Stop TB Partnership

Stop TB Partnership warns of a temporary shortage of quality-assured Streptomycin

10 November 2010 - Geneva - The Stop TB Partnership anticipates a temporary shortage of quality-assured Streptomycin. This shortage, which is also affecting other suppliers, is related to quality issues of the Active Pharmaceutical Ingredient (API) source used by one of the main Streptomycin suppliers of the Partnership's Global Drug Facility (GDF). Additionally, as major donors and technical agencies have adopted more stringent quality assurance policies, GDF is not in the short-term able to secure sufficient quantities of Streptomycin that meet the new stringent criteria (see GDF Quality Assurance Policy [.pdf]).

GDF has been working actively to mitigate these challenges by identifying and contracting new eligible manufacturers and suppliers of Streptomycin. GDF is also working with industry and the WHO Prequalification Programme to facilitate the inspections and certifications necessary for alternative manufacturers to become eligible for supply by GDF.

Countries are advised to consider different temporary solutions. National TB programs may find it necessary to shift existing in-country drug stock of Streptomycin between treatment centres to cover basic needs until the supply situation improves. Alternatively, if countries choose to buy Streptomycin from other sources, it is highly recommended that quality assurance criteria for the selection of anti-TB medicines and manufactures be adhered to as donor requirements may apply (see GDF Quality Assurance Policy [.pdf] and Global Fund Quality Assurance Policy [.pdf] for specific requirements).

For GDF recipient countries, the current problem means that over the next six to nine months, Streptomycin will be available in limited quantities and have longer lead times for delivery (i.e.; 6-8 months). GDF advises countries to ensure sufficient funds be available to cover the increased cost of retreatment (Category II). The most up-to-date prices are posted here. Products from the new suppliers may require in-country registration prior to importation, causing further delay.

Current WHO treatment recommendations should be strictly adhered to. The latest WHO guidelines emphasize the following:

  • Specimens for culture and drug susceptibility testing (DST) should be obtained from all previously treated TB patients at or before start of treatment. In settings where rapid molecular-based DST is available, the results should guide the choice of regimen-- i.e.; those patients detected as having MDR-TB should be placed on an MDR-TB regimen.*
  • In settings in which conventional culture and DST are available (i.e. where DST results may be reported only after 2-3 months)--or if they are not available--an empiric MDR regimen should be administered to patient groups with a high likelihood of MDR-TB, such as patients in whom an initial first-line treatment has failed.*
  • In patient groups with medium or low likelihood of MDR, and in those who have demonstrated drug susceptibility--as a temporary measure until the shortage of quality assured Streptomycin is resolved--a regimen of 3HREZ/5HRE could be considered. This treatment should be given daily and under direct observation, preferably for the whole duration of treatment, but at a minimum for the intensive phase of treatment.

GDF will make every effort to respond to shortages and impending stock outs and will allocate Streptomycin to those countries in greatest need. GDF will maintain regular contact with countries to get updates on stock levels and consumption data.

*World Health Organization (WHO). Treatment of Tuberculosis Guidelines. Fourth Edition. WHO/HTM/TB/2009.420 Geneva, Switzerland: WHO, 2010, pages 38-41. Document available here.