FDA Commissioner Stresses Doctor Patient Relationship; Ohio Lifts HCQ Rule, while Most States Maintain Restrictions

FDA Commissioner appeared on the NBC Today program on July 30, and he emphasized on that occasion the doctor patient relationship. He also talked on other networks. This follows the “White Coat Summit” that attracted considerable attention and which we previously covered. 

While the FDA emphasizes the doctor patient relationship and does not prevent the use of hydroxychloroquine-based therapies for COVID-19, most US States keep on restricting hydroxychloroquine. See this document produced by the Association of American Physicians and Surgeons.

An interesting development was the intervention of the Governor of Ohio to request the boards regulating medical doctors and pharmacies to rescind their new regulations restricting the use of HCQ. 

Question: Once and for all, should people be taking hydroxychloroquine?

Hahn: “Just to be clear, we revoked an EUA – Emergency Use Authorization – at the request of another governmental agency BARDA, and this was for a drug that was used for sick hospitalized patients. We had data that when this drug is combined with others, there were some risks associated with that. But the question you are asking me is a decision between a doctor and a patient. A doctor and a patient need to assessed the data that is out there. FDA does not regulate the practice of medicine. And that’s in the privacy of the doctor patient relationship that this decision should be made. 

Question: Are you concerned about misinformation about this drug in particular

Hahan: “What I am concerned about is that FDA provides all the information available about the side-effects, potential side-effects as well as the efficacy. As you know, these drugs have been approved for number of years, for other indications by the FDA. We know they are safe in those settings. We want to make sure the right information is provided to (allow?) them make those decisions.”

In a related development, Hahn called on people having had COVID-19 to donate blood, to facilitate the use of plasma therapy.

Ohio Restricts, then Lifts Restriction on HCQ

On July 30, Ohio governor Richard Michael DeWine issued a statement regarding the use of hydroxychloroquine, which was about to be severely restricted in Ohio by its board of pharmacy.

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“I agree with the statement from Dr. Steven Hahn, Commissioner of the Food and Drug Administration, that the decision about prescribing hydroxychloroquine to treat COVID-19 should be between a doctor and a patient.  Therefore, I am asking the Ohio Board of Pharmacy to halt their new rule prohibiting the selling or dispensing of hydroxychloroquine or chloroquine for the treatment or prevention of COVID-19.  The Board of Pharmacy and the State Medical Board of Ohio should revisit the issue, listen to the best medical science, and open the process up for comment and testimony from experts.”

The justification that was advanced by the board of pharmacy is explained by its communications director.

“Basically, it’s a patient safety issue” … “We’re looking at the best science to determine what’s best for the patients of Ohio” … “They could still be used in clinical trials” said Cameron McNamee, director of policy and communications for the board.

https://www.usatoday.com/story/news/health/2020/07/30/ohio-pharmacy-board-reverses-hydroxychloroquine-ban-mike-dewine-request/5547751002/

See various statements below

Statement from Governor DeWine on Hydroxychloroquine

July 30, 2020

(COLUMBUS, Ohio)—Ohio Governor Mike DeWine issued the following statement regarding the new rule issued by the Ohio Board of Pharmacy regarding the use of hydroxychloroquine to treat COVID-19:

“I agree with the statement from Dr. Steven Hahn, Commissioner of the Food and Drug Administration, that the decision about prescribing hydroxychloroquine to treat COVID-19 should be between a doctor and a patient.  Therefore, I am asking the Ohio Board of Pharmacy to halt their new rule prohibiting the selling or dispensing of hydroxychloroquine or chloroquine for the treatment or prevention of COVID-19.  The Board of Pharmacy and the State Medical Board of Ohio should revisit the issue, listen to the best medical science, and open the process up for comment and testimony from experts.”

Richard Michael DeWine is an American politician and attorney currently serving as the 70th governor of Ohio. A member of the Republican Party, DeWine is a former United States Senator, elected in 1994 and re-elected in 2000.

July 30 2020 Update

Requirements for Dispensing or Selling Chloroquine and

Hydroxychloroquine in Ohio

As a result of the feedback received by the medical and patient community and at the request of Governor DeWine, the State of Ohio Board of Pharmacy has withdrawn proposed rule 4729:5-5-21 of the Administrative Code. Therefore, prohibitions on the prescribing of chloroquine and hydroxychloroquine in Ohio for the treatment of COVID-19 will not take effect at this time.

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This will allow the Board to reexamine the issue with the assistance of the State Medical Board of Ohio, clinical experts, and other stakeholders to determine appropriate next steps.

Licensees should be aware that emergency rule 4729-5-30.2 is no longer effective and the requirements of that rule, including the inclusion of a diagnosis code on any prescription for chloroquine and hydroxychloroquine, are no longer applicable. 

——————

July 20 2020 – Administrative Code Rule

4729:5-5-21 Prescription requirements for chloroquine and

hydroxychloroquine.

(A) No prescription for chloroquine or hydroxychloroquine may be dispensed by a pharmacist or sold at retail by a licensed terminal distributor of dangerous drugs, including prescriptions for patients residing in Ohio dispensed or sold at retail by nonresident terminal distributors of dangerous drugs as defined in rule 4729:5-8-01

of the Administrative Code, unless the prescription bears a written diagnosis code from the prescriber or a statement indicating its veterinary medical purpose.

(B) Except as provided in paragraph (C) of this rule, prescriptions issued for chloroquine or hydroxychloroquine for prophylactic use related to COVID-19 or for the treatment of COVID-19 are strictly prohibited unless otherwise approved by the board’s executive

director in consultation with the board president, at which time a resolution shall issue. Upon the effective date of this rule, all previous approvals for the use of chloroquine or hydroxychloroquine shall be deemed void and must be approved using the process outlined in this paragraph.

(C) The prohibition in paragraph (B) of this rule does not apply to prescriptions issued as part of a documented institutional review board-approved clinical trial to evaluate the safety and efficacy of the drugs to treat COVID-19. Prescriptions must include documentation that the patient is enrolled in a clinical trial.

(D) Paragraphs (B) and (C) of this rule shall also apply to medication orders and outpatient prescriptions dispensed by institutional pharmacies as defined in agency 4729 of the Administrative Code.

———

Emergency Rule for Dispensing Chloroquine and

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Hydroxychloroquine – Effective 3/22/2020

On March 22, 2020, Governor Mike DeWine authorized the State of Ohio Board of Pharmacy to file emergency rule 4729-5-30.2 of the Administrative Code, which reads:

4729-5-30.2 – Prescription requirements for chloroquine or

hydroxychloroquine

(A) Unless otherwise approved by the board’s executive director, no prescription for chloroquine or hydroxychloroquine may be dispensed by a pharmacist or sold at retail by a licensed terminal distributor of dangerous drugs unless all the following apply:

(1) The prescription bears a written diagnosis code from the prescriber; and

(2) If written for a COVID-19 diagnosis, the diagnosis has been confirmed by a positive test result, which is documented on the prescription and both of the following apply:

(a) The prescription is limited to no more than a fourteen-day supply; and

(b) No refills may be permitted unless a new prescription is furnished.

(B) Prescriptions for either presumptive positive patients or prophylactic use of chloroquine or hydroxychloroquine related to COVID-19 is strictly prohibited unless otherwise approved

by the board’s executive director in consultation with the board president, at which time a resolution shall issue.

This rule is now effective and enforceable.

To assist licensees in complying with this rule, the Board has developed the following frequently asked questions document: www.pharmacy.ohio.gov/COVIDrx 

If you need additional information, the most expedient way to have your questions answered is to e-mail the Board by visiting: www.pharmacy.ohio.gov/contact.

———

State Medical Board of Ohio – July 30 2020

Requirements for Dispensing or Selling Chloroquine and Hydroxychloroquine in Ohio

July 30, 2020

As a result of the feedback received by the medical and patient community and at the request of Governor DeWine, the State of Ohio Board of Pharmacy has withdrawn proposed rule 4729:5-5-21 of the Administrative Code. Therefore, prohibitions on the prescribing of chloroquine and hydroxychloroquine in Ohio for the treatment of COVID-19 will not take effect at this time. 

 This will allow the Pharmacy Board to reexamine the issue with the assistance of the State Medical Board of Ohio, clinical experts, and other stakeholders to determine appropriate next steps. 

Licensees should be aware that emergency rule 4729-5-30.2 is no longer effective and the requirements of that rule, including the inclusion of a diagnosis code on any prescription for chloroquine and hydroxychloroquine, are no longer applicable.  

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