The Politicization Of Hydroxychloroquine: Q & A With Dr. Jane Ruby

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Dr. Jane Ruby speaks with MRCTV's Beau Davidson about her personal experience with COVID-19 and her efforts to seek hydroxychloroquine as treatment.

Ruby claims, that as President Trump optimistically touts HCQ availability for Wuhan Virus victims, Democrat governors are systematically blocking the hopeful treatment, even against “Right to Try” laws for patients who want to try the treatment.

You can watch her discuss her experience in the video above.

MRCTV followed up with a series of questions for the Virginia Department of Health following the interview, the complete list of questions and the e-mailed responses from the VDH are available below:

1. What is your definition of "restricted usage" in the outpatient setting, and does that mean no off-label prescription?

Early reports suggested that stockpiling of hydroxychloroquine and other medications may have been occurring nationally through the issuance of prescriptions written for large quantities with refills for persons without COVID-19 disease resulting in shortages for patients that are taking these medications for chronic conditions. While prescribing for off-label use remains legal, “restricted usage” in this context refers to the practice of prescribing these medications only when there is sufficient evidence for the use of the drugs and to prioritize the medications in the outpatient setting for patients continuing therapy related to a non-COVID-19 diagnosis. Recently, both the Infectious Diseases Society of America and the National Institutes of Health released COVID-19 treatment guidelines. There continues to be a paucity of data. These drugs are recommended to be given in the context of a clinical trial, if available, when used for COVID-19.

2. What facilities are permitted to make such decisions? Are there specific facilities in VA conducting clinical trials?

All facilities should use the available literature, treatment guidelines, clinical experts, and local epidemiology to create facility-specific treatment guidelines for the diagnosis, management, and treatment of COVID-19. This should be a multi-disciplinary approach and as the knowledge surrounding this virus increases, guidelines should be revised.

There are facilities in Virginia participating in clinical trials, however, VDH does not keep a list. Information about individual clinical trials related to COVID-19 and the participating locations can be found here.

3. When you advise community pharmacists to use judgment to determine whether a prescription is "valid," do you mean to say this prohibits usage for COVID19 patients?

Pharmacists must always use professional judgement to ensure that only valid prescriptions are dispensed, as required by law. Commensurate with the Code of Virginia, a valid prescription is one that is issued for a medicinal or therapeutic purpose in the usual course of treatment or for authorized research and when a bona fide practitioner-patient-pharmacist relationship exists. Pharmacists are not prohibited from dispensing drugs pursuant to valid prescriptions for COVID-19 patients. However, because evidence for the use of these drugs for COVID-19 patients is limited and recent national trends suggested inappropriate prescribing for stockpiling or hoarding purposes resulting in drug shortages for those patients using these drugs for chronic conditions, pharmacists were reminded to use professional judgement to ensure the prescription is valid and is not simply an attempt to stockpile or hoard drug.

VDH also provides additional recommendations for in the treatment of COVID-19 at

http://www.vdh.virginia.gov/coronavirus/frequently-asked-questions/disease-treatment/

4. Is there an adequate supply of these specific drugs in pharmacies across Virginia, or in the public facilities as well?

Hydroxychloroquine and chloroquine are two medications being evaluated for possible effectiveness against the novel coronavirus COVID-19. The safety and efficacy of these medications have not been approved by the Food and Drug Administration for use in COVID-19 treatment. With COVID-19 response rapidly evolving, we may experience some changes in drug supply. However, supply must be protected for patients who have existing prescriptions for these drugs that are non-COVID-19 related for conditions such as Lupus, Arthritis, Sjogren’s

Syndrome and other autoimmune disorders.

Early patterns of prescribing across the nation initially showed prescriptions being written for people without active COVID-19. This may have temporarily increased the likelihood of a potential shortage for patients who have a confirmed diagnosis of COVID-19 and for people who need this medication for ongoing treatment of chronic conditions. Overall, pharmacists report that drug shortages in hydroxychloroquine have improved since the issuance of the Clinician Letter and any shortages currently appear to be sporadic and regional.

In effort to ensure the continued availability of hydroxychloroquine, additional efforts have been put into action. There have been some restrictions on prescription amounts by pharmacies and insurance companies to conserve this medication supply. Some insurance companies are adding prior authorizations in efforts to increase access to those who really need hydroxychloroquine and to mitigate a potential drug shortage. Efforts to increase production by Mylan, Teva, Sanofi, Novartis, and other manufacturers of hydroxychloroquine will notably help ensure medication will be available for all who need it. The FDA has also allowed outsourcing facilities and pharmacies to compound hydroxychloroquine or chloroquine phosphate. The FDA has continued to work with manufacturers to increase supply and manufacturing. Several states, including but not limited to Idaho, Ohio, Texas, Nevada, and Rhode Island, have implemented policies to place restrictions on prescribing and dispensing. All of the measures above are to protect the continued supply, discourage hoarding the drug or to worry excessively about being unable to obtain it.

5. If a COVID19 patient is quarantined at home and not hospitalized, is it VA policy to prevent that patient from receiving hydroxychloroquine, azithromycin, or other anti-virals?

The drugs listed are prescription medications and can be prescribed by authorized healthcare providers and dispensed by pharmacists in accordance with the Code of Virginia (referenced above in question 3). VDH does not prevent patients receiving medications that are prescribed in a legal and ethical manner.

At this time, the CDC recommended treatment in an outpatient setting consists of supportive care, relief of symptoms, drinking plenty of fluids, staying at home to rest, and practicing home isolation and social distancing within the household to avoid spreading infection to others. Over- the-counter (OTC) medication can help with symptoms. All OTC medication should be used according to the package instructions. For persons with mild illness, these measures may be all that is needed. For persons who develop emergency warning signs (e.g., trouble breathing, persistent pain or pressure in the chest, new confusion or inability to arouse or bluish lips) immediate medical attention is needed and 911 should be called.

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