STORAGE OF MEDICINAL

PRODUCTS(GOOD
STORAGE PRACTICE)
THIRD YEAR
HOSPITAL PHARMACY
COLLEGE OF PHARMACY ,
ALASMARYA UNIVERSITY ZLITAN
LIBYA
DRUG STORAGE

The expiry periods of pharmaceutical products have meaning only if the products are stored
under proper conditions; otherwise, products are likely to lose their potency before the actual
date of expiry.

Proper storage of medication is always an important consideration during periods of extreme

heat or cold.

Drugs can undergo physical, chemical & microbial changes on storage.

Recommended storage conditions:

 Store below -5oC (freeze)

 Store between (2 to 8)oC (refrigerate, do not freeze)
 Store below 25oC (air conditioning)
 Store below 30oC (room temperature)

Drug Storage Room Standards:

 A lockable room
 Adequate lighting
 A temperature of below 25oC, with air conditioning units that operate 24 hrs per day &
are connected to an emergency power supply.
 A vaccine refrigerator for storage of vaccines & anti-venom.
 A nominated refrigerator for cold storage of pharmaceutical products that requires
refrigeration.
 Adequate shelving for appropriate storage of the different categories of drugs.

All drugs are grouped in the following categories:

 Refrigerated ( Heat sensitive products)

 Oral ( solid & liquid )
 Injectable
 Topical
 Infusion
 Inhalation

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  Non Drug

In the Central pharmacy or Pharmacy main store, all drugs are displayed or kept in different
ways regarding the most easiest way to dispense.

Like-

 Alphabetically
 Therapeutic class wise
 Brand wise and so on.

STORAGE AND STOCK MANAGEMENT

The expiry periods of pharmaceutical products have meaning only if the products are stored
under proper conditions; otherwise, products are likely to lose their potency before the actual
date of expiry.

Good storage practice requirements

Every community pharmacy, however large or small, needs to store and manage its medicine
stocks effectively.

There must be systems to ensure

• Secure storage.

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• Clean and correct environmental conditions during storage.

• Accurate and effective record keeping.

• Effective stock rotation and expiry monitoring.

• Effective fire and theft prevention.

• Effective rodent/ pest control

Sample Stock record card

STORAGE

The need for proper storage

• The storage of medicines and other products is an important requirement of Good Pharmacy
Practice.

Appropriate storage of medicines is essential –

 To ensure that the potency is maintained.

 To prevent deterioration/spoilage/degradation.
 To ensure/maintain physical integrity.
 To ascertain that the quality and safety is maintained throughout their shelf life.

Storage requirements need to be considered on 2 aspects:

A) Integrity of medicines: medicines should be stored in such a way so as to maintain their

integrity and potency.

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• Maintain the right temperature required.

• Protect from excessive humidity.

• Keep medicines away from direct sunlight.

• Protect from pests and rodents.

b) Physical location

• Should be easy to locate.

• Accessible.

• Orderly/systematically placed

Storage according to temperatures is a must, no matter which pattern of storage is followed.

Also, within a particular storage area, segregated storage may be maintained. In a refrigerator,
for example, medicines may be stored in trays, racks and the freezer, according to the
temperature required.

Whatever pattern of storage is selected, all the personnel should ensure that

• The stocks are stored in an orderly manner.

• The medicines are kept back in the same place from where they were removed.

• All medicines are arranged neatly once in a while.

• The personnel should be careful while storing the medicines.

• They should not throw the medicines haphazardly.

Correct way wrong way

Direct storage of cartons on the floor should be avoided because, besides being an unhealthy
practice, the contents may also be damaged by moisture

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  Store medicines in shelves with glass shutters for visibility.
 Closed shelves further prevent dust from going in, especially where most pharmacies are
located along busy roads.
 Some medicines have to be refrigerated or stored in a cool or cold place. Having a
refrigerator or two (as per the need of the pharmacy) is essential to store such medicines
at temperatures mentioned on the label

Refrigeration

• All cold chain equipment should meet required standards.

• Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer
temperatures each time the door is opened. Vaccines should always be stored on the middle
shelves of the refrigerator.

• Consumable products like juices, energy drinks, etc., should not be stored along with medicines
in refrigerators. If required, they may be kept in a separate refrigerator.

The Cold Chain

Vaccines are sensitive to heat and freezing and must be kept at the correct temperature from the
time they are manufactured until they are used. The system used for keeping and distributing
vaccines in good condition is called the cold chain. The cold chain consists of a series of storage
and transport links, all designed to keep vaccines within an acceptable range until it reaches the
user.

Logistics and logistics management include vaccines, equipment and supplies that are needed to
support the cold chain

Maintenance of the cold chain requires vaccines and diluents to be:

• collected from the manufacturer or an airport as soon as they are available;

• transported between 2ºC and 8ºC from the airport and from one store to another;

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• stored at the correct temperature in primary/central and intermediate vaccine stores and in
health facilities;

• transported between 2ºC and 8ºC to outreach sites and during mobile sessions;

• kept between 2ºC and 8ºC range during immunization sessions; and

• kept between 2ºC and 8ºC during return to health facilities from outreach sites.

The figure illustrates the cold chain.

After vaccines reach the health facility you must:

• Keep them between 2ºC and 8ºC in your health facility refrigerator.

• Carry them to the immunization session in a vaccine carrier with frozen ice packs or ice.

• Keep the vaccines cool using a foam pad in the vaccine carrier while you immunize the
children.

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Vaccine Vial Monitor (VVM)

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VVMs are used in certain areas of the world, including Asia and Africa. They change color at
temperatures specific to the vaccine. For example, a VVM will change color for OPV, the most
heat sensitive of vaccines, if a vial is kept at 37 degrees C for 2 days. However, for TT, will
change if kept for 30 days at 37oC

Temperature/climatic conditions:

• An air-conditioned environment where temperature can be controlled is recommended for

pharmacies. Air conditioning offers the option of setting the temperature as per requirements.

• It is ideal to have an air conditioner to maintain the temperature below 25oC, as most medicines
require storage below this temperature. Secondly, this temperature is pleasing to both the staff
and the visiting customers, too.

In the absence of an air conditioner, circulating fans may be used.

Humidity or moisture control

• Moisture or humidity can affect the stability of medicines such as tablets, capsules, powders.

• Gelatin capsules become soft, and swell on absorption of moisture

• The presence of moisture may encourage the growth of microbes. It is therefore essential to
control humidity

Calibrated thermometers and manometers can be used to detect temperature and humidity in the
pharmacy.

• Temperature charts should be available for ready reference.

Drug storage Room Stock Control

Stock Inventory

1. Annual inventory

2. Bi- annual inventory

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3. Monthly inventory

4. Weekly inventory

5. Real time inventory

To uphold quality standards in drug storage room:

a) Rotate stock so that the stock closest to expiry date is kept in front.
b) Maintain FEFO / FIFO / LIFO procedure.
c) Make sure that there are no expired drugs on the shelves.
 First-expiry/first-out procedure(FEFO)
 First-in/first-out procedure (FIFO)
 Last-in/first-out procedure (LIFO)

Drug stability

It means the ability of the pharmaceutical dosage form to maintain the physical, chemical,
therapeutic & microbial properties during the time of storage & usage by the patient.

Expiry Dates

Expiry date means that drug cannot be used after this date due to the chance of chemical
degradation, harmful to patient or low potency.

 If the expiry date is expressed as month/year only (e.g., 3/2013), this shall be interpreted
to mean that the drug may be safely used through the last day of that month, i.e.,
3/31/2013.
 If the expiration date is expressed as month/day/year (e.g., 15/3/2013), this shall be
interpreted to mean that the drug may be safely used through that day only.

Chemical stability of the active ingredient

As the rate of decomposition usually doubles for every 100C rise in temperature, it is important
to comply with the storage conditions specified on the container

Once opened, the shelf-life of some products, e.g. eye drops, will be determined not by
decomposition of the active drug but by the risk of microbial contamination.

Stability after opening drug container The stability of products is variable. A product which is
stable in its container may become unstable once the container is opened.

The expiry date will be shorter in case of-

 Eye drops: can be used for one month after opening the droppers.

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  Antibiotic syrups & suspensions: generally can be used for one week by storage in room
temperature & for two weeks by storage in refrigerator
 Ampoules: must be used immediately but the vials (multidose) are stable for 24 h in the
presence of preservatives.
 Nebulizer solution: can be used for one month after opening.
 Insulin: once punctured, it must be used within 28 days.
 Syrup/Suspension (except antibiotics): can be used for one month after opening.
 Tablets & capsules: remain stable in the package but after removal expiry date will be
changed

Factors affecting drug stability:

Temperature: high temperature accelerates oxidation, reduction & hydrolysis reaction which
leads to drug degradation.

pH: acidic & alkaline pH influence the rate of decomposition of most drugs. Many drugs are
stable between pH 4 - 8.

Moisture: water catalyses chemical reactions as oxidation, hydrolysis & reduction reaction.
Water promotes microbial growth.

Light: affects drug stability through its energy or thermal effect which leads to oxidation
Oxygen: exposure of drug formulations to oxygen affects their stability.

Drug incompatibility: reactions between components of pharmaceutical dosage forms itself or

between these components & cover of the container

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