M-3: PHI Pharmacist: General concepts and Principles of SCM in NTEP

Supply Chain Management (SCM) is the handing of flow of goods and material from point of origin to point of consumption, with the objective to ensure that the supplies are present for utilization without any interruption. It covers everything from procurement and sourcing of raw materials to delivery of final product to the consumer, along with the related logistics. It will also include the related information systems that enable monitoring and exchange of information.

Effective SCM ensures the following:

• Continuous availability of quality-assured medicines/ products at the right time and at all healthcare levels.
• Minimizes wastage by preventing expiry of drugs at all levels, maintenance of adequate stock levels and accurate records.
• Maximizes patient care by coordination in all departments and by minimizing human errors/ medication errors.
• Economically viable by minimizing monetary loss (e.g., through pilferage) and optimizing cost via bulk purchasing or according to consumption needs.

Robust supply chain management systems have two main components:

1. Physical flow: Involved the movement and storage of supplies
2. Information flow: Allows the various stakeholders to coordinate and control the flow of supplies

Resources

• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020.
• NTEP Training Modules 5-9 for Programme Managers & Medical Officers, 2020.
• Guidelines for Programmatic Management of Drug-resistant TB, 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 of the following statements are correct about supply chain management?	It is useful to ensure a continuous supply of good quality medicines.	It is an essential activity that must be undertaken by health programmes.	It helps reduce the cost burden on the healthcare system.	All of the above	4	Effective SCM is an essential activity that ensures a continuous supply of good quality medicines and cost optimization.	​

 

 

 

 

Under the National TB Elimination Programme (NTEP), the anti-TB drugs are procured at the centre level by the Central TB Division (CTD), Ministry of Health and Family Welfare (MoHFW), and supplied to the central warehouses.

From the central level warehouses, the drugs are supplied to different State Drug Stores (SDS) and further distributed to District Drug Stores (DDS) and sub-district level (TB Unit (TU) Store and Peripheral Health Institute (PHI)).

This movement of drug flow is monitored in real-time through Ni-kshay Aushadhi.

 

Figure: Flowchart Showing the Overview of Distribution of Drugs

Abbr: CMSS: Central Medical Services Society; GDF: Global Drug Facility; CTD: Central TB Division; GMSD: Government Medical Store Depot; SDS: State Drug Store; DDS: District Drug Store; TU: TB Unit; PHC: Primary Health Centre; PHI: Peripheral Health Institute.

 

Resources

• Standard Operating Procedure Manual Procurement & Supply Chain Management, CTD, MoHFW, India, 2018.
• Procurement, Supply Chain Management & Preventive Maintenance, Module 6, CTD, MoHFW, India.

Various stocks are maintained at different levels. To facilitate the monitoring of the quantity of these stocks, these are classified as follows:

1. Active Stock: It refers to those stocks which have passed all quality parameters and those which are ready to use/ dispatch for consumption. This is the heart of a warehouse and mostly uses the major chunk of storage. The First Expiry First Out (FEFO) principle will apply to this section of the drug stock.
2. Quarantine Stock: The stock which is pending for quality testing or not yet prepared for active usage is called quarantine medicines. This stock is kept in a separate area that is called the quarantine area and is not to be disbursed for usage until they are declared as active stock.
3. Safety Stock: Buffer stock or safety stock is the amount of stock or medicine set aside to meet the requirements of the facility/ store at the time of an emergency like unforeseen demand or depleting stock. However, this stock should be frequently checked for expiry and replenished at right time to prevent its expiry.
4. Damaged Stock: The medicines or stocks which are found damaged during the delivery at a particular facility/ warehouse in terms of packaging/ leakage/ broken, are to be identified and kept separately as damaged stock. The idea is to return them to the supplier with the proper Damage Stock Report Form. The pharmacist needs to mark such damaged stock in the delivery challan at the time of the receipt.
5. Substandard Stock: Substandard medicines/ items are products that do not meet the quality standards and specifications. These items should be kept separately to avoid their use. These stocks need to be reported to the parent store. As per the directions, these stocks either need to be returned to the supplier or disposed of in accordance with the biomedical waste management guidelines.
6. Lost in Transit Stock: It refers to the stock which is either misplaced/ lost during transportation. The pharmacist needs to report such stock in the delivery challan at the time of the receipt and the same needs to be reported to the supplying store immediately.
7. Expired Stock: Ideally, the warehouse should not have an expired medicine/ item if a proper FEFO mechanism is adopted for dispatch. However, in certain situations, drugs/ items may get expired and may not be suitable for usage as recommended by the manufacturer. Such stock is called Expired Stock. These expired drugs/ items need to be kept separately in a demarcated area and are labelled as expired drugs/ items and are to be disposed of, in accordance with the prevailing biomedical waste disposal guidelines after obtaining necessary approvals.

Resources

• Operational Guidelines for TB Services at Health & Wellness Centres, MoHFW, GoI, 2020.

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct Answer	Explanation	Page ID	Part of Pre-Test	Part of Post-Test
Which of the following is true regarding the use of medicines which are kept in quarantine?	Can be used in an emergency.	Can be used before the quality test result.	Can never be used.	Can be used if the particular item passes the quality test or is declared as active stock.	4	Quarantine medicines are not to be disbursed for usage until they are declared as active stock.		Yes	Yes

Minimum Stock

 A minimum stock level is a threshold value that indicates the level below which actual medicine stock should not normally be allowed to fall.

In other words, a minimum stock level is a minimum quantity of a particular drug/ medicine that must be kept at all times.

The main factors to consider when fixing the minimum stock level are:

• Average consumption
• Time needed to procure/ receive from supplies/ reporting facility, i.e., Lead time
• Reorder level (a fixed stock level between the maximum and minimum stock levels, at which a request for supply will be placed)

The minimum stock level can be calculated by applying the following formula:

Minimum Stock Level = Reorder level - (Average consumption per time period under consideration x Time taken for delivery)

(time period may be day/ week/ month/ quarter)

Maximum Stock

A maximum stock level is the upper limit of stock that should not be exceeded under normal circumstances without the prior agreement of the management.

The aim of setting a maximum stock level is to maintain the inventory level at the warehouse.

The main factors to consider when fixing the maximum stock level are:

• Average consumption
• Availability of storage space
• Economic order quantity
• Time needed to procure/ receive from supplies/ reporting facility
• Cost of carrying inventory or cost of storage

The maximum stock level can be calculated by applying the following formula:

Maximum Stock Level = Reorder level + Reorder quantity - (Minimum consumption per time period under consideration x Minimum time taken for delivery)

 

Figure: Stock Re-ordering Level; Source: Inventory Management.

 

Resources

• Maximum STock Level in Inventory Management, Interlake Mecalux.
• Inventory Management.

 

Assessment

 

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	Part of Pre-test​	Part of Post-test​
The stock of drugs should not normally fall below the minimum stock level.	True	False			1	A minimum stock level is a threshold value that indicates the level below which actual medicine stock should not normally be allowed to fall. In other words, a minimum stock level is a minimum quantity of a particular drug/ medicine that must be kept at all times.	​	Yes	Yes

The principle of First-Expired, First-Out (FEFO) means that the drugs which are due to expire first, are to be issued first. 

The FEFO principle ensures that the product with the shortest expiry date is utilised at the earliest within its shelf-life. 

Following the FEFO principles, the stocks need to be placed/ arranged/ stacked in a sequential manner. 

 

Steps Followed for Implementing FEFO

 

1. Check Expiry Date
   • The expiry date of the stock need to be checked at the time of receipt of supplies with the release order/issue voucher. 
   • The ‘Expiry Dates’ should be marked in bold letters, 3” to 4” in size, on the drug cartons with a marker pen, for easy identification and control of drugs immediately on their arrival.
   • The pharmacist need to record for expiry date of the stock in the Ni-kshay Aushadhi or in stock register.
      
2. Storing Supplies with Different Dates of Manufacture and Expiry in Different Batches
   • Different batches of supplies with different dates of manufacture and expiry should be stored separately.
   • Supplies that are past their date of expiry should never be stored with the items which are still being used and the storekeeper should ensure that there is no stocking of supplies beyond their date of expiry.
      
3. Checking the Utilisation Pattern Before Issuing Drugs
   • The storekeeper should strictly follow FEFO principles to ensure that all short-expiry drugs should be distributed to  the State/ District/TU/ Peripheral Health Institute based on the utilisation pattern of each.
   • The storekeeper is also expected to install appropriate tools to periodically monitor controls over the expiry position of drugs held in stocks mainly through storage of drugs of a particular description at one place, expiry-wise stacking and marking expiry dates on cartons/ drug boxes with marker pens.
   • The Pharmacist need to check for Expiry date from the physical stock and Ni-kshay Aushadhi prior to issue.
   • In case of short-expiry supplies, the distribution should be on the rational basis keeping in view the utilization pattern to ensure judicious consumption.
      
4. Frequent Checks/ Physical Verification
   • Frequent check and physical verification to be carried out by the supervisory officer on regular basis. This ensures that the older drugs are being used first and that none of the drugs are past their date of expiry.

 

Resources

 

• Module for STS - Part 2: Ensuring Proper Registration and Reporting, CTD, MoHFW, India.
• Training Modules (5-9) for Programme Managers and Medical Officers, CTD, MoHFW, India.

 

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
The principle of FEFO means that the 'drugs which are due to expire first, are to be issued first.’	TRUE	FALSE			1	The principle of FEFO means that the 'drugs which are due to expire first, are to be issued first.’		Yes	Yes

The short expiry drugs are the drugs which are left with a short shelf-life and need to be utilised immediately to avoid their expiry. 

Shelf-life of a drug is defined as a period during which the drug will last without deterioration, provided all precautions for good storage practices have been undertaken. The shelf-life of anti-TB drugs ranges from 3-5 years after which the chances of losing efficacy and probability of side effects increase rapidly. Therefore, it is important to ensure that appropriate steps are taken as soon as the drugs reach the critical stage to ensure their usage well within their shelf-life.

Identification of Short Expiry Drugs 

• Short expiry depends on two main factors, duration of the treatment and the time taken for transit from one level to the next lower level, i.e., from State Drug Stores (SDS) to the District TB Centre (DTC) --->Tuberculosis Unit (TU) ---> Peripheral Health Institute (PHI).
• Whenever the drugs are dispatched,  the transit duration (approx.3 months), possible treatment interruption (approx. 1 month), a probable extension of the Intensive Phase (1 month) and the buffer stocking norm under each facility should be taken into account, to calculate if the drug is expiring shortly.

Principles of Management of Short Expiry Drugs 

• For the drugs whose expiry date is mentioned only as month and year, the last day of that particular month should be considered as the date of expiry.
• Expiry-wise stacking of the drugs, marking of expiry dates on cartons/ drug boxes with marker pens and periodic monitoring of the expiry position of the drugs.
• The expiry date should be highlighted in yellow to flag attention to the drugs facing the risk of expiry.
• First-Expiry-First-Out (FEFO) principle should be strictly followed in the case of short-expiry drugs which means the drugs near to expiry should be issued first.
• All the details about the drug quantity and expiry date should be recorded and reported in Ni-kshay Aushadhi.
• A review of drug adequacy should be conducted monthly/quarterly by the officer in charge to identify any stock imbalances or excessive short expiry drugs and implement corrective measures accordingly.
• The distribution of short expiry drugs on a rational basis, keeping in view the utilisation pattern of each district to ensure timely consumption of close to expiry drugs.

Resources

• Standard Operating Procedure Manual Procurement & Supply Chain Management, CTD, MoHFW, India, 2018.
• Procurement, Supply Chain Management & Preventive Maintenance, Module 6, CTD, MoHFW, India.

Assessment

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	Part of Pre-test​	Part of Post-test​
If the date of expiry is mentioned as 'Dec-2022', what is the last date of expiry for that drug?	1-Dec-2022	10-Dec-2022	31-Dec-2022	None of the above	3	For the drugs whose expiry date is mentioned only as month and year, the last day of that particular month should be considered as the date of expiry.	​	Yes	Yes

Buffer stock refers to a reserve that is used in unforeseen emergencies. It is also known as strategic stock or safety stock. This mandates close monitoring of drug stocks and maintaining buffer stock at all levels following the stocking norms to ensure an uninterrupted supply of drugs.

 

Importance of Maintaining Buffer Stock

 

1. To cover for delays/ disruptions (if any) in the supply chain.
2. To manage instances where more patients are initiated on treatment than the actual expected patients in a particular month.
3. To ensure that no patient is sent back due to a shortage of drugs at any point in time.
4. For smooth functioning of the programme on a national level.

 

Buffer stock to be maintained at different levels under NTEP

 

For adult drugs ( 3-3-2-2)	State Drug Store	District Drug Store	Tuberculosis Unit	Peripheral Health Institution
	3 months	3 months	2 months	1 month
For paediatric drugs (3-3-4)	3 months	3 months	4 months	Not stocked at PHI level

 

Resources

• Standard Operating Procedure Manual Procurement & Supply Chain Management, CTD, MoHFW, India, 2018.
• Guidelines for PMDT in 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
At the state level, it is essential to maintain buffer stocks equivalent to how many months?	1	2	3	4	3	At the state level, buffer stocks equivalent to 3 months at SDS should be maintained.		Yes	Yes

Lead time is defined as the time interval between the order generation for a product and its receipt/ availability for use. Lead time for a product depends upon the type of product, quantity available in the market/ manufacturer and the weather conditions in which it is transported.

In supply chain management lead time plays a very important role as it is mandatory to place reorders in time to avoid stocking out the product. Poorly managed lead time can lead to stock out and leads to delays in supplying the product to clients or end users.

 

Lead Time = Reordering delay (Time period) + Supply Delay (Time period)

 

Figure: Lead Time in Supply Chain Management

 

Benefits of Reduction in Lead Time

 

• Minimises stock-outs 
• Helps to get medicines/ items on time
• Reduces the wastage of inventory
• Gives the estimation of demand

 

How to Reduce the Lead Time

 

• Stop ordering surplus inventory
• Keep an eye on the inventory level
• Cut out as many steps as possible
• Maintain the inventory as per the storage capacity
• Continuous follow-up with the supplier or the facility

 

Resources

• Strategies to Reduce lead Time in Your Supply Chain.

 

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct Answer	Correct explanation	Page ID	Part of Pre-Test	Part of Post-Test
Poorly managed lead time leads to stock-outs.	True	False			1	Poorly managed lead time can lead to stock out and leads to delays in supplying  the product to clients or end-user.		Yes	Yes

N-ikshay platform has a module for drug dispensation to patients. This feature is used for:

• Adding details of the product and quantity of drugs issued to patients.
• Printing and downloading the details of drugs dispensed as a prescription to share with the patients.
• Saving the time spent in repetitive data entry by copying previous dispensation details.
• Logging details of drugs that are returned by patients.
• Ensuring timely dispensation of drugs to patients by accessing the list of patients whose refill is due through the ‘Refill Due Task List’.

The stepwise details of adding dispensation are shown in the figure below.

 

 

 

Figure: Workflow for "Add Dispensation" on Ni-kshay; Source: Ni-kshay Portal.

 

Steps for Dispensation to Patients in Ni-kshay

 

1. Click on the ‘Add Dispensation’ button.
2. Search by episode ID or dispensation ID.
3. Enter dispensation details:

• Enter the “Date of Prescription”.
• The type of regimen gets auto-populated based on the test results.
• Enter the “Date of  Dispensation”.
• “Weight Band” is getting auto-populated. 
• The phase also gets auto-populated based on the test.
• Enter the “Current Weight”.

4. Enter drug issuing facility details.

• Select the State.
• Select the District.
• Select the “Drug Issuing Facility Type”.
• Select the “Drug Issuing Facility Name”.

5. Enter Product Details.

• Click on “Add” if required to add more product(s).
• Select the “Source” from the list.
• Select the prescribed product name from the drop-down option, it is a mandatory field.
• It is an auto-populated field based on the chosen product.
• Enter the “Quantity” as per the prescription, it is a mandatory field.
• Select the quantity less than or equal to the available quantity.

6. Enter Refill Details.

• Enter the dosing start date as per the prescription, it is a mandatory field.
• Enter the number of days of dispensation as per the prescription, it is a mandatory field.
• Enter remarks, if any.

In case a patient returns drugs, the same can be recorded under Return Dispensation. 

 

Resources

• Ni-kshay Portal.

 

Assessment

Question	Answer 1	Answer 2	Correct Answer	Correct Explanation	Page ID	Part of Pre-Test	Part of Post-Test
Ni-kshay can be used for entering details of drugs returned by patients	TRUE	FALSE	1	Ni-kshay drug dispensation module is used for: Adding details of the product and quantity of drugs issued to patients. Printing and downloading the details of drugs dispensed as a prescription to share with the patients. Saving the time spent in repetitive data entry by copying previous dispensation details. Logging details of drugs that are returned by patients. Ensuring timely dispensation of drugs to patients by accessing the list of patients whose refill is due through the ‘Refill Due Task List’.		Yes	Yes

Inventory Management (IM) is a systematic approach to ordering, receiving, storing, issuing and reordering drugs and other commodities. IM is a critical element in supply chain management which ensures the availability of the right products in the right place at the right time.

 

Figure: Overview of Inventory Management in NTEP

Abbr: SDS: State Drug Store; DTC: District Tuberculosis Centre, NTEP: National Tuberculosis Elimination Programme.

 

Under the National TB Elimination Programme (NTEP), IM refers to the activities carried out by the officer-in-charge of logistics and includes the following:

1. Determination of Stock Status at the SDS and DTCs/ Subordinate Stocking Points: The pharmacist will determine the drug stock status of their store and of all the sub-units up to PHIs through Ni-kshay Aushadhi.
2. Review of Adequacy of Stock: The Pharmacist will analyse the adequacy of stocks on the basis of the available stock and estimated consumption as per the stocking norms.
3. Correction of Imbalances through Transfers: Based on the review of drug adequacy, the officer-in-charge will flag all the sub-stores that are significantly under or overstocked.
   1. The needs of sub-stores flagged as understocked will be addressed through the Additional Drug Request (ADR) or Drug Transfer Advice (DTA) mechanism.
   2. The stocks at the sub-stores flagged as overstocked or with close to expiry drugs will also be corrected by the DTA mechanism.
   3. These transfers will only be authorised by the State TB Officer (STO)/ District TB Officer (DTO)/ officer-in-charge and should be recorded in Ni-kshay Aushadhi.
4. Replenishment of Stock: The stocks at the stores are replenished on a quarterly basis, pursuant to the review and validation of the reports available in the Ni-kshay Aushadhi.

 

Resources

• Standard Operating Procedure Manual, Procurement & Supply Chain Management, Central TB Division, Ministry of Health and Family Welfare, Government of India.

 

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 drug-stocking point/s are required to fill the QRPML?	SDS	DDS	TU	All the above	4	For the purpose of IM, all the drug-stocking points are required to fill and submit Quarterly/ Monthly Report on Programme Management & Logistics (QRPML).		Yes	Yes

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

• Standard Operating Procedure Manual Procurement & Supply Chain Management, CTD, MoHFW, India, 2018.
• Procurement, Supply Chain Management & Preventive Maintenance, Module 6, CTD, MoHFW, India.
• Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India, NTEP, CTD, MoHFW, 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 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

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

 

• Standard Operating Procedure Manual Procurement & Supply Chain Management, CTD, MoHFW, India, 2018.
• Procurement, Supply Chain Management & Preventive Maintenance, Module 6, CTD, MoHFW, India.
• Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India, CTD, MoHFW, 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
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

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

• Training Module (1-4) for Programme Managers and Medical Officers, NTEP, MoHFW, 2020.
• Procurement, Supply Chain Management & Preventive Maintenance, Module 6, CTD.
• Module for Laboratory Technicians, CTD, MoHFW, India, 2005.
• Standard Operating Procedure Manual Procurement & Supply Chain Management, CTD, MoHFW, India, 2018.

 

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

 

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

• Procurement, Supply Chain Management & Preventive Maintenance, Module 6, CTD, MoHFW, India.
• 99DOTS: A Low-Cost Approach to Monitoring and Improving Medication Adherence. In Tenth International Conference on Information and Communication Technologies and Development (ICTD ’19), Cross et al., Ahmedabad, India, 2019.
• 99 DOTS. International Journal of Contemporary Medical Research, 2016;3(9):2760-2762.

 

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

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

 

• Technical and Operational Guidelines for Tuberculosis Control, Central TB Division, Ministry of Health and Family Welfare, Government of India, 2005. 
• Training Modules (5-9) for Programme Managers & Medical Officers. Central TB Division, Ministry of Health and Family Welfare, Government of India, 2020. 

 

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

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

Ni-kshay Aushadhi is a web-based portal that deals with the management of stocks (anti-TB drugs, consumables and other commodities) across all the stocking points across the National TB Elimination Programme (NTEP), i.e., Government Medical Store Depot (GMSD), Central Medical Services Society (CMSS) warehouses, State Drug Stores (SDS), District Drug Stores (DDS), TB Units (TUs) including Peripheral Health Institutes (PHIs).

Ni-kshay Aushadhi also helps in real-time management of stock position, providing expiry details of commodities, routine/ Additional Drug Request (ADR) Requirements, and patient-wise consumption of drugs at all levels.

Table 1: Nikshay Aushadhi Stakeholders

User	Services
Central TB Division (CTD)	1. Quantification 2. Purchase Order (PO) generation 3. Quality control 4. State warehouse Drug Transfer Advice (DTA) 5. Monitoring of nation-wide stock & expiry
CMSS warehouse	1. Quantification 2. Purchase request generation 3. Advance shipment details 4. Supplier delivery details 5. Release Order (RO) to SDS 6. Acknowledge desk 7. Transfer of drugs to other warehouses
GMSD	1. Quantification 2. Acknowledge desk 3. Advance shipment details 4. Transfer of drugs to other warehouses
Supplier	1. View Purchase Order (PO) and delivery schedule 2. Enter dispatch details 3. View receipt 4. Demand vs issue
SDS/ DDS/ Drug-resistant TB Centre (DR-TBC)/ TU	1. Routine/ ADR & dispatch to sub-stores 2. Acknowledge desk 3. Transfer of drugs to other warehouses 4. Issue voucher DTA 5. Box preparation, box modification, unpacking and box completion 6. Local purchase
PHI	1. Routine/ ADR  2. Acknowledge the receipt of drugs 3. Issue to patient 4. Return from patient

 

The Ni-kshay Aushadhi can be used for the following purposes:

• Quantification and forecasting
• Monitoring and distribution
• Data management and analysis
• Recording and reporting of the drugs related data
• Training and capacity building
• Quantification of drugs
• Issue/ dispatch
• Return of drugs
• Drug request management - Routine/ ADR
• Stock management (like drug inventory, Physical Stock Verification (PSV))
• Packaging/ repackaging
• Receive from store/ Acknowledge desk
• Quality control management

 

Figure: Supply chain management in NTEP through Ni-kshay Aushadhi; Source: Ni-kshay Aushadhi Manual

 

Resources

• Ni-kshay Aushadhi Portal.

 

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct Answer	Correct Explanation	Page ID	Part of Pre-Test	Part of Post-Test
Ni-kshay Aushadhi can be used for the quantification and forecasting of drug stocks.	True	False			1	The Ni-kshay Aushadhi can be used for the following purposes: Quantification and forecasting Monitoring and distribution Data management and analysis Recording and reporting of the drugs-related data Training and capacity building Quantification of drugs Issue/ dispatch Return of drugs Drug request management - Routine/ ADR Stock management (like drug inventory, PSV) Packaging/ Repackaging Receive from store/ Acknowledge desk Quality control management Miscellaneous		Yes	Yes

Ni-kshay Aushadhi offers a utility-based broadcasting window that alerts the user about the management of event-based and job-based activities that need immediate attention.

This utility in Ni-kshay Aushadhi is known as the Alert Dashboard and primarily gives alerts about drugs with near expiry and drug acknowledgements that are pending.

Figure: Ni-kshay Aushadhi Alert Dashboard; Source: Ni-kshay Aushadhi Portal.

 

Drug expiry alert: This alert lists out all the drugs from the inventory of the store that is going to expire in the next three months. The utility of this alert is to make necessary arrangements beforehand that will ensure that these drugs are utilized before their expiry dates.

Acknowledgement pending alert: This alert lists out all the transfers/requests made by different sources whose acknowledgement is pending for more than 15 days.

 

Resources

Ni-kshay Aushadhi Manual, Central TB Division, Ministry of Health and Family Welfare, Government of India

Assessment

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	Part of Pre-test​	Part of Post-test​
The drug expiry alert lists out the drugs that will expire in what duration?	Next 3 months	Next 3 days	Next 3 years	Next 3 weeks	1	Drug expiry alert lists out all the drugs from the inventory of the store that is going to expire in the next three months.		Yes	Yes

Ni-kshay Aushadhi allows the users to view a number of autogenerated reports.

These reports available under the Acknowledgement desk of Ni-kshay Aushadhi are listed below:

Figure 1: Reports in Ni-kshay Aushadhi

 

Figure 2: Reports section in Ni-kshay Aushadhi; Source: Ni-kshay Aushadhi Portal.

 

Definition of the Reports

 

Report	Description
Expiry Details	This report gives the description of expired drugs in the store. The report can be viewed on the basis of drug categories and for any facility mapped with the store
Stock in Hand Record	This report gives a description of available drug stocks in the store. The report can be viewed on the basis of drug categories and for any facility mapped with the store
Stock Ledger Report	This is a digital stock register wherein you can check all the details relevant to a specific drug during a specified period of time. The details include opening balance, received quantity, issued quantity, and closing balance.
Issue Register	This is a digital record of supplies issued by a Store to its mapped stores and facilities
Box Preparation Register	This is a digital record of drug boxes prepared by a store.
Damaged/ Lost Item Details	This is a digital record of damaged and lost items at a particular store. The report can be viewed on the basis of the drug category and for any facility mapped with the store.
Receive from Third Party Report	This is a digital record of receipt of supplies from any facility mapped as a third party with a particular store. The report can be viewed separately for all the mapped third parties and for a specified duration of time.
Transfer Order	This report is a digital record of outward transfers made by a store.
Issue to Third Party Report	This is a digital record of supplies issued to any facility mapped as a third party with a particular store. The report can be viewed separately for all the mapped third parties and for a specified duration of time.
Receipt Register	This is a digital record of supplies received by a store. The receipts can be viewed on the basis of category as well as for a specified period of time.
Write-Off Details	This is a digital record of drugs condemned by the stores.

 

Resource

Ni-kshay Aushadhi Manual, Central TB Division, Ministry of Health and Family Welfare, Government of India.

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 does the stock ledger report contain?	Opening and closing balance	Received quantity	Issued quantity	All the above	All the above	A stock ledger is a digital stock register wherein you can check all the details relevant to a specific drug during a specified period of time. The details include opening balance, received quantity, issued quantity, and closing balance.