRA has commenced work on the development of an online pharmacovigilance (PhV) education module for veterinarians in Ireland. Once available the module will be hosted with existing Continuing Veterinary Education modules on the UCD website. It is anticipated that the module will be available in 2019.
The HPRA participated in the first ad-hoc focus group meeting at the European Medicines Agency (EMA) at the end of 2016, which included representatives of the practising veterinary profession specialised in food-producing animals. The aim of the meeting was to consider and develop aspects for encouraging reporting of suspected adverse events (SAEs) in food-producing animals. Further focus group meetings are planned, with the first meeting due to consider poultry in Q
The EMA and national competent authorities continue to release publications to their respective websites aimed at promoting PhV and the safe use of veterinary medicinal products (VMPs). The EMA published the 2017 Veterinary Pharmacovigilance Public Bulletin at the end of Q1. The HPRA has recently published a number of safety advisory notices and it is anticipated that the annual report on SAEs for 2017 will be published by the end of Q2. The HPRA is encouraged by the increased reporting trend in recent years as presented in Figure 1 below.
Recently published guidance
The HPRA wishes to highlight that the following PhV guidance documents were adopted by the European network and published during 2017 & 2018:
Compliance monitoring – top tips
Further to today’s presentation on PhV inspections, the HPRA recommends that marketing authorisation holders focus on the following areas to ensure ongoing compliance with PhV requirements:
EudraVigilance Access Policy (open for public consultation until 27th June 2018)
PhV system
Ensure that variation applications are submitted to update the DDPS when required
It is not a requirement to name the deputy QPPV in the DDPS, therefore subsequent variation applications can be avoided if this information is omitted.
PSURs
Ensure that the ratio of SAEs is calculated in addition to the incidence of adverse reactions
Include details of databases and search terms used for literature searches
Include an electronic searchable line listing if there are more than 20 reports in the PSUR
SAE reports
Ensure that there is a reliable method in place for recording Day 0 (the first point of receipt within the company) for serious SAE reports
Ensure that all customer-facing staff receive at least basic PhV training
Ensure that there is an out of hours PhV reporting facility
Latest VeDDRA list of clinical terms
Reflection paper on non-spontaneous adverse event reports
Latest PSUR worksharing list of active substances
Updated Q&A on synchronisation of PSUR submission schemes for
VMPs authorised through national, MRP and DCP
Figure 1: Annual number of SAE reports received by the HPRA