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February 12, 2019, 15:48 GMT / Source: Kaiser Health News
By correcting one potential error, the Health Care Agency of Ventura County (Calif.) Has accidentally introduced another – and dangerous vaccine that thousands of people have received in the process.
In October 2017, district health officials changed concerns that vaccines were getting too hot while being transported to clinics from protocol. But a routine audit in November revealed that the ice packets they used may have frozen some of the medicines and reduced their effectiveness. The agency then offered to re-immunize everyone who had received a vaccine delivered in an incorrect package.
"There is no way to tell if they were not effective," said Jason Arimura, director of pharmacy services for Ventura County Medical Center. From an abundance of caution "we have just informed everyone."
The number of affected patients: 23,000.
Ventura County is far from the only case of vaccines that are feared to be ineffective in reaching patients. In the past 13 months alone, 117 children may have received affected vaccines against polio, meningococcal disease and the human papillomavirus at a clinic of the Indian health service in Oklahoma City for incorrect cooling. Similar problems with temperature control resulted in January that a health clinic in Indianapolis would send letters to revaccine 1,600 people, according to local news reports.
On February 1, Kentucky officials announced that potentially ineffective and contaminated vaccines were being administered to multiple companies in Kentucky, Ohio and Indiana. The statement did not reveal how many people were affected.
The federal government sets standards for the storage of vaccines. However, not all healthcare providers are responsible according to these guidelines.
The Vaccines for Children (VFC) program, which offers these medicines at no cost to children from low-income families, requires clinics, doctors and other suppliers to undergo annual audits and use high-quality equipment such as continuous temperature monitoring devices. It also requires that problems be reported to the federal authorities.
More than 44,000 doctors participate in the program and provide vaccines to 90 percent of the children in the country, according to the Centers for Disease Control and Prevention.
But medical facilities outside the program – such as many pharmacies and internists with private practices that treat adults or children who are not in the VFC program – do not have a comparable federal overview. Storing vaccines and reporting cases of patients receiving ineffective medicines is largely at their discretion. The vaccines involved in the recall of Ventura County were not part of the Vaccines for Children program.
Experts said that most hospitals, clinics and doctors are vigilant in correctly storing their vaccines. And research suggests that compromised vaccines administered to patients are not harmful.
L.J Tan, chief strategy officer for the non-profit vaccination group Immunization Action Coalition, said the nation's vaccine supply is probably one of the safest in the world & # 39; is.
But if these drugs are not used properly, they waste expensive drugs and the use of compromised vaccines "could be a bag of non-immunized people," said Dr. Julie Boom, pediatrician and director of the immunization project in Texas Children & # 39; s Hospital. "And we do not want this to happen."
In Ventura County, the temperature problems related to vaccines against flu, tetanus, diphtheria, whooping cough and hepatitis B. County health officials told patients who had undergone tuberculosis and others who had received penicillin to treat syphilis that their medications might also have been compromised.
Up to January about 1,200 returned to be vaccinated again, Arimura said. The revaccination of all 23,000 people would cost $ 1.3 million, he added.
Vaccines are extremely sensitive to temperature fluctuations. In some cases, exposure of a vaccine to the wrong environment can effectively kill living viruses and damage proteins in the vaccines, according to Tan. In general, temperature problems occur during the transportation of medicines.
Without proper monitoring, it is almost impossible to say whether vaccines are exposed to extreme temperatures, Boom said.
A report from the Inspector General of the Ministry of Health and Human Services in 2012 showed that three-quarters of the 45 sampled health care providers – all of whom were part of the Vaccines for Children program – were exposed to their vaccines for inaccurate temperatures for at least five cumulative hours.
A separate study by researchers from the Federal Centers for Disease Control and Prevention published in 2015 showed that 23 percent of the vaccination errors reported to the federal surveillance system from 2000 to 2013 related to incorrect storage or use of expired vaccines.
Since these reports, the CDC has set additional requirements for the children's program, including the daily registration of the minimum and maximum temperature of the vaccine storage unit.
Dr. Paul Hunter, associate professor of family medicine and community health at the University of Wisconsin, said that federal supervision is "very good".
"They do it very consistently in the big picture," he said.
For doctors and clinics outside the federal monitoring system, financial worries often force them to pay special attention to vaccines and similar drugs. One vaccine dose can cost hundreds of dollars.
Sanford Health, a South Dakota-based healthcare system with operations in the Midwest, is working to make federal requirements the standard for vaccines at its healthcare providers. The system started Vax Champ, a six-month training program for nurses to learn how to store and treat vaccines. The program requires participants to periodically take photos of their vaccine supplies and send a list of all their inventory for review.
Funding for the program came from the vaccine manufacturer Sanofi Pasteur.
Andrea Polkinghorn, leader of the immunization strategy for Sanford Health, says vaccine storage systems differ greatly from provider. Buying storage equipment of pharmaceutical quality is expensive, she said, and providers are in different stages of the upgrade.
"But if you compare that with the expected loss of vaccines," said Polkinghorn, "the end is worth it."
Kaiser Health News is a non-profit news service about health issues. It is an editorial independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.