1. Development of Country-Specific Plans for TB Drug Selection and Use China, Brazil, and Indonesia

2. Overall Observations Overall context is critical. Must also consider political issues and issues of leadership. Strategies also need to address these issues. National laws prohibiting competition (Indonesia) between manufacturers, or those that require drugs to be purchased from specific manufacturers (Brazil) impose constraints on TB programs. National decentralization laws impact the effectiveness of national programs (China, Brazil, Indonesia).

3. Observations Related to Selection Operational challenges of introducing FDCs are greater than those of modifying existing FDCs (Brazil) Expand the number of WHO-certified bioavailability labs Expand the number of quality-assurance labs Lack of options to procure FDC drugs implies that market conditions impact selection

4. Observations Related to Use Important to consider variations in the delivery system: – Community approaches – Non-medical treatment observers – Family health model in Brazil Important to provide guidelines in the use of FDCs In addition to incentives for patient adherence, it is important to emphasize provider incentives and develop guidelines

5. Use, Continued Must look at incentives for all stakeholders in the health system and consider the entire delivery system. Lack of experience with FDCs for TB: current intermittent regimen used in China is not consistent with use of 4-drug FDCs. Important to use OR to evaluate implementation of FDCs in program setting before rolling out. Effective strategies to influence the private sector are needed (Brazil, Indonesia). Example: PPM DOTS strategies. Effective strategies are needed to increase patient knowledge and stimulate demand. Example: IEC campaigns.

6. Observations Related to Procurement Lack of policies that allow for effective competition. Assessments that show the lack of competition as an obstacle to drug availability are needed, as well as those that show how resources are not being used effectively. Transparency is critical. A central TB-drug procurement body may be effective. China has multiple ways to procure drugs for NTP (e.g., WB loans, government funding). This imposes challenges for coordination, standardization, and quality assurance.

7. Procurement, Continued Partners (donors) procure with their own methods. Need better coordination so that donors have a uniform policy. Example: Interagency coordination group in China. Quality assurance procedures are inadequate. Generally, quality checks happen only postproduction.

8. Observations Related to Distribution Inadequate distribution schedule (Indonesia distributes once a year, depending on the budget cycle which is broader than the TB program) Absence of a buffer stock (Indonesia) No clear mechanism to manage the distribution of donated drugs (Indonesia) Distribution problems relate to poorly functioning drug-management information systems (Indonesia, China, Brazil) Delays in distribution cause drugs to expire