ISPE Study Reports on Root Causes for Drug Shortages

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ISPE study reveals quality systems of manufacturing as the leading cause of drug shortages.

The International Society for Pharmaceutical Engineering (ISPE) has released results of a recent survey that find manufacturing quality systems to be the leading cause of drug shortages. The report states that factors resulting in drug shortages “are multi-factorial, often resulting from issues within the quality systems, which can be affected by key aspects of organizational governance and the quality of interactions with regulatory authorities.”

ISPE’s 2013 Drug Shortages Survey, part of the organization’s Drug Shortages Initiative, was sent to industry professionals and companies and was created to identify the technical, engineering, quality, and regulatory issues impacting drug shortages. Key findings cited in the survey were problems with manufacturing quality systems that included issues with aseptic processing equipment involved in the manufacture of sterile drugs. Respondents indicated that companies that had avoided supply shortages had an organizational focus on strong quality systems aimed at ensuring compliance. Lack of regulatory-company interaction was also cited as a problem. Respondents believed the quality of interaction with regulators could be improved.


“This survey reveals many new opportunities for ISPE to lead and support the industry in further dialogue around process improvements that may support drug shortage mitigation while also advancing our collective understanding of the causes of drug shortages,” said Nancy S. Berg, ISPE president and CEO in a press release. “We look forward to working with our members and regulatory and industry partners to build global solutions for ensuring a reliable supply of medicines. While this study and its findings are significant for the industry and regulatory authorities, it is equally important for each of us individually; after all, as patients, we count on having the medicine we need.”