Hydroxychloroquine given to 205 rehab center residents without approval, PA report says

A long-term care facility in Pennsylvania gave 205 residents hydroxychloroquine to treat COVID-19 without receiving proper approval from the state Department of Health, according to a report from the agency.

Hydroxychloroquine is an antimalarial drug that has been used experimentally to treat COVID-19. President Trump has promoted the drug as a way to treat the coronavirus despite concerns from some experts, at one point saying he was taking it himself daily.

According to the report, “the treatment is not currently approved by the U.S. Food and Drug Administration for preventing a person from being infected with COVID-19.”

The FDA has also said hydroxychloroquine has shown “no benefit for decreasing the likelihood of death or speeding recovery” from COVID-19. Dr. Anthony Fauci, the nation’s top infectious disease expert, told Good Morning America on Tuesday that an “overwhelming” number of studies have not found the drug can effectively treat coronavirus patients.

The Pennsylvania Department of Health completed its survey of Brighton Rehabilitation and Wellness Center on June 16 and determined that 205 of the center’s 435 residents had signed a consent form and been given hydroxychloroquine without the center receiving proper approval from the health department.

Under Pennsylvania law, experimental treatment in a nursing home is not permitted without the approval of the health department and the written approval of the resident, the report said.

The consent form indicated the treatment was experimental, according to the report, but the health department said the facility did not get proper approval to administer the drug and did not report “medication errors and adverse events” that residents may have experienced while taking hydroxychloroquine.

Adverse events include death, hospitalization and persistent or significant incapacity, according to the report.

The center has since stopped administering hydroxychloroquine to residents and will be randomly audited to ensure that the drug is not being prescribed to treat COVID-19, the report said.

In a statement to CNN, the Brighton center said the health department had given the facility approval to “incorporate the use of oral formulations of chloroquine phosphate (CQ) and hydroxychloroquine sulfate” into treatment for residents.

“Like all medical treatments, hydroxychloroquine would have to be prescribed by a treating physician, with full prior consent of residents and/or their legal guardians,” director David Thimons said in the statement. “Facility staff only assist with administering medications. After the FDA revoked the emergency use authorization, our residents’ physicians immediately removed the drug from treatment regimens.”

The Brighton center has been hit hard by the coronavirus, with 332 residents testing positive for COVID-19 since the onset of the pandemic, according to data from the health department. Seventy-three residents have died. More than 100 staff members have also tested positive, the data show.

Earlier this month, the family of Elizabeth Wiles, a longtime worker at the Brighton center who died of COVID-19, filed a wrongful death lawsuit against the facility and her employer, Healthcare Services Group, CNN reported.

The complaint alleged that the center, where Wiles worked in housekeeping and laundry services, let the coronavirus “spread through the Brighton (center) unchecked, infecting and killing numerous residents and workers at the facility, including plaintiff’s decedent Elizabeth Wiles,” according to the outlet.

In a statement to CNN, Brighton Rehabilitation and Wellness Center said Wiles was not an employee of the center and that it did not set or supervise her schedule, adding that “we do not yet know whether Ms. Wiles acquired COVID-19 at all, let alone at our facility.”

“As for the unfounded allegations, we will not tolerate litigation through slander and are working with counsel to determine the appropriate legal response,” the center said, according to CNN.

This story was originally published July 29, 2020 at 9:14 AM with the headline "Hydroxychloroquine given to 205 rehab center residents without approval, PA report says."