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

ABSTRACT

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.

KEYWORDS:

• Risk minimisation measures
• risk management
• effectiveness evaluation
• pharmacovigilance
• educational interventions

Declaration of interest

The authors are employees of OXON epidemiology which provides research services to the pharmaceutical industry in therapeutic risk management. There are no conflicts of interest to declare directly relevant to the subject matter or materials discussed in the manuscript. A Rubino was a scientific administrator to the European Medicines Agency 2010-2015. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Disclaimer

While we endeavour to ensure that the information provided is correct, OXON Epidemiology is not responsible for any errors or omissions, or for the results obtained from the use of this information. It should not be relied upon as an authoritative statement of the law or as a source of legal advice. OXON Epidemiology will not be held liable for any loss, damage or inconvenience arising as a consequence of any use of information provided.

Additional information

Funding

This paper has not been funded.