People in North Carolina trying to get a COVID-19 vaccine at a local pharmacy might be a bit confused these days over whether they need a prescription.
On Monday, state health director Larry Greenblatt rescinded a standing order that had been in place since Sept. 12 that acted as a statewide prescription for anyone 65 and older to roll up their sleeve for a pharmacist and get a jab. The order also covered anyone 18 and older with certain medical conditions and risk factors.
Now, though, federal guidelines have changed, generating questions about who is eligible for the vaccine and what those who qualify need so they can get one.
Jay Campbell, executive director of the North Carolina Board of Pharmacy, has waded through the new Centers for Disease Control and Prevention (CDC) guidelines and matched them with requirements under state law.
Here’s how he breaks down who can get a COVID vaccine at a North Carolina pharmacy.
For any adult 18 and older:
- They can get a vaccine with a prescription.
- Anyone without a prescription can get a shot after having a conversation about the pros and cons of vaccination with a pharmacist. “The CDC says that’s shared clinical decision making,” Campbell said. “All that really means is the pharmacist and the patient should have a discussion about the COVID vaccine, and then the patient makes the decision.”
For pediatric patients:
- Anyone ages 7 to 18 can also come into a pharmacy and obtain a vaccine without a prescription—with parental or guardian consent and the shared decision-making with a pharmacist.
- Parents or caregivers of children younger than 7 should contact their health care provider, a local clinic or health department to find out if they are offering COVID vaccines, according to the state Department of Health and Human Services.
The CDC updated its immunization schedules on Oct. 6 for children and adults to include recent recommendations by the CDC’s Advisory Committee on Immunization Practices—a group at the root of much controversy since U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. fired all of the previous members and seated his own, some who share his long-held vaccine skepticism.
The new guidelines incorporate the committee’s recommendations for “shared clinical decision-making, which references “providers including physicians, nurses and pharmacists.”
‘Informed consent’
For several years after the development of the COVID vaccines during the first administration of President Donald Trump under Operation Warp Speed, the federal effort that created an accelerated time frame during the pandemic from the clinical trial phase to the manufacturing and distribution, many became accustomed to easy access to the shots for anyone six months and older.
Now that Kennedy is leading the public health agency things have changed.
“Informed consent is back,” Jim O’Neill, Deputy Secretary of Health and Human Services and acting CDC director, said in a statement announcing the new guidelines. “CDC's 2022 blanket recommendation for perpetual COVID-19 boosters deterred health care providers from talking about the risks and benefits of vaccination for the individual patient or parent. That changes today.”
The system has become a bit more complex, requiring the extra step of a discussion with a clinician. Still, to the relief of many in public health, the new guidelines stop short of requiring a prescription for the vaccines. That proposal was narrowly defeated by the new advisory committee meeting in September.
Much of the uncertainty that has reigned in recent months about who can get a COVID vaccine comes after the U.S. Food and Drug Administration rescinded the Emergency Use Authorization of the shots put in place during the pandemic. At the same time, the FDA approved a new round of COVID boosters that target the newer strains of the virus but caused unease when the agency limited them to people who are 65 or older or have other health risks.
Public health advocates raised concerns about excluding healthy children from access as some places, North Carolina included, were seeing late summer COVID surges.
The rescinding of the Emergency Use Authorization before Kennedy’s new immunization advisory committee developed new guidelines for the shots created the dilemma in North Carolina that prompted Greenblatt, state health director since May 25, to issue his standing order that was in place from Sept. 12 to Oct. 13.
Bridging the gap
By law, pharmacists in North Carolina follow the advisory committee guidelines. So, without the emergency authorization, people who didn’t meet the FDA criteria had to prove their “need” for a shot by providing a prescription. Lack of authorization could lead some insurers to not cover the cost of the shot.
Pharmacists and other health care providers were uncertain how to proceed and let the state health department and pharmacy board know.
“It’s been a lot more complicated this fall than it ever has been,” Campbell told NC Health News.
Campbell laid out the timeline, noting that before the CDC incorporated the advisory committee’s recommendations into its vaccine guidelines, pharmacists were able to administer the COVID vaccines to anybody with a prescription.
“That created this whole thing where everybody was like, ‘Well good grief, do I have to have an office visit to get a prescription?’” Campbell said.
That put stress on health care providers who had to either arrange in-office visits or take the time to phone in prescriptions for vaccines that had been readily available. Greenblatt’s standing order addressed that gap.
“I very much appreciate Dr. Greenblatt and his team over at DHHS working with us to help bridge the availability challenge,” Campbell said.
In announcing the decision to rescind the order, the state health department said it had helped more than 80,000 people in North Carolina get the vaccine under Greenblatt’s order.
"Our goal is to improve access and reduce barriers to getting and staying healthy and vaccines remain the best way to protect yourself, loved ones, and your community," Devdutta Sangvai, DHHS secretary, said in a statement. "The COVID-19 vaccine is one of the most effective means available to prevent serious illness, hospitalization, and death this respiratory season. We are grateful that North Carolinians who choose to receive the vaccine have an easily accessible path forward to do so."
This article first appeared on North Carolina Health News and is republished here under a Creative Commons Attribution-NoDerivatives 4.0 International License.
North Carolina Health News is an independent, non-partisan, not-for-profit, statewide news organization dedicated to covering all things health care in North Carolina. Visit NCHN at northcarolinahealthnews.org.
