Clinical standards for the management of adverse effects during treatment for TB The International Journal of Tuberculosis and Lung Disease
Abstract BACKGROUND: Adverse effects (AE) to TB treatment cause morbidity, mortality and treatment interruption. The aim of these clinical standards is to encourage best practise for the diagnosis and management of AE. METHODS: 65/81 invited experts participated in a Delphi process using a 5-point Likert scale to score draft standards. RESULTS: We identified eight clinical standards. Each person commencing treatment for TB should: Standard 1, be counselled regarding AE before and during treatment; Standard 2, be evaluated for factors that might increase AE risk with regular review to actively identify and manage these; Standard 3, when AE occur, carefully assessed and possible allergic or hypersensitivity reactions considered; Standard 4, receive appropriate care to minimise morbidity and mortality associated with AE; Standard 5, be restarted on TB drugs after a serious AE according to a standardised protocol that includes active drug safety monitoring. In addition: Standard 6, healthcare workers should be trained on AE including how to counsel people undertaking TB treatment, as well as active AE monitoring and management; Standard 7, there should be active AE monitoring and reporting for all new TB drugs and regimens; and Standard 8, knowledge gaps identified from active AE monitoring should be systematically addressed through clinical research. CONCLUSION: These standards provide a person-centred, consensus-based approach to minimise the impact of AE during TB treatment. Keywords: tuberculosis, adverse effects, management, toxicity, drugs, safety
SHOW FULL ABSTRACT K P Singh, A C C Carvalho, R Centis, L D’Ambrosio, G B Migliori, S G Mpagama, B C Nguyen, R E Aarnoutse, A Aleksa, R van Altena, P K Bhavani, M S Bolhuis, S Borisov, N van't Boveneind-Vrubleuskaya, J Bruchfeld, J A Caminero, I Carvalho, J G Cho, L Davies Forsman, M Dedicoat, K Dheda, K Dooley, J Furin, J M García-García, A Garcia-Prats, A C Hesseling, S K Heysell, Y Hu, H Y Kim, S Manga, B J Marais, I Margineanu, A-G Märtson, M Munoz Torrico, H M Nataprawira, E Nunes, C W M Ong, R Otto-Knapp, D J Palmero, C A Peloquin, A Rendon, D Rossato Silva, R Ruslami, A M I Saktiawati, P Santoso, H S Schaaf, B Seaworth, U S H Simonsson, R Singla, A Skrahina, I Solovic, S Srivastava, S L Stocker, M G G Sturkenboom, E M Svensson, M Tadolini, T A Thomas, S Tiberi, J Trubiano, Z F Udwadia, A R Verhage, D H Vu, O W Akkerman, J W C Alffenaar, J T Denholm
1Department of Infectious diseases, University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia 2Victorian Infectious Disease Unit, Royal Melbourne Hospital, VIC, Australia 3Laboratório de Inovações em Terapias, Ensino e Bioprodutos (LITEB), Instituto Oswaldo Cruz, Fundação Oswaldo Cruz, Rio de Janeiro, RJ, Brazil 4Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Tradate, Italy 5Public Health Consulting Group, Lugano, Switzerland 6Kilimanjaro Christian Medical University College, Moshi, , United Republic of Tanzania 7Kibong’oto Infectious Diseases Hospital, Sanya Juu, Siha, Kilimanjaro, United Republic of Tanzania 8Woolcock Institute of Medical Research, Viet Nam and University of Sydney, NSW, Australia 9Department of Pharmacy, Research Institute for Medical Innovation, Radboud University Medical Center, Nijmegen, The Netherlands 10Grodno State Medical University, Grodno, Belarus 11Asian Harm Reduction Network (AHRN) and Medical Action Myanmar (MAM), Yangon, Myanmar 12Indian Council of Medical Research-National Institute for Research in Tuberculosis, University of Groningen, Groningen, the Netherlands 13Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands 14Moscow Research and Clinical Center for Tuberculosis Control, Moscow, Russia 15Department of Public Health TB Control, Metropolitan Public Health Services, The Hague, The Netherlands 16Departement of Medicine Solna, Division of Infectious Diseases, Karolinska Institutet, Stokholm, Sweden 17Departement of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden 18Department of Pneumology. University General Hospital of Gran Canaria “Dr Negrin”, Las Palmas, Spain 19ALOSA (Active Learning over Sanitary Aspects) TB Academy, Spain 20Paediatric Department, Vila Nova de Gaia Hospital Centre, Vila Nova de Gaia Outpatient Tuberculosis Centre, Vila Nova de Gaia, Portugal 21Sydney Infecious Diseases Institute (Sydney ID), The University of Sydney, Sydney, NSW, Australia 22Westmead Hospital, Sydney, NSW, Australia 23Parramatta Chest Clinic, Parramatta, NSW, Australia 24School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia 25Department of Infectious Diseases, Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK 26Centre for Lung Infection and Immunity Unit, Department of Medicine, Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa 27South African Medical Research Council Centre for the Study of Antimicrobial Resistance, University of Cape Town, Cape Town, South Africa 28Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK 29Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA 30Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA 31Tuberculosis Research Programme, SEPAR (Sociedad Española de Neumología y Cirugía Torácica), Barcelona, Spain 32Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg, South Africa 33Department of Pediatrics, University of Wisconsin, Madison, WI, USA 34Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, VA, USA 35Department of Epidemiology, School of Public Health and Key Laboratory of Public Health Safety, Fudan University, Shanghai, China 36Tuberculosis Department Latin American Society of Thoracic Diseases, Lima, Peru 37Department of Infectious Diseases and Microbiology, The Children’s Hospital at Westmead, Westmead, NSW, Australia 38Centre of Excellence in Infectious Diseases Research, Antimicrobial Pharmacodynamics and Therapeutics Group, Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK 39Clínica de Tuberculosis, Instituto Nacional de Enfermedades Respiratorias, México City, Mexico 40Division of Paediatric Respirology, Department of Child Health, Faculty of Medicine, Universitas Padjadjaran, Hasan Sadikin Hospital, Bandung, Indonesia 41Department of Pulmonology of Central Hospital of Maputo, Maputo, Mozambique 42Faculty of Medicine of Eduardo Mondlane University, Maputo, Mozambique 43Infectious Disease Translational Research Programme, Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, 44National University of Singapore Institute for Health Innovation & Technology (iHealthtech), Singapore 45Division of Infectious Diseases, Department of Medicine, National University Hospital, Singapore 46German Central Committee Against Tuberculosis (DZK), Berlin, Germany 47Hospital Muniz and Instituto Vaccarezza, Buenos Aires, Argentina 48Infectious Disease Pharmacokinetics Laboratory, College of Pharmacy and Emerging Pathogens Institute, University of Florida, Gainesville, FL, USA 49Universidad Autonoma de Nuevo Leon, Facultad de Medicina, Neumología, CIPTIR, Monterrey, Mexico 50Faculdade de Medicina, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil 51TB/HIV Research Centre, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia 52Department of Biomedical Sciences, Division of Pharmacology and Therapy, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia 53Department of Internal Medicine, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia 54Centre for Tropical Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia 55Division of Respirology and Critical Care, Department of Internal Medicine, Faculty of Medicine, Universitas Padjadjaran/Hasan Sadikin General Hospital, Bandung, Indonesia 56 University of Texas Health Science Center at Tyler, Tyler, TX, USA 57Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden 58Department of TB & Respiratory Diseases, National Institute of TB & Respiratory Diseases, New Delhi, India 59Republican Research and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus 60National Institute of Tuberculosis, Lung Diseases and Thoracic Surgery, Faculty of Health, Catholic University, Ružomberok, Vyšné Hágy, Slovakia 61 Department of Medicine, The University of Texas at Tyler School of Medicine, TX, USA 62Department of Pharmacy Practice, Texas Tech University Health Science Center, Dallas, TX, USA 63Department of Clinical Pharmacology and Toxicology, St Vincent’s Hospital, Sydney, NSW, Australia 64Department of Pharmacy, Uppsala University, Uppsala, Sweden 65Infectious Diseases Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant’Orsola, Bologna, Italy 66Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy 67Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK 68Department of Infectious Diseases, Austin Hospital, Melbourne, VIC, Australia 69P. D. Hinduja National Hospital and Medical Research Centre, Mumbai, India 70Department of Paediatrics, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands 72Department of Pulmonary Diseases and Tuberculosis, Groningen, University of Groningen, Haren, the Netherlands 73Tuberculosis Center Beatrixoord, University Medical Center Groningen, University of Groningen, Haren, the Netherlands 74Victorian Tuberculosis Program, Melbourne Health, VIC, Australia 