Prescription Digital Therapeutics and the Need to Expand Knowledge Among Clinicians

While the number of prescription digital therapeutics (PDTs) continues to expand as possible treatments or adjunctive treatments for the management and prevention of various medical conditions, the degree of knowledge about the availability of PDTs appears to be still limited among both health care providers and patients who may benefit from them.

Various health care providers were asked about their knowledge and use of PDTs, and the following responses were obtained:

A registered nurse stated, “I have not heard of prescription digital therapeutics; however, the concept seems very favorable as an alternative or adjunctive therapy for some patients. It is up to prescribers to expand awareness about these therapies and identify patients who may be ideal candidates for them.”

A nurse practitioner stated, “I have heard of prescription digital therapeutics but do not know much about them. They may be useful, but it depends on the patient. Younger patients may adapt to using them more easily since technology is an everyday part of life for this patient group, but older patients may have issues with them depending on their willingness to use them and their comfort level with using digital platforms. Some patients may prefer the use of cognitive behavioral therapy as part of their treatment plan. Overall, it depends on taking into consideration the patient’s preferences and using shared decision making.”

An endocrinologist stated, “I have read several publications on prescription digital therapeutics, but I have limited knowledge about them and, to date, have not prescribed them for any patients. However, I would like to learn more about them and would consider using them. I have several patients who use the various wellness apps on their mobile devices to keep track of blood pressure, glucose, sleeping habits, etc., and these patients would be ideal candidates for available prescription digital therapies if applicable to their particular health needs. I think the use of prescription digital therapeutics will expand once more clinicians are aware of them. As the number of people diagnosed with chronic diseases continues to grow, the availability of additional therapies can significantly improve clinical outcomes.”

Recent Literature and Data on PDTs

In a recent publication in the journal Pharmacy Today,¹ the author discussed the issue of expanding the use of PDTs and also included information from a recent commentary in the Journal of the American Pharmacists Association², which explored the use of both digital therapeutics and the role of pharmacists. In the article, authors Timothy Aungst, PharmD, associate professor of pharmacy practice at the Massachusetts College of Pharmacy and Health Sciences, and Gigi Shafai, PharmD, stated, “There isn’t much information in the published literature about DTx and PDTs for pharmacists to read about at this time. Most published literature is targeted toward payers and health care decision-makers, and yet very little toward helping the majority of pharmacists understand what new technological developments are going on in health care.”^1,2 The health experts also indicated that there will be continuing changes and updates to the role of digital health data in helping clinicians make essential modifications to therapies per patient need, and pharmacists will need to be equipped to comprehend how novel technologies will affect a patient’s medication regimen.^1,2 Additionally, Dr. Shafai stated, “Pharmacists will need further education and training on digital health tools such as PDTs since they may be involved in direct dispensing or support.” 1,2

In a recent publication in Advances in Therapy,³ authors indicated that the slow acceptance and integration of PDTs into clinical practice may be due to many clinicians not being familiar with PDTs.³ The authors recommended that information about PDTs and other digital technologies be integrated into curriculums for these healthcare providers to expand knowledge of PDTs.³ The authors wrote, “Much work remains to facilitate full integration of PDTs into clinician and organizational workflows, to ensure coverage of these treatments for patients, and to streamline all of the steps required to prescribe and implement PDTs for the patients who need them."³

In a press release, the manufacturer Akilli announced its strategic plan to shift from a prescription to a non-prescription business model to pursue regulatory approval for over-the-counter labeling of its products.^4,5 In June 2023, the company released EndeavorOTC, created on the same technology as Akili’s EndeavorRx, the world’s first and only FDA-authorized video game treatment prescribed for children 8-12 years old with ADHD. EndeavorOTC is now available without a prescription for adults 18 years and older nationwide.^4,5 For more information, click here.

Conclusion

Health experts indicate that the number of digital therapeutics and PDTs is increasing, and the role of technology in treatments continues to evolve. Due to their unique mechanism of action, PDTs provide prescribers and patients with additional treatment options for certain conditions beyond the scope of conventional therapies, which can be used as stand-alone therapies or in conjunction with traditional therapies.² The latest PDT was approved in July 2023 as a behavioral therapeutic device for adults with T2DM, and the indications for PDTs continue to grow. There is clearly a need to expand awareness about these therapies and their roles in the treatment paradigm. In order to counsel patients about PDTs and identify ideal candidates who may benefit from the innovative treatments, pharmacists should explore the available information about PDTs.

Valuable Resources

Valuable resources include:

• Digital Therapeutics Alliance website
• FDA Digital Health Center of Excellence 
• AMCP Prescription Digital Therapeutics 

References

1. Increasing use of prescription digital therapeutics. American Pharmacists Association. https://pharmacist.com/Publications/Pharmacy-Today/Article/increasing-use-of-prescription-digital-therapeutics. Accessed September 22, 2023.
2. Shafai G, Aungst TD. Prescription digital therapeutics: A new frontier for pharmacists and the future of treatment. J Am Pharm Assoc (2003). 2023;63(4):1030-1034. doi:10.1016/j.japh.2023.03.012. 
3. Brezing CA, Brixner DI. The rise of prescription digital therapeutics in behavioral health. Adv Ther. 2022;39(12):5301-5306. doi:10.1007/s12325-022-02320-0. 
4. Akili Announces Business Transformation, Focusing on Non-prescription Model - Akili. investors.akiliinteractive.com. https://investors.akiliinteractive.com/news/news-details/2023/Akili-Announces-Business-Transformation-Focusing-on-Non-prescription-Model/default.aspx. Accessed September 22, 2023.
5. Akili Releases EndeavorOTCTM Video Game Treatment to Improve Attention in Adults with ADHD - Akili. investors.akiliinteractive.com.  https://investors.akiliinteractive.com/news/news-details/2023/Akili-Releases-EndeavorOTCTM-Video-Game-Treatment-to-Improve-Attention-in-Adults-with-ADHD/default.aspx. Accessed September 22, 2023.