This guest post was provided by GHC member United States Pharmacopeial Convention (USP).
The United States Pharmacopeial Convention (USP) promotes and supports end-to-end quality assurance across health systems in partnership with regulatory authorities, policymakers, donors, and other key stakeholders. Through multiple programs, USP provides technical assistance, workforce development, and sets standards to improve access to quality-assured, life-saving medicines that protect patients. USP’s longstanding partnership with United States Agency for International Development (USAID) has led to significant advancements in medicine quality in priority regions, with key activities currently implemented through the Promoting the Quality of Medicines (PQM) program in 34 countries.
Most tuberculosis (TB) cases can be treated with first line, or preferred, medicines. However, bacteria that cause TB can become resistant to first line medicines, which causes a condition known as multi-drug resistant TB (MDR-TB). In 2015, the World Health Organization (WHO) estimated that of the 580,000 people requiring multi-drug resistant tuberculosis (MDR-TB) treatment, only 20% were enrolled in therapy. For individual patients, this form of TB can mean longer, less effective, and more expensive treatment, which is inhibited further if the medicine provided is not quality-assured. Therefore, increasing supply of and access to quality-assured second line MDR-TB medicines is a high priority in treatment efforts.
Kanamycin is one of the key second line medicines used for treatment of MDR-TB. In 2016, to help increase the availability of quality-assured kanamycin, PQM negotiated the purchasing price with manufacturers based on the costs incurred by the producer in exchange for technical assistance. This intervention had two significant results: the price of quality-assured kanamycin fell, becoming available in liquid form for widespread distribution for the first time to the Global Drug Facility, WHO’s procurement mechanism. The price of 1-g kanamycin solution made available through PQM’s intervention is 73% less than the same product from other suppliers; the intervention also set the lowest price benchmark for 0.5-g and 1-g kanamycin injection solutions on the global public health market, which is expected to drive down the price of kanamycin produced by other manufacturers as well. Ultimately this will enable donors and national TB programs to save millions in public health funding, allowing more efficient and widespread service delivery.