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  • Storage norms

    Learning Objectives

    What are the norms to store  anti-Tb drugs in different Levels - SDS, DDS, TU,PHI

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To preserve the quality of medicines, good storage practices should be in place at all levels, which requires that staff are appropriately trained and storage conditions adequate.

 

General Guidelines on Storage of Drugs

 

Mechanisms to improve TB stock management in central or peripheral drug stores are:

  1. Stock rotation follows a First-expiry, First-out (FEFO) approach.
  2. The cleanliness of the area is ensured.
  3. The environment of the warehouse protects medicines from factors that could inhibit their effectiveness or use, such as sunlight, heat, cold, moisture, pests and theft.
  4. The stock area is divided into zones for easy location of different products.
  5. There is a designated area for second-line TB medicines.

 

Storage Guidelines under the National TB Elimination Programme (NTEP)

 

Under NTEP, space requirements change at the state, district and peripheral levels according to the NTEP stocking norms, but all other requirements remain the same as shown in the table below. The State TB Officer (STO)/ District TB Officer (DTO) must ensure that the pharmacist/ storekeeper adheres to the following guidelines on the proper storage of drugs.

 

Table: Guidelines for the Storage of Anti-TB Drugs in NTEP Drug Stores

Space Requirements at the State Drog Store (SDS)
  • For every ten lakh population, provision should be made for the storage of about 45 cartons (of 20 boxes each), of Patient-wise Boxes (PWBs) for new cases (PC-1) and PWBs for retreatment cases (PC-2) taken together.
  • This is approximately equivalent to 6 months requirement of drugs. For this volume of drugs, the minimum space requirement may be approximated as 50 cubic feet.
  • For loose drugs, space provision would be 10% of space allocated to PC-1 and PC-2 PWB cartons. These could alternatively be stored in cupboards/ almirahs where volumes are low and should be kept under lock and key. Do not stack drug cartons on the floor or on top of one another.
Room Requirements
  • The store should preferably comprise one large room. Where multiple rooms exist, these should be contiguous or proximate to each other.
  • The ceiling must have a height of at least 5 metres.
  • There should be a lockable door and at least one window with a grill and wire meshing.
  • Properly lit with extra light points for plugging in the required office equipment.
  • An even-level, ‘pukka’ floor.
Stacking Requirements
  • Ensure that different drug/ consumable items are clearly segregated and stacked on separate racks.
  • Different batches of drugs with different dates of manufacture and expiry are stored separately to facilitate FEFO principles (drug batches with the most recent expiry are issued first)
  • Mark ‘Expiry Dates’ in Bold Letters 3” to 4” in size, on the drug cartons with a marker pen, for easy identification and control of drugs immediately on their arrival.
  • Separate and dispose of damaged or expired products without delay as soon as approval of the same has been received, according to the biomedical waste guidelines.
Temperature and Humidity Control
  • To keep humidity levels below the maximum 60% recommended for storage of drugs ensure appropriate ventilation and air circulation, and do not open cartons/ drug boxes unless necessary.
  • Hydro thermometers are to be installed up to TB Unit (TU) drug store levels to monitor humidity and temperature regularly.
  • Overhead exhaust fan required.
  • Plastered walls and ceiling with whitewash without any kind of seepage in the room.
  • The store should be clean, dry and well-ventilated.
  • Ceiling and sidewalls should preferably be insulated, ensuring that the ambient temperature during peak summer does not result in damage to anti-TB drugs. The ambient temperature may be taken as 15-25°C or depending on climatic conditions, up to 30°C.
  • PWBs/ cartons should be placed on shelves ensuring that there is sufficient space between shelves and walls of the storeroom.
  • A regular power supply should be available for air conditioning.
Protection from Sunlight
  • Shade the windows or use curtains if they are in direct sunlight.
  • Keep products in cartons/ drug boxes.
  • Do not store or pack products in sunlight.
  • Maintain trees around the premises of the drug store to help provide shade and cooling. Check their condition regularly to prevent any untoward incidents.
Fire Safety
Ensure that the fire safety equipment is available and accessible, and that personnel are trained to use it.
Others
  • Store medical supplies separately, away from rodents, insecticides, chemicals, old files, office supplies and other materials.
  • Stores should not have any odour or indications of contamination and should be sanitised periodically including pest control measures.

 

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​
Concerning storage of anti-TB drugs, which of the following is correct? Stock rotation follows a First-expiry, First-out (FEFO) approach. Store drugs away from direct sunlight. Hydro thermometers are to be installed up to TU drug store levels to monitor humidity and temperature regularly. All of the above 4

Appropriate anti-TB drug storage conditions include keeping drugs away from direct sunlight, maintaining appropriate temperature and humidity and following a FEFO approach.

 

  Yes Yes

 

 

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