Additional Risk Minimization Measures
Most safety concerns are sufficiently addressed by routine risk minimization measures (RMM). Careful consideration should be given to whether the risk minimization objectives could be reached with routine measures, and only in that case when they are not considered sufficient, it should be considered which additional risk minimization measures are the most appropriate. Additional RMM should focus on important safety concerns.
PharmExpert organizes following additional RMMs to address important safety concerns:
– Educational materials;
– Direct healthcare professional communications (DHPCs);
– Pregnancy prevention programmes (PPP);
– Controlled access programmes.
Educational Material
An educational material contains the following information elements:
- Up-to-date, objective, unambiguous and clear statements summarizing the nature of the safety concern(s). Also, the risk and outlining the specific actions are better to take by healthcare professionals or patients in order to minimize the risk and use the product safely;
- Guidance for the specific actions, e.g. on the prescribing, including indication/contraindication/ patient selection, treatment duration, diagnostic testing, therapeutic monitoring, product handling, preparation for administration, administration, switching to another treatment, or when to seek medical attention in the case of signs or symptoms indicating a possible adverse reaction;
- Reference to the SmPC or the PL whenever possible; in the case of digital educational materials, these could refer to the SmPC or PL through a hyperlink.
Direct Healthcare Professional Communications (DHPCs)
DHPC is a safety communication tool that may also serve as an additional RMM. It is appropriate to consider the DHPC in situations where it is important to inform timely all relevant healthcare professionals of a risk and actions to take for risk minimization.
Pregnancy Prevention Programmes (PPPs)
PPP is a set of tools that aims at minimizing exposure to a medicinal product during pregnancy. It is relevant to take into account the situations where the product has teratogenic effects.
Typical objectives of a PPP are to:
- Avoid that female patients are pregnant when starting the treatment; and
- Avoid that female patients become pregnant during and, if relevant, for a specific period after stopping treatment;
- It is better to avoid the male patient becomes the father of the child during and, if relevant, for a specified period after stopping treatment.
Additional Risk Minimization Measures Demo-Procedure
Controlled Access Programmes
A controlled access programme is a tool or set of tools that seeks to control access to a medicinal product beyond the level of control applied to medicinal products by means of routine RMM. It may restrict the time period of validity of a prescription. Also, it is able to restrict the maximum prescribed amount in a single prescription, or require a visual reminder as part of the labelling of the outer packaging.
Controlled access programmes considered and applied only in exceptional situations of an important safety concern. Usually it is the concern with a severe impact on the patient or the (unborn) child exposed in utero. Also in cases of a significant public health impact, taking into account the nature of the risk and the likelihood that this risk cannot be managed by other RMM.
