Author(s):
Amber Vyas, Tanu Bhargava, Surendra Saraf, Vishal Jain, Darshan Dubey
Email(s):
darshandubey@gmail.com
DOI:
10.52711/2231-5713.2023.00047
Address:
Amber Vyas1, Tanu Bhargava2, Surendra Saraf3, Vishal Jain1, Darshan Dubey2*
1University Institute of Pharmacy, Pt. Ravishankar Shukla University, Raipur (CG)
2Institute of Pharmacy, Vikram University, Ujjain (MP)
3Columbia College of Pharmacy, Tekari, Raipur (CG)
*Corresponding Author
Published In:
Volume - 13,
Issue - 4,
Year - 2023
ABSTRACT:
A field known as "digital medicine" is focused with using technology as aid for assessment and involvement in the interest of better public health. Digital medical solutions are built on top-notch technology and software that supports the practice of medicine broadly, including treatment, rehabilitation, illness prevention, and health promotion for individuals and across groups. Digital medical products can be used independently or in conjunction with pharmaceuticals, biologics, devices, and other products to enhance patient care and health outcomes. With the use of smart, easily accessible tools, digital medicine equips patients and healthcare professionals to treat a variety of illnesses with high-quality, safe, and efficient measures and data-driven therapies. The discipline of digital medicine includes both considerable professional knowledge and responsibilities linked to the usage of these digital tools. The application of these technologies in digital medicine is supported by the development of evidence. Technology is causing changes in medicine. Wearable and sensors are becoming more compact and affordable, and algorithms are becoming strong enough to forecast medical outcomes. Nevertheless, despite quick advancements, the healthcare sector lags behind other sectors in effectively utilizing new technology. The cross-disciplinary approach necessary to develop such tools, needing knowledge from many experts across many professions, is a significant barrier to entry. The participation in digital medicine programs is optional, complies with all legal requirements and standards, and protects patient data in line with relevant state and federal privacy legislation, just like other data created and maintained in electronic medical records. Aside from helping doctors more correctly titrate dosages and assess how well a treatment works, experts say digital medicine programs hold promise as a solution to the problem of medication adherence.
Cite this article:
Amber Vyas, Tanu Bhargava, Surendra Saraf, Vishal Jain, Darshan Dubey. A Review on digital medicine and its implications in drug development process. Asian Journal of Pharmacy and Technology. 2023; 13(4):263-9. doi: 10.52711/2231-5713.2023.00047
Cite(Electronic):
Amber Vyas, Tanu Bhargava, Surendra Saraf, Vishal Jain, Darshan Dubey. A Review on digital medicine and its implications in drug development process. Asian Journal of Pharmacy and Technology. 2023; 13(4):263-9. doi: 10.52711/2231-5713.2023.00047 Available on: https://ajptonline.com/AbstractView.aspx?PID=2023-13-4-5
REFERENCES:
1. https://www.ftc.gov/business-guidance/resources/mobile-health-apps-interactive-tool.
2. Plowman RS, Peters-Strickland T, Savage GM. Digital medicines: clinical review on the safety of tablets with sensors. Expert Opinion on Drug Safety. 2018; 17(9):849-52.
3. Norouzi-Gheidari N, Hernandez A, Archambault PS, Higgins J, Poissant L, Kairy D. Feasibility, safety and efficacy of a virtual reality exergame system to supplement upper extremity rehabilitation post-stroke: a pilot randomized clinical trial and proof of principle. International Journal of Environmental Research and Public Health. 2020;17(1):113.
4. Frias J, Virdi N, Raja P, Kim Y, Savage G, Osterberg L. 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. 2017;19(7):e246.
5. Senbekov M, Saliev T, Bukeyeva Z, Almabayeva A, Zhanaliyeva M, Aitenova N, Toishibekov Y, Fakhradiyev I. The recent progress and applications of digital technologies in healthcare: a review. International Journal of Telemedicine and Applications. 2020.
6. Abernethy A, Adams L, Barrett M, Bechtel C, Brennan P, Butte A, Faulkner J, Fontaine E, Friedhoff S, Halamka J, Howell M. The promise of digital health: Then, now, and the future. NAM Perspectives. 2022.
7. Martani A, Geneviève LD, Poppe C, Casonato C, Wangmo T. Digital pills: a scoping review of the empirical literature and analysis of the ethical aspects. BMC Medical Ethics. 2020 ;21:1-3.
8. Elenko E, Underwood L, Zohar D. Defining digital medicine. Nature Biotechnology. 2015; 33(5): 456-61.
9. Torjensen I. Devising ways to improve medicines adherence. Pharm. J. 2015; 295: 7883.
10. https://www.fda.gov/medical-devices/digital-health-center-excellence/what-digital-health.
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. 2018-05-23. 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.
14. Michie S, Yardley L, West R, Patrick K, Greaves F. 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. 2017; 19(6):e232.
15. Kasoju N, Remya NS, Sasi R, Sujesh S, Soman B, Kesavadas C, Muraleedharan CV, Varma PH, Behari S. Digital health: trends, opportunities and challenges in medical devices, pharma and bio-technology. CSI Transactions on ICT. 2023:1-20.
16. Fowler J, Cope N, Knights J, Fang H, Skubiak T, Phiri P, Rathod S, Peters-Strickland T. T96. Results of the Hummingbird study a multicentre, pragmatic trial of a digital medicine system. Schizophrenia Bulletin. 2020; 46(Suppl 1):S267.
17. Citrome L. A review of aripiprazole in the treatment of patients with schizophrenia or bipolar I disorder. Neuropsychiatric Disease and Treatment. 2006; 2(4):427-43.
18. Rohatagi S, Profit D, Hatch A, Zhao C, Docherty JP, Peters-Strickland TS. Optimization of a digital medicine system in psychiatry. The Journal of Clinical Psychiatry. 2016 ;77(9):13486.
19. https://psychscenehub.com/psychinsights/digital-medicine-systems-psychiatry/
20. Coravos A, Goldsack JC, Karlin DR, Nebeker C, Perakslis E, Zimmerman N, Erb MK. Digital medicine: a primer on measurement. Digital Biomarkers. 2019 May 9;3(2):31-71.
21. Zhang SX, Tan LW, Li LJ. Introduction to Digital Medicine. Beijing: Science Press; 2015:3e19.
22. Wang ZG, Zhang L, Zhao WJ. Progress in digital medicine. Chinese Journal of Traumatology. 2017; 20(05):297-8.
23. Liao XB. Internetþ, what should be added on? China Digit Med. 2016;11:2e4.
24. heng-Guo Wang, Liang Zhang, Wen-Jun Zhao, Progress in digital medicine , Chinese Journal of Traumatology 20 (2017) 297e298.
25. https://www.fda.gov/about-fda/cdrh-transparency/evaluation-automatic-class-iii-designation-de-novo-summaries.
26. "This digital pill wants to make following your prescription easier". PBS NewsHour. 2018-05-23. Retrieved 2018-07-05.
27. MD, Robert Glatter. "Barton Health First To Offer New Digital Medicine Developed By Proteus Digital Health". Forbes. Retrieved 2018-07-05.
28. "Children's Health Dallas testing 'digitized drugs' with sensors inside". Dallas News. 2016-08-19. Retrieved 2018-07-05.
29. Belluck P. First digital pill approved to worries about biomedical ‘big brother’. New York Times. 2017 Nov 14;13.
30. "Digital Pill That Tracks Use When Swallowed Gets FDA Approval". Bloomberg.com. 2017-11-14. Retrieved 2018-04-27.
31. "The Digital Pill Era Is Here—And It Could Help Solve a $300 Billion Health Care Problem". Fortune. Retrieved 2018-04-27.
32. Ten Haken I, Ben Allouch S, Van Harten WH. The use of advanced medical technologies at home: a systematic review of the literature. BMC public health. 2018;18(1):1-33.
33. World Health Organization. Global atlas of medical devices [Internet]. Geneva: World Health Organization; 2017. 480 p.[cited September 18, 2017].(WHO Medical device technical series)
34. Fromer MJ. FDA introduces new phase 0 for clinical trials: some enthusiastic, some skeptical. Oncology Times. 2006 ;28(15):18-9.
35. Federal Trade Commission. Mobile health apps interactive tool. Federal Trade Commission [Internet]. 2016 Apr.
36. Van Norman GA. Drugs and devices: comparison of European and US approval processes. JACC: Basic to Translational Science. 2016;1(5):399-412.
37. National Institute for Health and Care Excellence. Evidence Standards Framework for digital Health Technologies. 2019 March [cited 2019 Apr 13]. Available from: https://www.nice.org.uk/Media/Default/About/what-we-do/our-programmes/evidence-standards-framework/digital-evidence-standards-framework.pdf
38. Nebeker C, Murray K, Holub C, Haughton J, Arredondo EM. Acceptance of mobile health in communities underrepresented in biomedical research: barriers and ethical considerations for scientists. JMIR Mhealth and Uhealth. 2017; 5(6):e6494.
39. Bloss C, Nebeker C, Bietz M, Bae D, Bigby B, Devereaux M, Fowler J, Waldo A, Weibel N, Patrick K, Klemmer S. Reimagining human research protections for 21st century science. Journal of medical Internet Research. 2016; 18(12):e329.
40. Basic HHS Policy for Protection of Human Research. Expedited review procedures for certian kinds of research involving no more than minimal risk and for minor changes in approved research, 45 CFR 46. 110 (2009) [regulation on Intranet] [cited 2019 Apr 13]. Available from: https://www.hhs.gov/ohrp/sites/default/files/ohrp/policy/ohrpregulations.pdf
41. Paul SM, Mytelka DS, Dunwiddie CT, Persinger CC, Munos BH, Lindborg SR, Schacht AL. How to improve RandD productivity: the pharmaceutical industry's grand challenge. Nature reviews Drug Discovery. 2010; 9(3):203-14.
42. Allen M. You snooze, you lose: Insurers make the old adage literally true. Pro Publica. 2018.
43. Mehta I. Amazon’s new patent will allow Alexa to detect a cough or a cold. Artificial Intelligence. 2018 ; 15: 3.
44. Perakslis ED. Protecting patient privacy and security while exploiting the utility of next generation digital health wearables. BMJ Opinion. 2019 Jan 18.
45. Coravos A, Chen I, Gordhandas A, Stern AD. We should treat algorithms like prescription drugs. Quartz, February 14.
46. Matwyshyn AM. The internet of bodies. Wm. and Mary L. Rev.. 2019; 61: 77.
47. Rockoff JD. JandJ warned insulin pump vulnerable to cyber hacking. Wall Street Journal [Internet]. 2016.\
48. Fox-Brewster T. Medical devices hit by ransomware for the first time in US hospitals. Forbes, May. 2017 May.
49. Coravos A, Chen I, Gordhandas A, Stern AD. We should treat algorithms like prescription drugs. Quartz, February 14.
50. Matwyshyn AM. The internet of bodies. Wm. and Mary L. Rev.. 2019; 61: 77.
51. Rockoff JD. JandJ warned insulin pump vulnerable to cyber hacking. Wall Street Journal [Internet]. 2016.
52. Fox-Brewster T. Medical devices hit by ransomware for the first time in US hospitals. Forbes, May. 2017 May.
53. Schiappa M, Chantry G, Garibay I. Cyber security in a complex community: A social media analysis on common vulnerabilities and exposures. In2019 Sixth International Conference on Social Networks Analysis, Management and Security (SNAMS) 2019 Oct 22 (pp. 13-20). IEEE.
54. Perakslis ED, Stanley M. A cybersecurity primer for translational research. Science Translational Medicine. 2016; 8(322):322ps2-.
55. Woods B, Coravos A, Corman JD. The case for a hippocratic oath for connected medical devices. Journal of Medical Internet Research. 2019; 21(3):e12568.