Why Are So Many Patients Noncompliant?
Neil ChesanowDisclosuresJanuary 16, 2014
AN EPIDEMIC OF NONCOMPLIANCE
If you're baffled by how many of your patients, particularly those with chronic conditions, don't take their medications as prescribed — if at all — you're not alone. Doctors from coast to coast feel frustrated by the same thing.
In 2011, Consumer Reports published a survey of 660 primary care physicians, "What Doctors Wish Their Patients Knew." The number-one complaint by far: Patients didn't take the doctors' advice or otherwise follow treatment recommendations.
"Most of the doctors we surveyed said it affected their ability to provide optimal care," the editors wrote. "Thirty-seven percent said it did so 'a lot.'"
In fact, the number of patients who are noncompliant has reached epidemic proportions, and doctors' inability to provide optimal care as a result has mushroomed into one of the most pressing problems in healthcare today.
? In the United States, some 3.8 billion prescriptions are written every year, yet over 50% of them are taken incorrectly or not at all.
? In a survey of 1000 patients, nearly 75% admitted to not always taking their medications as directed.
? A study of over 75,000 commercially insured patients found that 30% failed to fill a new prescription, and new prescriptions for chronic conditions such as high blood pressure, diabetes, and high cholesterol were not filled 20%-22% of the time.
? Even among chronically ill patients who regularly fill their prescriptions, only about half the doses taken are taken as their physicians intend.
? Poor compliance accounts for 33%-69% of drug-related adverse events that result in hospital admissions.
? Poor compliance with medication regimens is associated with up to 40% of nursing home admissions.
? In a study of over 8400 senior health plan enrollees, only 1 in 3 of those who began treatment with concurrent antihypertensive and lipid-lowering drugs were taking both medications as directed or at all at 6 months.
? In a study of over 240,000 patients who were given a new prescription for an antidepressant, less than 30% were still taking the medication 6 months later.
? Compared with patients who follow instructions, patients who don't take their medications as intended have a risk for hospitalization, rehospitalization, and premature death that is 5.4 times higher if they have hypertension, 2.8 times higher if they have dyslipidemia, and 1.5 times higher if they have heart disease.
? The number of patients with serious cardiac conditions who don't take their medications is especially baffling and problematic. In a study of 34,501 patients age 65 or older, only 26% of those who began a statin regimen to reduce the risk for coronary heart disease maintained a high level of use 5 years later; the greatest decline occurred during the first 6 months of treatment.
? Even after a life-threatening event, compliance with medication regimens remains surprisingly poor. Within 2 years of initiating therapy, only half of patients hospitalized for acute myocardial infarction (MI) were still taking their prescribed statins, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blockers (ARBs).
One upshot: Poor medication compliance is implicated in over 125,000 US deaths per year.
Yet compliance — which is used interchangeably with the term "adherence," although the latter is gaining ground — has been exhaustively studied. More than 40,000 peer-reviewed papers on the subject have been published, "yet the rates of poor adherence have not changed significantly over the past several decades and continue to remain at an unacceptable level," observes URAC, a healthcare accreditation organization, in a white paper prepared for industry leaders.
Or, as former Surgeon General C. Everett Koop once put it with his customary forthrightness, "Drugs don't work in people who don't take them."
The $290-billion question — $290 billion being how much poor compliance is estimated to cost the US healthcare system each year — is, why?
AN UNBELIEVABLY COMPLICATED PROBLEM
One reason noncompliance has been such a tough nut to crack is its daunting complexity. Patients don't take their medications for a multitude of reasons, many of them emanating from the murky depths of human psychology, and which the patients (not to mention medical researchers) may not fully understand.
To complicate matters, these reasons vary from patient to patient. That rules out a one-size-fits-all solution. Internist William Shrank, MD, MSHS, Chief Scientific Officer and Chief Medical Officer of Provider Innovation and Analytics at CVS Caremark, has served as lead author or coauthor in over 100 studies on patient compliance with medication. His conclusion: "There is no silver bullet."
Researchers have analyzed the steps involved in compliance to better understand where the process breaks down. First the patient must receive the right prescription from a doctor or other provider. The new prescription must then be filled, the seemingly simple act of which can be a major barrier to compliance. The patient must then make it through the first 6 months on the medication, when the risk for noncompliance is highest. If the medication is for a chronic condition, it must then be taken as intended — indefinitely.
"'Adherence is the result of getting through these four steps successfully," notes the RAND Corporation, a nonprofit research organization, in a report aimed at policymakers in Washington, "and a single policy option is not going to address each of these challenges to adherence."
To thicken the plot, a patient's unique cluster of reasons for not complying at any given time isn't stable. With the loss of a job, for example, medications may become unaffordable, so the patient stops taking them, or cuts the pills in half to make them last longer, or skips some doses.
After a divorce, job loss, or any traumatic event, depression may set in; taking medication as directed may then be the last thing on the patient's mind.
Or a compliant patient may suffer a medication-related adverse event. As a result, she may stop taking her pills, as up to 20% of patients do because of perceived side effects.
Does the patient tell the doctor? Probably not. Why? The doctor is so busy; she doesn't want to be a bother. Or she doesn't like the doctor, so this is how she retaliates. Or she decides that her ill effects are a sign that she's taking too many drugs, so she goes off-regimen. Or she consults with a friend on a social networking Website for patients with similar chronic conditions, and the friend advises her to try alternative medicine instead.
"Is it widely known that adherence is a cluster of behaviors and not a single construct?" asks internist John F. Steiner, MD, MPH, Research Director at Kaiser Permanente's Institute for Health Research in Denver, and a thought leader on medication compliance issues. "No, that's actually a radical claim."
It may be radical, but researchers are putting patients, doctors, and the healthcare system itself under a microscope to better understand this ever-shifting cluster of behaviors and why it so often results in noncompliance. While many questions remain unanswered, here's what has been learned to date.
PATIENT BELIEFS AND BEHAVIORS ARE OFTEN BARRIERS
Patients with chronic conditions may spend only a few hours a year in your office, but they spend roughly 5000 waking hours each year living the rest of their lives. During that time, out of touch with their doctors and generally unmonitored by the healthcare system, many are allowed to quietly, invisibly slip off their regimens.
In 2009, a team of researchers at Kaiser Permanente combed through much of the vast literature on compliance and distilled the sea of data down to several important patient-related barriers. They include forgetfulness; lack of knowledge about the medication and its use; cultural, health, and/or religious beliefs about the medication; denial or ambivalence regarding the state of their health; financial challenges; lack of health literacy; and lack of social support.
Forgetfulness is the number-one barrier to compliance, experts believe, although a survey of 10,000 patients found that only 24% ascribed noncompliance to forgetfulness. Up to 20% failed to take medications because of perceived side effects, 17% had cost issues, and 14% didn't feel the need to take medication; they believed it would have little or no effect on their disease.
Among patients with chronic conditions, such as high blood pressure and high cholesterol, noncompliance tends to be highest if symptoms aren't experienced.
Myopic? Perhaps. But when doctors are patients, they tend to act just like everyone else. Steiner likes to ask an audience of physicians for a show of hands of who has ever taken an antibiotic. Many hands are raised. He then asks how many doctors took the full course of antibiotics even after their symptoms abated. Many hands go down.
Even the Sickest Patients May Not Take Their Drugs
Noncompliance is plentiful in patients who exhibit symptoms too — even for life-threatening conditions. Not even a brush with death is enough to get some patients to stick to their regimens. According to one study, after hospitalization for acute MI, about 24% of patients still had not filled their cardiac medication prescription a week after being discharged.
In another study, among patients discharged with prescriptions for aspirin, statins, and beta-blockers after an episode of acute MI, about 34% stopped at least 1 medication and 12% stopped all 3 medications within a month.
A third study found that only about 40% of patients were still taking statins 2 years after hospitalization for acute coronary syndrome. Compliance was even lower for patients taking statins for chronic coronary artery disease.
A major reason why many patients go off-regimen is the cost of drugs. But even when patients are given drugs gratis, compliance improves only slightly. One much-discussed study looked at 2845 Aetna health plan members discharged from the hospital after an acute MI episode who were given all of their drugs — statins, beta-blockers, ACE inhibitors, ARBs — for free, comparing them with 3020 Aetna enrollees who had the usual prescription coverage. In the usual-coverage group, compliance rates were 36%-49%. But without the cost barrier, the rates were only 4%-6% higher.
What could account for this underwhelming result? Could depression play a role? Although the investigators noted cardiac-related comorbidities of patients at baseline, they didn't ask about depression. Yet a meta-analysis of 31 studies that collectively included 18,000 people found that depressed patients with a variety of chronic illnesses, including diabetes and heart disease, had 76% greater odds of being noncompliant compared with patients who weren't depressed.
At least you can understand why depressed patients may lack the motivation to stay on regimen, but, confoundingly, so do many patients who aren't depressed. As Shrank and cardiologist Lisa Rosenbaum, MD, noted in a 2013 paper:
Though patients may be forthcoming about the more practical challenges [to adherence], the psychological barriers are tougher to identify and articulate. Patients don't generally tell their physicians, 'Every time I look at that pill bottle, it reminds me that I'm ill' or 'I tend to discount future benefits as long as I feel well today.' Such underlying psychological mechanisms probably contribute to nonadherence far more than we realize and help explain why existing interventions have brought only modest improvements.
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