Thursday, September 4, 2014

ISPE Previews Plan To Prevent Drug Shortages

Last week, International Society for Pharmaceutical Engineering (ISPE) released the introductory summary of its Drug Shortages Prevention Plan, with the goal of maintaining a reliable supply of life-saving medications to patients all over the world.
ISPE’s first step in developing the plan was an anonymous survey conducted online in February of 2013.  Data retrieved from the survey sparked a year-long conversation with leaders of 30 major pharma companies, global regulators and industry professionals.
So far, the European Medicines Agency (EMA) and Medicines and Healthcare Products Regulatory Agency (MHRA) have weighed in, and other regulatory agencies are expected to offer input in the near future.
According to ISPE, the plan revolves around a six part initiative which seeks to foster global standards of quality control from corporate to factory, create and sustain organizational systems, and open clear channels of communication between drug manufacturers and health authorities. The plan hopes to help drug makers identify the root causes of problems in the supply chain and expeditiously manage and mitigate risk.
The ISPE plan follows a similar strategy outlined by the FDA in 2013 following the Food and Drug Administration Safety and Innovation Act (FDASIA) which President Obama signed into Law in 2012.  This act established an American task force to address drug shortages and called for a plan to combat the problem.
According to the New York Timesshortages have persisted despite FDA efforts to stem the problem. Though the FDA was succeeding in preventing more shortages, the total number of shortages continued to grow.
Ralph Neas, CEO of the Generic Pharmaceutical Association, explained this persistence, saying that the only way to prevent drug shortages was through the collaboration between regulators and manufacturers.
The key difference between the FDA strategy and the plan outlined by ISPE is that culpability and responsibility is spread equally across the board between manufacturer and government regulatory agency.
Nancy Berg, ISPE CEO, explained, “Our goal is that the pharmaceutical industry will use the Plan not only to help it look holistically across the supply chain, but also as a roadmap to use in challenging its current processes, systems, and practices and to identify potential gaps and risks.”
The ISPE emphasizes that there is no “one size fits all” approach to solving global issues with drug shortages. The project is intended to be what ISPE describes as a “toolbox” from which drug makers can select ideas and strategies most appropriate to their needs.
The ISPE will publish the plan in its entirety in October of 2014.

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