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Within the field of digital health, digital medicine is a category of pharmaceuticals which combines a prescription medication with an ingestible sensor component.[1] Digital medicines are designed to communicate to mobile and/or web-based applications that a patient has taken a specific dose of medication at a certain time.[2] Because of the ingestible sensor component and association with prescription pharmaceuticals, products in this category require regulatory oversight and clinical validation.[3]

Digital medicine(s) aim to improve pharmaceutical therapy by improving patient adherence.[4][5]

Differentiation from similar disciplines

Digital medicine is sometimes confused with similar disciplines, including the broader category of digital health, as well as digital therapeutics, another digital health subset. Digital health offerings use digital technologies to enhance human health in some capacity.[6] Within this broader category, programs that include a prescription medication with an ingestible sensor component are considered digital medicines. By contrast, digital therapeutics are associated mainly with web-based health management tools and stand-alone health apps, generally without a prescription medication element.[7]

Approval pathways

The ingestible sensor component associated with digital medicines was originally approved in 2012 by the U.S. Food and Drug Administration (FDA) through the Center for Devices and Radiological Health via a de novo pathway for novel, low-risk medical devices.[8] This approval has been accompanied by FDA 510(k) clearances.[8] The ingestible sensor is CE marked in Europe.[1] A New Drug Application for the first fully integrated pharmaceutical with ingestible sensor component, Otsuka Pharmaceutical's ABILIFY MYCITE® (aripiprazole with Proteus ingestible sensor), was approved by the FDA in November 2017.[9]

With its approval of the digital pill, the FDA confirmed that the review of digital medicines includes assessment of the ingestible device component, and that no additional safety and efficacy data is required for the original pharmaceutical.[7]

Indications

Digital medicines are being used for a variety of conditions in commercial and clinical settings. Medications with ingestible sensors are being prescribed in the treatment areas of hypertension, diabetes, hypercholesterolemia, heart failure, Hepatitis C, mental health, HIV, TB and organ transplantation.[10][11][12]

In January 2016, Barton Health became the first institution to commercially offer digital medicines to patients with chronic medical conditions.[13] In 2016, Children's Health in Dallas, Texas became the first to commercially use digital medicines with pediatric patients.[14]

Ethical concerns

Bioethicists have expressed concerns around technologies that log and share information about patients’ medication-taking behavior.[15] These concerns exist from the perspective of both individual and collective patient rights. However, proponents note that participation in digital medicine programs are voluntary, comply with all applicable laws and standards, and protect patient data in accordance with applicable state and federal privacy regulations, as with other data generated and stored in electronic medical records.[16] Experts add that digital medicine programs show promise as a solution to medication adherence, and help physicians more accurately titrate dosages and determine how well the medication worked.[17]

References

  1. ^ a b "Qualification opinion on ingestible sensor system for medication adherence as biomarker for measuring patient adherence to medication in clinical trials" (PDF). European Medicines Agency. Feb 2, 2016. Retrieved April 27, 2018. {{cite web}}: Cite has empty unknown parameter: |dead-url= (help)
  2. ^ "Decoding Digital Medicine | eyeforpharma". social.eyeforpharma.com. Retrieved 2018-04-27.
  3. ^ Plowman, R. Scooter; Peters-Strickland, Timothy; Savage, George M. (2018-08-13). "Digital medicines: clinical review on the safety of tablets with sensors". Expert Opinion on Drug Safety: 1–4. doi:10.1080/14740338.2018.1508447. ISSN 1474-0338.
  4. ^ Frias, Juan; Virdi, Naunihal; Raja, Praveen; Kim, Yoona; Savage, George; Osterberg, Lars (2017-07-11). "Effectiveness of Digital Medicines to Improve Clinical Outcomes in Patients with Uncontrolled Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-Randomized Pilot Clinical Trial". Journal of Medical Internet Research. 19 (7): e246. doi:10.2196/jmir.7833. PMC 5527253. PMID 28698169.{{cite journal}}: CS1 maint: unflagged free DOI (link)
  5. ^ "Devising ways to improve medicines adherence". Pharmaceutical Journal. Retrieved 2018-04-27.
  6. ^ "Definition of Digital Health - Paul Sonnier". Paul Sonnier - Story of Digital Health. Retrieved 2018-04-27.
  7. ^ a b Michie, Susan; Yardley, Lucy; West, Robert; Patrick, Kevin; Greaves, Felix (2017-06-29). "Developing and Evaluating Digital Interventions to Promote Behavior Change in Health and Health Care: Recommendations Resulting From an International Workshop". Journal of Medical Internet Research. 19 (6): e232. doi:10.2196/jmir.7126. ISSN 1438-8871. PMID 28663162.{{cite journal}}: CS1 maint: unflagged free DOI (link)
  8. ^ a b "EVALUATION OF AUTOMATIC CLASS III DESIGNATION (DE NOVO) FOR PROTEUS PERSONAL MONITOR INCLUDING INGESTION EVENT MARKER" (PDF). FDA.gov. {{cite web}}: Cite has empty unknown parameter: |dead-url= (help)
  9. ^ Commissioner, Office of the. "Press Announcements - FDA approves pill with sensor that digitally tracks if patients have ingested their medication". www.fda.gov. Retrieved 2018-04-27.
  10. ^ Frias, Juan; Virdi, Naunihal; Raja, Praveen; Kim, Yoona; Savage, George; Osterberg, Lars (2017-07-11). "Effectiveness of Digital Medicines to Improve Clinical Outcomes in Patients with Uncontrolled Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-Randomized Pilot Clinical Trial". Journal of Medical Internet Research. 19 (7). doi:10.2196/jmir.7833. ISSN 1439-4456. PMC 5527253. PMID 28698169.{{cite journal}}: CS1 maint: unflagged free DOI (link)
  11. ^ Holly, Robert. "This 'smart pill' can help Rush patients remember their meds". chicagotribune.com. Retrieved 2018-07-05.
  12. ^ "This digital pill wants to make following your prescription easier". PBS NewsHour. Retrieved 2018-07-05.
  13. ^ MD, Robert Glatter,. "Barton Health First To Offer New Digital Medicine Developed By Proteus Digital Health". Forbes. Retrieved 2018-07-05.{{cite news}}: CS1 maint: extra punctuation (link) CS1 maint: multiple names: authors list (link)
  14. ^ "Children's Health Dallas testing 'digitized drugs' with sensors inside". Dallas News. 2016-08-19. Retrieved 2018-07-05.
  15. ^ Belluck, Pam (2017-11-13). "First Digital Pill Approved to Worries About Biomedical 'Big Brother'". The New York Times. ISSN 0362-4331. Retrieved 2018-04-27.
  16. ^ "Digital Pill That Tracks Use When Swallowed Gets FDA Approval". Bloomberg.com. 2017-11-14. Retrieved 2018-04-27.
  17. ^ "The Digital Pill Era Is Here—And It Could Help Solve a $300 Billion Health Care Problem". Fortune. Retrieved 2018-04-27.
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