Updated July 9, 2022 - 9:57 am
On Wednesday, the U.S. Food and Drug Administration took the unusual step of authorizing pharmacists to directly prescribe antiviral medication Paxlovid to patients testing positive for COVID-19.
But don’t expect to get a prescription right away from your neighborhood pharmacist for the pills studies have found dramatically reduce the risk of developing serious illness.
Major pharmacy chains and a state regulatory agency said Friday that they’re continuing to work with the FDA on how to best implement the change, including whether any new costs will be passed on to patients. Although the details still need to be worked out, the change was applauded by the industry.
“I’m elated,” said Christina Madison, an associate professor at the College of Pharmacy at Roseman University in Southern Nevada.
The change eliminates a barrier to getting treatment, especially in rural areas and “medical deserts” where a pharmacy is “the only place a person can get medical information for miles,” she said.
The FDA announced Wednesday it had revised its emergency use authorization for Pfizer’s Paxlovid to allow pharmacists to prescribe it to eligible patients.
“Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” said Dr. Patrizia Cavazzoni, director for the FDA’s Center for Drug Evaluation and Research.
The FDA said that patients testing positive for COVID-19 should first consider seeking care from their regular health care provider. If they are being evaluated by a pharmacist, patients will need to provide electronic or printed health records that are less than a year old. These records include the most recent reports of laboratory blood work, to be reviewed for kidney or liver problems that could make a patient ineligible for the treatment. They’ll also need to provide a list of all medications so the pharmacist can screen for potentially serious interactions with Paxlovid.
The FDA’s guidance states that a pharmacist should refer a patient for a clinical evaluation by a physician or other provider if sufficient patient information is unavailable or if modification of other medications is needed due to a potential drug interaction.
Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in those 12 or older weighing at least 88 pounds who are at high risk for progression to severe COVID-19 due to age or underlying health conditions. Studies showed that Paxlovid, a combination of two different pills — nirmatrelvir and ritonavir — reduced the risk of hospitalization and death by 88 percent.
A patient with a recent diagnosis of COVID-19 who is at heightened risk should get the medication, said David Wuest, executive secretary of the Nevada State Board of Pharmacy. “The pharmacies have the drugs. If they’re trained and capable of doing it, that’s the quickest way for the patient to get it.”
Adopting the change will mean training pharmacy staff, he said, as well as getting clarification on the rules related to reimbursement and record keeping, said Wuest, who believes some pharmacies could begin to prescribe the drug next week.
Giant pharmacy chains CVS and Walgreens said they’re preparing to implement the change.
“We’re pleased that the Food and Drug Administration (FDA) recognizes the clinical capabilities of pharmacists and are currently evaluating their guidance and actively working to expand access for patients by positioning our pharmacists to assess patients and prescribe oral antivirals as appropriate,” Monica Prinzing, CVS corporate communications senior manager in the western region, said in an email.
“We will continue to work closely with the administration and federal agencies on the recent update to the Emergency Use Authorization for Paxlovid,” Walgreens representative Rebekah Pajak said in an email, adding that implementation of the change would begin in “socially vulnerable and medically underserved communities.”
Should pharmacists prescribe?
However, some question whether pharmacists, instead of doctors, ought to be prescribing the medication.
“While the majority of COVID-19 positive patients will benefit from Paxlovid, it is not for everyone and prescribing it requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving — requirements far beyond a pharmacist’s scope and training,” Dr. Jack Resneck Jr., president of the American Medical Association, said in a statement.
“In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams — teams that include pharmacists,” he said. “But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up.”
Wuest said pharmacists possess the needed training.
“Pharmacists are trained to look at laboratory work. They’re trained to do those kinds of things,” he said. “I’m not concerned about that at all.”
Wuest and Madison noted that Nevada pharmacists already are authorized by the Legislature to prescribe certain drugs, including birth control pills and medication to prevent HIV.
The federal government has taken other steps to make it easier to deliver COVID-19 treatments. The federal PREP Act supersedes state requirements, such as more limited licensing or scope of practice requirements, that could prohibit a qualified person from prescribing, dispensing or administering COVID-19 therapeutics.
For more information on accessing COVID-19 therapeutics, visit nvhealthresponse.nv.gov/find-treatment or call 800-401-0946.