Physician Administration of Edaravone

What is Edaravone?

Edaravone is an intravenous medication prescribed to help slow the symptom progression of amyotrophic lateral sclerosis (ALS or “Lou Gehrig’s disease”).

Currently, Edaravone is available in the United States, Japan, and Korea; however, it is not authorized for sale in Canada.

While not available in Canada, some patients have purchased Edaravone abroad and legally imported it under Health Canada’s Personal Importation Policy.1 When Edaravone is legally imported, federal law does not prohibit authorized health professionals, including physicians and nurses, from administering it.

College Position

In keeping with the College’s mandate to serve and protect the public interest, we recognize the importance of ensuring that patients have safe access to new drug therapies, especially when there are limited treatment options available.

While Edaravone’s status as an unapproved drug restricts physicians from prescribing it, physicians are not restricted from administering Edaravone, provided that they have the necessary knowledge, skills, and judgment to do so safely and effectively. This expectation is no different than that which applies any time a physician provides a treatment to a patient.

In addition to administering Edaravone directly to a patient, physicians are also permitted to delegate the administration of Edaravone, in accordance with the College’s Delegation of Controlled Acts policy, or issue an initiating order to a Registered Nurse or Registered Practical Nurse to administer it. The College of Nurses of Ontario has recently released a statement to articulate the expectations of nurses with respect to the administration of Edaravone.

As with any other treatment or procedure, physicians must ensure that they meet the standard of care when administering Edaravone, and ensure that all other professional and legal duties are met when doing so, including obtaining informed consent, documenting consent in the patient’s record, and managing any adverse events that may arise.

Endnotes

1 For further information on the personal importation of health products, see Health Canada’s “Guidance Document on the Import Requirements for Health Products under the Food and Drugs Act and its Regulations” (GUI-0084).