ISPE, the International Society for Pharmaceutical Engineering, reports it will work with stakeholders worldwide to produce a Drug Shortages Prevention Plan to guide the pharmaceutical and biopharmaceutical industry in establishing reliable, robust and resilient supply chains. The plan, which will be based on ISPE research with the input of its membership, company leaders, and regulators, will serve as a roadmap that when implemented, is intended to reduce drug shortages. The plan will address organizational strategies, such as aligned governance and communication practices, manufacturing and quality systems, and measures of supply-chain robustness and quality.
The ISPE Drug Shortages Prevention Plan will be ISPE's second major output on this topic since launching its Drug Shortages Initiative in 2012. This second phase of the initiative is aimed at addressing the root causes of drug shortages to prevent delay of supply. The ISPE Drug Shortages Prevention Plan will provide a component of ISPE input to an European multi-association task force, moderated by ISPE, which intends to provide the European Medicines Agency a proposal and plan that address the prevention of drug shortages due to manufacturing quality issues.
In 2012, ISPE formed a Drug Shortage Task Force to help stakeholders better understand the root causes of global drug shortages and to define mitigation strategies that can help prevent drug shortages. In ISPE’s initial approach, the group led a survey in 2013 that revealed multifactorial causes of drug shortages, as well as success strategies for avoiding supply interruptions
“Our research findings indicated that, while shortages are often the result of quality systems or related deficiencies, what was equally profound was that those companies with dedicated and sophisticated systems for avoiding drug shortages were clearly more successful in avoiding supply disruptions and shortages,” said Nancy Berg, ISPE’s President and CEO, in an ISPE statement. “Recognizing the impact of these success strategies motivated ISPE to develop its Drug Shortages Prevention Plan and to develop guidance on organizational strategies for drug shortages prevention, which include the engagement of company leadership and execution of governance, culture, especially a culture of quality risk management throughout the supply chain, and insightful quality metrics.”
ISPE’s Drug Shortages Prevention Plan will feature an organization and product lifecycle approach to ensuring a more reliable supply through development of company-wide drug shortages strategic plans, aligned governance, good communication, ongoing capability building (which includes training), regulatory interaction, and integrated quality systems. The development of industry-wide quality metrics is being addressed by ISPE through a parallel Quality Metrics Initiative, led by another ISPE expert team recommending to FDA and other health authorities a set of common metrics on which the health and reliability of a company’s production and quality systems and products can be assessed.