About The ISPE Drug Shortages Initiative

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The prevention of drug shortages is critically important to public health. As a not-for-profit global organization with both industry and regulator Members in 90 countries, the International Society for Pharmaceutical Engineering (ISPE) is uniquely positioned to facilitate communication between the different sectors of the pharmaceutical industry and global health authorities as it seeks to understand and address this complex problem.

“Any effort to effectively address the complex and multi-faceted issues contributing to drug shortages requires close technical collaboration and clear communication between the pharmaceutical industry and global health authorities,” says Nancy S. Berg, ISPE President and CEO.

Beginning in late 2012, ISPE’s Drug Shortage Initiative, led by a task force of industry leaders, has been working on ways to better understand the root causes and possible mitigations for drug shortages.

As a first step, the Task Force developed an anonymous survey seeking the input of pharmaceutical industry professionals and companies. See About the Survey for more information about the survey instrument and the questions we asked.

By design, the ISPE Task Force has limited the scope of its work to the technical, scientific, manufacturing, quality and compliance issues associated with a company’s supply chain and related to its ability to source, manufacture, and distribute products that have resulted in drug shortages. For example, consider the following areas of concern:

  • Insufficient manufacturing capacity, exacerbated by industry consolidation, leading to fewer firms making the product
  • Product quality issues that result in temporary or permanent halting of production
  • Lack of secure, consistent availability of active ingredients, components, containers, or closures of suitable quality, even reagents for quality control tests, which can be exacerbated by the increasing globalization of the supply chain for ingredients and manufacturing
  • Shifts in demand that arise from shortages of another drug – causing a chain reaction of shortages
  • Unexpected market outcomes from new approvals e.g. generic manufacturing capacity does not meet expectations, manufacturer of newly approved entity does not have sufficient capacity to meet market demands.

“Better understanding of the root-causes of drug shortages resulting from technical, scientific, manufacturing, quality and compliance issues is a critical step in establishing a strategy for drug shortage prevention,” Berg said.

ISPE believes that the survey data it has collected can provide the pharmaceutical industry and global health authorities with much needed information to support the development of different risk-based approaches, using modern quality systems, to mitigate and prevent drug shortages, including potential shortages in breakthrough products approved based on limited development programs.

“While the ultimate goal is to prevent shortages occurring in the first place, we will do all we can to provide strategies and guidance to those with relevant capacity to enable them to produce high quality drugs in response to a potential or actual shortage in a short timeframe,” Berg added.

Through its Drug Shortages Initiative ISPE will also leverage its international network to lead industry-regulator collaboration regarding drug shortages through meetings and conferences. In addition, ISPE will continue to work with and through the International Leadership Forum, a group of global industry leaders who gather twice a year under the auspices of ISPE to explore issues of importance to industry.

“We are immensely grateful to regulators from Europe and the United States, as well as representatives of the major European Industry Associations, for collaborating with ISPE on this important global initiative,” says Berg.

Last Update: 08 July 2013

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