Reconstitution of Bedaquiline [Bdq] Bottle

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

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.
• Standard Operating Procedure Manual - Procurement & Supply Chain Management, MOHFW, GOI.

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