LAC DPH Health Advisory: Temporary National Shortage of Rifampin Oral Capsules March 3, 2022 FDA, LAC DPH, Los Angeles, Los Angeles County, Los Angeles County Department of Public Health, Pulmonary TB, Rifampin 1395 Key Messages There is a temporary national shortage of rifampin oral capsules attributable to product discontinuations, equipment malfunction, and shortage of an active ingredient. Rifampin is the cornerstone of multi-drug treatment regimens for active tuberculosis (TB) disease. Rifampin is also a component of two preferred short-course preventive treatment regimens for latent TB infection (LTBI). Healthcare providers and pharmacies in Los Angeles County should assess current inventories of rifampin oral capsules and notify the Los Angeles County Department of Public Health (LAC DPH) Tuberculosis Control Program if experiencing stock-outs of any rifamycin product. Situation On December 22, 2021, the FDA announced a temporary national shortage of oral rifampin capsules attributable to product discontinuations, equipment malfunction, and shortage of an active ingredient. Since that time, LAC DPH has continued to augment local supplies of oral rifampin capsules by accessing the National TB Emergency Drug Stockpile. Nonetheless, beginning in mid-January 2022, multiple local pharmacies in Los Angeles County have reported challenges with the timely procurement of oral rifampin capsules for the treatment of patients with both active TB disease and LTBI. LAC DPH anticipates that the current oral rifampin capsule shortage may continue to affect local healthcare providers and pharmacies until April 2022. The current oral rifampin capsule shortage is compounded by ongoing national shortages of lyophilized rifampin powder for intravenous injection and oral rifapentine tablets. The Role of Rifampin in TB Control and Elimination Pulmonary TB is an airborne transmissible disease, and rifampin is the cornerstone of modern multi-drug treatment regimens for active TB disease. Rifampin-containing regimens shorten total treatment duration, improve TB-free survival, and diminish infectiousness in patients with active TB disease. Rifampin is also a component of two short-course preventive treatment regimens: 4 months of daily rifampin (4R), and 3 months of daily isoniazid plus rifampin (3HR). The efficacy of LTBI treatment in preventing progression to active TB disease is ≥90%. Due to improved real-world completion rates, equivalent efficacy, and favorable tolerability, rifamycin-based short-course regimens are preferred over conventional isoniazid monotherapy. Temporary or ongoing drug shortages alone should not be seen as justifications to postpone, interrupt, or otherwise compromise the effectiveness of treatment for patients with active TB disease and LTBI. Actions Requested of Providers Assess inventory and notify of rifamycin stock-outs Assess current inventory of rifampin oral capsules and other rifamycins. Notify LAC DPH’s Tuberculosis Control Program (TBCP) immediately if experiencing stock-outs of rifampin, rifabutin, or rifapentine (see Reporting and Consultation below for contact information). Prioritize treatment of active TB disease Prioritize patients with active TB disease to receive rifampin-based multi-drug treatment. Consider rifabutin as an alternative for patients who have relative or absolute contraindications to rifampin, including clinically significant drug-drug interactions or prior history of severe adverse drug reactions. Please request clinical consultation with TBCP subject matter expert(s) if considering use of the new 4-month high-dose rifapentine-moxifloxacin regimen for the treatment of active TB disease, as use of this regimen warrants special diagnostic and monitoring procedures. Considerations for treatment of LTBI During the temporary oral rifampin shortage, consider preferential use of the rifapentine-based preventive treatment regimen for LTBI: once-weekly, high-dose isoniazid plus rifapentine (3HP) via either directly observed or self-administered therapy. For patients with a contraindication to 3HP, continue to use a preferred rifampin-based preventive regimens for LTBI: 4 months of daily rifampin (4R), and 3 months of daily isoniazid plus rifampin (3HR). For patients who are unable to take a rifamycin-based preventive regimens, 6 or 9 months of daily isoniazid monotherapy are acceptable alternatives. If a rifampin-based regimen is discontinued early for any reason, LTBI treatment can be completed with a proportionate duration of another recommended regimen. Reporting and Consultation All suspected or proven cases of tuberculosis should be reported in writing within 1 working day. Los Angeles County DPH TB Control Program: Download forms at http://ph.lacounty.gov/tb/reporting.htm and fax to 213-749-0926 For inquiries, call 213-745-0800 during business hours. For urgent consults after hours call 213-974-1234 and ask for the physician on call. Long Beach Health and Human Services: Download forms at http://www.longbeach.gov/health/diseases-and-condition/reporting-requirement/tb-laws-and-regulations/ and fax to 562-570-4391. For inquiries, call 562-570-4283 or 562-570-4235. Pasadena Public Health Department: Download forms at https://www.cityofpasadena.net/public-health/wp-content/uploads/sites/32/Pasadena-Confidential-Morbidity-Report-CMR-Form-09-2011.pdf?v=1590182630275 and fax to 626-744-6115 or send by encrypted/secure email to nursing@cityofpasadena.net. For inquiries, call 626-744-6089. Additional Resources • LAC DPH TB provider webpage ph.lacounty.gov/tb/healthpro.htm This communication was sent by Julie Higashi MD, Director, Tuberculosis Control Program, Los Angeles County Department of Public Health. To view a printable PDF of this communication and other LAHAN communications, please visit publichealth.lacounty.gov/lahan. If this message was forwarded to you, please join LAHAN here.