A Pennsylvania rehabilitation and wellness center gave more than 200 patients hydroxychloroquine without approval, state health department says

This is the Brighton Rehabilitation and Wellness Center in Brighton Township, Pennsylvania, on May 12. By Alec Snyder, CNN

(CNN) -- The Pennsylvania Department of Health issued a report Tuesday that found the Brighton Rehabilitation and Wellness Center in Beaver provided 205 patients with hydroxychloroquine without receiving prior DOH approval.

The department said in its report that hydroxychloroquine is not an approved medication to prevent Covid-19 and noted its possible side effects, some of which are unknown but could include "sickness, permanent injuries, and/or death."

The Department of Health completed their survey June 16 but reports do not appear on its website until at least 41 days after their completion date, the report says.

"Based on facility documents, U.S. Food and Drug Administration (FDA) documents, facility record and staff interviews it was determined that the facility failed to obtain the necessary approval from the Pennsylvania Department of Health (PA DOH) prior to administering a medication that is not a generally accepted practice in the medical community, is not a currently approved medication by the FDA for treatment of the COVID-19 virus outside of the hospital setting for an 'Experimental Post Exposure Prophylaxis' treatment for 205 of 435 residents," the report said.

The center was found to have attempted to administer the medication in conjunction with zinc tablets, the report said. The consent form residents apparently signed to take the medication identified the treatment as experimental, but it says Brighton Center did not report any possible errors in providing the medication or any adverse effects residents may have experienced.

Brighton Center told CNN that the Pennsylvania Department of Health granted "consent and approval" to have them "incorporate the use of oral formulations of chloroquine phosphate (CQ) and hydroxychloroquine sulfate" into their treatment regimens, according to a statement they released.

Dr. David Thimons, the facility's medical director, said in the statement that they met with the department on April 10.

"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. Facility staff only assist with administering medications. After the FDA revoked the emergency use authorization, our resident's physicians immediately removed the drug from treatment regimens."

Facility named in wrongful death lawsuit

CNN has previously reported on Brighton Rehabilitation and Wellness Center, as it is the subject in a wrongful death lawsuit filed earlier in July. Elizabeth Wiles, a housekeeping employee who was contracted to work at Brighton, died May 10, apparently from Covid-19. Her family alleges the virus "spread through the Brighton unchecked, infecting and killing numerous residents and workers at the facility, including plaintiff's decedent Elizabeth Wiles," according to previous reporting.

Brighton issued a statement to CNN regarding the lawsuit saying, "Ms. Wiles was not an employee of our facility, nor did we supervise her or set her schedule. Further, we do not yet know whether Ms. Wiles acquired COVID-19 at all, let alone at our facility." The statement went on to say, "As for the unfounded allegations, we will not tolerate litigation through slander and are working with counsel to determine the appropriate legal response." The company said, "it is scientifically recognized by OSHA and Workers' Compensation Boards that where and how exactly an individual contracted this virus cannot be determined."

Brighton Center has had one of the worst Covid-19 outbreaks among long-term care facilities in Pennsylvania. As of July 28, the facility reported 332 resident cases, 113 staff cases and 73 resident deaths, according to data on the Department of Health's website.

To rectify the situation, the report determined the center cannot retroactively receive permission for its issuance of hydroxychloroquine. While it acknowledged the center is no longer providing hydroxychloroquine, the Department of Health will nonetheless be auditing the center to ensure compliance.

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