Good vigilance practice in pregnancy: A multistakeholder approach to optimising the effectiveness of risk minimisation measures to prevent harms from teratogenic medicines

When new medicines are approved for use in the general population the drug company responsible for the medicine has to make sure that certain measures are in place to avoid unnecessary harm. These are known as risk minimisation measures (RMMs). This is particularly important when the medicine may cause harmful effects to an unborn child when a medicine is taken before or during pregnancy. One example of such a medicine is valproate which is used in epilepsy. Children exposed to this medicine during pregnancy have one third (30%) chance of serious developmental effects and one in ten chance of some physical defect. Therefore, preventing or limiting the use of these medicines during pregnancy or protecting against pregnancy is essential to prevent adverse outcomes. There are standard methods for getting the information on the use of these medicines during pregnancy out to those prescribing or dispensing them. This includes sending out letters on the risks during pregnancy, educational materials, or extra monitoring during pregnancy. 
Our research will look at: (i) how well this information is made available and used in Ireland, using surveys to prescribers and pharmacists, and (ii) whether the information changes prescribing of these medicines to women in practice, using the data from all claims made by pharmacists over time (drug utilisation study). Three main medicines will be examined including: valproate (used for epilepsy), thalidomide (used for a form of blood cancer starting in the bone marrow) and isotretinoin (used for a skin condition). A key goal of this research will be to provide evidence on how well the measures to prevent adverse outcomes from the use of these medicines during pregnancy are received and used by prescribers and pharmacists and provide next steps for improving this.

Award Date
20 April 2018
Award Value
Principal Investigator
Professor Kathleen Bennett
Host Institution
Royal College of Surgeons in Ireland
Applied Partnership Awards