Interruptions in supplies of second-line antituberculosis drugs--United States, 2005-2012.

Second-line drugs (SLDs) are essential for treating multidrug-resistant and extensively drug-resistant tuberculosis (MDR TB* and XDR TB†). Drug shortages, in which supplies of all clinically interchangeable versions of a given Food and Drug Administration (FDA)-regulated drug become inadequate to meet actual or projected user demand, have been well-documented in many areas of medicine; for several years, drug shortages in the United States have affected the availability of SLDs for treatment of TB. In November 2010, a nationwide survey of TB control programs conducted by the National Tuberculosis Controllers Association (NTCA) indicated that shortages and other problems that hinder access to SLDs interfere with patient care and could promote the development of drug resistance as well as the transmission of drug-resistant Mycobacterium tuberculosis. This report focuses on the growing issue of TB drug shortages and summarizes the findings of that survey, which indicated that 26 (79%) of the 33 responding health departments, representing approximately 75% of the U.S. TB burden, reported MDR TB during 2005-2010. Of these 26, 21 (81%) faced difficulties with SLD procurement, citing nationwide shortages (100%), shipping delays (71%), lack of resources (62%), and a complicated procurement process related to investigational new drug (IND) protocols (48%) as the main reasons. Adverse outcomes or other problems related to difficulties with SLD procurement were reported by 19 (90%) of 21 jurisdictions, with treatment delay (58%), a treatment lapse or interruption (32%), or the use of an inadequate regimen (32%) most commonly reported. Potential solutions for alleviating SLD shortages include stockpiling drugs centrally, sharing SLDs among jurisdictions, obtaining drugs from foreign manufacturers, and taking advantage of new legal requirements for drug suppliers to report shortages and impending shortages to FDA within a specified timeframe. Reliable, consistent access to SLDs will require the collaboration of CDC, FDA, state and local health departments, national health professional societies, and the pharmaceutical industry.