Best practices in stores

1) Drug Store Personnel

All personnel (pharmacist, store assistant, Senior Treatment Supervisor (STS), etc.), designated to handle the drug store should receive proper training in relation to good storage practices, regulations, procedures and safety as well as stock monitoring and expiry management.

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Figure 1:  Drug Store Personnel; Source: msf.org.

2) Drug Store Premises and Facilities

Storage Space

• The storage space must be designed or adapted to ensure sufficient capacity for the orderly storage of the various categories of materials and products and allow free movement of drug boxes as well as the personnel.

• Physical or other equivalent validated (e.g. electronic) segregation should be provided for the storage of rejected, expired, recalled or returned materials or products. 

• The drug stores should follow a written sanitation programme for the premises to keep it clean and free from contamination. 

• Clear signage should be displayed outside the drug store, the door should be lockable and only authorised personnel should be allowed to enter.

Storage Conditions

• Humidity and temperature must be monitored regularly to maintain drug efficacy as per their shelf life.

Figure: Drug Store; Source: Standard Operating Procedure Manual Procurement & Supply Chain Management, CTD, MoHFW, India, 2018.

3) Drug Storage Requirements

Documentation and records:

• All the credit/ debit of drug stocks should be reported on Ni-kshay Aushadhi in order to avoid disrupting the supply chain management and ensure the smooth functioning of the programme. 

• Physical stock registers should be maintained to avoid missing out on reporting any information related to drug batches, receipt, issue, return, storage, etc.

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Figure 3: Stock Register         

Receipt of incoming material: 

• All incoming drugs should be checked for any damage, or shortage of quantity and all the related documents should be verified at each level drug store.

Labelling of boxes: 

• The drug boxes should be labelled in bright colour on the visible side of the cartons so as to quickly identify the regimen, drug type and quantity and expiry of drugs in that box. 

• Labels should be prepared separately for each individual batch of drugs.

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Figure 4: Labelled Drug Boxes           

Expiry management: 

• First Expiry First Out (FEFO) principle should be strictly followed while storing as well as issuing the drugs. 

• Near to expiry drugs should be stacked at the lower level for ease of accessibility and ones which are far from expiry should be stacked on top. 

• Drugs should preferably be stored regimen-wise owing to the availability of space.

Stock rotation and control: 

• Periodic stock reconciliation should be performed by comparing the actual and recorded stocks and all significant stock discrepancies should be investigated as a check against inadvertent mix-ups and/or incorrect issues. 

• Due precautions must be taken for partially used and damaged drugs to ensure effective utilization and disposal respectively.

4) Returned Drugs' Management: All returned drugs should be handled in accordance with approved procedures and records should be maintained. They should be verified against the issue voucher, batch number and quantity before accepting returns. The re-issue of returned drugs that are much within the expiry date should only be undertaken only after approval from the nominated officer -in charge following a satisfactory quality re-evaluation.

5) Dispatch and Transport: The dispatch and transport of drugs should be documented and done in such a way that their integrity is not impaired. All storage conditions are to be maintained during the transportation of drugs.

6) Product Recall: In case of defective materials, the drug store must ensure there is a set protocol to recall all the defective products from the market promptly and effectively.

7) Waste Disposal: All expired drugs should be kept outside and away from the drug store to avoid any mix-ups. If any drug expires due to reasons beyond control, it should be disposed of as per the procedures laid down in the Rules under Drugs & Cosmetics Act and Biomedical Waste (Management and Handling) Rules of Govt. of India.

Resources

• WHO Technical Report Series, No. 908, 2003; Annex.9: Guide to Good Storage Practices for Pharmaceuticals.

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

• Standard Operating Procedure Manual Procurement & Supply Chain Management, CTD, MoHFW, India, 2018.

 Assessment