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. This unique research project highlights some of the ways that shortages might be prevented.
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. Among the elements identified by the ten participating pharmaceutical companies as the reasons for shortages are market withdrawals, ineffective supply chain design, few purchaser-manufacturer incentives, limited market insight into future demand, and regulatory expectations. In addition to improvements in product and manufacturing quality and current Good Manufacturing Practice (cGMP) compliance, the report concludes that drug shortages could be reduced with improvements in internal-demand-forecasting abilities; overall supply chain maturity; and the relationships between a manufacturer, a provider, and regulators.
The ISPE Drug Shortage Assessment and Prevention Tool represents an important element of the implementation stage, providing a succinct way to look at the ISPE Drug Shortages Prevention Plan and analyze your risks in each of the dimensions cited and mitigate those risks. The Drug Shortage Assessment and Prevention Tool can be used as part of a company’s overall drug shortages prevention program.
First use the Drug Shortage Assessment and Prevention Tool as a reflection paper, to help you look holistically across your entire supply chain. The tool will assist you in evaluating your current processes, systems and practices and assess the risks in the 6 different dimensions compared with a ‘desired state’ as described in the ISPE Drug Shortages Prevention Plan.
The tool itself will provide a succinct way to measure your gaps from the best practices recommended in the prevention plan and assess potential risks in the supply chain and take proactive measures where possible to prevent shortages.
“This 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,” said ISPE President and CEO John Bournas. “With this tool, manufacturers will mitigate problems before they arise allowing them to provide an uninterrupted supply of safe, quality medicines to patients worldwide.”
In addition to analyzing potential gaps in your organization supply chain, use of the tool will also help you prepare for any questions a regulator may ask concerning your ability to avoid a potential drug shortage or manage an actual shortage.
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.
Download the ISPE Drug Shortages Prevention Plan ( 3 MB)
The ISPE Drug Shortages Prevention Plan was developed by ISPE’s Drug Shortages Task Team of expert pharmaceutical and biopharmaceutical industry members.
The ISPE Drug Shortages Prevention 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:
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. Read the report - Prevention of Drug Shortages Based on Quality and Manufacturing Issues ( 867 KB).
This research was produced at the request of FDA and examines timeframes for upgrading facilities and equipment, one of the identified causes of drug shortages. Learn more about the research - Understanding Global Regulatory Filings Timelines: Upgrading Aseptic Processing Equipment or Facilities ( 189 KB).
In February 2013, ISPE collaborated with health authorities and different sectors of the pharmaceutical industry in its initiative regarding the prevention and mitigation of drug shortages.
As a first step, ISPE's Drug Shortages Task Team developed a comprehensive electronic survey aimed at professionals working in the pharmaceutical industry.
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 Task Team suspected might be contributing to drug shortages.
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