Drug Shortages for Infectious Diseases Are Increasing

Laird Harrison

February 07, 2012

February 7, 2012 — More and more drugs for infectious diseases are in short supply, with serious consequences, according to a study published online January 19 in Clinical Infectious Diseases.

The number of infectious disease drug shortages rose from 6 in 2005 to 17 in 2010, report Milena M. Griffith, PharmD, an infectious diseases fellow at Midwestern University in Downers Grove, Illinois, who is affiliated with Northwestern Memorial Hospital, and colleagues.

The shortages can be life-threatening in infectious diseases because there are some drugs for which it is hard to find an alternative, the researchers note.

"There have been a lot of reports of patient harm as a result of the shortages," including 1 death, Dr. Griffith told Medscape Medical News.

The researchers tabulated drug shortages by using a list maintained by the American Society of Health-System Pharmacists (ASHP) and the US Food and Drug Administration (FDA).

Although the largest number of infectious disease drugs in short supply are antibacterial, antifungal, antiviral, and other infectious disease drugs also have appeared on the shortage list in recent years, the researchers have found.

"For the benefit of our patients, all physicians should be prepared with alternative plans to treat without the full armamentarium of antimicrobials," writes Ira Leviton, MD, from Montiefiore Hospital in the Bronx, New York, in an accompanying commentary.

The ASHP draws its information from reports of hospital pharmacists and from drug manufacturers, whereas the FDA depends on voluntary reporting by manufacturers. At this time, the FDA only reports on "medically necessary" drugs, Dr. Griffith said.

Medically necessary is defined as: "Any drug product used to treat or prevent a serious disease or medical condition for which there is no other adequately available drug product that is judged by medical staff to be an appropriate substitute."

The US Congress is mulling bills that would force drug companies to tell the FDA about expected shortages. Another bill, introduced February 1, would require the agency to speed up review of drugs proposed for approval that could help ease shortages, and force the US Drug Enforcement Agency to ease regulations on controlled substances in short supply, such as Adderall to treat attention-deficit/hyperactivity disorder.

Although the problem of drug shortages for such mental health conditions and for cancer have been well documented, the shortage of infectious disease drugs also deserves attention, said Dr. Griffith.

Drug shortages are becoming more crucial in infectious diseases because more organisms are developing resistance to commonly prescribed drugs. At the same time, the number of new drugs in the specialty is declining. Although 4 new molecular anti-infective entities became available in 2005, 2006, and 2007, that number dropped to 1 in 2008, with 2 in 2009 and 1 in 2010, the researchers report.

Few Alternatives for Drugs in Short Supply

Their article lists examples of many drugs in short supply for which the alternatives may not be as effective or may increase the risk for adverse reactions.

Increased mortality can result from delays in appropriate anti-infective therapy for patients with bacterial sepsis, bloodstream infections, nosocomial pneumonia, ventilator-associated pneumonia, and community-acquired pneumonia, the researchers say.

In other cases, clinicians have been forced to rely on drugs that for which the safety or efficacy simply are not as well known. For example, streptomycin, which has recently been in short supply, is a "keystone" in treating gentamicin-resistant enterococcal infections, said Dr. Griffith. Evidence for second-line therapies is only anecdotal.

The exact reasons why some drugs are hard to obtain can be hazy, coauthor Marc H. Scheetz, PharmD, MSc, told Medscape Medical News. "There is an awful lot of speculation about why this occurs. The FDA point to manufacturers and says it's manufacturing issues. The manufacturers point to the FDA and say it's because of overregulation," said Dr. Scheetz, an assistant professor of pharmacy practice at Midwestern University who is affiliated with Northwestern Memorial Hospital.

Some of the speculation focuses on consolidation within the industry, with many drug companies merging. If a single company is the sole manufacturer of a particular drug, and that manufacturer encounters problems such as impurities or a shortage of raw materials, supplies of that drug may quickly run out.

In addition, observers have blamed hoarders and speculators who buy up large quantities of a drug when it is available at a low price in hopes of reselling at a much higher price.

It can take months for a company to begin manufacturing a drug it has not made before, said Dr. Griffith. At this time, manufacturers must notify the FDA 6 months before ceasing manufacture of a medically necessary drug. Broadening the category of drugs that fall within that definition would help soften the effect of shortages, said Dr. Griffith.

Josh Adler, MD, chief medical officer of the University of California, San Francisco (UCSF), Medical Center, told Medscape Medical News that he agrees with that assessment.

UCSF has had to change regimens for many patients because the treatment of choice was not available, he said. This can be difficult because hospitals develop careful protocols built around a particular drug, and it is often not possible to simply swap one agent for another.

The university is working hard to stock up on drugs that might be in short supply, find alternatives using drugs in the same class as those that are sometimes hard to get, and develop a network with other hospitals that can share supplies when patients are in critical need, said Dr. Adler.

"We have not had an epidemic of adverse events because hospitals are putting so much effort into dealing with this issue," he said. "I'm sure it's increasing the cost and could potentially harm the patient."

Adi V. Gundlapalli, MD, PhD, an assistant professor at the University of Utah School of Medicine in Salt Lake City, told Medscape Medical News in an email that his institution, too, has been hit with shortages in infectious disease drugs. "Specifically, I recollect shortages in [intravenous] acyclovir (for herpes encephalitis patients) and also [intravenous] trimethoprim/sulfamethoxazole (for specific conditions such as Stenotrophomonas bacteremia)."

In addition to more advance notice about shortages, clinicians would benefit from reliable guidelines about how to switch from a preferred medication to an alternative, he said.

Dr. Griffith, Dr. Scheetz, and Dr. Gundlapalli have disclosed no relevant financial relationships.

Clin Infect Dis. Published online January 19, 2012. Article abstract, Commentary

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