ISPE
ISPE (the International Society for Pharmaceutical Engineering) 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 that provide quality medicines to patients without interruption.
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, can significantly reduce drug shortages. It will address optimal organisational strategies, such as aligned governance and communication practices, effective manufacturing and quality systems, and appropriate measures of supply chain robustness and quality. This effort addresses rising concerns around drug shortages within companies, among global health authorities, and for patients who depend on a reliable and available supply of quality medicines.
The ISPE Drug Shortages Prevention Plan will be the Society’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 2013 survey provided clear evidence that mitigating shortages requires a holistic approach that encompasses both the organisational and technical issues affecting drug manufacturing and quality.
“How much of the increasing number and severity of incidents of drug shortages within our industry are fundamentally tied to a lack of understanding, or even concern for, the risk profiles of our current supply chain structure?” questioned Andy Skibo, Regional VP, Biologics Supply, AstraZeneca/MedImmune. “I therefore welcome ISPE’s initiative to tackle the root causes of shortages for the benefit of all stakeholders — ISPE Members, industry companies, regulators and health authorities, third-party providers and patients.”
The ISPE Drug Shortages Prevention Plan will provide a key component of the Society’s input to a European multi-association task force, moderated by ISPE, which intends to provide EMA with a proposal and plan that address the prevention of drug shortages owing to manufacturing quality issues.
In 2012, ISPE formed a drug shortage task force in order 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 to this challenge, the group led a comprehensive survey in 2013 that revealed multi-factorial causes of drug shortages as well as success strategies for avoiding supply interruptions. Those companies that have adopted organisational drug shortage prevention strategies, including contemporary governance, progressive cultures and effective quality systems, were successful in the avoidance of drug shortages and supply interruptions.
ISPE’s Drug Shortages Prevention Plan will feature an organisation and product lifecycle approach to ensuring a more reliable supply of medicines through development of company-wide drug shortages strategic plans, aligned governance, good communication, ongoing capability building (which includes training), proactive regulatory interaction and integrated quality systems. The development of industry-wide quality metrics is being addressed by the Society 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.
ISPE, www.ispe.org.
For more information on ISPE’s Drug Shortages Prevention Plan, contact Carol Winfield, cwinfield@ispe.org.