PhD defence R.D.C. (Remy) Francisca

Summary:

Additional risk minimisation measures (aRMMs) may be necessary to minimise the risk of serious adverse events or to ensure these adverse events are recognized in a timely manner and are treated adequately. Since aRMMs were introduced, the proportion of medicines for which aRMMs were required at the time of authorisation has risen to approximately 30%. New European legislation that came into force in 2012 had no effect on this percentage, though the definition of aRMMs were altered slightly and the justification for aRMMs were changed. aRMMs were required for different types of adverse events. Noticeably, aRMMs were often required to minimise risks associated with medication errors, drug interactions and off-label use. Risks for which aRMMs are required may also become apparent after marketing authorisation. The probability of aRMMs becoming required within 10 years after authorisation was 6.9%. Conversely, aRMMs may also become unnecessary after authorisation. The probability of aRMMs becoming unnecessary within 10 years after authorisation was 8.3%. The effectiveness of aRMMs was measures using different methods and effectiveness was defined in different ways. The interpretation of effectiveness studies was challenging and most often led to a request for additional studies.