The same sensor technology integrated into smart pill bottles is also being incorporated on a much smaller scale- the pills themselves. In 2012, Proteus Digital Health received FDA clearance for its ingestible sensor that can be integrated into tablets or capsules during pharmaceutical manufacturing.10 Less than 1mm square in size and comprised mainly of silicon, the sensor transmits a unique and private digital code to identify the medication, dose, and time of ingestion upon contact with stomach fluid. The stomach fluid acts as a power source to activate the sensor in transmitting the digital code to a battery-operated patch worn on the left side of the body just below the chest.11 Lastly, the patch sends the information to a Bluetooth-enabled device and a secured centralized database. Using the secure Helius application for smartphones, tablets, and computers, the information can be viewed by the patient or, with permission, to their caregivers or clinicians. The patch may be worn for up to one week; it also can detect and relay information on heart rate, physical activity, and inactivity. In 2010, Proteus announced a collaboration with Novartis to develop and commercialize products with the sensor in the field of organ transplantation with option rights for cardiovascular and oncology product applications, as well as rights to use the technologies in clinical trials for pharmaceutical product development.12 A 12-week open-label single-arm exploratory study of twenty kidney transplant patients in stable condition after an average of 6.0±5.0 years post-renal transplantation evaluated the sensor and patch accuracy vs. directly observed ingestions (DOI) in medication adherences and timing adherence. The patients were prescribed enteric-coated mycophenolate sodium (ECMPS) that included the sensor technology system. The sensor system reported a 100% detection accuracy rate over 34 directly observed ingestions, 99.4% in ECMPS that included the sensor, and 99.3% in detecting the ingestion of two ECMPS capsules taken simultaneously.13
Challenges to Improving Medication Adherence with Technology
Improving patient medication adherence can be difficult if social and economic factors (age, race, sex, socioeconomic status), patient-related factors (knowledge, attitude, beliefs), condition and treatment-related factors (severity of the symptoms and disease, complexity of the medical regimen, duration of treatment, adverse effects), provider characteristics (communication skills, training, and resources), and settings (drug coverage, cost sharing of medication, and access to medication and clinical care) are barriers to drug therapy.4 Technology may not improve adherence if one or more of these are significant factors in which real-time monitoring is not the solution. The World Health Organization (WHO) recommendations for patient adherence to long-term treatments, including diet and/or lifestyle changes, include the need for clinicians to assess patient readiness to adhere to a therapeutic plan and provide guidance and support rather than blame if nonadherence occurs.2
As the incidence of chronic illnesses continues to climb, medication adherence will become more important than ever in disease control and reducing healthcare-associated costs. Although technology may not resolve all issues linked to patient medication nonadherence, innovations utilizing sensors like the AdhereTech smart pill bottle and the Proteus sensor system could contribute to improved outcomes in pharmacologic treatments seen in clinical trials and patient therapies.
- Improving Prescription Medicine Adherence is Key to Better Health Care. PhRMA, the Pharmaceutical Researchers and Manufacturers of America. www.pharma.org. 2011 Jan. Accessed August 25, 2014.
- Adherence to long-term therapies: Evidence for Action. World Health Organization 2003. http://whqlibdoc.who.int/publications/2003/9241545992.pdf. Accessed August 25, 2014.
- Roebuck MC, Liberman JN, Gemmill-Toyama M, Brennan TA. Medication adherence leads to lower health care use and costs despite increased drug spending. Health Aff. 2011;30(1):91–9.
- Vrijens B & Urquhart J. Methods for measuring, enhancing, and accounting for medication adherence in clinical trials. Clin Pharmacol Ther. 2014 Jun;95(60):617-26. doi: 10.1038/clpt.2014.59.
- Guidance for industry: Enrichment strategies for clinical trials to support approval of human drugs and biological products. U.S. Food and Drug Administration. 2012 Dec. www.fda.gov. Accessed August 25, 2014.
- Windham BG, Griswold ME, Fried LP, Rubin GS, Xue QL, Carlson MC. Impaired vision and the ability to take medications. J Am Geriatr Soc. 2005 Jul;53(7):1179-90.
- Hayes TL, Larimer N, Adami A, Kaye JA. Medication adherence in healthy elders: small cognitive changes make a big difference. J Aging Health. 2009 Jun;21(4):567-80.doi: 10.1177/0898264309332836.
- AdhereTech. http://www.adheretech.com/. Accessed August 25, 2014.
- Weill Cornell to test AdhereTech’s wireless pill bottle, thanks to NYC grant. Weill Cornell Medical College. July 25, 2013. http://weill.cornell.edu/news/news/2013/07/weill-cornell-to-test-adheretechs-wireless-pill-bottle-thanks-to-nyc-grant.html. Accessed August 25, 2014.
- Proteus Digital Health announced FDA clearance of ingestible sensor. Proteus Digital Health. July 30, 2012. http://www.proteus.com/proteus-digital-health-announces-fda-clearance-of-ingestible-sensor/. Accessed August 25, 2014.
- Hafezi, H, Robertson TL, Moon, GD, Au-yee K, Zdeblick MJ. An ingestible sensor for measuring medication adherence. IEEE Trans Biomed Eng. 2014 Jul 21. [Epub ahead of print]. doi: 10.1109/TBME.2014.2341272.
- Proteus Digital Health. Proteus Biomedical announces license and collaboration agreement for sensor-based pharmaceuticals. 2010 Jan 12. http://www.proteusdigitalhealth.com/proteus-biomedical-announces-license-and-collaboration-agreement-for-sensor-based-pharmaceuticals/. Accessed August 25, 2014.
- Eisenberger U, Wüthrich RP, Bock A, Ambühl P, Steiger J, et al. Medication adherence assessment: high accuracy of the new Ingestible Sensor System in kidney transplants. Transplantation. 2013 Aug 15;96(3):245-50. doi: 10.1097/TP.0b013e31829b7571.