MEE-SHEW CHEUNG1, VISHAL KASHYAP², MARLA PHILLIPS¹*
*Corresponding author
1. Xavier University, 3800 Victory Parkway, Cincinnati, OH 45207 USA
2. University of Graz, Elisabethstraße 50b, 8010 Graz, Austria

Abstract

The Xavier University Integrity of Supply Initiative was launched in 2012 to identify areas for improvement related to the reliability of incoming supply for the pharmaceutical and medical device industries. Our work to date has identified a major paradigm shift in which data generated by the pharmaceutical and medical device manufacturers themselves point to failures which they are injecting into the supply process, not their suppliers. Cognizant of this shift, Good Supply Practices (GSPs) are being developed for implementation by the manufacturers across the pharmaceutical and medical device industries with the ultimate goal of increased reliability of incoming supply.

CURRENT STATE OF SUPPLY CHAIN MANAGEMENT

In 2011, the Pew Charitable Trust organization issued a report that delineated the complexity of the highly globalized pharmaceutical supply chain and the challenges industry and regulators need to overcome in order to have better supply chain control (1). A major area of focus in that report was the increased selection of and reliance on foreign suppliers by the pharmaceutical industry - particularly for the Active Pharmaceutical Ingredient. Using foreign suppliers resulted in the lack of knowledge of those suppliers, the challenge in developing sufficient relationships with those suppliers, and the lack of awareness of how the business culture in those regions could and did impact patient safety. The pharmaceutical supply chain is also plagued by drug shortages, which has resulted in global patient harm. In 2011, drug shortages rose to an all-time high of 251 medically necessary drugs affected, primarily related to generic sterile injectable products (2). Recent studies have demonstrated that instead of poor supply chain management as originally believed, the vast majority of drug shortages have actually resulte ...