National Drug Shortages Are Increasing

San Francisco—National drug shortages are on the rise and can have costly implications for the healthcare system, but possible legislation could help address the problem, according to a presentation at the AMCP annual meeting.

The Contemporary Issues session, titled Drug Shortages and the Impact on Managed Care Pharmacy, provided an update on trends, while describing Congressional and industry efforts to address growing shortages. Joseph Hill, MA, director of federal legislative affairs for the American Society of Health-System Pharmacists (ASHP), led the session, along with Sherry Andes, senior drug information specialist at informedRx, Inc., a subsidiary of SXC Health Solutions, Inc.

The number of new drug shortages identified each year has been steadily increasing since 2007, with 267 new national shortages reported in 2011. The most common drug classes in short supply are central nervous system medications, antibiotics, and chemotherapy drugs. According to the presentation, 60% to 70% of all reported shortages are injectable therapies.

The reasons for these shortages can vary, but 42% in 2010 have been attributed to product quality issues. Other top reasons for shortages were product discontinuation (18%) and production capacity issues (18%).

These shortages can cost the healthcare industry time and money. Based on the presentation, it is estimated that pharmacists spend an average of 9 hours a week managing drug shortages, while pharmacy technicians devote an estimated 8 hours a week to the shortages. In addition, drug shortages are associated with $216 million nationally in annual labor costs.

Congress, the FDA, and the drug industry are all working to minimize this issue in the United States.

Currently, there are 2 bipartisan bills in Congress to address drug shortages: Senate bill 296 (S 296) and House of Representatives bill 2245 (HR 2245). Both bills would establish early warning systems and include stipulations that would require manufacturers to notify the FDA of an interruption in production. Under the bills, both of which are supported by ASHP, these notifications would be confidential and the FDA would post information only related to actual shortages.

In addition, the FDA would create a list of drugs that are vulnerable to a shortage and could work with manufacturers to develop an alternative active pharmaceutical ingredient (API), back-up supplies or find other ways to minimize or avoid such a shortage.

Early notification has appeared to be beneficial in the past. According to the FDA, 195 additional shortages were prevented due to confidential notification from manufacturers in 2011.

The 2 bills differ in that S 296 applies only to drugs while HR 2245 would apply to both drugs and biologics. In addition, HR 2245 spells out fines for failure to report shortage information and has earned support from Hospira.

In addition to congressional bills, an executive order was signed in October that provides surge staffing for the FDA Drug Shortage Program and directs the FDA to work with the Department of Justice to investigate price gauging.

The US Government Accountability Office also released a report in November that urged the adoption of the early warning system and suggested that the FDA develop an information system to manage data to aid in shortages.

Recent FDA action has given some support to the idea that an early warning system could aid in preventing shortages. The FDA worked behind the scenes to ramp up production of methotrexate and to help manufacturers import temporary supplies of doxil.

Other legislation is also being considered including HR 3839, which would create a public national critical drug list, require expedited FDA approval for drugs identified as critical, and would call for the Attorney General to increase quotas for controlled drugs that have shortages.

The generic manufacturers have also weighed in by suggesting the Accelerated Recovery Initiative, which, if approved by the FTC, would use an independent third party to serve as an information broker to the supply chain.

The session concluded with a look toward the future. According to the presentation, if the Prescription Drug User Fee Act reauthorization includes a generic user fee program, which is something strongly supported by ASHP, it could help with drug shortages by making approvals of older, generic drugs faster and making it easier for manufacturers to enter the market. Another promising sign that help may be on the way is the interest from Congress.