Manufacturers must specify the required storage temperature of their products. This may be generalized to room temperature, cool temperature, refrigerated, or frozen. The Table3 provides a guide for temperature management.
The CDC recommends best practices for storing refrigerated medications, including checking and recording the minimum and maximum temperature daily or, if the thermometer does not record minimum and maximum temperatures, checking and recording the temperature twice daily. The CDC also recommends that staff note their initials when documenting temperatures.
Finally, part of these best practices includes acting upon cases of temperature excursions.4 In case of temperature excursions, call the manufacturer of the medication and tell them the length of time the drug has been out of range temperature. They will advise as to how long the product can stay out of range temperature and whether the product can still be used.4
Security
Pharmacy security not only plays a role in inventory safety but is also important to patient safety. Pharmacy security deters theft and robbery while ensuring medications are protected from tampering. By implementing stringent security protocols, including the use of high-quality safes, pharmacies can provide untampered medications to their patients, effectively preventing misuse or abuse.
Pharmacies are required to store their Schedule II medications in a safe. The safe must be Drug Enforcement Administration–approved and locked whenever a medication is not being retrieved or stored. Some safes are time delayed, opening a few minutes after a code is entered. The wait time can feel like an eternity, but this is ultimately a safer way to store Schedule II products.
Medication Rotation
Pharmacies should implement a first-in, first-out inventory management system so that the oldest stock bottle is used first and new stock bottles are placed behind the existing stock bottles. This helps ensure medication is used prior to the expiration date, thereby preventing waste.
Segregation
Drug expiration dates reflect the period during which the product is known to remain stable, which means it retains its strength, quality, and purity when it is stored according to its labeled storage conditions.5 It is important to be aware of the potential harms that may occur from taking an expired medicine or one that may have degraded because it was not stored according to the labeled conditions. If a drug has degraded, it might not provide the patient with the intended benefit because it has a lower strength than intended. In addition, when a drug degrades, it may yield toxic compounds that could cause patients to experience unintended adverse effects. Patients with serious and life-threatening diseases may be particularly vulnerable to potential risks from drugs that have not been stored properly.5
Additionally, pharmacy staff should monitor inventory for recalls and act appropriately when a medication is recalled. Recalled medications are those that are withdrawn or removed from distribution or use for which deficiencies are reported in quality, safety, or efficacy. For these reasons, expired and recalled drugs must be isolated and segregated from pharmacy shelves in a timely manner. These medications must be quarantined in an area that ensures they will not be used until they can be appropriately disposed of.
Although managing storage can be laborious and time-consuming, it is a crucial part of pharmacy management and, ultimately, patient safety. Both pharmacists and pharmacy technicians can play an active role in taking the steps necessary to ensure optimal storage of medications.
References
1. Guideline on good storage practices for pharmaceuticals (GSP). National Medicines Regulatory Authority. August 27, 2021. Accessed April 3, 2024. https://nmra.gov.lk/images/2021/Pharmacy/GL-015-Good_Storage_practices_for_pharmaceuticals_Guideline_final-nmra-finalized_-ee_1_2_1.pdf
2. Safe storage of medications. US Department of Health and Human Services Indian Health Service. Accessed April 3, 2024. https://www.ihs.gov/painmanagement/safestorage/
3. Proper medicine storage in pharmacies is important, and temperature monitoring is the key. TempGenius. Accessed April 3, 2024. https://tempgenius.com/proper-medicine-storage-inpharmacies-is-important-and-temperature-monitoring-is-the-key
4. Temperature monitoring best practices for refrigerated vaccines–Fahrenheit (F). CDC. Updated February 2018. Accessed April 3, 2024. https://www.cdc.gov/vaccines/hcp/admin/storage/downloads/temp-fridge.pdf
5. Expiration dates - questions and answers. FDA. Updated October 24, 2022. Accessed April 3, 2024. https://www.fda.gov/drugs/pharmaceutical-quality-resources/expiration-dates-questions-andanswers