Risk Management Plans: reassessment of safety concerns based on Good Pharmacovigilance Practices Module V (Revision 2)—a company experience

Table 2 Risk Minimization Measures for risk management planning

Activity
*Routine RMMs beyond standard clinical care*^a
• Performing a test before the start of treatment • Monitoring of laboratory parameters during treatment • Monitoring for specific signs and symptoms • Adjusting the dose or stopping the treatment when adverse events are observed or laboratory parameters change • Performing a wash‐out procedure after treatment interruption • Providing contraception recommendations • Prohibiting the use of other medicines while taking the product • Treating or preventing the risk factors that may lead to an adverse event of the product • Recommending long‐term clinical follow‐up to identify delayed adverse events in early stages
*Additional RMMs*^b
• DHPCs • Educational programs/materials for healthcare professionals and/or patients (e.g., administration guide, checklist for prescribing, patient card, patient educational leaflet) • Controlled access programs • Controlled distribution systems • Pregnancy prevention programs
*Evaluation of RMMs*
• RMMs included in the RMP should be re-evaluated periodically • Effectiveness of RMMs should be assessed in accordance with GVP Module XVI (see Table 1) [7]

DHPCs Direct Healthcare Professional Communications, GVP Good Pharmacovigilance Practices, RMMs Risk Minimization Measures, RMP Risk Management Plan
^aOnly routine RMMs that recommend specific activities/steps that go beyond what is already integrated in standard clinical care qualify for inclusion in the RMP (e.g., treatment protocols or clinical guidelines)
^bSome additional RMMs (e.g., patient cards, controlled access programs, pregnancy prevention programs) might need to be retained for the lifetime of the product

ISSN: 2055-0294