Airplanes and medications seem like items that don’t mix well. In fact, the discussion of a recent webinar suggests otherwise, at least as it relates to risk management. Captain Ben Berman shared experiences from his role as former Chief of Major Investigations of the U.S. National Transportation Board in which he served as a member of the major accident go-team responsible for safety studies about flight crew human factors.
The airline industry has established a standard for user (passenger) safety that may be unsurpassed. Airline carriers, employees, regulators, and manufacturers have collaborated (sometimes begrudgingly) during the past decades to create a very high standard of performance and a “failure is not an option” culture. This is sensible considering the fact that failures have a high probability of leading to catastrophic consequences.
Those of us involved in mitigating the risks of medications may be able to learn from the pathway towards success (there is still improvement to be realized) that the airline industry has pioneered. Here are some early behaviors that we may follow.
- Use science-based methods to assess risks and proactively model system performance. Risk assessment methods such as failure modes and effects analysis (FMEA) have proved to be useful in both the airline industry and in medication safety risk management. Only rarely has prospective modeling been used to estimate the effectiveness of REMS, but this is a promising opportunity.
- Conduct systematic analysis of feedback from real-life performance. The NTSB provides this type of feedback for major failures, but there are examples of airline employees providing real-time essential feedback that improves safe operations. In pharmaceuticals, we need to implement REMS with an orientation toward managing the program for optimal effectiveness. This requires ongoing evaluation of program operation to determine ways to continually make progress toward goals. We recommend the establishment of a REMS Effectiveness Management Process.
- Use procedural safeguards. Checklists and procedures are essential safety practices for pilots and other airline employees. Recent studies have demonstrated the utility of such methods in the delivery of medical care.* We should consider building these types of tools into risk mitigation programs. But we also need to remain cognizant that any such tools need to be designed collaboratively with end users to make sure they are actually feasible.
- Operate above the regulatory bar. Regulatory standards are important for assuring a minimum level of user safety. But the ultimate arbiter of the acceptable safety standard is the user community. Airline passengers would not accept the airlines operating at merely the required regulatory standards; they have higher standards in many areas. Likewise, patients may not accept the risk mitigation standards specified by FDA in REMS. In some cases, we may need to operate beyond the minimum level required by regulatory standards.
To find out more, please view the webinar at www.paragonrx.com/experience/webinars. We would appreciate your feedback and thoughts on the topic and the webinar. Please post a comment below to let us know what you think.
*Haynes, A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population. NEJM. January 29, 09