SURVEY DESIGN IN THE ASSESSMENT OF THE IMPLEMENTATION OF RISK MINIMISATION MEASURES FOR MEDICINAL PRODUCTS
Author(s)
Prieto L*;Hidalgo-Simon A, Arlett P European Medicines Agency, London, United Kingdom
The introduction of the risk management plan (RMP) has ensured greater proactivity to the pharmacovigilance and post-authorisation benefit risk assessment of human medicines. An RMP may include risk minimisation measures (RMM), public health interventions intended to prevent the occurrence, or reduce the impact of adverse drug reactions associated with the exposure to a drug. The new EU legislation on pharmacovigilance explicitly requires the active monitoring of the outcome of RMM, placing obligations on regulators and industry for this purpose. In this respect, the European Medicines Agency’s good pharmacovigilance practices module dedicated to the practical implementation of the legislation on the evaluation of the effectiveness of RMM foresees a dual evidence approach. This approach builds on the assessment of two distinct levels of evidence: the actual implementation of the RMM, and the attainment of its final objective(s). The approach requires research encompassing analysis of implementation (process indicators), and traditional epidemiological research addressing the attainment (final outcome indicators) of RMM. Surveys are usually involved in the assessment of process indicators, in particular when RMM imply the provision of educational information to healthcare professionals (HCP) and the surveys are intended to measure what the HCP have learned. This paper aims to conceptualise the construction of surveys designed for the analysis of implementation of RMM. Such surveys should be developed following the principles of content validation. This requires a body of relevant questions (items), the sample population to which it will be administered, and a test plan. The test plan includes the type of items to be used, the number of items, the length of administration, how it is to be administered, and how it is to be scored and analysed in terms of item difficulty and discrimination. The paper concludes with a checklist to assist stakeholders in designing surveys for RMM assessment purposes.
Conference/Value in Health Info
2013-11, ISPOR Europe 2013, The Convention Centre Dublin
Value in Health, Vol. 16, No. 7 (November 2013)
Code
PRM243
Topic
Methodological & Statistical Research
Topic Subcategory
Confounding, Selection Bias Correction, Causal Inference
Disease
Multiple Diseases