FDA Hopes Prescription Mistakes Can Be Avoided By Proposed Electronic Prescribing Rule

Federal drug regulators are moving to require companies to distribute drug prescribing information electronically, moving away from the decades-old practice of paper drug prescribing guides, in a move meant to better disseminate information about potential drug side effects and their health risks to patients. 

This week, the FDA published a new proposed rule in the Federal Register, which would require manufacturers to provide electronic drug prescribing information for drugs and biological medical products. It bans the use of paper prescribing information except for special exemptions in the proposed rule.

Paper prescribing guides could sit for weeks or months in a doctor’s office or on a pharmacy shelf, with no updates. This could result in prescription mistakes when drugs are accidentally prescribed to patients, because the prescriber is unaware of new contraindications or new side effects that could impact the patient’s health.

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“The paper form of the prescribing information may not contain the most current information because it may have been printed and distributed prior to more recent labeling changes, while the electronic form of prescribing information can be updated in real-time,” the agency notes in the rule. “FDA is taking this action to ensure that the most current prescribing information for prescription drugs will be available and readily accessible to health care professionals at the time of clinical decision making and dispensing.”

The prescribing information would be posted on the FDA’s labeling repository web site, labels.fda.gov. Manufacturers would be required to update that information every time there is a label change and must review and verify that the information posted on the web site is accurate and the most up-to-date version possible.

The proposed rule requires that drug container labels direct health care professionals to the web site to look at the prescribing information and would also have to provide a toll-free number where an e-mailed, faxed or mailed paper copy of the prescribing guide could be obtained.

The FDA’s new rule would grant exemptions in special situations, such as with drugs stockpiled for an emergency, during which there may be a lack of power or internet access.

The FDA is accepting public comment on the proposed rule until March 18, 2015. See the Federal Register notice for ways to submit electronic or written comments.


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