TAMPA, Fla. — The International Society for Pharmaceutical Engineering on Wednesday announced that it has released a preview of its Drug Shortages Prevention Plan aimed at helping the pharmaceutical industry avoid drug shortages and maintain a reliable supply of medications.
"Our goal is that the pharmaceutical industry will use the plan not only to help them look holistically across the supply chain, but also as a roadmap to use in challenging their current processes, systems and practices and to identify potential gaps and risks," stated ISPE CEO and president, Nancy Berg. "Having the input of regulatory authorities has been invaluable to the effort because it helps to clarify what expectations regulators have regarding necessary steps toward drug shortage prevention and mitigation."
ISPE's Drug Shortages Prevention Plan was reviewed by regulators from the European Medicines Agency and the Medicines and Healthcare Products Regulatory Agency, with further regulatory review anticipated.
The plan was developed by ISPE and its pharmaceutical and biopharmaceutical industry members, and describes how industry can best prevent drug shortages from occurring by discovering root causes and through creating and sustaining organizational cultures supported by leadership, business processes and quality systems that will ensure a resilient and reliable supply of medications.
The plan was organized around a "six dimension" framework comprised of: corporate quality culture; robust quality systems; metrics; business continuity planning; communication with authorities; and building capability. In each chapter, the plan provides answers to questions posed within each of the six dimensions, and also offers "real world" case studies that illustrate how best practices can be established.
Examples of the questions answered within each framework include:
Corporate quality culture – How can organizations foster practices, values and a philosophy that require employees at all levels to subscribe to quality?;
Robust quality systems – What triggers can affect production and the integrity of the supply chain and potentially lead to a drug shortage? How can those triggers be identified and eliminated?;
Metrics – How can metrics be tailored to help identify risks and mitigate them?;
Business continuity planning – At a time when supply chains are more global and complex, how can quality and competence be assured in production, factories, materials, machines, equipment and expertise?;
Communication with authorities – How can rapid and comprehensive communication with health authorities help to prevent potential shortages before they occur, or mitigate with expedience shortages that do materialize?; and
Building capability – How can capability be built to identify the true root causes of drug shortages, train employees, improve knowledge and knowledge management, as well as strengthen employee commitment to quality?