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Research Article

Off-Label Use of Medical Products

Page 419 | Received 21 Dec 2010, Accepted 21 Dec 2010, Published online: 25 May 2011

Abstract

The National Association of EMS Physicians (NAEMSP) believes that emergency medical services (EMS) medical directors may prescribe any legally marketed product for off-label use. This document is the official position of the NAEMSP.

The National Association of EMS Physicians believes that:

  • Emergency medical services (EMS) medical directors may prescribe or administer any legally marketed product for an off-label use with the authorized practice of medicine in the exercise of appropriate medical judgment for the best interest of the patient.

  • If EMS medical directors use a product for an indication not in the approved or cleared labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain awareness of the product's use and effects.

  • In the case of an adverse event with an off-label use, EMS medical directors should submit a report to the manufacturer and the Food and Drug Administration (FDA) in accordance with relevant FDA guidelines.

  • EMS medical directors should disclose all conflicts of interest to their respective EMS agencies and adhere to all state and federal laws and regulations.

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