ISPE’s Drug Shortages Initiative 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.
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. For nearly a decade, ISPE has been instrumental in facilitating communication between the different sectors of the pharmaceutical industry and global health authorities related to drug shortages.
Drug Shortages News
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iSpeak BlogISPE is pleased to announce that its Drug Shortages Initiative Task Team is launching a new phase of work to focus on business continuity planning for the prevention of drug shortages. We invite your company to participate. The first activity is a benchmarking study that will launch in May 2021 and be used to assess best practices and industry accomplishments in the area of business continuity...
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Online ExclusivesAs noted in the ISPE Drug Shortages Prevention Plan,1 business continuity planning is a powerful, methodology, essential...
- 1International Society for Pharmaceutical Engineering. “ISPE Drug Shortages Prevention Plan: A Holistic View for Root Cause to Prevention.” October 2014. https://ispe.org/DrugShortagesPreventionPlan
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iSpeak BlogThe individual stories of patients—and their families—are welcome reminders to the pharmaceutical industry about just how meaningful pharmaceutical development, manufacturing, and delivery are every day to those patients and their families.
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Special ReportsWhen faced with large-scale disruptive events such as the COVID-19 pandemic, the emergency and business continuity plans of drug manufacturers and event-specific actions of health authorities may not always be sufficient to prevent shortages of critical medical products. However, early, transparent engagement with health authorities is a powerful opportunity for drug manufacturers to...
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Drug Shortage Webinars
Opportunities for Drug Shortage Prevention – Industry and Regulator Views
Webinar Presented on 30 September 2021 - It has been and continues to be critical to ensure uninterrupted supply for all essential drug products that address serious medical conditions and support emergency healthcare. This webinar has been developed in response to the increasing interest in how best to ensure continuous pharmaceutical supply. Industry and regulatory experts will reflect on the current state of drug shortage prevention and share thoughts on how we may do better.
Resolving & Avoiding Drug Shortages & the Health Crises They Create
Webinar Presented on 1 September 2020 - Drug shortages are not just a supply chain problem. They are a problem for patients. Sometimes these patients are so at risk, resolving the shortage could make the ultimate difference.
For more information, contact RegulatoryAffairs@ISPE.org.