DR-TB HIV Coordinator: General concepts in TB Treatment

The goals of tuberculosis treatment are:

• Rendering the patient non-infectious, breaking the chain of transmission and decreasing the infection​ pool

• Decreasing case fatality and morbidity by ensuring relapse-free cure

• Minimising and preventing the development of drug resistance.  ​

To meet the goals of treatment, the regimens should be:

• Safe, easy to administer and aid treatment adherence
• Long enough to achieve the long-term cure of the disease, and short enough to increase patient compliance.

Any treatment regimen which reduces the pill count but increases the overall treatment success is an ideal regimen to meet the goals of tuberculosis treatment.  

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.

Assessment

​

Under the National TB Elimination Programme (NTEP), strategies adopted in the treatment of TB are based on the available scientific and operational researches. These strategies are combined to ensure better treatment outcomes for the TB patients. The main strategies include:

Domiciliary Treatment

• This is a strategy that allows for the treatment of TB in a patient’s home.
• Domiciliary chemotherapy proved to be as effective as sanatoria treatment (which was the historical way of treating TB) and achieved higher cure rates.
• The patients having the social benefits of being at home. 

Short Course Chemotherapy (SCC)

• Chemotherapy of TB underwent revolutionary changes in the 70s owing to the availability of two well-tolerated and highly effective drugs – rifampicin and pyrazinamide.
• These drugs allowed for SCC and made it possible to simplify treatment and reduce its duration without reducing the therapeutic effect.
• Now with SCC regimens, it is possible to treat and cure TB patients in 6 months.
• When given daily, these regimens are effective, achieve high cure rates, prevent the emergence of drug resistance and minimize relapses.
• The shorter duration also contributes to improvement in treatment adherence.

Directly Observed Treatment (DOT)

DOT is a method whereby a trained healthcare worker or another trained designated person (treatment supporter) watches a patient swallow each dose of anti-TB drugs and document it.

• DOT can reduce the development of drug resistance, treatment failure, or relapse after the end of treatment.
• Many patients who do not receive directly observed treatment stop taking drugs once they feel better.
• Hence, by providing DOT, the NTEP ensures that patients receive the right drugs, in the right doses, at the right intervals and for the right duration.

The modern treatment strategy is based on standardized short-course chemotherapy regimens largely administered on a domiciliary basis, utilising the DOTS strategy and proper case management to ensure completion of treatment and cure.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Treatment of Tuberculosis Disease, CDC, 2006.
• Guide on Tuberculosis Control for Primary Health Care Providers, WHO, 2015.
• Treatment of Tuberculosis: Guidelines for National Programmes, WHO, 2003.

Assessment

Tuberculosis treatment and its different regimens have scientific backgrounds for their formulations. To understand this, we need to know about the mode of action of each anti-TB drug first.

Mode of Action of Anti-TB Drugs

Anti-TB drugs have the following three actions:

1. Early bactericidal activity: Killing of actively growing bacilli (in the phase of rapid multiplication and uninhibited metabolic activity).
2. Sterilizing activity of persisting bacilli, i.e., metabolically inhibited organisms in a quasi-dormant state.
3. Ability to prevent the emergence of drug resistance.

The ranking of first-line drugs with respect to their type of activity is indicated in Table 1 below.

Table 1: Ranking of first-line anti-TB drugs used in the treatment of drug-sensitive TB, based on the mode of action and activity

Thus, each drug has unique characteristics and drug combinations will make the regimen more effective.

Need for Long Duration of Treatment of TB

• Anti-TB drugs mostly kill actively multiplying tubercle bacilli.
• When bacilli have low metabolic activity, i.e., when bacterial growth has almost come to a standstill and the organisms are “dormant”, they are not killed by otherwise bactericidal drugs. Such organisms are referred to as persisters*.
• Though they may survive in the presence of drugs, behaving as if they were drug-resistant, they are in fact susceptible to the drugs.
• Thus, if for some reason these organisms regain their ability to multiply freely, they would be killed by the very drugs that had not harmed them before.
• When dormant bacilli again become metabolically active and start multiplying during effective chemotherapy, they are soon killed.
• Once chemotherapy has been completed, the revived bacilli may continue to multiply and thus cause relapse.
• This explains why conventional chemotherapy needs to be of long duration.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Tuberculosis Case-finding and Chemotherapy: Questions and Answers, K. Toman.

 Assessment

Standard TB Treatment is divided into two phases

• Intensive Phase(IP): In this phase,
  • Kills most of the TB bacteria during the first 8 weeks of treatment, but some bacteria can survive longer
  • Therefore, more drugs are administered to kill the bacteria and reduce the severity of disease.
  • Treatment in this phase usually is of short duration(2 to 6 Months or more) in comparison to Continuation Phase(CP)

• Continuation Phase(CP): In this phase,
  • All the remaining TB bacteria are in the dormant stage i.e., stage when growth and development of bacteria are temporarily stopped.
  • Therefore, fewer but powerful antibiotics are administered to kill those bacteria. 
  • Treatment in this phase usually lasts longer than Intensive Phase(IP)(4 to 18 Months or more)

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Fixed-dose combinations (FDCs) are drug formulations where two or more drugs are combined physically into one formulation such as a tablet or pill.

This is more convenient to the patients taking medicines and it also simplifies the supply chain.

Resources:

• Technical and Operational Guidelines for TB Control in India 2016

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Fixed-Dose Combination(FDC) provides a simple approach to deliver the correct number of drugs at the right dosage as all the necessary drugs are combined in a single tablet. By altering the number of pills according to the patient’s body weight, complete treatment is delivered without the need for calculation of dose

Figure: Advantages of Fixed Dose Combination(FDC)

A regimen means a prescribed systematic form of treatment for a course of drug(s). For TB treatment, Multi drug combination of regimen is followed. 

All TB drug regimens have an initial intensive phase(IP) followed by a continuation phase(CP). 

Following are some of the main TB drug regimens used based on the drug resistance pattern detected for TB patients.

• First-Line Anti TB Drugs(Prescribed for Drug Sensitive TB DS-TB)
  • Daily weight band wise FDC

• Second-Line Anti TB Drugs (Prescribed for Drug Resistance TB - DR-TB)
  • H Mono Poly Regimen
  • Shorter oral Bedaquiline containing MDR-TB regimen
  • Longer oral Bedaquiline containing regimen
  • Shorter injectable containing MDR-TB regimen

It is extremely important for any type of TB patient to be initiated on the right treatment at the earliest in order to have better treatment outcomes. Therefore as soon as the patient is diagnosed, s/he should immediately be traced with the help of the Community Health Officer (CHO) of the Health and Wellness Centres (HWC), TB Health Visitors (TBHV) / Senior Treatment Supervisor(STS) and the health facility doctors and initiated on the appropriate treatment regimen.

Steps in TB Treatment Initiation

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Figure: Flowchart-Treatment Initiation

Resources

• Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India, CTD, MoHFW, India, 2021.
• Training Modules (1-4) for Programme Managers and Medical Officers, CTD, MoHFW, India.

Assessment

To know the TB treatment response and to determine that if patient is cured, TB patients are clinically evaluated at the end of every four weeks of treatment, and they are also followed up by performing sputum test at end of each treatment phase (i.e. Intensive phase and Continuation phase)

TB patients during clinical evaluations are assessed to

• Identify possible adverse reactions to medications;
• Check for any comorbid conditions;
• Weight change;
• monitor adherence; and determine treatment efficacy by observing their symptoms

Although each patient responds to treatment at a different pace, all TB symptoms should gradually improve and eventually go away.

Patients whose symptoms do not improve during the first 2 months of treatment, or whose symptoms worsen after improving initially, should be re-evaluated for adherence issues and development of drug resistance.

When a TB patient consumes all the doses under the prescribed regimen, then Treatment Outcome is declared for a Patient.

Treatment success is considered when a TB patient either Cured or Treatment completed is accounted in treatment success

Adverse Drug Reaction (ADR): An unwanted or harmful reaction experienced following the administration of a drug or a combination of drugs, under normal conditions of use, and is suspected to be related to the drug.

Adverse Event (AE):  Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease that presents in a patient during the course of treatment or the procedure, regardless of whether it is considered related to the medical treatment or procedure.

• An AE does not necessarily have a causal relationship with the treatment.
• ​​Suspected ADR and actual ADRs are a subset of AEs, as can be seen in the figure below. 

Figure: Relationship between adverse events, suspected adverse reactions and adverse reactions 

The table below highlights the difference between an ADR and an AE.

Resources

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.
• Ready Reckoner for Medical Officer - Adverse Drug Reactions Associated with Anti-TB Drugs Identification and Management, 2019. 
• WHO - A Practical Handbook on the Pharmacovigilance of Medicines Used in the Treatment of Tuberculosis, 2012.
• Technical and Operational Guidelines for TB in India, 2016.

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Adverse Drug Events are classified on the basis of severity:

1. Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:

• Results in death
• Is life-threatening (subject was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it is more severe)
• Requires inpatient hospitalization or prolongation of existing hospitalization
• Results in persistent or significant disability/incapacity
• Results in a congenital anomaly/birth defect
• Results in suspected transmission of any infectious agent via the medicinal product
• Is medically important

​

2. Non-serious Adverse Drug Reaction (ADR) Associated with the Use of Drugs: Any adverse drug reaction that does not meet the above criteria to be a serious AE and is considered associated with the use of the drug .

4. Life-threatening: Any event in which the patient was at risk of death at the time of the event; but does not refer to an event, which hypothetically might have caused death if it were more severe.

5. Associated with Use of the Drug: An adverse event is considered associated with use of the drug if the attribution is possible, probable or very likely.

Resources

• Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India, March 2021
• Ready Reckoner for Medical Officer - Adverse Drug Reactions Associated with Anti-TB Drugs Identification and Management, 2019 
• WHO - A Practical Handbook on the Pharmacovigilance of Medicines Used in the Treatment of Tuberculosis, 2012
• Technical and Operational Guidelines for TB in India, 2016

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Adverse Drug Reactions(ADR) are classified into serious and non-serious ADR depending upon the intensity of symptoms experienced by the patient. Below is the brief overview

1. Counsel and reassure the patient as the common occurring adverse effects usually resolve with time.
2. Advise the patient to take all the drugs together.
3. Advise patient to take light meal (biscuits, bread, rice etc.) before taking drugs.
4. Inform patients that they may take drugs embedded in banana or at the bedtime to reduce their associated side effects.
5. Encourage patients to keep themselves hydrated by increasing fluid intake.
6. Provide ORS (Oral Rehydration Solution) to counter dehydration due to loose motion and vomiting.

Figure: Referral to PHI for ADR

Resources:

• Training Guide for Peripheral Health Workers on Adverse Drug Reactions

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Follow-up Sputum Examination is useful for the clinical follow-up which helps in assessing the response to treatment, and to establish cure or failure at the end of treatment.

Significance:

The most important tool in the diagnosis of tuberculosis is direct microscopic examination of appropriately stained sputum specimens for acid-fast bacilli (AFB). The technique is simple and inexpensive, and used in the detection of tuberculosis. Sputum microscopy is also useful for the clinical follow up which helps in assessing the response to treatment, and to establish cure or failure at the end of treatment.

Schedule

In case of Drug-sensitive Tuberculosis (DS-TB), the follow-up is done at the end of Intensive Phase (IP) and at the end of Continuation Phase (CP).

In case of Drug-resistant Tuberculosis (DR-TB), the follow up schedule is different for all the three regimen described below:

Isoniazid (H) mono/ poly DR-TB regimen

• Monthly from month 3 onwards, till the end of treatment
• Conduct sputum microscopy within 7 days, if the smear at month 4 or later is positive to rapidly ascertain bacteriological conversion/ reversion.

Shorter oral Bedaquiline-containing Multidrug-Resistant (MDR)/ Rifampicin-Resistant (RR)-TB regimen

• Monthly from 3^rd month onwards, till end of IP
• Monthly in extended IP, only if previous month S+ve
• Conduct sputum microscopy within 7 days, if the smear at 6 months is positive to rapidly ascertain bacteriological conversion/ reversion.

Longer oral M/ XDR-TB regimen

• With culture at Culture and Drug Susceptibility (C&DST) lab
• Conduct sputum microscopy within 7 days if any smear at 6 month or later is positive to rapidly ascertain bacteriological conversion/ reversion.

Post Treatment Follow-Up

After completion of treatment, the patients should be followed-up at the end of 6, 12, 18 & 24 months for detecting recurrence of TB at the earliest. In presence of any clinical symptoms and/or cough, sputum microscopy and/or culture should be considered. This is important in detecting recurrence of TB at the earliest.

Implications

The sputum follow-up examination is a quick and reliable method which helps in monitoring the progress of the treatment and gives an early indication of any recurrence.

Assessment

The Tuberculosis Treatment Card is a paper-based recording form that is kept in the institution treating the TB patient under the National TB Elimination Programme (NTEP). It is a pre-requisite documentation related to treatment services offered to TB patients under NTEP.

Uses of the TB Treatment Card

The TB treatment card is primarily used for:

1. Documenting administered drugs with their dosages
2. Documenting follow-up investigation results
3. Monitoring adherence to treatment
4. Recording adverse events
5. Recording treatment outcomes

There are two pages in the TB treatment card and details in each page is delineated in the table below.

Important Points to Note

• The TB treatment card is filled at the Peripheral Health Institution (PHI) when a patient is initiated on treatment.
• The original TB treatment card is kept at the PHI and updated fortnightly.
• A duplicate treatment card is to be given to the treatment supporter for documentation of daily events. 
• The treatment supporter should be trained on how to record the treatment card. 
• Details on the patient’s HIV status are not included in the treatment supporter’s copy to maintain confidentiality.

The figure below shows the 1^st page of the TB treatment card. Click here to access the full form in the NTEP Training Modules 1-4 for Programme Managers & Medical Officers, p. 223.

Figure: First Page of the TB Treatment Card; Source: NTEP Training Modules 1-4 for Programme Managers & Medical Officers, p. 223

Resources

• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020.

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In the National TB Elimination Programme (NTEP), the ‘NTEP TB identity card’ is provided for their identification and record of clinical follow-ups.

The identity card is completed for each patient who has a Tuberculosis (TB) Treatment Card, and it is kept with the patient. Information from the TB Treatment Card is used to complete the identity card.

There are 3 parts in the NTEP TB identity card and details in each part is delineated in Table 1.

The information contained in this card will help to continue treatment in case the patient is transferred or admitted to any other health facility any time during the treatment period. The TB identity card is shown in Figure 1.

Figure 1: NTEP TB Identity Card; Source: NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020

Resources

• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020

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The Programmatic Management of Drug-resistant Tuberculosis (PMDT) treatment book is a document that is issued to all patients who are diagnosed with DR-TB and are placed on a regimen for DR-TB. It is given in annexure 31 under the PMDT guidelines 2021.

The PMDT treatment book is to be kept with the patient and should be brought along whenever s/he comes to Drug-resistant TB Centre (DR-TBC) or District TB Centre (DTC) or Health Facility (HF) for clinical follow-up or for Adverse Drug Reaction (ADR) management and should be filled out by the healthcare provider.

The PMDT treatment book contains the following sections:

• Details about the patient, treatment supporter, TB unit from where the patient is availing treatment
• Reason for testing, previous TB treatment history, type of TB, current TB treatment regimen with the date of diagnosis and treatment initiation
• Information on an initial home visit, Drug Susceptibility Test (DST) results for different anti-TB drugs, contact investigation, DR-TB committee meetings
• Information about weight and height of the patient, different weight bands for DR-TB regimen, different types of anti-TB drugs prescribed to patients and their dosages, eligibility and consent of patient if a new drug has been prescribed
• Information on investigations, follow-up results, details about monthly administration of drugs with the weight of patient for the full duration of treatment
• Information on retrieval action taken for a patient who has missed doses, any ADR reported and their management
• Detailed clinical notes written by the treating physician during each visit
• Information about treatment outcome and post-treatment periodic follow-up
• General information about the TB disease, mode of transmission, treatment, drugs in the regimen, side effects of drugs, and a few important do’s and don’ts for the patient.

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Figure: PMDT Treatment Book; Source: Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India, 2021, CTD, MoHFW, India.

Resources

• Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India, CTD, MoHFW, India, 2021.
• Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India, CTD, MoHFW, India, 2017.

Assessment

This is a line list of confirmed DRTB cases on treatment based on current health facilities.

Description: This register gives details about the tests and final interpretation based on the treatment start date and notification date:

• Health Facility ( Diagnosing & current facility details, ie.. State/District/ TU/PHI).
• Date of diagnosis and basis of diagnosis.
• Date of TB treatment initiation and regimen type.
• CBNAAT and Truenat Details - CBNAAT MTB Result, Rif Resistance, final interpretation and date reported.
• F line LPA and S line LPA Final interpretation.

Video: DRTB Treatment Register

TB patients may not stay in one place throughout the treatment duration. When they move from one place to other, there should be a mechanism to hand over the responsibility of continuing the patient's treatment in a facility near the new place of the patient. This is the concept of patient transfer and can be easily managed in Nikshay portal.

• The transfer module in Nikshay enables transfer requests of patients between Health Facilities (HFs) across the country.
• Provision of shifting of patient from one HF to another is possible if the patient changes his/her residence for the purpose of treatment.
• The requests are of two types: “Transfer In” and “Transfer Out”.
• All transfer requests needs to be accepted by the “District/ TB Unit (TU)/ Peripheral Health Institute (PHI)” where the transfer request is made in order for it to take effect.
• Transfer requests can be made to even the District/ TU level. However, it can be completed only once the “Transferred to PHI” has been assigned.

Figure: Transfer Management in Nikshay; Source: Nikshay Zendesk, Nikshay Knowledge Base, Advanced Transfer in Web.

Steps in Transfer of TB Patient

1. In Nikshay, the referring HF updates details from the current HF of patient to the HF where patient is being transferred.

2. The receiving HF gets the intimation about the transfer.

The patient transfer module also provides the provision to pull the patient belonging to another HF to the recipient HF. The accountability of the transferred patients is now with the receiving HF and the treatment initiating facility.

A separate transfer register is also available to get details about various transfers from and to a given district, which can be downloaded from Nikshay reports.

Resources

• Nikshay Zendesk, Nikshay Knowledge Base, Advanced Transfer in Web.
• Guidelines for PMDT in India, 2021.

Assessment

In order to achieve TB treatment success, a good treatment support plan for the patients is essential.  The National TB Elimination Programme (NTEP) recommends developing a treatment support plan for each patient at the time of treatment initiation. A holistic Treatment Support Plan (TSP) must include the following:
 

1) Treatment Supporter (TS) for each patient

• A Treatment Supporter (TS) who is acceptable and accessible to the patient and accountable to the health system (healthcare worker/ community volunteer/ private practitioner/ family member) identified in mutual consultation with the patient and provider during pre-treatment evaluation. 
• The assigned TS should be able to receive training on drug administration, adherence monitoring, Adverse Drug Reaction (ADR) referrals etc., and perform these functions.
   

2) Periodic review of patient’s treatment

• Treatment Initiation counselling and monthly or need-based (in high TB burden areas) follow-up counselling to all TB patients and their family members must be included through staff who have expertise in the same, to address both bio-medical and psycho-social issues that could impact treatment.
• The TSP must also include a protocol for the field monitoring staff to capture each instance of treatment interruption and Adverse Drug Reactions, so that they can be effectively addressed before the patient turns lost to follow-up.

3) Psychosocial Support to TB patients and their families

• Counselling to the patients experiencing stigma, discrimination, marital/family discords, substance users etc. by the trained staff, and appropriate referrals for psychiatric ,de-addiction support etc. should be offered whenever required.
• The focus should be on observing, identifying and capturing above mentioned factors during treatment initiation as well as in each follow up visit.
• Home visit follow ups with consent from the patients must also be included in the TSP which may allow for better understanding and management of psycho-social issues.
• As an extension of TSP, community engagement activities which includes key persons such as politicians, religious leaders, self-help groups, TB champions etc by the TB staff is recommended to raise awareness and sensitise the communities about TB and also articulate a whole-of-society approach to ending TB.
   

4) Referral linkages for needy TB patients - to central and state government’s various social welfare and protection schemes and additional nutrition support services

• With the aim to eliminate catastrophic expenditure due to TB, the Government of India (GoI) has insisted on linking TB patients and households to the applicable government social welfare and protection schemes.
• The treatment supporters and the health systems staff who are in regular contact with the patients (Senior Treatment Supervisors, TB Health Visitors, District Programme Supervisors) should be trained in referral linkages so as to enable further support to the patients and their family members to avail the benefits under schemes.
• The GoI has rolled out a Direct Beneficiary Transfer (DBT) mechanism to support TB patients' nutrition (Ni-kshay Poshan Yojana) and travel during treatment whereas several state governments have also initiated certain state-specific schemes for TB patients across the country.
• Further as a part of patients treatment support, the GoI has initiated the ‘Nikshay Mitra’ campaign under the ‘Pradhan Mantri TB Mukth Bharat Abhiyan’ where in persons/companies/societies can adopt an entire block/ward to provide nutrition support to TB patients for a specific treatment period.
   

5) Treatment Completion Counselling

The TSP must include an end of treatment counselling for all patients, on the importance of post treatment follow ups and holistic self-care approach for leading an overall healthy life and also the ability to focus on life after TB treatment completion.

Resource

• Training Modules (1-4) for Programme Managers & Medical Officers, NTEP, 2020.
• National Strategic Plan for Tuberculosis Elimination 2017-2025, RNTCP, 2017.
• Pradhan Mantri TB Mukt Bharat Abhiyaan - Guidance Document,  CTD, India, 2022.

Assessment

​The management principles of Extrapulmonary Tuberculosis (EPTB) are shown in the figure below.

Figure: Ten principles about what every EPTB patient in India needs as a basic standard of care

Abbr: CBNAAT:Cartridge-based Nucleic Acid AMplification Test; PTB: Pulmonary TB; NTEP: National TB Elimination Programme

Diagnosis of EP-TB

• All efforts need to be made to get a microbiological confirmation whenever a sample is available. 
• Clinical diagnosis can be made by treating physician based on the clinical features, lab investigations, imaging studies and by ruling out other causes

Treatment Regimen and Duration for EPTB

The treatment regimen and schedule for EPTB cases will remain the same as for pulmonary TB (2HRZE/ 4HRE). However, the duration of the continuation phase in EPTB may be extended in special situations such as TB Meningitis, bone and spine TB etc.

Role of Surgery in EPTB Cases

• Surgery is sometimes required for the diagnosis of EPTB. It is reserved for management of late complications of the disease.

Monitoring Treatment Response

• Response to treatment in EPTB may be best assessed clinically. Clinical follow-up is the most important criterion for the follow-up of EPTB patients. The clinician can assess the patient’s condition by checking weight gain and a decrease/ increase in presenting clinical symptoms.
• Investigations such as Acid-fast Bacilli (AFB) microscopy, chest X-ray, liver function tests, serum creatinine, and USG-abdomen can be used to monitor the treatment status.

The treatment support and other monitoring activities remain the same as for pulmonary TB.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Index TB Guidelines on Extra-pulmonary Tuberculosis for India, Central TB Division, 2016.

Assessment

Treatment interruption is defined as a patient-initiated episode in which the patient discontinues TB treatment. All efforts must be made to ensure that TB patients do not interrupt treatment or are not lost to follow-up. Action should be taken to promptly retrieve patients who fail to come for their daily dose by the treatment supporter

The management of treatment interruptions is made based on the following criteria:

i. Type of case: Whether new, relapse or failure

ii. Duration of treatment taken: Less than one month/ more than one month. This helps in assessing the risk of the presence of drug resistance.

iii. Duration of Interruption: Less than one month/ more than a month.

If treatment interruption is more than one month, the outcome is declared as ‘lost to follow up’.

If a patient returns to the health facility after interrupting treatment for more than one month, the patient sample needs to be subjected to Drug Susceptibility Testing (DST) to determine resistance/ sensitivity status to anti-TB drugs.

In case the interruption is for less than one month, the same treatment regimen is completed to complete all doses.

Modes of Retrieval

TB treatment is supervised by a trained treatment supporter (a health worker, family member or community volunteer). The residential address is verified for all TB patients by home visits. However, in case of treatment interruption, patient retrieval action is required.

Retrieval can be done by the following modes:

1. Retrieval of patients interrupting treatment within 24 hours of discontinuation is done by the Treatment Supporter (TS) or Accredited Social Health Activist (ASHA)/ Auxilliary Nurse Midwife (ANM)/ Multipurpose Worker (MPW). The reason for interruptions should be reviewed carefully and efforts made to counsel and bring the patient back for treatment.

2. If the TS is not successful in retrieving such patients, it should be reported to the next higher level of supervisors, like Senior Treatment Supervisor (STS), and they should take all efforts to counsel and retrieve the patient.

3. If the patient interrupts treatment on more than one occasion, the Medical Officer of the Peripheral Health Institute (MO-PHI) should visit the patient’s home. The MO-PHI should give intensive counselling to the patient and may provide additional support to continue the treatment without interruption.

4. Innovative use of information and communication technologies for treatment adherence monitoring through 99 DOTS, Medication Event Reminder Monitor (MERM), etc. are also beneficial in finding missed doses and initiating retrieval action by the health staff.

Resources

1. Training Modules (1-4) for Programme Managers and Medical Officers.

2. Guidelines for PMDT in India, 2021.

Assessment

The treatment for TB is demanding in terms of duration of treatment, adverse drug reactions, the requirement of prolonged adherence by patients and catastrophic expenditures. The presence of a special condition added on by a TB diagnosis makes it even more challenging.

To improve the outcomes for such challenging situations, the programme recommends certain modifications in the regimen, which are listed in the table below.

Table: Management of TB in Special Situations

Management of Adverse Drug Reactions (ADRs) in Special Situations

• The actual management of ADR begins during the treatment initiation counselling, where the patient should be instructed in detail about potential adverse effects due to the prescribed drug regimen and when they occur, to notify a healthcare provider.
• Treatment Supporter (TS) should be trained to closely monitor the patient for any signs of ADR (especially, since drug-drug interaction could happen) daily so that they can be recognized and managed quickly.
• The TS should also be trained to identify ADR as major and minor.
• A symptom-based approach should be followed to manage minor ADR where the patient is usually able to tolerate anti-TB drugs and continue medication with symptomatic treatment. Appropriate referrals should be made for all major ADRs that may require hospitalization of the patient.
• If the adverse effect is mild and not serious the treatment regimen must be continued with the help of ancillary drugs, if needed.
• For most second-line drugs related ADR, reducing the dosage/ terminating the offending drug can be considered and should be decided by the Nodal/District Drug-resistant TB Centre (N/DD- TBC) committee.
• Psychosocial support, patient education and motivation through TS and other patient support groups are also effective ways to manage the ADRs.

Resources

• Guidelines on Programmatic Management of Drug Resistant TB (PMDT) in India, CTD, MoHFW, India, 2021.
• Training Modules (1-4) for Programme Managers and Medical Officers, CTD, MoHFW, India.

Assessment

A death review or mortality audit is a means of documenting the causes of death and the factors that contributed to it, identifying factors that could be modified and actions that could prevent future deaths, putting the actions into place and reviewing the outcomes.

The aims of the audit or review of deaths in hospitals and health services are to:

• Ensure that all deaths are identified and discussed, and confidentiality is maintained.
• Assign a cause or causes to each death.
• Determine whether the care given was consistent with evidence-based clinical practice, standards of care or the care desired by professionals.
• Determine the social, environmental and nutritional risk factors for any death.
• Determine possible modifiable factors in the care of each person who dies.
• Change modifiable factors to improve the quality of care and avoid similar deaths in the future.
• Improve the quality and completeness of patient documentation.
• Provide an opportunity for reflection and support to HCWs.
• Let families know that their relative’s life was valued, the death is being taken seriously and HCWs are committed to learning and improving their practice.

Under the National TB Elimination Programme (NTEP), death audits provide insights into the chain of social, economic and clinical events leading to TB deaths and guide the programme in taking appropriate actions to prevent them.

Process for Undertaking Death Audits

An overview of the process for undertaking a TB death audit is shown in the figure below. Under NTEP, the following stakeholders are involved in the process:

• The medical officer should conduct an in-depth audit of all the deaths occurring amongst TB patients irrespective of initiation of treatment.
• Similarly, the District TB Officer (DTO) should conduct the death review of all Multidrug-resistant TB (MDR-TB) patients who died.

Figure: Overview of the process for undertaking a TB death audit

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• A Guide to Conducting TB Patient Mortality Audits using a Patient-centered Approach, KNCV, USAID and MSH, 2012.
• Operational Guide for Facility-based Audit and Review of Paediatric Mortality, WHO, 2018.

Assessment