Donald T. Allegra, MD, is a nationally recognized infectious diseases physician, and a founder of the largest clinical practice in the state of New Jersey focusing on prevention, diagnosis, and treatment of infectious disease. He estimates that temperature-sensitive medicines used in his practice, primarily vaccines and antibiotics, represent more than 80 percent of his drug inventory.
The physicians and staff there are well trained in the rigors of storing and handling cold chain medicines. But mistakes happen. Delivered, unopened boxes may sit overnight on the front step of the office. An electrical storm can shut down power. Any one of a number of circumstances may impact the carefully controlled temperature environment and lead to cold chain breaks.
An increasing number of pharmaceutical products prescribed in the US—including insulin, vaccines, biologics, chemotherapeutic agents, blood products, and many antibiotics—are temperature-sensitive and require special shipping and storage processes to ensure they stay within the specified temperature range for the entire life of the product.The logistics and service market to manage distribution of cold chain pharmaceutical and biotech products also is growing. The dollar value of cold chain biologics and pharmaceutical shipments was $147 billion in 2008, and is projected to rise to $187 billion in 2011, according to the Biopharma Cold Chain Sourcebook 2010.
But while the US pharmaceutical industry keeps up with the commercial demand for temperature-sensitive medicines, it falls behind in applying technologies that manage the cold chain from point of manufacture to point of administration to patients.
The cold chain distribution process officially begins when products are released from the manufacturer's warehouse. From that point on, the cold chain journey often is a complex series of multiple touch points, facilities, vehicles, modes of transportation, and personnel.
Of late, the industry is particularly concerned about the final leg of the cold chain—the "last mile"—which refers to the critical period of time between delivery to an office/clinic/pharmacy and patient administration. It is during this time when temperature-sensitive, life-saving medicines are most vulnerable to cold chain breaks.