Appendix 14: Storage of Drugs

Definition and Concept

Storage

The term used to describe the safe keeping of all finished drugs and pharmaceuticals awaiting dispatch. The term is also applied for safe stores in hospitals and dispensaries under the specified conditions, so as to maintain their quality and potency.

Storage Conditions

The condition specified for storing the product e.g., temperature, humidity, container, etc.

Quality

The ability of drug product to satisfy the users need.

Dosage Form

Refers to the gross physical form in which a drug is administered to or used by a patient.

Drug Product

A dosage form containing one or more active therapeutic ingredients along with other substance included during manufacturing process.

Finished Product

A medicinal product which has completed all stages of manufacture including packaging.

Strength

The concentration of the drug substance (e.g., weight/weight, weight/volume or unit dose/volume basis) and the potency i.e. the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed, e.g., in terms of units by reference to a standard).

Stability

Degree of resistance to chemical and physical changes, the efficacy of the preparation must remain constant or change only within the limit specified by official compendia.

Expiration Date

The date placed on the immediate container label of a drug product that designates the date through which the product is expected to remain within specifications. Kinetically it is the time required for 10 % of the material to disappear.

Storage Procedure and Instructions

Drugs must be stored under conditions which Minimise deterioration, contamination or damage. They must be stored under conditions compatible with their recommended storage requirements of temperature and humidity and where necessary to comply with legal requirements, under secured or segregated conditions.

Appropriate storage conditions are:

Temperature or humidity controlled environment must be equipped with suitable indicators, recorders and/or failure warning devices which must be checked at appropriate intervals and the results are coded. Recording thermometers should be used. Temperature in uncontrolled storage products should also be monitored.

Temperature should be measured at different levels in the warehouse and if necessary, storage of sensitive drugs should be restricted to locations in the warehouse where these will be protected from extreme conditions. Temperatures of the refrigerators, deep freezers, and Relative Humidity in humidity control area as well as general areas of storage at room temperature should be recorded on a daily basis.

Storage conditions not related to temperature are indicated in following terms:

Drug storage should be regularly checked for cleanliness and good order and for misplaced/deteriorated/out dated stock. All stocks should be checked regularly for obsolescence and degradation. Drugs with expired shelf life should be destroyed unless an extension of shelf life is granted following the satis- factory results or re-analysis. All due precautions should be observed to preclude issues of outdated Drugs.

Some categories of supplies require special storage condi- tions which include vaccines, narcotics, and combustibles e.g., vaccines require both refrigerator and freezers.

Narcotics and other controlled substances should be kept in secure locking rooms with only one entrance. The keys should be kept in a secure place, preferably a safe. Only the warehouse director and one another person should have access to them.

Inspection for Deterioration

Pharmacists should be aware that deterioration of drug product may happen even before their expiration. This may occur perhaps due to improper storage or the fact that the product may require critical storage conditions not stated on the label. Hence, inspection should include frequent product examination to detect signs of product deterioration which differ according to dosage form. Some examples, where deterioration may be physically detected are given here. The Pharmacists in the Stores should prepare an exhaustive list of following deterioration/spoilage indicators and keep them.

Liquid Dosage Forms

Slight gradual discolouration, Swirly precipitation, Whickering: pin hole at ampoule tip that leaks solution which precipitate or crystalline solid matter, clouding, fading of colour, Cake sedimentation (suspension), Creaming and cracking (emulsion), Discolouration.

Semisolid Dosage Forms

Ointments creams, gels and suppositories -Change in consist- ency and feel to touch, Phase separation, Discolouration, Surface crystal growth

Solid Dosage Forms

Surface chipping or pitting (plain tablets), Deformation (capsules), Increased hardness, Discolouration, Colour fading (coloured tablets), Chipping of coat (coated tablets).
Most vitamins, hormones enzymes are highly sensitive to oxidation and photo decomposition.
The integrity of packaging of dosage form is one of the important tasks of inspection for pharmacist as these protect the drug in a tailored fashion.
After each inspection, products showing any signs of instability should be subjected to sample analysis to ensure quality.

Drug Products Requiring Special Storage

Conditions

Aerosols

Aerosols should be stored in a clean separate area away from heat and sunlight because the container contents are under pressure, filled containers must be checked for weight loss over the expiration dating period, for contents under pressure. The label should display “Do not expose to heat or store at a temperature above 400C, keep out of reach of children”.

Creams

Creams can be destroyed under extreme temperature fluctuations hence, these should be stored at temperature above 100C and not exceeding 300C. If the creams are opened and diluted they should not be kept for more than 14 days to avoid microbial contamination.

Ophthalmic Solutions and Drops

They should be stored according to the conditions specified on the label. After opening they should not be used for more than one month at home and not more than 15 days in hospitals.

Capsules

Extremes of humidity and temperature should be avoided. High humidity (> 60% RH) at 210C to 240C produce more lasting effects. Capsules become softer, tackier and blotted. If temperature is increased the capsule shells may melt and fuse together. High temperature (>400C) in dry place may cause cracking of capsule shell therefore capsules should be stored in air-conditioned area in which the humidity does not exceed 45% RH at 21 to 240C.

Suppositories

Suppositories should be protected from heat and preferably stored in the refrigerator. Polyethylene glycol suppositories and suppositories enclosed in solid shell are less prone to distortion at temperature slightly above body temperature. Glycerinated gelatin suppositories should be protected from heat, moisture and dry air by packaging in well-sealed containers and storing in a cold place.

Vaccines

Liquid vaccines are to be stored between 20 to 80C and should not be frozen. All lyophilized vaccines should be stored between 20 to 80C and for long term storage can be kept at or below -200C or otherwise as specified in the individual monographs. Oral polio should be stored in a freezer -20 to -180C.

Communicating the Prescription to the

Patient

It is important that the drugs reach the patient in good and potent conditions and the patient should know and understand fully how to keep them till they are consumed. It is equally important that the patient should know the way each medicine is used. This will improve compliance and health outcome desired by the physician.

Communicating how and where to store the drugs to the Patient

The following table may be used to guide and provide information on the way to store the drugs when they are dispensed to the patients. This is based on the recommended storage conditions as given on the labels of the drug products and Indian Pharmacopoeial notes in the General Chapters.

On the label

Meaning

Tell the Patient/ Representative of the Patient

Do not storeover 80C

To be stored in refrigerator (from +20C to +80C)

Keep in the General Compartment of the refrigerator and do not keep in the place where you make Ice.

Do not store over 300C

To be stored at roo temperature (from +20C to +300C)

m Keep in any part of the house, except in Bath room/ Kitchen. Do not keep near or in the window area.

Do not freeze

To be kept in refrigerator (from +20C to +80C but not in the freezer chamber)

Keep in the General Compartment of the refrigerator and do not keep in the place where you make Ice.

Protect from moisture

To be stored in normal humidity at room temperature (RH less than 60%); to be provided by the manufacturer in a moisture-resistan container

The manufacturer would have provided such products in a moisture-resistant container/or packages. Keep in any part of the house, except in Bath room/Kitchen. Donot keep near or in the window area.

Protect from moisture

To be stored in a light-resistant cupboard/drawer; to be provided by the manufacturer in a light-resistant container.

The manufacturer would have provided such drug products in a light-resistant container/package. Keep in a cupboard/drawer or in a box with lid closed, in any part of the house, except in Bath room/Kitchen or near or in the window area.

Transit period care and Use of Cool Packs

It is equally important to ensure that patients who carry drugs requiring special storage conditions like anti-cancer drugs, several types of insulins, vaccines, sera, toxoids, would need to carry them in cold conditions till they reach the place where they will keep for some time before usage or to another hospital/nursing home till it is administered. In such cases during transit they need to be packed in “Thermo cool boxes with lid”, (#) with the drug product packs kept surrounded by adequate number of “Cool Packs”.(#) “Cool Packs are available which come ready filled with such special liquid in sealed bags or plastic packs, which on keeping overnight in freezer compartment of a refrigerator becomes solid ice. Such packs help in keeping the drug products in the box retain temperatures below 80C for as much as 8 to 10 h, which is generally adequate for transit protection. In case such cool packs are not available, it is recommended to use normal “Hot cases” (#) that people use to carry food, but stuffing the inside of the hot case boxes with sufficient ice cubes surrounding the drug packs kept inside, and the hot case suitably closed and sealed with sealing tapes. Cool packs can also be made by packing sufficient ice cubes into suitable sized self sealing polybags. (#) Several Pharmacists are known to innovate this way and they do serve for short transit times of up to one to two h.