Digital Pill: Overview

Introduction

The role of technology in health care has grown steadily, as evidenced by the US Food and Drug Administration (FDA) launching digital health initiatives and focusing more resources on regulating software and devices. The use of mobile devices in medical practice is known as mHealth. This encompasses familiar devices such as smartphones and fitness trackers as well as less visible but increasingly important technology such as the digital pill. Such developments have proven both potentially revolutionary and highly controversial, and one of the primary issues facing the FDA today is how to properly regulate innovation without stifling it.

First approved by the FDA in late 2017, digital pills highlight some of these regulatory issues and controversies. The term refers to a pill with an ingestible sensor embedded in it along with medication. Smaller than a grain of rice, the sensor tracks adherence, or a patient's rate of successfully taking their prescribed dosage of medication at the correct frequency. The first approved example, known as Abilify MyCite, worked along with a wearable sensor and a smartphone application to alert the patient's doctor when the pill has been taken. The technology also holds the potential to perform a number of other functions, including regulating the release of a drug, noting the patient's vital signs, and transmitting data to other parties.

Proponents claim that digital pills will drastically improve health care outcomes by raising adherence rates. This would not only save the hundreds of billions of dollars lost to nonadherence each year through avoidable doctor and hospital visits, but also save lives. Critics, however, question the ethics and information security of the technology, particularly with patients who may not be able to give informed consent.

Understanding the Discussion

• Adherence: A patient's record of taking medicine as prescribed, following the correct dose and schedule.
• Informed consent: The process by which a patient agrees to a test or treatment only after being made aware of its purpose, risks, benefits, and alternate options by a medical professional.
• mHealth: The use of mobile devices in health care regimens, treatments, or evaluations.
• US Food and Drug Administration (FDA): Federal agency charged with regulating medicine and medical technology.

History

To understand the issues surrounding the digital pill, it is important to look at the development of FDA policy surrounding medical devices and technology. The Food, Drug, and Cosmetic Act, originally drafted in 1938 and subsequently revised, gave the FDA the authority to regulate medical devices. During the 1960s and 70s, computer-powered devices became a growing part of health care, helping doctors to diagnose patients and share data with other physicians. In 1981, the FDA established the Task Force on Computers and Software, which did not lay down formal rules for evaluation or approval but instead simply established that the FDA was researching digital medicine.

As computers became more capable of health-care-oriented tasks, proponents viewed technology as a way to save money while also improving the quality of health care by reducing human error and making care more accessible. These ideas have informed FDA policy, but historically, there has been little legislative support for expanding the use of digital devices. In 2012, Congress passed the Drug Administration Safety and Innovation Act, but this act, continuing the FDA's longtime operational strategy, did not implement specific review or regulation policies.

Because the human and technical resources needed to thoroughly test all new products would be vast, the FDA often uses what is called 510(k) approval. This is a pre-market approval process for devices that are considered "substantially equivalent" to existing approved products. The rationale behind the 510(k) approval process is that it cuts out unnecessary review components, because if a product is similar to an existing safe and effective product, some information is already known. The FDA's approach to regulating new technology has long been to offer guidelines and recommendations rather than strict rules. This approach is based on the idea that too much regulation stifles innovation. Software-reliant technologies such as the digital pill, however, are much more sophisticated and complex than devices such as electrocardiograms or infusion pumps to administer intravenous medication that the FDA regulated under earlier guidelines. The agency struggled to keep up with medical software and other technology, leaving it largely unregulated even as it became prevalent.

While the digital pill operates in a groundbreaking way, it has a number of antecedents similarly designed to address nonadherence and medication monitoring. These devices range from simple alarms to "smart pill" dispensers. Special blister packs can keep track of when pills are removed from the packaging. Some of these devices interact with computers to record data on adherence. More recently, mobile apps have been created to perform some of the same functions. US Pharmacist reported, however, that most of these antecedent devices have drawbacks. Most importantly, they depend upon the patient's willingness and determination to take their medicine.

Other devices have used similar technologies to digital pills, but with different primary goals. In capsule endoscopy, widely known as the PillCam, a pill-sized camera is swallowed and films the digestive tract. Similarly, the so-called SmartPill records and wirelessly transmits data such as temperature, pH, and pressure as it passes through a patient's system. The digital pill is different from these information-gathering devices because in addition to recording information about the patient's body, it contains medication. While the first approved digital pill in the United States, Abilify MyCite, was based around the antipsychotic drug aripiprazole, the technology has the potential to be used for many kinds of medications. Potential applications of the digital pill include treating tuberculosis, hypertension, diabetes, Alzheimer's disease, and hepatitis C. Advanced digital pills could even be used to monitor blood alcohol levels to prevent drunk driving.

As originally developed, digital pills are actually fairly simple in concept. The pill itself contains a sensor that when ingested sends a signal to another, wearable sensor. The second sensor then transmits the fact that the drug has been taken to a smartphone app, which relays the information to the patient's doctor and other approved parties such as family members. The wearable sensor can also collect and transmit other health information. However, while this allows doctors to monitor adherence, it still leaves patients ultimately responsible for remembering and choosing to take their medication. Proponents of digital pill technology suggest that eventually pills can be developed that will help overcome these issues. For example, an advanced pill might only need to be swallowed once and then would regulate medication dosage automatically, making it impossible for patients to forget to take their medicine.

The Digital Pill Today

The groundbreaking digital pill Abilify MyCite, a product of Otsuka Pharmaceutical and Proteus digital health, was approved piecemeal. Only some components received 510(k) approval, while final approval was a more complex and lengthy process. Proteus had developed an ingestible digital sensor by 2008, and began working with the FDA to determine how this new technology would be regulated. Meanwhile, it also partnered with drug companies to explore integrating drug administration with the sensor. In 2010, the FDA gave 510(k) approval to Proteus's wireless personal health monitor, the wearable patch that interacts with the actual digital pill. In 2012 the basic ingestible sensor itself received FDA clearance to be classified as a medical device. The FDA finally approved the entire Abilify MyCite package as an antipsychotic drug used to treat schizophrenia and bipolar disorder in November 2017.

The first US approval of a digital pill immediately attracted considerable media attention. Supporters hailed it as a breakthrough in the often difficult effort to monitor patient adherence, potentially saving lives and resources. The New York Times noted, for example, that nonadherence cost approximately $100 billion each year as of 2017, mainly due to patients requiring further treatment after missing doses. However, many observers were skeptical of the digital pill phenomenon, noting the expense of such technology and the lack of evidence that it in fact would have any effect on adherence. Ethicists also noted the complex issues of trust and consent involved with digital drugs. Many health-care industry observers noted that by the mid-2020s, digital pills were still not in widespread use due in part to such obstacles.

Bibliography

Emspak, Jesse. "FDA Approves First 'Digital' Pill: How Does It Work?" , 16 Nov. 2017, www.livescience.com/60963-how-does-digital-pill-work-abilify.html. Accessed 1 Mar. 2018.

Figge, Helen L. "Electronic Tools to Measure and Enhance Medication Adherence." , vol. 36, no. 4, 2010, pp. 6–10, www.uspharmacist.com/article/electronic-tools-to-measure-and-enhance-medication-adherence. Accessed 1 Mar. 2018.

Lynch, Holly Fernandez, and I. Glenn Cohen, editors. . Columbia UP, 2015.

Molteni, Megan. "Medicine Is Going Digital. The FDA Is Racing to Catch Up." , 22 May 2017, www.wired.com/2017/05/medicine-going-digital-fda-racing-catch/. Accessed 1 Mar. 2018.

Vaidya, Manasi. "Why Aren't Digital Pills Taking Off?" Pharmaceutical Technology, 8 Aug. 2022, www.pharmaceutical-technology.com/features/why-arent-digital-pills-taking-off/?cf-view. Accessed 28 May 2024.