With over a third of coronavirus-linked deaths in the United States having occurred in care homes, their residents are understandably at the head of the line now that vaccines are being rolled out. However, it’s not just a simple question of turning up and going from room to room administering doses – consent has to be given, and informed consent at that.
Which is not so simple when dealing with dementia patients, naturally.
There are over three million elderly or infirm in care facilities in the United States, and while the government has said that the capability exists to vaccinate them all within the next week, practically that isn’t possible given that in many cases, relatives and/or medical decision makers will have to be contacted in advance – and they may also disagree on what’s best for their infirm relative, adding to the delays involved.
Anticipating the problem, the US government told pharmacy chains Walgreens and CVS that they can secure consent “however they want,” the Washington Post reports, with support from the Centers for Disease Control and Prevention (CDC) which has advised that “verbal consent is enough.” At first, the pharmacies baulked and demanded written consent forms signed even in triplicate, in some cases, but they later relented, after multiple complaints. Walgreens and CVS are now sufficing with verbal consent, and are also accepting emailed consents from medical decision makers for those deemed incapable of deciding for themselves.
Scott Gottlieb, a former FDA commissioner, said the government should have been more proactive in preparing consent forms in advance. However, other officials pointed out that advance consent wasn’t possible, given that the FDA first had to review the vaccine data from Pfizer and other companies, and only then could a consent form be prepared.
“FDA's staff were reviewing the terms of the authorization and Pfizer-BioNTech's fact sheets – which contain many important details that providers need, including risks providers must know prior to administering the vaccine to a patient – up until the time of authorization,” said Stephanie Caccomo, an FDA spokeswoman. “This information absolutely must be accurate and complete; incomplete or outdated information would be detrimental to the delivery of vaccines to recipients.”
Vaccinations have already begun at several nursing homes in Florida and Ohio. General Gustave F. Perna, who oversees logistics for the federal vaccine distribution effort under Operation Warp Speed, said that 1,100 of 70,000 facilities would receive vaccines by Monday before expanding to “thousands” a day.