Teratogenic Risk Impact and Mitigation (TRIM): Study Protocol for the Development of a Decision Support Tool to...

Area of Science:

• Pharmacovigilance and Drug Safety
• Regulatory Science
• Reproductive Toxicology

Background:

• Preventing prenatal exposure to teratogenic medications is crucial for public health.
• Current Risk Evaluation and Mitigation Strategy (REMS) programs for 11 teratogenic drugs in the US may not target the most impactful medications.
• The public health impact of teratogenic medications lacking REMS is not well-defined.

Purpose of the Study:

• To develop an innovative decision support tool for prioritizing teratogenic medications for risk mitigation.
• The tool will utilize explicit, quantifiable criteria for evidence-based prioritization.
• Facilitate informed regulatory decision-making regarding teratogenic drug safety.

Main Methods:

• A national panel will develop the Teratogenic Risk Impact and Mitigation (TRIM) tool using a modified Delphi approach.
• Multi-criteria decision analysis and discrete choice experiments will determine criteria weights.
• TRIM scores will be calculated for 24 teratogenic drugs (12 with REMS, 12 without) identified via claims data, assessing prenatal exposure prevalence.

Main Results:

• The TRIM tool provides a systematic framework for evaluating teratogenic medications.
• Quantifiable criteria and estimated weights will be applied to assess risk impact.
• TRIM scores will be generated for drugs with and without existing REMS programs.

Conclusions:

• The TRIM tool offers explicit, quantifiable, evidence-based criteria to inform regulatory decisions on teratogenic medication risk mitigation.
• TRIM scores can serve as benchmarks for evaluating existing and new teratogenic medications for REMS implementation.
• This approach aims to enhance the effectiveness of regulatory risk mitigation strategies for teratogenic drugs.