The Digital Pill: A second set of eyes in the lives of patients

Patient prescription noncompliance is a major issue in United States healthcare. Many medications have incredible capabilities in their powers to mitigate, control, and sometimes even cure diseases but without medication, many of these controllable conditions and diseases can cause major harm to the body. For example, roughly half the people with untreated hypertension die of heart disease related to poor blood flow, and another third die of stroke; with medication, however, this condition can be controlled. According to the Centers for Disease Control and Prevention, patients aren’t taking their medication as prescribed 50% of the time. This leads to 125,000 deaths per year and between $100 billion and $300 billion annually of avoidable healthcare costs. In response, the digital pill was created. This technology is intended to increase adherence rates through a system of tracked medication ingestions. The patient takes the medication and the information is then sent to a portal which is accessible by elected individuals like doctors and family members. Theoretically, increased adherence leads to better health for patients. However, the technology potentially risks the autonomy of patients. This paper will consider the preeminent values in healthcare,–safety and autonomy– in a discussion of the ethics of this patient monitoring technology. There is tremendous hope for the digital pill, but there may be serious implications, especially if the information starts acting as evidence or as government agencies and insurances providers get involved. The question is, whose responsibility is adherence?


 

Imagine the following scenarios. Your little brother just recieved a kidney transplant and he needs to take all of his medicine correctly or the transplant could fail. Your grandmother lives in California and suffers from diabetes. Her diabetes medication is important to her health but as she has aged, she’s become more forgetful. Wouldn’t you agree that it would be good to have a way to check that these people are taking their medicine? The digital pill was created to do exactly that: allow for the monitoring of medication intake. Now consider that you are the patient. Would you want to be monitored? Would you want your doctor to treat you based on what your data looks like from the digital pill? What if your insurance provider said they wouldn’t insure you until you can prove that you are actually taking the medicine? These are some of the questions that digital pill raises and will be further discussed later in this paper.

The digital pill is a technology that was approved by the United States Food and Drug Administration in the fall of 2017. It records patient ingestions through a three-part system, including a sensor built into an existing medication. It was created to reduce rates of non-adherence–an issue that plagues the nation (Commissioner).

Non-adherence is a major issue in the United States healthcare system; some consider it a public health crisis. As defined by the World Health Organization, adherence in medicine is “the degree to which the person’s behavior corresponds with the agreed recommendations from a health care provider” (Jimmy). Non-adherence describes a patient’s failure to follow a physician’s instructions such as not filling prescriptions, or taking the medication at the wrong times or in incorrect dosages. Between $100 billion and $300 billion annually of avoidable health care costs have been attributed to non-adherence in the US. These costs are often emergency procedures and needs like emergency room visits, surgeries, and extra medication (Igua). According to the Centers for Disease Control and Prevention, “medication is not taken as prescribed 50 percent of the time” and “for patients prescribed medications for chronic diseases, after six months, the majority take less medication than prescribed or stop the medication altogether.” This issue actively affects society causing 125,000 deaths per year in the United States. It is a cycle of non-adherence leading to greater use of healthcare services that puts financial pressure on the patient and, beyond a certain level, negatively influences patient adherence (Center).

At first, the digital pill may seem like a perfect, almost fairytale solution. More medication means more health, right? It is not that simple. Upon closer examination, the digital pill does benefit patient safety but in many circumstances, it risks autonomy.  This emphasizes the tension between safety and autonomy that has long existed in healthcare. Autonomy is one of the fundamental values of a good life and a basic principle of medical ethics; it is the right or condition of self-government. Autonomous individuals act intentionally, with understanding, and without controlling influences. Philosopher Immanuel Kant applied the value of autonomy to define the concept of personhood and human dignity. Autonomy and rationality are Kant’s two criteria for a meaningful life. Not only are medical professionals expected to “do no harm”, otherwise known as non-maleficence, as sworn during the Hippocratic Oath, but they are expected to practice beneficence. Beneficence is defined as an action that is done for the benefit of others (Pantilat). Medical professionals are expected to do good for their patients, but the question is whether that means respecting their autonomy or protecting their safety. This becomes especially difficult when the two values cannot coexist.

The digital pill leads to the question: what is more important in healthcare, safety or autonomy. While this question is beyond the scope of this paper, it is important to consider. This paper will more closely examine the question: who is responsible for adherence? The answer to that question gets at the heart of how much autonomy a patient has or deserves in order to protect their health. The challenging question is whether and to what extent it is okay to take away patients’ autonomy in the interest of safety.

 

The Issue: Medical Non-adherence

Many medications have amazing capabilities in their powers to mitigate, control, and sometimes even cure diseases, but without medication, many of these manageable conditions and diseases can cause major harm to the body. For example, roughly half the people with untreated hypertension die of heart disease related to poor blood flow (ischemic heart disease) and another third die of stroke. In the United States, 71 percent of adults with hypertension do not have their blood pressure under control, putting them in danger (Harvard). However, with medication, this condition can be controlled.

Unfortunately, the issue is not unique to patients with high blood pressure. The patient group who are generally the least compliant are those with chronic diseases. As defined by the U.S. National Center for Health Statistics, “a chronic disease is one lasting 3 months or more… chronic diseases generally cannot be prevented by vaccines or cured by medication, nor do they just disappear” (Definition). For some of these diseases, like hypertension, patients can go off their medication and still not feel major unpleasant symptoms. Seventy-seven percent of patients are compliant when their medication is to cure a disease while only 63 percent are compliant with medication for prevention. The bigger issue, however, seems to be that rates of compliance drop to around 50 percent for either prevention or cure when the medication is to be taken over a long period. Other groups that have high rates of non-adherence are elderly patients: an average rate of 55 percent noncompliance; patients with psychotic disorders, in this case schizophrenic patients in the United States, around 48 percent; and patients with infectious diseases, around 26 percent non-adherence (Jimmy). There is especially a risk to not only the patient but also to the public for patients with infectious diseases- such as Hepatitis C and tuberculosis- that are not fully compliant to their medication. This demonstrates that non-adherence is not only a personal issue but also truly a public health crisis.

The issue of non-adherence becomes complex because there are so many different causing factors. According to the Food and Drug Administration, reasons for people not taking their medicine include “not understanding the directions, forgetfulness, multiple medications with different regimens, unpleasant side effects or the medication doesn’t seem to be working” (Center). These can essentially be grouped into two categories: intentional and unintentional. Some patients do wish to adhere to their medical instruction but are unable to. Some of these factors include lack of understanding of their condition or medication regimen, complex drug regimens, financial burden, and forgetfulness. However, some patients purposefully do not take their medication as prescribed. Some of the reasons a patient may deliberately not adhere include wanting to avoid side effects, wanting to be “natural” or wishing to be less reliant on drugs, or not believing in medicine.

The symptoms of certain mental illnesses also pose additional challenges to adherence. According to the study The prevalence and correlates of untreated serious mental illness, Health Services Research, the most significant cause of non-adherence among these individuals is anosognosia: impaired ability to understand and perceive his or her illness. Anosognosia causes patients to believe they are not sick. This symptom is common for schizophrenia and bipolar disorder. Other reasons include significant unpleasant side effects to antipsychotics, stigma around treatment of mental illness, fear of forced hospitalization, depression, cognitive impairments, and substance use/abuse (Causes). Non-adherence for serious mental illness is especially problematic because it has been associated with “increased use of emergency psychiatric services, violence, arrests, and an increased risk of suicide attempt, poor social and occupational functioning, and reduced quality of life” (Velligan). These factors are more difficult to deem intentional or unintentional because technically the patient is consciously choosing not to take the medicine but their thoughts are influenced by the illness. Although they are technically competent, their decisions may be different than if they did not have a mental illness.

There have been efforts to increase the rates of adherence by other means. For example, there was a study done that distributed home blood pressure monitors to 200 patients. When the patient visited the office, the doctor and patient were able to review the blood pressure data and discuss any barriers if the patient was not adherent or reapproach the drug regimen if the patient was adherent but the medication did not control the blood pressure as expected. In addition, the system allowed the provider to see medical coverage and in turn pick a drug that worked for the patient financially. The rate of Reliant’s hypertension control went from 68 percent in 2011 to 79 percent in 2014. It was likely the increased collaboration between the doctor and the patient based on the data provided by the monitor that increased the adherence. However, blood pressure is a relatively easy measurement to take and so this solution is only applicable to patients with high blood pressure. This study proved that this type of technology can increase rates of adherence (Neiman).

Non-adherence is a consequential problem in healthcare. Some would argue that focusing efforts on increasing rates of adherence would be most useful. However, since it is so complicated many approaches have failed in solving or even significantly reducing the issue.

 

The Response to Non-adherence: The Digital Pill

The digital pill is a medical technology created to address the issue of non-adherence. The system allows for monitoring of a patient’s medication ingestions to ensure that the patient is taking their medication as prescribed. The Food and Drug Administration approved the sensor itself in 2012 but in the fall of 2017, the digital pill was first approved for use as Abilify MyCite. The company that developed the sensor, Proteus Digital Health, stated that the pill is meant to “mitigate the high costs of uncontrolled diseases”. Another goal of the technology is to optimize therapies. The objective data given by the digital pill allows receivers of the information, doctors and researchers in the case of a study, to see what is working and what is not so they can adjust or eliminate medication from a treatment. The means by which the technology is expected to raise adherence is by increasing collaboration between patients and caregivers and providing objective data (Proteus).

The system consists of three parts: an Ingestible Event Marker (IEM) sensor, the MyCite Patch, and the MyCite app/web-based portals. The patch, similar to an adhesive bandage, is worn on the abdomen. A pill is embedded with a sensor that has a silicon chip, which has a logic circuit. The sensor is about the size of a grain of salt and is made out of elements found in the typical diet, copper and magnesium, so it is completely safe and the ingestion does not cause discomfort. When the sensor encounters the hydrochloric acid in the stomach, the pill is dissolved and the sensor is left behind. The device will generate a current when it meets these stomach acids. The circuit in the chip creates a small current and the wearable sensor (the patch) can detect the changes because the body is conductive. It works in a similar way as an electrocardiogram, or EKG: machines that monitor heartbeats through the changes of electrical current in the body. The pill sends a signal that encodes a number, which the wearable patch uses to identify the pill, which then records the ingestion. The data the patch collects is sent to the smartphone app at which point the patient is prompted for information such as how they feel, their activity level, and their stress levels. This is optional information, but also helpful for the doctor as it allows better interpretation of how effectively the medication is treating the patient–especially since medication acts differently in every patient. From there, anyone who has access (as decided by the patient) can view the data regardless of location (Emspak).

In terms of privacy, at the moment the patient has full control over who has access to their information. However, as with many new technologies, the rules may change as new uses are uncovered and more groups become involved. For example, if the government finds this as a way to reduce the costs of patients, they may require that the information be shared with them to reduce the spending of government-funded healthcare like Medicare and Medicaid; this idea will be further explained later in this paper. In addition, it is likely that if the patient were voluntarily using this technology they would take advantage of its full capabilities– the most novel, the sharing ability.

Currently, the digital pill is only approved for use in Abilify (generic name aripiprazole), an antipsychotic. The combination of the Abilify and the digital sensor is called Abilify MyCite. It is FDA approved for treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.

Although Abilify is the only drug that is currently approved to include the digital component, there are many other populations besides those with mental illness who could potentially benefit from the technology. The most promising use for the future is for patients who have high risk, chronic conditions; some examples include multidrug-resistant tuberculosis, diabetes, and hypertension. Other populations that the digital pill system could be helpful for include patients who take opioids, the elderly, and children. The opioid epidemic is a major issue in our country, addiction often starts from prescription medicines, and the addiction is often unintentional. By watching how much patients are taking, the risk of addiction would likely decrease. Older patients may have difficulties remembering to take their medication or need a caretaker to administer it for them. The digital pill may allow these kinds of patients, like children and the elderly, to take the medication themselves with assistance only when needed.

Another factor to note is the cost of the digital pill versus the standard version. The medication with the sensor is likely to be more expensive. However, it may be more cost-effective for a patient to be adherent and healthy. As mentioned, non-adherence can be very costly down the line, possibly more so than the medication. The FDA warns that the link between increased adherence and the digital pill has not yet been proved. If it becomes evident that the technology significantly raises patient adherence, and, in turn, saves money, the digital pill may become even more integrated into medication regimens and wanted by insurance companies and physicians (Center).

The digital pill is a novel technology in the era of digital medicine. It has great potential to minimize rates of non-adherence. Since it has gone through many tests and has proven to be safe to patients, it should continue to be used in areas where the ethics prove it acceptable.

 

Safety

The foremost way the digital pill benefits patient health is objective data provided about the patient’s compliance or lack of it. If the information is being shared with a care team, assuming they are doing their job in monitoring it, non-adherence cannot go unnoticed. Whether this means the patient is better able to keep himself or herself on track or the doctor is able to better understand their patient and their needs, the objective data is likely to overall increase adherence rates. Sometimes patients do not trust their doctors or want to present a good facade to avoid a negative reaction from their doctor, otherwise known as a social desirability bias. This becomes even more dangerous to the patient because if the doctor thinks that the patient is taking their medicine and it is just not working, they will often titrate the dose or add new medications to supplement the original. This poses more risk to the patient because higher dosages and more medications increase the potential side effects, add additional complexity to the regimen, and pose a further financial burden on the patient; factors that may not only directly affect the patients’ health but also may lead to non-adherence (Derkin). Because it is objective data that is provided, the patient may be more inclined to relay their thoughts, as the physician already knows that there is some issue that needs to be addressed.

As previously mentioned, there are many unintentional reasons that patients do not adhere. The digital pill system has the potential to combat many of these factors because of the objective data that it provides.

Sometimes patients do not fully understand either the instructions that they have been given from a medical professional or their condition. A lack of understanding of their condition may mean that the patient does not understand the severity and possibly may not see the need for medication (or at least the amount prescribed). Essentially, these patients need more education from their physician. The digital pill allows for this because it increases the collaboration between the patient and the doctor with the data as a starting point for discussion. The physician is able to see that the patient is not being adherent at which point they have a conversation with the patient to understand where the disconnect lays. The physician can explain the diagnosis or medication regimen in a different way and until the patient fully understands why and how they need to take their medicine.

The benefit of the increased collaboration created by the digital pill extends to curtail other factors as well: complex drug regimens, for example. Although some patients may not want to admit a struggle with the complexity of their medication regimen, once the patient admits to it or it is discovered by the physician, they can work together to adjust the schedule or dosages as it fits best with the patient’s lifestyle.

The patient would be able to look at the data and see if they have missed any doses as well as at a calendar with the times they need to take their medicine to help remind them to do so. This is likely to help minimize patient forgetfulness.

The expense of medication is one of the leading factors that leads to non-adherence. When a patient deems the cost too high, they will often decide ways to avoid the high cost such as not fill the prescription or self-change their dosages to preserve the amount of medicine; for example, taking a pill once every two days instead of every day. One case found a woman filled her prescription in Mexico in attempts to get it cheaper. The medication she was given, warfarin, was different from what she was meant to get– Ramipril. It acted essentially as poison to her body in the dosages that she was taking. The woman waited two days after being admitted to the emergency room with severe bleeding to admit that she had gotten her medication in Mexico (Grissinger). This is just one example of how avoiding costs of medication can be extremely harmful to the patient if not immediately, in the end. A physician with the data to notice the non-adherence can first explain that although the patient may be saving money short-term their health will take a toll and likely lead to more expensive emergency costs such as emergency room visits, surgeries, and extra medication. In addition, the physician can work with the patient with their financial constraints in mind to create a plan with the lowest cost. One way this is attainable is opting for the generic version of a drug.

The digital pill may also benefit patients who are intentionally not adhering through discussion with a physician. There are misconceptions about medication. For example, a patient who wants to be more natural would try to minimize the amount of medication they take. Some believe that medication is unnecessary (whether all the time or in certain circumstances) and they may do a test where they will not take their medicine for a couple weeks or a month or two and if they do not feel different, they conclude the medicine is unnecessary. While these patients may not immediately feel different, there is a risk for the long run especially with “silent conditions” like heart disease. Here, the physician can step in and explain that although they feel fine now, the consequence can be deadly (Brody). Another reason some patients consciously avoid taking medicine is fear of side effects. While the digital pill cannot control side effects, the physician can take more time to explain the health consequences of not taking the medicine versus the potential side effects of taking it.

The digital pill offers a new mode of personalized medicine. For the reasons previously mentioned, the objective data the pill provides leads to increased collaboration between the patient and the physician, which can address many of the issues of non-adherence. However, patients who are already compliant can have their medication adjusted to further benefit them. One example is patients who take opioids. A study was conducted with patients who were prescribed a digital form of oxycodone and released from an emergency department after an acute bony fracture. The patients were able to view their own data and ensure that they were taking the correct amounts at the right times. Their physicians were also able to check in on how they were taking their medicine and how it was affecting their pain. The physicians were able to titrate the doses to minimize the pain in the patients while also minimizing the amounts of opioids the patients were taking. This is especially important for opioids because addiction is often accidental. Minimizing the amount that is taken may minimize the risk for addiction. In addition, because addiction is often accidental, many patients would likely be cooperative with such a digital system. Some patients may even want to have their physician aware of their intake with opioids because some fear addiction, which may make them less likely to take their medication. There are no reliable prescription patterns for opioids because pain is harder to measure than other parameters for other conditions like blood pressure. Therefore, a personalized and adapting regimen is to the best benefit of the patient (Chai).

The digital pill poses minimal risk to patient health. The FDA cautions that the data may not be in real time or there may be a malfunction and the ingestion may not occur. The physician may be deciding a treatment plan based on the digital pill; therefore, a missing ingestion could affect the treatment plan. However, it is unlikely that one recording would cause drastic change. The doctors just need to be aware of the potential for the digital pill to have slight malfunctions. Virtually every medical technology has the potential to malfunction. However, the potential positive value the digital pill adds seems to overshadow the potential for it to malfunction. There are some warnings for the Abilify MyCite, such as an increased risk of death for elderly patients with dementia-related psychosis, but those are related to the Abilify medication rather than the digital component (Commissioner).

The side effects for antipsychotics can be severe so it is less straightforward to argue that better adherence to antipsychotics is directly better for the patient; some report that they feel worse.  For example one patient remarked that their “emotional states were blunted” from the Abilify (Graedon). Antipsychotics may be an exception to the direct relationship between using the digital pill for better adherence and the best interest of the patient. However, the ingestions and patient feedback can help the physician better figure out how to treat the illness for that patient.

The digital pill has promise to increase rates of adherence; it is a benefit to patient safety. However, it is important to consider the impact the digital pill has on patient autonomy before deciding in which situations the digital pill should be used.

 

Autonomy

Imagine a patient who has just had bypass surgery but wants to continue to smoke. This is not the best decision in terms of safety. The paternalistic approach would say that they cannot smoke but promoting autonomy would say that he could make his own decisions. This highlights that sometimes autonomy comes at the expense of safety. Another example is euthanasia. Jack Kevorkian is a well-known activist for a terminally ill patient’s right to die through assisted-suicide. He was put on trial in 1996 to determine the lawfulness of Dr. Kevorkian’s assistance in the deaths of Marjorie Wantz and Sherry Miller in 1991. During the trial, his defense attorney, Geoffrey Fieger, asked, “[d]on’t you have a greater duty to not listen to the desire of the patient, but just to keep the patient alive?” However, he responded “[n]o. Unfortunately, that has crept into medical practice. [It is penetrated too deeply]. The patient’s autonomy always should be respected, even if it is absolutely [contrary to] best medical advice and what the physician wants.” Kevorkian’s thinking gets at a medical professional’s simultaneous duty to respecting the autonomy of the patient. While many Americans did agree with Kevorkian’s actions, many disagreed as well (The Kervorkian Verdict). Some called him a hero while others referred to him as “Dr. Death”. Though this is an extreme example, it exemplifies well when autonomy comes into conflict with safety.

The digital pill is another example of when safety and autonomy conflict. The technology’s purpose is to help the health of patients yet the following examples will show how it affects autonomy–most often taking it away. The question is whether is it ever acceptable to seize autonomy with the intent of increasing health.

The digital pill system may offer increased autonomy through increased agency. Autonomy and agency are very similar but autonomy describes the ability to make one’s own decisions while agency is the ability to control one’s actions. They often exist simultaneously but it is possible to have one and not the other. Being in a prison or in a bed with amyotrophic lateral sclerosis (ALS) are examples of a lack of agency because although these individuals can think for themselves, they cannot do whatever they wish. Their actions are restricted.  Lack of total agency is an issue that can persist for some patients concerning taking care of themselves including taking medication. For example, patients with caretakers and children. Elder patients sometimes choose to, or are placed (by a family member or friend), rely on an individual to help give their medication. A child is an example because their actions may be partially controlled by a parent. Parents will often help their children take their medication. While these individuals still have the ability to control their actions, there may be a third party partially controlling what they do. The digital pill may allow these patients more freedom from outside assistance. Because the system has the monitoring ability, the caretaker may observe from a distance and step in only when the help is necessary. Izayah Chamberlain, a 15-year-old boy being treated at Children’s Health Hospital in Dallas for a kidney transplant, is an example of the potential for increased agency among patients who otherwise would have help taking their medication. Taking the full regimen of medication for a kidney transplant is essential to the acceptance of the new organ. His mother was worried that Izayah would mistake his medication. He used the digital pill system for his post-transplant medication and his mother received the information so she was assured that he was taking it correctly. Izayah was able to self-administer the medicine and the transplant was successful. He was able to take care of himself (Smart Pills). The digital pill may not only just allow these patients who may otherwise require assistance to take their medicine on their own but it may allow them to even live on their own. For example, an elderly patient who does not want to go into assisted living can use the digital pill to live on his or her own while still staying safe by having monitoring from a distance. Assuming that they wish for more independence, this is a situation where the digital pill is beneficial to the patient.

While the digital pill offers a step forward in the name of agency, there is a multitude of potential downfalls for patient autonomy. The foreseeable cause: coercion. Coercion is directly or indirectly forcing someone to make a decision they would not otherwise make. Some potential sources of coercion with the digital pill include family and friends, physicians, and insurance providers.

People want their family members and friends to be healthy. The digital pill is a technology that is likely to keep patients healthier. As a result, if the digital pill seems like an option to ensure the safety of a patient, a family member or friend may guilt (whether intentional or not) the patient into consenting to use the technology. For example, a child may beg their mother struggling with severe diabetes to use the digital pill possibly stating that they love their mother and do not want to see her go. While the patient may genuinely want to use the technology to ensure their health for their children, their spouse, or other family members or friends, if they are being coerced it is no longer an autonomous decision.

As promised during the Hippocratic Oath, a physician’s job is to protect their patient’s health and help them get better. Even beyond professional responsibility, physicians often have personal values and feel a personal responsibility to help their patients. Seeing as patient non-adherence can be a frustrating problem for physicians, and the digital pill is likely to increase adherence, a physician may want a patient to use it. As a result, a doctor may filter the information they share with patients about the digital pill or the patient’s condition to really push to use the technology. For example, the physician may not share or put emphasis on the side effects. This would be problematic as it prohibits the patient from making a fully autonomous decision especially important because the digital pill has the monitoring and data collecting aspect. In addition to a personal wish to treat patients, some medical practices and institutions function as an outcome-based system. As medication adherence expert Marie T. Brown, MD, FACP, an associate professor at Rush Medical College and Rush University Medical Center in Chicago added:

If a patient walks in and is not taking their medicine and their blood pressure is uncontrolled, in an outcome-based system that may lead to lower reimbursement for the practice. What could that motivate? That might motivate the doctor to become frustrated with the patient and hope they leave the practice (Brown qtd. In Durkin).

Although the quality of healthcare is ideally independent of money, it sometimes can play a role. If a physician is motivated by a monetary incentive in some way, or even if they are in a position where they need the positive reflection of their work, they may be even more bias towards the treatment that would give the most success for their patient. In addition to withholding full information about the treatment options or the patient’s condition, a physician may play to the emotions of the patient like stating that the patient has to do it for their family who is counting on them.

Insurance providers may also be a dangerous source of coercion of patients. Because the digital pill consists of the original medication (which may already be expensive) plus the digital component, it will likely be costly. However, the costs of not taking medication– like elaborate emergency surgeries– may be even greater. Not only are insurances responsible for covering emergency costs but they lose money in wasted medication. There are high-valued medications like hepatitis C drugs that offer a cure but cost about $1000 a pill; every hepatitis C pill that is not taken is essentially throwing out $1000 that can be used elsewhere (Durkin). For these reasons, insurance companies may find interest. Because it could be so beneficial to them, insurance providers may offer discounts to patients who prove that they are taking their medication– discounts that some may not be able to refuse out of a need for extra money support. Therefore, the digital pill has a greater risk to harm autonomy for the patient with a lower income. Interesting considering that the digital pill seems to be more beneficial for patients with lower incomes because it would help them avoid emergency costs. The possibility of insurance providers to offer a discount is similar to a study that was published in JAMA Internal Medicine that suggests that incentivizing patients with human immunodeficiency virus leads to more patients taking their medicine and in turn lower mortality rates (Firger). This shows that incentivizing patients is on the horizon but while it could be beneficial to insurance companies or whoever is paying for the drug, it comes at the expense of the patient’s full autonomy.

The digital pill also raises another concern for patient autonomy if it becomes the only option for a drug. Many patients would choose to take the digital pill form of their required medication. In addition, the technology has not been difficult to understand even among older patients. However, it may become problematic if a patient willingly takes the digital pill but when they want to come off, they are either pressured to stay on it or the medication is only offered in the digital form. For example, what if a certain type of tuberculosis medication essential to the health of those suffering from this disease is only offered with the digital component. Even if no one directly forces these patients to use the digital pill, the option to either use it for health or not and die is forceful in and of itself.

The digital pill could inhibit patient autonomy in many realistic situations. While there is the potential to increase autonomy for patients who otherwise would need caretakers, the risks outnumber the benefits. The loss of autonomy seems to be a significant risk for all patients, but it becomes especially problematic for patients who do not want to take their medication at all including patients who do not want the side effects, do not believe in medicine or want to be natural, as well as patients who fear technology or monitoring. The loss of full autonomy for a patient who wants to follow their physician’s instructions but for one reason or another has difficulty is not necessarily an issue because they would likely decide themselves to listen to the physician. However, it does raise concern if a patient has a lack of autonomy and then decides they no longer align their beliefs with their physician. With these situations, especially coercion, it is particularly likely that a patient may not realize they have been influenced in their decisions. While this seems problematic, it is less of an issue for a patient, who still has control over their decisions, to be influenced than a patient whose health as in danger because they are not taking their medication. Ideally, a patient would have full autonomy but at the end of the day, as long as they have the ability to make their own decisions and the patient can decide if they want to discontinue the use of the digital pill, it is acceptable, especially if the patient is in better health because of it.

 

Slippery Slope

The aforementioned problematic scenarios prove a potential risk to the patient’s autonomy. While those raise issues, there is also a slippery slope more dangerous—if the information acts as evidence. In the age of technology and big data, there is a widespread fear of information being hacked or in the wrong hands. Being another piece of technology, the digital pill seems susceptible to the same concerns. Some questions may be, where does the information go, who is in charge of it, what if the information is no longer mine? These questions point to the Big Brother concern. The digital pill currently has a system to protect the privacy of the patient. However, as more groups uncover more uses of the technology, the rules around how the information is handled and who has the option to use the digital pill versus who is forced to, may change.

As of now, the physician is meant to work with their patient and do everything they can to keep their patient adherent. However, a physician’s best effort does not always lead to desired outcomes, which can become frustrating. As mentioned, some physicians work on an outcome based system as well as the fear of liability. Seeing, as the digital pill may be a solution to this issue, beyond coercion, a physician may refuse to treat a patient unless they use the digital pill and can prove that they are following the instructions that the physician is giving. This is another way patients can feel forced to use the digital pill.

Coercion comes into play with discounts offered by insurance companies but imagine if the insurance company requires the use of the digital pill and that the information is shared to get any insurance in the first place. Drug costs are high across the boards, but it is important to consider this situation with both private and public healthcare companies. A private healthcare insurance company may be more lenient towards their customers as they want to keep business. However, public healthcare agencies are funded by the government, which essentially comes out of taxes from citizens. These agencies are likely to want to find new ways to cut their costs. A requirement to share information with not only a business of which the patient is not related but also with the government would likely cause more fear from patients. Not only would this loose autonomy for patients but their privacy as well.

The digital pill system may also act as a way to bypass court hearings and long trials to determine competency. A patient who consciously does not take their medication may be seen as less than competent, especially if used as evidence against the patient in a divorce, hearing to determine ownership of children, or when a family member does not think their loved one is suited to take care of themselves and wants control over their actions. This seems especially likely for patients with mental illness especially since there is already a stigma around mental illness and that patients with these conditions are unable to function “normally”. Since the digital pill produces clear records of a patient’s adherence, it is easier to determine whether they are taking their medication or not. This data may become criteria for competency in certain circumstances. While it may be helpful for cases where a patient truly is not competent and needs another individual to make their decisions, the incontrovertible data leaves less room for a patient, or even their lawyer, to advocate for them.

The information from the digital pill could go from a helpful conversation starter between a patient and their physician to evidence casts away a patient’s autonomy and with it, privacy. Once the information acts as evidence, the power shifts from the patient to the holder of the information. As opposed to the scenarios described in the previous section, most about coercion, the loss of autonomy becomes more likely and increasingly problematic along the slippery slope. Once the digital pill gets to the larger scale, it becomes more difficult for a patient to argue their position and expression their opinions and specific situations. Imagine a single mother with four children. She often misses her doses because she is running from job to job to support her family. At the first level, the mother can discuss the reasons for the holes in her ingestion data with her physician. However, insurance companies, for example, may be less willing to hear out a patient who is essentially just costing them money. Beside autonomy, patient voice is lost, the risk intensifying as the digital pill becomes more used with different groups in situations beyond just the benefit of the patient. These extreme risks of loss of autonomy are not acceptable especially because most of the reasons for the loss are not counteracted by a gain in safety, which goes back to the question of whether a loss of autonomy is okay because of a benefit for safety.

 

Conclusions

Non-adherence is a major issue that not only costs money but also lives. Although the issue has the greatest effect on the patient, loved ones are hurt, hospitals and insurance providers lose money, and the greater public is affected. When patients are non-adherent to their medication, the healthcare industry loses money, which comes out of taxes on the people, and infectious diseases may not be treated properly leading to potential spread. The United States government stepped in to require vaccinations for certain diseases because that was affecting public health parallel to how non-adherence to medication for infectious diseases may circle back to the public. The digital pill was created as a solution to this problem; more adherence should be linked to better individual health, which should be linked to not only better public health but also to less money lost. So, wouldn’t the digital pill serve only to the benefit of both the individual and the public? Not quite. The technology poses a severe risk to individual autonomy and as a result, privacy. It can be means of greater and more productive conversation between a patient and their physician, which gives greater patient voice, but a slippery slope may take it all away. One may assert that patients who do not take their medicine and harm themselves and possibly the public deserve to be forced to take the medicine prescribed to benefit their health. However, the issue is that it is hard to draw the line.

The digital pill is beneficial to the patient in some circumstances but harmful in others; it is important to use it with caution. The technology seems to be of best use for patients that want to use it. The opioid, hypertension, and tuberculosis studies are illuminating examples of success for patients who are attentive and cooperative with the intention of getting better or maintaining their health. Although working with patients who either are, or have the potential to, unintentionally fail to take their medication properly will not get rid of all of the costs from non-adherence, it will reduce most while not taking away patient autonomy. Accidental reasons for non-adherence comprise most of the costs. In fact, non-adherence of patients with mental illness do not cost the healthcare system the most money: an assumption one may make considering it was the first use of the technology (Cutler). This brings up the question about why the first approval was with a medication to treat mental illness considering other conditions have non-adherence rates just as high, some with arguably worse effects. While untreated schizophrenia leads to an increase risk of suicide, non-adherence for a condition like tuberculosis is likely to cause death (Higashi). In addition, antipsychotics can have severe side effects to the point where some may argue, including patients themselves, that patients are better not taking any medication than taking the antipsychotics. Many patients have said that with Abilify, they do not feel like themselves. In addition, although patients with conditions like schizophrenia are technically competent, their condition often influences their decisions. Schizophrenia also has a symptom of paranoia, which suggests that these patients would be afraid of the monitoring feature of the digital pill (“Scizophrenia”). There are so many nuances for the application in patients with mental illness so the question comes back to, why pick Abilify as the first application? Motives are in question. “Big pharma” is a term refers to the massive pharmaceutical companies that make billions of dollars every year. This is controversial because some think that the prices are too high, robbing patients of money who need these medications (Who). Considering that the digital pill is likely to be an expensive version of an existing medication, and the first use of it is controversial, it may feed into the skepticism of pharmaceutical companies. Some may question if the digital pill is necessary or if it is just a ploy to feed more money to these companies. Even if this were not the case, it would give the digital pill a bad reputation, which would make it harder for the technology to be used in productive situations.

For the reasons outlined, the physician must be conscious of when they use the digital pill. As mentioned, the patient must want to use it or the risks for autonomy are too great. In addition, the privacy rules must stay intact and the information must stay between the patient and whomever they wish and trust. The core of the slippery slope is the patient’s information getting into the wrong hands, often with dangerous power to essentially control the patient. Once the digital pill is used at the next level with groups who may not have the patient’s best interest above their own, such as insurance or government agencies, the toll on the patient is not worth the benefit for the other stakeholders. With its simple use, the digital pill can be and is proving to be, advantageous to a variety of stakeholders including patients, care teams, physicians, and society as a whole.

 

 

 

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