For most drugs, current required risk minimization procedures, such as product labeling, are sufficient. However, some drugs may have certain safety risks that warrant additional precautions. For such drugs, the FDA and EMEA recommend implementing risk minimization programs, also referred to by the FDA as risk minimization action plans (RiskMAPs). Depending on when certain risks are identified, the need for a RiskMAP may be realized either before or after a drug is on the market. If your drug requires a RiskMAP, our experts can help you design the program in a cost-effective measurable way.
When is a RiskMAP needed?
To maximize health benefits while minimizing potential drug risks, sponsors are responsible for determining when RiskMAPs are appropriate. To do so, it is important to weigh the results of the pre-approval risk assessment, gauge the preventability of potential adverse events and consider the likelihood of beneficial health outcomes. For example, a RiskMAP could be implemented to minimize teratogenic drug exposures, enhance safeguards for addictive drugs or provide drug administration training for products with non-standard handling requirements.
RiskMAP Tools
Depending on your drug’s specific issue(s), a variety of RiskMAP tools can be used to adequately minimize patient risk in the least burdensome way. These tools include:
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Targeted education and outreach campaigns to health care practitioners and patients
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Patient and physician agreement and consent processes
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Tracking requirements for physicians, pharmacists and patients
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Reminder systems, processes or forms
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Systems and processes to track or limit drug distribution
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Systems and processes to verify patient eligibility and compliance
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Real-world epidemiological safety studies by using databases, patient registries, surveys or other methods
Designing Your RiskMAP Evaluation Plan
Our risk management experts can work with you to develop a robust RiskMAP evaluation plan to ensure that you are accomplishing your health benefit and safety goals and that the tools you’ve implemented are working effectively. We can provide you the evidence you need to assess and amend your program as appropriate. We are skilled in the application of failure mode and effect analysis (FMEA) to evaluate the relative contribution of each component of your RiskMAP and determine if any need modification or elimination. Our evaluation and review services include:
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Comprehensive studies of educational materials
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Surveys of knowledge, attitudes and practice
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Prescribing compliance studies
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Retrospective database analyses
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Prospective observational studies and registries with real-time prescribing, adherence and safety monitoring
