The US Food and Drug Administration (FDA)’s approval of the first-ever digital pill, Abilify MyCite, an aripiprazole tablet for the treatment of schizophrenia, marks the closest we have come to revolutionising the way the uptake of pills is monitored
On a global scale, the United States and Great Britain, the world’s first and fifth strongest economies, respectively, suffer the dreadful ramifications of medication non-adherence
. In the United States, non-adherence is described as an ‘out-of-control epidemic’, which costs more than any other disease entity — roughly between $10bn and $289bn each year
. And medication non-adherence is directly linked to 125,000 deaths and up to 10% of all hospitalisations in the United States each year. Medication non-adherence is reported to take 200,000 lives in the European Union and cost the NHS £500m each year
Attaining medication adherence requires a multi-disciplinary approach. Unfortunately, one or more involved parties usually falls short. Non-adherence ranges from not initiating the uptake of pills, to stopping taking them after initiation, to not taking the correct dose or at the right time, or both. In the case of polypharmacy (three or more medicines a day), non-adherence rates skyrocket.
On a field-focused scale, Pan et al’s meta-analysis revealed that the majority of 88 clinical trials spanning 35 years of breast cancer treatment failed to provide details with about adherence
. Furthermore, non-adherence to medications in breast cancer prevention and treatment as with adjuvant endocrine therapy, is reported to be high
Abilify MyCite is a pill with an embedded sensor. Information (on ingestion, dose and batch of medication) is transmitted to a wearable skin patch (changed weekly) when the pill comes into contact with stomach acids. The information is then transmitted via Bluetooth to a smartphone application. Patients can share these data with family members and caregivers. The pill is metabolised and excreted like any other pill.
The sensor was FDA-approved in 2012. Preliminary data on blood pressure and diabetes drugs, with this sensor as a stand-alone pill, show reported benefit to patients
. Abilify MyCite has not yet been proven to increase adherence and more studies are needed to confirm such correlation. It does not necessarily provide ‘real-time’ tracking because the detection of ingestion is said to take from half an hour to two hours, and transmission can be delayed or may not occur. Patients with abnormalities in stomach acidity might suffer inconsistencies. Healthcare professionals must ensure that patients are willing and capable of using this system, and train them to use the drug, patch and phone application.
Ethical issues have been raised: will such system be hacked and subsequently expose patients’ private history of medications? Will children and those who are incompetent take those pills with no consent or must a judge authorise their use?
The approval of this digital pill may:
- Overcome the perennial challenge of patients adhering to medications;
- Open doors for other medication technology combos in the coming years;
- Facilitate the creation of libraries on adherence, which will significantly benefit patients and clinical trial data.
University of Texas MD Anderson Cancer Center
 Viswanathan M, Golin CE, Jones CD et al. Interventions to improve adherence to self-administered medications for chronic diseases in the United States: a systematic review. Ann Intern Med 2012;157(11):785–95. doi: 10.7326/0003-4819-157-11-201212040-00538
 Abderrahman B. Medication non-adherence in breast cancer prevention and treatment. Pharm J 28 September 2017. Available at: http://www.pharmaceutical-journal.com/opinion/blogs/medication-non-adherence-in-breast-cancer-prevention-and-treatment/20203424.blog (accessed December 2017)
 Business Wire. Proteus Digital Health presents interim results at ACC from a randomized controlled clinical study of proteus discover. Available at: http://www.businesswire.com/news/home/20160404005086/en/Proteus-Digital-Health-Presents-Interim-Results-ACC (accessed December 2017)