Bedaquiline Donation: Technical Assistance Request Form


Request from

Name of Institution:
Address:
Phone number:
Email address:

Submitted to

USAID Bedaquiline Donation Program

Areas of Technical Assistance requested

The country is requesting technical assistance to meet the following condition(s).

Effective treatment and monitoring: Treatment must be closely monitored for effectiveness and safety, using sound treatment and management protocols approved by relevant national authorities.
Yes No Priority
Proper patient inclusion: Special caution is required when bedaquiline is used in people aged 65 and over, and in adults living with HIV. Use in pregnant women and children is not advised.
Yes No Priority
Informed consent: Patients must be fully aware of the potential benefits and harms of the new drug, and give documented informed consent before embarking on treatment.
Yes No Priority
Adherence to WHO recommendations: All principles on which WHO-recommended MDR-TB treatment regimens are based, must be followed, particularly the inclusion of four effective second-line drugs. In line with general principles of TB therapeutics, bedaquiline alone should not be introduced into a regimen in which the companion drugs are failing to show effectiveness.
Yes No Priority
Active pharmacovigilance and management of adverse events: Active pharmacovigilance measures must be in place to ensure early detection and proper management of adverse drug reactions and potential interactions with other drugs.
Yes No Priority

Partnerships

1. Is the country working with any partners (NGO, academic, etc.) or consultants on strengthening the MDR TB program, or pharmacovigilance? Please list below

Name of the partner organization or consultant:
Technical area of support:
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2. Are there any additional partners or consultants working with the country on TB (not specific to MDR TB) that could be provide technical assistance to country? Please list below

Name of technical partner or consultant:
Technical area of support:
Click the button to include your information: