DR-TB HIV Coordinator: General concepts of SCM

Supply Chain Management

Content

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:

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

Resources

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Which 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.

Principles of Supply Chain Management

Content

To ensure successful implementation, sustainability and quality services under the National TB Elimination Programme (NTEP), some guiding principles in Supply Chain Management (SCM) and drug logistics are to be ensured. These are showcased in the figure below.

Figure: Principles of SCM under NTEP

Important Points

Timely procurement, uninterrupted supply and maintenance of stock and in-time distribution of anti-TB drugs and other consumables are essential for quality services.
Monitoring of drug supply from the central to peripheral health institute level through web-based real-time software, Nikshay-Aushadhi, is crucial to avoid under-stocking (and delays in treatment initiation) and over-stocking (resulting in wastages).
Maintaining appropriate storage and stacking norms i.e., different batches of drugs with different dates of manufacture and expiry are stored separately so as to facilitate First-expiry-first-out (FEFO) principles, viz., drug batches with the most recent expiry are issued first.

Under FEFO, the storekeeper at the drug store is responsible for:

Installing appropriate tools to periodically monitor controls over the expiry position of drugs.
Exercising prudence in the case of short-expiry drugs, wherein distribution is on a rational basis that considers the utilization pattern. This includes the following:
- The storekeeper marks ‘Expiry Dates’ 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.
- Routine monitoring of the stock position of all drugs.
- Maintaining proper records.
- Analyzing shelf-life analysis of drug stocks at all levels regularly.

Resources

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
What is FEFO?	FEFO is the division that manages drug receipts under NTEP.	FEFO is a supply chain principle that is used to forecast consumables that are required by the programme.	FEFO means First-expiry-first-out and it is a principle to be followed when issuing drugs/ consumables.	None of the above	3	FEFO means First-expiry-first-out and it is a principle to be followed when issuing drugs/ consumables.

Drug distribution flow

Content

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

Logistics

Content

'Logistics' is the process of planning and implementing the efficient transportation and storage of supplies (drugs, consumables and other related items) from the point of origin to the point of consumption through a systematic mechanism.

Figure: Flowchart depicting overview of logistics under National TB Elimination Programme (NTEP)

Resources

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
From where do the PHIs receive supplies?	GMSD	CMSS	SDS	TU	4	The PHIs receive the supplies from the TU.		Yes	Yes

Ni-kshay Aushadhi

Content

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

Overview : Return and Reconstitution

Content

Return

Return is the process of returning the drug to the parent/ issuing store. This is generally followed whenever there are situations like lost to follow-up, transfer out, death, etc.
Ni-kshay Aushadhi is being used to record and report the process.
At present, the return of drugs from the patient/ treatment supporters is taking place in Ni-kshay (in Drug Dispensation Module)
All the unconsumed drugs should be brought back by the treatment supporter to the Peripheral Health Institute (PHI)---->Tuberculosis Units (TU)---->District TB Centre (DTC) within the shortest possible time in order to ensure that they can be re-used in the future.
Return of Bedaquiline (Bdq): Partially used Bdq bottle should be sent back to State Drug Stores (SDS) wherein it will be accounted for.
Return of Delamanid (Dlm): Leftover Dlm tablets should be returned back to the District Drug Stores (DDS).

Reconstitution

Reconstitution is defined as the process of re-packaging the returned anti-TB drugs in the event of loss to follow-up/ death/ discontinuation for any reason, back into a full treatment course for issuing to other patients.
If the expiry of the remaining drugs is less than six months, the same may be issued at the Nodal Drug-resistant TB Centre (NDR-TBC) for patients while they are admitted and later adjusted from the long expiry bottle that is issued on discharge.
The reconstitution exercise is carried out only for the Bedaquiline drug and is done at the SDS.
First Expiry First Out (FEFO) principle should be strictly followed while issuing re-constituted drugs to the patients and also be cautious about the reconstituted drugs belonging to the different expiry batches.
The reconstituted drugs should be accounted for and reported in Ni-kshay Aushadhi through the Box-preparation module under the Packaging/ Re-packaging service.

Resources

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Where is the reconstitution of Bdq drugs carried out?	District Drug Store	State Drug Store	Tuberculosis Unit	Peripheral Health Institute	2	The reconstitution of Bdq drugs should be carried out only at the State Drug Store.		Yes	Yes

Reconstitution Register

Content

A Reconstitution Register (RR), as the name suggests, is a register used to record the details of drug boxes reconstituted from the leftover/ remaining/ unused drug boxes of patients who have defaulted, died, failed treatment, or transferred out.

This register in the format shown below (Figure) is maintained at all the District Tuberculosis Centres (DTCs).

Figure: Reconstitution Register

Abbr: IP: Intensive Phase; CP: Continuation Phase; PC: Product Code; PP: Prolongation Pouch

The RR consists of 13 columns designated by small alphabets 'a' to 'm'. The information in the relevant columns is filled by the pharmacist or storekeeper of the district under the supervision of the District Tuberculosis Officer (DTO).

Reconstitution of the drugs and hence updation of the RR is done once a quarter. However, this interval can sometimes be shorter based on the need.

The following key information is recorded in the RR:

Serial no. and date in columns ‘a’ and ‘b’
Receipt transactions in columns 'c' to 'e'. These include information about the source and type of the Patient-wise Boxes (PWB) returned for reconstitution in
Constituents of the returned PWBs in columns 'f' to 'j'. Separate columns for IP and CP are provided.
Withdrawal transactions in columns 'k' to 'm'.

Note: Receipt transactions shall be recorded in the RR in blue ink, whereas withdrawals for reconstitution purposes, shall be in red ink for clear demarcation

At present, reconstitution is carried out for Bedaquiline (BDQ) only. Unlike other second-line drugs, reconstitution of BDQ takes place at the State Drug Store (SDS) under the supervision of the State Tuberculosis Officer (STO). The number of the tablets received back and the newly reconstituted bottles from these tablets are recorded in appropriate columns of the reconstitution register.

Resources

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Reconstitution registers are maintained at?	DMC	PHI	DTC	STC	3	Reconstitution registers are maintained at all the District Tuberculosis Centres (DTCs).		YES	YES

Recording reconstitution in Nikshay Aushadhi

Content

Box reconstitution means to unpack the prepared boxes into loose medicine. The loose medicine is then added back to the inventory of the store where reconstitution is done. Any box whether complete, incomplete, or modified can be reconstituted. Reconstitution can be done at State Drug Store (SDS) and District Drug Store (DDS) level only and once reconstituted, the box will no longer exist in the inventory. The process of reconstitution in Nikshay Aushadhi is known as box unpacking and involves the following steps:

Figure 1: Overview of process of recording of reconstitution in Nikshay Aushadhi

Detailed procedure:

Step 1: Go to the Nikshay Aushadhi website and click on login. Enter your user ID, Password, the captcha text and click login.

Step 2: Reach the ‘Box unpacking’ window following the path Home-menu>services>packing/repacking>Box unpacking and select your store. Select the TB subcategory then drug name and click on the ‘go’ tab.

Step 3: The system will show all the available boxes (complete, incomplete, and modified) with batch number, expiry Date, stock Quantity, and Stock Status. Select the desired box to be unpacked.

Figure 2: Box unpacking window in Nikshay Aushadhi

Source: Nikshay Aushadhi portal

Step 4: Once selected the system will show details of the drugs in that box. Any quantity less than or equal to the stock quantity of that box can be unpacked. For example, if the stock quantity of the selected box is 100 then any number of boxes between 1 and 100 van be unpacked. Specify the number of the boxes to be unpacked and then click the ‘save’ tab to complete the process. Upon completion, the system will generate the ‘box unpacking complete’ alert. After unpacking the box, the drugs from the box will be added loose into the inventory.

Figure 3: Saving details of box reconstitution

Source: Nikshay Aushadhi portal

Resources

Nikshay 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
Box unpacking can be done at	SDS	DDS	Both 1 and 2	At any store	3	Box unpacking can be done at SDS, and DDS level only		YES	YES

Disposal of expired supplies

Content

Expiry management of supplies is crucial to avoid financial losses and harm to patients.

If any drug expires due to reasons beyond control, the write-off of expired drugs should be as per the guidelines given in NTEP National Strategic Plan. As per NSP, the State is allowed to write off up to 2% of the cost of the annual supply of drugs on implementation of Drug Sensitivity Testing (DST) guided treatment and 2% cost of rapid molecular test cartridges. The expired stock should be disposed-off as per the Bio-medical Waste (Management and Handling) guidelines of Govt. of India.

Disposal of Expired/Discarded Medicines

Colour of the bag to be used: Yellow

Figure 1: Disposal of expired supplies according to Bio-Medical Waste Management Rules 2016

Updating in Ni-kshay Aushadhi

To dispose of or remove the expired/rejected drugs from the online inventory, follow the steps below:

Go to the ‘Write-Off/Disposal’ process in Stock Management,
Click on the ‘Request’ button to generate the disposal request,
Select the ‘Expired or Rejected’ category, and the system will show the respective drugs
Select the drug with an expired batch and enter the quantity
Click on the ‘Save’ button.

Figure 2: Write-off/disposal register in Nikshay Aushadhi Source: Nikshay Aushadhi portal

Figure 3: Entering details of expired drugs in the write-off/disposal register in Nikshay Aushadhi Source: Nikshay Aushadhi portal

Steps to follow

After saving, select the request and click on the ‘Write-off’ button,
Verify the drug details and select the type of write-off as ‘Burned/Buried’,
Enter the ‘Remarks’, and click on the ‘Save’ button,
System will generate the voucher, and the drug quantity will be deducted from the inventory.

Figure 3: Expired drug details in Nikshay Aushadhi Source: Nikshay Aushadhi portal

Condemnation of laboratory supplies

Figure 4: Process of condemnation of laboratory supplies which are non-functional, obsolete, non-reparable equipment in NTEP’s laboratories

Information is required in below mentioned format to condemn the lab equipment:

Figure 5: Form GFR 10 Source: General Financial Rules 2017, Ministry of Finance, Department of Expenditure, GoI

The request for the replacement of the equipment condemned has to be submitted to State TB Officer (STO)/Central TB Division (CTD) in the below-mentioned format:

Figure 6: Annexure 4 for details of equipment for condemnation Source: Guidelines for the condemnation and replacement of Tuberculosis (TB) laboratory equipment under the Revised National Tuberculosis Control Programme (RNTCP) 2019

Resources

1. Guidelines for Management of Healthcare Waste as per Biomedical Waste Management Rules, 2016

2. Guidelines for the condemnation and replacement of Tuberculosis (TB) laboratory equipment under the Revised National Tuberculosis Control Programme (RNTCP) 2019

Assessment:

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Disposal of expired supplies is done in which colour bag?	Yellow	Red	White	Blue	1	Discarded or expired medicine in yellow coloured non-chlorinated plastic bags

color coding and type of container

Content

The National TB Elimination Programme (NTEP) utilizes different coloured bags for the segregation of waste generated in TB laboratory settings as shown in the table below.

Table: Waste Segregated and Collected According to Colour-coded Bags
Yellow bag: Broomsticks Parafilm tape & plastic bag – contaminated with samples Löwenstein-Jensen (LJ) media without the bottle Microbial sample/ blood/ body fluids contaminated paper/ cotton/ swab Blood bags Microbiological cultures Truenat chips (MTB/ Rif) Used mask/ gowns Expired medicines/ drugs/ antibiotics
Red bag: Specimen collection tubes Sputum cups Cartridge Based Nucleic Acid Amplification Test (NAAT)/ Truenat cartridges Infected plastic Contaminated tips Pasteur pipettes Polymerase Chain Reaction (PCR) tubes Mycobacteria Growth Indicator Tube (MGIT) tubes Disposable LJ tubes Contaminated falcon tubes Used gloves Contaminated droppers Empty Cartridge-based Nucleic Acid Amplification Test (CBNAAT) reagent bottles
Blue bag: Glass slide in Truenat machine and used microscopy slides. Slides should not be broken.

All these bags are to be labelled with the Biohazard logo (figure below) on them.

Figure: Biohazard Logo

Waste generated in the Culture Drug Susceptibility Testing (CDST) laboratories is autoclaved prior to segregation in colour-coded bags.
The biohazard materials are collected and handed over to handlers authorized by the pollution control board.
Personnel handling/segregating biomedical wastes must use appropriate Personal Protective Equipment (PPE) and should be trained in spill management.

Resources

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