The Importance of Proper Medicine Storage
There are several factors that pharmaceutical companies examine when developing medications, including dosage, mode of administration, side effects, safety, effects of an overdose, and efficacy. Additionally, they spend a significant amount of time understanding how these medications are affected by climatic conditions to determine how they should be stored. As such, different medications come with varying requirements of storage or recommendations from manufacturers. Some have to be refrigerated, others frozen, and some are stable at room temperature. In this write-up, we look at why storing medicine properly is essential and how temperature monitoring is vital.
Regardless of its size or capacity, every pharmacy must store medicine effectively. If not stored appropriately, medications can be exposed to varying environmental changes, making them lose their efficacy and potency. If such drugs are ingested, they can be harmful to consumers’ health.
Why proper Storage is Essential
Ensures that medication maintain their potency
Makes sure the integrity of drugs is maintained
Prevents medication from spoiling/deteriorating
Asserts that the quality and safety of medications is guaranteed throughout their shelf life.
Essentially, the storage of medications depends on various climatic conditions such as temperature, humidity, and sunlight. According to the code of ethics, pharmacists should ensure that their facilities have the right equipment to store medicines with different temperatures, moisture, and sunlight requirements.
Medication Storing Temperatures
As mentioned earlier, manufacturers always specify whether the medications from their companies should be stored at room temperature, cool temperature, refrigerators, or freezers. Check out the table below for the temperature guide:
Medication Package Temperature Degrees Celsius
Room Temperature 15 to 25
Cool Temperature 8 to 15
Refrigeration 2 to 8
Freezing -10 to -25
Luckily, room temperature pharmaceutical storage is subject to regulation by the US Food and Drug Administration (FDA). It offers guidelines to ensure that all facilities that store, warehouse, handle, market or display medications maintain them in the required conditions.
In Section 2111.166, the 21CFR205.50 FDA guidelines state that:
According to the manufacturer’s requirements, all drugs should be stored at their appropriate temperature ranges and in the rightful conditions.
If the manufacturer has not provided any storage requirements, the medication should be stored in a controlled room with adequate ventilation, lighting, temperature, space, humidity, and security.
Pharmacies should record the temperature and humidity in storage rooms using manual, electrochemical, or electronic monitoring equipment and devices, and logs should be used to record the environmental changes in the facilities.
Best Practices for Medication Storage
Although the placement of temperature and humidity monitors in various parts of each storage is essential, proper temperature is critical in those rooms and the sales floor. A sudden change, such as power outage or heatwave, can alter the room temperature, causing medications to physically change or lose its potency. Therefore, you need to put in place a few measures to reduce the potential damage of medications:
*Ensure Proper Ventilation and Lighting
*Make sure that your facility has appropriate air circulation and lighting. Open the air vents and windows to allow the free flow of air. However, ensure that they are fitted with screens to keep out birds and insects.
*Maintain Airtight Packaging
Pharmacists should ensure that all drugs are securely packaged. Ensure that all lids are closed and don’t open containers that are not in use.
Depending on the climatic conditions in your area, you can install an air conditioner to facilitate an adequate supply of fresh air into your storage facilities.
*Keep Medication Away from the Walls and Floors
All pharmacy equipment and medication shelves should be at least 4 inches from the wall. Cartons or packages with medicines should be placed on pallets and not on the floor.
*Medicine Storage and Temperature Monitoring Equipment
*Every pharmacy should have properly maintained and cleaned storage and monitoring devices. This ensures that they don’t give out compromised medications, thereby protecting themselves against medicine replacement and litigation costs and losing the confidence of patients.
*Refrigerators and Freezers
While it’s not unlikely to find pharmacies that use domestic refrigerators, these types of storage equipment are not ideal for storing all medication. For starters, they have an uneven distribution of temperature and boast a normal operating range of 0 to 10 degrees Celsius. Additionally, when their doors are opened, they can lead to temperature fluctuations, making internal temperature monitoring a challenging task.
According to the CDC, pharmacies should have only this type of Refrigerators and Freezers:
Pharmaceutical-grade or purpose-built refrigerators or freezers. These are designed to store cold chain products, even the high-risk ones such as vaccines. These boast an operating system that allows for uniform temperature profile and swift temperature pulled down when the doors are opened.
Your units should be large enough to store extensive inventories without crowding, especially in the busiest months of the year. The units should be positioned in an area with good circulation away from direct sunlight. They should be placed at least 4 inches off the wall and at least one to two inches above the ground.
Another critical element during medicine storage is temperature monitoring. The CDC recommends that every medication holding facility should have temperature monitoring devices to detect any temperature fluctuations. The use of continuous monitoring and recording devices that are known as “digital data loggers” is what the CDC recommends.
Storing medications in the right temperature range is not a mare recommendation, but rather a requirement that guarantees drugs’ optimum quality throughout their shelf life. Failure to store these products in the specified temperature ranges can impede their efficacy, quality, and effectiveness.
Continuous monitoring and recording help health professionals detect even the slightest deviation in storage units’ and the facility’s temperature. This ensures that any leak or error that is causing a surge or reduction in temperature is corrected in due time to prevent any spoilage or damage. Even if it’s for a brief period, a small change in humidity and temperature can lead to an irreversible loss of efficacy, especially when it comes to biotechnology-derived products, vaccines, and insulin.
The CDC advises pharmacies to use digital data loggers that have the following features:
Can display the current, minimum, and maximum temperature.
Have some kind of alarm that sends a signal when there are out-of-range temperatures.
Can be programmed to measure and record temperatures at least every thirty minutes.
Pharmacists must stabilize temperatures in storage units and rooms before they use them. This can be done for two to three days before storage. The minimum and maximum temperatures are recorded in every workday. And once you get the same temperature ranges for two consecutive days, it means that a stable temperature range has been attained.
Proper Medicine Storage in Pharmacies is Important, and Temperature Monitoring is the Key