Professional Organizations Issue Statement on Medications for COVID-19

The American Medical Association, American Pharmacists Association, and American Society of Health-System Pharmacists issued a joint statement Wednesday addressing inappropriate ordering, prescribing, or dispensing of medications for treating the novel coronavirus (COVID-19). The statement also highlights the important roles that pharmacists, physicians, and health systems play in being just stewards of health care resources during times of emergency, and national disaster.¹

“Physicians’ and pharmacists’ first and foremost ethical obligation in situations of epidemic, disaster, or terrorism is to provide urgent medical care, and ensure availability and appropriate use of necessary medications. This requires close coordination with the entire health care team to help ensure patients receive the testing, treatments, follow-up care, and medications they need,” the statement reads.¹

According to the statement, these professional organizations are aware that some physicians and others are prophylactically prescribing medications currently identified as potential treatments for COVID-19, typically for themselves, their families, or their colleagues. These medications include chloroquine or hydroxychloroquine, and azithromycin. In addition, some pharmacies and hospitals have been purchasing excessive amounts of these medications in anticipation of potentially using them for COVID-19 prevention and treatment.¹

“We strongly oppose these actions. We collectively support state and federal requirements that direct a prescription must be written only for a legitimate medical purpose,” the statement reads. “We also strongly support a pharmacist’s professional responsibility to make reasonable inquiries to a prescriber to resolve any questions about a prescription. If a prescription is not for a legitimate medical purpose, it should not be written, and it should not be dispensed."¹

Chloroquine and remdesivir were recently authorized by the FDA for compassionate use in treating COVID-19. Neither of these 2 drugs are approved by the FDA for treating this virus, although chloroquine is approved for other indications, including malaria. The compassionate use authorization allows patients with serious or life-threatening cases of COVID-19 to have access to them as investigational medicinal products, as prescribed therapies.²

The organizations’ joint statement emphasized that whether these medications are used to treat COVID-19 is a determination that should be made on a case-by-case basis with physicians, pharmacists, and other members of the health care team working together and resolving questions.¹

“We applaud the innumerable selfless acts by health care professionals across the nation who are putting themselves in harm’s way to provide care to America’s patients," the organizations said.

However, the statement also cautioned hospitals, health systems, and individual practitioners that, along with lack of FDA approval for treating patients with COVID-19, there is no incontrovertible evidence to support off-label use of medications for this virus. The organizations urged against stockpiling of these medications for COVID-19 with a warning that doing so could have grave consequences for patients with conditions for which these medications are indicated by FDA approval.¹

“The health care community must collectively balance the needs of patients taking medications on a regular basis for an existing condition with new prescriptions that may be needed for patients diagnosed with COVID-19. Being just stewards of limited resources is essential,” the statement reads.¹

In addition, the organizations addressed confusion possibly resulting from state government agencies and boards that are issuing emergency rules limiting or restricting access to chloroquine, hydroxychloroquine, or other emerging therapies, or requiring new procedures for physicians, other health care professionals, and patients. They urged state government agencies and boards to emphasize professional responsibility, and a need for professional judgement under these new policies.¹

“In a time of national pandemic, now is not the time for states to issue conflicting guidance, however well-intentioned, that could lead to unintended consequences,” the associations said. “The nation’s physicians and pharmacists continue to demonstrate remarkable leadership on a daily basis. We are confident in physicians’ and pharmacists’ judgment to make the right decisions for their patients, communities and the health care system overall.”¹

Finally, the statement applauds continuing efforts to conduct clinical trials and generate evidence related to medications that could help mitigate the pandemic. That some pharmaceutical manufacturers are increasing production of high-demand medications, as well as supplying them for use in clinical trials, is encouraging, according to the associations.¹

For up-to-date information on COVID-19 for pharmacy professionals, visit Pharmacy Times' coronavirus resource center.

REFERENCES

• Joint Statement of the American Medical Association, American Pharmacists Association, and American Society of Health-System Pharmacists on Inappropriate Ordering, Prescribing or Dispensing of Medications to Treat COVID-19 [news release]. AMA, APhA, ASHP. [email] Issued March 25, 2020. Accessed March 25, 2020.
• FDA Announces Two Drugs Given ‘Compassionate Use’ Status in Treating COVID-19. Pharmacy Times website. https://www.pharmacytimes.com/news/fda-announces-two-drugs-approved-for-compassionate-use-in-treating-covid-19 Published March 19, 2020. Accessed March 25, 2020.