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ISPE Drug Shortage Initiative Supports Global Efforts to Understand Drug Shortages

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,” said Nancy S. Berg, ISPE President and CEO.

Over the past several months, ISPE’s Drug Shortage Initiative, led by a task force of industry leaders, has been developing an anonymous survey designed to better understand the underlying issues and possible root causes regarding drug shortages.

By design, the ISPE task force has limited the scope of this unique survey 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 recognizes that there are many other factors that may impact the supply of drugs, including regional economic factors, differing regulatory requirements, insurance programs, and government procurement procedures. However, given ISPE’s technical expertise, the ISPE task force determined that this drug shortage survey was not the appropriate tool to examine these issues.

ISPE’s Drug Shortage Survey, which will be distributed in February 2013, will include questions probing the following areas: (1) Underlying Root Causes of Drug Shortages, (2) Company Strategies to Prevent or Alleviate Drug Shortages, and (3) Regulatory Bodies: Ability to Prevent / Help Avoid Drug Shortages. ISPE expects preliminary results to be available in June 2013.

ISPE believes that the anonymous survey data will provide the pharmaceutical industry and global health authorities with much needed scientific data 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.

ISPE also will take this critical drug survey data and 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. We look forward to learning more about drug shortages through our Drug Shortage Survey and sincerely appreciate your thoughtful participation,” said Berg.

About ISPE

ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA and offices in Brussels, Belgium, Singapore and Shanghai, China. Visit www.ISPE.org for more information.

About the International Leadership Forum

The International Leadership Forum (ILF) is a global advisory group of pharmaceutical manufacturing, development, engineering and quality executives working through ISPE. The ILF is dedicated to providing leadership and direction on critical technical issues facing the industry, aligning the industry globally, establishing dialogue with regulators to discuss critical technical issues, identifying opportunities for innovation, promoting consistency and seeking worldwide harmonization where appropriate. Visit www.ISPE.org/Community/International-Leadership-Forum for more information.

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