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Technology can shrink the risks of off-label drug use

Prescribing medications for off-label use is legal, but it's rarely reimbursed and it's under-researched. Patients will have to rely on each other to learn more about it.

Are patients receiving the right health messages, especially when it pertains to the off-label drug use of their prescriptions? This question occurred to me when reading "Drug Safety in the Digital Age," in the New England Journal of Medicine Perspective article.

The authors of the article comment that surveys reveal how patients are researching medical information on the Internet now more than ever.

Before I share my thoughts, I should explain that physicians and other prescribers, including nurse practitioners and physician assistants, generally have the legal ability to prescribe medications for an intended use that is approved by the FDA -- as well as for uses that are not approved by the FDA.

The latter is often called off-label use, and although it is legal, it is usually not reimbursed by health insurance plans. Some patients will pay cash to take a medication for off-label purposes. This off-label use may be very safe if we already have a wealth of patient data on the use of the medication for this purpose. Or, off-label drug use could be very risky when there is a dearth of information about the potential risks and benefits associated with using the medication in a certain scenario.

Returning to the topic of drug safety in the digital age, the New England Journal of Medicine article addresses some interesting findings pertaining to medication safety warnings, such as boxed warnings. The article does not dig into the issue of off-label use because drug manufacturers are not legally allowed to promote or advertise off-label use of their products.

So, if a drug commonly used to treat diabetes is used off-label by some non-diabetic patients who are overweight, the drug manufacturer is not allowed to promote or advertise this to healthcare providers or patients. Patients who are not clinically depressed using antidepressant medication to sleep would be another example of off-label use.

Since many people openly discuss their health conditions and their use of medications on the Internet, there is more access to anecdotal stories from patients about how a certain "wonder drug" made a difference in their lives. This example of social media sharing has made it easier for people to find information about off-label drug use. Drug companies' medication safety messages, however, do not include warnings about off-label uses, because they're not approved to be used that way in the first place -- leaving patients without key information about the downsides of a drug's off-label use.  

The current regulatory framework does not allow manufacturers to promote off-label use, so how will those patients who are taking medications for off-label purposes receive accurate information about drug safety? Perhaps online resources should include a section about off-label use so that more patients can be made aware of safety issues. Since off-label use is so prevalent, there needs to be a better way to allow patients to report and talk about adverse events that occur when they are using medications for off-label purposes.

The recent launch of openFDA has allowed a wide range of healthcare professionals to develop innovative ways to use public health data to improve medication safety. Currently, openFDA provides application programming interfaces and raw data to the FDA's publically available drug adverse event reports. Perhaps we will see innovative examples driven by crowdsourcing and collaboration in the near future. Maybe the medical community will find creative ways to use digital technology to address the challenges of communicating drug safety messages regarding off-label use.

About the author: 
Joseph Kim is a physician technologist who has a passion for leveraging health IT to improve public health. Dr. Kim is the founder of NonClinicalJobs.com and is an active social media specialist. Let us know what you think about the story; email editor@searchhealthit.com or contact @SearchHealthIT on Twitter.

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This was last published in September 2014

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