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

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

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

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

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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

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

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

Resources

• Standard Operating Procedure Manual Procurement & Supply Chain Management, CTD, MoHFW, India, 2018.
• Guidelines for PMDT in India, 2021. 

Assessment

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

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:

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2. Consumables

Various consumables used are:

Image

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

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

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

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.

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

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

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:

Image

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

Each state needs to have one fully operational State Drug Store (SDS) for every 5 crores of population.

In larger states/ difficult terrain, more than one SDS can be established as per National Tuberculosis (TB) Elimination Program (NTEP) guidelines.

It is responsible for effective management of medicines and other logistics and ensuring an uninterrupted supply of good quality 1st & 2nd line anti-TB medicines for adult and paediatric patients.

Structure and Human Resource

In most states, NTEP SDS is part of the state TB cell. However, few states have more than one SDS.

The SDS Pharmacist under the overall guidance of the State TB Officer (STO) is responsible for procurement and supply chain management activities at the state/ SDS level.

Available human resources at SDS include:

• 1 Pharmacist cum Storekeeper
• 1 Store Assistant (additional post if >1800 second-line monthly boxes preparation per month)

Functions of NTEP SDS 

1. Receipt of drugs and lab-related logistics at SDS and the subsequent updating of stock records
2. Issue/ dispatch of drugs and logistics to District Drug Stores (DDS)
3. Inventory Management (procedures for tracking and replenishment of drug inventory at the SDS and subordinate stocking points within the state)
4. Drug expiry management
5. Physical verification & reconciliation of drug stocks
6. Digitisation of NTEP drug and logistic records into Ni-kshay Aushadi and monitoring of the performance of DDS, TB units and other health units
7. Ensure space & storage arrangements as per NTEP guidelines
8. Secure custody of anti-TB drugs and logistic
9. Follow the guidelines for storage and distribution of first- and second-line anti-TB drugs, paediatric drugs, lab consumables and Nucleic Acid Amplification Test (NAAT) related logistics etc.
10. Arrangements for transportation of drugs from the SDS to various stocking units in the State
11. Reconstitution of second-line anti-TB drugs, especially new drugs like Bedaquiline
12. Quality Assurance of anti-TB drugs.

Figure: State Drug Store; Source: Tamilnadu Medical Services Corporation Limited Web Portal.

Infrastructure Required for SDS

• Accessibility: Located on a wide road, providing easy access to transportation vehicles and facilitating free movement of drugs to and from the store
• Space for staff, equipment and records: Adequate space for accommodating staff, office equipment (computer, printer etc.) and store records and registers
• Space required for storing drugs: Depends upon the population to which the store caters, as well as the number of months for which stocks are to be stored 
• Other specifications: One large room with a ceiling height of at least 5 metres, a lockable door, at least one window with grill, proper lighting, and even level concrete floor, plastered walls, and a ceiling with whitewash. The room should not have any kind of seepage in it.
• Storage shelves: Should be made of 40 mm bore mild steel pipes, ensuring sufficient gap between cartons from the ceiling, floor, and walls, facilitating ventilation and free movement of air
• Temperature and humidity regulations: Hydro thermometers should be installed to monitor humidity and temperature regularly. The recommended temperature for storage of drugs is below 25°C and humidity levels are below 60%.
• Power supply: Regular power supply should be available in the SDS. Arrangements for backup power supply should also be made through solar panels or fuel-based power generators.
• Telecommunications: Each SDS should have an independent telephone connection, a computer with internet connectivity, specific email address for communication.

Resources

• Standard Operating Procedure Manual, Procurement & Supply Chain Management, Central TB Division, Ministry of Health and Family Welfare, Government of India, 2018.
• Standard Operating Procedures Manual for State Drug Stores, Central TB Division, MoHFW, GoI, 2012.

Assessment

To ensure smooth and timely distribution of anti-tuberculosis drugs within the state, store facilities at the district level in all the states are built as per the National TB Elimination Programme (NTEP) guidelines. These facilities under the programme are called District Drug stores (DDS).

DDS is responsible for ensuring an uninterrupted supply of good quality first & second line anti-TB medicines and other supplies to the mapped TB Units (TUs) and Peripheral Health Institutes (PHIs).

Structure and Human Resource

The number of these DDSs within a state would depend upon the population and geography of that particular state.

The human resource requirement at DDS is similar to that of State Drug Store (SDS) and includes:

• 1 Pharmacist cum storekeeper
• 1 Store Assistant (In case monthly Patient-wise Box (PWB) are prepared at DDS)

Functions of NTEP DDS 

1. Receipt of drugs and lab-related logistics at DDS and the subsequent updating of stock records
2. Issue/ dispatch of drugs and logistics to TUs and PHIs
3. Inventory Management (procedures for tracking and replenishment of drug inventory at the DDS and subordinate stocking points within the state)
4. Drug expiry management
5. Physical verification & reconciliation of drug stocks
6. Digitisation of NTEP drug and logistic records into Ni-kshay Aushadhi
7. Ensuring space and storage arrangements as per NTEP guidelines
8. Secure custody of anti-TB drugs and logistics
9. Following the guidelines for storage and distribution of first- and second-line anti-TB drugs, paediatric drugs, lab consumables and Nucleic Acid Amplification Test (NAAT) related logistics, etc.
10. Arrangements for transportation of drugs from the DDS to the subordinate stocking units in the district
11. Quality Assurance of anti-TB drugs

Figure: Storage of Supplies in a Store

Infrastructure Required for DDS

• Accessibility: Located on a wide road, providing easy access to transportation vehicles, and facilitating free movement of drugs to and from the store
• Space for staff, equipment, and records: Adequate space for accommodating staff, office equipment (computer, printer, etc.) and store records and registers
• Space required for storing drugs: Depends upon the population to which the store caters, as well as the number of months for which stocks are to be stored 
• Other specifications: One large room with a ceiling height of at least 5 metres, a lockable door, at least one window with grill, proper lighting, and even level concrete floor, plastered walls, and a ceiling with whitewash. The room should not have any kind of seepage in it.
• Storage shelves: Should be made of 40 mm bore mild steel pipes, ensuring sufficient gap between cartons from the ceiling, floor, and walls, facilitating ventilation and free movement of air
• Temperature and humidity regulations: Hydro thermometers should be installed to monitor humidity and temperature regularly. The recommended temperature for storage of drugs is below 25°C and humidity levels are below 60%.
• Power supply: Regular power supply should be available in the DDS. Arrangements for backup power supply should also be made through solar panels or fuel-based power generators.
• Telecommunications: Each DDS should have an independent telephone connection, a computer with internet connectivity, specific email address for communication.

Resources

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

Assessment

Tuberculosis Unit (TU) is the administrative unit under the National Tuberculosis Elimination Programme (NTEP) which is responsible for conducting activities at the sub-district/ block level. 

Peripheral Health Institution (PHI) is the most peripheral health facility under the NTEP which is responsible for providing anti-TB care to the underserved/ hard-to-reach populations.

Structure and Human Resources

The Medical Officers (MO) at the TB Unit (TU) and the PHI level are responsible for the activities and reporting of the respective TU and PHI drug stores.

Staff available at TU drug store/ PHI are:

• One pharmacist

• In case the pharmacist is not available, the Senior Treatment Supervisor (STS) is required to handle the TU drug store activities. 

As it is not a stocking point, the PHI drug store does not require a pharmacist/ storekeeper. It is handled directly by the MO in charge of the PHI who issues drugs to the patients.

Function of TU and PHI Drug Stores

• The TU drug stores function as both consumption and stocking points for drugs and are responsible for the supply of drugs to the PHI.

• The PHI drug stores serve only as a consumption point where the drugs are issued to the patients.

Infrastructure Required for the TU/ PHI Drug Stores

Storage space: There should be sufficient space available to stock the supplies required for the maximum number of TB patients to be initiated on treatment under that facility. Should have a lockable door, at least one window with a grill, a ceiling height of at least 3 metres, and 'pukka' flooring with plastered walls and ceiling. Windows should be open to allow air circulation, screens/ wire mesh should be installed on the windows to keep out insects and birds.

Shelves, racks & storage arrangements: Shelves should be made of 40 mm. bore medium quality mild steel pipes with sufficient ‘gap’ between cartons from the ceiling, floor and walls, facilitating ventilation and avoiding seepage from the walls into the boxes.

Stacking arrangements: Drugs should be stacked as per the First Expiry First Out (FEFO) principle, i.e., the boxes expiring earlier should be stored at ground level and those expiring later should be on a higher level.

Control of humidity and temperature: Humidity levels should be kept below 60% and the drugs should not be exposed to direct sunlight to maintain their efficacy. Hydrothermometers, cooling facilities (coolers and ceiling fans) and dehumidifiers may be installed at the TU drug stores as the need may be.

Regular power supply: Regular power supply should be available, especially in drug stores where humidity and temperature control devices have been installed.

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 for Storage of Second-line Anti-TB Drugs for Revised National TB Control Programme (RNTCP).

Assessment

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1) Drug Store Personnel

All personnel (pharmacist, store assistant, Senior Treatment Supervisor (STS), etc.), designated to handle the drug store should receive proper training in relation to good storage practices, regulations, procedures and safety as well as stock monitoring and expiry management.

Image

Figure 1:  Drug Store Personnel; Source: msf.org.

2) Drug Store Premises and Facilities

Storage Space

• The storage space must be designed or adapted to ensure sufficient capacity for the orderly storage of the various categories of materials and products and allow free movement of drug boxes as well as the personnel.
• Physical or other equivalent validated (e.g. electronic) segregation should be provided for the storage of rejected, expired, recalled or returned materials or products. 
• The drug stores should follow a written sanitation programme for the premises to keep it clean and free from contamination. 
• Clear signage should be displayed outside the drug store, the door should be lockable and only authorised personnel should be allowed to enter.

Storage Conditions

• Humidity and temperature must be monitored regularly to maintain drug efficacy as per their shelf life.

Figure: Drug Store; Source: Standard Operating Procedure Manual Procurement & Supply Chain Management, CTD, MoHFW, India, 2018.

3) Drug Storage Requirements

Documentation and records:

• All the credit/ debit of drug stocks should be reported on Ni-kshay Aushadhi in order to avoid disrupting the supply chain management and ensure the smooth functioning of the programme. 
• Physical stock registers should be maintained to avoid missing out on reporting any information related to drug batches, receipt, issue, return, storage, etc.

Image

Figure 3: Stock Register         

Receipt of incoming material: 

• All incoming drugs should be checked for any damage, or shortage of quantity and all the related documents should be verified at each level drug store.

Labelling of boxes: 

• The drug boxes should be labelled in bright colour on the visible side of the cartons so as to quickly identify the regimen, drug type and quantity and expiry of drugs in that box. 
• Labels should be prepared separately for each individual batch of drugs.

Image

Figure 4: Labelled Drug Boxes           

Expiry management: 

• First Expiry First Out (FEFO) principle should be strictly followed while storing as well as issuing the drugs. 
• Near to expiry drugs should be stacked at the lower level for ease of accessibility and ones which are far from expiry should be stacked on top. 
• Drugs should preferably be stored regimen-wise owing to the availability of space.

Stock rotation and control: 

• Periodic stock reconciliation should be performed by comparing the actual and recorded stocks and all significant stock discrepancies should be investigated as a check against inadvertent mix-ups and/or incorrect issues. 
• Due precautions must be taken for partially used and damaged drugs to ensure effective utilization and disposal respectively.

4) Returned Drugs' Management: All returned drugs should be handled in accordance with approved procedures and records should be maintained. They should be verified against the issue voucher, batch number and quantity before accepting returns. The re-issue of returned drugs that are much within the expiry date should only be undertaken only after approval from the nominated officer -in charge following a satisfactory quality re-evaluation.

5) Dispatch and Transport: The dispatch and transport of drugs should be documented and done in such a way that their integrity is not impaired. All storage conditions are to be maintained during the transportation of drugs.

6) Product Recall: In case of defective materials, the drug store must ensure there is a set protocol to recall all the defective products from the market promptly and effectively.

7) Waste Disposal: All expired drugs should be kept outside and away from the drug store to avoid any mix-ups. If any drug expires due to reasons beyond control, it should be disposed of as per the procedures laid down in the Rules under Drugs & Cosmetics Act and Biomedical Waste (Management and Handling) Rules of Govt. of India.

Resources

• WHO Technical Report Series, No. 908, 2003; Annex.9: Guide to Good Storage Practices for Pharmaceuticals.
• Procurement, Supply Chain Management & Preventive Maintenance, Module 6, CTD, MoHFW, India.
• Standard Operating Procedure Manual Procurement & Supply Chain Management, CTD, MoHFW, India, 2018.

 Assessment

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

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

Image

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

Resources

• Ni-kshay Aushadhi Portal.

Assessment

Ni-kshay Aushadhi portal has various dashboards at the state level.

Figure 1: Dashboard in State Login; Source: Ni-kshay Aushadhi Portal.

Various dashboards are:

1. Stock Reports

In this dashboard user can see the store wise report of the stock, status of the stock medicine/store wise, expiry detail of the particular store of the any facility.

Figure 2: Stock Detail Dashboard; Source: Ni-kshay Aushadhi Portal.

2. Consumption Report

In this consumption report dashboard, the user can see the consumption report of the particular facility/ store. According to this, they can issue the medicine as per their consumption report, so the inventory can be managed accordingly at the store.

Figure 3: Consumption Report Dashboard; Source: Ni-kshay Aushadhi Portal.

3. Enquiry Reports

In this particular dashboard the user can see the active and inactive facility/ store, those who are not submitting the real-time data in the portal and due to this the proper consumption of the medicine and the real-time data cannot be fetched at the higher level.

Figure 4: Enquiry Report Dashboard; Source: Ni-kshay Aushadhi Portal.

Resources

• Ni-kshay Aushadhi Portal.

Assessment

Ni-kshay Aushadhi has a feature known as the District Dashboard which allows the users at the District Drug Stores (DDS) to monitor the performance of the district and the subordinate stores by creating autogenerated reports. These include:

• Stock reports
• Enquiry reports
• Closing balance status

Figure 1: District Dashboard; Source: Ni-kshay Aushadhi Portal.

Figure 2: Reports on District Dashboard; Source: Ni-kshay Aushadhi Portal.

Stock Reports

It is a digital record which enables the user at the DDS to check the availability of various drug stocks available in the DDS and its subordinate stores. It also provides information about the supplies at the stores that are going to expire within a range of less than 90 days to less than 270 days.

Figure 3: Stock Report; Source: Ni-kshay Aushadhi Portal.

Enquiry Reports

It is a digital record that enables the user to monitor the usage of Ni-kshay Aushadhi at the DDS and its subordinate stores. It keeps a record of activities ranging from the most recent to those done in the last six months. It also shows store-wise hierarchy details of that particular district.

Figure 4: Enquiry Report; Source: Ni-kshay Aushadhi Portal.

Closing Balance Status

It is a digital record that enables the user to monitor the submission status of the monthly closing balance of DDS and its subordinate stores.

Resources

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

Assessment

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

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

Resource

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

Assessment

The State Drug Store (SDS) pharmacist will perform the following activities:

1. Receipt of drugs: The state drug store may receive drugs from Government Medical Stores Depots (GMSDs) and Central Medical Store Services (CMSS) as a part of central supply, from drug stores of other states as a part of inter-state drug transfer and from district drug stores or other SDSs as a part of intra-state transfers. The pharmacist of the SDS will receive these drugs and maintain records relevant to this activity in Ni-kshay Aushadhi. 
2. Issues/ dispatches: The pharmacist of the SDS will issue and dispatch drugs under the following circumstances:

• Routine quarterly supplies to District Tuberculosis Centers (DTCs)
• Routine supplies to Nodal Drug-Resistant TB Centers (NDR-TBCs)
• Routine supply of cartridges and chips to the Nucleic Acid Amplification Testing (NAAT) labs
• Supplies to DTCs against Additional Drug Requests (ADR)
• Transfers to other SDS(s) in the same state
• Transfers to SDS(s) in other states

3. Prepare stock statements: The SDS pharmacist will prepare a Monthly Stock Statement (MSS) providing details of receipts, issues, and opening/ closing balance of drug items, on the last day of each calendar month. 
4. Data entry and record maintenance: The pharmacist of the SDS will maintain relevant records in the Bin Cards (BC) and record all the transactions in Ni-kshay Aushadhi. Stock Registers (SR) may also be used if real-time transactions are not recorded in the system.
5. Visits to DDS: The pharmacist of the SDS is also required to visit the DDSs, TB Units (TUs), and Peripheral Health Institutes (PHIs) and discuss the issues, and challenges and provide resolution and training support to the sub-level.
6. Monitoring: The SDS pharmacist will closely monitor the performance of the linked DDS, TUs and PHIs by periodically checking the records (both physical registers and online entries on N-ikshay Aushadhi). The SDS pharmacist is also required to perform physical stock verification of the DDS, TUs and PHIs and cross-check the same with the stock status in the stock register and other relevant records.
7. Analysis of reports: The SDS pharmacist will analyse the reports submitted by the DDSs to identify under/overstocked DDSs, and the DDSs with near-expiry drugs. The analysis of the reports will also help the pharmacist in forecasting the future requirement of these DDSs, TUs and PHIs.

Resources

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

Assessment

The District Drug Store (DDS) pharmacist is responsible for managing the supply chain of all drugs and commodities at the district level under the National TB Elimination Programme (NTEP).

The DDS Pharmacist is involved in the following activities:

Figure: Role of District Drug Store (DDS) Pharmacist in National Tuberculosis Elimination Programme (NTEP)

1. Receipt of drugs: The DDS will receive drugs from the State Drug Store (SDS) as per the requirement. The pharmacist of the DDS will receive these drugs and maintain records relevant to this activity.  

2. Issues/ dispatches: The pharmacist of the DDS will issue and dispatch drugs under the following circumstances:

• Routine quarterly supplies to Peripheral Health Institutes (PHIs)

• Routine supplies to District Drug-resistant TB Centres (DDR-TBCs)

• Supplies to PHIs against Additional Drug Requests (ADR)

• Routine supply of Cartridge-based Nucleic Acid Amplification Testing (CBNAAT) cartridges and Truenat chips to the PHI stores

• Routine supplies to the private health facilities mapped with the district stores

3. Prepare stock statements: The DDS pharmacist will prepare a Monthly Stock Statement (MSS) providing details of receipts, issues, and opening/ closing balance of drug items, on the last day of each calendar month.

4. Data entry and record maintenance: The pharmacist of the DDS will maintain relevant records in the Bin Cards (BC) and record all the transactions in Ni-kshay Aushadhi. Stock Registers (SR) may also be used, if real-time transaction are not recorded in system.

5. Visits to TUs and PHIs: The pharmacist of the DDS is also required to visit the TUs and PHIs discuss the issues, challenges and provide resolution, training support to the sub-level.

6. Monitoring: The DDS pharmacist will closely monitor the performance of the linked TUs and PHIs by periodically checking the records (both physical registers and online entries on Ni-kshay Aushadhi). The DDS pharmacist is also required to perform physical stock verification of the TUs and PHIs and cross-check the same with the stock status in the stock register and other relevant records.

7. Analysis of reports: The DDS pharmacist will analyse the reports submitted by the linked TU to identify under/overstocked TUs, and the TUs with near-expiry drugs. The analysis of the reports will also help the pharmacist in forecasting the future requirement of these TUs.

Resources

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

Assessment

Every Tuberculosis Unit (TU)/ Peripheral Health Institution (PHI) store has a pharmacist who ensures proper supply chain management of anti-TB drugs and other supplies at the TU and PHI level. TU/PHI pharmacist performs the following functions:

Image

Figure 1: Role of Tuberculosis Unit (TU)/Peripheral Health Institution (PHI) Pharmacist

1. Receipt of supplies: The pharmacist of the TU/PHI will receive supplies from District Drug Store (DDS) and maintain records relevant to this activity.  
2. Issues / dispatches by TU/PHI store: The pharmacist of the TU/PHI will issue supplies under the following circumstances:

• Routine monthly supplies to PHIs
• Supplies to PHIs against Additional Drug Requests (ADR)
• Routine supply of CBNAAT cartridges and Truenat chips to the NAAT labs.
• Routine supplies to the private health facilities mapped with the PHI stores
• Supply of medicines to the patients

3. Prepare stock statements: The TU/PHI Pharmacist will prepare a Monthly Stock Statement (MSS) at the last day of each calendar month. 

4. Data entry and record maintenance: The pharmacist of the TU/PHI will maintain records in the Bin cards (BC) and Stock registers (SR). The pharmacist will also make relevant entries in 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

Ensuring adherence to correct treatment is crucial in the outcome of tuberculosis and hence it is essential to develop a patient-centred approach to treatment administration.

• A Treatment Supporter (TS) who is acceptable and accessible to the patient as well as accountable to the health system should be identified in consultation with the patient during pre-treatment evaluation.
• The TS can either be a healthcare worker, community worker/ volunteer or private practitioner or family member.
• If a family member is identified as TS s/he should be trained to give medication under supervision at the residence, under close monitoring by Community Health Officer (CHO)/ Accredited Social Health Activist (ASHA)/ Auxilliary Nurse Midwife (ANM)/ Multipurpose Workers (MPW) with support from Tuberculosis Health Visitor (TBHV)/ Senior Treatment Supervisor (STS).

Role of TS in Supply Chain Management

• Whenever a patient is initiated on treatment, the monthly patient-wise boxes are issued to the TS of the patient.
• In the case of Bedaquiline (Bdq) since the treatment is initiated at the Nodal/ District DR-TB Centre (N/DDR-TBC), on discharge, the patient is issued the remaining bottle of Bdq drug, which is then handed over to the TS.
• In the case of Delamanid (Dlm), on discharge from the N/DDR TBC the remaining drugs for the rest of the first month are issued to the patient which is then handed over to the TS.
• In any case, TS is responsible for issuing the medicines to the patient on a daily basis until the end of the course, thereby ensuring Direct Observation of Treatment (DOT).
• The TS are also responsible for collecting/ receiving month-wise boxes throughout the treatment duration of the patient.
• The TS is assigned to the Ni-kshay database with respect to the particular patient and issued a Treatment Card to maintain a record of all drugs consumed by the patient.
• In case of death/ loss to follow-up/ discontinuation of treatment due to any reason or in case of change/ modification of the regimen, the TS is responsible for returning the issued patient wise box back to the treatment centre and also ensuring that the new/modified regimen box is issued to the patient.

Resources

1. Standard Operating Procedure Manual Procurement & Supply Chain Management, CTD, MoHFW, India, 2018.
2. Procurement, Supply Chain Management & Preventive Maintenance, Module 6, CTD, MoHFW, India.
3. Direct Benefi­t Transfer Manual for National Tuberculosis Elimination Programme, Central TB Division, Ministry of Health & Family Welfare, India, 2021.

Assessment