Pharmacist: Stores in NTEP

Each state needs to have one fully operational State Drug Store (SDS) for every 5 crores of population.

In larger states/ difficult terrain, more than one SDS can be established as per National Tuberculosis (TB) Elimination Program (NTEP) guidelines.

It is responsible for effective management of medicines and other logistics and ensuring an uninterrupted supply of good quality 1st & 2nd line anti-TB medicines for adult and paediatric patients.

Structure and Human Resource

In most states, NTEP SDS is part of the state TB cell. However, few states have more than one SDS.

The SDS Pharmacist under the overall guidance of the State TB Officer (STO) is responsible for procurement and supply chain management activities at the state/ SDS level.

Available human resources at SDS include:

• 1 Pharmacist cum Storekeeper
• 1 Store Assistant (additional post if >1800 second-line monthly boxes preparation per month)

Functions of NTEP SDS 

1. Receipt of drugs and lab-related logistics at SDS and the subsequent updating of stock records
2. Issue/ dispatch of drugs and logistics to District Drug Stores (DDS)
3. Inventory Management (procedures for tracking and replenishment of drug inventory at the SDS and subordinate stocking points within the state)
4. Drug expiry management
5. Physical verification & reconciliation of drug stocks
6. Digitisation of NTEP drug and logistic records into Ni-kshay Aushadi and monitoring of the performance of DDS, TB units and other health units
7. Ensure space & storage arrangements as per NTEP guidelines
8. Secure custody of anti-TB drugs and logistic
9. Follow the guidelines for storage and distribution of first- and second-line anti-TB drugs, paediatric drugs, lab consumables and Nucleic Acid Amplification Test (NAAT) related logistics etc.
10. Arrangements for transportation of drugs from the SDS to various stocking units in the State
11. Reconstitution of second-line anti-TB drugs, especially new drugs like Bedaquiline
12. Quality Assurance of anti-TB drugs.

Figure: State Drug Store; Source: Tamilnadu Medical Services Corporation Limited Web Portal.

Infrastructure Required for SDS

• Accessibility: Located on a wide road, providing easy access to transportation vehicles and facilitating free movement of drugs to and from the store
• Space for staff, equipment and records: Adequate space for accommodating staff, office equipment (computer, printer etc.) and store records and registers
• Space required for storing drugs: Depends upon the population to which the store caters, as well as the number of months for which stocks are to be stored 
• Other specifications: One large room with a ceiling height of at least 5 metres, a lockable door, at least one window with grill, proper lighting, and even level concrete floor, plastered walls, and a ceiling with whitewash. The room should not have any kind of seepage in it.
• Storage shelves: Should be made of 40 mm bore mild steel pipes, ensuring sufficient gap between cartons from the ceiling, floor, and walls, facilitating ventilation and free movement of air
• Temperature and humidity regulations: Hydro thermometers should be installed to monitor humidity and temperature regularly. The recommended temperature for storage of drugs is below 25°C and humidity levels are below 60%.
• Power supply: Regular power supply should be available in the SDS. Arrangements for backup power supply should also be made through solar panels or fuel-based power generators.
• Telecommunications: Each SDS should have an independent telephone connection, a computer with internet connectivity, specific email address for communication.

Resources

• Standard Operating Procedure Manual, Procurement & Supply Chain Management, Central TB Division, Ministry of Health and Family Welfare, Government of India, 2018.
• Standard Operating Procedures Manual for State Drug Stores, Central TB Division, MoHFW, GoI, 2012.

Assessment

To ensure smooth and timely distribution of anti-tuberculosis drugs within the state, store facilities at the district level in all the states are built as per the National TB Elimination Programme (NTEP) guidelines. These facilities under the programme are called District Drug stores (DDS).

DDS is responsible for ensuring an uninterrupted supply of good quality first & second line anti-TB medicines and other supplies to the mapped TB Units (TUs) and Peripheral Health Institutes (PHIs).

Structure and Human Resource

The number of these DDSs within a state would depend upon the population and geography of that particular state.

The human resource requirement at DDS is similar to that of State Drug Store (SDS) and includes:

• 1 Pharmacist cum storekeeper
• 1 Store Assistant (In case monthly Patient-wise Box (PWB) are prepared at DDS)

Functions of NTEP DDS 

1. Receipt of drugs and lab-related logistics at DDS and the subsequent updating of stock records
2. Issue/ dispatch of drugs and logistics to TUs and PHIs
3. Inventory Management (procedures for tracking and replenishment of drug inventory at the DDS and subordinate stocking points within the state)
4. Drug expiry management
5. Physical verification & reconciliation of drug stocks
6. Digitisation of NTEP drug and logistic records into Ni-kshay Aushadhi
7. Ensuring space and storage arrangements as per NTEP guidelines
8. Secure custody of anti-TB drugs and logistics
9. Following the guidelines for storage and distribution of first- and second-line anti-TB drugs, paediatric drugs, lab consumables and Nucleic Acid Amplification Test (NAAT) related logistics, etc.
10. Arrangements for transportation of drugs from the DDS to the subordinate stocking units in the district
11. Quality Assurance of anti-TB drugs

Figure: Storage of Supplies in a Store

Infrastructure Required for DDS

• Accessibility: Located on a wide road, providing easy access to transportation vehicles, and facilitating free movement of drugs to and from the store
• Space for staff, equipment, and records: Adequate space for accommodating staff, office equipment (computer, printer, etc.) and store records and registers
• Space required for storing drugs: Depends upon the population to which the store caters, as well as the number of months for which stocks are to be stored 
• Other specifications: One large room with a ceiling height of at least 5 metres, a lockable door, at least one window with grill, proper lighting, and even level concrete floor, plastered walls, and a ceiling with whitewash. The room should not have any kind of seepage in it.
• Storage shelves: Should be made of 40 mm bore mild steel pipes, ensuring sufficient gap between cartons from the ceiling, floor, and walls, facilitating ventilation and free movement of air
• Temperature and humidity regulations: Hydro thermometers should be installed to monitor humidity and temperature regularly. The recommended temperature for storage of drugs is below 25°C and humidity levels are below 60%.
• Power supply: Regular power supply should be available in the DDS. Arrangements for backup power supply should also be made through solar panels or fuel-based power generators.
• Telecommunications: Each DDS should have an independent telephone connection, a computer with internet connectivity, specific email address for communication.

Resources

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

Assessment

Tuberculosis Unit (TU) is the administrative unit under the National Tuberculosis Elimination Programme (NTEP) which is responsible for conducting activities at the sub-district/ block level. 

Peripheral Health Institution (PHI) is the most peripheral health facility under the NTEP which is responsible for providing anti-TB care to the underserved/ hard-to-reach populations.

Structure and Human Resources

The Medical Officers (MO) at the TB Unit (TU) and the PHI level are responsible for the activities and reporting of the respective TU and PHI drug stores.

Staff available at TU drug store/ PHI are:

• One pharmacist

• In case the pharmacist is not available, the Senior Treatment Supervisor (STS) is required to handle the TU drug store activities. 

As it is not a stocking point, the PHI drug store does not require a pharmacist/ storekeeper. It is handled directly by the MO in charge of the PHI who issues drugs to the patients.

Function of TU and PHI Drug Stores

• The TU drug stores function as both consumption and stocking points for drugs and are responsible for the supply of drugs to the PHI.

• The PHI drug stores serve only as a consumption point where the drugs are issued to the patients.

Infrastructure Required for the TU/ PHI Drug Stores

Storage space: There should be sufficient space available to stock the supplies required for the maximum number of TB patients to be initiated on treatment under that facility. Should have a lockable door, at least one window with a grill, a ceiling height of at least 3 metres, and 'pukka' flooring with plastered walls and ceiling. Windows should be open to allow air circulation, screens/ wire mesh should be installed on the windows to keep out insects and birds.

Shelves, racks & storage arrangements: Shelves should be made of 40 mm. bore medium quality mild steel pipes with sufficient ‘gap’ between cartons from the ceiling, floor and walls, facilitating ventilation and avoiding seepage from the walls into the boxes.

Stacking arrangements: Drugs should be stacked as per the First Expiry First Out (FEFO) principle, i.e., the boxes expiring earlier should be stored at ground level and those expiring later should be on a higher level.

Control of humidity and temperature: Humidity levels should be kept below 60% and the drugs should not be exposed to direct sunlight to maintain their efficacy. Hydrothermometers, cooling facilities (coolers and ceiling fans) and dehumidifiers may be installed at the TU drug stores as the need may be.

Regular power supply: Regular power supply should be available, especially in drug stores where humidity and temperature control devices have been installed.

Resources

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

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

• Guidelines for Storage of Second-line Anti-TB Drugs for Revised National TB Control Programme (RNTCP).

Assessment

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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.

Image

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.

Image

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.

Image

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