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Vaccine Rollout Needs Better Healthcare Regulations
Townhall.com ^ | December 24, 2020 | Leah Vukmir

Posted on 12/24/2020 10:33:54 AM PST by Kaslin

Hope is here for those awaiting a COVID-19 vaccine. Three pharmaceutical companies, AstraZeneca, Moderna and Pfizer have reported efficacy rates of 90%, 94.5% and 95% respectively. This is encouraging news almost a year since the start of the devastating COVID-19 global pandemic.

As plans ramp up for distribution and administration of the vaccine, state lawmakers should enact public policies to facilitate widespread administration to countless Americans. They should start by reviewing and revising pharmacy practice statutes in preparation for a vaccine many will flock to receive. Pharmacists are integral members of the army of health care providers who will be needed for wide scale vaccine administration.

The U.S. Department of Health and Human Services (HHS) has taken important, but insufficient, steps in the right direction. In September of this year, it issued a Guidance for licensed pharmacists and pharmacy interns regarding the COVID-19 vaccine. One month later, HHS issued another Guidance regulating pharmacy technicians and interns relating to childhood vaccine administration and COVID-19 testing.

While these actions are intended to provide a clear path for comprehensive administration, in actuality they are a “one-size fits all” approach that may actually hinder pharmacists, interns and technicians in some states from participating in a wide scale vaccination plan. Some states have eased restrictions on pharmacists, interns and technicians more than what is allowed under the HHS guidances. HHS recognized this possibility could exist and permits that in those cases states may follow their own statutes for pharmacist administration.

At first blush this sounds ideal - providing states with the authority to decide. Unfortunately, an unintended consequence of this allowance is that some states will be forced to follow the more restrictive HHS guidelines because their state statutes only relate to FDA-approved vaccines. The new COVID-19 vaccines are not currently FDA-approved. They are, instead, allowed under an Emergency Use Authorization from the federal government. As such, states would have no choice but to follow more restrictive guidelines if they want to administer the new vaccine.

There are three key obstacles in the HHS Guidance reports for states on the forefront of pharmacist practice reform:

The first barrier is the requirement that licensed pharmacists must complete a minimum of two hours of approved immunization-related continuing pharmacy education during each state licensing period. Many states do not require continuing education specific to immunizations. This requirement will place a strain on pharmacists and their state examining boards. The additional training requirement will serve as an obstacle for pharmacists who will need to find and complete immunization-specific continuing education in the coming weeks in order to participate in COVID-19 vaccine administration.

Another barrier the HHS guidance presents relates to the requirement that pharmacy technicians be “certified” in order to administer vaccines. In many states, pharmacy technician certification is not mandated. While many health care systems, pharmacy chains and individual pharmacies require certification, they are not mandated by the state since the technicians are under the direct supervision of the pharmacist. If a technician is not currently certified, it will be extremely challenging for them to get certified in the coming weeks. These technicians will greatly help in mass vaccine administration efforts.

A final impediment in the HHS issued guidance is the requirement that licensed pharmacists must inform vaccine patients who are children and their parents of the importance of primary care well-child health visits with licensed providers. Once again, not all states require this advice from the pharmacist. Teenagers aged 16-18 years who - in many states - do not legally need to have an adult present to receive vaccines will find themselves in the position of not being able to walk or drive themselves to the pharmacy. This inconvenience could lead to delays in vaccine administration, especially in rural areas.

While these actions are intended to provide a clear path for comprehensive administration, in actuality they are a “one-size fits all” approach that may actually hinder pharmacists, interns and technicians in some states from participating in a wide scale vaccination plan. Some states have eased restrictions on pharmacists, interns and technicians more than what is allowed under the HHS guidances. HHS recognized this possibility could exist and permits that in those cases states may follow their own statutes for pharmacist administration.

At first blush this sounds ideal - providing states with the authority to decide. Unfortunately, an unintended consequence of this allowance is that some states will be forced to follow the more restrictive HHS guidelines because their state statutes only relate to FDA-approved vaccines. The new COVID-19 vaccines are not currently FDA-approved. They are, instead, allowed under an Emergency Use Authorization from the federal government. As such, states would have no choice but to follow more restrictive guidelines if they want to administer the new vaccine.

There are three key obstacles in the HHS Guidance reports for states on the forefront of pharmacist practice reform:

The first barrier is the requirement that licensed pharmacists must complete a minimum of two hours of approved immunization-related continuing pharmacy education during each state licensing period. Many states do not require continuing education specific to immunizations. This requirement will place a strain on pharmacists and their state examining boards. The additional training requirement will serve as an obstacle for pharmacists who will need to find and complete immunization-specific continuing education in the coming weeks in order to participate in COVID-19 vaccine administration.

Another barrier the HHS guidance presents relates to the requirement that pharmacy technicians be “certified” in order to administer vaccines. In many states, pharmacy technician certification is not mandated. While many health care systems, pharmacy chains and individual pharmacies require certification, they are not mandated by the state since the technicians are under the direct supervision of the pharmacist. If a technician is not currently certified, it will be extremely challenging for them to get certified in the coming weeks. These technicians will greatly help in mass vaccine administration efforts.

A final impediment in the HHS issued guidance is the requirement that licensed pharmacists must inform vaccine patients who are children and their parents of the importance of primary care well-child health visits with licensed providers. Once again, not all states require this advice from the pharmacist. Teenagers aged 16-18 years who - in many states - do not legally need to have an adult present to receive vaccines will find themselves in the position of not being able to walk or drive themselves to the pharmacy. This inconvenience could lead to delays in vaccine administration, especially in rural areas.


TOPICS: Culture/Society; Editorial; Government
KEYWORDS: coronavirus; fda; hhs; vaccine

1 posted on 12/24/2020 10:33:54 AM PST by Kaslin
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To: Kaslin
As Fauci has said many times....this vaccine will not stop you from getting Covid....

and from another source...you just won't get so sick and die.

2 posted on 12/24/2020 10:37:43 AM PST by Sacajaweau
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To: Kaslin

I don’t feel safe leaving home to get the vaccine. Mail it to me and I will mail back saying I took it. Just as good as voting by mail.


3 posted on 12/24/2020 10:38:48 AM PST by JerryBlackwell (some animals are more equal than others)
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To: Sacajaweau

Sacajaweau wrote: “As Fauci has said many times....this vaccine will not stop you from getting Covid....”

That’ incorrect. Fauci said they hadn’t tested the Pfizer vaccine to see if it stopped infection only that it prevented the symptoms. They have tested the other vaccine and it does prevent infections.


4 posted on 12/24/2020 10:45:26 AM PST by DugwayDuke (Biden - Not My President!)
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To: Kaslin

I’m sorry it’s a burden for pharmacists to get two hours of CME in a license period. I have to do 80 hours with six hours of mandatories on things that are shall we say politically driven

I am sorry the pharmacists are annoyed that they need to refer people to primary care. Gee. This is appropriate. Pharmacists aren’t physicians snd do not and should not have prescriptive authority.

I agree with HHS in these regulations. They frankly are not enough. However, given the gross amount of medicine practiced right here on freerepublic by non licensed people I guess I shouldn’t complain.


5 posted on 12/24/2020 10:46:03 AM PST by gas_dr (Trial lawyers AND POLITICIANS are Endangering Every Patient in America: INCLUDING THEIR LIBERTIES)
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To: Kaslin
Both the wife and I have had the china virus. Neither of us is comfortable about the vaccines. Although Uncle Sam injected me plenty from birth through to my separation in '83 there is something about this that just doesn't feel right.
The last couple decades have taught me to be leery of anything Uncle Sam does, and especially so of anything they really want to give you.
It just seems that this virus is too convenient. The vaccine coming out after the election is too convenient. The vaccine being free is too convenient. The WHO suddenly redefining what Herd Immunity is and does and how it is obtained is too convenient.
My wife is a nurse and has turned down the free shot twice. She just texted me that they are subtly suggesting that she get one.
Are we just paranoid?
6 posted on 12/24/2020 10:47:58 AM PST by Semper Vigilantis (FYI: People SUCCEED, States SECEDE.)
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To: gas_dr

I never take medical advise posted here on FR.

I use Dr. Google.

:)


7 posted on 12/24/2020 10:48:00 AM PST by 2111USMC (Aim Small Miss Small)
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To: DugwayDuke

https://www.webmd.com/vaccines/covid-19-vaccine/news/20201027/early-vaccines-wil-prevent-symptoms-not-virus


8 posted on 12/24/2020 10:49:04 AM PST by Sacajaweau
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To: 2111USMC

Shockingly that is probably safer.


9 posted on 12/24/2020 10:49:19 AM PST by gas_dr (Trial lawyers AND POLITICIANS are Endangering Every Patient in America: INCLUDING THEIR LIBERTIES)
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To: 2111USMC

advise = advice


10 posted on 12/24/2020 10:49:34 AM PST by 2111USMC (Aim Small Miss Small)
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To: Kaslin
Vaccine Rollout Needs Better Healthcare Regulations

The vaccine rollout needs a better rollout. No indication how or when my elderly mom can get vaccinated. Her primary care physician says he hasn't heard anything about it, and her pharmacy says the same thing.
11 posted on 12/24/2020 10:50:26 AM PST by AnotherUnixGeek
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To: Sacajaweau

Screw vaccines. ESPECIALLY this one !

You’re a MORON of you get this messenger RNA bullcrap

But it’s a free country to be a moron


12 posted on 12/24/2020 10:56:55 AM PST by Truthoverpower (The guv-mint you get is the Trump winning express ! Yea haw ! Trump Pence II! Save America again )
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To: Semper Vigilantis

I am a registered nurse and this week the free vax’s have been offered. Me and at least 5 nurses I know are not taking it. I see them pushing it but will respond with “My Body My Choice”. If the say I could be responsible with someone’s death I’ll say just what abortion does. Im sorry. I do not trust the government


13 posted on 12/24/2020 11:00:38 AM PST by Osagegirl
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To: Kaslin

Not enthusiastic about the vaccine but going the regulatory approach would probably delay implementation for at least a year, if not longer. Changing regulations is like steering a battleship, not done quickly or easily.


14 posted on 12/24/2020 11:33:16 AM PST by caseinpoint (Don't get thickly involved in thin things.)
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To: Truthoverpower
You’re a MORON of you get this messenger RNA bullcrap

Do you even know what mRNA is? Do you even know what a virus is and how it infects you?

15 posted on 12/24/2020 11:33:49 AM PST by Republican Wildcat
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To: Sacajaweau

Yes, I understand Fauci said that, but there is new information now available. (Your link is dated 28 Oct, that’s two months ago.)

Link partially quoted:

Unlike Pfizer, Moderna has preliminary data that suggest its vaccine stops infection, not just symptoms.

Some early data suggest that the Moderna vaccine might protect vaccinated people from asymptomatic infections as well as symptomatic disease. While it’s clear that the vaccine, along with Pfizer’s, prevents people from developing COVID-19 symptoms, stopping infections entirely is crucial to curb the coronavirus’ spread and build immunity in communities.

Of more than 14,000 people who received a placebo, 38 tested positive for the coronavirus — without showing symptoms — after their first injection but before their second. Only 14 who received the Moderna vaccine, however, were asymptomatic carriers of the virus when those people were tested before their second dose, the company reported. That two-third reduction in COVID-19 cases without symptoms in the vaccine arm of the trial compared with the placebo group hints that some infections could be prevented, even after a single vaccine dose.

Pfizer hasn’t yet released any data showing whether its vaccine prevents asymptomatic COVID-19 cases. But because it works much like Moderna’s does, “I don’t think there’s any reason to believe that there will be a difference between the two,” Naggie says.

https://www.clevescene.com/scene-and-heard/archives/2020/12/24/how-does-the-moderna-covid-19-vaccine-compare-to-pfizers


16 posted on 12/24/2020 11:38:36 AM PST by DugwayDuke (Biden - Not My President!)
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To: Truthoverpower

You’re a moron if you don’t understand mRNA and continue to rail against it with incorrect knowledge. Just sayin!


17 posted on 12/24/2020 11:45:05 AM PST by gas_dr (Trial lawyers AND POLITICIANS are Endangering Every Patient in America: INCLUDING THEIR LIBERTIES)
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To: Kaslin
I have a cousin who is a principal in a major venture capital firm and I found out today that his entire family including relatives who flew up from out of state just for this purpose were given the vaccine this week. None of them are high risk. Just rich liberals.

This is how it's working.

18 posted on 12/24/2020 1:35:07 PM PST by pepsi_junkie (Often wrong, but never in doubt!)
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To: Truthoverpower

“You’re a MORON of you get this messenger RNA bullcrap.”

Sorry, never learned to speak gibberish.


19 posted on 12/24/2020 3:53:45 PM PST by traderrob6
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