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Introduction of Bedaquiline for the Treatment of Multidrug-Resistant Tuberculosis at Country Level

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Introduction of Bedaquiline for the Treatment of Multidrug-Resistant Tuberculosis at Country Level Introduction of bedaquiline for the treatment of multidrug-resistant tuberculosis at country level Implementation plan World Health Organization APRIL 2015 WHO FINAL PRE-FORMATTED VERSION APRIL, 2015 1 © World Health Organization 2015 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for non-commercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. WHO/HTM/TB/2015.10 WHO FINAL PRE-FORMATTED VERSION APRIL, 2015 2 Contents Abbreviations.................................................................................................................................................................................. 5 Definitions ........................................................................................................................................................................................ 6 1. Why an implementation plan? ................................................................................................... 8 Introduction ..................................................................................................................................................................................... 8 WHO recommendation for the use of bedaquiline ...................................................................................................... 9 Objective of the implementation plan ............................................................................................................................. 11 2. Establishing the implementation plan ................................................................................. 12 Step 1: Establishing the framework for the introduction of bedaquiline at country level ...... 12 a. Assess the national context ............................................................................................................................................ 12 b. Contact relevant units/departments at the health ministry............................................................................... 14 c. Identify implementing partners ................................................................................................................................... 14 d. Create a national implementation Task Force and a Technical Working Group ......................................... 14 e. Coordinate with the National Regulatory Authority ............................................................................................. 16 f. Establish a dialogue with pharmaceutical companies .......................................................................................... 16 g. Ensure appropriate procurement system for bedaquiline.................................................................................. 16 h. Organize sensitization workshops .............................................................................................................................. 17 Step 2. Meeting the minimal requirements for introduction of bedaquiline ............................... 18 a. Laboratory capacity .......................................................................................................................................................... 18 b. Drug resistance survey .................................................................................................................................................... 20 c. Clinical Review Committee ............................................................................................................................................ 21 d. Case management ............................................................................................................................................................. 21 e. Recording and reporting system .................................................................................................................................. 22 f. Monitoring and evaluation ............................................................................................................................................ 22 g. Pharmacovigilance ............................................................................................................................................................ 22 h. Budget ................................................................................................................................................................................... 25 i. Technical assistance ......................................................................................................................................................... 26 j. Drug supply system .......................................................................................................................................................... 26 k. Checklist for country preparedness and planning ................................................................................................ 26 Step 3: Development of a national plan for the introduction of bedaquiline .............................. 30 Selection of model of introduction and pilot sites .................................................................................................... 30 Developing a national plan for introduction of bedaquiline ............................................................................... 32 a. Rationale for the introduction of bedaquiline at country level ......................................................................... 32 b. Development or update of national clinical guidelines ........................................................................................ 32 c. Development of plans for laboratory needs ............................................................................................................. 33 d. Recording and reporting ................................................................................................................................................. 33 e. Monitoring and evaluation ............................................................................................................................................. 33 f. Pharmacovigilance ............................................................................................................................................................ 34 g. Ethical aspects .................................................................................................................................................................... 35 h. Calculation of drug needs ............................................................................................................................................... 35 i. Training of managers and staff ..................................................................................................................................... 35 j. Human resources development plan .......................................................................................................................... 35 k. Timeline development ..................................................................................................................................................... 36 l. Budget development ........................................................................................................................................................ 36 m. Obtaining consensus from donor agencies ............................................................................................................... 36 Step 4: Implementing the introduction of bedaquiline ...................................................................... 38 a. Identify patients eligible for treatment with bedaquiline ................................................................................... 38 b. Informed consent .............................................................................................................................................................. 40 c. Clinical Review Committee consultation
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