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Title of Trip Report Drug Use Reviews—A Practical Strategy to Ensure the Rational Use of Anti-Tuberculosis Medicines November 2014 Drug Use Reviews—A Practical Strategy to Ensure the Rational Use of Anti-Tuberculosis Medicines This report is made possible by the generous support of the American people through the US Agency for International Development (USAID), under the terms of cooperative agreement number AID-OAA-A-11-00021. The contents are the responsibility of Management Sciences for Health and do not necessarily reflect the views of USAID or the United States Government. About SIAPS The goal of the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program is to assure the availability of quality pharmaceutical products and effective pharmaceutical services to achieve desired health outcomes. Toward this end, the SIAPS result areas include improving governance, building capacity for pharmaceutical management and services, addressing information needed for decision-making in the pharmaceutical sector, strengthening financing strategies and mechanisms to improve access to medicines, and increasing quality pharmaceutical services. Recommended Citation This report may be reproduced if credit is given to SIAPS. Please use the following citation. SIAPS. 2014. Drug Use Reviews—A Practical Strategy to Ensure the Appropriate Use of Anti- Tuberculosis Medicines. Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program. Arlington, VA: Management Sciences for Health. Key Words Multidrug-resistant tuberculosis drug therapy; multidrug-resistant tuberculosis prevention and control, Anti-tubercular agent administration and dosage; drug use review; rational drug use. Systems for Improved Access to Pharmaceuticals and Services Center for Pharmaceutical Management Management Sciences for Health 4301 North Fairfax Drive, Suite 400 Arlington, VA 22203 USA Telephone: 703.524.6575 Fax: 703.524.7898 E-mail: [email protected] Website: www.siapsprogram.org ii TABLE OF CONTENTS Abbreviations and Acronyms ....................................................................................................... v Acknowledgments ..................................................................................................................... vii Foreword .................................................................................................................................... ix How to Use This Resource......................................................................................................... xi Overview .................................................................................................................................... 1 Background ................................................................................................................................ 3 The Problem of Drug Resistance in Tuberculosis ................................................................... 3 Problems with Anti-Tuberculosis Medicine Use ...................................................................... 3 Drug Use Review of Anti-Tuberculosis Medicines .................................................................. 6 How to Implement a Drug Use Review Strategy ......................................................................... 9 Phase 1. Plan the DUR Strategy ...............................................................................................11 Step 1. Establish Responsibility for the DUR Process ........................................................11 Step 2. Develop Procedures ..............................................................................................12 Step 3. Elements of Drug Use Reviews .............................................................................19 Step 4. Define All Services Where Anti-TB Drugs are Used ...............................................23 Step 5. Prepare Data Collection Forms ..............................................................................24 Step 6. Orient Data Collectors............................................................................................30 Phase 2: Conduct the DUR .......................................................................................................31 Step 7. Collect Data ...........................................................................................................31 Step 8. Tabulate Data ........................................................................................................31 Step 9. Interpret Data .........................................................................................................33 Phase 3: Implement an Improvement Plan ................................................................................34 Step 10. Make Recommendations for Improvement .........................................................34 Step 11. Disseminate Results and Discuss the Improvement Plan ...................................35 Step 12. Implement the Improvement Plan ......................................................................35 Phase 4: Assess Effectiveness of the Intervention ....................................................................36 Step 13. Conduct a Follow-up DUR .................................................................................36 Step 14. Review and Discuss Follow-up Data ..................................................................36 Step 15. Evaluate the Strategy .........................................................................................36 Step 16. Plan and Implement the Next Cycle ...................................................................37 Conclusion ................................................................................................................................39 Annex A. Published Criteria for Anti-Tuberculosis Treatment ....................................................41 First-Line Drugs.....................................................................................................................41 Second-Line Drugs ............................................................................................................. 104 Group 5 Drugs .................................................................................................................... 210 New Drugs .......................................................................................................................... 255 Regimens ............................................................................................................................ 277 Annex B. Sample Data Collection Forms ................................................................................ 279 Annex C. Sample DUR Results Summary Report ................................................................... 295 Annex D. Sample Drug Use Review Activity Tracker............................................................... 299 iii Drug Use Reviews—A Practical Strategy to Ensure the Rational Use of Anti-Tuberculosis Medicines Annex E. Therapeutic Drug Monitoring of Anti-TB Medicines .................................................. 301 Method 1. Dosing Modifications Based on Percentage of Usual Dose ................................ 302 Method 2 Dosing Modifications Based on Serum Levels (Hartford Hospital) ....................... 302 Method 3. Sawchuk and Zaske ........................................................................................... 303 Method 4 Bayesian Method for PK Parameter Estimation .................................................. 307 Annex F. Hepatotoxic, Nephrotoxic, Neurotoxic, And Ototoxic Drugs ...................................... 309 Hepatotoxic Drugs ............................................................................................................... 309 Nephrotoxic Drugs .............................................................................................................. 310 Neurotoxic Drugs ................................................................................................................ 313 Ototoxic Drugs .................................................................................................................... 320 Annex G. Potentially Overlapping Toxicities of Antiretrovirals and Anti-Tuberculosis Agents .. 339 Annex H. Tyramine- and Histamine-Containing Foods ............................................................ 341 Annex I. Managing Drug Interactions with Antiretrovirals and Rifampicin ................................ 345 Annex J. Managing Drug Interactions with Antiretrovirals and Rifabutin ................................. 347 Annex K. Drugs That Prolong the QT Interval or Induce Torsades de Pointes ........................ 349 References ............................................................................................................................. 351 iv ABBREVIATIONS AND ACRONYMS AMR anti-microbial resistance DOTS core approach underpinning the Stop TB strategy for TB control DR-TB drug-resistant tuberculosis DS-TB drug susceptible tuberculosis DST drug susceptibility testing DUR drug use review FDC fixed-dose combination HIV human immunodeficiency virus IV intravenous IM intramuscular MDR-TB multidrug-resistant tuberculosis M&E monitoring and evaluation MSH Management Sciences for Health NPV National Pharmacovigilance Center NTP National Tuberculosis Program NSAID non-steroidal anti-inflammatory drug OR operations research PPM
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