A new investigation shows that as much as ¾ of the vaccinations the providers are administering could possibly be ineffective due to improper storage methods.
According to an investigation by the Department of Health and Human Services’ Office of the Inspector General (HHS OIG) found that many providers of immunizations meant for low-income children don’t store the vaccines at proper temperatures, potentially rendering them ineffective and placing children at risk for contracting serious diseases.
Inspectors visited the offices of 45 providers in five states who offered free immunizations as part of the government’s Vaccines for Children (VFC) Program. Nationwide, about 44,000 offices and clinics participate in the program. The Centers for Medicare & Medicaid Services pay for the vaccines, and the Centers for Disease Control and Prevention distribute them.
The investigation found that 76 percent of the providers stored the vaccines at temperatures that were either too hot or too cold. They also found that 13 providers stored expired vaccines along with nonexpired vaccines. In addition, they said they found that none of the providers properly managed the vaccines according to VFC program requirements.
“As a result, the 20,252 VFC vaccine doses that we observed during site visits may not provide children with maximum protection against preventable diseases and may be vulnerable to fraud, waste and abuse,” according to the report. “These doses were worth approximately $800,000.”
The storage problem could potentially lead to less effective vaccines, but doesn’t pose a safety risk, the HHS OIG said.
In 2010, about 40 million children received 82 million VFC vaccines at a cost of approximately $3.6 billion, and providers must meet certain requirements for storage and management.
While the report is concerned with vaccines offered under the VFC program, doctors say the government’s investigation is an important reminder to all clinicians about the need to properly and carefully store all vaccines.
“The temperature has to be monitored throughout the entire time, from the time it leaves the manufacturer to the time it spends in transit to the time it’s delivered to the clinic and it’s used in the clinic,” said Dr. William Schaffner, chair of preventive medicine at Vanderbilt University Medical Center. “We want every dose given to every child to provide the optimum protection as it’s intended,” he said.
In its report, the Inspector General’s Office recommends that CDC take steps to ensure that providers who participate in the VFC program do their jobs.
“We want them to work with the grantees and providers to make sure that they’re storing vaccines properly, then put in better inventory control mechanisms so there’s less inventory on hand so that creates less chances that vaccines can expire,” said Dwayne Grant, the regional inspector general for the Office of Inspector General in Atlanta.
Dr. Anne Schuchat, director of CDC’s National Center for Immunization for Immunization and Respiratory Diseases, told ABC News the vaccination program has helped protect many children from preventable diseases, but acknowledged there was a breakdown in the vaccine management process.
“We’re doing our root cause analysis right now to try and understand the key factors that lead up to these issues,” she said. “There have been changes in the equipment, the refrigerators. There are many vaccines recommended now, and maybe there are more doses being stored in the average office than there used to be.”
The CDC says disease rates haven’t gone up because of vaccines affected by temperature problems.
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