Pharmacists Are Stepping Up To Stop Drug Hoarding
On March 20, as the coronavirus pandemic continued to escalate, President Trump touted an anti-malarial drug, hydroxychloroquine, as a potential “game changer” in the battle against COVID-19. His comments were in reference to a small study in France, which claimed that a combination of hydroxychloroquine and the antibiotic azithromycin helped COVID-19 patients recover. Although Dr. Anthony Fauci (during the same press briefing) urged caution and stated that these drugs could not be used to prevent—rather than treat—COVID-19, President Trump’s comments nonetheless ignited a chain reaction that quickly rippled all across the country.
Hydroxychloroquine is not only an anti-malarial drug; it is also widely used to treat lupus and rheumatoid arthritis. Just days after the President speculated that the it could be used for COVID-19, some doctors began hoarding hydroxychloroquine (and the related drug from which it is derived, chloroquine) by writing prescriptions for themselves, their families, and office staff. Some doctors told pharmacy staff that the purported patient had rheumatoid arthritis or lupus, which the pharmacist suspected was not true based on that person’s medical history. In other cases, doctors attempted to call in prescriptions for hundreds of pills at a time, or with unlimited refills, yet refused to specify a diagnosis.
Reports began rolling in from all over the country that patients who needed the drugs for their approved indications could not get them. These drug shortages posed a serious health risk to patients who depend on those medications to stay well, particularly those with lupus. Lupus is a systemic autoimmune disease that causes inflammation affecting many different body systems. Without proper treatment, patients can suffer potentially fatal organ damage. Even in the short term, withdrawal from hydroxychloroquine can trigger flare-ups that cause fever, fatigue, joint pain, and/or ulcers. There is no good alternative treatment.
The doctors’ stockpiling quickly drew the ire of enforcement officials, state governments, and medical associations. The U.S. Attorney in Cleveland issued a statement vowing: “If there’s a shortage that’s driven by panic in the medical profession, that cannot stand. So we are committed to going after this.” Ohio Attorney General David Yost warned, “Where we find doctors or others who are abusing their professional licenses to help themselves or associates, we will move swiftly to identify and prosecute any wrongdoing that is a violation of federal or state law.” And the president of the American Medical Association issued a statement “calling for a stop to any inappropriate prescribing and ordering of medications, including chloroquine or hydroxychloroquine, and appealing to physicians and all health care professionals to follow the highest standards of professionalism and ethics.”
Though the practice of hoarding medications is ethically dubious (one pharmacist likened it to “the captain of a ship taking the only lifeboat where other passengers are forced to drown”), it is unclear whether the prescribing physicians’ conduct is actually illegal. Doctors are permitted to, and regularly do, prescribe drugs for off-label uses. Moreover, hydroxychloroquine and chloroquine have little potential for abuse and are not strictly regulated. Accordingly, unlike opioids or even Ritalin, their prescription and distribution is not subject to prosecution or enforcement actions under the federal Controlled Substances Act. If doctors are falsifying diagnoses, they may be liable under the civil False Claims Act (FCA), but this would require the submission of a claim for payment to a federal program such as Medicare; if the doctors paid cash or used private insurance, there would be no FCA violation (though they may have violated state fraud laws). Attorney General Barr has threatened to use a provision of the Defense Production Act to prosecute people who hoard medical supplies like masks and respirators and sell them at excessive prices. However, this statute would not apply to drug hoarding by physicians, both because drugs are not encompassed within the law’s definition of “materials” and because there is no indication that these doctors plans to resell the medications, rather than keep them for personal use.
For now, individual pharmacists, as well as state boards of pharmacy, have stepped up to plug this enforcement gap and preserve supplies of the drugs for current patients. Because hydroxychloroquine and chloroquine are not controlled substances, pharmacists do not have a “corresponding responsibility” under DEA regulations to fill only those prescriptions “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” See 21 C.F.R. 1304(a). Nonetheless, many pharmacists recently have assumed the responsibility to refuse to fill hydroxychloroquine and chloroquine prescriptions that are indicative of hoarding. In several states, pharmacy boards have issued emergency restrictions or guidelines instructing pharmacists not to fill prescriptions under suspicious circumstances. In other states, governors have issued executive orders doing the same, based on advice from their state’s pharmacy board. Presently, the states with some sort of restriction include Idaho, Kentucky, Nevada, North Carolina, Ohio, Oklahoma, Texas, and West Virginia. Other states will likely follow suit.
The emergency restrictions vary from state to state, but have included prohibitions on dispensing the drugs unless the prescription contains a written diagnosis of a condition the drugs have been proven to treat (i.e., lupus or rheumatoid arthritis) restricting prescriptions to a 14-day supply unless a patient has previously taken the medications, barring prescriptions for COVID-19 unless the patient had tested positive for the virus (to discourage prophylactic use), and empowering pharmacists to utilize their professional judgment to refuse to fill a prescription if doctors are writing for themselves or family members or in excessive quantities. The Illinois Pharmacists Association also instructed its members about how to file administrative complaints against doctors prescribing the medications inappropriately.
On March 30, the FDA unexpectedly granted an emergency use authorization (EUA) permitting hospitals to use hydroxychloroquine and chloroquine to treat COVID-19 patients. This is not the same as FDA approval for this use, but rather reflects the agency’s determination that in the context of the present public health emergency—in which no other treatments are available—the potential benefits of even an untested and unproven drug outweigh the risks.
However, this development is unlikely to alleviate the shortages at retail pharmacies or deter future hoarding by doctors. The drugs that are authorized under the EUA will come from the Strategic National Stockpile and be distributed directly to public health authorities for hospital use, bypassing outpatient retail pharmacies. Moreover, the EUA only authorizes doctors to prescribe the drugs for patients who (1) are hospitalized, (2) have been diagnosed with COVID-19, and (3) for whom a clinical trial is not available, or their participation is not feasible.
In other words, the EUA does not give doctors the green light to stockpile the drugs or prescribe them prophylactically. Thus, it will remain crucial for pharmacists to resist this practice and ensure that the present needs of actual patients are prioritized over the speculative needs of potential patients.
If you have questions about your state pharmacy board’s position on this issue, or about your ethical and legal obligations during the COVID-19 epidemic, please call us and we will be happy to assist you.
April 1, 2020