ISPE, the International Society for Pharmaceutical Engineering, has released a preview of its Drug Shortages Prevention Plan aimed at helping the pharmaceutical industry avoid drug shortages and maintain a robust and reliable supply of medications to patients world-wide.
The plan, a first for the industry, was developed by ISPE and its expert 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 organisational cultures supported by leadership, business processes and quality systems that will ensure a robust, resilient and reliable supply of medications — many lifesaving — to patients worldwide. The introductory summary to the plan provides a first look at what is covered in the complete plan.
ISPE’s Drug Shortages Prevention Plan was reviewed by regulators from the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA), with further regulatory review anticipated.
“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,” said 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.”
The plan was developed by the ISPE drug shortages task team that built upon the results of ISPE’s landmark 2013 study on drug shortages and organised their effort 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.
Corporate quality culture — how can organisations 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 materialise?
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?
To ensure a comprehensive approach, the task team engaged with leaders from more than 30 major pharmaceutical companies and for more than a year, gathered stakeholder input from hundreds of industry professionals at ISPE’s conferences and workshops. Industry senior management, with considerable influence on organizational culture and alignment, were engaged in the process.
“One thing the task team learned from their interviews with members of industry was that quality systems can only be effective where there is a strong emphasis on a ‘corporate quality culture’ throughout the organisation,” said Francois Sallans, vice president and chief quality officer, Johnson & Johnson, and chair of the ISPE drug shortages task team. “This became clear when data from the 2013 Survey was analysed, but it became even more apparent when the team linked a quality culture to the other elements, such as metrics and capacity building. We hope companies can use the plan as a 'toolbox' from which they can select the drug shortage prevention tools most appropriate for them.”
According to Berg, ISPE’s 2013 study on drug shortages provided clear evidence that mitigating shortages requires a holistic approach that includes careful alignment of organisational aspects — people — as well as the technical aspects of process and production in understanding risks and signals indicating a drug shortage may be possible. The plan builds on this data and incorporates significant follow-up input from stakeholders on how drug shortages can be prevented.
ISPE will release the complete Drug Shortages Prevention Plan during the 2014 ISPE Annual Meeting that will be held 12–15 October in Las Vegas, Nevada, USA. The plan’s recommendations will be presented publicly for the first time at a session led by members of the ISPE drug shortages task team on 14 October.