How Pharmacists Can Protect Patients from Outdated COVID-19 Treatment

Hydroxychloroquine is an ineffective and potentially dangerous treatment for COVID-19, yet prescriptions for patients with the virus continue. Protecting people from this misguided therapy means pharmacists must take a stand and question the prescribed treatment.

Risks and Rewards of Hydroxychloroquine

When hydroxychloroquine came to the attention of the American public in 2020, it was commonly described as a malaria treatment. Besides being used to prevent malaria, it is often prescribed to treat autoimmune disorders including lupus and rheumatoid arthritis. Millions of Americans living with these chronic disorders depend on the drug to manage their symptoms.

Though it is approved for long-term use in autoimmune patients, hydroxychloroquine is a high-risk drug with well-known potential for adverse effects (AEs).¹ Most AEs are mild and include headache, dizziness, and gastrointestinal distress.

In some patients, AEs are far more severe. Hydroxychloroquine is known to cause permanent changes to vision and hearing, suicidal thoughts, severe hypoglycemia, heart arrhythmia, and heart failure. Long-term patients on the drug are carefully monitored for early signs of toxicity.¹

Early Optimism Fades into Concerns

During the spring of 2020, as the United States struggled to understand and contain the first wave of the COVID-19 pandemic, President Donald Trump touted the benefits of hydroxychloroquine in combating the virus, going so far as to say he took a preventative regimen himself. Trump’s optimism was rooted in anecdotal evidence and a few studies whose early results were inconclusive indicated that hydroxychloroquine might be effective against COVID-19.²

When news of the drug’s potential hit the media, a frightened public clamored for it. The president’s endorsement further legitimized the treatment, though scientists, including Trump’s chief medical advisers, cautioned that its efficacy had not been proven.

Desperate for anything that might slow the virus’s assault, on March 20, 2020, the FDA briefly authorized using the nation’s emergency stockpile of hydroxychloroquine to treat COVID-19. Overwhelmed and underinformed physicians began doling out prescriptions for the drug, reasoning that doing anything, even if it had a chance of being ineffective, was better than telling patients they could do nothing.

More than half of the new prescriptions written in March and April 2020 came from primary care physicians. The number of new prescriptions from physicians who did not typically prescribe hydroxychloroquine surged from 1143 to 75,569 in the span of 1 month—an 80-fold increase from the year before.³

The surge in prescriptions had 2 unintended consequences. First, the nation’s inventory of hydroxychloroquine quickly depleted. Autoimmune patients relying on the drug for long-term maintenance began rationing their pills as their prescriptions went unfilled.⁴

Second, the rise in new patients led to a deluge of negative AEs. Within 3 months, the FDA MedWatch system received more than 10,000 reports of serious incidents, including deaths, involving hydroxychloroquine.²

For 12 frenzied weeks, hydroxychloroquine flew out of pharmacies. Meanwhile, studies on the drug’s efficacy against COVID-19 continued—and the results were not good. The amount of data showing the drug might be effective in treating the virus were overshadowed by data indicating it was ineffective at best and harmful at worst.⁵

“The FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19,” the FDA said in a June 15 news release revoking the emergency use authorization (EUA). “In light of ongoing serious cardiac adverse effects and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks.”

State boards of pharmacy across the nation followed the federal agency’s lead, issuing policies that ranged from advising caution to restricting prescriptions to a 14-day supply only to those with a positive diagnostic test.³

Since the EUA was revoked, the rate of hydroxychloroquine prescription has dropped significantly, but it has not yet reached pre-COVID-19 levels. As the pandemic drags on and new virus variants surface, some physicians continue to prescribe the drug in the mistaken belief that it offers patients their best chance of recovery.

The Role of the Pharmacist as Gatekeeper

Pharmacists have 3 primary roles in public health: first responder, consultant, and medical partner. The ongoing debate about hydroxychloroquine and COVID-19 requires pharmacists to step into that third role and take responsibility for their patients’ welfare.

Pharmacists are not order-takers for physicians. They are partners collaborating with other health care professionals to get patients the treatment they need.²

The pharmacist is the last barrier between a patient and a drug. That is why it is so critical for pharmacists check for allergies, potential drug interactions, patient understanding of how to use the drug, and whether the prescription is appropriate for the diagnosis. The pharmacist who dispenses a drug to the patient is ultimately responsible for that patient’s welfare.

A prescription for an off-label use of a drug, such as using hydroxychloroquine to treat COVID-19, should trigger a red flag, particularly when the drug comes with such high risks. Before filling that prescription, a responsible pharmacist will contact the prescribing doctor to confirm the diagnosis and the treatment plan.

Physicians who do not routinely treat patients for autoimmune disorders may be unfamiliar with which medications conflict with hydroxychloroquine or with patient risk factors that increase the chances of AEs.⁶

Physicians may be unaware of the latest studies on the drug’s efficacy in treating COVID-19. Physicians are also unlikely to realize that off-label use of hydroxychloroquine is rarely covered by insurance, leaving patients to pay out-of-pocket for this expensive and ineffective treatment.

Pharmacists are often hesitant to question a physician’s prescribed regimen for fear of pushback.²

But this call does not have to be combative, both the physician and the pharmacist ultimately have the patient’s best interests at heart. The call is an opportunity for the pharmacist to discuss the risks and potential benefits of the prescribed drug with the physician.

The Road Ahead

Although hydroxychloroquine is no longer approved in the United States as a treatment for COVID-19, studies in its efficacy continue in other parts of the world.⁷ This open-ended status leads some medical professionals to continue prescribing it as a last-ditch effort to do something for COVID-19 patients.

To ensure the best possible health outcomes, pharmacists must stand their ground against inappropriate use of this high-risk drug.

About the Author

Tanapong Pantasri, PharmD, RPh, BCMTMS, is an experienced supervising clinical pharmacist with a successful background in the pharmaceutical field, including serving as a retail pharmacist. He is Board Certified in Medication Therapy Management (BCMTMS), HIV pharmacistTM (AAHIVP), and Certified in Immunization and COVID-19 vaccination administration. He holds an active pharmacist’s license in good standing with the New York State Board of Pharmacy and with the Pharmacy Council of Thailand. For more information, please email tanapong.tyler@gmail.com.

References

1. American Association of Poison Control Centers (2020). American Association of Poison Control Centers on Hydroxychloroquine Side Effects. Retrieved from https://piper.filecamp.com/uniq/Klk1IGw3Mzt29mhN.pdf.
2. Rosenthal M. (2020). Hydroxychloroquine: Where Pharmacy, Medicine and Politics Intersect. Pharmacy Practice News. Retrieved from https://www.pharmacypracticenews.com/Covid-19/Article/08-20/Hydroxychloroquine-Where-Pharmacy-Medicine-and-Politics-Intersect/59249.
3. Bull-Otterson L., Gray E.B., Budnitz D.S., et. al. (2020). Hydroxychloroquine and Chloroquine Prescribing Patterns by Provider Specialty Following Initial Reports of Potential Benefit for COVID-19 Treatment – United States, January-June 2020. CDC Morbidity and Mortality Weekly Report. Sept. 4, 2020 / 69(35);1210-1215. Retrieved from https://www.cdc.gov/mmwr/volumes/69/wr/mm6935a4.htm.
4. Nessel J. (2020). Patients With Lupus Experiencing Difficulties Accessing Hydroxychloroquine, Chloroquine. Pharmacy Times. Retrieved from https://www.pharmacytimes.com/view/patients-with-lupus-experiencing-difficulties-accessing-hydroxychloroquine-chloroquine.
5. U.S. Food and Drug Administration (2020). Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine. Retrieved from https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and.
6. Federation of State Medical Boards (2020). Joint Statement of FSMB, NABP, NCSBN on Inappropriate Prescribing and Dispensing of Medications During the COVID-19 Pandemic. Retrieved from https://www.fsmb.org/siteassets/advocacy/pdf/fsmb-nabp-joint-statement-covid-19-prescribing-fsmb-edits.pdf.
7. Robinson J. (2021). Everything You Need to Know About the COVID-19 Therapy Trials. The Pharmaceutical Journal, March 2021. Online:DOI:10.1211/PJ.2021.20208126. Retrieved from https://pharmaceutical-journal.com/article/feature/everything-you-need-to-know-about-the-covid-19-therapy-trials#Chloroquinehydroxychloroquine