In 2011, the U.S. Food and Drug Administration similarly reported that quality problems, such as contamination and the presence of foreign particles, accounted for about 46% of drug shortages that year—making it the most common cause. In 2011, a record 267 new drug shortages were reported; the next year, new drug shortages were down slightly to 204, according to the University of Utah Drug Information Service.
Companies that have avoided drug shortages, the ISPE survey suggests, are ones that have invested in strong systems with senior management support, resources and incentives to mitigate shortages. They also have built redundancies into their supply-chain operations. Greater interaction with regulatory authorities—inspections, approval processes, increased communication—was also credited as helping to prevent shortages.
The ISPE solicited responses globally for its survey for five weeks beginning Feb. 20, assuring individual and company respondents of complete anonymity. Participation came from 264 individuals and companies who provided information related to an actual drug shortage, a near miss or an effective drug shortage prevention program. The organization, which includes 20,000 members working on pharmaceutical and biologic medicines and medical delivery devices, plans to perform further analysis on its findings for future reports and recommendations.
“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,” ISPE President and CEO Nancy Berg said in a 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.”
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