Ph-Ch16: Drugs and consumables in NTEP

Types of drugs and consumables in NTEP

Content

National TB Elimination Programme (NTEP) has established a robust supply chain management to ensure an uninterrupted supply of drugs and consumables across the country.

The drugs, diagnostic equipment, etc., are procured mainly through the central level and the states are granted permission to procure some consumables through the local state or district level while abiding by the NTEP guidelines.

1. Anti-TB Drugs

The various type of anti-TB drugs are classified as follows:

2. Consumables

Various consumables used are:

Resources

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Which group of second-line drugs does Delamanid belong to?	Group A	Group B	Group C	Group D	3	Delamanid is a Group C second-line drug.		Yes	Yes

Drugs, injectables and related supplies in NTEP

Content

Under the National TB Elimination Programme (NTEP) a comprehensive supply management system is maintained through Ni-kshay Aushadhi wherein all the stocking points and implementing health facilities are required to update the stock utilisation, consumption, requirement and expiry on a near to real-time basis. The requirement of all items at all levels is then calculated based on the data reported.

Injectables under NTEP

The injectables used in TB treatment under NTEP are as follows:
- Amikacin
- Streptomycin
- Kanamycin
- Capreomycin
Amongst these, Amikacin and Streptomycin, have been downgraded to Group C under the World Health Organisation's (WHO) reclassification of anti-TB drugs and are not included if an adequate regimen can be built without them.
Kanamycin and Capreomycin are also no longer recommended for use.
They are currently used only in special situations where the regimen cannot be completed and are supplied as Type B boxes.
The District TB Officer (DTO) is responsible for issuing the injectables and the Peripheral Health Institute Medical Officer (PHI-MO) along with the Directly Observed Treatment (DOT) provider is responsible for making suitable arrangements during the intensive phase of the treatment for daily injections.

Other Related Supplies

The other supplies required whenever the injectable TB treatment regimen is used are as follows:
- Water container
- Disposable tumblers
- Sterile water
- Disposable needles and syringes
- Cotton
- Methylated spirit
In order to ensure accurate DOT, the DOT centre should have all the related supplies matched to the number of injection vials that are stocked in the centre.
There should also be a sufficient number of disposable needles and syringes for giving injections along with cotton and methylated spirit to ensure that the injections are always given under sterile conditions.
An adequate supply of sterile water, with enough water containers and disposable tumblers, must be ensured.

Procurement Injectables and Related Supplies under NTEP

The procurement of second-line drugs under the programme is done centrally depending on the policies and funding mechanism either through the Central Medical Services Society (CMSS) or through the Global Drug Facility (GDF). These are then distributed to implementing levels via State Drug Stores (SDS), District Drug Stores (DDS), Tuberculosis Unit (TU) and PHI. Other treatment-related supplies can also be procured at the state/ district level following NTEP guidelines/ General Financial Rules (GFR).

Resources

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
All the injection-related supplies should be matched to the number of injection vials stocked.	True	False			1	All the injection-related supplies should be matched to the number of injection vials stocked.		Yes	Yes

Laboratory consumables

Content

The National TB Elimination Programme (NTEP) laboratory network is composed of National Reference Laboratories (NRLs) at the national level, at the state level Intermediate Reference Laboratories (IRLs) and Culture & Drug Susceptibility Testing (C&DST) laboratories and at the peripheral level Designated Microscopy Centres (DMCs).

Each of these laboratories is responsible for performing various functions at its own levels.

Figure: Flowchart of Laboratory Consumables

Table: Laboratory Consumables

Laboratory Consumables	Description
Cartridge-based Nucleic Acid Amplification Tests (CBNAAT) machines and Cartridges	The CBNAAT machines and cartridges are procured by Central TB Division (CTD) and supplied to state/ district/ CBNAAT sites based on their requirement. Cartridges are supplied based on the stock availability, consumption and expected case load. Recording, reporting and monitoring of cartridges are done through Ni-kshay Aushadhi.
Binocular Microscope (BM) and LED Fluorescence microscopy (LED-FM)	The procurement of both items is undertaken by CTD and then delivered to the states/ districts. All LED-FM/ BMs should be covered by annual maintenance contracts by states/districts, at the end of their warranty periods. NTEP guideline recommends 1 BM for every Designated Microscopy Centre (DMC) and LED FMs only for the high case load facilities with >25 slides per day. Along with public sector DMCs, NTEP may also supply BMs to DMCs established in other sectors like ESIS, Public Sector Undertakings, Medical College, etc., if required.
Sputum containers	Calculation of requirement of sputum containers: For diagnosis: During the first week of each quarter, the number of new pulmonary smear-positive cases registered and treated during the last quarter in the district should be determined and this number should be multiplied by 10. 10 is the average number of symptomatic required to be examined for detecting one case of new pulmonary smear-positive tuberculosis and it includes all types of patients. Since two sputum specimens are taken for each symptomatic patient, further multiply the number obtained above by 2. The final number derived would be the required no. of slides for diagnosis. For follow-up: Two follow-up specimens are taken for the majority of patients (one at the end of the intensive phase and the other at the end of treatment), therefore one sputum container is needed for each follow-up. On the last working day of the quarter, count the number of sputum containers in stock and subtract from the required number as calculated above. Allow sufficient reserve stock for three months, add 10% to account for wastage of sputum containers, and account for the sputum containers in stock.
Slides	One slide is used to examine one specimen in a sputum container. Therefore, order a slightly higher number of slides, than the required no. of sputum containers to account for unavoidable breakage of slides. Order for both sputum containers and slides should be placed during the first week of the quarter. The supplies will be procured by the state/ district and supplied to all the peripheral health institutions in the district.

Resources

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Identify the correct statement from the options given below.	The CBNAAT machines and cartridges are procured at the district level as per the requirement.	The CBNAAT machines and cartridges are procured centrally and supplied to state/ district/ CBNAAT sites based on their requirement.	The CBNAAT machines and cartridges are procured at the Designated Microscopy Centre level as per the requirement.	The CBNAAT machines and cartridges are procured at the Tuberculosis Unit level as per the requirement.	2	The CBNAAT machines and cartridges are procured centrally and supplied to state/ district/ CBNAAT sites based on their requirement.		Yes	Yes

99 DOTS and MERM boxes

Content

99 DOTS

99 DOTS is an IT-enabled ‘pill-in-hand’ adherence monitoring system implemented by the National TB Elimination Programme (NTEP) for all Drug-sensitive TB (DS-TB) patients on a daily regimen.

Mechanism of 99 DOTS

In this system, the medicine blister packs (Figure 1) are wrapped with envelopes which have unique toll-free phone numbers printed on them.
Each time a patient dispenses the pills, they break through perforated flaps on the back of the envelope, revealing a hidden phone number.
The patient is expected to give a call to this toll-free number from his/her registered mobile number to report that they have consumed the medication.
This is documented and updated against the patients’ adherence record in Ni-kshay.
The sequence of hidden numbers cannot be predicted by patients but is known by the system for each month of medication prescribed.
If the call is not received from the patients by 3:00 p.m., an SMS reminder is sent to the patients on their registered mobile number.
If the patient still does not consume medications, the issue is escalated to the authority chain till corrective action is taken.
Additionally, the patient can also be remotely followed up with help of Call Centres or using an Interactive Voice Response (IVR).

Printing of 99 DOTS Envelopes

Specification for the printing of 99 DOTS envelopes is provided by Central TB Division (CTD) to all states and the envelopes are printed at the state level and then distributed to the districts.
The cost of printing and distribution of these envelopes should be budgeted in the state Programme Implementation Plan (PIP).

Advantages of 99 DOTS

Enables the NTEP staff to prioritise patients who need to be visited and counselled.
Empowers patients to be able to take charge of their own treatment.

Figure1: 99-DOTS Blister Pack

Figure 2: Colour-coded adherence calendar output of 99-DOTS patients based on calling

Medication Event Reminder Monitor (MERM) Box

The Medication Event Reminder Monitor (MERM) Box is an electronic pill box specially designed to monitor Multidrug-resistant TB (MDR-TB) treatment.

Mechanism of MERM

Medications are dispensed in blister packs and each drug is placed in a different partitioned compartment within the pillbox.
The MERM box contains a removable electronic battery-powered module when triggered by a magnetic sensor captures and stores data each time the container is opened, as a proxy for medication ingestion.
The MERM is programmed to provide audio-visual reminders to the patients to take medications at a specific time of the day.
The visual reminder consists of:
- Green light: Corresponds to a label encouraging the patient to take a dose.
- Yellow light: Alerts patients about the need to refill medications.
- Red light: Indicates a low battery and the need to replace the MERM’s battery.

The audio reminder consists of a ringing sound that would occur at the same time as the visual dose-taking reminder.

The data from the MERM boxes is transmitted every 72 hours using cellular networks and recorded on a computer server.
Each patient’s adherence history is presented as a colour-coded calendar (Figure 2) in which:
- Green suggested that the MERM was opened on a given day: Suggesting probable medicine was consumed.
- Red suggested that the device was not opened: Suggesting that medicine was probably not consumed.
In case there is a series of possible missed doses, i.e., red-coloured calendar days, it would result in automated SMS notifications to the patients and also prompt the system to address the interrupting patients who are potentially at higher risk for unfavourable outcomes.

Advantages of MERM box

Facilitates the identification of high-risk patients and prompt intervention by the system to improve adherence.
Facilitates storage and organisation of the multiple medications of the MDR-TB regimens.
Reduces the required frequency of patient visits to a health facility in comparison to facility-based DOT.

Figure 3:Medication Event Reminder Monitor (MERM) Box

Resources

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
What is the meaning of ‘Red-coloured calendar days’ received through the MERM box data?	Series of consumed doses.	Series of missed doses.	Series of missed calls to the toll-free number.	None of the above	2	Red-coloured calendar days in the MERM box data mean a series of missed doses.		Yes	Yes

General stocks and materials

Content

Information Education and Communication (IEC) Materials

The purpose of the IEC materials is to create awareness and disseminate information about the disease (signs and symptoms) diagnosis, and treatment to increase accessibility and utilisation of services among the general population.
IEC material also encourages the build-up of health-seeking behaviour among the masses in keeping with the focus on promotive and preventive health.
Under IEC, posters, flyers, leaflets, brochures, booklets, etc. are printed and circulated. It is the responsibility of the state to print IEC material in various languages and distribute it among the general population.
The surplus material is stored at the State Drug Store (SDS) for further distribution as and when required.

Printed Materials

As per the National TB Elimination Programme (NTEP) norms, the districts must use several forms and registers to record the diagnostic and treatment activities. In addition to these, the districts should maintain an adequate supply of printed material for the latest programmatic guidelines. These include the following:

Forms

NTEP request for examination of biological specimens: Used to request tests such as sputum smear microscopy, Nucleic Acid Amplification Test (NAAT), Line Probe Assay (LPA), culture and Drug Susceptibility Test (DST).
Treatment card (TB and Drug-resistant TB (DR-TB)): This card contains important information about a patient, such as their name, age, sex and address; type of disease; regimen prescribed; duration of treatment; etc.
Patient’s identity card (TB and DR-TB patients): The front part of the ID card has patient information, name and address of the TB Unit (TU)/ district and treatment details of the patient including disease classification, type of patient, sputum results, category and information on the date of starting treatment. The back portion of the ID card has the results of the follow-up sputum examination, appointment dates for visits for drug administration and treatment outcome.
Referral form for treatment (TB and DR-TB): Used when referring patients for treatment to other peripheral health institutions.
Transfer form: This form is to be used when transferring registered patients on treatment from one reporting unit to another.
TB notification forms

Registers

Tuberculosis laboratory register: Used to record the results of sputum smear examinations at the microscopy centres
Culture and DST laboratory register: Used to record the results of NAAT, LPA, culture and drug sensitivity testing
Tuberculosis notification register: Contains information on all TB patients registered in the area
Stock register: Used for recording the information on the stock of drugs and consumables received and issued by the health unit
Reconstitution register: Used for recording the receipt of drugs of patients who have defaulted, died, failed treatment or transferred out
Referral for treatment register: Maintained in all big hospitals and medical colleges where large numbers of cases are expected to be diagnosed and referred for treatment to other reporting units

Tablets

NTEP has provided tablet computers to all the key staff with the objective to support the system of capturing important information on a real-time basis. Distribution and storage of these tablet computers is another activity of the drug stores.

Programmatic guidelines

Technical and Operational Guidelines
National Guidelines on Programmatic Management of Drug-resistant TB
National Guidelines on Partnerships
Desk Reference (Charts on diagnostic algorithm, dosage of anti-TB drugs, any other)
Laboratory Manual for Sputum Smear Microscopy and NTEP Laboratory Network guidelines for Quality Assurance of smear microscopy for diagnosing TB
Guidance document on Nutrition Support to TB patients
Other relevant documents/ guidelines/ circulars circulated by the Central TB Division (CTD).

It is the responsibility of the state to determine once a year the number of forms and registers that would be needed during the following year. The states must ensure that there is an adequate supply of all the forms, registers and guidelines within the state and that sufficient funds are available for the same.

Once printed, all the forms, registers and guidelines are stored at the SDSs from where they are further distributed to the districts and other health units.

Resources

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
What is the purpose of the referral form for treatment?	Referring patients for treatment to other peripheral health institutions.	Transferring registered patients on treatment from one reporting unit to another.	Both 1 and 2	None of the above	1	The referral form for treatment is used when referring patients for treatment to other peripheral health institutions.		Yes	Yes

Various stocking points in NTEP

Content

Under the National TB Elimination Programmme (NTEP), there are various stocking points at different levels which help in the storage and distribution of supplies to ensure their uninterrupted availability at all levels.

The various stocking points under NTEP are:

Abbr: GMSD: General Medical Stores Depot; CMSS: Central Medical Services Society; SDS: State Drug Store; DDS: District Drug Store; TU: TB Unit; PHI: Peripheral Health Institute; HF: Health Facility.

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, NTEP, Central TB Division, Ministry of Health and Family Welfare, Government of India, 2021.

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Which stocking point/ points have a reserve stock of drugs for three months?	State Drug Store	District Drug Store	TU Drug Store	Both state and district drug stores	4	As per the standard NTEP norms, both SDS and DDS should have a reserve stock of drugs for three months.		Yes	Yes