NATIONAL GUIDELINES ON Drug Resistant Tuberculosis Management 2019

BACKGROUND
National TB programme is moving forward with the vision of TB Free Nepal by 2050 in accordance with the National Health Policy 2014 and under the strategic direction of the worldwide initiative to end TB – the End TB Strategy.

The goal of National Strategic Plan 2016-21 is to decrease the TB Incidence rate by 20%, from 2015 to 2021 i.e. to identify additional 20,000 new TB cases by next 5 years.

  • The overall objectives of NSP 2016-21 are as follows:
    • Objective 1:
      • To increase case notification through improved health facility-based diagnosis; increase diagnosis among children (from 6% at baseline, to 10% of total cases by 2021); examination of household contacts and expanded diagnosis among vulnerable groups within the health service, such as PLHIV (from 179 cases at baseline to over 1,100 cases in 2020/21), and those with diabetes mellitus (DM).
    • Objective 2:
      • To maintain the treatment success rate of 90% for all forms of TB (except drug resistant TB) by 2021
    • Objective 3:
      • To provide DR TB diagnose services to 50% of the presumptive MDR TB patients by 2018 and 100% by 2021 and to successfully treat at least 75% of those diagnosed.
    • Objective 4:
      • To expand case finding by engaging providers for TB care from the public sector (beyond MoH), medical colleges, NGO sector, and private sector through results based financing (PPM) schemes, with formal engagements (signed MoUs) to notify TB cases
    • Objective 5:
      • To gradually scale up Community System Strengthening Programme (CSS) at 60% of the local administrative units by 2018 and to 100% of the administrative units by 2021. It will help in creating a patient friendly ambience in the health facilities, advocacy for TB patients regarding their rights which will, in turn, contribute to the diagnosis and management of TB cases
    • Objective 6:
      • To contribute to health system strengthening through HR management and
        capacity development, financial management, infrastructure, procurement and supply management in TB
    • Objective 7:
      • To develop comprehensive Monitoring and Evalutaion system
    • Objective 8:
      • To develop plans so that NTP can function even at times of crises like natural disasters or public health emergencies.
  • THE MAIN CHANGES IN THE WHO 2019 RECOMMENDATIONS

It is recommended that any patient – child or adult – with RR-TB in whom isoniazid resistance is absent or unknown be treated with a recommended MDR-TB regimen, either a longer MDRTB regimen to which isoniazid may be added or a standardized shorter MDR-TB regimen.

  • Shared based decision making between doctor and patient for choice of treatment either longer or shorter regimens
  • A package of treatment adherence interventions may be offered to patients on TB treatment in conjunction with the selection of a suitable treatment administration option
  • In patients with confirmed rifampicin-susceptible and isoniazid-resistant tuberculosis, treatment with rifampicin, ethambutol, pyrazinamide and levofloxacin is recommended for a duration of 6 months. it is not recommended to add injactables.
  • Regrouping of medicine (A, B & C) based on most recent available evidence and all oral longer (Inj free) regimen is recommended
  • All three Group A agents and at least one Group B agent should be included to ensure that treatment should start with at least four TB agents likely to be effective and that at least three effective agents are included for the rest of treatment period after the Bdq is stopped by month 6
  • There is strong recommendation to use all Group A drugs(Mfx/Lfx, Bdq,Lzd) in longer regimen, until and unless there is contraindication to include in regimen.
  • Most patients can be treated with 18 months duration by using Longer Regimen
  • Kanamycin and capreomycin are no longer to be the part of treatment of RR/MDR-TB regimens. Only Amikacin or Streptomycin is to be used under certain conditions
  • Bedaquiline should be included in longer MDR-TB regimens for patients aged 18 years or more
  • Bedaquiline may also be included in longer MDR-TB regimens for patients aged 6-17 years
  • Delamanid may be included in the treatment of MDR/RR-TB patients aged 3 years or more on longer regimens
  • It is strongly recommended that Clavulanic acid should not be included in the treatment of MDR/RR-TB patients on longer regimen, only in combination use with Imipenem
  • Intensive phase of 6-7 months will only be considered if Injectables (Am, S) are part of regimen
  • In MDR/RR-TB patients on longer regimens, a total treatment duration of 18-20 months is suggested for most patients
  • Regimens without an injectable agent are considered not to have an intensive phase
  • On longer regimens, a treatment duration of 15 to 17 months after culture conversion is suggested for most patients
  • Any modifications on standard shorter regimen should be conducted under operational research conditions
  • aDSM is applicable to all RR TB patients
  • It is desirable for sputum culture to be repeated at monthly intervals.

This Guideline Includes :
INTRODUCTION 1
1.1 Background 1
1.2 Key definitions 4
1.3 Organisation of DR-TB control in Nepal 7
1.4 Roles and responsibility 7
2. DIAGNOSIS OF DR-TB 11
2.1 Identification of presumptive DR-TB 11
2.2 Management of presumptive DR-TB 11
2.3 Diagnostic tests 12
2.4 Diagnosis of extra-pulmonary DR-TB in the absence of DST 20
2.5 Diagnostic pathway 20
2.6 Diagnosis of DR-TB in special groups 22
3. REGISTRATION CATEGORY OF DR-TB 24
4. TREATMENT OF DR-TB 25
4.1 Patient Education 25
4.2. Drugs used to treat DR TB and Principles of Treatment 27
4.3. RR/MDR-TB treatment regimens 32
4.4 Shorter Standardized Treatment Regimen (SSTR) 36
4.5 Treatment of INHr TB 42
4.6 Treatment of MDR-TB in special situations 44
4.7 Adjuvant therapies and interventions 57
4.8 Surgery 57
5. MANAGEMENT AND MONITORING ASPECTS OF DR-TB 58
5.1 Preparation prior to starting second-line treatment 59
5.2 Treatment administration 60
5.3 Organization of the treatment 61
5.4 Drug Intake 62
5.5 Follow-up monitoring investigations during and after completion of treatment 63
5.6 Monitoring of treatment progress 66
5.7 Follow-up after the end of treatment 67
5.8 Palliative care 67
5.9 Management of contacts of MDR-TB patients 68
6. ACTIVE DRUG SAFETY MONITORING AND MANAGEMENT (ADSM) 69
6.1 Management of AEs or ADRs 72
6.2 Causality Assessment of the Serious Adverse Event (SAEs) 90
INFECTION CONTROL 91
7.1 General principles of infection control 91
7.2 Infection control at TB consultation room 94
7.3 DR-TB Patient isolation room 94
7.4 Infection control at home 95
7.5 Health worker and Infection Control 95
8. MONITORING AND EVALUATION FOR TB CONTROL PROGRAM 96
8.1 Recording and reporting of DR-TB programme 96
8.2 Monitoring of DR-TB Case Detection and Treatment Activities 100

Read & Download Full DR TB Management Guideline 2019 Here