While the FDA’s rules around marketing a boxed warning product provide a challenge, they do not eliminate the opportunity to leverage the EHR channel to reach prescribers.

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The adoption of Electronic Health Record (EHR) systems by U.S. healthcare professionals has surpassed 60%, significantly impacting the practice of medicine. For many prescribers, EHR platforms have become their new “Desktop”—similar to the reliance on Microsoft Outlook in the business setting. It serves as the center for care management, e-prescribing and patient communication. As the new center of clinical workflow, EHRs open the unique opportunity for bio/pharmaceutical companies to reach these prescribers within workflow, delivering product support messages at the point of prescribing after the exam room door has closed.

As marketers become more familiar with EHRs—and the opportunities that they open for bio/pharmaceutical brands—programs in workflow are becoming part of a brand’s strategic marketing plan. While not taking the place of other traditional tactics (such as direct-to-physician emails, in person or eDetailing, online programs, print collateral, etc.), more and more bio/pharmaceutical companies are embracing the EHR channel, and their brands are leveraging it to message to the prescriber.

For those marketing a brand with a boxed warning, messaging within the EHR may provide an additional opportunity to promote appropriate medication use to further enhance patient safety in a way that is meaningful and impactful for the prescriber because the interaction occurs within normal prescribing workflow.

 Identifying Appropriate EHR Tactics for Boxed Warnings

Foundational for any brand with a boxed warning is identifying an appropriate way to communicate both the risks and the benefits of the drug and to foster the appropriate use of the drug by the patient. The EHR environment is especially helpful since the prescribing information can be presented in a way that: (1) informs the prescriber and (2) provides information that the prescriber can discuss with the patient at the time of the visit.

Integrating brand messaging and information into EHR workflow requires a thoughtful approach. Marketers must find a way to deliver what may be very technical and extensive information to the prescriber for their use in workflow and materials such as advice on drug administration and/or Med Guides (if applicable) that can be used with the patient. In addition, many prescribers appreciate the ability to offer programs that help defray the cost of therapy—helping to ensure that the patient fulfills and adheres to the medication. In the EHR, brands have the opportunity to provide access to up-to-date prescribing information that makes them feel more secure in making treatment decisions.

For instance, any system within an EHR should contain a concise overview of key information that a prescriber needs when interacting with a patient. This medication-specific information should include safety messages (recent label updates, warnings and links to full prescribing information), medication support messages (links to medication adherence, patient education and other clinically relevant information) and financial support programs.

Another benefit of a system within an EHR is that it can be designed with a series of messages that can be customized based on the needs of the individual brand. For example:

• Header: Drug name and logo, link to contact the manufacturer

• Line 1: Link directly to the product’s full prescribing information

• Line 2: Boxed warning information, Drug Alerts and REMS programs (where necessary)

• Line 3: Product support message with link (and important safety information if needed)

• Line 4: Product support message with link (and important safety information if needed)

Because there can be a dedicated space for boxed warnings—in addition to a link to the full, updated FDA-approved prescribing information—pharma marketers can feel comfortable that the information is presented in a balanced way. In concert with a link to the boxed warning, the system could also present applicable REMS program information and/or Drug Safety Communications as well as additional product support information that can help brands present patient educational materials to reinforce the appropriate use of the medication. Many feel that this patient engagement is even more important for products with boxed warnings—since it can help patients take appropriate responsibility for using drugs as prescribed and in identifying any potential issues when they can be easily managed.

Supporting Brands Through the Process

The decision to explore an EHR strategy with a boxed product is only the first step. There are a number of discussions that need to take place at the brand level and in Medical-Legal-Regulatory (MLR) review meetings before the strategy can move forward. In supporting numerous companies through this process, we have identified a number of common questions:

• What has the FDA said about brands participating in EHRs?

In an article published in February of last year, Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation Research, stated, “First of all, we need to ensure that full and current FDA-approved labels are available within electronic health records and at the point of care. We need also to be able to deliver targeted drug alerts, box warnings and other key FDA messages directly to providers via the EHR and make sure that the information is available to them at the time the physician is electronically prescribing.”

Integrating up-to-date FDA-approved prescribing information into the prescriber’s workflow is effective for all products—but especially for drugs where the information is complex and subject to changes that are important to ensure safe and effective prescribing. The prescriber is with the patient and has the needed information in an accessible and easy-to-access solution.

• How can I make sure that prescribers are visually aware of the boxed warning?

We have worked with a number of EHR platform developers to understand the functionality of their systems, the way prescribers interact with those systems, and best practices for developing solutions for those systems. By consistently locating the boxed warning information directly under the full prescribing information, we have found that prescribers are easily able to locate and access the information quickly within workflow. REMS information, if applicable, is presented side-by-side along with the boxed warning.


The adoption of EHR systems has significantly impacted the practice of medicine, forever changing the prescribers’ workflow and opening the opportunity for bio/pharmaceutical companies to reach prescribers within workflow via their EHR systems. Marketers, of course, have to determine the best way to make their drug and patient information available in the EHR—whether via models that mimic more traditional advertising or via programs that offer the combination of prescribing information and patient support in a single, uncluttered “hub.”

  • Mukesh Mehta

    DPh, MBA, RPh, is Vice President of Clinical & Regulatory Solutions at PDR Network. With more than 30 years of bio/pharmaceutical and healthcare information experience, Dr. Mehta leverages an in-depth knowledge of the industry to counsel bio/pharmaceutical leaders in developing regulatory, commercial and patient safety programs.


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