Acta Scientific Medical Sciences (ASMS)(ISSN: 2582-0931)

Mini Review Volume 10 Issue 9

Software as a Medical Device (Samd) and Optimization of Pharmacological Therapy: The Case of Abilify Mycite® in Monitoring Therapeutic Adherence

Raffaele Maiello1, Daniela Maria Capuano2,3 and Roberto Verna1,2,3*

1Professor, Nandha College of Physiotherapy, The Tamilnadu Dr.M.G.R. Medical University, India
2Academy for Health and Clinical Research, Italy
3World Association of Societies of Pathology and Laboratory Medicine, Italy

*Corresponding Author: Roberto Verna, Research and Training Center for Health and Well-being, University Guglielmo Marconi, Italy.

Received: July 27, 2026; Published: September 04, 2026


In recent years, artificial intelligence has assumed a central role in the transformation of healthcare systems, enabling tools capable of supporting diagnosis, monitoring, and treatment with a level of personalization that was previously difficult to achieve. In this context, the convergence of algorithms, medical devices, and pharmacotherapy has fostered the emergence of digital medicine, a paradigm in which data are no longer merely a byproduct of the care pathway but become an integral part of the therapeutic intervention itself.

Keywords: Artificial Intelligence; Healthcare Systems; Algorithms; Medical Devices; Pharmacotherapy; Samd; Abilify MyCite®

References

  1. World Health Organization. “Adherence to long-term therapies: Evidence for action”. Geneva: WHO (2003).
  2. Topol EJ. “High-performance medicine: the convergence of human and artificial intelligence”. Nature Medicine1 (2019): 44-56.
  3. Rajkomar A., et al. “Machine learning in medicine”. New England Journal of Medicine14 (2019): 1347-1358.
  4. Hiemke C., et al. “Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology: update 2017”. Pharmacopsychiatry1-02 (2018): 9-62.
  5. International Medical Device Regulators Forum (IMDRF). “Software as a Medical Device (SaMD): Key definitions” (2013).
  6. European Commission. “Regulation (EU) 2017/745 of the European parliament and of the council on medical devices” (2017).
  7. International Medical Device Regulators Forum (IMDRF). “Software as a Medical Device: Clinical evaluation” (2017).
  8. Vrijens B., et al. “A new taxonomy for describing and defining adherence to medications”. British Journal of Clinical Pharmacology 5 (2012): 691-705.
  9. Osterberg L and Blaschke T. “Adherence to medication”. New England Journal of Medicine5 (2005): 487-497.
  10. Cutler DM and Everett W. “Thinking outside the pillbox-medication adherence as a priority for health care reform”. New England Journal of Medicine17 (2010): 1553-1555.
  11. Hafezi H., et al. “An ingestible sensor for measuring medication adherence”. IEEE Transactions on Biomedical Engineering 1 (2015): 99-109.
  12. S. Food and Drug Administration. “Drug Approval Package: Abilify MyCite®” (2017).
  13. Haddad PM., et al. “Nonadherence with antipsychotic medication in schizophrenia: challenges and management strategies”. Patient Related Outcome Measures 5 (2014): 43-62.
  14. Burris KD., et al. “Aripiprazole, a novel antipsychotic, is a high-affinity partial agonist at human dopamine D2 receptors”. Journal of Pharmacology and Experimental Therapeutics 1 (2002): 381-389.
  15. Peters-Strickland T., et al. “Usability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole”. Neuropsychiatric Disease and Treatment 12 (2016): 2587-2594.
  16. Cohen EA., et al. “Phase 3b multicenter, prospective, open-label trial to evaluate the effects of a digital medicine system on inpatient psychiatric hospitalization rates for adults with schizophrenia”. Journal of Clinical Psychiatry 3 (2022): 21m14132.
  17. Frias J., et al. “Effectiveness of digital medicines to improve clinical outcomes in patients with uncontrolled hypertension and type 2 diabetes”. Journal of Medical Internet Research 7 (2017): e246.
  18. Hadzi Boskovic D., et al. “Real-world evidence of aripiprazole tablets with sensor: treatment patterns and impacts on psychiatric healthcare resource utilization”. ClinicoEconomics and Outcomes Research 15 (2023): 487-498.
  19. Sideri K., et al. “Digital pills for the remote monitoring of medication intake: a stakeholder analysis and assessment of marketing approval and patent granting policies”. Journal of Law and the Biosciences 2 (2022): lsac029.
  20. Kirschbaum KM., et al. “Serum levels of aripiprazole and dehydroaripiprazole, clinical response and side effects”. World Journal of Biological Psychiatry 3 (2008): 212-218.
  21. Price WN and Cohen IG. “Privacy in the age of medical big data”. Nature Medicine1 (2019): 37-43.

 

Citation

Citation: Roberto Verna., et al. “Software as a Medical Device (Samd) and Optimization of Pharmacological Therapy: The Case of Abilify Mycite® in Moni- toring Therapeutic Adherence". Acta Scientific Medical Sciences 10.9 (2026): 54-64.

Copyright

Copyright: © 2026 Roberto Verna., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.




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