A pharmaceutical industry group announced plans in March to conduct what it described as the industry's first quality metrics pilot program.
The goal of the International Society for Pharmaceutical Engineering's yearlong program is to test a series of quality metrics that would support the Food and Drug Administration's plan to implement a risk-based inspection program.
It's the latest move in an ongoing conversation about how to stem the seemingly growing tide of national drug shortages and the toll such shortages take on patient care. That conversation eventually wends its way to the most frequently identified culprit of drug shortages -- quality issues in the pharmaceutical manufacturing process.
Two new reports were issued earlier this year. In February the University of Utah's Drug Information Service announced that the number of ongoing drug shortages is at an all-time high. And while the university cited several reasons, it named quality issues as the most common.
Nearly simultaneously, the U.S. Government Accountability Office in February shared some ugly data related to pharmaceutical quality. Its analysis of Food and Drug Administration data concluded that 40% of drug shortages reported between Jan. 1, 2011, and June 30, 2013, resulted from quality concerns "such as particulate matter or plant maintenance issues."
Moreover, it noted that another often-cited reason for drug shortages -- manufacturing capacity constraints -- frequently result from quality issues that require manufacturers to either slow down or temporarily stop production.
It's data such as these that lead to greater governmental scrutiny, which is precisely what happened in this instance. The sweeping FDASIA (U.S. Food and Drug Administration Safety and Innovation Act), signed into law less than two years ago, ushered in a raft of requirements that aim to improve product quality and reduce drug shortages.
The law also left unaddressed a whole host of questions and concerns, which the FDA has been working to tackle -- in many cases with input from industry and the public.
The ISPE's pilot program addresses the FDA's request for feedback on the broader use of quality metrics, as well as how such metrics support risk-based inspection, a requirement of the Food and Drug Administration's Safety and Innovation Act.
"This pilot program will provide a practical approach for both industry and regulators to refine metric selection and definition, and to develop an operational and pragmatic approach to implementation," said ISPE President Nancy S. Berg at the March announcement.
The pilot program builds on a series of ISPE efforts that date to early 2013. Most recently the organization issued a white paper in December 2013 that outlines a list of proposed quality metrics to support a risk-based inspection program.
Among the proposed quality metrics are batch rejection rate, rework and reprocessing rate, confirmed out-of-specification rate and "critical" complaints. The organization notes in its white paper that these metrics are lagging indicators and says additional work is needed on more advanced leading indicators.
The pilot aims to launch in June.
