The Food and Drug Administration (FDA) issued its proposed rule for the electronic distribution of prescribing information on Dec. 18, 2014. The rule is entitled, “Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products,” (see link at the end of this column). The FDA says the purpose of the proposed rule is to be sure that health professionals have access to the most current prescribing information for prescription drugs at the time of clinical decision-making and drug dispensing. Further, they note the action is in keeping with other FDA initiatives since 2003 that require various electronic submissions for drug approvals and listings, and Department of Health and Human Services actions to provide electronic health information to healthcare professionals, patients and the public.
The major provisions of the proposed rule include:
Requiring manufacturers to submit prescribing information to the FDA for posting on the agency’s publicly available “labeling repository” website, labels.fda.gov. For new drugs, the information would be submitted prior to the product being sold. For existing drugs, any changes to current labeling would trigger a resubmission within two days of FDA approval of the labeling change.
Requiring manufacturers to review labeling posted on the website to ensure what is posted on the repository is the most current prescribing information.
Requiring a product’s immediate package have a statement that directs healthcare professionals to the labeling repository website to view complete prescribing information.
Requiring a product’s immediate package contain a toll-free number for people to request the prescribing information from a manufacturer, who then could e-mail, fax, or mail a hard copy of the prescribing information to the requester.
Requiring the manufacturer to maintain the toll-free number so it is accessible 24 hours a day/seven days a week so that the information can be accessed regardless of Internet access.
The agency is allowed to create exemptions to the electronic labeling requirement in situations where it could adversely affect the drug’s safety, effectiveness, or purity; if it is not technologically feasible; or is otherwise inappropriate. The example the FDA gives is for a product that is intended to be used in an emergency room or is stockpiled for emergency use. In these cases the prescribing information may be distributed in paper form with the product or attached to the product’s packaging. Additionally, the rule does not apply to patient labeling, which includes patient package inserts and medication guides.
In accompanying discussion, the agency clarifies a number of issues related to the rule. First, prescribing information may contain instructions for the pharmacist for administering, reconstituting, mixing, diluting, or other product preparation. The FDA says that if the information is not concise enough to be printed on the product’s packaging, then often the pharmacist is referred to the product’s labeling.
Of those surveyed, 79% said they thought electronic labeling would improve the adequacy of drug information they can access at their workplace, and the majority felt it would improve patient safety and education.
Second, they discuss the use of product labeling in public health emergencies and natural disasters. They point out that first responders may have enough familiarity with the products they use that not having access to electronic information during a disaster may not prove too harmful. And most pharmacies have backup generators, they note.
Finally, they recognize that drugs produced for export would be required to have product labeling that meets the export country’s rules.
Once final, the rule would take effect six months later, and manufacturers would have two years after the final rule’s publication date to comply with its provisions.
The FDA discusses a number of other issues in its justification for the new rule. First, the FDA did conduct a study among 436 pharmacists practicing in chain, independent, and hospital pharmacies in rural and urban areas to assess their readiness to adopt paperless labeling. Of those surveyed, 79% said they thought electronic labeling would improve the adequacy of drug information they can access at their workplace, and the majority felt it would improve patient safety and education. Eighty-one percent of the pharmacists noted they use the prescribing information when counseling patients or verifying product dosages. Chain pharmacists said they primarily use corporately provided prescribing information rather than accessing the information directly at manufacturer websites, as other pharmacists reported. Of those surveyed, only 6% said they use paper labeling as a resource exclusively, and 4% said they did not have Internet access. Second, the agency said their analysis of safety labeling changes showed there are approximately 500 made annually, making immediate access to current product labeling very important. Because of the numerous labeling changes that occur, the FDA decided against a dual paper/electronic labeling distribution system. They also feel a dual system could cause confusion.
In the proposed rule, the FDA provides a summary of comments from an April 2, 2007, hearing they held on electronic prescribing information, noting that these comments were taken into account during the rules draft. One comment noted that an electronic system should not pose undue hardships to pharmacists and pharmacies with respect to workflow, process, or costs associated with implementing a new system. Of note, with regard to cost/benefit, the agency anticipates annual cost savings to industry of $52 million to $164 million from not printing paper labeling. They estimate cost increases to pharmacies of $47 million to $89 million to create access to the repository. They do not estimate the public health benefit associated with having the most current information accessible.
The electronic labeling requirement has been under development for quite some time. I encourage you to access the proposed rule and begin preparations for implementation with the anticipation of the publication of a final rule. CT
Marsha K. Millonig, R.Ph., M.B.A., is president of Catalyst Enterprises, LLC, in Eagan, Minn. The firm provides consulting, research, and writing services to help industry players provide services more efficiently and implement new services for future growth. The author can be reached at mmillonig@ catalystenterprises.net.