FARGO — Essentia Health is notifying up to 45,000 patients that medication or vaccines they received might have been compromised by improper temperature storage by a wholesale drug distributor.
Roughly half of those who could be affected received the flu vaccine. Essentia has written to patients to inform them of the possibility that injectable medications or vaccines they received might have been rendered less effective by improper storage.
Essentia is not making anyone available for interviews and is not divulging many details, including disclosure of what medications or vaccines in addition to the flu vaccine are now in question. Essentia is offering to revaccinate patients at no additional charge, according to a form letter sent to patients.
Health officials in North Dakota and Minnesota have been notified of the possibly compromised vaccines and medications.
In North Dakota, health officials referred the matter to the state Board of Pharmacy. “We are opening an investigation into the matter and talking to the parties involved,” said Mark Hardy, the pharmacy board’s executive director.
“It’s important that you’re looking out for patient care,” he said. “In this case, it may involve revaccination.”
Decisions about the appropriateness of revaccinating any patients will have to be made individually by the patients’ physicians, he said.
“All of the patients who may have been affected by this issue are being contacted by Essentia Health to determine next steps for revaccination or treatment to ensure they are getting the full benefits of these treatments,” Essentia said in its statement.
It’s too early to say whether there were any violations and whether penalties would be in order, Hardy said.
“We’re happy with what steps they’re taking,” he said of Essentia’s actions so far. “Certainly everybody we’ve talked to has been cooperative.”
According to an alert on Essentia’s website, a little more than 100 refrigerated injectable medications could have been compromised, but no “shelf stable” medications are at risk.
The vaccines and medications were given to patients seen at clinics, including Fargo, Jamestown and Valley City in North Dakota and including Moorhead, Detroit Lakes and Ada in Minnesota.
The problem was discovered in February, when Essentia took over management and storage of medications from a former distributor, Essentia spokeswoman Tara Ekren said Wednesday, April 8.
The drug warehouse is located in Fargo, according to Essentia.
“Based on the information we have, these medications may have been affected dating back to September 2017, at which time patients may have received those medicines. We no longer use the former distribution partner,” the statement said.
Essentia would not say whether faulty equipment or human error are to blame for the improper storage, or provide the name of the distributor.
“Certain vaccines and medications appear to have been stored outside of the recommended temperature range, potentially impacting their effectiveness,” said a response provided by Ekren. “The temperatures of those vaccines and medicines must be stored within precise temperatures — generally between 35-46 degrees Fahrenheit.”
Lindsey Mowrar of Fargo received a letter from Essentia informing him that his two children, ages 3 and 4, might have received vaccinations that are now in question.
Although Essentia is offering to revaccinate at no additional charge, he’s not in a hurry to accept the offer, given his concerns about possible exposure to the coronavirus.
“I’m not going to revaccinate my children right now because I don’t want to take the risk of taking them to the hospital,” where they could be exposed to the virus, he said.
“How many other parents have to go through this?” he asked.
A spokesman for the Minnesota Department of Health said the department does not have a regulatory role to play in the response because none of the vaccines were publicly funded.