0
We're unable to sign you in at this time. Please try again in a few minutes.
Retry
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
Retry
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Invited Commentary |

Off-label Drug Use and Adverse Drug Events Turning up the Heat on Off-label Prescribing

Chester B. Good, MD, MPH1,2,3,4; Walid F. Gellad, MD, MPH2,3
[+] Author Affiliations
1Pharmacy Benefits Management Services, US Department of Veterans Affairs, Hines, Illinois
2Division of General Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
3Center for Health Equity Research and Promotion, Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, Pennsylvania
4Department of Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy, Pittsburgh, Pennsylvania
JAMA Intern Med. 2016;176(1):63-64. doi:10.1001/jamainternmed.2015.6068.
Text Size: A A A
Published online

Extract

Yelling “Fire!” in a crowded theater without any imminent danger is an oft-cited example of free speech that is not protected. For many years, the US Food and Drug Administration (FDA) has prohibited the promotion of unapproved uses of drugs. This restriction has recently been challenged under the guise of free speech. In a potential landmark decision in August 2015, a federal judge ruled against the FDA’s restrictions on off-label drug promotion, referencing protection by the First Amendment.1 Critics of off-label drug promotion point to dietary supplements as an example of the kinds of claims that are commonplace when regulation is lax and worry about an erosion of the authority of the FDA to ensure safety and efficacy of drugs.2 Are these concerns about safety warranted? Does evidence show that off-label prescribing might be less safe than on-label prescribing? In light of these concerns, the study of off-label drug use and adverse drug events by Eguale and colleagues3 in this issue of JAMA Internal Medicine is particularly timely.

First Page Preview

View Large
First page PDF preview

Figures

Tables

References

Correspondence

CME
Also Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Please click the checkbox indicating that you have read the full article in order to submit your answers.
Your answers have been saved for later.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.
Submit a Comment
Evidence, not FDA approval, reduced adverse events
Posted on January 12, 2016
David L. Keller
none
Conflict of Interest: None Declared
The study by Eguale et al demonstrated that off-label prescribing is not associated with increased adverse drug events (ADEs) when supported by strong scientific evidence. Since off-label prescriptions backed by strong evidence are just as safe as prescriptions for FDA-approved indications, the FDA ban on promotion of the former denies patients the benefits of safe and scientifically proven medications. The focus must shift to suppression of off-label prescribing only when it is not backed by strong evidence. So says the evidence.

Submit a Comment

Multimedia

Some tools below are only available to our subscribers or users with an online account.

1,874 Views
2 Citations
×

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

Related Content

Customize your page view by dragging & repositioning the boxes below.

See Also...
Articles Related By Topic
Related Collections
PubMed Articles
Pharmaceutical and Medical Devices: FDA Oversight. Issue Brief Health Policy Track Serv 2015;():1-97.
Jobs
brightcove.createExperiences();