ISPE Releases Drug Shortages Prevention Plan At Annual Meeting

By Ed Miseta, Chief Editor, Clinical Leader

ISPE has released its Drug Shortages Prevention Plan at a media conference held during its annual meeting at Caesars Palace in Las Vegas. Present at the conference were new president and CEO John Bournas, strategic advisor John Berridge, and Drug Shortage Prevention Plan leaders Joe Famulare, Paul D'Eramo, Donna Gulbinski, and Sam Venugopal.

The plan is being billed by ISPE as a holistic view from root cause to prevention. It was developed as part of a multi-association initiative launched in response to a request from the European Medicines Agency for a plan aimed at preventing future drug shortages due to manufacturing and quality issues. It builds on the results of ISPE's 2013 Drug Shortages Survey that found manufacturing quality issues to be a major cause of drug shortages.

The framework proposed by the Task Team features six dimensions: Corporate Culture, Robust Quality System, Metrics, Business Continuity Planning, Communication With Authorities, and Building Capability. The following is a summary of each of the six dimensions:

Corporate Quality Culture

This dimension highlights the importance of organizations fostering cross-functional ownership of quality. It stresses that quality not be viewed as a hindrance to success, but as an absolute necessity to make decisions that best benefit patients. Companies should have a compliant quality system that drives the overall quality of the product throughout its lifecycle by focusing on cross-functional cooperation, management controls and problem escalation, and communication and transparency.

Robust Quality System

This dimension highlights the ability of the company's quality system to integrate applicable GMP regulations and complements ICH Q9. The plan proposes structuring the approach to developing strategies across a few key elements, including governance, culture, management controls, improvements to overall production, and process-related factors that contribute to shortages.

Metrics

The plan describes metrics as measures put in place to determine the performance of the quality system and other operational elements, such as supply chain and culture. Case studies in this section help illustrate how shortages might be avoided by defining and implementing a well-defined set of metrics across the organization. Cases explored a company's ability to:

• Integrate both supply chain and quality systems-related metrics to create more visibility into operational performance and identify potential risks
• Develop and use a series of risk assessments, metrics, and simulations to determine the amount of reserves necessary to protect against shortages
• Use a reliability room to predict risks across the supply chain consistently and efficiently

Business Continuity Planning

This dimension explores how companies can establish supply chains that are robust, redundant, and resilient to ensure continuity. Solutions developed in this section revolve around achieving robustness, building redundancy across the supply chain, and identifying mechanisms to test and monitor potential issues in the supply chain that could lead to a shortage.

Communication With Authorities

This dimension examines what companies can do to improve communication with regulatory agencies across the globe. It notes messages should be consistent and transparent and has a goal of reducing manufacturing downtime caused by a compliance driven supply disruption. It looks at the role of regulatory agencies and managing abnormal restrictions in supply.

Building Capability

The final dimension summarizes the capability needs required in order to realize for each of the elements described in the Drug Shortages Prevention Plan. The capabilities discussed revolve around training, learning, knowledge management, and mentorship.

With the plan now complete and available on the ISPE website, the work can now begin that will make drug shortages short and rare. "The 2013 Survey provided clear evidence that mitigating shortages required a holistic approach that includes organizational aspects—people—as well as technical aspects of process and production and understanding risks and the signals that a drug shortage may be possible," says Francois Sallans, VP and chief quality officer of Johnson & Johnson and chair of the Drug Shortages Task Team. "We hope companies will use the plan as a toolbox from which they can select the drug shortage prevention tools most appropriate for them."

Famulare closed the media conference by noting the plan is complete. It is now time to start looking at solutions and moving forward.  

For more information and to download a copy of the Drug Shortages Prevention Plan, click here.