Frances (Fran) M. Zipp, President of Lachman Consultant Services, Inc. and Member of ISPE Board of Directors

Serving as a member of the pharmaceutical industry is a privilege that brings with it significant personal responsibility. In recent years, preventing and mitigating drug shortages has become a critical concern for every pharmaceutical professional. ISPE is leading an international effort to understand, assess, and educate patients, providers, regulators, and manufacturers on this critical topic.

ISPE’s most recent contribution in this key area has been the development of a new product based on its 2013 Drug Shortages Survey and 2014 Drug Shortages Prevention Plan (DSPP). The ISPE “Drug Shortage Assessment and Prevention Tool” focuses on prevention and practical application to help industry assess its preparedness for mitigating drug shortages. The tool was circulated to key constituents on 31 August 2015 for initial review and comment.

Background

The DSPP developed as a result of discussions with regulatory agencies centered on providing proposals to address the prevention of drug shortages. A key focus emerged from these conversations that was shared by both industry and regulatory agencies such as US Food and Drug Administration, Japan’s Ministry of Health, Labour, and Welfare, and Health Canada: All agreed on the need to move from questioning key reasons for shortages to implementation of best practices. The DSPP, released in October 2014, was a global cross-industry effort.

To construct the Good Practice Tool, ISPE drew upon industry feedback from both the DSPP and its 2013 Drug Shortages Survey. The main objectives were as follows:

• Provide a holistic view of vulnerabilities within industry operations and supply chains
• Present recommendations for improvement
• Develop a framework by which industry could develop strategies and practices for each of the DSPP’s six dimensions

Using the Tool

The intent is for industry to use this tool as a means to achieve its desired state. It is essentially a gap analysis of current operations and the desired state for each of the DSPP’s six dimensions:

• Corporate culture
• Robust quality system
• Metrics
• Business continuity planning
• Communication with authorities
• Building capability

The tool consists of a background followed by a series of questions designed to facilitate examination of corporate practices linked to drug shortages. Many of the questions cannot be answered with a simple yes or no; they require analysis that will help determine what ISPE refers to as “maturity level indicators.” These are scored on a scale of 1 to 5, where 1 is the least mature and 5 is the most.

Once gaps are analyzed, the tool can help organizations assess their drug shortage preparedness, facilitate improvements, and increase supply reliability using a five-step process:

1. Commit to a shortage-prevention culture
2. Use the ISPE Good Practice Tool
3. Remediate
4. Embed as a part of the corporate culture
5. Engage with stakeholders (including regulatory authorities) to inform them of the changes implemented

Step 1 is self-explanatory: Without senior management commitment to address supply disruptions and improve supply chain robustness, the organization will struggle to reach its full potential in preventing shortages.

Step 2 is included in the Good Practice Tool, with questions designed to assess the gap between current operations and the desired state.

Step 3 uses the results from Step 2 to address vulnerabilities across the entire supply chain, from materials suppliers to contract manufacturing organizations.

Step 4 completes the internal assessment, with recommendations that should be integrated into corporate culture, including assessments from senior management that reflect success in achieving an uninterrupted supply of product.

Step 5 engages external stakeholders (e.g., suppliers, wholesalers, hospitals, regulatory authorities, etc.) in the improvement effort; this may include an update to the site master file.

Conclusion

ISPE’s new “Drug Shortage Assessment and Prevention Tool” can initiate invaluable discussions aimed at helping organizations identify their limitations, whether it be in process, governance, or skills. It can also help companies can focus their resources to reduce vulnerability to supply disruptions. The ultimate responsibility for each of us in the pharmaceutical industry is to maintain a consistent supply of critical quality medicines to patients worldwide.

ISPE will release this tool at its November 2015 Annual Meeting in Philadelphia. We hope you will join us and learn firsthand how to move discussions to practical solutions. ISPE also plans to produce training and education materials on each of the elements as we continue our commitment to this critical topic.