The Noncompliance Epidemic

Can We Get Patients to Be More Compliant?

Neil Chesanow


January 16, 2014

In This Article

Making Regimens Easier to Follow

The more pills patients must take every day, and the more often they must take them, the less compliant they will be, research shows.[50,51,52] Simplifying medication regimens is therefore a priority. Some important regimens have already been simplified.

For example, in 2006, the US Food and Drug Administration (FDA) approved a 3-ingredient, fixed-dose tablet as an antiretroviral treatment for adults with HIV.[50] The drug's active ingredients -- lamivudine, zidovudine, and nevirapine -- are in wide use in antiretroviral drugs. The recommended dosage, 1 pill twice a day, replaces multiple drug cocktails requiring daily administration to keep the virus in check. The new pill, it is hoped, will make it easier for patients to comply.

Similarly, combination medications for diabetes -- including metformin and glipizide, rosiglitazone and glimepiride, metformin and glyburide, rosiglitazone and metformin, and pioglitazone and glimepiride -- should improve compliance.[51]

In a study appearing in JAMA last September, researchers tested a "polypill" combining several different medications in 2004 people with cardiovascular disease. Most participants had already had a heart attack or stroke.[52]

Patients were randomly assigned to receive either the combination pill -- containing an antiplatelet to prevent clots, a statin, and a blood pressure-lowering drug -- or the usual medications separately.[52] After 15 months, more than 86% of patients taking the polypill were still compliant. Of those taking individual drugs, fewer than 65% remained on regimen.

Automated Hovering

Volpp and his colleagues at Penn point out that conventional approaches to improve patient engagement -- using visiting nurses or telemedicine services, for example -- are labor-intensive "and in general have not fulfilled their promise."[29]

The cost of such "hovering" is expensive, they note in a 2012 paper in the New England Journal of Medicine, and "therefore difficult to scale up and to justify, except for the very sickest patients, some of whom might be too sick to benefit."[29]

However, with the proliferation of health apps, wireless biometric devices, and other connected inventions, such hovering could theoretically be automated.

"The best targets for automated hovering are conditions whose management depends substantially on individual patients' behavior," Volpp and colleagues believe.[29] "Good targets are medication adherence in patients with heart failure or acute coronary syndromes, and efforts to manage diet, exercise, or weight."

By way of illustration, in their trials of patients taking warfarin who were entered into a lottery, the Penn researchers used devices called GlowCaps® to monitor compliance and therefore eligibility to win.[45,53] These smart pill bottle caps light up and make music to remind users to take their medication. If a dose is still missed, a cellular chip embedded in the cap will call the cell phone of the user, a family member or caretaker, and/or the patient's physician, and allows for detailed weekly and monthly reporting to patient and clinician.

GlowCaps are now being used to monitor compliance in a growing number of clinical trials. The company says that they are available to patients through health insurers at a physician's request.

Bringing the potential of automated hovering to an even more personal level is the invention of a smart pill. In 2012, the FDA approved Proteus Digital Health's ingestible biosensor and companion patch.[54] The pill is embedded with a tiny sensor made from silicon and natural ingredients. When swallowed, the pill uses stomach fluid as a power source to broadcast signals back to its battery-powered companion patch. Data on a patient's current condition, including time of medication ingestion, heart rate, body temperature, and even sleep patterns are then sent to a smartphone app used by a monitoring clinician.

In a small trial of 27 adults with bipolar disorder or schizophrenia, 2 types of patients in whom compliance is especially poor, ingesting the smart pill helped 67% of the participants take their medication within 2 hours of the designated time.[54] The mean adherence rate was 74%.

Other wireless device-app combinations are extending the possibilities for automated hovering. Sanofi-Aventis's FDA-approved iBGStar® glucometer, for example, connects directly to an iPhone® and helps patients with diabetes track glucose, insulin, and carbohydrates.[55] Personal data can be emailed to the patient's care team.

Another FDA-approved device-app combination is AliveCor's iPhone®-enabled Heart Monitor®.[56] The single-channel ECG device records, displays, stores, and wirelessly transfers a patient's ECG data to a primary doctor or cardiologist.

While a growing number of wireless devices have the capability to transmit information remotely, this capability is often rendered unusable by a lack of infrastructure on the part of insurers, hospitals, and integrated health systems to receive and evaluate incoming patient data and, if necessary, alert the patient's physician if the data are worrisome.

However, AliveCor recently introduced the infrastructure to make this possible, at least for its own device.[56] The firm offers a 24/7 monitoring service that includes review of ECG data by a US-based cardiac technician, or a more in-depth clinical review by a US board-certified cardiologist, for a minimal fee. Reviews, including the original ECG recording, can then be shared with the patient's cardiologist.

Expect more connected services like this, designed to interpret and relay incoming data from wireless biometric devices, to appear in coming months.


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