Patients, Providers, and the Public Hesitate to Adopt Digital Pills

October 03, 2022 - On November 13, 2017, Abilify MyCite became the first digital pill approved by the United States FDA. Since this approval and the initial surge of digital pills — sometimes called smart pills — the uptake and utilization have slowed due to ethical concerns. Abilify MyCite withdrew its application to the European Medical Agency in 2020 after the agency declared that the device’s evaluation was inadequate. Despite the hesitancy, the drugs can benefit the medical industry, and their market is expected to grow in the coming years.

What Is a Digital Pill?

BMC Medical Ethics defines digital pills as a drug–device technology that combines medications with monitoring devices. In essence, a smart pill is typically composed of an outer drug layer that looks like a traditional pill and an inner layer containing the sensor or device.

Types of Digital Pills

According to an article published by impacX, there are three different classes of smart pills: dissolvable sensors, cameras, and microchip sensors. While the three look similar, they each serve a different purpose. A press release by Research and Markets states that “based on application, the market is segmented into capsule endoscopy, drug delivery, and patient monitoring.”

Smart pills with dissolvable sensors are one of the most discussed forms of digital pills. Researchers in the Journal of Medical Internet Research state that these sensors are “an ingestible event marker made from a copper–magnesium pair of electrodes within a silicon insulating skirt disk 5 mm in diameter and 0.3 mm thick. On contact with gastric fluid, the sensor sends a unique digital code to allow identification and timestamping of the medication and dose form.”

Digital pills with a camera are relatively self-explanatory. The camera will transmit data to the healthcare provider, allowing them to visualize the digestive tract.

Finally, digital pills with a microchip or sensor that does not dissolve can record vitals for up to 16 hours and proceed through the digestive tract.

Goals and Benefits of Digital Pills

Investigators in the Journal of Medical Internet Research heavily imply that the primary goal of digital pills is to improve medication adherence and optimize treatment.

Medication Adherence

In this publication, the authors suggest that nonadherence can be identified using digital pills and may help justify more expensive treatment options. Providers will no longer have to guess whether a patient outcome is due to an insufficient treatment plan or inadequate adherence.

In addition to better analyzing patient medication adherence, digital pills can incentivize patients to maintain medication routines, reducing healthcare spending. The Journal of Law and the Biosciences states that nearly 50% of patients with chronic disease do not adhere to treatment worldwide. Beyond that, researchers said that “non-optimized medication therapy costs up to $528.4 billion, which is equivalent to 16% of the total US healthcare expenditure in 2016.”

Assuming digital pills allow for improved medication adherence, the healthcare industry will see improved patient outcomes and a reduced financial burden.

Remote Patient Monitoring

In addition to tracking medication adherence, digital pills can also act as remote patient monitoring devices. Some sensors can detect internal body temperature, pH, and pressure and transmit the data to a healthcare provider. This knowledge can assist providers in detecting medical conditions and forming treatment plans.

Diagnostic Imaging

Finally, digital pills can potentially improve diagnostic imaging. The Alliance of Advanced Biomedical Engineering states that technology could function as a form of diagnostic imaging and replace endoscopy procedures typically used to diagnose gastrointestinal disorders.  

“The capsule endoscopy segment is sub-segmented into small bowel video capsule endoscopy, colon capsule endoscopy, controllable capsule endoscopy, storable capsule endoscopy, and other capsule endoscopies,” stated the Research and Markets press release.

Drawbacks and Hesitancy

Despite the plethora of potential benefits, there is a significant hesitancy to adopt digital pills. The Journal of Law and the Biosciences shares those digital pills “would serve well to avoid unnecessary healthcare costs and reduce the anxiety of patients and their relatives. However, digital pills might also diminish patient autonomy, reduce privacy, or promote inadequate use of pharmaceutical resources.”

Hesitancy

Researchers in the Journal of Medical Internet Research surveyed 767 patients, 1238 public participants, and 246 healthcare professionals between January and August 2020.

The researchers concluded that 35.3%, 30.4%, and 15.8% of patients, public participants, and providers were willing to take digital pills. In addition, they noted that the rate of acceptance of digital pills for me was nearly double that of women.

Investigators in the publication stated that “two-thirds of patients and public participants in this study refused to take digital pills. Their arguments were grounded in the fear of possible serious clinical and ethical harms.”

Patient–Provider Relationships  

The Journal of Law and the Biosciences states that universal use of digital pills for medication adherence and remote patient monitoring may alter patient–provider relationships. Currently, patients and providers base their relationships on mutual trust.

Researchers in the journal suggest that remote patient monitoring negates that critical factor. As stated in the publication, “the introduction of digital pills replaces this framework with a new policy in which monitoring and control play a key role. It is no longer the patients who reveal data to the physician on a voluntary basis. Instead, the physician becomes a kind of ‘Big Brother’ who knows everything about the patient even though they are unwilling to share such information.”

Pharmaceutical Ethics

In addition to altering patient–provider relationships, the introduction of digital pills and how they are marketed presents an ethical concern. Some providers believe digital pills will drive the pharmaceutical industry away from patient benefits.

The Journal of Law and the Biosciences asserts that the healthcare industry must “not forget that the pharma industry is guided by a strong interest in enhancing human health while making a profitable business of it. It may happen that, for this purpose, it focuses its attention on the monitoring system rather than on the medicine it incorporates, or worse still, the system is used as a means of revaluing a medicine that would otherwise be almost obsolete.”

Other Considerations

Other considerations which have made people hesitant to adopt digital pills include issues of privacy, autonomy, and costs.

While collecting the data can be extremely valuable, makings sure that it is secure and private is equally as important. As with any data sharing, many patients and providers are concerned about the safeguards — or lack thereof — that are in place to protect patients. 

Beyond issues of privacy, it is thought that the use of digital pills will reduce patient autonomy. Patient informed consent would be critical when it comes to implementing digital pills. 

Finally, developing, testing, and regulating digital pills would be exceptionally costly. As the effects of the technology are not fully understood, extensive research and clinical trials would need to be conducted across multiple diverse patient populations to determine the impact.

Projected Market Growth

According to a recent press release by Research and Markets, the smart pill market is expected to grow in the next six years to $5,300.85 million. To put that in context, in 2021, the market was valued at only $2,314.71 million.

“With the new features and technologies, vendors can attract new customers and expand their footprints in emerging markets. This factor is likely to drive the smart pills market. The North America smart pills market is expected to grow at a good CAGR during the forecast period,” concluded the press release. 

Research and Markets anticipate that a primary consumer of smart pills will be the geriatric population who suffer from more chronic and acute conditions. The press release states, “patients with chronic diseases who follow a specified dose of medication at the target site are anticipated to form a large customer base for advanced drug delivery products. The increasing demand for minimally invasive surgical procedures has led to innovative techniques such as capsule endoscopy.”

The report also identifies multiple market drivers, such as the rising demand for minimally invasive surgical procedures and increased strategic collaboration. Despite the potential for market growth, the pills have a high cost of production, and there may be difficulties in market opportunities.

Looking Ahead

Considering the projected market growth, the adoption of digital pills seems inevitable. That said, it is up to researchers, clinicians, manufacturers, and regulatory organizations to ensure a safe, effective, and ethically-sound integration of these devices.

Clinicians in the Journal of Medical Internet Research suggest “that digital pills should not be considered a mere change in the form of drug administration but a complex intervention requiring specific evaluation before extended use in clinical routine practice as well as an ethical and legal framework to ensure safe and ethical collection and use of health data through a patient-centered approach.”