Drug Storage
Introduction
Once, I received a query from a ward nurse:
- If a product label mentioned that "Do not store over 25°C", is it fine for us to keep the medication in fridge?
- What does a cool place on the product label mean?
Tips for Patients
Storing medication properly is important to ensure it works as intended to prevent poisoning accidents.
- Read the label to know the recommended storage temperature range.
- Always keep medicine in its original container. Keep out of reach and sight of children.
- Store medicines a cool, dry place.
- Heat, air, light and moisture may damage medicine.
- Do not store medications at
- Car for long hours - due to exposure to high heat
- Bathroom cabinet - due to the and moisture and shower
- Near stove or microwave at kitchen - due to heat and moisture
- Fridge, unless instructed in product leaflet.
- Once the medication bottle is opened, the cotton and desiccant must be discarded as they pull moisture into the bottle.
Importantly, do not take medicine that has changed colour, texture, or smell, even if it has not expired.
.jpg "Storing Medications")
.jpg "Storing Medications")
Storage Temperature
According to Guidelines on Good Distribution Practice 2013, where temperature is not stated (in terms or range) on the labels of materials and/or products and/or cosmetics, the following definitions should be followed:
- Freezer
The temperature is thermostatically controlled between -20°C and -10°C - Refrigerator
The temperature is thermostatically controlled between 2°C and 8°C - Cold place
The temperature does not exceed 8°C - Cool place
The temperature is between 8°C and 15°C - Room temperature
The temperature is between 15°C and 30°C - Warm
The temperature is between 30°C and 40°C - Excessive heat
The temperature is above 40°C - Do not store over 30°C
The temperature is between 2°C and 30°C - Do not store over 25°C
The temperature is between 2°C and 25°C - Do not store over 15°C
The temperature is between 2°C and 15°C - Do not store over 8°C
The temperature is between 2°C and 8°C - Do not store below 8°C
The temperature is between 8°C and 25°C
NOTE: Click to know more on examples of cold chain items.
Requirements of Drug Storage Area At Pharmacy
Premises should have sufficient security to prevent unauthorised access and misappropriation of the products/cosmetics. Visitors should be accompanied.
Premises should protect products/cosmetics from contamination and deterioration by light, moisture and temperature.
- Storage areas should also be provided with adequate lighting and ventilation to enable all operations to be carried out accurately and safely.
There should be adequate storage areas to allow orderly and segregated storage of various categories of products/cosmetics: those in quarantine and released, rejected, returned and recalled.
- These designated storage areas should be clearly marked and restricted to authorised personnel.
- Products/cosmetics should be segregated from non-medicinal products (medical devices, etc.).
Appropriate and suitable storage conditions should be provided for hazardous, sensitive and dangerous products such as combustible liquids and solids, pressurised gases, highly toxic substances and radioactive materials/products subject to local legislations and appropriate security and safety measures
Rest, wash and refreshment rooms for personnel should be adequately separated from the storage area.
- The presence of food, drink, smoking materials or medicinal products for personal use should be prohibited in the storage area.
Products should be stored off the floor and suitably spaced to permit cleaning and inspection.
- Pallet should be well maintained and kept in a good state of cleanliness.
The storage area should be designed and equipped to prevent the entry of insects, rodents and other pests/animals.
- There should also be a written programme for pest control and appropriate record should be kept.
The storage area should be equipped with recorders or devices that will continuously monitor the storage condition and record the relevant readings such as maximum and minimum temperature and humidity of the day.
- Appropriate actions on the premises, equipment and/or products/cosmetics should be taken when the storage conditions are not met and these actions should be recorded.
The records and devices for monitoring the storage conditions should be located in areas that are most likely to show fluctuations and/or the hottest and coldest locations where appropriate.
- The measuring equipment should be calibrated for the requiring operating range at regular intervals. Such calibration records should be maintained.
The CDC recommends a calibrated thermometer or a digital data logger be connected to a buffered temperature probe in the refrigerator and freezer. An example of a buffered probe is one immersed in a vial of liquid (e.g. glycol). This prevents false readings due to the rapid changes in air temperature that occur when refrigerator doors are opened.
Read and document refrigerator and freezer temperatures at least twice each workday (in the morning and before the end of the workday).
Cold room, freezer room, refrigerator and freezer must be fitted with an alarm system to alert personnel if any occurrence of temperature beyond specifications.
- Periodic testing programme on the alarm should be established to ensure the alarm system is functioning.
Household freezer units or dormitory-style refrigerators should not be used for medication storage.
- Household-style unit refrigerators and freezers are only acceptable if they have been independently tested and found to comply with the temperature control requirements of a recognized standard for pharmaceutical refrigerators or freezers.
Alternative power source should be established to ensure temperature remained and the temperature/humidity detector will continue functioning in the event of power failure.
- Periodic testing programme on alternative power systems should be established to ensure that it works.
- Alternative plan to provide alternative areas where storage temperature equivalent should be provided if no alternative power systems can be provided.
Cold Chain Breach
At work, when we repeatedly open and close the refrigerator door, the temperature inside fridge may fluctuate slightly above 8°C. Should we consider this as a cold chain breach?
- Australian Pharmaceutical Formulary and Handbook (APF) states that a cold chain breach refers to a situation in which a temperature sensitive product has been exposed to temperatures outside the specified range of the product - excluding deviations of up to +12°C for less than 15 minutes, such as from opening the refrigerator door during routine use or restocking.
If a cold chain breach occurs (possible reasons: power outages, compressor failures, natural disasters and etc.), you should isolate the product(s) in the refrigerator and contact the manufacturer for further advice. By experience, the manufacturer might ask for information about the following:
- The minimum and maximum temperature readings
- When the thermometer was reset
- When the accuracy of the thermometer was last checked (i.e. calibration)
- The estimated time the product was exposed to temperature outside the specified range for the products
- The batch number of the product(s) and quantity involved
After gathering all the information required, the manufacturer will then provide you an advice based on temperature excursion data that they have.
- Temperature excursion is a deviation from given instructions. It is defined in the WHO Model Guidance as "an excursion event in which a Time Temperature Sensitive Pharmaceutical Product (TTSPP) is exposed to temperature outside the range(s) prescribed for storage and/or transport.
Attached here is a 2007 article on "Room-temperature storage of medications labelled for refrigeration". I do find an interesting yet thoughtful statement in this practice report:
- According to the manufacturers surveyed, the medications included in the table may be returned to the refrigerator within the time period listed without affecting stability or expiration. This table may help to avoid unnecessary drug loss and expenditures due to improper storage temperatures.
Do you agree?
Comments
Post a Comment