HSP

The vast majority of hospitals have had to restrict the use of life-saving chemotherapy and other critical-care drugs in the past six months to cope with an unprecedented shortage of hospital-based drugs.

More than 80% of hospitals surveyed by the American Hospital Association reported they had to delay treatment and almost 70% said patients received less-effective, substitute drugs. Three out of four hospitals reported rationing or restricting the use of drugs in short supply. In some cases, such as a leukemia drug called cytarabine, there are no effective substitutes.

The survey, which included more than 800 hospitals, was released on Capitol Hill Tuesday as part of push for legislative action. A separate survey commissioned by the American Society of Health-System Pharmacists estimated the additional labor cost for hospital staff to deal with the shortages at $216 million a year. Pharmacists and technicians spend about 17 hours a week managing drug shortages.

The FDA reported a record 178 drug shortages in 2010. Although the agency doesn't have figures for 2011, the FDA said the shortages "have continued at a rapid pace." Most of the shortages involve older, generic drugs that are administered through an injection or intravenously. They include chemotherapy drugs to treat cancer, antibiotics to treat infections and nutritional drugs for patients who can't eat. There are also ongoing shortages of drugs used in emergency rooms and intensive-care units.

More than 90% of hospitals reported shortages of surgery or anesthesia drugs and emergency-care drugs, and two-thirds reported shortages of chemotherapy drugs. Almost half the hospitals in the survey reported coping with 21 or more shortages in the last six months.

The shortages are growing more severe in part because of industry consolidation that means many injectable generic drugs are now made by one or two companies such as Teva Pharmaceutical Industries Ltd. (TEVA, TEVA.TV) or Hospira Inc. (HSP). When one company runs into a manufacturing problem with a product or decides to quit making a drug, competing companies can't quickly fill the void.

The ASHP survey showed the biggest shortage in 2010 involved a drug called succinylcholine injection which is commonly used in procedures to insert a tube into patients' airways to help them breathe.

The product is made by Hospira and Sandoz, a unit of Novartis AG (NVS). Production at Hospira was slowed last year when the company couldn't get enough active pharmaceutical ingredient and Sandoz couldn't immediately fill the gap. Hospira said full production has resumed. Sandoz didn't immediately return a request for comment.

There are bills pending in both the Senate and House that would require companies to notify the FDA as soon as they have problem that could result in a shortage. The House bill, by Reps. Diana DeGette (D., Colo.), and Tom Rooney (R., Fla.) would subject companies to fines of as much as $10,000 per day, with a cap of $1.8 million, for failure to comply with reporting requirements. The measure will also allow the FDA to post letters from companies informing the FDA of potential or actual shortages in order to give hospital pharmacists a better gauge of how long a particular shortage might last. Hospira and the FDA support the bill.

Sen. Amy Klobuchar (D., Minn.), the co-sponsor of a similar Senate bill, said the legislation is meant as an early warning system. While some companies do notify the FDA about potential problems like shortages of ingredients used to make drugs, Klobuchar the system as "haphazard."

Current law requires companies to report to the FDA in cases where they are the only supplier of a drug and they plan to quit making it.

The FDA has said 38 shortages were prevented in 2010 from companies who voluntarily gave the agency early notification of a problem with a drug. In some cases, the advanced warning gave the FDA time to work with competing manufacturers to ramp up production to avert a shortage.

 
  -By Jennifer Corbett Dooren; Dow Jones Newswires; 
  202-862-9294; jennifer.corbett@dowjones.com 
 
 

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