Effectiveness of Risk Minimization Measures to Prevent Pregnancy Exposure to Mycophenolate-Containing Medicines in Europ

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ORIGINAL RESEARCH ARTICLE

Effectiveness of Risk Minimization Measures to Prevent Pregnancy Exposure to Mycophenolate‑Containing Medicines in Europe Terri Madison1 · Barbara Donner2 · Roger Mutter2 · Roberto Mingrino2 · Giuseppe Alvaro2 Published online: 28 September 2019 © Springer Nature Switzerland AG 2019

Abstract Introduction  In 2015, the European Medicines Agency (EMA) requested additional Risk Minimization Measures (RMM), consisting of a Direct Healthcare Professional Communication (DHPC), a Guide for Healthcare Professionals (HCPs), and a Guide for Patients, to prevent pregnancy exposure to mycophenolate-containing medicines. Objectives  This study assessed the effectiveness of the additional RMM for any mycophenolate-containing medicine among prescribers of these products in Europe. Methods  A cross-sectional survey was conducted among prescribers of mycophenolate-containing medicines in five European countries via the administration of 19 questions checking knowledge levels for the key messages included in the additional RMM. Results  Of 79,783 invitations sent to potential prescribers of mycophenolate-containing medicines, 295 HCPs accessed the survey, giving an overall response rate of 0.4% (range 0.1–8.6%). A total of 231 prescribers were included in the primary analysis. Knowledge levels for 15 questions was fair (50 to