FDA Proposes Electronic Prescription Drug Information Rule

The federal Food and Drug Administration (FDA) has proposed a new rule for electronically distributing the prescribing information to go with drugs and other biological products to health care professionals. The new means of distribution is intended to replace paper prescribing information, which may be outdated by the time it reaches such professionals and may result in drug prescription errors.

According to the notice published on December 18, manufacturers must distribute the prescribing information about drugs and products such as blood or blood components through an electronic data base and not, with notable exceptions, through paper handouts. Manufacturers will be required to submit labeling changes to the FDA to be published on the website FDA.labels.org. They are also responsible for reviewing changes submitted to the website to ensure their accuracy.

Packaging information sent from manufacturers would include a notice directing health care providers to the website and providing a toll-free telephone number at which further requests for information would be received. The number would be maintained by the manufacturer and would be available 24 hours per day, 7 days per week. The phone number is designed to provide an alternative source of information, should the internet be unavailable under certain circumstances.

New rule meant to avert drug prescription errors

The agency is concerned specifically about information that manufacturers distribute to health care professionals, especially pharmacists. While doctors and nurses typically do not dispense drugs and thus do not receive the printed versions of the prescribing information, pharmacists do receive the information with the drugs. They often complain about the small print and the multiple folds in the paper that make the information difficult to read.

More troubling is the fact that such printed information may stay in storage for weeks even as label changes are instituted. The updates on the website would allow pharmacists to receive such label changes in “real time.” The agency hopes that such more timely updates would help to avoid drug prescription errors or dangers.

Certain exemptions will be permitted. The FDA would consider such exemptions if compliance with the new requirements would compromise safety or effectiveness, would not be possible or would otherwise not be appropriate. The agency gave the example of a drug stockpiled for emergency as a case where the electronic distribution of information would not be an acceptable option. Another example would be a drug intended for emergency room use.

Agency believes that changes would result in long-term financial benefits

In addition to safer and more accurate distribution of prescription drugs and related safety information, the FDA believes that electronic updates would result not only in a reduction in medical negligence claims, but in overall financial savings for health care providers. The agency expects that after “initial set-up costs,” net savings will be between $5 million and $74 million.

The new guidelines would not have to do with labeling included with prescriptions given directly to patients (including inserts with medication guides) or with promotional information.

The proposed change in revisions is known as Docket No. FDA-2007-N-0363. The agency invites comments on the proposed revisions, which are due by March 18.

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