Featured Research

from universities, journals, and other organizations

Off-label Use Often Not Evidence-Based: Physicians Lack Knowledge Of Off-label Drug Use And FDA Approval Status, Study Finds

Date:
August 23, 2009
Source:
University of Chicago Medical Center
Summary:
In a recent national survey, a substantial minority of physicians erroneously believed that certain off-label uses of prescription drugs were FDA approved. This mistaken belief encourages them to prescribe these drugs, despite the lack of scientific evidence supporting such use. Overall, physicians were able to correctly identify the FDA-approval status of just over half of the 22 drug-indication pairs (i.e., a particular drug prescribed for a particular condition) included in the survey.

In a recent national survey, a substantial minority of physicians erroneously believed that certain off-label uses of prescription drugs were approved by the Food and Drug Administration. This mistaken belief could encourage them to prescribe these drugs, despite the lack of scientific evidence supporting such use.

"Off-label prescribing is common, but researchers have not always known why. Our research shows that some off-label prescribing might be driven by mistaken beliefs about FDA approval and the level of evidence supporting off-label drug use," said G. Caleb Alexander, MD, MS, Assistant Professor of Medicine at the University of Chicago Medical Center and corresponding author of the research, which will be published in the journal Pharmacoepidemiology and Drug Safety.

"The results indicate an urgent need for more effective methods of informing physicians about the level of evidence supporting off-label drug use—especially for common off-label uses that are ineffective or carry unacceptable risks of harm."

Overall, physicians were able to correctly identify the FDA-approval status of just over half (mean 55%) of the 22 drug-indication pairs (i.e., a particular drug prescribed for a particular condition) that were included in the survey.

In many cases, the proportion of physicians who erroneously believed a particular drug was FDA approved for a specific indication was higher among physicians who had prescribed the drug for that indication.

For example, 26% of all physician respondents erroneously believed that lorazepam was FDA approved for chronic anxiety. That figure rose to 33% for physicians who had prescribed lorazepam for chronic anxiety.

And 13% of all physician respondents erroneously believed that quetiapine (Seroquelฎ) was FDA approved for dementia with agitation. That figure rose to 19% for physicians who had prescribed quetiapine for dementia with agitation. At the time of the study there was even an FDA-advisory specifically urging caution regarding the off-label use of quetiapine in patients with dementia.

The survey of 1,199 physicians (599 primary care physicians and 600 psychiatrists) was conducted in 2007-2008 and included 22 drug-indication pairs. The indications varied in their FDA approval status from on-label use to off-label use supported by medical evidence to off-label use deemed to be ineffective. (The level of evidence supporting or not supporting each specific use was based on Drugdex, an independent drug compendium.)

The FDA makes it clear that they regulate the marketing of prescription drugs, not prescribing. The agency approves drugs for marketing with an official "label" that stipulates an indication, dose, intended population, duration of use, and other specifications. However, physicians and other licensed prescribers are free to prescribe any approved drug for any indication, whether or not the indication is included on the drug's FDA-approved label.

"Some physicians and health care experts maintain that physicians should know the evidence, not the FDA labeling. However, knowledge about FDA labeling can be important because FDA approval of a drug for a specific indication indicates a clear threshold of evidence supporting that use," said Donna Chen, MD, Assistant Professor of Biomedical Ethics, Public Health Sciences, and Psychiatry at the University of Virginia. Dr. Chen is the lead author of the research, entitled "U.S. physician knowledge of the FDA-approved indications and evidence base of commonly prescribed drugs: results of a national survey".

A study published in the Archives of Internal Medicine by other investigators in 2006 indicated that approximately 21% of drug uses in the United States occur for off-label purposes, with 73% of those cases lacking scientific evidence of the drug's effectiveness. The highest rates of off-label use were for anticonvulsants (74%), antipsychotics (60%) and antibiotics (41%).

"We hope our research will increase awareness of off-label prescribing and highlight the pressing need for more evidence-based use of prescription drugs," Alexander said. "Although some off-label uses are well-supported, many are not. New ways are needed to help physicians tap the scientific evidence supporting various prescription drug uses."

Some disadvantages of off-label use:

  • May diminish public expectation that drugs will be evaluated for safety and efficacy before use
  • Blunts industry incentives to perform studies required for FDA label changes
  • Drugs used off label may have unrecognized safety and efficacy problems
  • Promotes use of drugs in populations (e.g., children, the elderly) for which they have not been tested

Some advantages of off-label use:

  • Allows for clinical innovation, especially for patients who do not respond to standard treatments
  • May be only available option for uncommon conditions or for patient populations that have not been studied
  • Allows physicians to anticipate growing evidence of efficacy prior to formal evaluation
  • Increases return on investment for pharmaceutical firms

Source: G. Caleb Alexander, MD, MS, Assistant Professor of Medicine at the University of Chicago Medical Center


Story Source:

The above story is based on materials provided by University of Chicago Medical Center. Note: Materials may be edited for content and length.


Journal Reference:

  1. Donna T. Chen, Matthew K. Wynia, Rachael M. Moloney, G. Caleb Alexander. U.S. physician knowledge of the FDA-approved indications and evidence base for commonly prescribed drugs: results of a national survey. Pharmacoepidemiology and Drug Safety, 2009; n/a DOI: 10.1002/pds.1825

Cite This Page:

University of Chicago Medical Center. "Off-label Use Often Not Evidence-Based: Physicians Lack Knowledge Of Off-label Drug Use And FDA Approval Status, Study Finds." ScienceDaily. ScienceDaily, 23 August 2009. <www.sciencedaily.com/releases/2009/08/090821135011.htm>.
University of Chicago Medical Center. (2009, August 23). Off-label Use Often Not Evidence-Based: Physicians Lack Knowledge Of Off-label Drug Use And FDA Approval Status, Study Finds. ScienceDaily. Retrieved July 23, 2014 from www.sciencedaily.com/releases/2009/08/090821135011.htm
University of Chicago Medical Center. "Off-label Use Often Not Evidence-Based: Physicians Lack Knowledge Of Off-label Drug Use And FDA Approval Status, Study Finds." ScienceDaily. www.sciencedaily.com/releases/2009/08/090821135011.htm (accessed July 23, 2014).

Share This




More Health & Medicine News

Wednesday, July 23, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Courts Conflicted Over Healthcare Law

Courts Conflicted Over Healthcare Law

AP (July 22, 2014) — Two federal appeals courts issued conflicting rulings Tuesday on the legality of the federally-run healthcare exchange that operates in 36 states. (July 22) Video provided by AP
Powered by NewsLook.com
Why Do People Believe We Only Use 10 Percent Of Our Brains?

Why Do People Believe We Only Use 10 Percent Of Our Brains?

Newsy (July 22, 2014) — The new sci-fi thriller "Lucy" is making people question whether we really use all our brainpower. But, as scientists have insisted for years, we do. Video provided by Newsy
Powered by NewsLook.com
Scientists Find New Way To Make Human Platelets

Scientists Find New Way To Make Human Platelets

Newsy (July 22, 2014) — Boston scientists have discovered a new way to create fully functioning human platelets using a bioreactor and human stem cells. Video provided by Newsy
Powered by NewsLook.com
Gilead's $1000-a-Pill Drug Could Cure Hep C in HIV-Positive People

Gilead's $1000-a-Pill Drug Could Cure Hep C in HIV-Positive People

TheStreet (July 21, 2014) — New research shows Gilead Science's drug Sovaldi helps in curing hepatitis C in those who suffer from HIV. In a medical study, the combination of Gilead's Hep C drug with anti-viral drug Ribavirin cured 76% of HIV-positive patients suffering from the most common hepatitis C strain. Hepatitis C and related complications have been a top cause of death in HIV-positive patients. Typical medication used to treat the disease, including interferon proteins, tended to react badly with HIV drugs. However, Sovaldi's %1,000-a-pill price tag could limit the number of patients able to access the treatment. TheStreet's Keris Lahiff reports from New York. Video provided by TheStreet
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins