Mounting drug shortages delaying treatment

Production delays and quality issues have led to nationwide shortfalls that could mean the difference between life and death.

By Christine S. Moyer — Posted Aug. 1, 2011

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Internist Charles Cutler, MD, gets an email at least twice a month from a hospital near his Norristown, Pa., practice notifying him of drugs that are unavailable due to national shortages. Although drug supply shortages have occurred in his more than 30 years in practice, they have never been this bad.

"I don't ever remember these common medicines not being available," said Dr. Cutler, a member of the American College of Physicians Board of Regents.

The affected medications include chemotherapy drugs and treatments for allergies and hypertension. Also on the list are pain medication and drugs to treat heart conditions.

The Food and Drug Administration saw a record number of shortages in 2010, and there are more supply problems this year, particularly among generic sterile injectables.

Contributing to the shortages are production delays and quality issues, including particulate matter found injectable drugs, which then could not be used due to patient safety concerns. The FDA also said too few manufacturers are producing the older and widely used generic sterile injectables to meet the nation's needs.

Many companies choose not to produce these products because they are not as profitable as other drugs and manufacturing them is complex, said Roslyne Schulman, director of policy development at the American Hospital Assn. 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.

For many primary care physicians, the shortage is largely a nuisance, forcing them to spend extra time teaching patients the new dosage instructions and potential side effects of substitute drugs. But in the inpatient setting, a shortage can lead to dire consequences.

"For us in oncology ... the drugs [affected by shortages] are important in life-and-death situations," said Eyal Attar, MD, a hematologist/oncologist at Massachusetts General Hospital in Boston and an assistant professor of medicine at Harvard Medical School. "These patients are really fighting for their lives. When we have to triage medicine and find alternative medicine, it's frustrating, and it makes us concerned that we may not be providing the best level of care."

Escalating shortfalls

In 2010, there were shortages of 178 drugs in the U.S., according to the FDA. That is the greatest number since the agency began tracking the issue in 2005, when there were shortages of 61 drugs.

The situation has reached a crisis level, particularly in hospitals, where a majority of the medications are used, Schulman said.

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 medical facilities implemented rationing and/or restrictions for drugs that are in short supply.

Overall, "the situation is definitely getting worse," Schulman said. "The shortage is making it much more difficult to provide safe and effective care to patients."

One example of rationing occurred in 2010 during a national shortage of cytarabine, a chemotherapy drug used to treat several malignancies. At Massachusetts General Hospital, the drugs were first administered to children with leukemia and those with diseases for which there was no known alternative treatment of equal efficacy, Dr. Attar said.

Other patients received alternative regimens until the shortage was resolved. In the last few months, the hospital has had an adequate supply of the drug.

To help ensure patient safety, the pharmacy department at the hospital spends at least two hours each week discussing how to handle the newest shortage. The hospital's chief pharmacy officer, Margaret Clapp, said the staff discusses what other drugs doctors can use and then educates doctors and nurses about how to manage the new drugs.

"The drug shortage has been absolutely brutal," Clapp said. "Normally, we would expect to see narcotics run out near the end of the year. ... But I consistently have had 16 to 18 pages of shortages."

Dr. Cutler has had to identify alternative medications to replace Medrol (methylprednisolone) and Dyazide (triamterene/hydrochlorothiazide), which both were in short supply.

He said a prescription for an unfamiliar drug can unsettle some patients, particularly those with a chronic disease who are used to taking a certain medication.

In those situations, he explains how the medicine works and assures patients it is safe and effective. "I tell them, 'It's a little bit different [from your previous medication], but it's unlikely that you'll experience any difference in the way you feel. But if you do, we'll deal with it.' "

He said primary care physicians are frustrated by the time spent determining alternative regimens, educating patients about a new drug and answering questions.

Health care organizations, including the AHA, want Congress to establish an early warning system of drug shortages and mandate that manufacturers report drug interruptions or discontinuances to the FDA. Bills are pending in the House and Senate.

Schulman said the bills are a good first step, but the health community needs to continue working with lawmakers to identify other solutions.

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A growing problem

A record number of drug shortages occurred in 2010, and there are an increasing number of supply problems this year. The number of shortages has almost tripled in the five years since the FDA began tracking the problem.

Year Drug
2005 61
2006 56
2007 90
2008 110
2009 157
2010 178

Source: Food and Drug Administration

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External links

"AHA Survey on Drug Shortages," American Hospital Assn., July 12 (link)

Food and Drug Administration on drug shortages (link)

American Society of Health-System Pharmacists (link)

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