Concern About Risk to Patients
The reality is that cold chain breaks can, and do, happen at any time. They are surprisingly common. Research tells us that
most physicians who handle temperature-sensitive medicines have experienced a cold chain break at some point, and they are
very concerned about the associated risk to patients.
According to a recent Harris Interactive research study of primary care physicians (PCPs) and specialists about their experiences
and perceptions about the pharmaceutical cold chain, 83 percent of PCPs and 72 percent of specialists reported experiencing
delivery/storage-related breaks in the cold chain.
The study also shows that physicians overwhelmingly agree that cold chain breaks—and the cumulative exposure of drugs to temperatures
outside the specified range—pose risks to patients and public health.
They are specifically concerned about loss of product potency, a known effect of temperature abuse. And across the study primary
care and specialist physicians (pediatricians, endocrinologists, hematologists/oncologists, and rheumatologists) reported
being concerned about potential adverse events related to heat-damaged products, ineffective treatment interrupting protocols,
and ineffective treatment and/or no symptom relief.
Not surprisingly, the PCP and pediatricians subgroup reported being particularly concerned about the potential for outbreaks
of preventable disease caused by the administration of heat-damaged vaccines. Pediatricians are the highest prescribers of
vaccines. Herein lies the problem: Perhaps unaware of temperature damage, they could unwittingly administer the medicine,
putting patients at risk for treatment failures, interruption in treatment protocol, and possible adverse events.
Or, suspecting temperature damage but without a means to confirm it, they discard medicines that are OK to use. In both cases,
the impact of this issue has broad-reaching effects.
Impact of Product Waste
All temperature-sensitive pharmaceutical and biologic products—those that require refrigeration to avoid heat damage, and
those that must avoid freezing—are at risk of temperature damage if handled improperly.
In an effort to understand the public costs of improper vaccine storage, the CDC's AIM Vaccine Storage and Handling Working
Group examined and quantified the financial value of incidents that cause heat and freeze damage resulting in vaccine waste.
The study looked at vaccine waste resulting from storage failures, from 45 of 64 participating immunization programs, during
an eight-week period in 2009.
The study included both heat and freeze incidents during storage. Heat damage is known to cause a reduction in vaccine potency,
and has the potential to render a vaccine completely ineffective. Freeze damage destroys vaccine; and freeze events are particularly
difficult to identify in products previously frozen, and then thawed.
The study found that the total value of publicly funded vaccines wasted in the eight-week time frame was $1,167,781. Extrapolated
to one year, the value for publicly funded vaccines is $7,590,580. Recall these figures reflect waste costs for storage-related
events only, and do not include events causing damage and waste that occur during shipping prior to arrival at physicians'
Looking at it another way, consider that the US government through the Vaccines for Children Program (managed by the CDC)
purchases approximately 80 million doses of vaccine per year, at an estimated average price per dose of $35. Assuming a 3
percent rate of waste due to adverse temperature exposure on $2.8 billion per year spent on vaccines for children (a 2002
study estimated 1 percent to 5 percent), the cost of vaccine waste is potentially $84 million annually.