Pharmacist: Packaging

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

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	Part of Pre-test​	Part of Post-test​
Which DR-TB regimen has only one standard PWB prepared for the entire duration of treatment?	Shorter oral Bdq-containing regimen	Longer oral M/XDR regimen	H - mono/ poly DR-TB regimen	None of the above	3	In comparison to other DR-TB regimens, a full treatment course should be prepared for the entire duration of 6 months.	​	Yes	Yes

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

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
What is the colour of the box used for packaging patient-wise monthly drugs?	Outer brown and inner white	Outer white and inner brown	Outer blue and inner white	Outer white and inner blue	2	The colour of the box used in the packaging of the monthly patient-wise box is outer white and inner brown.		Yes	Yes

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

 

 

 

S.No.	Drug Name	UOM	Strength(No.)	Batch No.	DOE	No. Of Unit	Dosage Per Day
1	Clofazimine 100mg [PC40]	Cap	100 MG	NCG2009A	Feb/2022	30	1.00
2	Cycloserine 250mg [PC24]	Cap	250 MG	ECE2023A	Dec/2021	60	2.00
3	Linezolid 600mg [PC38]	Tab	600 MG	BLN2001A	Dec/2022	30	1.00
4	Moxifloxacin 400mg [PC39]	Tab	400 MG	EMC62004A	Feb/2023	60	2.00
5	Pyridoxine 100mg [PC26]	Tab	100 MG	EPD92001A	Jan/2023	30	1.00
Lot No. : 2160010822				Total : 210
Date Of Expiry Of Box : Dec/2021

 

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

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
The labels prepared for a particular cycle may be pasted over the boxes prepared for any other cycle.	True	False			2	The labels prepared for a particular cycle should be pasted over the boxes prepared during that cycle only.		Yes	Yes

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

Type A box		Use in Intensive Phase (IP) as well as Continuation Phase (CP)
Drugs	Strength	16-29 kg	30-45 kg	46-70 kg	>70 kg
Tab. Levofloxacin*	250/ 500 mg	250 mg *30 tab	250 mg *30 tab + 500 mg *30 tab	500 mg *60 tab	500 mg *60 tab
Tab. Clofazimine	50/ 100 mg	50 mg *30 tab	100 mg *30 tab	100 mg *20 tab	100 mg *60 tab
Tab. Ethambutol	400/ 800 mg	400 mg *30 tab	800 mg *30 tab	400 mg *30 tab + 800 mg *30 tab	600 mg *60 tab
Tab. Pyrazinamide	500/ 750 mg	750 mg *30 tab	500 mg *30 tab + 750 mg *30 tab	500 mg *60 tab + 750 mg *30 tab	500 mg *30 tab + 750 mg *60 tab
Tab. Pyridoxine	50/100 mg	50 mg *30 tab	100 mg *30 tab	100 mg *30 tab	100 mg *30 tab

* 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.

Type B box		Use in IP
Drugs	Strength	16-29 kg	30-45 kg	46-70 kg	>70 kg
Tab. Isoniazid	100/ 300 mg	300 mg *30 tab	300 mg *60 tab	300 mg *90 tab	300 mg *90 tab
Tab. Ethionamide	125/ 250 mg	125 mg *30 tab + 250 mg *30 tab	250 mg *60 tab	250 mg *90 tab	250 mg *120 tab
Bedaquiline bottle	100 mg	Jar of 188 tablets for full course

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

Type A box		Use in Intensive Phase (IP) as well as Continuation Phase (CP)
Drugs	Strength	16-29 kg	30-45 kg	46-70 kg	>70 kg
Tab. Moxifloxacin-High Dose	400 / 800 mg	400 mg *30 tab	400 mg *30 tab	400 mg *60 tab	400 mg *60 tab
Tab. Clofazimine	50/ 100 mg	50 mg *30 tab	100 mg *30 tab	100 mg *20 tab	100 mg *60 tab
Tab. Ethambutol	400/ 800 mg	400 mg *30 tab	800 mg *30 tab	400 mg *30 tab + 800 mg *30 tab	600 mg *60 tab
Tab. Pyrazinamide	500/ 750 mg	750 mg *30 tab	500 mg *30 tab + 750 mg *30 tab	500 mg *60 tab + 750 mg *30 tab	500 mg *30 tab + 750 mg *60 tab
Tab. Pyridoxine	50/100 mg	50 mg *30 tab	100 mg *30 tab	100 mg *30 tab	100 mg *30 tab
Type B box		Use in IP
Drugs	Strength	16-29 kg	30-45 kg	46-70 kg	>70 kg
Inj. Kanamycin	15mg/kg/day	500 mg *24 inj.	750 mg * 24 inj.	750 mg *24 inj.	1000 mg *24 inj.
Tab. Isoniazid-high dose	100/ 300 mg	300 mg *30 tab	300 mg *60 tab	300 mg *90 tab	300 mg *90 tab
Tab. Ethionamide	125/ 250 mg	125 mg *30 tab + 250 mg *30 tab	250 mg *60 tab	250 mg *90 tab	250 mg *120 tab

 

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

Standard PWB		Continue till Complete Treatment
Drugs	Strength	16-29 kg	30-45 kg	46-70 kg	>70 kg
Tab. Levofloxacin	250 / 500 mg	250 mg *30 tab	500 mg *30 tab + 250 mg *30 tab	500 mg *60 tab	500 mg *60 tab
Tab. Linezolid#	600 mg	600 mg *30 tab#	600 mg *30 tab	600 mg *30 tab	600 mg *30 tab
Tab. Clofazimine	50/ 100 mg	50 mg *30 tab	100 mg *30 tab	100 mg *30 tab	100 mg *30 tab
Tab. Cycloserine	250 mg	250 mg *30 tab	250 mg *60 tab	250 mg *90 tab	250 mg *120 tab
Tab. Pyridoxine	50/100 mg	50 mg *30 tab	50 mg *30 tab	50 mg *30 tab	50 mg *30 tab
Bedaquiline bottle	100 mg	1 Jar (Jar of 188 tablets for full course)

# 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

Standard PWB		Continue till complete treatment
Drugs	Strength	16-29 kg	30-45 kg	46-70 kg	>70 kg
Tab. Levofloxacin	250/ 500 mg	250 mg *180 tab	250 mg *180 tab + 500 mg *180 tab	500 mg *360 tab	500 mg *360 tab
Tab. Rifampicin	150/ 300/ 450 mg	300 mg *180 tab	450 mg *180 tab	300 mg *360 tab	300 mg *360 tab + 150 mg *180 tab
Tab. Ethambutol	400/ 800 mg	400 mg *180 tab	800 mg *180 tab	400 mg *180 tab + 800 mg *180 tab	800 mg * 360 tab
Tab. Pyrazinamide	500/ 750 mg	50 mg *180 tab	7750 mg *180 tab + 500 mg *180 tab	750 mg *180 tab + 500 mg *360 tab	750 mg *360 tab + 500 mg *180 tab
Tab. Pyridoxine	50/100 mg	50 mg *180 tab	100 mg *180 tab	100 mg *180 tab	100 mg*180 tab

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

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Which type of drug box is issued to the patient on all oral H-mono/ poly regimen?	Type A	Type B	Type A & Type B	Type C	1	A patient initiated on all oral H-mono/poly DR-TB regimen will receive the monthly type A box.		Yes	Yes

Process of Preparation of Boxes

All drugs used in various Drug-resistant Tuberculosis (DR-TB) regimens under the National Tuberculosis Elimination Programme (NTEP) are supplied through a centralised procurement system at the Central TB Division (CTD).

Drug Flow under NTEP

• The Government Medical Store Depot (GMSD)/ Central Medical Services Society (CMSS) supply the loose drugs to the State drug Store (SDS).  
• The loose drugs are packed into patient-wise boxes at the SDS for various regimes.

Preparation of Patient-wise boxes under NTEP

• Preparation of patient-wise boxes is carried out mainly at the SDS and occasionally in the District Drug Stores (DDS).
• Each month, the patient in the Intensive Phase (IP) shall be put on Type A and Type B boxes.
• During the Continuation Phase (CP), the patient will be put on only Type A box for the entire duration.
• In case the regimen does not have separate IP and CP, only Type A box with all drugs is issued.
• For preparing the drug boxes, patients are classified into weight bands of <16 kg, 16-29 kg, 30-45 kg, 46-70 kg and >70kg.
• For <16 kg patients, boxes will be prepared from the loose drug provided.

 

Constituents of Monthly Patient-wise Box for DR-TB Patients as per Regimen and Weight Band

1. Shorter Regimen (Oral Bedaquiline-containing regimen, oral injectable regimen)

Figure 1: Constituents of monthly type A & B patient-wise box of shorter oral Bedaquiline-containing regimen and shorter injectable regimen; Source: Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India; NTEP, CTD, MoHFW, India, 2021.

 

2. Longer oral M/XDR-TB regimen

Figure 2: Constituents of monthly standard patient-wise box of Longer oral M/XDR-TB regimen; Source: Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India; NTEP, CTD, MoHFW, India, 2021.

     

3. H-mono/ poly DR-TB Regimen

Figure 3: Constituents of the monthly standard patient-wise box of H-mono/poly DR-TB regimen; Source: Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India; NTEP, CTD, MoHFW, India, 2021.

 

Resources

• Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India; NTEP, CTD, MoHFW, India, 2021.
• Procurement, Supply Chain Management & Preventive Maintenance, Module 6; CTD, MoHFW, India.

 

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
What are the weight bands classified for the preparation of patient-wise drug boxes under NTEP?	<16 kg, 16-35 kg, 35-50 kg, 50-70 kg and >70kg	<16 kg, 16-30 kg, 30-50 kg, 50-70 kg and >70kg	<16 kg, 16-29 kg, 30-45 kg, 46-70 kg and >70kg	<15 kg, 15-29 kg, 30-47 kg, 48-70 kg and >70kg	3	For preparing the drug boxes, patients are classified into weight bands of <16 kg, 16-29 kg, 30-45 kg, 46-70 kg and >70kg.		Yes	Yes

Recording Box Preparation in Ni-kshay Aushadhi

As per the National TB Elimination Programme (NTEP) guidelines, CTD procures loose medicines for the treatment of DR-TB patients. These loose medicines are packed into Monthly Patient-Wise Boxes (PWB). PWB are prepared only at the State Drug Store (SDS) and District Drug Store (DDS) levels. Depending upon the availability of drugs, two types of boxes can be prepared in Ni-kshay Aushadhi.

Complete box – contains all the required drugs as per the regimen

Incomplete box – has less than the required number of drugs as per the regimen

 

Figure 1: Overview of the process of recording box preparation in Ni-kshay Aushadhi

Detailed stepwise procedure: 

Box Preparation

Step 1: Go to the Ni-kshay Aushadhi website and click on login. Enter your User ID, Password, and then the captcha text and click login.

Step 2: Reach the ‘Box Preparation Window’ following the path Home-menu > Services > Packing/Repacking > Box preparation and select the appropriate options as per the regimen from the drop-down menus of different sections given in the window and then press the ‘Go’ tab.

 

Figure 2: Box completion window in Ni-kshay Aushadhi

Source: Ni-kshay Aushadhi portal

Step 3: Select the drug from the checkbox. The system will auto-fill the quantity required as per the box preparation quantity.  Batch of near expiry date will be highlighted in pink colour. This is to be noted that the expiry date of the nearest expiry drug in the box will be the expiry date of the box itself. You can select any batch as per your requirement.

 

Figure 3: Entering details of the box

Source: Ni-kshay Aushadhi portal

Step 4: After selecting the batch, click on ‘Add’ button to add the drug to the box.  The system will highlight the added drug into the table with green colour. Repeat the process for all the drugs in the regimen. When all the drugs are added into the box as per the required quantity, the system will highlight  them in green.

Figure 4: Details of drugs added to the box

Source: Ni-kshay Aushadhi portal

Step 5: Enter the ‘Remarks’ if required and click on the ‘Save’ button.  The system will generate the voucher. You can save or print the voucher.

Figure 5: Voucher generated

Source: Ni-kshay Aushadhi portal

Note: If the available number of drugs is less than required, the selection could still be saved, and a voucher generated. Such boxes will be shown in blue in the view boxes section and are called as incomplete boxes.

Box Completion

This process involves adding the remaining drugs to the prepared incomplete boxes and can also be done at the receiving store. The process can be repeated multiple times depending upon the availability of the remaining drugs.

Steps to be followed in Ni-kshay Aushadhi:

Step 1: Reach the ‘Box Completion’ window following the path Menu > Services > Packing/Repacking > Box completion and enter your store name.

Step 2: On selecting the regimen from Tuberculosis (TB) subcategory, those batches with incomplete boxes will be displayed within the ‘Batch’ section. On selecting the batch from the Drug Details section will get displayed.

Step 3: Select a drug from the Drug Details table. Once selected, the batch details table of that drug will appear. Select the batch and add the drug quantity into the ‘To Be Added Qty' column.

Figure 6: Box completion window

Source: Ni-kshay Aushadhi portal

Step 4: Click on the 'Add' button. The selected row in the drug details gets coloured in green, which means that the given drug has been successfully added.

Step 5: Repeat steps 3 and 4 to fill more drugs and complete the box. Click on 'Save' to complete the process and generate the voucher.

Resource

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

Assessment

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	Part of Pre-test​	Part of Post-test​
Where can box preparation be done?	SDS only	SDS and DDS only	TU	DDS only	2	This activity can be done at the SDS and DDS levels only.		Yes	Yes