FDA working with drugmakers to prevent shortages

Health professionals across the country have been scrambling for alternatives to critical medications affected by the this year's record number of drug shortages.

There were about 200 shortages as of Sept. 30, according to the Food and Drug Administration. That marks an increase from the nation's previous record of 178 such events in 2010.

Contributing to the shortages are production delays, discontinuation of medications and manufacturing and quality problems, the FDA said. The agency aims to prevent shortages by working with manufacturers to address the issue and helping other companies ramp up production of the drugs, said Capt. Valerie Jensen, RPh, associate director of the Drug Shortage Program within the FDA's Center for Drug Evaluation and Research.

But she said there often is little the agency can do to avert a deficit of needed medication.

"We have limited authority with shortages," Jensen said during a Sept. 30 webinar on prescription drug shortages. "The key to preventing shortages is receiving early notification. If we don't hear about the problem before it is a shortage, we can't prevent [it]."

Complicating matters is that companies rarely have to notify the FDA of drug manufacturing issues, she said. The exception is when a company plans to discontinue a lifesaving drug for which it is the only manufacturer.

If the FDA knows that information ahead of time, it can help ensure that health professionals continue to have access to the medication by such measures as temporarily importing the drug from another country.

There is no penalty for companies that fail to inform the FDA of plans to stop producing critical medication. However, more companies have been voluntarily reporting manufacturing problems this year than they did in 2010, Jensen said. That information has enabled the FDA to prevent more than 99 shortages.

For example, she said companies notified the agency of potential drug supply problems due to the March earthquake in Japan. To remedy the problem, the FDA worked to qualify other drug suppliers.

When there is a quality issue, such as the crystals that appeared in cytarabine injection vials this year, the agency works with manufacturers to remedy the problem and boost production to prevent a shortage.

Consequences of shortages

Similar to 2010, the drugs most affected by this year's shortages are older, sterile injectables, which are mostly used in hospitals. Part of the problem is that too few manufacturers produce the medications to meet the nation's needs, the FDA said.

Many companies choose not to make these products because they are not as profitable as other drugs, and manufacturing them is complex, medical experts say.

As a result, physicians increasingly are prescribing substitute regimens. The problem, doctors say, is that alternative therapies often are not as effective as recommended treatments. Risk of medical errors also is greater when doctors prescribe medications with which they are unfamiliar.

Nearly all of the 820 hospitals surveyed by the American Hospital Assn. experienced at least one drug shortage in the last six months, according to a July report. Almost half had 21 shortages or more.

Consequently, 82% of hospitals delayed patient treatment. More than three in four facilities implemented rationing and/or restrictions for drugs that are in short supply.

AHA President and CEO Richard Umbdenstock said at the time that the number of drugs in short supply is increasing at an alarming rate and hospitals are working diligently to reduce the impact on patients. He said health professionals need more notice about drug shortages so they have time to act to ensure that patient care is not disrupted.

"We continue to work with the manufacturers on these issues," Jensen said. "We encourage voluntary reporting [of production issues] and continue to track the number of shortages and reasons for them."