Newswise — (Tampa, Florida, USA, Oct. 9, 2014) - ISPE, the International Society for Pharmaceutical Engineering, will release its Drug Shortages Prevention Plan on October 14 at its 2014 Annual Meeting in Las Vegas, Nevada. A media conference will be held at 2:45 p.m. in the Neapolitan IV room at Caesar’s Palace. ISPE Task Team members who developed the Plan will be available for comment at that time.

The ISPE Drug Shortages Task Team developed the Plan as part of a multi-association initiative launched in response to a request from the European Medicines Agency (EMA) for a collaborative action plan aimed at preventing drug shortages due to manufacturing and quality issues. A world first, presenting a global and holistic response uniquely addressing shortages at both the product and process levels, the Plan lays out how industry can best prevent drug shortages from occurring by identifying the root causes of supply disruptions and creating a quality culture that will ensure a robust, resilient and reliable supply of medications – some life-saving – to patients worldwide.

The newly developed Drug Shortages Prevention Plan builds on the results of ISPE’s 2013 Drug Shortages Survey that cited manufacturing quality issues as a major cause of drug shortages. This Plan is global in nature and represents a continuum of work done to date supporting the US Food and Drug Administration (FDA)’s Strategic Plan for Preventing and Mitigating Drug Shortages and ongoing communications with other health authorities, such as Health Canada and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

“ISPE’s Drug Shortages Prevention Plan is part of a significant and continuing effort since 2011 to ensure a safe, quality and reliable drug supply,” said ISPE President and CEO John Bournas. “We owe patients a sense of security by meeting their expectations for a reliable and continuous supply of the medications that are so important to them and their families. Accordingly, when members of the pharmaceutical industry discover and put to work the valuable insights included in the Plan, particularly those promising to strengthen the integrity of the supply chain and those describing how to place a greater emphasis on end-to-end quality, a real difference can be made in the lives of patients.”

John Berridge, ISPE Strategic Advisor and member of ISPE’s Drug Shortages Task Team, knows all too well what the effects of a drug shortage can mean to patients after one of his medications became unavailable.

“A life-sustaining, medication, one that I have to take every day, became unavailable from the supplier,” recalled Berridge. “It meant that I had to undergo a number of medical tests to determine which of the other available sources, and what dose of those sources, would be best since the efficacy and side effect profiles vary with the supplier. Finding a safe and suitable replacement took six weeks.”

That caused great anxiety, said Berridge, who was an early advocate for investigating the root causes behind drug shortages and developing a shortage prevention plan for the pharmaceutical industry. His unfortunate experience also reminded him of how we take for granted a safe and available drug supply.

“Too often we assume that the drugs we need will always be available,” said Berridge. “That we have so much faith in the pharmaceutical industry says a lot about the industry, but things can go wrong from time to time and we must be constantly ensuring that the industry does all it can to ensure that patients always have access to the drugs they need.”

As a global effort at stopping drug shortages before they occur, the Plan represents a collective investigative and remedial effort by pharmaceutical and biopharmaceutical industry experts. It has been reviewed by regulators from the EMA and US FDA, and by national competent authorities including the Spanish Agency of Medicines and Medical Devices (AEMPS) and the Medicines and Healthcare Products Regulatory Agency (MHRA).

In creating the Plan, the Task Team engaged with leadership from more than 30 major pharmaceutical companies and included input from experts from several pharmaceutical associations, including the Association of the European Self-Medication Industry (AESGP), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Generic Medicines Association (EGA), the Parenteral Drug Association (PDA), and the Plasma Protein Therapeutics Association (PPTA).

Building upon the results of ISPE’s 2013 Drug Shortages Survey, ISPE organized the Plan around a “six dimension” framework comprised of: Corporate Quality Culture; Robust Quality System; 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 successful strategies to avoid supply disruptions and shortages.

For example:•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 lead to a drug shortage? And, how can those triggers be identified and eliminated?•Metrics – How can metrics be tailored to help identify and mitigate risks?•Business Continuity Planning – At a time when supply chains are more global and complex, how can quality be assured in production, factories, materials, machines, equipment and experts? What are the risks that might need to be considered?•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 increased to identify the true root causes of supply disruptions and drug shortages, train employees, improve knowledge and knowledge management, as well as strengthen employee commitment to quality?

“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 François 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 were analyzed, but it became even more apparent when the Team linked a quality culture to the other elements, such as metrics and capability building. We hope companies will use the Plan as a “toolbox” from which they can select the drug shortage prevention tools most appropriate for them.

“The 2013 Survey also provided clear evidence that mitigating shortages required a holistic approach that includes organizational aspects – people – as well as technical aspects of process and production and understanding risks and the signals that a drug shortage may be possible,” explained Sallans.

“We want to thank the members of industry and the Task Team for their hard work and also thank regulators from the many agencies who played an advisory role,” concluded Bournas. “The creation of this Plan has been a true team effort and one that will ultimately benefit not only the industry and regulators, but, most importantly, it promises to have a great impact on the lives of patients.”

• Introductory Summary of the ISPE Drug Shortages Prevention Plan: http://www.ispe.org/drug-shortages-initiative/plan-intro-summary.pdf • Current Drug Shortages:o Reported to EMA: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000376.jsp&mid=WC0b01ac05807477a6o Reported to FDA: http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm#tabs-4

About ISPEISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA. Visit www.ISPE.org for more information. ###

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