The document discusses proper inventory management and storage conditions for medicines at central drug stores. It provides guidelines for storing medicines based on their stability, including temperature ranges and other environmental conditions. Specific standard operating procedures are outlined for storage, stock management, expiration checking, and disposal of expired drugs. Proper cold chain management is crucial, with refrigerators and freezers used to store vaccines within the required temperature ranges. The key elements of the cold chain including personnel, equipment, and procedures are also summarized.
2. • Potency of medicine is retained for sufficient duration of
time after their manufacturing, provided they stored in a
recommended storage condition.
• Some of these conditions are listed below
• Keep in cool, dry place
• Store in dark at 2-8 °C
• Store at room temp
• Keep in cool and dark place
• Do not store above 25°C
• Store below 30°C. do not freeze
• The storage condition mentioned on label should be
interpreted and complied with the Schedule P of Drug &
Cosmetic act 1945.
3. Indian pharmacopeia specifies the following storage conditions
Storage condition Specification
Cool Temp. NMT 8°C
Cool Temp. between 8°C & 25°C
Room temp Temp. prevailing in working are
Warm Temp between 30-40°C
Excessive heat Temp. above 40°C
• Storage facility used for medicine should be dry and clean & monitored
within acceptable temp. and humidity limits.
• Medicine should be stored off the floor
• Based on the stability testing results the storage condition is decided and
displayed on the label.
• All person handling medicine should receive proper training
• Person working in hospital pharmacy should wear suitable protective
working garments.
4. • Pharmacist must be aware of the importance of the
storage.
• Thus right from designing storage area, its cleanliness
and maintenance up to identification, isolation and
disposal of expired/ damaged products and
documentation of these activities require sincere
attention of pharmacy staff
5. SOP regarding storage & stock management
1. Upon arrival of medicines, check for correctness
and transfer the products to their resp. areas
2. Store the products in an organized and orderly
manner with the label bearing the product in the
front.
3. First expire drug out should be basis of dispensing
drugs
4. Avoid direct contact to sunlight
5. Store controlled drug substances in the designated
areas
6. Store expired goods in the store room with marking
‘ Expired”
7. Temperature should be daily checked and recorded.
6. Cold chain
• Cold chain is a system of storing and transporting vaccines at
recommended temperatures from the point of manufacture to the
point of use.
7. Cold Chain - Key elements
• The key elements of the cold chain are:
• Personnel Equipment Procedure
11. Ice-lined refrigerator
(ILR)
• Maintains a cabinet temperature between +2°C and +8°C.
• It is used to store UIP vaccines at the PHC and district
levels.
• An ILR with a top-opening lid prevents loss of cold air
during door opening and can keep vaccines safe with as
little as 8 hours electricity supply in a 24-hour period.
• ILRs are available in two sizes – large (for districts) and
small (for PHCs).
• In case baskets are not available, two layers of empty ice
packs can be laid flat on the bottom of the ILR to avoid
contact with the inside floor of the cabinet.
• Vaccines should never be kept on the floor of the ILR.
12.
13. Dos and Dont’s for ILR use
Dos Dont’s
Keep all vaccines including those
returned under open vial policy in the
basket supplied along with the ILR.
Do not store any other drugs/non-UIP
vaccines in the ILR.
Store diluents at +2°C to +8°C at least
24 hours before use.
Do not open the ILR frequently.
Leave space in between the vaccine
boxes.
Do not keep food or drinking water in
the ILR.
Place a thermometer in the basket in
between the vaccines.
Do not keep vaccines which have
expired and have crossed the discard
point of VVM.
Keep freeze-sensitive vaccines at the
top of the basket.
Do not disturb the thermostat setting
frequently.
Keep heat-sensitive vaccines in the
bottom of the basket.
Do not place heavy weight on the ILR.
Arrange vaccines as per their expiry
dates. (
Do not store excess stock of vaccines,
14. Deep freezer (DF)
• Freezing ice packs in the DF maintains the cabinet
temperature between -15°C and -25°C.
• Unlike the ILR, the DF has little or limited holdover
time, which is dependent on the number of frozen ice
packs in it and the frequency of opening
• At the PHC level, DF is used only for preparation of
ice packs.
• At the district headquarters, DFs have been supplied
for storage of recommended vaccines such as OPV
and preparation of ice packs.
15.
16.
17.
18. Cold box
• A cold box is an insulated box used for
transportation and emergency storage of
vaccines and ice packs. It is available in
two sizes, large and small. It is used to:
• collect and transport large quantities
of vaccines;
• store vaccines for transfer up to 5
days,
• if necessary for outreach sessions or
when there is a power cut; store
vaccines in case of breakdown of
ILR, as a contingency measure;
• also used for storing frozen ice
packs, e.g. during emergencies and
before campaigns.
19.
20. Ice packs
• Ice packs are plastic containers filled with water. These
are hard frozen in the deep freezer.
• They are placed inside a vaccine carrier and cold box to
improve and maintain the holdover time.
• They are also used in ILRs as inside lining to improve and
maintain holdover time during electricity failure.
26. Periodic checking of expiry
• SOP for checking expiry
1. Identify & assign the responsibility to a pharmacist
2. Check every product on shelf for expiry date
3. Remove the near expiry product in a designated area
4. Maintain record of each activity
5. In case of expired drug ‘SOP for disposal of expired drugs’
to be followed
• SOP for disposal of Expired drugs
1. Chief pharmacist will receive the expired drug along with
records
2. Determine the cost of expired drugs
3. Notify the concerned higher authority
4. Request for appropriate action to be taken
5. Send the expired drugs in appropriate packages to return
back
6. Maintain the records of action taken
27. Disposal methods
1. Return to manufacturer
• Wherever practical the possibility of returning
unusable drugs for safe disposal by the manufacturer
should be explored; particularly drugs which present
disposal problems, such as antineoplastic.
2. Landfill
• To landfill means to place waste directly into a land
disposal site without prior treatment or preparation.
Landfill is the oldest and the most widely practiced
method of disposing of solid waste.
28. 3. Waste immobilization
• Encapsulation
• Encapsulation involves
immobilizing the
pharmaceuticals in a solid
block within a plastic or steel
drum.
• They are filled to 75% capacity
with solid and semi-solid
pharmaceuticals, and the
remaining space is filled by
pouring in a medium such as
cement.
• Inertization
• Inertization is a variant of
encapsulation and involves
removing the packaging
materials, paper, cardboard
and plastic, from the
pharmaceuticals.
• The pharmaceuticals are then
ground and a mix of water,
cement and lime added to
form a homogenous paste.
• The paste is then transported
in the liquid state by concrete
mixer truck to a landfill and
decanted into the normal
urban waste.
29. 4. Sewer
• Some liquid pharmaceuticals, e.g. syrups and
intravenous (IV) fluids, can be diluted with water and
flushed into the sewers in small quantities over a
period of time without serious public health or
environmental affect.
5. Burning in open containers
• Pharmaceuticals should not be destroyed by burning at
low temperature in open containers, as toxic pollutants
may be released into the air.
6. Medium temperature incineration
• using a two-chamber incinerator that operates at the
minimum temperature of 850°C, with a combustion
retention time of at least two seconds in the second
chamber
30. 7. Novel high temperature incineration
• e furnaces that operate at temperatures well in
excess of 850°C, have long combustion retention
times, and disperse exhaust gases via tall chimneys,
often to high altitudes. During burning the cement
raw materials reach temperatures of 1450°C while
the combustion gases reach temperatures up to
2000°C.
8. Chemical decomposition
• If an appropriate incinerator is not available, the
option of chemical decomposition can be used in
accordance with the manufacturer's
recommendations, followed by landfill. This method
is not recommended unless chemical expertise is
readily available.
32. Disposal of narcotics
• Controlled drug should be immobilized under supervision
of authorized officer by any following two methods
A. Landfill
B. Incineration
Summary of disposal methods
Disposal method Type of waste Comments
Medium temp.
incineration at
850 °C
Solid, semisolid,
powder &
controlled drugs
Antineoplastic
best incinerated
at high temp
High temp
incineration at
1200°C
Solid, semisolid,
powder ,
antineoplastic &
controlled drugs
expensive
33. Disposal of cytotoxic drugs
• Cytotoxic drug disposal
Methods to be used Method not to be used
Return to the supplier Low & medium temp.
incineration
High temp. incineration Disposal to sewers
Waste encapsulation Directly to landfill