key: cord-0966733-9p31wskk
authors: Stoj, Victoria J.; Grant-Kels, Jane M.
title: Dermatoethics: Self-Prescribing Plaquenil during the COVID-19 Pandemic
date: 2020-04-23
journal: Int J Womens Dermatol
DOI: 10.1016/j.ijwd.2020.04.006
sha: 1b1300d760cc07aee7ea54f8bc060a5764330898
doc_id: 966733
cord_uid: 9p31wskk

nan

105 (Table 1 and 2) 1, [9] [10] [11] [12] [13] [14] [15] . In many jurisdictions, the laws and regulations are taking "The joint statement is in response to reports of physicians and others prophylactically prescribing, medications currently identified as potential treatments for COVID-19 (e.g., chloroquine or hydroxychloroquine, azithromycin) for themselves, their families, or their colleagues. There also are reports that some pharmacies and hospitals have been purchasing excessive amounts of these medications in anticipation of potentially using them for COVID-19 prevention and treatment. The organizations strongly oppose these actions. Prescribing hydroxychloroquine, chloroquine, and azithromycin for yourself, family, friends and co-workers in anticipation of a COVID-19 related illness can significantly impact drug supplies, which may negatively impact the health of existing patients who are established on these medications for the treatment of indicated disease states as approved by the FDA. Further, such prescribing may lead to improper use of these medications which can cause harm. Prescribers should exercise caution and refrain from prophylactic prescribing in light of the State of Public Health Disaster Emergency.  Prescribers should include the diagnosis code or diagnosis with prescriptions issued for hydroxychloroquine, chloroquine, and azithromycin. Including this information may prevent communications from the pharmacy which in turn will expedite the time to treat.  Prescribers should limit the amount prescribed of hydroxychloroquine, chloroquine, and azithromycin, unless otherwise deemed appropriate by the prescriber (e.g., 14-day supply, etc.)." Michigan 11 "The Michigan State Medical Society and the Michigan Pharmacists Association recognize the need to maintain adherence to appropriate prescribing and dispensing of prescription drugs…" . "…reminder that prescribing hydroxychloroquine or chloroquine with the intent to stockpile the drug may create a shortage for patients with lupus, rheumatoid arthritis, or other ailments for which chloroquine and hydroxychloroquine are proven treatments. Any prescription medicine that may be effective in treating COVID-19 must be reserved for Michigan's sickest and most vulnerable patients." New York 12 "No pharmacist shall dispense hydroxychloroquine or chloroquine except when written as prescribed for an FDA-approved indication; or as part of a state approved clinical trial related to COVID-19 for a patient who has tested positive for COVID-19, with such test result documented as part of the prescription. No other experimental or prophylactic use shall be permitted, and any permitted prescription is limited to one fourteen dayfourteen-day prescription with no refills. " Ohio 13 "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." "UPDATED 3/26/20 -the Pharmacy Board's Executive Director, in consultation with the Pharmacy Board President have authorized the dispensing of chloroquine or hydroxychloroquine for presumptive positive patients for either of the following:  For use 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.  For the continuation of inpatient treatment for COVID-19 using chloroquine or hydroxychloroquine for patients discharged from a hospital. The prescriber shall be required to notate on the prescription that the patient has been discharged from the hospital and the prescription shall be for no more than a fourteen-day supply."

Tennessee 14 "We want providers and pharmacists to act with their best discretion to ensure patients continue to receive appropriate treatment in times of shortages. We discourage inappropriate prescribing or hoarding of this medication for prophylaxis or treatment of COVID-19, which may limit access for patients that require these medications for therapy for approved indications. "The joint statement is in response to reports of physicians and others prophylactically prescribing, medications currently identified as potential treatments for COVID-19 (e.g., chloroquine or hydroxychloroquine, azithromycin) for themselves, their families, or their colleagues. There also are reports that some pharmacies and hospitals have been purchasing excessive amounts of these medications in anticipation of potentially using them for COVID-19 prevention and treatment. The organizations strongly oppose these actions.

Stockpiling these medications-or depleting supplies with excessive, anticipatory orders-can have grave consequences for patients with conditions such as lupus or rheumatoid arthritis if the drugs are not available in the community. The health care community must collectively balance the needs of patients taking medications on a regular basis for an existing condition with new prescriptions that may be needed for patients diagnosed with COVID-19. Being just stewards of limited resources is essential." 

Guideline/Statement Iowa 10  "Prescribing hydroxychloroquine, chloroquine and azithromycin for COVID-19 prophylactic use is discouraged and not recommend by the Boards at this time.

Prescribing hydroxychloroquine, chloroquine, and azithromycin for yourself, family, friends and co-workers in anticipation of a COVID-19 related illness can significantly impact drug supplies, which may negatively impact the health of existing patients who are established on these medications for the treatment of indicated disease states as approved by the FDA. Further, such prescribing may lead to improper use of these medications which can cause harm. Prescribers should exercise caution and refrain from prophylactic prescribing in light of the State of Public Health Disaster Emergency.  Prescribers should include the diagnosis code or diagnosis with prescriptions issued for hydroxychloroquine, chloroquine, and azithromycin. Including this information may prevent communications from the pharmacy which in turn will expedite the time to treat.  Prescribers should limit the amount prescribed of hydroxychloroquine, chloroquine, and azithromycin, unless otherwise deemed appropriate by the prescriber (e.g., 14-day supply, etc.)." Michigan 11 "The Michigan State Medical Society and the Michigan Pharmacists Association recognize the need to maintain adherence to appropriate prescribing and dispensing of prescription drugs…" . "…reminder that prescribing hydroxychloroquine or chloroquine with the intent to stockpile the drug may create a shortage for patients with lupus, rheumatoid arthritis, or other ailments for which chloroquine and hydroxychloroquine are proven treatments. Any prescription medicine that may be effective in treating COVID-19 must be reserved for Michigan's sickest and most vulnerable patients." New York 12 "No pharmacist shall dispense hydroxychloroquine or chloroquine except when written as prescribed for an FDA-approved indication; or as part of a state approved clinical trial related to COVID-19 for a patient who has tested positive for COVID-19, with such test result documented as part of the prescription. No other experimental or prophylactic use shall be permitted, and any permitted prescription is limited to one fourteen day prescription with no refills. " Ohio 13 "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." "UPDATED 3/26/20 -the Pharmacy Board's Executive Director, in consultation with the Pharmacy Board President have authorized the dispensing of chloroquine or hydroxychloroquine for presumptive positive patients for either of the following:  For use 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.  For the continuation of inpatient treatment for COVID-19 using chloroquine or 289 290 291 hydroxychloroquine for patients discharged from a hospital. The prescriber shall be required to notate on the prescription that the patient has been discharged from the hospital and the prescription shall be for no more than a fourteen-day supply."

Tennessee 14 "We want providers and pharmacists to act with their best discretion to ensure patients continue to receive appropriate treatment in times of shortages. We discourage inappropriate prescribing or hoarding of this medication for prophylaxis or treatment of COVID-19, which may limit access for patients that require these medications for therapy for approved indications. "

Re: Request for Emergency Use Authorization For Use

Chloroquine Phosphate or Hydroxychloroquine Sulfate Supplied From the 207 Strategic National Stockpile for Treatment of 2019 Coronavirus Disease. U.S. 208 Food and Drug Administration

Therapeutic Options for COVID-19 Patients. Centers for Disease 212 Control and Prevention

Hydroxychloroquine and azithromycin as a 216 treatment of COVID-19: results of an open-label non-randomized clinical trial

In Vitro Antiviral Activity and Projection of Optimized 221 Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute 222 Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Potential Shortages of Hydroxychloroquine 225 for Patients with Lupus During the Coronavirus Disease

Covid-19: six million doses of hydroxychloroquine donated to 229 US despite lack of evidence

States Say Some Doctors Stockpile Trial Coronavirus Drugs, for 231 Themselves. The New York Times

Treating Self or Family

AMA. AMA, APHA, ASHP issue joint statement about COVID-19 242 medications

11.12. Department of Licensing and Regulatory Affairs

State Medical Board of Ohio. Ohio Attorney General Dave Yost Issues 260 Statement on Prescribing Chloroquine and Hydroxychloroquine

!!N0rdg9Wr!8-273 ZCrb826gYkpwoNWXGIKkzQQTa7YlU20l5fU16jM1Uk7KjXZcnHw76pI9yL6Q$ 274 Last accessed

Table 1. Sources and Guidelines on Prescribing Hydroxychloroquine