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West Virginia University College of Law
West Virginia Regulation Off-Label Use of Drugs for COVID-19 Treatment
In the 2022 Regular Session of the West Virginia ( WV ) Legislature , HB 4309 was introduced regarding the off-label use of three drugs to treat coronavirus disease ( COVID-19 ). If passed , HB 4309 would authorize physicians and pharmacists to fill and dispense hydroxychloroquine , chloroquine , or ivermectin to inpatients and outpatients with COVID-19 .
Hydroxychloroquine and chloroquine are both approved to treat and prevent malaria . The Food and Drug Administration ( FDA ) approves ivermectin as an antiparasitic drug . These drugs have been found to have an off-label use as a prophylaxis for patients with COVID-19 . Delegate Guy Ward , primary sponsor of the bill , claims there is more evidence that these drugs are effective against COVID-19 , but that “ many healthcare professionals are reluctant to prescribe them because of the negativity about these drugs coming from mainstream national media .”
WV ’ s HB 4309 § 30-3-16a would grant physicians , physician assistants , or advanced practice registered nurses with prescriptive authority to prescribe these drugs for off-label use as a therapeutic drug for treating both outpatients and inpatients with COVID-19 . The bill claims that the off-label use of the drugs as a therapeutic drug provides prophylaxis for patients with COVID-19 .
WV ’ s HB 4309 § 30-5-10a would require that pharmacists fill therapeutic drugs for patients with COVID-19 if the drugs are available and prescribed . If a pharmacist does not fill or dispense the prescriptions when the drugs are available , the pharmacist will be subject to a $ 5,000 fine . The bill states that filling and dispensing the prescribed drug would not constitute unprofessional conduct or other grounds for discipline . The bill further states that if a patient does react to these drugs , the pharmacist that filled the drugs is not subject to any liability .
While WV Legislature HB 4309 would allow for the prescription of hydroxychloroquine , chloroquine , and ivermectin for the off-label use of COVID-19 , the FDA has warned against this off-label use of these drugs for COVID-19 treatment .
In March 2020 , the FDA approved an Emergency Use Authorization ( EUA ) to allow the distribution of hydroxychloroquine and chloroquine to treat adult and adolescent COVID-19 patients of at least 110 pounds and hospitalized with COVID-19 when a clinical trial is not available or participation is not feasible .
However , in April 2020 , the FDA issued a Drug Safety Communication ( DSC ) cautioning against the off-label use of hydroxychloroquine or chloroquine for COVID-19 outside hospital settings or clinical trials . The FDA issued this DSC due to the risk of arrhythmias . The FDA and the National Institutes of Health stated that “ hydroxychloroquine should ONLY be taken for the treatment of COVID-19 under the direction of a doctor in a clinical study .” Due to the risk of abnormal heart rhythms from these drugs , the FDA had limited the EUA to only inpatients , so the patient could be under careful heart monitoring .
Further , the FDA has not yet authorized or approved Ivermectin to treat patients with COVID-19 . The FDA advises against the use of Ivermectin to treat or prevent COVID-19 , stating that there is currently no data available to show that Ivermectin is effective against COVID-19 .
WV Legislature HB 4309 has been sent to the House Health and Human Resources . WV HH 4309 could offer more accessible treatment plans for COVID-19 but could also create risks to patients given the FDA advisory on the off-label use of these drugs . If this bill passes , it will require pharmacists to fill these prescriptions for the off-label use to both inpatients and outpatients or risk getting a $ 5,000 fine . The bill does offer some protection to pharmacists fulfilling the prescription by preventing any liability for patients ’ reactions to the off-label use . Healthcare providers should be aware of the risks associated with the off-label use of these drugs to best inform their patients .
References
1 . H . B . 4309 , 2022 Reg . Sess . ( W . Va . 2022 ). https :// www . wvlegislature . gov / Bill _ Status / bills _ text . cfm ? billdoc = HB4309 % 20 INTR . htm & yr = 2022 & sesstype = RS & i = 4309 .
2 . H . B . 4309 , 2022 Reg . Sess . ( W . Va . 2022 ). https :// www . wvlegislature . gov / Bill _ Status / bills _ text . cfm ? billdoc = HB4309 % 20 INTR . htm & yr = 2022 & sesstype = RS & i = 4309 .
3 . AHFS Patient Medication Information . Bethesda ( MD ): American Society of Health-System Pharmacists , Inc .; c2019 . Hydroxychloroquine ; [ updated 2020 October 15 ; cited 2022 August 5 ]. https :// medlineplus . gov / druginfo / meds / a601240 . html .
4 . Food and Drug Administration , ( 2021 , December 10 ) Why You Should Not Use Ivermectin to Treat or Prevent COVID-19 . U . S . Food & Drug Administration . https :// www . fda . gov / consumers / consumer-updates / why-you-should-not-use-ivermectin-treat-orprevent-covid-19 .
5 . WDTV News Staff . ( 2022 January 20 ). Bill introduced by House that would allow prescription of certain drugs to treat COVID-19 . WDTV . https :// www . wdtv . com / 2022 / 01 / 20 / bill-introduced-byhouse-that-would-allow-prescription-certain-drugs-treat-covid-19 /.
6 . H . B . 4309 , 2022 Reg . Sess . ( W . Va . 2022 ). https :// www . wvlegislature . gov / Bill _ Status / bills _ text . cfm ? billdoc = HB4309 % 20 INTR . htm & yr = 2022 & sesstype = RS & i = 4309 .
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