Clinical standards for the dosing and management of TB drugs
Jan‐Willem C. Alffenaar, Sophie L. Stocker, Lina Davies Forsman, Anthony J. Garcia‐Prats, Scott K. Heysell, Rob E. Aarnoutse, Onno W. Akkerman, Alena Aleksa, Richard van Altena, W. Arrazola de Oñata, Perumal Kannabiran Bhavani, Natasha van’t Boveneind-Vrubleuskaya, Anna Cristina Calçada Carvalho, Rosella Centis, Jeremiah Chakaya, Daniela María Cirillo, Jin‐Gun Cho, L. D´Ambrosio, Margareth Pretti Dalcolmo, Paolo Denti, Keertan Dheda, Greg J. Fox, Anneke C. Hesseling, H. Y. Kim, Claudio U. Köser, Ben J. Marais, Ioana Mărgineanu, Anne‐Grete Märtson, M. Munoz Torrico, Heda Melinda Nataprawira, Ong C, Ralf Otto-Knapp, Charles A. Peloquin, D. R. Silva, Rovina Ruslami, Prayudi Santoso, Radojka M. Savić, Rupak Singla, Elin M. Svensson, Alena Skrahina, Dick van Soolingen, Shashikant Srivastava, Marina Tadolini, Simon Tiberi, Tania A. Thomas, Zarir Udwadia, Dinh Hoa Vu, W Zhang, Stellah Mpagama, Thomas Schön, Giovanni Battista Migliori
Abstract
BACKGROUND: Optimal drug dosing is important to ensure adequate response to treatment, prevent development of drug resistance and reduce drug toxicity. The aim of these clinical standards is to provide guidance on ‘best practice´ for dosing and management of TB drugs. METHODS: A panel of 57 global experts in the fields of microbiology, pharmacology and TB care were identified; 51 participated in a Delphi process. A 5-point Likert scale was used to score draft standards. The final document represents the broad consensus and was approved by all participants. RESULTS: Six clinical standards were defined: Standard 1, defining the most appropriate initial dose for TB treatment; Standard 2, identifying patients who may be at risk of sub-optimal drug exposure; Standard 3, identifying patients at risk of developing drug-related toxicity and how best to manage this risk; Standard 4, identifying patients who can benefit from therapeutic drug monitoring (TDM); Standard 5, highlighting education and counselling that should be provided to people initiating TB treatment; and Standard 6, providing essential education for healthcare professionals. In addition, consensus research priorities were identified. CONCLUSION: This is the first consensus-based Clinical Standards for the dosing and management of TB drugs to guide clinicians and programme managers in planning and implementation of locally appropriate measures for optimal person-centred treatment to improve patient care.