Recent state inspection reports have revealed that nursing homes in Pennsylvania and Texas treated residents with hydroxychloroquine without state authorization and without the informed consent of those it was being administered to. Photo by Caroline Blumberg/EPA-EFE
Aug. 27 (UPI) -- Three Democratic senators on Thursday called for an investigation into the experimental use of hydroxychloroquine in nursing homes to treat COVID-19 patients following reports its was administered to residents without their informed consent and proper approvals.
In a letter sent to Christi Grimm, inspector general of the Department of Health and Human Services, Sens. Bob Casey, D-Pa.; Elizabeth Warren, D-Mass., and Ron Wyden, D-Ore.; requested she investigate whether the Centers for Medicare and Medicaid Services properly monitored the drug's off-label use to treat COVID-19 in nursing homes, whether proper steps were taken to ensure the patients were protected and to see to what extent it was administered without proper approval or consent.
Citing recent state inspector reports, the senators said a Pennsylvania nursing home administered the medicine without proper state approval to 205 of its 435 residents. In Texas, state inspection officials found a nursing home treated a cognitively impaired patient for COVID-19 with hydroxychloroquine without the consent of the individual's guardian.
The senators said that with regular inspections suspended and visits restricted by families and the ombudsman due to the pandemic, other such instances of the drug's improper use may have occurred without notice.
"The use of this experimental treatment on patients without proper approval and without their consent is a violation of patient rights," they wrote.
A drug used to treat Lupus and malaria, hydroxychloroquine gained national attention after President Donald Trump mentioned it as a possible medicine to be used to combat COVID-19 in March and in May said that he was taking the experimental treatment.
The senators have called for Grimm to investigate whether nursing homes received informed consent to administer the drug, whether staff tracked and reported adverse effects caused by the drug, whether CMS acted to ensure the nursing homes followed all Medicare and Medicaid requirements and whether
They also sent letters to the heads of the Food and Drug Administration and CMS requesting information concerning hydroxychloroquine.
In the letter, the senators accused the Trump administration of issuing "misleading statements" concerning hydroxychloroquine, stating it is "doubling down" on its promotion of it early in the pandemic despite growing scientific evidence demonstrating it is not an effective treatment against COVID-19.
"This mixed messaging from the administration, coupled with an absence of clear guidance, has led to the drug's continued use, even after the FDA issued warnings about its safety," the letter to Stephen Hahn of the Food and Drug Administration said.
A drug used to treat Lupus and malaria, hydroxychloroquine gained national attention after President Donald Trump mentioned it as a possible medicine to be used to combat COVID-19 in March and in May said that he was taking the experimental treatment.
The senators have called for Grimm to investigate whether nursing homes received informed consent to administer the drug, whether staff tracked and reported adverse effects caused by the drug, whether CMS acted to ensure the nursing homes followed all Medicare and Medicaid requirements and whether
They also sent letters to the heads of the Food and Drug Administration and CMS requesting information concerning hydroxychloroquine.
In the letter, the senators accused the Trump administration of issuing "misleading statements" concerning hydroxychloroquine, stating it is "doubling down" on its promotion of it early in the pandemic despite growing scientific evidence demonstrating it is not an effective treatment against COVID-19.
"This mixed messaging from the administration, coupled with an absence of clear guidance, has led to the drug's continued use, even after the FDA issued warnings about its safety," the letter to Stephen Hahn of the Food and Drug Administration said.
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