A descriptive review of additional risk minimisation measures applied to EU centrally authorised medicines 2006-2015.

BACKGROUND

Guidance on therapeutic risk management, first released in EU in 2005, was updated in 2012-2013 with increased requirements on additional risk minimisation measures (aRMM). This study describes aRMM imposed at initial EU central marketing authorisation of medicines in 2006-2015.

METHODS

Non-generic medicines authorised between 01/01/2006 and 31/12/2015 were identified in the European Public Assessment Report (EPAR) database. Data on aRMM, including effectiveness measures were extracted, tabulated and analysed with Excel 2016 for chi-square p value estimates and linear regression modelling as appropriate.

RESULTS

The EPAR database encompassed 717 medicines, including 550 non-generic products authorised in 2006-2015. Those authorised with aRMM accounted for 26% (144/550). Yearly frequency ranged from 12% (6/49) in 2008 to 41% (13/32) in 2010, though no time-trend was detected. Antineoplastic/immunomodulating products were the most prevalent (26%, 38/144). All aRMM consisted of educational interventions, mostly targeting physicians/nurses (96%, 139/144). Patients were targeted in 50% of instances (72/144). Effectiveness evaluation was limited to 31% (44/144) of medicines, though an accelerated increase by year was detected.

CONCLUSIONS

Through 2006-2015, aRMM were imposed to approximately a quarter of EU centrally authorised medicines. No time-trends were observed. Updated regulatory guidance did not appear to impact frequency of aRMM, type of interventions, or target population, however, further investigation is required. Effectiveness measurements, though increasing in time, remained limited to a minority of instances.