New Study on U.S. Drug Shortages Calls for Establishment of Early Warning System

For some time now, there have been shortages in the supply of key drugs, many of which have been key treatments for patients undergoing therapy for extremely serious and life-threatening conditions.  The FDA has developed a page on its website that overviews current drug shortages as part of a larger collection of resources on the issue, including links to the President’s Executive Order, schematics offering an example of the supply chain, and other useful tools to gain perspective on the issue.

Today a study was released on U.S. drug shortages that sheds a more granular light on what has occurred.  The study was conducted by the IMS Institute for Healthcare Informatics – Drug Shortages:  A Closer Look at Products, Suppliers and Volume Volatility –  and examines data to assess some of the underpinning characteristics of the shortage and to make some recommendations.

The report made some key observations:

• While such shortages have been disruptive, they have been concentrated narrowly with generic injectable and oncology representing the largest share of shortages;
• While the shortages involve a number of suppliers, the true focus is only on one or two manufacturers;
• While total volume for many affected products has been stable or growing, there is nevertheless a great deal of volatility;
• A subset of 75 drugs has seen supply volume fall substantially;

The IMS Institute puts forth a recommendation that either industry or the FDA itself establish a system to provide early warning of pending supply problems for patients and their providers that includes a “volatility index, risk identification, demand forecasting and predictive modeling.”   You can download a copy of the full report here.

The IMS Institute will be conducting a Webinar on the report at noon today and replays as well as the full report will be available at the IMS Institute website.

The IMS Institute is represented by TogoRun, an agency in the Omnicom Group of communications companies – which is also the parent company of my employer, Fleishman-Hillard.