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In February 2013 the International Society for Pharmaceutical Engineering (ISPE) collaborated with health authorities and different sectors of the pharmaceutical industry in its initiative regarding the prevention and mitigation of drug shortages.  As a first step, ISPE’s Drug Shortages Initiative Task Force developed a comprehensive electronic survey aimed at professionals working in the pharmaceutical industry.

The intent of the anonymous survey was to better understand the underlying issues and possible root causes of drug shortages.  With well over 100 items in several branches of inquiry, the survey was complex and time-consuming.  ISPE understood that an instrument of this nature would possibly reduce the number of responses, but the Task Force believed enough data would be generated to ensure a representative sample from key subgroups. The benefits of this comprehensive look at the possible underlying causes of drug shortages where believed to far outweigh the downside of the survey’s length.

Review the survey questions here ( 477 KB).

ISPE believes that any effort to effectively address this complex and multi-faceted public health problem

• requires close technical collaboration and clear communication between the pharmaceutical industry and global health authorities and
• should include an appropriate examination of the underlying 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 the shortage of a company’s specific drug.

With this in mind, ISPE limited the scope of the survey to the technical and GMP compliance related issues the ISPE Task Force suspected might be contributing to drug shortages. ISPE recognized 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. While out of scope for this survey, the survey instrument made allowances for respondents to add free text comments so they could be considered in interpreting the survey results. As part of its ongoing analysis of the survey data, ISPE will refer to the comments for various items to provide context for understanding the quantitative results and to assist in crafting/defining the scope for any future projects resulting from this first phase of the initiative.

ISPE believes that the data from this first Drug Shortages Survey has the potential to provide the pharmaceutical industry and health authorities with much needed data to support additional discussion and development of different risk-based approaches to mitigate and prevent drug shortages.

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