2nd Quarter 2007

A Risk Minimization Action Plan: What Is It?

By Jim Shamp

A Risk Minimization Action Plan (RiskMAP), as defined by the FDA, is a strategic safety program designed to meet specific goals and objectives in minimizing known risks of a product while preserving its benefits. iPLEDGE, which is for isotretinoin (Accutane®), is an example of a safety program with a RiskMAP. Isotretinoin is used to treat severe acne (benefit) but causes severe birth defects if taken during pregnancy (risk).

The first step in developing a RiskMAP is defining the program's goal. For example, the goal of iPLEDGE is to minimize fetal exposure to isotretinoin. The second step is to translate the goal into measurable objectives for the program. The objectives for iPLEDGE are to prevent a pregnant woman from starting therapy and to prevent a woman on therapy from getting pregnant.

To achieve the objectives, RiskMAPs use tools from three categories:

• targeted education and outreach,
• reminder systems, and
• performance-linked access systems.

Targeted education and outreach tools are used to increase the knowledge and modify the behaviors of key people, like doctors and patients, who have the ability to minimize the drug's risks. Examples of tools in this category are "Dear Healthcare Professional" letters, training programs, and medication guides.

Reminder systems are used to prompt or remind involved individuals of the risks and steps that should be taken to reduce the risk of a product. Reminder systems are usually used in conjunction with targeted education and outreach tools. A consent form signed by both the patient and doctor is an example of a reminder system.

Performance-linked access systems link drug access to the existence of evidence that specific actions have been performed, such as laboratory testing. These systems are usually considered burdensome by involved individuals and have the potential to disrupt patient care.

The final step in developing a RiskMAP is designing the evaluation plan. The evaluation plan is used to measure how well the RiskMAP is achieving its goals and objectives. The tools must be adjusted or changed if a RiskMAP is not achieving the goals and objectives.

The iPLEDGE program employs tools from all three categories to achieve its goal and objectives.

Contact Covance today to help address your product safety objectives with a progressive Risk Minimization Action Plan.