The Number of Drug Shortages Remains High and Nearly Half Involve Generic Sterile Injectables

The number of drug shortages reported each year remains high, although  there was a decrease in 2012 relative to the record number of new  shortages reported in 2011. 2.) 3.) During a  shortage, providers may have to cancel or delay procedures, which can  have detrimental health effects on patients. Supply Disruptions Stemming from Quality Problems Frequently Identified as Triggering Recent Shortages

			Quality Problems Leading to Shortages

The most frequently cited immediate cause for a drug shortage was that a  manufacturer halted or slowed production after a quality problem was  identified, resulting in a supply disruption. One manufacturer representative said that while  manufacturers have experienced disruptions due to natural disasters, this  has been rare. Half of the studies (10 of 20) we reviewed suggested that the  immediate causes of drug shortages, such as quality problems, are driven  by an underlying cause that stems from the economics of the generic  sterile injectable drug market. Among other things, FDA is working to improve its  response to drug shortages by implementing FDASIA’s requirements and  the recommendations we made in 2011. FDA Has Prevented More Potential Shortages and Has Improved Its Ability to Respond to Shortages That Do Occur

FDA has taken steps that have prevented more potential shortages and  improved its ability to resolve existing drug shortages since 2011,  including expediting review of ANDAs and supplements, working with  manufacturers to increase production, and using its regulatory discretion  to allow certain products to remain on the market or bring new products to  market. FDA has also taken steps to respond to the recommendations we made  in our 2011 report. The first such data check was completed in 2012. In addition, FDA has not conducted routine analyses of its existing drug  shortage database to identify, evaluate, and respond to the risks of drug  shortages proactively. Many shortages are prolonged, with some spanning multiple  years. These shortcomings could hinder FDA’s efforts to  understand the causes of shortages as well as undermine its efforts to  prevent them from occurring. Recommendations

To enhance its oversight of drug shortages, particularly as the agency  fine-tunes the manner in which it gathers data on shortages and  transitions from its database to a more robust system, we recommend  that the Commissioner of FDA take the following two actions: develop policies and procedures for the use of the existing drug  shortages database (and, ultimately, the new drug shortages  information system) to ensure staff enter information into the database  in a consistent manner and to ensure the accuracy of the information  in the database; and  conduct periodic analyses using the existing drug shortages database  (and, eventually, the new drug shortages information system) to  routinely and systematically assess drug shortage information, and  use this information proactively to identify risk factors for potential  drug shortages early, thereby potentially helping FDA to recognize  trends, clarify causes, and resolve problems before drugs go into  short supply. Specifically, to  review trends in recent drug shortages that occurred from January 1,  2007, through June 30, 2013, we analyzed data from the University of  Utah Drug Information Service (UUDIS), which were the most recent data  available at the time we did our work. These data are generally regarded  as the most comprehensive and reliable source of drug shortage  information for the time period we reviewed and are what we used in  preparing our 2011 report. Department of Health and Human Services. Food and Drug  Administration. activities. manufacturer and association representatives and to FDA for comment. Further, in response  to new Food and Drug Administration Safety and Innovation Act  (FDASIA) authority, the agency is in the process of establishing a risk- based inspection schedule for all establishments. Standards for Internal Control in the Federal Government.
Why GAO Did This Study

From prolonged duration of a disease, to permanent injury, to death, drug shortages have led to harmful patient outcomes. FDA—an agency within the Department of Health and Human Services (HHS)—is responsible for protecting public health and works to prevent, alleviate, and resolve shortages. In 2011, GAO recommended that FDA should enhance its ability to respond to shortages. In 2012, FDASIA gave FDA new authorities to improve its responsiveness and mandated GAO to study drug shortages.
In this report, GAO (1) reviews the trends in recent drug shortages and describes what is known about their effect on patients and providers; (2) examines the causes of drug shortages; and (3) evaluates the progress FDA has made in addressing drug shortages. GAO analyzed data from FDA and the University of Utah Drug Information Service, which is generally regarded as the most comprehensive source of drug shortage information for the time period we reviewed. GAO interviewed officials from FDA and other federal agencies, organizations representing patients and providers, and drug manufacturers. GAO also reviewed the literature, relevant statutes, regulations, and documents.

What GAO Found

The number of drug shortages remains high. Although reports of new drug shortages declined in 2012, the total number of shortages active during a given year—including both new shortages reported and ongoing shortages that began in a prior year—has increased since 2007. Many shortages are of generic sterile injectable drugs. Provider association representatives reported that drug shortages may force providers to ration care or rely on less effective drugs.
The immediate cause of drug shortages can generally be traced to a manufacturer halting or slowing production to address quality problems, triggering a supply disruption. Other manufacturers have a limited ability to respond to supply disruptions due to constrained manufacturing capacity. GAO's analysis of data from the Food and Drug Administration (FDA) also showed that quality problems were a frequent cause. GAO also identified potential underlying causes specific to the economics of the generic sterile injectable drug market, such as that low profit margins have limited infrastructure investments or led some manufacturers to exit the market.
While shortages have persisted, FDA has prevented more potential shortages in the last 2 years by improving its responsiveness. Among other things, FDA implemented Food and Drug Administration Safety and Innovation Act (FDASIA) requirements and recommendations GAO made in 2011. FDA has also initiated other steps to improve its response to shortages, such as developing procedures to enhance coordination between headquarters and field staff. However, there are shortcomings in its management of drug shortage data that are inconsistent with internal control standards. For example, FDA has not created policies or procedures governing the management of the data and does not perform routine quality checks on its data. Such shortcomings could ultimately hinder FDA's efforts to understand the causes of specific shortages as well as undermine its efforts to prevent them from occurring. In addition, FDA has not conducted routine analyses of the data to proactively identify and evaluate the risks of drug shortages.

What GAO Recommends

FDA should strengthen its internal controls over its drug shortage data and conduct periodic analyses to routinely and systematically assess drug shortage information, using this information to proactively identify drug shortage risk factors. HHS agreed with GAO's recommendations.