Establish Technical Working Groups

  • Develop a national implementation plan for new medicine introduction. Examples of key areas include:
    • Active drug surveillance monitoring and management (aDSM) approach and electronic tools for data collection (such as PViMS), collation and analysis.
    • Laboratory/diagnostic requirements for bedaquiline and delamanid use
    • Table with list of baseline exams/tests, follow up and monitoring can be found here)
    • Monitoring , supervision, and mentoring approach for activities
    • Clinical management of patients
    • Staff capacity and skills building plan
    • Resource mobilization plan ( e.g., funds, technical assistance)
    • Desired timeframe for implementation
  • Develop clinical guidelines and standard operating procedures (SOPs) for clinicians
  • Agree on evidence-based assumptions for planning purposes, such as —
    • Number of eligible patients for new drug use over a defined time period
    • Country specific new drug regimen including companion medicines (in accordance with WHO recommended regimen structure)
    • Planned treatment sites
  • Plan for procurement and supply chain management for new and companion medicines. Examples of activities include quantification, supply planning, and use of an early warning system using tools like QuanTB to prevent stock-outs and minimize wastage of medicines.
Please note that eligible countries can obtain bedaquiline for free through the USAID Bedaquiline Donation Program
  • However, countries have to secure funds for–
    • Procurement of companion medicines
    • Shipping fees for bedaquiline and companion medicines
    • Port clearance fees
    • In country distribution costs (depending on country requirements)
  • Obtain approval from country appropriate bodies. Identify key people within each group who are responsible for gaining the approval and ensuring that implementation is in alignment with country objectives. These groups include ethics committee, MOH, regulatory approval for new drug use (medicine waiver approval or medicine registration

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