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STORAGE OF
PHARMACEUTICALS
1
STORAGE AND PRODUCT SHELF LIFE
 Shelf life- is the length of time a product may be
stored without affecting the usability and safety of
the item, if the product is stored under the prescribed
conditions.
 Most products have the expiration date already labelled
on them.
 To find this important date look in the following places:
 On the carton in which the product is shipped
 On the inner box, packaging of the product
 On the product itself.
2
FOLLOWING FEFO
 FEFO means ―first-to-expire, first-out.
o Always distribute products that will expire before
other products.
o To apply FEFO, Store Managers and Health Facility
In-Charges should:
 Write the expiry dates on the outside of cartons.
o Place the cartons or products so that the first to
expire are stacked in front of or on top of products
that will expire later.
3
……..
 • Arrange cartons so that arrows point up.
• Ensure visibility of
– Labels
– Expiry dates
– Manufacturing dates
• First expire first out (FEFO)
 • Store supplies in a manner accessible for
FEFO, counting, and general management.
• Separate and dispose of damaged or expired
products immediately.
• Ensure Security
4
STOCK KEEPING
 Follow the manufacturer or shippers directions
 Ensure safe custody of poisons
 Place liquid products on the lower shelves
 Store cold storage products in appropriate
temperature zones
 Keep narcotic and psychotropic substances with a
high secured places
 Separate damaged, expired and returned products and
dispose using established procedures
 Store in a manner of FIFO policy
 Report to appropriate body for redistribution of
medicines with near expire date. 5
STOCK ROTATION
 Periodic stock reconciliation should be performed
 Issue products that will expire first (FEFO)
 To facilitate FIFO & FEFO, place products that may
expire first in front of products with a latter expiry
date.
 Write expiry dates on stock cards
 Supplies with no expiry or manufacture date should
be stored in the order received and dispensed
accordingly.
6
STORAGE GUIDELINES
 In general, supplies should be protected from sun,
heat, and water.
 Follow manufacturer recommendations for storing
supplies.
 This information is usually printed on the product
carton and boxes.
7
THE FOLLOWING ARE GENERAL STORAGE
GUIDELINES FOR PHARMACEUTICALS.
 Clean the storeroom regularly
 Store pharmaceuticals in a dry, well-lit, well
ventilated storeroom –out of direct sunlight.
 Protect storeroom from water penetration.
 Keep fire safety equipment available,
accessible, and functional, and train
employees to use it.
 Store latex products away from electric
motors and fluorescent lights.
8
……..
 Maintain cold storage, including a cold chain, as
required.
– Ex. Insulin, Oxytocin, vaccines
– Damage if the cold chain is broken
– Refrigeration (electric or kerosene powered)
– Cold boxes or insulated coolers
 Limit storage area access to authorized personnel
and lock up controlled substances.
 Stack cartons at least 10 cm off the floor, 30 cm
away from the wall and other stacks, and no more
than 2.5m high.
– promote air circulation
– facilitate the movement of stock
– cleaning and inspection
– Pallets - pest, water, and dirt
– Stocked pallet, Pallet racking, Shelves 9
……..
 Store medical supplies away from insecticides,
chemicals, old files, office supplies and other
materials.
– shelf life
– Reduce space
– Make products less accessible
 Store pharmaceuticals to facilitate FEFO
procedures and stock management.
10
……..
 Arrange cartons with arrows pointing up, and
with identification labels, expiry dates, and
manufacturing dates clearly visible.
 Separate unusable pharmaceuticals from
usable pharmaceuticals and dispose of
damaged or expired products, Remove them
from inventory immediately and dispose of
them using established procedures.
11
……..
 Store flammable products separately from
other products. Take appropriate safety
precautions. Ensure that fire safety equipment is
available
and accessible and personnel are trained to
use it.
– Strictly prohibit smoking in the store.
– Place smoke detectors
– Check smoke detectors every 2–3 months to
ensure that they are working properly.
• Stopping the fire
12
……..
 – fire extinguishers
– water douses wood and paper fires
– use buckets of sand
– Train staff in the use of the available fire safety
equipment
– Flammables
• Must be stored in special buildings or rooms.
• well ventilated and fireproof.
13
……..
 Store flammable products separately from
other products.
– bottled gas or kerosene powers
– Refrigerators
– Alcohol
– mineral spirits power
– Bunsen burner
Store away from other products
Fire extinguisher.
14
……..
15
……..
16
……..
17
……..
18
……..
19
……..
20
……..
21
STORAGE CONDITIONS
 Medicines do not keep indefinitely. Some can be
kept for only a short time.
 Loss of drug (such as hydrolysis or oxidation),
 Loss of vehicle (such as evaporation or water or
other volatile ingredient),
 loss of uniformity (such as caking of a suspension
or creaming of an emulsion),
 change in bioavailability (particularly tablets)
 change of appearance (such as colour changes)
22
……..
2 classes:
 Normal storage conditions
 Special storage conditions
 Cold storage conditions,
 Combustible/flammable and Secured
23
NORMAL STORAGE CONDITIONS
 Dry, Well-ventilated premises at temperatures of
15-25 °C or, depending on climatic conditions, up to
30°C. Extraneous odours & intense light – Must be
excluded.
 Protect from moisture : No more than 60%
relative humidity eg: Nitro glycerine sublingual
tablet
 Protect from light : Provide to patient in a light-
resistant container eg: Tinctures
 Photosensitive products : Shade the windows or
use curtains.
24
SECURED STORAGE CONDITIONS
 Keep narcotics drugs, psychotropic substance,
other controlled substances and their
documents should be kept in securely locked
rooms or cupboards.
 The keys should be kept in a secure place and it is
preferable that only the chief of pharmacy should
have access to them.
– Dangerous when misused
– Stolen for sale on the black market
Limit access to the storeroom
Track the movement of products.
Physical inventories 25
COMBUSTIBLE / FLAMMABLE
 Some categories of drugs and supplies require
special storage conditions.
 These include narcotic and psychotropic
substances, and combustibles.
 Special or separate rooms.
 All stores should be equipped with fire
extinguishers.
26
COLD STORAGE CONDITIONS
 Store products that are sensitive to freezing or very
low temperatures on the upper shelves.
 If there is enough space, place a few plastic bottles
of water in the refrigerator.
 Do not keep staff food in the refrigerator. Opening
and closing the door may lower the temperature
and cause medicines to deteriorate. Record the
temperature daily. Check that there is enough
space around the refrigerator so air can move
freely.
27
TERMS RELATED TO STORAGE TEMPERATURE
28
GOOD STORAGE PRACTICES
 Storage condition based on temperature
– information directly from the manufacturer.
– In a deep freeze (-15°C)
– In a refrigerator/cold 2°C -8°C
– Cool temperature 8°C-15°C
– Room temperature 15°C - 25°C
29
GOOD STORAGE PRACTICES
 Clean and disinfect storeroom regularly
– Rodents and insects
– Avoid food and drink
• Store supplies in a dry, well-lit, well-ventilated
storeroom out of direct sunlight.
– extreme heat and exposure
– E.g Latex condom (> 40 oC )
– air conditioning
– ceiling fans and forced ventilation.
– Avoid direct sunlight( dark colored or opaque
bottle
30
GOOD STORAGE PRACTICES
 Secure storeroom from water penetration.
– Destroy supplies and packaging
– Repair leaky roofs and windows
– Use dehumidifiers
– Stack supplies off the floor on pallets
• 10 cm high and 30 cm away from walls
• Store condoms and other latex products away
from electric motors and fluorescent lights.
– Emit ozone → rapidly deteriorate condoms
– proper packaging (i.e., boxes and cartons)
– Keep away from light and motors
31
GOOD STORAGE PRACTICES
 Ensure that fire safety equipment is available
and accessible and personnel are trained to
use it.
– Strictly prohibit smoking in the store.
– Place smoke detectors
– Check smoke detectors every 2–3 months to
ensure that they are working properly.
• Stopping the fire
32
GOOD STORAGE PRACTICES
 – fire extinguishers
– water douses wood and paper fires
– use buckets of sand
– Train staff in the use of the available fire safety
equipment
– Flammables
• Must be stored in special buildings or rooms.
• well ventilated and fireproof.
33
GOOD STORAGE PRACTICES
 Maintain cold storage, including a cold chain,
for commodities that require it.
– Ex. Insulin, Oxytocin, vaccines
– Damage if the cold chain is broken
– Refrigeration (electric or kerosene powered)
– Cold boxes or insulated coolers
34
CONDUCTING VISUAL INSPECTION
 To ensure the quality of pharmaceuticals, it is important
to conduct visual inspections of the products.
 Visual inspection is the process of examining
products and their packaging by eye to look for
problems in product quality.
 A visual inspection should be completed each time
products are handled:
 when receiving, issuing or dispensing pharmaceuticals,
or when conducting a physical count.
35
WHEN CONDUCTING A VISUAL INSPECTION, BE
SURE TO CHECK THE FOLLOWING:
 Package and product integrity: check for damage
to packaging.
 Manufacturing defects: incomplete set, missing or
illegible identification information.
 Labelling: Make sure that products are labeled
with the date of manufacture or expiration, lot
number and manufacturer‘s name.
36
PRODUCT ARRANGEMENT IN THE PHARMACY
STORE
 To improve pharmaceuticals management
efficiency (storage, recording, reporting and
resupply) store arrangement in the pharmacy store
should match the pre printed list in the
facility RRF.
37
ARRANGEMENT OF MEDICINES
 Shelves: Steel or Treated wood (Strong & robust)
 Method of arrangement: Pharmacotherapeutic
category, alphabetical order by generic name and
dosage form.
 Arrange each dosage form separate and distinct
areas, Leave sufficient empty space, Well
ventilated, dry and place protected from direct sun
light and heat, liquids in lowest shelf, do not store
anything directly on floor, always store cold-chain
items in refrigerator.
38
……..
39
CONDUCTING A PHYSICAL COUNT
 A physical count (also called Physical Inventory) is
an actual count of the quantity of each
pharmaceutical at any given time.
 It is one of the most frequent pharmaceuticals
management activities in health facilities.
40
……..
 A physical count of pharmaceuticals in the
storeroom should be conducted cyclically or
annually and the Bin Cards and Stock Record
Cards should be updated.
 A physical count of the products in the storeroom is
done to verify that the stock balance found on the
Bin Card and the Stock Record Card shows the
correct number of usable pharmaceuticals that are
available in the storeroom.
41
……..
 If the quantity on the Bin Card or the Stock Record
Card does not match the quantity on the shelf, the
Bin Card and the Stock Record Card should be
updated and an adjustment should be entered.
 Instructions on how to complete a physical count of
the storeroom and make adjustments to
the Bin Card and the Stock Record Card.
42
REFERENCES
1.Standard Operating Procedures (SOP) Manual
for the Integrated Pharmaceuticals Logistics
System in Health Facilities of Ethiopia, Third
Edition
2.
43

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STORING PHARMACEUTICALS.pptx

  • 2. STORAGE AND PRODUCT SHELF LIFE  Shelf life- is the length of time a product may be stored without affecting the usability and safety of the item, if the product is stored under the prescribed conditions.  Most products have the expiration date already labelled on them.  To find this important date look in the following places:  On the carton in which the product is shipped  On the inner box, packaging of the product  On the product itself. 2
  • 3. FOLLOWING FEFO  FEFO means ―first-to-expire, first-out. o Always distribute products that will expire before other products. o To apply FEFO, Store Managers and Health Facility In-Charges should:  Write the expiry dates on the outside of cartons. o Place the cartons or products so that the first to expire are stacked in front of or on top of products that will expire later. 3
  • 4. ……..  • Arrange cartons so that arrows point up. • Ensure visibility of – Labels – Expiry dates – Manufacturing dates • First expire first out (FEFO)  • Store supplies in a manner accessible for FEFO, counting, and general management. • Separate and dispose of damaged or expired products immediately. • Ensure Security 4
  • 5. STOCK KEEPING  Follow the manufacturer or shippers directions  Ensure safe custody of poisons  Place liquid products on the lower shelves  Store cold storage products in appropriate temperature zones  Keep narcotic and psychotropic substances with a high secured places  Separate damaged, expired and returned products and dispose using established procedures  Store in a manner of FIFO policy  Report to appropriate body for redistribution of medicines with near expire date. 5
  • 6. STOCK ROTATION  Periodic stock reconciliation should be performed  Issue products that will expire first (FEFO)  To facilitate FIFO & FEFO, place products that may expire first in front of products with a latter expiry date.  Write expiry dates on stock cards  Supplies with no expiry or manufacture date should be stored in the order received and dispensed accordingly. 6
  • 7. STORAGE GUIDELINES  In general, supplies should be protected from sun, heat, and water.  Follow manufacturer recommendations for storing supplies.  This information is usually printed on the product carton and boxes. 7
  • 8. THE FOLLOWING ARE GENERAL STORAGE GUIDELINES FOR PHARMACEUTICALS.  Clean the storeroom regularly  Store pharmaceuticals in a dry, well-lit, well ventilated storeroom –out of direct sunlight.  Protect storeroom from water penetration.  Keep fire safety equipment available, accessible, and functional, and train employees to use it.  Store latex products away from electric motors and fluorescent lights. 8
  • 9. ……..  Maintain cold storage, including a cold chain, as required. – Ex. Insulin, Oxytocin, vaccines – Damage if the cold chain is broken – Refrigeration (electric or kerosene powered) – Cold boxes or insulated coolers  Limit storage area access to authorized personnel and lock up controlled substances.  Stack cartons at least 10 cm off the floor, 30 cm away from the wall and other stacks, and no more than 2.5m high. – promote air circulation – facilitate the movement of stock – cleaning and inspection – Pallets - pest, water, and dirt – Stocked pallet, Pallet racking, Shelves 9
  • 10. ……..  Store medical supplies away from insecticides, chemicals, old files, office supplies and other materials. – shelf life – Reduce space – Make products less accessible  Store pharmaceuticals to facilitate FEFO procedures and stock management. 10
  • 11. ……..  Arrange cartons with arrows pointing up, and with identification labels, expiry dates, and manufacturing dates clearly visible.  Separate unusable pharmaceuticals from usable pharmaceuticals and dispose of damaged or expired products, Remove them from inventory immediately and dispose of them using established procedures. 11
  • 12. ……..  Store flammable products separately from other products. Take appropriate safety precautions. Ensure that fire safety equipment is available and accessible and personnel are trained to use it. – Strictly prohibit smoking in the store. – Place smoke detectors – Check smoke detectors every 2–3 months to ensure that they are working properly. • Stopping the fire 12
  • 13. ……..  – fire extinguishers – water douses wood and paper fires – use buckets of sand – Train staff in the use of the available fire safety equipment – Flammables • Must be stored in special buildings or rooms. • well ventilated and fireproof. 13
  • 14. ……..  Store flammable products separately from other products. – bottled gas or kerosene powers – Refrigerators – Alcohol – mineral spirits power – Bunsen burner Store away from other products Fire extinguisher. 14
  • 22. STORAGE CONDITIONS  Medicines do not keep indefinitely. Some can be kept for only a short time.  Loss of drug (such as hydrolysis or oxidation),  Loss of vehicle (such as evaporation or water or other volatile ingredient),  loss of uniformity (such as caking of a suspension or creaming of an emulsion),  change in bioavailability (particularly tablets)  change of appearance (such as colour changes) 22
  • 23. …….. 2 classes:  Normal storage conditions  Special storage conditions  Cold storage conditions,  Combustible/flammable and Secured 23
  • 24. NORMAL STORAGE CONDITIONS  Dry, Well-ventilated premises at temperatures of 15-25 °C or, depending on climatic conditions, up to 30°C. Extraneous odours & intense light – Must be excluded.  Protect from moisture : No more than 60% relative humidity eg: Nitro glycerine sublingual tablet  Protect from light : Provide to patient in a light- resistant container eg: Tinctures  Photosensitive products : Shade the windows or use curtains. 24
  • 25. SECURED STORAGE CONDITIONS  Keep narcotics drugs, psychotropic substance, other controlled substances and their documents should be kept in securely locked rooms or cupboards.  The keys should be kept in a secure place and it is preferable that only the chief of pharmacy should have access to them. – Dangerous when misused – Stolen for sale on the black market Limit access to the storeroom Track the movement of products. Physical inventories 25
  • 26. COMBUSTIBLE / FLAMMABLE  Some categories of drugs and supplies require special storage conditions.  These include narcotic and psychotropic substances, and combustibles.  Special or separate rooms.  All stores should be equipped with fire extinguishers. 26
  • 27. COLD STORAGE CONDITIONS  Store products that are sensitive to freezing or very low temperatures on the upper shelves.  If there is enough space, place a few plastic bottles of water in the refrigerator.  Do not keep staff food in the refrigerator. Opening and closing the door may lower the temperature and cause medicines to deteriorate. Record the temperature daily. Check that there is enough space around the refrigerator so air can move freely. 27
  • 28. TERMS RELATED TO STORAGE TEMPERATURE 28
  • 29. GOOD STORAGE PRACTICES  Storage condition based on temperature – information directly from the manufacturer. – In a deep freeze (-15°C) – In a refrigerator/cold 2°C -8°C – Cool temperature 8°C-15°C – Room temperature 15°C - 25°C 29
  • 30. GOOD STORAGE PRACTICES  Clean and disinfect storeroom regularly – Rodents and insects – Avoid food and drink • Store supplies in a dry, well-lit, well-ventilated storeroom out of direct sunlight. – extreme heat and exposure – E.g Latex condom (> 40 oC ) – air conditioning – ceiling fans and forced ventilation. – Avoid direct sunlight( dark colored or opaque bottle 30
  • 31. GOOD STORAGE PRACTICES  Secure storeroom from water penetration. – Destroy supplies and packaging – Repair leaky roofs and windows – Use dehumidifiers – Stack supplies off the floor on pallets • 10 cm high and 30 cm away from walls • Store condoms and other latex products away from electric motors and fluorescent lights. – Emit ozone → rapidly deteriorate condoms – proper packaging (i.e., boxes and cartons) – Keep away from light and motors 31
  • 32. GOOD STORAGE PRACTICES  Ensure that fire safety equipment is available and accessible and personnel are trained to use it. – Strictly prohibit smoking in the store. – Place smoke detectors – Check smoke detectors every 2–3 months to ensure that they are working properly. • Stopping the fire 32
  • 33. GOOD STORAGE PRACTICES  – fire extinguishers – water douses wood and paper fires – use buckets of sand – Train staff in the use of the available fire safety equipment – Flammables • Must be stored in special buildings or rooms. • well ventilated and fireproof. 33
  • 34. GOOD STORAGE PRACTICES  Maintain cold storage, including a cold chain, for commodities that require it. – Ex. Insulin, Oxytocin, vaccines – Damage if the cold chain is broken – Refrigeration (electric or kerosene powered) – Cold boxes or insulated coolers 34
  • 35. CONDUCTING VISUAL INSPECTION  To ensure the quality of pharmaceuticals, it is important to conduct visual inspections of the products.  Visual inspection is the process of examining products and their packaging by eye to look for problems in product quality.  A visual inspection should be completed each time products are handled:  when receiving, issuing or dispensing pharmaceuticals, or when conducting a physical count. 35
  • 36. WHEN CONDUCTING A VISUAL INSPECTION, BE SURE TO CHECK THE FOLLOWING:  Package and product integrity: check for damage to packaging.  Manufacturing defects: incomplete set, missing or illegible identification information.  Labelling: Make sure that products are labeled with the date of manufacture or expiration, lot number and manufacturer‘s name. 36
  • 37. PRODUCT ARRANGEMENT IN THE PHARMACY STORE  To improve pharmaceuticals management efficiency (storage, recording, reporting and resupply) store arrangement in the pharmacy store should match the pre printed list in the facility RRF. 37
  • 38. ARRANGEMENT OF MEDICINES  Shelves: Steel or Treated wood (Strong & robust)  Method of arrangement: Pharmacotherapeutic category, alphabetical order by generic name and dosage form.  Arrange each dosage form separate and distinct areas, Leave sufficient empty space, Well ventilated, dry and place protected from direct sun light and heat, liquids in lowest shelf, do not store anything directly on floor, always store cold-chain items in refrigerator. 38
  • 40. CONDUCTING A PHYSICAL COUNT  A physical count (also called Physical Inventory) is an actual count of the quantity of each pharmaceutical at any given time.  It is one of the most frequent pharmaceuticals management activities in health facilities. 40
  • 41. ……..  A physical count of pharmaceuticals in the storeroom should be conducted cyclically or annually and the Bin Cards and Stock Record Cards should be updated.  A physical count of the products in the storeroom is done to verify that the stock balance found on the Bin Card and the Stock Record Card shows the correct number of usable pharmaceuticals that are available in the storeroom. 41
  • 42. ……..  If the quantity on the Bin Card or the Stock Record Card does not match the quantity on the shelf, the Bin Card and the Stock Record Card should be updated and an adjustment should be entered.  Instructions on how to complete a physical count of the storeroom and make adjustments to the Bin Card and the Stock Record Card. 42
  • 43. REFERENCES 1.Standard Operating Procedures (SOP) Manual for the Integrated Pharmaceuticals Logistics System in Health Facilities of Ethiopia, Third Edition 2. 43