M-5: PHI Pharmacist: Logistics and Distribution of Drugs and consumables

Packaging involves the process of packing loose second-line anti-TB drugs into one-monthly Patient-wise Boxes (PWBs) also known as the standardised drug boxes for shorter, longer Multidrug/ Rifampicin-resistant TB (MDR/RR-TB) and for H-mono/ poly Drug-resistant TB (DR-TB) regimen.

• The drug box preparation is preferably done at the State Drug Store (SDS) level. However, in states that have built the capacity of districts, the exercise of preparation of standard PWBs may also be conducted at District Drug Stores (DDS) under the guidance and supervision of the District TB Officer (DTO).
• The DDS is supplied monthly PWBs as per the standard regimens as well as loose medicines for replacement.
• Under certain circumstances, the drug box may also be prepared at the district level, like unpacking of unused/ partially used boxes and modification of regimen as per replacement advised by the DR-TB centre.

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

Assessment

In the National Tuberculosis Elimination Programme (NTEP), packaging of loose drugs into Type A, B & C boxes are done at the State Drug Stores (SDSs) under the guidance of the State TB Officer (STO)/ Medical Officer (MO)/ Drug logistics in-charge.

Specifications for packaging of patient-wise monthly drug box

Common for both Type A and Type B boxes

• Material: Punching ring flap model (1 side pin) 3 ply corrugated, top paper 230 gsm, ply 150 gsm and the inner wall of 180 gsm.
• Opening: From the top with the attached lid.
• Packing: Box should be stapled with heavy pins.
• Colour: Outer white and inner brown

Type A Box

• Size: 10.5” x 7.5” x 3.25”  (inch)
• Partitions in the box: 3 ply white to white vertical and 12 horizontal, fitting in to vertical serially
• Size of partition: Horizontal: 7.5” x 2.75” – Vertical 10” x 2.75”
• In each Type A box, one pouch of silica gel desiccant of 4 gm weight should be kept.
• One monthly pouch of capsule Cycloserine and tablet Ethambutol each should be made from a plastic bag with a zip lock facility in which a 1 gm pouch of silica gel desiccant should be kept.

Type B box

• Size: 11” x 4” x 4”  (inch)

Figure 1: Type A Box; Source: Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India; CTD, MoHFW, India, 2017.

Figure 2: Type B Box; Source: Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India; CTD, MoHFW, India, 2017.

Specifications for Labelling of Patient-wise Monthly Drug Box

• Once the patient-wise monthly drug box is prepared, labels for these drug boxes should also be prepared to contain all details about the drugs within the box and printed directly from the Ni-kshay Aushadhi system.
• Labels should be generated for each cycle of box preparation and contain expiry-wise drug content of the boxes and should be pasted over the boxes prepared during that cycle only.
• The label should be marked with a bold marker pen and pasted on the visible side of the carton.
• Labelling the drug boxes helps in facilitating the storekeeper to follow the First Expiry First Out (FEFO) principle, avoids excessive stocking of shortage drugs/ drug stock imbalances, enables issue of the regimen-wise box systematically and the barcode present on the label helps to ensure better inventory, tracking and supply chain management.

Resources

• Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India; CTD, MoHFW, India, 2017.
• Standard Operating Procedure Manual Procurement & Supply Chain Management; CTD, MoHFW,India,2018.
• Procurement, Supply Chain Management & Preventive Maintenance, Module 6; CTD, MoHFW, India.

Assessment

Importance of Labelling the Drug Boxes

• It helps to identify regimen-wise boxes quickly
• It helps the storekeeper in practising the First Expiry First Out (FEFO) principle
• Ensures better inventory management
• Strengthens the tracking and supply chain through the bar code present on the label

Contents of the label

Figure 1: Drug Box label; Source: Packaging and Repackaging,Nikshay Aushadhi User Manual; CTD, MoHFW, India.

Method of Labelling the Drug Boxes

Figure 2:Label pasted on the drug box

• The labels should be pasted on the visible side of the carton.
• The label should be in bold colours for quick identification.
• There should be different coloured labels for different regimens as well as for the intensive and continuation phases.
• The label should be pasted in an oblong manner on the box to allow quick readability.
• The label should be generated through the Ni-kshay Aushadhi during each cycle of box preparation and printed directly from the system.
• The labels prepared for a particular cycle should be pasted over the boxes prepared during that cycle only.

Resources

• Standard Operating Procedure Manual Procurement & Supply Chain Management; CTD, MoHFW,India,2018.
• Procurement, Supply Chain Management & Preventive Maintenance, Module 6; CTD, MoHFW, India.
• Packaging and Repackaging,Nikshay Aushadhi User Manual; CTD, MoHFW, India.

Assessment

There are two types of monthly Patient Wise Boxes (PWB) issued to the TB patients.

1) Type A: Contains oral drugs that are used for treatment during both the Intensive Phase (IP) and Continuation Phase (CP).

2) Type B: Contains injectables which are prescribed for Intensive Phase (IP) only

Based on the regimen and weight band of the patients , PWB are prepared and issued to the patients.

Contents of PWB

1. PWB for Shorter Oral Bedaquiline-containing MDR/RR-TB Regimen: Constitutes both Type A and Type B box

* When moxifloxacin is prescribed under exceptional conditions instead of levofloxacin, the modified box with moxifloxacin (normal dose) can be prepared from the standard box at DDS.

2. PWB for Shorter Injectable-containing Regimen: Constitutes both Type A and Type B box

3. PWB for Longer Oral M/XDR-TB Regimen : Constitutes only Type A box as there is no separate IP/CP under this regimen

# Tab. Linezolid available in 600 mg only. When prescribed with modified dose of 300 mg Once Daily (OD), patient should be advised to divide the pill in half.

4.  PWB for H-mono/poly DR-TB Regimen: Constitutes only Type A box as there is no separate IP/CP under this regimen

In comparison to other DR-TB regimens, a full treatment course should be prepared for the entire duration of 6 months.

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

The patient on shorter oral Bedaquiline-containing multi-drug resistant (MDR)/rifampicin resistant TB (RR-TB) regimen shall be put on Type A and Type B box when initiated on treatment on a monthly patient wise box (PWB). Bedaquiline (Bdq) needs to be issued separately and stopped after 6 months. The patient should be provided with only Type A boxes when started on continuation phase (CP).​

Resources

• Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India, March 2021

Kindly provide your valuable feedback on the page to the link provided HERE

Standard Patient-wise Boxes (PWBs) are constituted for TB patients initiated on Isoniazid (H) Mono/ Poly Drug-resistant TB (DR-TB) regimen. 

This regimen has no segregation in terms of Intensive Phase (IP) or Continuation Phase (CP), hence drugs are provided in a single type of PWB. 

Table: Constituents of standard PWB (6 months) of H mono/ poly DR-TB regimen; Source: Guidelines for PMDT, India 2021, p134

Resources

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.
• Central TB Division, MoHFW. Training Modules (5-9) for Programme Managers & Medical Officers, 2020.
• Standard Operating Procedure Manual - Procurement & Supply Chain Management, RNTCP.
• Technical and Operational guidelines for TB in India, 2016.

Kindly provide your valuable feedback on the page to the link provided HERE

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

• Standard Operating Procedure Manual Procurement & Supply Chain Management, CTD, MoHFW, India, 2018.
• Return from Patient, Ni-kshay Aushadhi User Manual, CTD, MoHFW, India.
• Packaging and Repackaging, Ni-kshay Aushadhi User Manual, CTD, MoHFW, India.

Assessment

Under the National TB Elimination Programme (NTEP), the return process is facilitated through the Ni-kshay Aushadhi. 

Return from the sub store to the parent store

• This is used to return drugs from the sub-store to the parent store, like from the Peripheral Health Institute (PHI) drug store to the Tuberculosis Unit (TU) drug store.

 Steps in Ni-kshay Aushadhi for returning from the sub store to the patient store

Flowchart 2: Process of return from the sub store to the parent store on Ni-kshay Aushadhi

Figure 2: 5 - Return Request Desk, 6 - Returning Drugs Entry, 7 - Return Voucher; Source: Return from Patient, Nikshay Aushadhi User Manual, CTD, MoHFW, India.

Resources

• Standard Operating Procedure Manual Procurement & Supply Chain Management, CTD; MoHFW,India,2018.
• Return from Patient, Nikshay Aushadhi User Manual, CTD, MoHFW, India.

Assessment

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

Timely procurement and an uninterrupted supply of medicines and other consumables are important requirements for the successful implementation and sustainability of the programme. 

In a vast country like India where >70% of the population resides in rural areas, it is a challenge to transport sputum samples, drugs, consumables and other items on time and subsequently may result in delayed diagnosis and treatment initiation. 

To combat this, the National TB Elimination Programme (NTEP) developed a multi-sectoral engagement strategy and entered into agreements with various ministries like the railways, road transport, aviation and communications for transportation of NTEP supplies and specimen transport across the countries through one of these modes.

Various Transportation Modes Utilised under NTEP for the Transport of Drugs and Other Supplies

Significance

• Utilising the existing government facilities for the transport of supplies is a cost-effective strategy.

• Quick transportation of specimens can lead to effective TB testing and enhance the resulting output. 

• Early diagnosis and treatment initiation can contribute to minimising the further transmission of disease.

• Strengthening the NTEP's supply chain management system to ensure the last-mile delivery of drugs.

• Timely availability of drugs and other related supplies can majorly contribute to the treatment outcome.

• Reaching out to the key populations served by various ministries such as workers, miners, migrants, tribal populations, women & children, etc. who are also highly vulnerable to TB.

Resources

• Procurement, Supply Chain Management & Preventive Maintenance, Module 6, CTD, MoHFW, India.

• Integrating Indian Post and National Tuberculosis Elimination Programme - A New Way Ahead, J Comp Health, 2021, 9(2):94-96.

• MoU between Ministry of Railways, GoI and Central TB Division, MoHFW, India, 2019.

Assessment

Transportation in a supply chain refers to the movement of products from one location to another, which begins at the start of the supply chain as materials make their way to the warehouse and continue all the way to the end-user.

The following considerations should be kept in mind before transporting the supplies:

Packaging

Proper packing of supplies is the most important aspect of transportation. Following are the components of good packaging:

• Labelling: All the supplies should be labelled properly before transportation. The important information which should be displayed on the labels include product name/ content, product strength (for drugs only), batch number, date of manufacturing, date of expiry, and storage conditions requirement. Safety instruction in the form of labels (like fragile, temperature-sensitive, direction) should be pasted on the boxes.
• Radio Frequency Identification (RFID)/ Barcode Scanning: Barcoding of packages before transporting ensure better tracking of the packages. In addition, entering data using barcoding is fast and reliable, significantly reduces human error and increases efficiency, and easy identification of product information.
• Security: Supplies that are damaged upon arrival can cause major problems. Not only do we lose the cost of the original item and shipping, but we may also have to send replacements at an additional cost. Hence, it is important that the supplies are packed in such a manner that the packaging keeps them safe during the transit.
• Storage Conditions: Majority of the supplies transported under National TB Elimination Programme (NTEP) are temperature sensitive and fluctuations above or below the manufacturer’s labelled storage temperature range may adversely affect product quality. Hence, the supplies should be transported in such a manner that the transportation temperatures meet manufacturer’s instructions.  

Resources

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

Assessment

The following supplies are sent to the District Drug Store (DDS)/ TB Units (TUs):

1. Anti-TB drugs (first and second-line):

Drugs once received by the State Drug Store (SDS) are transported to the districts. The districts then transfer the drugs to the TUs which in turn supply them to the Peripheral Health Institutes (PHIs).

2. Diagnostic materials

The following diagnostic materials will be supplied by the SDS to the DDS and TUs:

• Cartridge-based Nucleic Acid Amplification Testing (CBNAAT) machines and cartridges
• Truenat machines and chips
• Binocular Microscopes (BMs) and Light Emitting Diode (LED) Fluorescence Microscopes (FM)
• Laboratory consumables: Sputum containers, slides, and 50 ml centrifuge tubes.

3. Treatment-related supplies

These include the following:

•  Syringes
•  Needles
•  Water for injections
•  Water containers
•  Disposable tumblers, etc.

4. Stationery, forms, Information, Education and Communication (IEC) materials

Different registers, forms, and IEC material will also be supplied from the SDS to the DDS/ TUs.

Transportation

The states may hire Third-party Logistics (3PL) for transporting these supplies to the DDS and TUs.

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

Based on the reports from Ni-kshay Aushadhi, the stock is supplied from SDS to the district drug store to its Tuberculosis Units (TUs) and then to the Peripheral Health Institutions (PHIs).

This is done through the transport agencies which is hired from  Central /State level.

Below is the details of transport mechanism from SDS TO DDS & DDS TO TU.

Figure 1. Operational flow from SDS TO DDS

Figure 2. Operational flow from DDS TO TU

Resources

1. Standard Operating Procedure Manual Procurement & Supply Chain Management RNTCP, MoHFW, GoI 2018

Assessment: