Pharmacist: Return and Reconstitution

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

Process of Return of Drugs

Content

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

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Return of drugs from the parent store is facilitated on Ni-kshay Aushadhi through which of the following options?	Return from patient	Return Request Desk	Both of the above	None of the above	2	In Ni-kshay Aushadhi, return from the parent store is facilitated through the ‘Return Request Desk’.		Yes	Yes

Reconstitution of Bedaquiline [Bdq] Bottle

Content

The reconstitution of Bedaquiline (Bdq) bottle should be done at the State Drug Store (SDS).

In case of lost to follow-up/ death/ transferred-out/ treatment stopped patients, Bdq bottle shall be brought back from the treatment centre to the Health Facility (HF) to the TB Unit (TU) to the District TB Centre (DTC) within the shortest possible time.

A partially used Bdq bottle shall be sent back to the SDS for repackaging.
The remaining tablets in the bottle received back shall be accounted for in the stock register and Nikshay-Aushadhi at the SDS.
Upon reconstitution, the bottle shall be accounted for in the stock register (loose tablets to be mentioned in the remarks column) to be issued as per First-expire-first-out (FEFO) principles.
When reconstitution is done, tablets of the same expiry can be considered using the same container to a maximum of 188 tablets.
These reconstituted containers shall be used for the treatment of subsequent patients found eligible for Bdq.
All such drugs that are taken from the new containers shall be collected as a group of 188 tablets of the same expiry and put in a light-resistant container as per the advice from the manufacturer.
The actual expiry of tablets should be mentioned over the container.
In the event of the SDS falling short of 188 tablets from an expiry batch, reconstitution can still be done using a number of tablets to complete 188 tablets with another expiry batch.
- In such a case, tablets of the respective expiry should be retained in their same respective containers and issued to patients and providers with counselling to consume the tablets with the nearest expiry first.
If the expiry of the remaining tablets is less than six months, the same shall be consumed at the Nodal/ District Drug-resistant TB Centre (N/DDR-TBC) for admitted patients. It will be adjusted from the new long expiry bottle on discharge.

Resources

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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