UPDATE 7/30/2020: At the request of Governor DeWine, the Ohio Board of Pharmacy has withdrawn this rule and will reexamine the issue.
COLUMBUS (WCMH) — Beginning July 30, an Ohio Board of Pharmacy rule goes into effect banning the dispensing of hydroxychloroquine for the treatment or prevention of COVID-19.
The rule prohibits pharmacies from selling or dispensing hydroxychloroquine and chloroquine for use as a coronavirus treatment without approval from the board’s executive director. It also specifies that all prior approvals for the drugs are no longer applicable.
The rule does not apply to board-approved clinical trials. Participants must have documentation that they are part of such a trial. It does not apply to prescriptions to treat other conditions.
The rule reads:
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 COVID19 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
REMINDER: Based on ongoing analysis and emerging scientific data, FDA has revokedOhio Board of Pharmacy
the emergency use authorization (EUA) to use hydroxychloroquine and chloroquine to
treat COVID-19 in certain hospitalized patients when a clinical trial is unavailable or
participation is not feasible. The agency made this determination based on recent results
from a large, randomized clinical trial in hospitalized patients that found these medicines
showed no benefit for decreasing the likelihood of death or speeding recovery.
Scientific studies have shown hydroxychloroquine can do more harm than good when used to treat symptoms of COVID-19.
Many high-quality studies have found no evidence that hydroxychloroquine, when used with or without the antibiotic azithromycin, helps treat coronavirus infection or prevent serious disease from it. They include studies commissioned by the U.S. National Institutes of Health, the World Health Organization and universities in the U.S. and around the world.
Because of the lack of benefit and the risks of serious side effects such as heart rhythm problems, the U.S. Food and Drug Administration recently revoked its brief authorization of emergency use of the drug for COVID-19. NIH treatment guidelines also specifically recommend against hydroxychloroquine’s use, except in formal studies.
The Associated Press contributed to this report.