FDA Grants Permission to Pharmacists to Prescribe Pfizer's Covid Pill
Paxlovid is an effective oral medicine for avoiding severe cases of COVID-19 in those at high risk for developing the infection. However, after the completion of treatment for some patients, those individuals had a return of their symptoms, which prompted the CDC to issue a health advisory regarding the so-called "COVID-19 rebound."
Six months after authorities gave an emergency use license for Paxlovid, physicians say they still have substantial uncertainties about prescribing guidelines for the leading medication for high-risk Covid patients.
On Wednesday, the Food and Drug Administration added pharmacists to the list of qualified medical specialists to recommend Pfizer-produced pills for treating Covid-19 patients.
The number of prescribers who can place prescriptions for Paxlovid therapy will significantly increase due to this move, which is designed to make it easier for patients to get the medication.
Over 300,000 licensed pharmacists are employed throughout the country. This trade group has been advocating for the move.
In the past, prescribing the treatment was restricted to only medical professionals such as doctors, nurses, and physician assistants.
Because of this restriction, patients frequently had to scramble to find a doctor who would prescribe the medication and then a place that would dispense the pills, which had to be taken within five days of the onset of the symptoms.
The difficulty of acquiring Paxlovid has been one factor that has contributed to inequalities in access to the treatment.
According to a recent analysis conducted by the Centers for Disease Control and Prevention (CDC), the rates of medication dispensing for Paxlovid and another treatment made by Merck that is very similar to it was lowest in the poorest ZIP codes in the country during the first five months that the treatments were available.
Patients can get a prescription for the pills immediately after testing positive for the virus and at the exact location, which is typically a CVS MinuteClinic. This is one of the steps the Biden administration took earlier this year to expand treatment access by launching a "test to treat" program. The goal of this program was to allow patients to get a prescription for the pills immediately after testing positive for the virus.
However, a nurse practitioner or physician assistant needed to be present to get a prescription for the medication at those clinics. Most pharmacies do not employ either of those types of medical professionals.
In most cases, pharmacists do not have the same prescribing authority as medical doctors or registered nurses; however, in recent years, they have been gaining more authority in certain states to prescribe commonly used medications for conditions that are simple to treat.
In general, doctor's groups have opposed efforts to expand pharmacists' prescribing authority, citing concerns about the potential safety risks posed by pharmacists' limited knowledge of a patient's medical history.
According to the Food and Drug Administration (FDA), this includes both electronic and printed medical records that are less than a year old. These records should also include the most recent reports of laboratory blood work for the state-licensed pharmacist to review in order to check for kidney or liver problems. Alternatively, the pharmacist could get this information by consulting with the patient's primary care physician or another health care practitioner.
In order for the pharmacist to check for potentially dangerous drug interactions, patients should also submit a list of any prescriptions they are currently taking, including any over-the-counter medications they may be taking.
If there is not enough information for the pharmacist to evaluate patient safety, the pharmacist should send the patient to a physician; advanced practice registered nurse, or a physician assistant who is licensed to prescribe medications for a clinical examination.
Patients taking Covid who wish to obtain a prescription for the pills from a pharmacist were advised by the Food and Drug Administration on Wednesday to bring the results of any recent blood tests and a list of any other medications they are currently taking.
A component of the treatment offered by Pfizer can cause severe adverse effects if it interacts with certain medications, including those commonly used to treat high cholesterol and cardiovascular problems.
According to the agency, pharmacists should direct patients to other prescribers if the records and information about other medications are unavailable. This recommendation was given if pharmacists were unable to access the necessary information.
Since the end of the previous year, patients with Covid who are at high risk and are at least 12 years old have had access to Paxlovid through an emergency authorization.
Even though there were only a limited number of supplies available at first, pharmacies in the United States filled more than 800,000 prescriptions in the first five months that it was available.
The application for Paxlovid's full approval was submitted by Pfizer just the week before last.
Paxlovid is a medication prescribed to patients with moderate to mild symptoms of COVID and at high risk of developing severe COVID. It has been given the go-ahead for use by adults and youngsters over the age of 12 who weigh at least 88 pounds.
Patients are considered eligible for the medication under the new authorization if they are a part of the population authorized to get the medication and have a positive at-home rapid antigen test or a positive PCR test. In addition, the patient must be in the population that is authorized to get the medication.
According to the regulatory agency, conducting a PCR test to validate the results of a positive at-home test is optional. Even though there has been some movement in expanding the usage of Paxlovid, there is still a large amount of paperwork involved in getting it.
Dr. Anthony S. Fauci: "The Rebound"
After disclosing that he had suffered what appeared to be a "rebound" of Covid-19 after taking a five-day course of the pills, Dr. Anthony S. Fauci, President Biden's top medical adviser for the coronavirus pandemic, sought on Wednesday to discourage doubts about the antiviral drug Paxlovid. Fauci made this statement after disclosing that he had suffered what appeared to be a "rebound" of Covid-19 after taking the pills.
He did this in order to allay some of the worries that have been expressed over the medicine. "Paxlovid did what it was supposed to do," Dr. Fauci, who is 81 years old, said in an interview. He believed that the treatment, which Pfizer manufactured, kept him out of the hospital when he first tested positive for the virus on June 15. "Paxlovid did what it was supposed to," Dr. Fauci said.
He continued by saying that he believed the medication also lessened the severity of his initial symptoms.
Dr. Fauci has been immunized against Covid and has also undergone two booster vaccination doses.
There is anecdotal evidence, including his own, that people whose Covid symptoms eased after using Paxlovid and who even tested negative afterwards experienced a recurrence of symptoms. This evidence comes from patients who took Paxlovid to treat their symptoms of Covid. The evidence in this case comes from patients who took Paxlovid and afterwards developed Covid. Patients who took Paxlovid and afterwards developed Covid provided this proof. According to Dr. Fauci, that is precisely what happened with him; he recently tested positive again after having negative results three days in a row.
Dr. Fauci stated that he would be interested in seeing a study that compared a course of Paxlovid taken over the course of five days to a course taken over the course of ten days "to see if you can prevent the rebound by giving it for five extra days."
Dr. Fauci completed his second course of treatment and said that his symptoms were "essentially gone." He had tested positive on Tuesday, but at the time of the interview on Wednesday, he had not yet tested himself again. Dr. Fauci noted that his symptoms were "essentially gone, except for a little bit of a stuffy nose."
"When people hear about people rebounding, I think there is understandable confusion," he said. "I think there is understandable confusion."
"Don't get that idea in your head that that's what Paxlovid was designed to do in the first place. It's not designed to stop you from getting back up after you fall. Its purpose is to keep you from having to check into a hospital. I'm 81 years old, I was at risk of being admitted to the hospital, and I didn't even come close to being sick enough to be admitted to the hospital."