Tuberculosis Drug Supply Interruptions and Shortages

Dear Colleague Letters

May 11, 2023

Dear Colleagues:

The Division of Tuberculosis Elimination (DTBE) has been made aware of the tuberculosis (TB) drug shortage challenges that many of you are experiencing. Some of you have reported difficulty accessing isoniazid (INH), rifampin (RIF), rifapentine (RPT), ethambutol (EMB), or pyrazinamide (PZA).

Factors that have contributed to these shortages and lack of access include loss of manufacturers, interruptions in supply chains, variations in geographic distribution, erratic drug supplies, increasing costs, and lack of active ingredients that may be imported.

Unreliable drug supplies have made caring for TB patients more difficult, with some of you reporting the need to revise treatment plans, priorities, and program practices because of supply disruptions for first line TB drugs. Since December 2021, FDA has classified rifampin (RIF) as in short supply (FDA Drug Shortages – Rifampin). Currently FDA is not reporting INH, EMB, or PZA to be in shortage.

To avoid treatment disruptions in the event of a national drug shortage, DTBE established a TB Drug Stockpile that can release units to programs when there is a national shortage (as defined by FDA) or when drugs in the stockpile are going out of date. DTBE released units of RIF to multiple TB programs early this year. The DTBE Stockpile presently has INH and RIF on order.

If supply chain or other issues prevent you from procuring antituberculosis medications, you are encouraged to pursue the following options in whatever order is reasonable given the circumstances, access, and likelihood of success for your program:

• Reach out to all four major distributors for drug availability; when a distributor has limited availability of a TB drug, another may have that drug available.
• Negotiate TB drug loan/repayment agreements and potentially borrow from other programs.
• Explore obtaining shipment direct (drop shipments) from manufacturers. Manufacturers are usually listed on distributors' ordering portals; however, sometimes drop shipments need to be arranged through distributors.
• Pursue obtaining the drug in question on the retail market.
• Consult with your DTBE Project Officer about ordering drugs from the CDC Stockpile when there is a national shortage (as defined by FDA) or when stockpile drugs are going out of date.

Given the repeated local supply disruptions that have been seen over the past two years, you are encouraged to take proactive measures to reduce drug supply interruptions:

• Develop contingency plans for obtaining specific drugs in the event of local or regional drug supply interruptions.
• Consider contracting with a back-up supplier(s), if possible.

Unfortunately, DTBE is not authorized to effect change in national or regional drug supplies or costs.

We encourage you to keep your CDC Project Officers informed about drug shortages.

Respectfully,

Terence Chorba, MD, DSc, LLM, MPH, MPA, FACP, FIDSA
Chief, Field Services Branch, Division of Tuberculosis Elimination
National Center for HIV, Viral Hepatitis, STD, and TB Prevention
Centers for Disease Control and Prevention