Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
User Safety Risk Assessment (USRA) - Part of the overall Risk / Benefit Assessment of veterinary medicinal products (VMP) in Europe
Jürgen Blömer (Abschlußjahr: 2012)
Language: English
The special situation of VMP is that they are need to be administered by owners, veterinarians or farmers. On the human side the patients mostly take the medicinal product on their own and only in special cases like babies, really ill or old people the products need to be administered by other people. The benefit risk evaluation for VMPs is even harder than on the human side because the risks for the animal patient and also the risks for the human user have to be considered. This is the special challenge of the USRA for VMPs and affords a lot of experience of the people involved. There is a need for clear guidance to improve the quality of the assessment and to avoid misunderstandings between sponsors, authors of the USRAs and the regulators.Following aspects should be taken into consideration while doing the USRA: Hazard identification and characterisation, exposure, risk characterisation, risk management and risk communication. Following resources can be used: pharmacological studies, toxicity studies, microbiological safety studies, target animal safety studies and pharmacovigilance data. As a result and in order to achieve a safer use of VMPs possible risks and safe handling approaches should be stated in the product information. The following information should be contained: Special precautions to be taken by the person administering the medicinal product to animals; special precautions for storage, special precautions for the disposal of unused medicinal products or waste materials, if any.
To provide guidance and advice on USRA a guideline on user safety for pharmaceutical veterinary medicinal products has been published by the CVMP, through its Safety Working Party. The newest revision of the guideline is published by the EMA and came into effect in October 2010 and provides clearer guidance and advice on the procedures for User Safety Risk Assessments, laying out a strategy and reasonable approaches, without being overly prescriptive. The presentation outline of the USRA makes more sense and will provide a better story. The guideline applies to all Marketing Authorisations for pharmaceutical veterinary medicinal products including renewals and variations that have an impact on user safety.
Due to the public bulletins published by authorities the majority of reported events results from exposure to topically administered products for use against parasites (approximately 50%) or they are caused by accidental self-injection by practitioners or owners during vaccinations or other administration of injectable products (approximately the remaining 50%). The main adverse events occuring are Eye irritation, Pruritus and Nausea. Rather unspecific symptoms like tachycardia, diarrhoea, indisposition and headaches are reported to occur following recognition of the unwanted application.
The intention of the USRA is to address the hazards and related risks of a VMP, and to recommend risk management and risk communication measures which should ensure safe use, minimise risks and hence reduce the number of ADRs in humans related to the use of VMPs. Any new information may influence one of the steps of the USRA and results in a modification, an addition to the product labelling or in a refusal of the marketing authorisation. Post marketing Pharmacovigilance activities are important to detect rarer effects and should ensure a positive benefit-risk profile of medicines used under field conditions and make their use even safer than at the time of authorisation, by taking into account the real life experience and adapting the conditions of use accordingly.
If there are the same conditions for the generic product than for the reference product there should be no need for a self-standing USRA to avoid unnecessary costs and unharmonised product literature due to different outcomes of the assessment. The safety expert working group outlined the user safety for veterinary drugs as a potential new topic. The aim should be a harmonised guidance document for all participating countries in order to achieve a harmonised approach and avoid extra costs for authorities and industry.
Pages: 47, Annex: 1, Pages 54