Stop TB Partnership Global Drug Facility (GDF) working to mitigate shortage of quality-assured streptomycin

17 January 2011 - Geneva - Following GDF's warning in November about an anticipated temporary shortage of quality-assured streptomycin, countries were advised to consider different temporary solutions, including shifting existing in-country stock of streptomycin between treatment centres to cover basic needs and purchasing streptomycin from other sources while adhering to quality assurance criteria.

Since then, GDF has been able to identify manufacturers producing streptomycin in accordance with its quality assurance policy, although the production capacity of these producers is limited to covering national needs only; and production prices are high.

GDF will begin delivering streptomycin in the first quarter of 2011, in limited supply until at least mid-2011. The allocation of these stocks to existing GDF orders will be prioritized by the date an order was received and countries' stock levels, but multiple shipments may be needed to fulfil an order to completion. New orders placed for quality-assured streptomycin through GDF remain subject to substantial lead times, with delivery unlikely before end-2011.

In parallel, GDF is working with industry in countries including China, India and South Africa and with WHO experts on quality and safety of medicines to facilitate the inspections and product assessments necessary for alternative manufacturers to become eligible for supply by GDF.

GDF will remain in contact with countries to collect information on their stock levels and inform them of the status of their streptomycin orders.

The shortage has been related to quality issues of the Active Pharmaceutical Ingredient source used by one of the main streptomycin suppliers of the Partnership's Global Drug Facility (GDF). Additionally, more stringent quality assurance policies [.pdf] adopted by major donors and technical agencies have made it difficult for GDF to secure, in the short term, sufficient quantities of streptomycin meeting the new criteria.

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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 [.pdf].