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October 10, 2019
FDA and Digital Technologies: Striving for better patient safety and improved industry compliance
By: Heather McIntire and Katie Miinch

There is no aspect of our lives that is not touched by digital technologies – and the label and instructions with your medication should not be the exception. Software and digital solutions related to prescription drug use could play a critical role in providing the right information, in the right format to patients and healthcare providers -- all faster than ever before. Earlier this year, Accenture responded to a request for feedback on a draft guidance published by the FDA on how the FDA might foster the use of prescription drug-related software; ; within our response, we explored ideas for encouraging the development and adoption of prescription drug-use related software, electronic labeling, and Self-Monitoring, Analysis and Reporting Technology (SMART) solutions.

Prescription Drug-Use Related Software: Delivering updates in real-time

While it is clear the FDA is moving in the right direction, there is an opportunity to further reduce the barriers and make it easier for pharmaceutical companies to adopt and use innovative prescription drug-use related software solutions. One application could be to deliver labeling information electronically—all with the focus of improving patient experience and safety.

By providing label information in an electronic format, patients and prescribers could receive updates in real-time, versus relying on the printed label provided by the pharmacist that can be outdated the minute it is printed.

To encourage the use of this technology, health authorities could reduce the number of reviews necessary for the electronic label, instead managing reviews in a similar way to promotional material. For example, if the sponsor company has previously received approval of label content, the sponsor company should be allowed to use an exact replica of this information in a mobile application. The elimination of an additional review would only be possible if the digital label is a direct match with language that the agency has previously reviewed and approved.

To further encourage the use of prescription drug-use-related software, the FDA also could consider implementation of a “patient-friendly” version of the product label. Currently, the Package Insert leveraged in the US (USPI) is viewed as most valuable to prescribers; however, the USPI is included in and on product packaging, which is provided to patients. Sponsor companies might be more apt to use innovative technologies as a communication vehicle or as a mechanism to exchange product information with patients if a patient-friendly label (similar to a patient leaflet available in the European Union) is adopted by the FDA.

Labeling of the future: SMART, patient-centric, digital technologies

Beyond using prescription drug-use-related software for the delivery of the traditional labeling information, patients could also benefit from the approval and use of SMART technologies. It’s important to understand that SMART has evolved to include technologies with embedded automation that can be activated through an intuitive user interface. This approach can enable patients to take control of how they receive information about their medication from their healthcare providers.

By digitizing portions of the approved label for both prescription and over-the-counter drugs, the patient could interact at home with SMART technology to understand when and how the medication should be administered, and what side effects might be experienced. Better yet, if the patient has also connected their prescription with a monitoring device (e.g., fitness tracker, heart rate monitor), and provided consent, a healthcare provider could reach out to patients if an issue is detected.

There are other benefits as well. For example, a SMART, digitized label could instruct the patient to “take product x after eating and with a glass of water.” If the patient uses the electronic labeling experience to create a daily reminder to take the drug, the software could remind the patient to eat before and drink water with the medication—and point out the implications if the patient doesn’t follow the guidance.

Providing information that aligns to the previously approved label content, including single-level decision trees or helpful lifestyle modification recommendations, the e-label could improve the patient experience and the effectiveness of the drug – all while potentially requiring no additional FDA review, since the information has already been previously approved.

The FDA and sponsor pharmaceutical companies should collaborate to ensure a solid understanding of all expectations relating to software development lifecycle processes and documentation. Ultimately, the pharma or biotech company must adhere to and ensure that the software consistently provides the content as expected, regardless of external factors (e.g. routine mobile operating system updates).

To ensure the software behaves as expected, the FDA could consider request additional information, such as wireframes; test methodology, scripts, examples, and reports; and validation documents. This approach could be considered an ultra-light version of the pilot Medical Device pre-certification program the FDA launched last year. In cases where the software output is considered low risk, sponsors could also include methods and results from patient focus groups or other research that is less intensive than human factors studies.

The FDA continues to make tremendous strides toward encouraging pharmaceutical companies to use digitalization to improve the safety, adherence and effectiveness of drugs and therapies. This focus promises to bring these potentially life-changing solutions to patients more effectively -- and faster -- than ever before.

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