Clinical standards for the management of adverse effects during treatment for TB

Author:

Singh K. P.1,Carvalho A. C. C.2,Centis R.3,D´Ambrosio L.4,Migliori G. B.3,Mpagama S. G.5,Nguyen B. C.6,Aarnoutse R. E.7,Aleksa A.8,van Altena R.9,Bhavani P. K.10,Bolhuis M. S.11,Borisov S.12,van´t Boveneind-Vrubleuskaya N.13,Bruchfeld J.14,Caminero J. A.15,Carvalho I.16,Cho J. G.17,Davies Forsman L.18,Dedicoat M.19,Dheda K.20,Dooley K.21,Furin J.22,García-García J. M.23,Garcia-Prats A.24,Hesseling A. C.25,Heysell S. K.26,Hu Y.27,Kim H. Y.28,Manga S.29,Marais B. J.30,Margineanu I.11,Märtson A-G.31,Munoz Torrico M.32,Nataprawira H. M.33,Nunes E.34,Ong C. W. M.35,Otto-Knapp R.36,Palmero D. J.37,Peloquin C. A.38,Rendon A.39,Rossato Silva D.40,Ruslami R.41,Saktiawati A. M. I.42,Santoso P.43,Schaaf H. S.25,Seaworth B.44,Simonsson U. S. H.45,Singla R.46,Skrahina A.47,Solovic I.48,Srivastava S.49,Stocker S. L.50,Sturkenboom M. G. G.11,Svensson E. M.51,Tadolini M.52,Thomas T. A.26,Tiberi S.53,Trubiano J.54,Udwadia Z. F.55,Verhage A. R.56,Vu D. H.57,Akkerman O. W.58,Alffenaar J. W. C.28,Denholm J. T.

Affiliation:

1. Department of Infectious diseases, University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia, Victorian Infectious Disease Unit, Royal Melbourne Hospital, VIC, Australia

2. Laboratório de Inovações em Terapias, Ensino e Bioprodutos (LITEB), Instituto Oswaldo Cruz, Fundação Oswaldo Cruz, Rio de Janeiro, RJ, Brazil

3. Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Tradate, Italy

4. Public Health Consulting Group, Lugano, Switzerland

5. Kilimanjaro Christian Medical University College, Moshi, United Republic of Tanzania, Kibong´oto Infectious Diseases Hospital, Sanya Juu, Siha, Kilimanjaro, United Republic of Tanzania

6. Woolcock Institute of Medical Research, Viet Nam and University of Sydney, NSW, Australia

7. Department of Pharmacy, Research Institute for Medical Innovation, Radboud University Medical Center, Nijmegen, The Netherlands

8. Grodno State Medical University, Grodno, Belarus

9. Asian Harm Reduction Network (AHRN) and Medical Action Myanmar (MAM), Yangon, Myanmar

10. Indian Council of Medical Research-National Institute for Research in Tuberculosis, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands

11. Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands

12. Moscow Research and Clinical Center for Tuberculosis Control, Moscow, Russia

13. Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands, Department of Public Health TB Control, Metropolitan Public Health Services, The Hague, The Netherlands

14. Departement of Medicine Solna, Division of Infectious Diseases, Karolinska Institutet, Stokholm, Sweden, Departement of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden

15. Department of Pneumology. University General Hospital of Gran Canaria “Dr Negrin”, Las Palmas, Spain, ALOSA (Active Learning over Sanitary Aspects) TB Academy, Spain

16. Paediatric Department, Vila Nova de Gaia Hospital Centre, Vila Nova de Gaia Outpatient Tuberculosis Centre, Vila Nova de Gaia, Portugal

17. Sydney Infecious Diseases Institute (Sydney ID), The University of Sydney, Sydney, NSW, Australia, Westmead Hospital, Sydney, NSW, Australia, Parramatta Chest Clinic, Parramatta, NSW, Australia

18. Departement of Medicine Solna, Division of Infectious Diseases, Karolinska Institutet, Stokholm, Sweden, Departement of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden, School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia

19. Department of Infectious Diseases, Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK

20. Centre for Lung Infection and Immunity Unit, Department of Medicine, Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa, South African Medical Research Council Centre for the Study of Antimicrobial Resistance, University of Cape Town, Cape Town, South Africa, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK

21. Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA

22. Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA

23. Tuberculosis Research Programme, SEPAR (Sociedad Española de Neumología y Cirugía Torácica), Barcelona, Spain

24. Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg, South Africa, Department of Pediatrics, University of Wisconsin, Madison, WI, USA

25. Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg, South Africa

26. Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, VA, USA

27. Department of Epidemiology, School of Public Health and Key Laboratory of Public Health Safety, Fudan University, Shanghai, China

28. Sydney Infecious Diseases Institute (Sydney ID), The University of Sydney, Sydney, NSW, Australia, Westmead Hospital, Sydney, NSW, Australia, School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia

29. Tuberculosis Department Latin American Society of Thoracic Diseases, Lima, Peru

30. Sydney Infecious Diseases Institute (Sydney ID), The University of Sydney, Sydney, NSW, Australia, Department of Infectious Diseases and Microbiology, The Children´s Hospital at Westmead, Westmead, NSW, Australia

31. Centre of Excellence in Infectious Diseases Research, Antimicrobial Pharmacodynamics and Therapeutics Group, Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK

32. Clínica de Tuberculosis, Instituto Nacional de Enfermedades Respiratorias, México City, Mexico

33. Division of Paediatric Respirology, Department of Child Health, Faculty of Medicine, Universitas Padjadjaran, Hasan Sadikin Hospital, Bandung, Indonesia

34. Department of Pulmonology of Central Hospital of Maputo, Maputo, Mozambique, Faculty of Medicine of Eduardo Mondlane University, Maputo, Mozambique

35. Infectious Disease Translational Research Programme, Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Tradate, Italy, Division of Infectious Diseases, Department of Medicine, National University Hospital, Singapore

36. German Central Committee Against Tuberculosis (DZK), Berlin, Germany

37. Hospital Muniz and Instituto Vaccarezza, Buenos Aires, Argentina

38. Infectious Disease Pharmacokinetics Laboratory, College of Pharmacy and Emerging Pathogens Institute, University of Florida, Gainesville, FL, USA

39. Universidad Autonoma de Nuevo Leon, Facultad de Medicina, Neumología, CIPTIR, Monterrey, Mexico

40. Faculdade de Medicina, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil

41. TB/HIV Research Centre, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia, Department of Biomedical Sciences, Division of Pharmacology and Therapy, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia

42. Department of Internal Medicine, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia, Centre for Tropical Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia

43. Division of Respirology and Critical Care, Department of Internal Medicine, Faculty of Medicine, Universitas Padjadjaran/Hasan Sadikin General Hospital, Bandung, Indonesia

44. University of Texas Health Science Center at Tyler, Tyler, TX, USA

45. Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden

46. Department of TB & Respiratory Diseases, National Institute of TB & Respiratory Diseases, New Delhi, India

47. Republican Research and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus

48. National Institute of Tuberculosis, Lung Diseases and Thoracic Surgery, Faculty of Health, Catholic University, Ružomberok, Vyšné Hágy, Slovakia

49. University of Texas Health Science Center at Tyler, Tyler, TX, USA, Department of Medicine, The University of Texas at Tyler School of Medicine, TX, USA, Department of Pharmacy Practice, Texas Tech University Health Science Center, Dallas, TX, USA

50. School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia, Department of Clinical Pharmacology and Toxicology, St Vincent´s Hospital, Sydney, NSW, Australia

51. Department of Pharmacy, Research Institute for Medical Innovation, Radboud University Medical Center, Nijmegen, The Netherlands, Department of Pharmacy, Uppsala University, Uppsala, Sweden

52. Infectious Diseases Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant´Orsola, Bologna, Italy, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy

53. Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK

54. Department of Infectious diseases, University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia, Department of Infectious Diseases, Austin Hospital, Melbourne, VIC, Australia

55. P. D. Hinduja National Hospital and Medical Research Centre, Mumbai, India

56. Department of Paediatrics, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands

57. National Drug Information and Adverse Drug Reaction Monitoring Centre, Hanoi University of Pharmacy, Hanoi, Vietnam

58. Department of Pulmonary Diseases and Tuberculosis, Groningen, Haren, the Netherlands, Tuberculosis Center Beatrixoord, University Medical Center Groningen, University of Groningen, Haren, the Netherlands

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.

Publisher

International Union Against Tuberculosis and Lung Disease

Subject

Infectious Diseases,Pulmonary and Respiratory Medicine

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