CHO-M4: Adherence Managament

Tuberculosis(TB) is curable if patients are treated with effective, uninterrupted anti-tuberculous treatment. Treatment adherence is critical for curing individual patients, controlling the spread of infection in the community, and minimizing the development of drug resistance.

Adherence to treatment means that a patient follows the recommended course of treatment by taking all the prescribed medications for the entire length of time, as necessary. In other words, “right dose for the right duration”.

In Drug Sensitive Tuberculosis(DSTB), a TB patient completes 168 doses of TB treatment and adheres to TB treatment.

Adherence to tuberculosis(TB) treatment is important for promoting individual and public health. Poor adherence to TB treatment results in:

• More individual suffering and death,
• Costly treatment as treatment regimens lengthen and
• Increases the risk for Drug Resistant Tuberculosis

Proper treatment of all forms of TB is critical to reducing individual morbidity and mortality and to interrupting transmission among family and community members.

Recording of Treatment Adherence can be done as

• Manually by DOT/Health Care Provider in TB Treatment Card of a patient.
• Self-reported by Patient using digital tools for reporting adherence using 99 DOTS and MERM technologies.

Monitoring Treatment Adherence:

All TB patients should be monitored to assess their response to TB treatment. Nikshay Adherence calendar has a colour legend for various doses taken by a patient

Figure: Sample Nikshay Adherence Calendar in web and Mobile App

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Figure: DSTB Treatment Card (Paper)
 

99DOTS is a low-cost digital adherence technology built-in Nikshay that uses inexpensive packaging(envelopes or stickers) with medication that enables people taking medication to engage with their treatment daily. This packaging, distributed to TB patients taking medications, has a hidden number behind perforated flaps on the external envelope; in some cases, the number may be fixed outside the medication blister or pill bottle. This number can be a toll-free number that can be called to register daily adherence or a code sent by SMS, USSD, or other communication channels. Calling or messaging the number is free!

Figure: 99 DOTS Envelope

MERM: The Medication Event Reminder Monitor(MERM) is a digital pillbox that provides daily pill-taking reminders and facilitates remote monitoring of medication adherence. This system provides visual and audible reminders for both daily dosing and refill,.transmits this data to a server so that healthcare providers can remotely visualize patients’ dosing histories to support enhanced adherence counselling. 

Figure: MERM Box

A Treatment Supporter can be any person such as a Medical Officer, MPWs, community volunteers working with the program etc. Even a patient’s relative or family member can be a Treatment Supporter.

As per NTEP guidelines, salaried NTEP/General Health System staff may also be assigned as treatment supporters for a patient.  However, they will not be eligible for any honorarium.

A patient can only be linked to one treatment supporter at a time in Nikshay.

Missed Dose recording in Nikshay:

For recording missed doses in Nikshay, following steps should be followed:

Manual recording of Adherence in Nikshay:

in Nikshay, Adherence can only be recorded only if there is corresponding dispensation being issued to a Patient 

Figure: Steps to record manual dose in Nikshay

Recording in Patient Treatment Card:

Figure: Filled Treatment card for TB Patient

Video: Features of 99 DOTS

Video: Benefits of 99 DOTS

The 99DOTS product consists of customised envelopes (see Figure 1) that fit around the tuberculosis medication blister pack distributed to patients. 

Figure 1: 99DOTS Envelope

Universal Envelopes (Figure 2): Each adult patient gets the same sleeve, regardless of their weight band.

These are new envelopes that are currently being introduced by the program. Weight band wise envelopes will be used while the stock lasts, but new requirements by the state will be fulfilled by providing universal envelopes.

There are 2 types of these envelopes: 1 envelope for IP: Intensive Phase, and 1 envelope for CP: Continuation Phase, for both Macleods and Lupin Fixed-dose Combinations (FDCs). These envelopes are only to be used for adult patients on anti-TB treatment using FDCs.

Figure 3: Universal 99DOTS Envelopes

Using the Universal Envelope

• The counsellor/ pharmacist/ treatment supporter write the number of pills per day the patient should take on the envelope.
• Every day, the patient will take the prescribed number of pills and reveal 1, 2, or 3 hidden phone numbers. The patient calls any one of the numbers they reveal that day.
• The patient should start at pill 1 and move in sequence (1,2,3…28), completing each column, and starting from the top of each row.
• The district should always have sufficient stock, which can be calculated as:
  • Number of IP strips = Number of IP envelopes + some buffer
  • Number of CP strips = Number of CP envelopes + some buffer

Advantages of the Universal Envelopes

• There is no need to estimate the requirements of weight band wise envelopes.
• Less space is required to store the envelopes.
• Stock-outs of envelopes for a particular weight band will not occur.
• It is easy for patients to follow the top to down arrow mark pattern while dispensing and ingesting medicines.
• Counselling time and dispensing time by pharmacists reduce per patient, thus increasing efficiency.

Resources:

• Nikshay 99DOTS Training Manual, 2021.
• Nikshay 99DOTS Universal Envelope Training Manual, 2021.
• 99 DOTS Website.

Assessment

The Medication Event Reminder Monitor (MERM) is a digital pillbox that has been designed to monitor Multidrug-resistant TB (MDR-TB) treatment in resource-constrained settings, using relatively affordable technology and drugs provided by the National TB Elimination Programme (NTEP).

Figure: MERM Container for Shorter/ Longer Oral MDR-TB Regimen; Source: Guidelines for PMDT in India, 2021, p143.

• This system is specifically designed to be used with multiple blister-packaged TB medications in Drug-resistant TB (DR-TB) regimens.
• The MERM provides programmable visual and audible reminders of daily dosing and monthly refill by capturing data on pillbox opening as a proxy for dose ingestion.
• It transmits these data to a server so that Healthcare Providers (HCPs)/ treatment supporters can remotely visualize patients’ dosing histories to support enhanced adherence counselling.
• In addition, by providing near real-time adherence data, the MERM can facilitate the identification of high-risk patients and prompt early intervention by HCPs to reduce non-adherence.
• When compared to facility-based Directly Observed Therapy (DOT) in which patients travel to clinics to be observed taking their medications, monitoring using the MERM may also reduce the required frequency of patient visits to TB clinics.

Resources

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.
• Standard Operating Procedure Manual - Procurement & Supply Chain Management, MOHFW, GOI.

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Video: MERM Box: Components

Video: MERM Box: MERM Allocation in Nikshay

The Adherence Summary dashboard  is designed primarily for treatment supporters and field staff to help them monitor the day to day adherence statistics of their patients and incorporate necessary actions wherever required. This dashboard enables staff at district level hierarchies and below to view real-time adherence information of all patients on treatment.

The adherence summary dashboard is available in both Ni-kshay web portal as well as the mobile application.

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Figure 1: Adherence Summary Dashboard; Source: Ni-kshay Web Portal (L) and Ni-kshay Mobile Application (R)

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Figure 2: Adherence Summary Dashboard; Source: Ni-kshay Web Portal

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 Figure 3: Adherence Summary Dashboard (contd.); Source: Ni-kshay Web Portal

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Figure 4: Adherence Summary Dashboard; Source: Ni-kshay Mobile Application

This dashboard provides a summary of the following:

• The Number of Patients currently enrolled on various Digital Adherence Technologies (99DOTS, MERM, VOT)
• Graph representing % of 'Average Adherence' of all patients on treatment
• Graph representing the % 'Digital Adherence' of all patients on treatment
• Real time update on the number of patients who have reported a dose (Digital + Manual) for the day and the number of patients who are yet to report a dose.
• Adherence Task Lists: This tab gives information on the number and proportion (%) of treatment interrupting patients based on the no. of doses missed,  which helps the NTEP staff to undertake immediate actions to bring such patients back on treatment.

Resources

• Adherence Summary View, v5, Nikshay Knowledge base, India, 2022
• Ni-kshay 2.0 App User Guide, CTD, MoHFW, India, 2018.
• Adherence Monitoring in Ni-kshay Version-2.0, CTD, MoHFW, India.

Assessment