ISPE’s Drug Shortages Prevention Plan Task Team Chair provides insight on the Team’s Approach
François Sallans, Chair of the ISPE Drug Shortages Task Team, is interviewed about ISPE’s Drug Shortage Prevention Plan in the September/October 2014 issue of Pharmaceutical Engineering. In the interview, Sallans discussed the purpose of the Drug Shortage Prevention Plan and how the Task Team approached development of the plan.
Sallans describes the Task Team seeking to understand how issues identified in ISPE’s 2013 Drug Shortages Survey could be resolved. The team observed that many of the companies that focused on Information Technology (IT) or on building redundant systems had not been able to avoid shortages, and they looked into what had allowed companies that didn’t focus on IT and redundancy to be more successful in avoiding shortages. This examination led the Team to further discussions with leaders of more than 30 major pharmaceutical companies, regulators from EMA, FDA and MHRA, and from industry professionals at ISPE conferences and workshops in Europe and the US.
The resulting ISPE Drug Shortage Prevention Plan – a first for the industry – is a holistic and comprehensive approach for avoiding drug shortages due to manufacturing and quality issues by discovering true root causes and by creating and sustaining organizational cultures supported by leadership, business processes and quality systems to ensure a robust, resilient and reliable supply of medication.
Sallans states that ISPE’s Drug Shortages Prevention Plan can help companies look holistically across their entire supply chain and challenge their current processes, systems and practices to identify the potential gaps. He further describes the plan as a “toolbox” from which companies can select the drug shortage prevention tools most appropriate for them. Sallans also discusses the role of metrics and corporate quality culture in successfully avoiding drug shortages.