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.
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.