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 regulatory members in 90 countries, 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.

ISPE began its drug shortages initiative in support of several global regulatory outreaches, including:

  • FDA Workshop on Approaches to Addressing Drug Shortage in 2011
  • Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012
  • EMA reflection paper on Medicinal Product Supply Shortages caused by Manufacturing/Good Manufacturing Practice Compliance Problems in 2012
  • EMA workshop in 2013

The ISPE Drug Shortages Team focuses on 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:

  • Insufficient manufacturing capacity, exacerbated by industry consolidation, leading to fewer firms making a 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.

“ISPE’s Drug Shortages Prevention Plan is part of a significant and continuing effort since 2011 to ensure a safe, quality and reliable drug supply,” said ISPE President and CEO John Bournas. “We owe patients a sense of security by meeting their expectations for a reliable and continuous supply of the medications that are so important to them and their families. When members of the pharmaceutical industry discover and put to work the valuable insights included in the Plan, particularly those promising to strengthen the integrity of the supply chain and those describing how to place a greater emphasis on end-to-end quality, a real difference can be made in the lives of patients.”

Through its Drug Shortages Initiative, ISPE will also leverage its international network to lead industry-regulator collaboration regarding drug shortages through meetings and conferences.

Download the Frequently Asked Questions about the ISPE Drug Shortage Initiative ( 123 KB).

ISPE is committed to the long term resolution and management of drug shortages by offering education and training programs to support implementation and effectiveness across the entire industry.

Direct questions to Maria Robertson, ISPE Senior Director, Marketing and Communications. Maria will direct them to the appropriate Drug Shortages Task Team member if necessary.

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