COVID-19 Resource Center
COVID-19 Resource Center
Source/Disclosures
Disclosures: Nachega reports receiving grants through Stellenbosch University from the NIH and serving as a coprincipal investigator of TOGETHER, a clinical trial of novel agents for the treatment of COVID-19 in South Africa that is supported by the Bill & Melinda Gates Foundation. Suleman reports receiving grant funding from the NIH.
May 07, 2020
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Off-label hydroxychloroquine, chloroquine use for COVID-19 poses threat to Africa

Source/Disclosures
Disclosures: Nachega reports receiving grants through Stellenbosch University from the NIH and serving as a coprincipal investigator of TOGETHER, a clinical trial of novel agents for the treatment of COVID-19 in South Africa that is supported by the Bill & Melinda Gates Foundation. Suleman reports receiving grant funding from the NIH.
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Jean Nachega
Fatima Suleman

Despite a lack of trials demonstrating the efficacy of chloroquine or hydroxychloroquine for the treatment of COVID-19, promotion and use of the two treatments has led to shortages, self-treatment and fatal overdoses, according to a perspective published in The American Journal of Tropical Medicine and Hygiene. The perspective suggests that African countries “strongly consider” putting prescription monitoring programs in place to ensure that off-label use of chloroquine and hydroxychloroquine is appropriate and beneficial for the treatment of COVID-19.

Safety issues regarding the use of chloroquine and hydroxychloroquine — as well as other “substandard and falsified medical products” — and related matters, including shortages and inflated pricing, put all countries at risk, but the potential issues may pose an especially large threat to Africa because of limitations specific to the continent’s health care system, according to the perspective.

Jean Nachega, MD, PhD, MPH, FRCP, FAAS, associate professor of epidemiology, infectious diseases and microbiology at University of Pittsburgh, adjunct associate professor of epidemiology and international health at Johns Hopkins Bloomberg School of Public Health and professor extraordinary of medicine and director of Center for Infectious Diseases at Stellenbosch University in Cape Town, told Healio that physicians should rely on “science and evidence” to inform decisions related to the use of chloroquine and hydroxychloroquine.

“To date, chloroquine and hydroxychloroquine have not been shown to be safe and effective for treating or preventing COVID-19,” Nachega said. “Chloroquine and hydroxychloroquine should be used for COVID-19 only when patients can be appropriately monitored in the hospital as required by the Emergency Usage Authorization or are enrolled in a clinical trial with appropriate screening and monitoring.”

According to Nachega, off-label use of chloroquine or hydroxychloroquine can cause abnormal heart rhythms, including ventricular tachycardia, and cardiac toxicity if either drug is used alone or combined with other medicines that are known to prolong the QT interval, such as azithromycin. Drug-drug interactions between chloroquine or hydroxychloroquine and medications for diseases that are common in Africa, like HIV and tuberculosis, can also, potentially, make the drugs ineffective or toxic. Fraud related to the black market of falsified and substandard drugs may further amplify these risks.

“Also, the widespread inappropriate use of azithromycin — when co-administered with chloroquine or hydroxychloroquine — is very concerning, as it may lead to shortages or selection of resistance. If those things happen, it would no longer be available for other highly prevalent, fatal bacterial infections in Africa for which it has been proven effective,” Nachega said.

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Pharmacists “should only dispense these medications with prescriptions for approved indications,” Fatima Suleman, PhD, MPharm, BPharm, professor at the University of KwaZulu-Natal’s School of Health Sciences and former Prince Claus Chair of Development and Equity at Utrech University, told Healio.

“If doctors do prescribe these medications, they should have a monitoring system in place in the event of serious side effects and adverse events,” Suleman said. “As there are no proven, registered therapies for COVID-19, doctors must keep abreast of the literature to look at outcomes from other practices and countries so that, if serious effects are discovered and published, the therapy can be stopped immediately for other patients.”

To ensure that educational information about COVID-19 treatment options is disseminated throughout Africa, Suleman encourages the use of regular webinars about interventions that have been successful, blogs on the AfreHealth website for health care professionals to share lessons, and the development of an online, publicly available COVID-19 module that is accessible to all health care professionals. She also noted that patient education regarding the use of chloroquine and hydroxychloroquine during the pandemic is important.

“Patients should be informed that these medications have no proven efficacy for COVID-19 and should be used under a doctor’s supervision only,” Suleman said. “Patients should be made aware of possible side effects or adverse events that might occur and told that, if these are present, they should see a doctor immediately.”

Suleman also emphasized that there is a need for a “collaborative network” in Africa to ensure coordinated production, distribution and post-marketing surveillance of any approved COVID-19 drug that aligns with low-cost distribution.

“African countries should strongly consider implementing prescription monitoring schemes to ensure that any off-label chloroquine and hydroxychloroquine use is appropriate and benecial during this pandemic,” she said.

“There remains an urgent need for high-quality evidence from ongoing randomized clinical trials in the US, Europe and African sites, to confirm the clinical value of chloroquine or hydroxychloroquine alone or in combination with other drugs for the treatment of COVID-19,” Nachega said. – by Eamon Dreisbach

Disclosures: Nachega reports receiving grants through Stellenbosch University from the NIH and serving as a coprincipal investigator of TOGETHER, a clinical trial of novel agents for the treatment of COVID-19 in South Africa that is supported by the Bill & Melinda Gates Foundation. Suleman reports receiving grant funding from the NIH.