Risk Management, RMPs, and REMS

Evaluation of Risk Minimization Measures

GVP Module XVI

What does EMA say in GVP Module XVI?

The European Medicines Agency (EMA) “Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimization measures: selection of tools and effectiveness indicators,” (Rev. 1) dated April 15, 2014, states that additional risk minimization measures/activities beyond those considered to be routine (such as labeling, pack size/design, and legal status) may be necessary to mitigate a risk if those measures are considered essential and are approved by the competent authorities. Additional risk minimization tools are constantly evolving and may include Dear Healthcare Professional communications, educational materials, controlled distribution systems, controlled access programs, and pregnancy prevention programs. Effectiveness of additional risk minimization measures must be evaluated to establish whether or not the intervention has been effective in meeting its objectives and, if not, the reason(s) and whether corrective actions are necessary.

What Risk Minimization Evaluation should be conducted?

Evaluations should be performed for each risk minimization tool and for the risk minimization program as a whole within 12-18 months after initial implementation (as an example of a suggested interval) and in conjunction with marketing authorization renewal. Evaluations should include 1) process indicators, which provide evidence that the implementation steps of the risk minimization measures have been successful, 2) outcome indicators, which provide an overall measure of the level of risk control achieved, and 3) determination if the risk minimization measures have had unintended negative consequences.

How can ParagonRx help?

ParagonRx uses robust, proven methods to assess the effectiveness of tools and programs associated with additional risk minimization measures in order to satisfy regulatory compliance and medical safety requirements in accordance with GVP Module XVI. Assessment capabilities include, but are not limited to, process indicators such as evaluating whether provision of information and guidance reached the target population, assessment of clinical knowledge and drug utilization studies and/or surveys to assess clinical behaviors, as well as outcome indicators such as post-authorization safety studies to evaluate the frequency and/or severity of adverse reactions in relation to drug exposure in a non-interventional setting.