DIA 2014 50th Annual Meeting "Celebrate the Past - Invent the Future"

Drug shortages are a significant public health threat that can delay, and in some cases even deny, critical care for patients. Critical drug shortages that involve issues with drug manufacturing tend to be persistent. This session will discuss key considerations to promoting and sustaining high quality drug manufacturing while ensuring a reliable supply of critical medicines. Purchase of new equipment, renovation of facilities, or implementation of new manufacturing processes and technologies are effective long-term solutions to shortages. However, it remains critical to patients when no alternative medicines are available, for manufacturers to be able to implement these changes while avoiding disruptions in ongoing supply. How does one improve manufacturing and quality systems to ensure a reliable supply of critical medicines in the long term while maintaining supply in the short term? This session will focus on case studies of sterile injectables, a dosage form with challenging considerations and timelines, to learn what has contributed to successful implementation and the limitations to overcome. We will cover manufacturing changes, communications with the FDA, management of production and supply, and submitting changes to the FDA. The audience will gain an overview of industry efforts to improve manufacturing facilities and products while avoiding shortages and the FDA's role. The session will also describe publicly available drug shortage related information, and early notification as a critical tool to mitigate and prevent shortages.