There’s a chain of responsibility that comes into play when proper storage of pharmaceutical products is on the line. Product viability ensures the intended effectiveness of the product, which then maximizes the health and well-being of the recipient or the consumer. The integrity of many products can be affected if left outside room temperature, while others can risk consumer safety if not properly—and consistently—refrigerated.
The product viability of pharmaceuticals starts at the source. All suppliers have an obligation to ensure proper storage conditions at their sites and to ensure that shipping processes maintain product integrity throughout product receipt by healthcare professionals. Those healthcare professionals monitor proper drug storage conditions until the products are dispensed and/or administered to patients. With so many crucial steps between creation and administration of pharmaceutical products, true safety, and integrity can only be accomplished through proper temperature monitoring. The proliferation of products that require cold chain management makes it incumbent upon the supplier to maintain the cold chain process at their sites and through delivery, and for the health care professional to properly receive and constantly monitor temperature integrity prior to administration or delivery to the patient. With so many crucial steps between creation and administration of pharmaceutical products, true safety and integrity can only be accomplished through proper temperature monitoring. The proliferation of products that require cold chain management makes it incumbent upon the supplier to maintain the cold chain process at their sites and through delivery, and for the health care professional to properly receive and constantly monitor temperature integrity prior to administration or delivery to the patient.
All pharmaceutical products have temperature storage requirements that can be found on their product packaging. Products with no visible instructions are allowed to be stored at room temperature, the understood requirement here being that anything warmer than room temperature could impact potency. All pharmaceutical products also have a listed expiration date. If products are stored outside of their temperature range, their viability can be affected and, even if still viable, may shorten the expiration date of the product, often substantially.
Many pharmaceutical products have a “controlled room temperature” storage requirement. The United States Pharmacopeia defines that “controlled room temperature” indicates a temperature maintained thermostatically that encompasses the usual and customary working environment of 20°C to 25°C (68°F to 77°F), that results in a mean kinetic temperature calculated to be not more than 25°C, and that allows for excursions between 15°C to 30°C (59°F to 86°F) that are experienced in pharmacies, hospitals, and warehouses.
Imagine if the air conditioning wasn’t functional for several days in the heat of summer. Could we be certain that the excursion didn’t not go over 86°F for these products? If it did, for how long and at what range of temperatures?
Many common medications can break down in temperature conditions beyond the excursion range. Here are some pretty common examples for modern consumers:
Extreme cold can be just as detrimental for other life-saving drugs. If the heat fails in the dead of winter, can we be certain that an excursion hasn’t occurred at the lower end of the permissible range? For example:
We’ve seen a proliferation of pharmaceuticals that have cold storage requirements, meaning they must be refrigerated or frozen and then maintained at the proper temperature range. For one, the varicella and zoster vaccines currently available require that they be stored in a freezer. Refrigeration-specific products that immediately
Pharmaceutical Temperature Monitoring: Adapting Your Business for Success 5 come to mind are insulins and vaccines, but they’re not alone. Other drugs that must be stored in the refrigerator, according to the Therapeutic Research Center, include:
Refrigerator temperature is defined as between 2°C to 8°C (36°F to 46°F). This will help ensure an average refrigerator temperature of 5°C (40°F). Freezer temperature is defined as between -25°C to -15°C (-13°F to 14°F). With such small ranges to work with, these products understandably pose additional challenges to proper storage. Many refrigerated and frozen pharmaceuticals can become unusable if excursions occur, or may have markedly reduced expiration dates, if usable.
For both ambient controlled room temperature and for the cold storage of pharmaceuticals, it’s vital to know that products are being maintained at the proper temperatures, especially when so many products have temperature-sensitive stability. There are myriad factors to consider in the cold storage area. Understanding product viability when improperly stored for a period of time is one issue, but ask yourself:
Born from research and guidance by manufacturers, the CDC, and other government agencies throughout the years, temperature storage standards have become more defined. If you store products with more sensitivity to temperature excursions in your refrigerator and freezer along with less sensitive products, then your standards have to be set to those products with the greatest amount of sensitivity to excursions. Ambient temperature must also be carefully monitored so that room temperature requirements are met.
Vaccines are one class of temperature-sensitive products where there’s been a great deal of guidance on storage and temperature monitoring. The Center for Disease Control (CDC) has redefined and refined the requirements for storing vaccines several times in recent years, and proper storage of vaccines based on CDC guidelines is a necessity to participate in the federal Vaccine for Children (VFC) program. Increasingly, many departments of health and state professional boards are looking to make the CDC standards for proper vaccine storage and temperature monitoring of refrigerated and frozen vaccines their standard for proper storage and monitoring of all cold chain products.
The CDC lists three basic tenets for proper temperature monitoring and storage:
Refrigerated vaccines should be stored at temperatures between 2°C and 8°C (36°F and 46°F). The thermostat should be set at mid-range to achieve a temperature of about 5°C (40°F), which will decrease the likelihood of temperature excursions. Vaccines stored in the freezer should maintain temperatures between -50°C and -15°C (-58°F and 5°F). The thermostat should be at the factory-set or mid-point temperature setting to assure appropriate frozen storage temperatures.
The CDC has always recommended that each unit storing vaccines must:
The CDC has also refined the types of systems and solutions that should be utilized to
be certain these recommendations are followed.
Several years ago, maintaining manual temperature logs with manual thermometers felt adequate to meet temperature monitoring standards. This practice, however, allowed for potential temperature excursions that went unnoticed. Even when realized, these deviations could not provide the range of temperatures during the excursion, nor the duration.
Today’s solutions are much more sophisticated, helping to ensure the temperature integrity of the product when dispensed or administered to the patient. For accurate temperature monitoring of refrigerated and frozen products, the system utilized should meet the following parameters.
1 The system should have a thermometer that provides continuous temperature monitoring with an active digital display. This provides the constant monitoring of temperature which assists in determining the stability of the refrigerator or freezer unit involved, and if it maintains acceptable temperature ranges throughout its cycle.
2 The thermometer should be certified and calibrated. In plain terms, this ensures the accuracy of the thermometer. The CDC recommends using only a calibrated thermometer with a Certificate of Traceability and Calibration Testing (also known as a Report of Calibration). This certificate, commonly known as a NIST certificate, provides the thermometer’s level of accuracy compared to a recognized standard, and comes with the thermometer upon purchase. The CDC recommends that a current and valid Certificate of Calibration Testing (Report of Calibration) should include:
Many regulatory rules in a number of states point to the fact that they will only accept certificate validity for no more than two years prior to requiring recalibration or replacement.
3 Use of a digital data logger (DDL) is a must. Digital data loggers are electronic devices that may be programmed to record temperatures at intervals throughout the day. Currently the CDC recommends that the digital data logger be set to measure the temperature every 15 minutes.
4 The CDC recommends DDLs with the following characteristics:
A. Detachable probe in a thermal buffered material (e.g. glycol, glass beads, sand, Teflon) for all refrigerated and frozen products.
D. Current, minimum, and maximum temperature indicator.
E. Recommended uncertainty of ± 0.5°C (± 1°F).
F. Logging interval (or reading rate) that can be programmed by the user.
well as allow the provider and regulator to view issues and document steps taken to ensure product integrity.
6 In a provider practice with multiple locations or a pharmacy chain, it’s also advisable that the system report excursion issues that haven’t been documented and addressed to team leaders for a location.
7 To meet the needs of the technology available for any provider, the ideal system will have the capability to be utilized via an Ethernet system, via Wi-Fi, or through a cellular system.
The current nature of pharmaceutical products is such that proper storage can directly link to the efficacy of the product, and to patient outcomes. We’ll continue to see changes in regulatory rules, laws, and inspections that focus on the storage of pharmaceutical products in the effort to always be improving upon safe practices and patient wellbeing.
To ensure the health, well-being, and safety of patients, it will be vital that temperature temperature monitoring with data loggers is in place to enable certainty of product viability throughout the product chain of delivery or administration to the patient. It’s integral that all staff at all locations be trained in the proper management and storage of all pharmaceutical products.
The most efficacious, practical, and thorough method to ensure proper temperature monitoring is to insist that your system meets the solutions listed above for both refrigerated and frozen products, as well as for ambient temperature monitoring of products that require controlled room temperature storage. Beyond ensuring product efficacy and maximizing therapeutic outcomes for patients, this system can also be a cost-saving tool. When excursions are addressed quickly and efficiently, you can minimize both product loss and potential danger to patients, both of which can cost your business money.