FDA working to tackle the program

With three months left to go in 2011, the federal Food and Drug Administration reported that it had already seen a record number of drug shortages, mostly sterile injectables.

“In 2010, we had the largest number of shortages ever, and in 2011, we’re continuing to see a very large number of shortages. We believe that number is up to around 200 now,” said Capt. Valerie Jensen, RPh, associate director of the Drug Shortage Program for the FDA Center for Drug Evaluation and Research. During an agency webinar, Jensen told journalists that there were 178 recorded shortages in 2010, up from 157 in 2009. Most of the shortages involve oncology, anesthesia and emergency medicine drugs, as well as intravenous electrolytes.

“When we look at the market for the older sterile injectables, only seven manufacturers are making up the large percentage of this market,” Jensen said. “Some of those companies are also contract manufacturers, so they may be making some brand-name drugs as well as some older drugs. And then there’s a lack of redundancy, so there’s usually not enough backup capacity.”

The top cause for injectable shortages in 2010 was related to product quality, including particulate, contamination and impurities. In fact, quality issues accounted for 54 percent of the year’s shortages. Other causes were:

• Manufacturing delays and capacity issues, 21 percent;
• Drug discontinuations, 11 percent;
• Raw material problems, 5 percent;
• Increased demand caused by another shortage, 4 percent;
• Loss of a manufacturing site, 3 percent;
• Component problems or shortages, 2 percent.

Another problem is that some of the critical drugs simply don’t make money for their manufacturers anymore. “The older, sterile injectables are not economically attractive,” said Jensen, noting that a 20ml vial of the sedative propofol sells for just 48 cents.

From the Hospital Perspective

These critical-drug shortages certainly aren’t news to hospitals and clinics, which deal with them daily on the healthcare front lines. In July, the American Hospital Association released the results of a survey of 820 hospitals – and nearly 100 percent of them reported a shortage during the first six months of this year. What’s more, almost half reported 21 or more drug shortages.

“The number of drugs in short supply is increasing at an alarming rate, and hospitals are working diligently to reduce the impact to the patients they care for,” AHA president and CEO Rich Umbdenstock said at the time.

The survey revealed that 82 percent of the responding hospitals delayed a patient treatment because of a shortage and more than half weren’t always able to provide the patient with the recommended treatment. Sixty-nine percent of hospitals reported that patients got a less effective drug. Most hospitals also expressed concern that they rarely or never receive advance notification of drug shortages or learn why the drug is in short supply.

In another survey, the American Society of Health-System Pharmacists, in partnership with the University of Michigan Health System, found that the labor costs and time required to manage shortages translates to an estimated annual impact of $216 million nationally.

The AHA and the ASHP teamed up this year to craft some recommendations to help ameliorate the growing problem. Those included establishing an early warning system, removing regulatory obstacles faced by manufacturers and the FDA to avert or mitigate shortages, improving communication and incentivizing drug manufacturers to stay in, re-enter or initially enter the market.

What the FDA Can Do

Jensen expressed some frustration that there’s only so much the FDA can do to help. “We have a limited authority when it comes to shortages,” she said. In fact, her program has just five full-time staff members, and the agency has just one regulation at its disposal. One federal law requires a sole manufacturer of a life-saving drug to notify the FDA if it intends to discontinue the drug’s production.

Thus, the success of the FDA’s efforts depends on the manufacturers themselves, Jensen explained. “The FDA can’t tell manufacturers how much drug to produce. That’s all up to the company. We’re trying to do what we can to help, and with the pharmaceutical companies, it’s really a voluntary participation for them to work with us.”

The key to preventing shortages, Jensen stressed, is early notification by manufacturers when there’s a problem. If that happens, there are a number of actions the FDA can take. During 2010, the FDA prevented nearly 40 shortages – 16 were halted by easing regulations and 13 by expediting reviews. Already this year, the FDA has prevented just over 100 shortages, she said.

“In rare cases, we’ve actually had importation as a way to help with these shortages,” Jensen explained. “We did this in 2010 with propofol. The propofol shortage was severe; we had two companies that were having quality issues and the third company was trying to meet demand and to help increase the supply.” Thus, the FDA approved a temporary importation of Europe’s version of the drug. This year, the FDA thwarted several potential shortages that could have been problematic as a result of the earthquake in Japan. “Several firms actually lost their suppliers,” Jensen said. “They let us know in time, and we were able to work with the companies to qualify other suppliers quickly before the companies ran out.”

Jensen said the ASHP actually maintains the most accurate and complete list of drug shortages. “When hospitals are facing a shortage and if they don’t see the information on our FDA website or on ASHP’s website, let us know,” she said. “Sometimes those are the first notifications that we do receive, so we do appreciate it, and we do appreciate hearing about impact. We know that these shortages are impacting hospitals, and we want to hear about it.”

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