(Management Case Study) Leveraging Data to Guide Efficient Drug Shortage Management, Mitigation, and Strategy on an Industry-Wide Level

This activity qualifies for live CPEL℠ recertification credit.

Purpose: Objective analysis should drive drug shortage management and strategy. Objective perspective can deter misinformation which can lead to a worsening or new shortage. In addition, objective analysis allows for more efficient and effective resolution of a shortage. This session will analyze real-world examples of effective rapid response in the abrupt Akorn Pharmaceuticals shut down and Pfizer Rocky Mount Plant disruption, as well as a proactive approach to shortage mitigation by analyzing an existing gap and call to action regarding Bacillus Calmette-Guérin (BCG) live vaccine and include perspectives from an analytics subject matter expert and a frontline, institutional pharmacy leader.

Methods: A multi-organizational and disciplinary Rapid Response Team (RRT) was formed after the abrupt closure of Akorn Pharmaceuticals and has continued providing industry guidance in disaster and emergency disruptions such as the Pfizer Rocky Mount plant disruption.

In an industry first, drug supply chain disruption analysis and guidance were completed on an industry-wide level. Members of this team include front-line clinical expertise, institutional and organizational leadership, analytics, marketing, and communications. A response and best practices diagram and operating procedures have been developed after this exercise and have allowed for industry-wide collaboration and communication. These procedures have advanced rapid response time from a 3-week response to 3-days, from time of event to publication of disruption brief and mitigation strategies.

The results of this process have been shared to multiple industry stakeholders, executive leadership, and have even been presented at the White House in an effort to push industry-wide best practices for collaboration and transparency in relation to drug shortage identification and mitigation.

The results, shared below, and subsequent evolution of the RRT should serve as a template for all stakeholders for developing an objective-based analysis for drug shortages. In addition, these processes have allowed for a proactive approach to drug shortage identification and existing market gaps and have led to successful advocacy with Bacillus Calmette-Guérin (BCG) live vaccine.

Results: The RRT was formally recognized and operationalized and now serves to provide rapid, industry-wide guidance for all sentinel-event relating to drug supply chain. Roles of key stakeholders and members of the team were defined and a protocol has been developed and deployed for all current and future event surveillance, assessment, and action.

A process diagram outlines the steps of the RRT, which are categorized as situational background, quantitative analyses, and clinical assessment, mitigation, and communication. A multidisciplinary team has been established composed of analytics, clinical, governmental relations, public relations, and communications subject matter expertise and clear roles have been established.

Additionally, processes have been developed for activation of rapid response versus a proactive, situational monitoring, or advocacy response. A continual process improvement process has also been developed for analysis after every sentinel-event.

Conclusion: An objective and organized approach to market surveillance, assessment, and action can lead to efficient and effective drug shortage response and strategy. Objective analysis paired with effective communication within a Rapid Response Team allows for industry-wide transparency and informed inventory management and drug stewardship while mitigating potential for protective purchasing or the unintentional cause of a worsening or new shortage.