Stories from the Edge: Maintaining Medication Temperature is Key to Patient Treatment

Did you know that, like the human body, certain medications can become less effective if they are exposed to extreme temperatures? It’s true, particularly when they get too hot or too cold. Medications that have been exposed to temperatures outside the range recommended by their manufacturers may not work as well as they should. That is why Preveon Specialty Pharmacy emphasizes controlling and monitoring the temperature of the highly sensitive biologics that it handles and asks patients to do the same.

Fevers Aren’t the Only “Temperature” Concern and Over-the-Counter Thermometers Aren’t the Only Way to Monitor Temperatures

Preveon may fill prescription medications, but it is not your typical pharmacy. It is a specialty pharmacy that focuses on high-cost, high-touch medication therapy for patients with complex disease states. Medications in the specialty pharmacy’s formulary range from oral to cutting edge injectable and biologic products. As such, Preveon takes an active and holistic role in managing patients’ treatment protocols in partnership with primary care teams.

In fact, as part of its unique Disease Therapy Management Program, Preveon clinical pharmacists serve as 24/7 advisors to patients receiving drugs or biologics, closely monitoring their compliance with treatment protocols as well as their bodies’ responses to each drug. They are highly invested in each patient’s success and want to ensure that nothing compromises the potential of a positive outcome, especially not a quality-compromised medication.

Preveon knows that the effectiveness of temperature-sensitive drugs and biologics is dependent on storage at the proper temperature throughout the cold chain, from storage at the pharmacy to handling during shipping. It is also dependent on how patients store their medications after receipt at home. For example, one study found that the majority of patients using biologic disease-modifying antirheumatic drugs (DMARDs) do not store their drugs within the recommended temperature range.

Measuring the temperature of the medication at any one point can confirm the current temperature, but how would you know if the medication was exposed to potentially damaging temperatures during picking, packing, shipping and unpacking? You wouldn’t – without advanced temperature monitoring tools. Thus, the reason why Preveon contacted Temptime Corporation, now a part of Zebra Technologies.

As clinical pharmacist, Phillip Hivale explains in the below video, Preveon wanted to give its pharmacists, order fillers and even patients a super-easy way to confirm whether or not a biologic has been exposed to a potentially damaging temperature level at any point in time. How? By looking at the label.

Check this out:

Integrity is the Priority in Today’s Pharmaceutical Supply Chains

Food safety is always on the minds of producers, warehouse operators, distributors and restaurateurs. Even home cooks and consumers are closely scrutinizing food quality these days. We want to know that the quality of what we’re putting into our bodies, or giving others to put into their bodies, hasn’t been compromised during storage, transport or preparation. 

That is why equal scrutiny must be given to pharmaceuticals – partially because of tight government and industry regulations, but mostly because of the correlation between a drug’s potency at the time of administration and its effectiveness. These prescriptions change hands many different times as they travel from the production facility to the “last mile” – whether that is in a clinic or a patient’s home.

Fortunately, a growing number of State Board of Pharmacy regulations and accreditation body standards are encouraging manufacturers, distributors, healthcare providers and specialty pharmacies, such as Preveon, to deploy technologies to demonstrate that the cold chain has been respected during handling. By putting multiple quality control measures in place throughout the cold chain, they can help maintain the potency of medications, particularly temperature-sensitive biologics.

For example, you may find wireless temperature sensors installed in cold storage facilities within manufacturing plants, warehouses, distribution centers and even hospitals and pharmacies to monitor climate conditions. They can even be attached inside the handheld coolers used for pharmacies’ courier delivery services, as you saw in the Preveon video above. However, those devices can’t be practically attached to individual drug packaging and are too expensive to be used in individual shipments to a patient’s home.

That is why color-changing temperature-sensing labels such as the LIMITmarker™ F-M used by Preveon have become so valuable to healthcare providers. They can simply, yet scientifically, indicate that drugs have been exposed to potentially damaging temperatures both prior to and after arrival at hospitals or patients’ homes and subsequently elicit corrective action. Both patients and caregivers have a way of knowing when the temperature control within a shipment has been compromised and may need to be replaced. As a result, they gain confidence in the integrity of these specialty treatments while simultaneously reducing the cost burden associated with “not knowing” about a drug’s quality.

(The average monthly cost of a specialty drug can exceed $5,000. And without the use of a temperature indicator in each shipment, there is an increased risk of the high-value delivery being rejected due to a suspected, but not verified, temperature excursion. The rejected shipment sets into motion a series of actions that result in a product reship and replacement, which is often a cost borne by the specialty pharmacy, and also a delay in the timely administration of the drug. When medications are not administered on time and according to the patient’s unique schedule, patients may experience an immediate increase in symptoms. Eliminating the direct and indirect costs of replacing a compromised shipment has a big impact on the specialty pharmacies’ profitability and the quality of life of the patient!)

In other words, temperature-monitoring technologies are well worth the investment given that peace of mind is priceless – to pharmaceutical manufacturers, distributors, physicians, pharmacists and patients.

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Editor’s Note:

You can learn about the many different temperature monitoring and sensing technology solutions being used to monitor many different temperature sensitive products, including food, vaccines, pharmaceuticals, and blood on Zebra’s website.