A digital pill is a tablet or capsule with embedded indigestible sensors that communicate about data outcomes related to when the medication is taken to a mobile application for access by the patient and treating their physicians. The novel digital pill system is designed to facilitate and improve patient compliance that is the most onerous issue, faced in the current health care system. Medication non-adherence and poor patient compliance leads to the substantial aggravation of disease, deaths and increased health care costs.

Digital pills track medication ingestion through small sensors that convey the information to a wearable patch on the patient’s skin. This patch in turn sends a confirmation of the compliance to the patient’s smartphone. Additionally, it transmits other metrics such as heart rate and the number of steps walked by the individual that day as well. Patients can then grant their doctor or caretaker access to this data. Howbeit, it totally depends on an individual with whom she/he wanted to share her/his data.

So, what’s coming in the near clinic???

It is worth noting here that, for the very first time, the US FDA has approved a digital pill, Abilify MyCite being developed by Otsuka Pharmaceutical in collaboration with Proteus Health for the treatment of bipolar disorder, schizophrenia, and depression.

Abilify MyCite pill (aripiprazole tablets with sensor) embedded with a safe-for-consumption electronic sensor, which transmits a message to a wearable bandage-like patch on the patient’s body. This wearable patch then conveys a message to an application on the smartphone regarding the drug administration and its accurate arrival at the target destination. In case, if an individual has selected to share this data, then it automatically sends to her/his treating physician.

Pipeline Activity

A company named, Etectrx is working on an “ID-CAP Digital capsule”, which is a standard hard gelatin or HPMC capsule embedded with ingestible wireless sensor. As stated by Etectrx, each time when an ID-Cap digital capsule is swallowed, the ID-Tag deploys EtectRx’s proprietary communications technology to transmit a very low power digital message from within the patient’s stomach. ID-Cap is currently only available for use in institutional Review Board -approved clinical research. A clinical trial employing ETectRx digital Capsule compounded with 5 mg oxycodone tablets have been conducted at Brigham and Women’s Hospital United States. This clinical trial was accessing the feasibility of a novel digital pill system to measure as-needed opioid ingestion patterns in patients discharged from the emergency department after an acute bony fracture and has demonstrated acceptability and usability conditions of digital pills as a medication monitoring method among patients with acute painful conditions.

Gilead is also conducting a clinical trial for the Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users and HIV infections. This specific trial is deploying Truvada as a novel, personalized, smartphone-based intervention (PrEPstep) that responds to real time PrEP adherence and non-adherence detected through the use of a digital pill.

What future holds??

The first ever approval of Abilify Mycite has raised a hope in the health care sector and unlatched the gates for the upcoming expected approval of other medication technologies in the forthcoming years. The field is well springed despite of some ethical concerns, as so many clinical studies are ongoing in different patient’s subgroups, which are tracking the medication adherence in patients with type II diabetes, uncontrolled hypertension and opioid ingestion patterns in individuals with acute pain. The system can also be designed and implemented to track and deliver the acidity and temperature real time levels inside the body without the need for more invasive and expensive procedures.

A long road ahead??

The advantages of digital pills are immense, and have unexpectedly garnered a hope among members of the healthcare sector, pharmaceutical researchers and clinician’s community. Positive outcomes include, faster recovery times due to a strict adherence with treatment regimens, reduced expenses due to wasted drugs and higher-quality clinical trials for studies involving prolonged medication use. Objective digital tracking pills could enable court-mandated treatment regimens to more efficiently meet the treatment goals, reduced the healthcare budgeting of the countries respective health authorities. However, beyond the digital healthcare setting, there are some ethical shortfalls as well such as data privacy and its accuracy that are being imposed as a risk factor while developing these medications. But as, so many studies are ongoing and some of them had already demonstrated the efficacy and acceptability of these pills in the current standard treatment practices, there are substantial chances that digital pills will find their way as a regular prescription base.

Ankit Nigam

Digital Marketing Associate