Report: Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430)
U.S. Department of Health and Human Service Office of the Inspector General (OIG) Complete Report
06-05-2012 Download complete report
Summary
WHY WE DID THIS STUDY
CDC’s Vaccines for Children (VFC) program provides free vaccines to eligible children through a network of 61 grantees and 44,000 enrolled providers. In 2010, approximately 82 million VFC vaccine doses were administered to an estimated 40 million children at a cost of $3.6 billion. VFC providers must meet certain requirements for vaccine management, such as storing vaccines within required temperature ranges and monitoring expiration dates, to ensure that these vaccines provide children with maximum protection against preventable diseases. These requirements are also intended to decrease VFC program fraud, waste, and abuse.
HOW WE DID THIS STUDY
Using CDC data, we selected a sample of 45 VFC providers from the 5 grantees with the highest volume of vaccines ordered in 2010. We conducted site visits at these providers’ medical practice locations, interviewed their vaccine coordinators, and observed their vaccine management practices. We also independently measured these providers’ vaccine storage unit temperatures for a 2-week period. Finally, we interviewed the five grantees’ VFC program staff regarding their program oversight.
WHAT WE FOUND
Although the majority of storage temperatures we independently measured during a 2 week period were within the required ranges, VFC vaccines stored by 76 percent of the 45 selected providers were exposed to inappropriate temperatures for at least 5 cumulative hours during that period. Exposure to inappropriate temperatures can reduce vaccine potency and efficacy, increasing the risk that children are not provided with maximum protection against preventable diseases. Thirteen providers stored expired vaccines together with nonexpired vaccines, increasing the risk of mistakenly administering the expired vaccine. Finally, the selected providers generally did not meet vaccine management requirements or maintain required documentation. Similarly, none of the five selected grantees met all VFC program oversight requirements, and grantee site visits were not effective in ensuring that providers met vaccine management requirements over time.
WHAT WE RECOMMEND
We recommend that CDC continue to work with grantees and providers to ensure that (1) VFC vaccines are stored according to requirements, (2) expired vaccines are identified and separated from nonexpired vaccines, (3) grantees better manage providers’ vaccine inventories, and (4) grantees meet oversight requirements. CDC concurred with all four of our recommendations and noted that vaccination is one of the most successful public health tools in preventing and controlling disease.
http://oig.hhs.gov/oei/reports/oei-04-10-00430.asp
Statement regarding Office of the Inspector General Vaccines for Children report June 7, 2012
On June 5, 2012 the U.S. Department of Health and Human Service Office of the Inspector General (OIG) released a report on “Vaccines for Children (VFC) Program: Vulnerabilities in Vaccine Management.“.
“…Contrary to some news reports, the OIG did not find that 76% of all vaccine was stored improperly. Thirteen of the 45 providers had expired vaccine that was stored alongside unexpired vaccine. The majority of expired vaccine doses identified in the April-May assessment were seasonal influenza vaccine. It is unlikely that such doses were administered.
“CDC is not recommending that parents revaccinate their children. The main concern with improper storage temperatures is that they can make vaccines less effective rather than less safe. The OIG report did not assess vaccine potency or effectiveness. While it is possible that some children have received less potent vaccines due to exposure to improper temperatures, our data do not suggest that this is a common or widespread problem. Our national monitoring indicates vaccines are doing their job at providing protection against disease. Most of the diseases we vaccinate against are at record low levels in the United States. Investigations of recent outbreaks of measles and pertussis have been associated with factors such as vaccine refusal and waning of immunity over time. In fact, patterns in these outbreaks suggest that children are receiving potent and effective vaccines. Our vaccine safety monitoring also indicates that we continue to have the safest vaccine supply in our history.
While the safety and health of our nation’s children has not been compromised by the issues identified by the OIG, the findings are important and underscore that we must do better at ensuring that all vaccines are stored properly at all times, including removing expired vaccine from units where viable vaccines are stored. The vaccines that protect children against serious and even deadly diseases should always be stored properly. CDC and our partners are working with a sense of urgency to address the problems identified in the OIG study.
CDC continues to encourage parents to vaccinate according to the U.S. recommended immunization schedule to provide the best protection for children from 16 serious and deadly diseases. If parents have questions about their child’s vaccinations, they should talk with their child’s doctor.
http://www.cdc.gov/media/releases/2012/s0607_children_vaccine.html