Joint statement of the American Medical Association, American Pharmacists Association and American Society of Health-System Pharmacists
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. 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.
We are issuing this joint statement to highlight the important role that physicians, pharmacists and health systems play in being just stewards of health care resources during times of emergency and national disaster. We are aware that some physicians and others are prescribing or dispensing medications currently identified as potential treatments or prophylaxis for COVID-19 (e.g., chloroquine or hydroxychloroquine, azithromycin) for themselves, their families, or their colleagues. In addition, some entities have been purchasing excessive amounts of these medications through commercial distribution channels in anticipation of potentially using them for COVID-19 prevention and treatment. We strongly oppose these actions that can lead to supply disruptions for patients who need these medicines for chronic conditions.
We collectively support state and federal requirements that direct a prescription must be written only for a legitimate medical purpose. Novel off-label use of FDA-approved medications is a matter for the physician’s or other prescriber’s professional judgment. 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. We encourage patient-centered care decisions, made on an individualized basis with patients’ informed consent about the risks and benefits associated with any treatment regimen. However, evidence-based science and practice must guide these determinations. Physicians, pharmacists and other members of the healthcare team are more than capable of working together and resolving questions.
At the same time, we caution hospitals, health systems, other entities, and individual practitioners that no medication has been FDA-approved for use in COVID-19 patients. Definitive evidence for the role of these drugs in treating COVID-19 patients has not been determined through robust clinical trials; decisions to use these medications off-label must be made with extreme caution and careful monitoring. Physicians, pharmacists, patients and policymakers must understand that these medications have dangerous side effects, that may lead to patient harm, including fatal cardiac arrhythmias. In the event that an adverse drug event is suspected or observed from any medication used to prevent or treat COVID-19, we urge healthcare providers to submit a report to FDA MedWatch. Stockpiling these medications—or depleting supplies with excessive, anticipatory orders— and price gouging in the midst of a pandemic, have grave consequences for patients with conditions such as lupus or rheumatoid arthritis if the drugs are not available in the community. 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.
We are further concerned by the confusion that may result from various state government agencies and boards issuing emergency rules limiting or restricting access to chloroquine, hydroxychloroquine or other emerging therapies or requiring new procedures for physicians and other healthcare professionals and patients. If these bodies promulgate new rules, we urge that they emphasize professional responsibility and leave room for professional judgment. We further urge that patients already on these medications for chronic conditions should not be negatively impacted by new laws, rules or other guidance. 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.
We applaud the ongoing efforts to conduct clinical trials and generate evidence related to these and other medications during a time of pandemic. We are also encouraged that some pharmaceutical manufacturers are increasing production of high-demand medications as well as supplying them for use in clinical trials.
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.
Editor's note
The updated joint statement provides further detail and clarification about key areas that have evolved in recent weeks, including in-patient use of certain medications compared to prophylaxis, the distribution/supply chain, safety considerations and the need for adverse-event reporting, and further supports the need for evidence/science to guide discussions and decisions.
