Last term, my Program Planning for Health Behavior Change workgroup was charged with using theory to help explain a health behavior and design a targeted intervention.  With several MDs in my group, we chose improving warfarin adherence to reduce risk of stroke in elderly patients with atrial fibrillation.

2.2 million Americans suffer from AF, a condition that causes a 4 to 5 fold increased risk for stroke. What is worse is that 5% of those ages 65+ have AF.  Luckily, warfarin is an inexpensive, generic drug that, if taken consistently and with regular physician monitoring, can reduce the risk of stroke for AF patients.   However, compliance is a problem and as a result non-compliant AF patients remain at risk for stroke.

My group utilized a PRECEDE/PROCEED framework to conduct a hypothetical needs assessment and identify the underlying causes of the problem that our resulting intervention would address.  This framework provides a conceptual way of organizing multiple levels of factors that explain prescription regimen noncompliance and identify places where an intervention may be effective.  Utilizing our course textbook, Health Behavior and Health Education: Theory, Research, and Practice by Glanz, Rimer, and Viswanath, we found that examining the following factors was particularly important in explaining whether one is adherent:

• Predisposing factors – the motivation or rationale for behavior and include one’s attitudes, beliefs, preferences, skills
• Reinforcing factors – the reward or incentive for persistent behavior such as social support, modeling, peer influence
• Enabling factors – direct or indirect antecedents that allow motivation to be realized, including environmental and structural factors

We also used social cognitive theory, which focuses on the individual as a health behavior change agent, and its theoretical constructs.  In reviewing the literature, we found that elderly AF patients may:

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The following guest post on the subject of drug adherence is written by Joyce A. Cramer. Joyce is Associate Research Scientist at Yale University School of Medicine as well as President of Epilepsy Therapy Project, a 501-c-3 organization accelerating new therapies for people with epilepsy.

“Drugs don’t work in people who don’t take them” said former Surgeon General C. Everett Koop. While performing research on this topic since the 1980s, I have been continually surprised that the results are uniform: People take, on average, three-fourths of medication as prescribed¹. This has held true across many diseases and types of medications. There seems to be no consequence so severe that everyone with that disorder takes all doses (e.g., organ transplantation, epilepsy, asthma, etc.).

One of the first studies I published included extensive neuropsychological testing. It showed that not taking all doses does NOT relate to intelligence². There are numerous studies showing the ineffectiveness of health education. Many people get good scores on knowledge linking disease control/management with medication, but do not carry-through by taking all doses.

Interviewing lots of people led me to realize that the main reason is forgetfulness (on a daily basis or during a disrupted schedule). I then developed a simple system to teach people skills on HOW to take their medication. It consists of asking the person (a) what is the best time of day to remember a dose, and (b) what daily activity can you link this to as a reminder³? Typical responses are the best time is in the morning (ask to set a range of time, i.e., 7-8 am), and link it to making coffee, taking the dog for a walk, etc. Only the person who is taking the medication can select the most convenient time and the personalized cue. The “Cramer Method” does work, as demonstrated in several studies.

The system works only when the person has accepted the diagnosis and need for treatment.

On the medical side, I teach doctors to ask whether the person is willing to take the medicine, then proceed to teach them how to set time and personalized cues. Explain that if the first cue does not work well, select another cue.

I often hear that someone had an exacerbation of symptoms after missing doses or discontinuing treatment. Sometimes the same person has multiple episodes until the personal lesion is learned. That’s human nature. I do not look at medication adherence as a complex behavior mediated by psychological issues. Much of it is a straightforward personal commitment based on choice, coupled with acceptable tactics to do what is being asked. Diseases differ in requirements, ranging from one tablet daily for hypertension to diet, exercise and oral or insulin treatments for diabetes. People differ in their willingness to perform health-related tasks – changing over time based on other priorities in their lives⁴. Yes, people make choices for which they are responsible, both actions and inactions. The doctor can’t make it happen without a willing partner.

1. Claxton & Cramer. Medication compliance: the importance of the dosing regimen. Clin Therapeutics 2001; 23: 1296-1310.
2. Cramer et al. How often is medication taken as prescribed ? A novel assessment technique. JAMA 1989; 261:3273-3277.
3. Cramer & Rosenheck. Enhancing medication compliance for people with serious mental illness. J Nervous Mental Dis, 1999; 187: 52-54.
4. Cramer et al. Compliance declines between clinic visits. Archives of Internal Medicine, 1990; 150:1377-1378.

As Robin illustrated in her post, poor medication adherence results in poor health outcomes for millions of Americans, and costs billions of dollars in increased medical costs.  When three-quarters of Americans concede they don’t take their prescription medications as directed, we are faced with a public health problem that demands a broad, multi-faceted response.

As the nation’s oldest consumer organization, the National Consumers League has long worked to improve medication safety, patient education, and consumer education in the health community.  With planning funds from the Agency for Healthcare Research and Quality (AHRQ), NCL is spearheading a first-of-its-kind national education campaign to raise consumer awareness of the importance of good medication adherence.  As called for in the 2007 NCPIE report, a public-private education campaign to motivate patients to improve their medication-taking behavior should be a national health priority.

Since the campaign planning phase got under way just a little more than a year ago, we have worked around the clock to bring together a diverse and committed group of stakeholders interested in improving medication adherence.  From government agencies to health care practitioner professional associations, community health plans to national health plans, pharmaceutical manufacturers to consumer advocates, the list of supporting organizations tops 100 and continues to grow.

The campaign, which NCL anticipates launching publicly in the third quarter of 2010, aims to educate consumers through mass media, including many new social media tools.  The depth and breadth of involvement from stakeholders will help reinforce the messages to ensure that consumers are educated, engaged, and empowered as they manage their health.  The campaign has involved health care practitioners (HCP) from the start, and HCPs will play an active role in improving adherence as they engage their patients.

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“What appears to be non-compliance from a medical perspective may actually be a form of asserting control over one’s own behavior.”

I’ve always liked this characterization of patient adherence from Peter Conrad, The Meaning of Medication: Another Look at Compliance. It takes into account the fact that we’re dealing with people. What many times seems irrational to us as healthcare professionals, has most times been rationalized by the people for whom we provide care.

Human behavior is complex. Behaviorists describe human development as a 4-part process: physical (how we grow or age), cognitive (how we think), emotional (how we feel) and social (how we are valued). In listening to (researching) tens of thousands of patients – across therapeutic categories – over the last two decades, I’ve found that the following hold true:

How Patients Think: Most people know only the most superficial facts about their health. However, when presented with unexpected, personally relevant information many are motivated to act (e.g. adhere). Women were motivated to do annual mammograms when they were told how much “finding a lump the size of various millimeter-size pearls” equated to surviving breast cancer.

This is not to say that we all need a Ph.D. in what ails us. Judith Hibbard’s work at the University of Oregon suggests that “controlling costs and achieving health care quality improvements require the participation of activated and informed consumers and patients”. Her model focuses on patients acquiring knowledge, confidence and skills to act.

How Patients Feel: Fear operates to produce adherence in one patient and rapid non-persistence in another. Trust, on the other hand – in the healthcare system, our personal healthcare providers, and health products and services – resonates across audiences.

Most of us don’t see or directly interact with many of the stakeholders involved in our heathcare (e.g. our governments, managed care organizations, pharmaceutical companies). Instead, we see or talk to our personal physicians, pharmacists, and health agents who provide service. Trust in daily, health interactions is key to patient adherence to a recommended plan of action.

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As I mentioned in my post last week, Disruptive Women in Health Care is tackling the issue of drug adherence, often referred to as America’s other drug problem.  From a health policy standpoint, the issues cross financial, clinical, behavioral, and cultural boundaries.

Over the next two weeks, Disruptive Women and guest bloggers, all experts in their respective field–each representing a different perspective — patient, physician, nurse, pharmacist, researcher, behaviorist, policy analyst, distributor, to name a few–will share their analyses, opinions, and solutions.

At the completion of this series, we will compile an e-book as we did when we tackled the issue of Comparative Effectiveness Research.

THE SCOPE OF THE PROBLEM

A new report, Thinking Outside the Pillbox: A System-wide Approach to Improving Patient Medication Adherence for Chronic Disease, issued by the New England Healthcare Institute (NEHI) found that patients who do not take their medications as prescribed pay a price in poorer health, more frequent hospitalizations and a higher risk of death.

Collectively, noncompliant patients incur up to $290 billion annually in increased medical costs–that’s $290 billion in avoidable medical spending every year, according to the NEHI report.

This is not a new problem, nor is it unique to the US.  In 2003, the World Health Organization (WHO) issued a landmark report entitled Adherence to Long-Term Therapies in which it noted:

Adherence to therapies is a primary determinant of treatment success. Poor adherence attenuates optimum clinical benefits and therefore reduces the overall effectiveness of health systems.

“Medicines will not work if you do not take them.”  Medicines will not be effective if patients do not follow prescribed treatment, yet in developed countries only 50% of patients who suffer from chronic diseases adhere to treatment recommendations. In developing countries, when taken together with poor access to health care, lack of appropriate diagnosis and limited access to medicines, poor adherence is threatening to render futile any effort to tackle chronic conditions, such as diabetes, depression and HIV/AIDS.
This report is based on an exhaustive review of the published literature on the definitions, measurements, epidemiology, economics and interventions applied to nine chronic conditions and their risk factors. These are asthma, cancer (palliative care), depression, diabetes, epilepsy, HIV/AIDS, hypertension, tobacco smoking and tuberculosis.

In the intervening years since the WHO issued its report, adherence has become more problematic.  Numerous reports highlight the ongoing challenges, which are especially critical in the mental health arena.

A study in the American Journal of Psychiatry found that close to 60% of schizophrenics who were prescribed anti-psychotic drugs did not take the medication as prescribed by their physicians.  “We looked at adherence to anti-psychotic medication because they form the backbone of treatment for schizophrenics,” said Dr. Dilip Jesete, co-author of the study.  “These medications are good, but only work when taken properly.”

The study found that psychiatric hospitalizations were higher for people who did not take their medication as prescribed.

When schizophrenics, a disease which affects over 2 million Americans, do not take their medication, they are at risk for dying by suicide.  Four out of ten people who suffer from schizophrenia attempt suicide and one in ten die by suicide.

SOLUTIONS

Despite the complexity of adherence related challenges, a number of promising solutions, innovative responses and well-researched efforts are underway.  Many of these will be described in greater detail in our Drug Adherence series.

Some of these include:

• Text message alerts to remind patients
• Greater use of health care teams
• Integration of health information technology
• Creation of online and offline medication management systems, reminders
• Health e-games
• Insurance reforms
• Public awareness campaigns
• Patient education
• Mobile phone applications
• Research in gender-based barriers

We look forward to your comments and input as we shed light on this critical policy issue.

It has been estimated that 3 out of 4 people report that they do not take their medications as directed, resulting in hundreds of billions of dollars annually in related medical costs and an enormous number of hospital admissions and readmissions.

The reasons for this are complex and varied.  This is a particularly vexing challenge for young, chronically ill patients, for people with mental health diagnoses and for the elderly who may suffer from memory impairment.  Anyone on a complicated drug regimen knows how committed one must be to remain adherent.

For some, cost is an issue while for others side effects can be unpleasant, travelling can compromise the best of intentions as can the need for refrigeration when none is available.  Some patients must take some drugs on an empty stomach and others on a full stomach.  Some patients are simply not ready to accept they have a serious, or lifelong illness. It is complicated.

Because the implications, both clinical as well as financial, are significant, we have invited a number of our Disruptive Women bloggers, as well as some other experts in the field, to join us in a series of policy posts on this critically important issue.

Beginning next week, on October 19th, we will launch our Drug Adherence series which will analyze this challenge from a number of perspectives:  patients, providers, researchers.  In addition, we will also offer innovative solutions.

At the completion of this series, we will compile all the posts into an e-book, just as we did when we tackled the issue of Comparative Effectiveness Research and created our Comparative Effectiveness Research e-book.

If  you or someone you help care for has experiences you would like to share, or you have research, solutions and other thoughts on this topic, I hope you will share them with us.