Physicians and hospitals criticized for hoarding and illegal prescribing of unproven coronavirus treatments; State pharmacy boards respond by issuing rules to curtail use of chloroquine and hydroxychloroquine as a preventative and to ensure availability for lupus and ra patients
Physicians and hospitals are inappropriately hoarding and illegally prescribing chloroquine and hydroxychloroquine for their own use and for the use of family members and friends according to state pharmacy associations and pharmacy boards. The two drugs have been promoted by President Donald Trump as “game-changers” in the possible treatment of COVID-19. A nationwide shortage of hydroxychloroquine sulfate and chloroquine phosphate tablets for treatment of lupus and rheumatoid arthritis patients has now occurred according to the March 24, 2020 reports of the American Society for Health-System Pharmacists.
News reports of hoarding and illegal prescribing of the two drugs has been featured in national media including CNN, ProPublica, National Public Radio (NPR) and Business Insider. The national medical and hospital associations do not mention the hoarding and illegal prescribing problem in their press releases or websites.
Hydroxychloroquine, sold under the brand name Plaquenil, is approved by the Food and Drug Administration (“FDA”) for treatment of lupus and rheumatoid arthritis. Chloroquine is an FDA-approved anti-malarial treatment. The FDA has not approved either drug to prevent infection by coronavirus or for treatment of COVID-19. Both drugs are only available through a physician’s prescription and are not sold over the counter.
To date, only one small study has suggested that the combination of hydroxychloroquine and the antibiotic azithromycin (Z-pack) may be effective in treating COVID-19. According to Bloomberg’s report on the deadly nature of more than one gram of chloroquine, China used the anti-malarial to treat coronavirus-infected patients as the result of encouraging results in clinical trials—but later cautioned physicians and health officials about chloroquine’s lethal side effects and cut back its usage. Hydroxychloroquine is less toxic than chloroquine.
Off-label prescribing is a common and legal practice in medicine—but only for patients, not for personal use by physicians and their family members and friends. According to medical ethics norms, off-label prescribing is justified when scientific evidence suggests the efficacy and safety of a medication for an indication for which the medication does not have FDA approval and when the practice is supported by expert consensus or practice guidelines.
Several state pharmacy boards, including Idaho, Nevada, Ohio, Oklahoma, Texas and West Virginia, have enacted emergency rules to stop physicians from unnecessarily prescribing chloroquine and hydroxychloroquine and to ensure that necessary supplies of the drugs are available lupus and rheumatoid arthritis patients.
Adopted on March 20, 2020, the Texas Board of Pharmacy Rule 291.30, Medication Limitations, applies to all classes of pharmacies and states:
No prescription or medication order for chloroquine, hydroxychloroquine, mefloquine, or
azithromycin, may be dispensed or distributed unless all the following apply:
- the prescription or medication order bears a written diagnosis from the prescriber consistent with the evidence for its use;
- the prescription or medication order is limited to no more than a fourteen (14) day supply, unless the patient was previously established on the medication prior to the effective date of this rule; and
- no refills may be permitted unless a new prescription or medication order is furnished.
Like their national counterparts, the Texas Medical Association and the Texas Hospital Association have made no announcement through press release or website notice to their members. The Texas Medical Board and the Texas Department of State Health Services have no mention of the Pharmacy Board’s new rule on their websites.
On March 23, 2020 in response to the spread of COVID-19, President Trump signed Executive Order 13910 to prevent hoarding of health and medical resources necessary to respond to the spread of COVID-19 within the United States, such as personal protective equipment and sanitizing and disinfecting products. The Executive Order intends that the products are appropriately distributed and to further the goal of protecting the U.S. healthcare system from undue strain. President Trump delegated his authority under the Defense Production Act to the Secretary of Health and Human Services to designate such resources as scarce materials or materials the supply of which would be threatened by accumulation. The Act prohibits any person from accumulating designated scarce or threatened materials (1) in excess of the reasonable demands of business, personal, or home accumulation, or (2) for the purpose of resale at prices in excess of prevailing market prices. Included in the Executive Order’s list of scarce or threatened resources is…”Drug product with active ingredient chloroquine phosphate or hydroxychloroquine HCI…”.
This law firm recommends that any Texas physician, hospital, or other health care provider that has purchased or accumulated a drug product with active ingredient chloroquine phosphate or hydroxychloroquine HCI for their personal, family’s, or friends’ use of the drug product as a preventative or treatment or for distribution or accumulation to physicians and other health care workers as a preventative or treatment without following Texas Department of Pharmacy Rule 291.30 or in violation of the Executive Order, return the drug product to the pharmacy or pharmaceutical manufacturer or supplier from which the drug product was purchased. There is insufficient evidence-based clinical information and no expert consensus or practice guideline as to the safety and efficacy of either drug as a preventative of infection by coronavirus or for treatment of COVID-19.
Purchases of the drug product for off-label clinical use or for clinical trials is not considered hoarding unless the accumulation violates either of the two prohibited accumulation criteria above.
If you have any questions, or need more information, please contact Lew Lefko at the contact information above.