// September 21, 2023

Beyond TB medicines: How quality assurance is elevating health systems in Central Asia

tuberculosis diagnosis

In Central Asia and Eastern Europe, multidrug-resistant tuberculosis (MDR-TB) accounts for a significant proportion of the global burden of drug-resistant TB cases. But while national TB programs that tackle MDR-TB are making progress in safeguarding the supply chain for better TB diagnosis and treatment, they’re also generating a much broader, positive effect in strengthening entire health systems.

Investments in TB are resulting in spillover benefits which strengthen health systems more broadly

Progress includes improving national regulatory oversight, expanding regional manufacturing, bolstering laboratory networks, and enhancing storage and distribution practices. These advances impact not only TB, but also other diseases, like HIV/AIDS, and improve maternal, newborn, and child health, making health systems stronger across the board, ensuring patients have access to quality-assured medical products.

Securing the supply chain for TB medicines in the Kyrgyz Republic

In the Kyrgyz Republic, the Ministry of Health recently adopted new guidelines for proper medicine storage and warehouse practices, as well as improved quality monitoring of medical products. Prior to this, state pharmacies across the country lacked clear and consistent direction for how to best store medical products, including those used to combat TB.

These guidelines, developed by USAID's Cure Tuberculosis project, led by JSI, in partnership with USP, provide robust support to state supply chain systems to ensure the appropriate supply, storage, and dispensing of all medicines within state health organizations.

Additional guidance outlines strategies, principles, and procedures for the quality monitoring of medical products that meet global standards.


Project spotlight: Combatting TB in the Kyrgyz Republic
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Broad public health impact

The guidelines were initially developed for the management of TB medicines for the National TB Center of the Kyrgyz Republic, however, after review, the Ministry of Health decided to adopt the guidance for all medicines, not just those used to combat TB.

This means that across local primary health care clinics, regional hospitals, and tertiary health centers, all pharmacy staff working at public health institutions may now follow the same proper storage and dispensing procedures according to World Health Organization (WHO) best practices. In this way, the Ministry of Health is working to assure quality across the medicine supply chain, including through improved sampling of stored medical products and quality control planning, to improve public health nationwide.

As a valuable tool for drug management with a focus on proper inventory, accounting, and classification of medical products, the guidance also serves as a practical manual for regular, ongoing training activities across state health care organizations.


Tackling drug resistant TB in Central Asia
How manufacturing, laboratory and regulatory systems, and pharmacovigilance are helping to combat TB.
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Registering medicines for TB and beyond in Uzbekistan

In addition to proper storage and distribution, swift registration of quality-assured medicines by national regulatory authorities is critical to maintaining a resilient medicine supply chain.

In Uzbekistan, the Promoting the Quality of Medicines (PQM+) program, funded by USAID and led by USP, helped streamline the registration of quality-assured TB medicines, which is also facilitating faster registration of other essential medicines.

PQM+ helped Uzbekistan reduce registration times for six TB products to an average of 35 days and decrease registration fees by 40 percent

One mechanism to expedite national approvals is the WHO collaborative procedure for accelerated registration of WHO prequalified products, which leverages information and assessments already collected or completed by WHO to accelerate in-country registration. While Uzbekistan was already a participating member of the WHO procedure, prior to PQM+ support, the national regulator had not previously used the mechanism for medicine to register medicines.

In partnership with Uzbekistan’s Center for Pharmaceutical Product Safety (CPPS), PQM+ developed standard operating procedures (SOPs) and guidelines, facilitated trainings on WHO requirements, and supported manufacturers with guidelines for how to develop and submit dossiers to register WHO prequalified medicines in the country.

Broad public health impact

While initially focused on TB products, the WHO procedure can be applied to other WHO prequalified essential medicines, not just those used for TB.

In fact, since the accelerated process was originally implemented, three manufacturers of WHO prequalified vaccines for childhood diseases have also registered their products in Uzbekistan through this process. In addition, multiple additional manufacturers are preparing submissions for other WHO-prequalified medicines.

Moving forward, the country is better positioned to use this approach to improve the registration of other WHO prequalified medicines and vaccines.


Building a resilient supply chain for TB
Preventing, treating, and curing patients with drug resistant TB is a major public health challenge.
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Importance of ensuring quality in the supply chain

Registration, storage, and distribution are key components of a resilient medicine supply chain. When medical products are properly registered, managed, and replenished in a timely manner, pharmacies ensure a consistent supply of medicines for patients and provide quality care and treatment.

Unfortunately, failing to properly register, store, or dispense medicines can have devastating effects on patients. When it comes to TB treatment in particular, these types of breakdowns in the medicine supply chain can be life-threatening. If quality is compromised, TB medicines may not work as intended, or can lead to the development of drug-resistant or multidrug-resistant TB.

ensuring quality across the supply chain
Animation by Sheyda Sabetian

Global impact of TB investments

Building capacity in the Kyrgyz Republic and Uzbekistan to better store and dispense medical products and quickly and effectively register medicines, highlights how investments in TB are resulting in spillover benefits which strengthen health systems more broadly.

Policies and activities originally designed with TB in mind, are having a larger national, regional, and global impact beyond a single disease. By assuring quality across the supply chain and improving access to quality-assured TB medicines, these programs are in turn strengthening systems for other essential medical products and resulting in broader adoption of quality assurance best practices.