TB Drug Shortages Put U.S. Patients in Peril, Study Finds

THURSDAY Jan. 17, 2013 -- Shortages of key tuberculosis drugs are posing a real hazard to patients throughout the United States, a new report finds.

The shortages are making it even more difficult to treat what's known as multidrug-resistant forms of the infectious respiratory illness, the researchers said. These patients often require so-called "second-line drugs" when the medication of choice fails.

For example, the new report cites the 2011 case of a father and his infant child who had each contracted TB. "Despite intensive efforts by public health personnel to obtain the two drugs [needed], the initiation of treatment was delayed by eight days for both patients, prolonging the father's infectious period and thereby increasing the risk for transmission to the community," wrote a team led by Dr. Barbara Seaworth of the University of Texas Health Science Center.

Matters were even worse for the baby, who had also contracted a form of meningitis and "was placed in a particularly dangerous situation," the researchers noted.

"TB meningitis in young children is a medical emergency, and delays in treatment lead to worse outcomes, such as severe [mental] impairment, epilepsy and death," according to the report published in the Jan. 18 issue of the Morbidity and Mortality Weekly Report, a journal of the U.S. Centers for Disease Control and Prevention.

In this case, both the father and baby did recover fully, but not every case involving drug shortages may turn out so well, the experts said.

In the new study, the National Tuberculosis Controllers Association surveyed TB programs across the United States and found that 81 percent of those that reported having patients with multidrug-resistant TB also said they had problems obtaining the medicines needed to treat these patients.

All of the programs that reported difficulties in obtaining drugs to treat multidrug-resistant TB listed nationwide shortages of the drugs as one of the reasons for the difficulties, according to the report.

In an accompanying editorial, experts noted that since September 2011, the supply of key second-line TB drugs has been "precarious."

"Kanamycin is no longer produced in the United States, streptomycin has been intermittently unavailable because of increased international demand, and capreomycin and amikacin have been available on an intermittent basis in only small amounts because of manufacturing problems and lack of raw materials," according to the editorial.

Other causes included shipping delays (noted in 71 percent of cases), lack of resources (62 percent), and the complicated process of obtaining certain drugs (48 percent).

As a result of difficulties obtaining drugs to treat multidrug-resistant TB, 58 percent of the TB programs reported delays in treating patients, 32 percent said there were lapses or interruptions in patient treatment, and 32 percent said they were forced to use an inadequate -- and potentially less effective -- treatment regimen.

Shortages disrupt the flow of care, as well, the editorial pointed out, leading to "rationing, increased drug costs, and inefficient use of staff time." They also "increase the risk for medication errors because regimens must be adjusted, leading to confusion over drug administration schedules, adverse reactions [side effects] and [drug-to-drug] interactions," the experts wrote.

Some efforts are underway to help ease the situation. In March of 2011, the Federal Advisory Council for the Elimination of Tuberculosis created a working group to address ongoing drug shortages, and in October 2011, a presidential order directed the U.S. Food and Drug Administration and the U.S. Department of Justice to fight drug shortages occurring across the health care spectrum.

"Reliable, consistent access to second-line drugs will require the collaboration of CDC, FDA, state and local health departments, national health professional societies, and the pharmaceutical industry," the study authors concluded.

More information

The American Lung Association has more about multidrug-resistant TB.

Posted: January 2013


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