At the time of approval of new medicines, the Marketing Authorisation Holder (MAH) is required to ensure risk
minimisation measures (RMMs) are in place to avoid unnecessary harm. This is particularly important when the
medicine is a teratogen and may be used by women before or during pregnancy. One example is valproate
used for epilepsy, and off-label for migraine headaches. Children exposed to valproate during pregnancy have a
30-40% chance of serious developmental disorders and/or physical defects in 10% of cases according to the
European Medicines Agency (EMA).
Therefore, early intervention in implementing additional RMMs (aRMMs) in the form or pregnancy prevention
plans (PPPs) is essential to prevent adverse outcomes from pregnancy. The standard method of implementing
aRMMs has been through Dear Health Care Professional(DHCP) letters, additional educational materials, or
other enhanced monitoring/intervention during pregnancy. At present there is no standard guidance on when PPPs should be implemented or whether effective in practice. The research proposed will explore this in an Irish
context using three medicines of interest; valproate, thalidomide and isotretinoin. The aims are to: (i) assess the
effectiveness of the aRMMs for the three medicines, by ascertaining the knowledge and attitudes of health care
professionals (HCPs) via cross-sectional surveys and (ii) describe the trends in utilization (drug utilization study)
of the three medicines before and after the dissemination of aRMMs using pharmacy claims data. Crosssectional
surveys of three groups of HCPs (GPs, specialist consultants and registrars and pharmacists) will be
conducted in conjunction with a drug utilization study to examine the impact of the individual aRMMs on the
pattern of medicines used in Ireland. A key goal of this research will be to provide the Knowledge User, patients,
HCPs, HSE and other stakeholders with evidence on the effectiveness of these measures and steps for future
implementation.
