US physicians concerned about health risk to patients from heat-damaged medicinal products

In a recent Harris Interactive survey of US physicians about the proper storage and handling of temperature-sensitive medicines prescribed and administered to patients, physicians reported being concerned about this issue, and the overwhelming majority are concerned that heat-damaged products resulting from cumulative exposure to temperatures outside the specified temperature range pose a health risk to patients. The announcement of the study findings was made today by Temptime Corporation.

“Now, with advancements in science and medicine trending toward increased use of biologics, vaccines and other temperature-sensitive medicines, we need far more vigilance around the cold chain to protect life-saving medicines from temperature abuse, and protect our patients from associated risk stemming from undetected temperature abuse.”

"Physicians have experienced cold chain breaks in clinical practice since we first began using medicines that required refrigeration," said Donald T. Allegra, MD., FACP, who is not affiliated with the study. "Now, with advancements in science and medicine trending toward increased use of biologics, vaccines and other temperature-sensitive medicines, we need far more vigilance around the cold chain to protect life-saving medicines from temperature abuse, and protect our patients from associated risk stemming from undetected temperature abuse."

The use of temperature-sensitive medicines such as vaccines, other protein based products, blood products, chemotherapeutic agents, to name a few - is growing worldwide. The US remains the largest market for biotech products, and holds 56% of the global biologics market. Temperature-sensitive products must be managed with strict storage and handling processes to ensure they are maintained at specific temperatures throughout the cold chain -- a term used to describe the systems employed to maintain a specific temperature or temperature range throughout the manufacturing, packaging and distribution of temperature-sensitive products.

"When products requiring refrigeration are exposed to cumulative temperatures outside the specified zone (usually 2°to 8°C/36°to 46°F), several things can happen which negatively affect the products," said Dr. Allegra. "There may be complete loss of product efficacy, or loss of product potency - which can lead to interruptions in treatment protocol, serious adverse events, and/or failure to relieve patient symptoms. The impact can go beyond individual patients to the public health level, particularly when vaccines are involved."

According to the Harris Interactive research, three in five physicians are at least "very concerned" about ineffective treatment and/or no relief of patient symptoms. More than half of physicians across all specialties surveyed are concerned about potential serious adverse events related to heat-damaged products. Primary Care Physicians (PCPs) and pediatricians (the top prescribers of vaccines) are most concerned of all specialists surveyed about outbreaks of preventable disease caused by administration of heat-damaged vaccines.