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No. 4, 2013

NTCA Responds to the Shortages of TB Drugs and Diagnostics

TB drugs and diagnostics are truly a lifeline for TB control. However, shortages and price increases periodically make these tools inaccessible to health care providers. A series of shortages and price increases in TB drugs and diagnostics started in the fall of 2012 and continued in 2013. To address these problems nationally, federal agencies and advocacy organizations need real-time, verifiable information about the scope and effects of these shortages.

The NTCA has been engaged in discussions with directors of TB control programs about the impact of these shortages on programs and on the patients served. For example, state program staff have been diverted from TB control activities to respond to frequent inquiries from local health departments and other community providers (hospitals, schools, correctional facilities, pharmacies, and long-term care facilities) about the shortages of tuberculin purified-protein derivative antigen solutions and how to meet state rules for testing. Program directors and healthcare providers have made decisions about setting priorities for whom to test, and ultimately to treat. 

The TB community needs firm, clear information to provide to federal agencies to document the shortages and the price increases; however, to date there has been no single place to report these issues. In response, the NTCA Drug Shortages Workgroup developed an online system to report shortages of, and price increases in, TB drugs and diagnostics.

The TB Drugs and Diagnostics Reporting Form was developed and pilot-tested by NTCA members. It is intended for use by personnel in state, regional, county, and city TB programs as well as in public and private sector organizations that include TB screenings in their health maintenance activities, such as universities, schools, correctional facilities, hospitals, and long-term care facilities, to report a shortage or price increase of a TB drug or diagnostic. Interferon gamma release assays (IGRAs) were added prior to release of the reporting form, in recognition that some areas experienced interruptions in supply during the TB biologics shortage.

Goals for this reporting and tracking system include-

  • Provide an interim notification system for drug and diagnostic supply issues until a national system is in place.
  • Collect information on challenges in the United States relating to accessing drugs and diagnostics.
  • Describe the frequency and distribution of shortages and cost escalations over time in the United States.
  • Describe the effects of shortages on patients, programs, and TB control efforts in the United States.
  • Describe the actions taken to resolve access problems.
  • Provide summary data in periodic intervals to NTCA, CDC, FDA, policy makers, advocacy groups, and manufacturers working towards continuous, affordable pharmaceutical and diagnostic supplies.
  • Provide documented evidence of price escalations to the proper federal agency for a federal investigation into the reported cost increases.

Attributes of the reporting mechanism include-

  • Feasibility; simple, easy to use, brief, accessible
  • Relevance to users in different settings
  • Provision of actionable data
  • Ability to provide periodic reports and to be maintained by NTCA
  • Provision of definitions, terms, and categories that can accurately capture intended information

The web-based reporting mechanism is available on the NTCA website’s home page, www.tbcontrollers.org. In addition to the link to the reporting mechanism, supplemental documents outline the background for the development of the reporting mechanism, instructions for the use of the reporting mechanism, and FAQs. 

Please use this new tool to report the shortages and price escalations you have experienced. We ask that you also inform your community partners about this new reporting mechanism, so the database will have input from public and private health providers. 

NTCA will report to TB Notes periodically on the status of the reporting mechanism, the information submitted to our federal partners, and the effectiveness of documenting these issues.

 

—Submitted by Jennifer Kanouse
and Donna Hope Wegener, on behalf of
the NTCA TB Drug Shortages Workgroup

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