ISPE Drug Shortages Prevention Model: Guidance for Drug Shortage Prevention Excellence
Published 2023, 24 pages
The ISPE Drug Shortages Prevention Model serves as a guide to help prevent drug shortages by providing quality, regulatory, and technical recommendations for the pharmaceutical manufacturing industry. The ISPE Drug Shortages Task Team developed the model as a follow up to the ISPE Drug Shortages Prevention Plan that was released in 2014. The model provides expanded guidance that reflects the new insight and best practices that have emerged in the past several years.
Drug Shortages: An Exploration of the Relationship between U.S. Market Forces & Sterile Injectable Pharmaceutical Products
Published 2017, 43 pages
As part of their ongoing commitment to patients, ISPE and The Pew Charitable Trust, supported by PricewaterhouseCoopers, conducted a collaborative research project to understand the market forces and other dimensions which impact companies’ decisions over how they react to potential or actual shortages. The study examined the relationship between manufacturing, supply chain and US market forces and how they contribute to the shortage of sterile injectable products. The study also assessed the elements that influenced the decisions companies made to reduce future shortages.
Published 2015, 71 pages
The ISPE Drug Shortage Assessment & Prevention Tool provides manufacturers across the spectrum of the bio/pharmaceutical industry with methods to locate current and future inconsistencies across the pharmaceutical manufacturing supply chain. By using this tool, manufacturers will mitigate problems before they arise allowing them to provide an uninterrupted supply of safe, quality medicines to patients worldwide. The tool will assist manufacturers in evaluating their current processes, systems and practices and assess the risks in the six different dimensions compared with a ‘desired state’ as described in the ISPE Drug Shortages Prevention Plan. In addition to analyzing potential gaps in their organization supply chain, use of the tool will also help manufacturers prepare for any questions a regulator may ask concerning their ability to avoid a potential drug shortage or manage an actual shortage.
Drug Shortages Prevention Plan
Published 2014, 100 pages
The ISPE Drug Shortages Prevention Plan is an actionable plan intended to help the pharmaceutical and biopharmaceutical industry avoid drug shortages that result from manufacturing and quality issues. The Plan is based in part on ISPE's groundbreaking 2013 Drug Shortages Survey which investigated manufacturing quality issues as a major cause of drug shortages. The Plan is organized into six dimensions, and contains recommendations and real-world case studies in each of these dimensions. The Plan builds on this data and incorporates significant follow-up input from stakeholders on how drug shortages can be prevented.
- Learn more about the ISPE Drug Shortages Prevention Plan
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 organizational 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.
“Our goal is that the pharmaceutical industry will use the Plan to not only 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 Francois Sallans, Vice President and Chief Quality Officer, Johnson & Johnson, and chair of the ISPE Drug Shortages Task Team in 2014. “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 which built upon the results of ISPE’s landmark 2013 study on drug shortages and organized its effort around a “six dimension” framework comprised.
In each dimension, the Plan provides answers to questions posed within each of the six dimensions, and offers “real world” case studies that illustrate how best practices can be established.
- 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?
- 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 conferences and workshops. Industry senior management, which has considerable influence on organizational culture and alignment, was 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 organization,” said Sallans. “This became clear when data from the 2013 Survey was analyzed, 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.”
Prevention of Drug Shortages Based on Quality Manufacturing Issues
Submitted to EMA 2014, 12 pages
ISPE’s Drug Shortages Prevention Plan formed part of an inter-association response to the European Medicines Agency’s (EMA’s) request to industry to provide solutions to the global problem of drug shortages caused by manufacturing.
- ISPE Coordinates an Inter-Association Task Force for Prevention of
Since 2012 ISPE’s Drug Shortages Team has been working to assure the reliable supply of medicines to patients by developing actionable plans for the prevention of shortages resulting from manufacturing issues. The plans have received attention from several health authorities.
In November of 2013 ISPE was invited to present an overview of its survey findings to the European Medicines Agency (EMA) at a workshop attended by several pharmaceutical associations and patient groups. The EMA noted that an effective drug shortages prevention plan would require a broad representation of industry experts and charged the associations in attendance with working together to develop and deliver a single, collaborative action plan for the prevention of drug shortages.
An Inclusive Task Force Formed
Recognizing the importance of collaboration to yield a singular approach, a Task Force was formed to address the prevention of drug shortages due to manufacturing quality issues. The Task Force is comprised of members from ISPE, the Parenteral Drug Association (PDA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Generic medicines Association (EGA), and the Plasma Protein Therapeutics Association (PPTA) was formed. The team also has participation from the EMA and six National Competent Authorities. By using the ISPE Drug Shortages Survey findings on the manufacturing quality causes of shortages, ISPE has taken a leading role in moderating and coordinating the group.
The Task Force focused on the quality system elements of drug shortages, including root causes, prevention and mitigation throughout the lifecycle, resilience of the supply chain and relevant training opportunities. The term “manufacturing quality issues” is defined as quality defects, failure of the manufacturing process and non-compliance with EU GMP or other EU quality requirements. As the member associations have complementary activities in these areas; the joint task force built upon and coordinated the unique perspectives and competencies of each organization. While there is a need to consider the totality of the supply chain, economic and market considerations were not within the scope of this group’s remit.
The Task Force’s deliverable, Prevention of Drug Shortages Based on Quality Manufacturing Issues, is an executable plan comprised of deliverables from each of the associations. The report summarizes complementary and collaborative work performed by organizations with individual membership (ISPE, PDA), as well as European pharmaceutical industry associations (EFPIA, EGA, PPTA, AESGP).
Drug shortages are a global issue and the solutions presented in the report can be used also outside the European Union.
Report on ISPE Drug Shortages Survey
Published 2013, 24 pages
In 2013 ISPE launched a comprehensive electronic survey to individuals working in the pharmaceutical industry to gather data on the technical, scientific, manufacturing, quality and compliance issues that have resulted in drug shortages. The intent of the anonymous survey was to better understand the underlying issues and possible root causes of drug shortages. With well over 100 items in several branches of inquiry, the survey was complex and time-consuming. ISPE limited the scope of the survey to the technical and GMP compliance related issues the ISPE Drug Shortages Team suspected might be contributing to drug shortages. ISPE’s goal in collecting this survey data was to provide the pharmaceutical industry and health authorities with scientific data to support the development of risk-based approaches, using modern quality systems, to mitigate and prevent drug shortages.
- The ISPE Drug Shortages Survey Revealed Multiple Root Causes for
—Key Aspects of Organizational Leadership and Regulatory Interaction Can Be Instrumental in Mitigating these Issues to Avoid Shortages—
Issues within the quality systems of manufacturing were identified as the leading cause of drug shortages in ISPE’s groundbreaking 2013 Drug Shortages Survey.
The Survey, which was aimed at identifying the technical, engineering, quality and regulatory issues impacting drug shortages. The study confirmed that drug shortages are multi-factorial, often resulting from issues within the quality systems, which can be affected by key aspects of organizational governance and the quality of interactions with regulatory authorities.
The highly complex instrument asked about the technical, engineering, quality, governance and regulatory issues believed to impact drug shortages. ISPE envisions using the results to support industry and regulators in the development of risk-based approaches to mitigating these occurrences.
While no single technical or manufacturing cause for drug shortages was identified, the key findings include:
- Issues within the quality systems of manufacturing can lead to drug shortages. Respondents weighted quality issues as the single most important factor leading to drug shortages. Within the quality systems, the data suggested that issues with aseptic processing equipment are a significant factor in sterile drug shortages. In addition, quality issues leading to drug shortages or near misses were present during technology transfer in a small but significant number of cases.
- Companies that have successfully avoided drug shortages focus on strong quality systems, and the involvement of company leadership is notable in those companies that avoid shortages. The top ranked success factor cited by companies that were successful in preventing shortages was an organizational focus on strong quality systems aimed at ensuring compliance with manufacturing regulations. Support from senior management to drive the drug shortage prevention programs, as well as well-defined metrics tailored to proactively identify the potential risk of a shortage, adequate resources for the prevention program and specific organizational goals to prevent shortages differentiated the companies who successfully avoided a shortage from those that did not.
- Improved regulatory interaction can mitigate the likelihood of a shortage. A significant number of respondents indicated that issues related to Health Authority Inspections and approval processes also played an important role in drug shortages. Respondents identified a number of areas where they believed the level and quality of interaction with regulators could be improved. Interestingly, an additional differentiator of companies that successfully avoided shortages was their emphasis on building strong relationships with regulatory authorities. Respondents from companies that avoided shortages also cited the importance of fostering communication links between the companies and the regulators as an important success factor.
ISPE deployed the Drug Shortages Survey to its global database of members and non-members for five weeks beginning February 20, 2013. The organization also worked with several reporters and publications covering the pharmaceutical industry to ensure maximum outreach and participation by industry participants with direct knowledge of actual drug shortages and shortages that had been narrowly avoided. In addition to seeking respondents to answer the survey items based on their individual experiences and opinions, ISPE also encouraged companies to compile an enterprise-level response and to designate a member of their staff to enter the information into the electronic survey system. In this way, duplication of data was minimized while still allowing individuals in the industry to share their personal (i.e. non-company) views. Complete anonymity was assured for all respondents.
The survey generated participation by individuals and companies from around the world who provided data concerning an actual drug shortage, a near miss, or an effective shortage prevention program.