In 2018, the US Food and Drug Administration (US-FDA) approved for the first time the commercialisation of a digital pill(1), that is, a medication that includes a sensor able of informing whether the patient has taken the prescribed drugs and whether he/she has done it at the right time. The patient must sign consent so that the information recorded can be received by his/her prescribing physician and up to four other people, generally relatives. Naturally, this flux of information is subject to privacy legislation.
The key element of the digital pill is a sensor that generates electrical signals when the tablet disintegrates due to stomach fluids. After several minutes, that signal is detected by a “band-aid” patch, that should be replaced every week, located on the left side of the patient’s chest. The patch sends the information (drug-taking date and time and the patient’s activity level) via Bluetooth to a smartphone app. The app allows the patients to add additional information about their mood and other health parameters, both to his/her doctor and caretakers. This sensor is conformed of copper, magnesium, and silicon, safe ingredients found in many foods. This technology is a significant advance to fight lack of therapeutic adherence, a treatment’s problem whose annual cost is estimated to be over 100 billion dollars only in the US (2), due to the hospital admissions and additional treatments that entails.
The use of a digital pill system requires additional effort, such as carrying an adhesive or using a smartphone app. Therefore, this technology may be more useful in poly-medicated patients (usually the elderly, more suspect for forgetfulness), and those who require long-lasting treatments (such as drugs against tuberculosis (4 ) which must be taken for several months or even years), and those patients in treatments whose effectiveness is critical on the correct fulfilment of the medical prescription (vg immunosuppressive drugs).
The Abilify® (Aripiprazole ), prescribed for schizophrenic patients (5), bipolar disease (6), and, in association with anti-depressants drugs, in depressive illness (7), is the first commercialized digital pill. The decision to apply this technology to a psychotropic drug is not a coincidence. In many cases, the symptoms of these illnesses work as a deterrent to the correct use of the pharmaceuticals needed to treat them. As a significant example, schizophrenia, and the episodes of paranoia that provokes may trigger patients to stop correctly taking the medication, believing the doctor is trying to poison them. Adopting this technology could open possibilities of deinstitutionalization for many patients, enabling them to return to their homes.
The digitalized version of Abilify®, approved by the Food and Drug Administration and registered as Abilify MyCite®, is the result of a collaborative effort between the anti-psychotic’ manufacturer, the Japanese pharmaceutical company Otsuka Pharmaceuticals, and the Californian company Proteus Digital Health. The latter, that developed the detecting device, has already reported benefits of 400 million dollars after transferring the rights of its use to companies such as Novartis AG and Medtronic. The Abilify® patent has recently expired. Thus, different laboratories can market generic versions of Aripiprazole. However, Otsuka Pharmaceuticals maintains the exclusive sale of the digitalized version (Abilify MyCite®). The Japanese firm is still to set the selling price, which will be decided on the success of the device during restricted marketing time.
This technology is expected to, and already has, created a lot of commercial interest due to its many possible applications. Digital pills are currently being tested in patients with heart disease, stroke, antiretroviral treatments, and diabetes; some studies showing that it improved therapeutic adherence in patients with uncontrolled hypertension (8). Taking into consideration the raging opioid epidemic in the USA, the technology could be beneficial for the control of patients with opioid treatment. It could also be of great use for clinical trials and has been used for that matter since 2016, being a useful tool to tackle the empirical problem of attrition. Until now, the sensor has not been embedded in tablets. Pharmacies could be commissioned to put it in a capsule along with re-packaged and dispensed medication.
AidCure and EtectRx, pharmaceutical firms focused on digitalized medication, have designed their versions of the digital pill technology. The system developed by AidCure, successfully applied to patients under treatment for tuberculosis, goes along the lines of the one currently commercialized by Otsuka Pharmaceuticals. However, the sensor manufactured by EtectRx, the ID-Cap®, has some innovative characteristics. ID-Cap®, made of magnesium and silver chloride, is encapsulated together with tablets and does not require an external patch since the radio signals are picked up by a data reader that hangs around the neck. Soon, the reader could also be integrated into wrist-watches or smartphones. The ID-Cap® is already tested with opiates, anti-retroviral and other drugs.
Insurance companies, an essential party in the medical sector, may also become advocates for the digital pill, encouraging its use through co-payment’s discounts.
Nonetheless, the implementation of this technology has raised many ethical considerations regarding privacy and freedom of will. Peter Kramer, psychiatrist and author of the informative book «Listening to Prozac,» which contributed immensely to make this kind of antidepressants undeniable blockbusters, has been critical of the use of digital pills, stating that it is like «packaging the medication with a gossip.» In other words, this practice can be coercive and contravene individual rights. Otsuka Pharmaceuticals has hired several bioethics experts to address these issues.
Zaragoza, December 2019
- Scooter Plowman R., et al. Digital medicines: clinical review on the safety of tablets with sensor. Expert Opinion on Drug Safety 2018; 17(9): 849-52.
- The Human Data Science Company. In: https://www.iqvia.com/de-de/locations/germany. Consult: November, 2017.
- Pae C.U. A review of the safety and tolerability of aripiprazole. Expert Opin Drug Safety 2009; 8: 373-86.
- López-Tricas J.M. El esquivo bacilo de Koch. In: http://www.info-farmacia.com/historia/el-esquivo-bacilo-de-koch. (info-farmacia.com).Consult: November, 2017.
- Croxtall J.D. Aripiprazole: a review of its use in the management of schizophrenia in adults. CNS Drugs 2012; 26: 155-83.
- Dhillon S. Aripiprazole: a review of its use in the management of mania in adults with bipolar I disorder. Drugs 2012; 72: 133-62.
- Pae C.U., et al. Aripiprazole as adjunctive therapy for patients with major depressive disorder: overview and implications of clinical trial data. CNS Drugs 2011; 25: 109-27.
- Proteus Digital Health Presents Interim Results at ACC from a Randomized Controlled Clinical Study of Proteus Discover. In: http://www.businesswire.com/news/home/20160404005086/en/Proteus-Digital-Health-Presents-Interim-Results-ACC. Consult: November, 2017.
- Abilify Mycite®, safety and effectively. In: https://www.otsuka-us.com/media/static/ABILIFY-MYCITE-PI.pdf?_ga=2.55560360.246223314.1575991043-655250763.1575991043. Consult: December 2019.
Zaragoza, December 2019
López-Tricas, JM MD