Drug manufacturers may no longer be required to distribute prescribing information on paper—with limited exceptions—and instead may have to distribute that same information electronically.
The FDA recently issued a proposed rule that, if enacted, would require drug manufacturers to submit to the agency prescribing information to be posted on the FDA’s website, allowing the information to be changed each time there is a change in the labeling. The rule also would require manufacturers to review and ensure that the information on the FDA’s website is correct, notify the agency if revisions are required and include a statement on the drug packaging directing patients to the website. Additionally, to ensure the information is available when Internet access is not available to a healthcare provider, manufacturers would be required to maintain a toll-free phone number to receive requests for the manufacturer to send an emailed, faxed or mailed paper copy of the information. The phone number service must be available 24 hours a day, seven days a week.
The FDA questioned the effectiveness of distributing prescribing information on paper. The prescribing information that is the subject of the proposed rule is the paper version that is on or in the package from which the drug is dispensed – the one “printed on thin paper in small size font, and … folded multiple times.” Though this prescribing information is intended for use by all healthcare professionals, the FDA noted that many now rely on electronic or other paper versions (liked the Physicians’ Desk Reference) compiled by third parties instead of the paper version issued by manufacturers. Physicians and nurses who write prescriptions typically do not receive the paper version because they do not dispense drugs and pharmacists and hospitals also typically rely on third-party compendia. Patients generally do not receive the paper information because pharmacists usually dispense drugs to patients in containers different from the manufacturer’s packaging. The electronic distribution requirements would not apply to patient labeling including patient package inserts or to prescribing information accompanying promotional labeling.
According to the FDA, another purpose of the proposed rule is to “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 decisionmaking and dispensing.” The paper form of the prescription information may have been printed and distributed before recent labeling changes and distributing the information electronically ensures it can be updated in real time.
The FDA notes that it may grant exemptions from the electronic distribution and labeling requirements in certain circumstances, including for a product intended for use in an emergency room or being stockpiled for an emergency.
The FDA will accept comments on the proposed rule until March 18, 2015.