The issue of off-label prescribing is a loaded subject. When one scratches the surface, one realizes the myriad limitations of such a construct related to the process of labeling, the monitoring of appropriate prescribing, the inadequacy of evidence to match the complexities of care, and the missed opportunities of leveraging our information systems to better optimize medication use for the care of patients.
Technically, off-label prescribing means the prescribing of medications or devices for indications or population subgroups that regulatory agencies have not officially approved. It is legal in many countries (including the United States) based on the premise that regulatory agencies do not have the authority to control the practice of medicine. But what does it really mean? There are many examples of efficacious medical therapies for conditions for which there has been no official indication approval. Aspirin therapy for acute coronary syndromes is a classic example: regulatory approval for its use did not occur until well after the evidence clearly demonstrated its benefit. The process of drug approval for specific indications is an onerous one, requiring substantial resources and financial risk to seek labeling indications. Even if there are available studies that demonstrate efficacy, the burden of indication application is on the pharmaceutical company. Unless there is reasonable probability for profit margins associated with such investment, the pharmaceutical industry is not likely to seek regulatory approval. Therefore, there is an obvious limitation of the process of labeling that inhibits not only the potential access to efficacious treatments but also the validity of labeling itself. A better process would allow an easier updating of indication labeling that is concordant and commensurate with the strength of the evidence.
Register and get free email Table of Contents alerts, saved searches, PowerPoint downloads, CME quizzes, and more
Subscribe for full-text access to content from 1998 forward and a host of useful features
Activate your current subscription (AMA members and current subscribers)
Purchase Online Access to this article for 24 hours
Thank you for submitting a comment on this article. It will be reviewed by JAMA Internal Medicine editors. You will be notified when your comment has been published. Comments should not exceed 500 words of text and 10 references.
Do not submit personal medical questions or information that could identify a specific patient, questions about a particular case, or general inquiries to an author. Only content that has not been published, posted, or submitted elsewhere should be submitted. By submitting this Comment, you and any coauthors transfer copyright to the journal if your Comment is posted.
* = Required Field
Disclosure of Any Conflicts of Interest*
Indicate all relevant conflicts of interest of each author below, including all relevant financial interests, activities, and relationships within the past 3 years including, but not limited to, employment, affiliation, grants or funding, consultancies, honoraria or payment, speakers’ bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued. If all authors have none, check "No potential conflicts or relevant financial interests" in the box below. Please also indicate any funding received in support of this work. The information will be posted with your response.
Some tools below are only available to our subscribers or users with an online account.
Download citation file:
Web of Science® Times Cited: 2
Customize your page view by dragging & repositioning the boxes below.
More Listings atJAMACareerCenter.com >
and access these and other features:
Enter your username and email address. We'll send you a link to reset your password.
Enter your username and email address. We'll send instructions on how to reset your password to the email address we have on record.
Athens and Shibboleth are access management services that provide single sign-on to protected resources. They replace the multiple user names and passwords necessary to access subscription-based content with a single user name and password that can be entered once per session. It operates independently of a user's location or IP address. If your institution uses Athens or Shibboleth authentication, please contact your site administrator to receive your user name and password.