Concerned that patient safety is at risk in the current system, the FDA formally suggests the healthcare industry change the way practitioners receive information about any medications they are prescribed.
A recent FDA proposal outlines its plans to change the method of labeling of certain products, including prescription medications, from written on paper to electronic means. Presently, prescribing information most frequently accompanies a drug either on or within a medication’s packaging. The FDA proposal posits patients can be put in danger if their treating physician possesses outdated prescribing information that doesn’t include newly-discovered or altered safety issues. If this information instead is only available electronically, providers could only access the latest, and most accurate, medication information and warnings.
The FDA would require packaging of future medications to feature language that informs healthcare professionals where they could access the electronic version of the prescribing information. There are some exceptions to the proposed rule. For example, it does not apply to any form of labeling intended for patients nor to prescribing information that’s part of promotional labeling. In both of those cases, paper distribution would still be permitted.
Any time a prescription drug manufacturer creates a new label or updates an existing one, it would need to submit the most recent label to the FDA’s labeling website if the proposal passes. The manufacturer then would have to review the label on the FDA’s publicly-accessible site to confirm it presents the most up-to-date information.
The FDA estimates the conversion to electronic dispersal will result in the healthcare industry saving between $5 million and $82.2 million over a 10-year period.
Comments on the proposal may be submitted, in either a written or electronic form, to the FDA until March 18, 2015.