Halloween.  What an annoying time of year.  There are the innocent children dressed by their overzealous parents in costumes ranging from silly to sexy, harassing me for candy and invading my personal home space.  Then there are the people decorating their yards with scary ghosts, goblins, and dead dummies, making it virtually impossible for me to take my three year-old daughter on a nice stroll through our usually unassuming neighborhood without freaking her out.

I’m more aggravated though about how some political circles have spooked the health reform debate.  It’s a perfect horror movie with serial killers of anything Obama, scare tactics aimed to torment and take advantage of citizens who are vulnerable and unlearned about a complex issue, and gangbangers of a majority party unwilling to compromise for bipartisanship.

Take for instance some of the absurd television and internet ads on health reform.  One ad claims that 300,000 women will die from breast cancer if health reform legislation is passed.  An online ad claims that in Massachusetts, you can go to jail if you don’t have the right health care insurance.

And vocal anti-reform providers are scaring people even more.  I participated in a recent panel discussion on health reform and afterwards, a businesswoman expressed fear of reform because a physician who had just worked to revive her 7 year-old niece from a deadly aneurism told her that her niece would have died had health reform been in effect because quality of care would be compromised.

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If medication adherence is a problem for adults, consider how difficult it is for young people with chronic medical conditions.

Alternate flavorings, formulations, and suspensions can help the medicine go down in children.  But what is the solution when taste is not the problem?  One approach we need to take is to put the young person center and first.  Talking past the child to the parents is a practice that continues today and even with many young adults patients.  If we want young people to succeed in self-medication management, they must be the drivers of their care.

Child-centered care:

 Psychoeducation: As soon as the child is able to participate, he needs to be educated about his condition and medication regimen so he understands what his happening to his body.  Participating in the decision-making process, e.g., whether to take the morning medicine after brushing teeth or at breakfast, protects the child’s autonomy and sense of control.

Contracts help in getting the young person to take ownership, and patient records are an age-old but effective method of monitoring adherence.  Children can check boxes on printed forms, manually or computerized; parents can help by incentivizing adherence with tokens or rewards.  Encouraging the child to share the record in the next medical visit further increases his autonomy – a critical issue when one loses the sense of control over one’s body.  Physician follow-up is critical to promoting adherence, e.g., counting pills, checking records.

Communication skills and understanding the young person’s perspective are key ingredients to building trust. A non-judgmental attitude along with a willingness to negotiate and temporarily modify medications can help a young person understand the need to adhere to a regimen.

Problems may surface when the child enters adolescence and considers engaging in risk-taking behaviors.  This is also the time to foster health self-management and start the transition process to adult-oriented health care.  As the teen matures, he must be educated and encouraged to learn about his condition and management. The physician should work with the family to develop a step-wise approach to increase responsibility, e.g., first succeed at level 1 for x months before moving up to level to 2.  For example:

1. Monitor patient-recorded adherence chart
2. Make doctor’s appointments and record on chart (physician visits are associated with adherence)
3. Order prescriptions and record on chart
4. Fill medication trays

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Mary R. Grealy is president of the Healthcare Leadership Council, a coalition of chief executives of the nation’s leading health care companies and organizations.  She is also the author of Prognosis:  A Healthcare Blog which explores the nexus at which healthcare policy meets healthcare practice.

If only it were an urban legend that senior citizens in the United States were cutting their physician-prescribed pills in half or ignoring their medications altogether in order to have enough money for food and utilities, but one doesn’t need academic studies to know that this kind of economically-forced non-adherence has too often been the case in our country.

After Congress passed the Medicare Modernization Act (MMA), creating the Part D prescription drug program, the Healthcare Leadership Council – an advocacy group comprised of chief executives of healthcare companies and organizations from all health sectors – literally took its show on the road. Having worked for passage of the MMA, we felt a responsibility to ensure that the new Part D program was implemented successfully and that seniors knew how to take advantage of the new benefit.

In community meetings across the country, I met with scores of elderly men and women who told me heart-wrenching stories of the hard choices they had to make between medications and other necessities, knowing they were putting their health at risk.

Has the Medicare Part D prescription drug program made a difference in drug adherence within this vulnerable population? The results are quite positive but they also show that further improvements remain necessary.

The impact of Part D on drug adherence among the elderly is unquestionable. A survey in April of this year by KRC Research (commissioned by Medicare Today, a coalition of local and national organizations we founded to provide reliable Part D information to seniors) found that three of every 10 Medicare beneficiaries reported that they are now taking medications that they had previously either skipped or rationed.

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The following guest post — part of our Drug Adherence series — is by Elizabeth Sozanski, who is currently Senior Director, Global Brand Strategy, and is the former Adherence Leader for AstraZeneca. In that role, she was responsible for building the adherence strategy and initiatives in support of 5 largest brands; had a leading role in developing adherence-related partnerships with multiple healthcare partners; and served as the main interface to the organization for adherence best practices aimed at improving appropriate care and healthcare outcomes.

In the many years that I’ve been with the pharmaceutical industry, few issues have been both as divisive and unifying the way medication adherence has, all at the same time. It’s divisive because various stakeholders in the healthcare space each own a different—and often seemingly conflicting—component of this common yet complex problem. It’s unifying because not a single one of those stakeholders can solve the issue on their own. The unique opportunity this situation creates is that, to address this costly and serious challenge with the price tag of $100 billion each year, we all have to come together and work across our boundaries and individual interests.

When I talk about healthcare stakeholders, I certainly include the manufacturers, but also a whole host of other key players in the healthcare space: starting with patients, doctors and nurses, and including managed care organizations, insurance companies, employers, public health organizations, policy-makers and regulatory bodies such as the FDA or EMEA.

As manufacturers, our hope is that patients who use our medicines benefit from their full value by using them appropriately. As an industry, we put so much effort into discovering and developing new medicines for patients—the therapeutic benefit of these medicines is clearly compromised unless an appropriate doctor-prescribed regimen is adhered to.

There are as many theories as they are people as to why patients deviate from their doctors’ guidance, and choose to “prescribe” their own treatment regimen instead. I won’t go into them because they have been very well covered already in this debate.

So what can a manufacturer do to address the issue? While no pharmaceutical company can single-handedly remove all of the underlying issues which drive patient adherence (in fact, none of the other healthcare stakeholders can either), there are many things we can do as an industry, and even more we can do if we partner with others in this challenging mission.

There are three key areas where we can bring particular value to this challenging issue:
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I was stunned to learn that New York City’s Bellevue Hospital was closing its birth center, leaving low income women in the city with no access to a birth center that accepts Medicaid.

Why are childbirthing centers in this country struggling to survive when they ought to be spreading? We know that they provide a wellness-model of pregnancy and birthing (as opposed to a disease model that hospitals have traditionally taken), use best practices in birthing, have excellent clinical outcomes, and save money. Staffed and usually managed by certified nurse midwives, childbirthing centers have been endorsed by the American College of Obstetricians and Gynecologists.

At the end of the Bush administration, someone in the Centers for Medicare and Medicaid Services realized that there was no mandate to pay these centers a “facility fee” that provided support for overhead. So, after years of paying this fee, CMS stopped paying it to childbirthing centers and now pays it only to hospitals.

The numbers I’ve seen suggest that a vaginal delivery in a hospital costs 5 to 6 times more than in a childbirthing center. Ruth Watson Lubic, one of the pioneers of the childbirthing movement, founder of the Family Health and Childbirthing Center in Washington, DC, and a Disruptive Woman, has estimated that using these centers for just Medicaid births could save the nation $1-2 billion each year.

As our nation struggles to figure out how to pay for reforming the insurance industry, we can start to reform health care delivery in affordable, quality ways by ensuring that all pregnant women have access to the childbirthing centers. For those who want to act now, you can sign a petition calling for restoration of the Bellevue Hospital center. Or learn more about legislation to require CMS to restore the facility fee to childbirthing centers.

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 fact is that although nearly 250 million Americans do have health insurance, according to a monthly survey of about 50,000 households done by the Bureau of Labor Statistics and the Census Bureau, an estimated 46 million Americans do not.

Listed below you’ll find arguments for not having health insurance that I hear on a regular basis. As a broker, I’ve provided a reality check for individuals to consider before making their final decision.

1. It costs too much.

The reality: Should a catastrophic illness or injury occur, it would likely bankrupt most people who do not have health insurance. It’s the terrible fact of life in 2009. Medical care is incredibly expensive, and employers are increasingly less likely to be able to support an injured or ill employee. So if something happens to you, and you have not saved enough money to support yourself if you are unable to work, odds are good that you will be in debt for astronomic health care bills and, unfortunately, many of us would be hard pressed to ever climb out of that financial hole. Don’t be scared. Just think long and hard about that.

2. It does not cover all of the health care needs that I have now, or might have in the future

The reality: The truth of the matter is that a good health insurance broker can usually find a policy that covers most every medical problem that is likely to arise. There are also resources that can be used to supplement your plan. For instance, if you need discount drugs, it is possible to fill your prescription at Wal-Mart or in Canada. Need a flu shot? You can get one at your local pharmacy. My mother always told me, “where there is a will, there is a way.” I believe that to my core. You just need to be clever and work at solving your own problems.

3. The drug benefit is insufficient on most health care plans.

The reality: See above. And do remember, you are your own best health care advocate. The health insurance plans cover many things, but you need to do some legwork to get everything you want and need for your own care.

4. The process of finding the right health insurance is too complicated.

The reality: Honestly, it really is not. Think about the old adage — “How do you eat an elephant? One bite at a time.” The same applies to health insurance. People think that the process of understanding a policy is just too difficult, so they tend to shut down before they even try to take the time to comprehend it. Don’t give up too soon.

5. I have a specific health issue that was not covered satisfactorily in the past, so I’m not inclined to buy health insurance again.

The reality: Please realize that not all policies are the same. There is definitely one that is right for each individual. Plus, there are often state-run programs that can address most insurance needs. If you had an issue it is likely that someone else did too, so take solace in the fact that you are not alone.

6. I am healthy and do not need health insurance today.

The reality: That’s true. Until, of course, you do need it. You will. You are human. Humans get sick and often need to see a doctor. So please, do not be stupid. Protect yourself against what is more than likely to come. In the case of a catastrophic incident, this ignorant assumption cannot be undone.

7. Obama will help me get free insurance.

The reality: I cannot believe how many times I have heard this in the last few months. I am the first to admit that President Obama is doing his best, but please stay grounded in the facts. The U.S. government is not going to give everyone a free health insurance policy. Unless you are very poor, forget this as an option. Take care of yourself today and buy an affordable health insurance policy.

8. I want to wait until health insurance is cheaper.

Having been in this industry for more than two decades I can speak from experience that health insurance companies are not in business to help you. Insurance is not going to get any cheaper — at least, not any time soon. It is heretic to admit, but insurance companies do not make billions for their shareholders by helping the little guy. We are easy targets. We have no lobbying power, and they know it.

The bottom line: Be smart. Buy a health insurance policy that will at least cover you in case of a catastrophic event. Health Savings Plans are a good option, and more solutions are coming on the market. The bottom line is that if you take care of yourself, you won’t regret it.

As this first full term at the Johns Hopkins Bloomberg School of Public Health has unraveled, I see how much they were prepping us during summer term.  My days have been filled with work, outside activity, caffeine, and a test of how long I can go without sleep and still be productive—similar to what I imagine the days are like for most of the Disruptive Women in Healthcare!  Classes this term included biostatistics, evolution of infectious diseases, program planning for health behavior change, health policy I, and public health economics seminar.  I chose the more rigorous biostatistics course (and will take others throughout the year) in an effort to become more quantitative and enhance my ability to analyze and conduct cost-effectiveness studies and economic evaluations in particular.  The course has its challenges, and there are certainly days when I wonder if I should have taken the other class, fondly known as “baby stats” to fulfill the requirement.  Health policy I: the social and economic determinants of health has been my favorite class, because not only have I learned about what the name of the course suggests (and health disparities is of great interest to me) but also how to develop a conceptual framework for a health policy problem and how to write testimony in an effort to get such an issue on a policymaker’s agenda.

In between classes, I have busied myself with all that the MPH program has to offer outside the classroom, as there is no shortage of activity competing for students’ every “free” moment.  For instance, I am part of a monthly health disparities journal club and am working with a professor on a book about Taiwan’s national health insurance system.  I am also now VP of Communications for Students Promoting HEalthcare REform (SPHERE), an organization spanning the school of public health and school of medicine whose goals are to assure that every person in the United States has the right to affordable, high-quality healthcare and to educate the Hopkins community.  So far the organization has had one event this year in which we heard from a panel that included representatives from Kaiser Family Foundation/The Commonwealth Fund, Johns Hopkins faculty, and local news radio, on the state of play in health reform.  We will be having other health reform educational events throughout the year and one major advocacy event in the spring.  As VP of Communications, I will be promoting events at the school, updating and enhancing our website, and possibly forming partnerships with other similar, local student groups.

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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.

This post was sent in by Joanna Burke, Strategic Communications for Regence Blue Cross Blue Shield.

Imagine going to a grocery store where none of the items had prices, and when you got to the checkout the cashier couldn’t tell you your total. Instead, he offered to mail you a bill for an unknown amount.

Although that sounds ridiculous, it’s exactly how our nation’s health care system often operates, and Regence BlueCross BlueShield has created a short (45 second) video highlighting the absurdity of that very situation.

The video is part of Regence’s What’s the Real Cost campaign designed to challenge people’s thinking about how far reform needs to go. It also explores the way choices consumers make each day can impact health care costs. Be sure to check out the five questions consumers can ask to change health care.

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.

No one wants to get the swine flu. That’s why so many people have panicked and are walking around wearing Michael Jackson masks. But should the new H1N1 vaccine be mandatory? A lot of people get a flu shot, a lot of people don’t. It’s your choice.But a new controversial regulation in New York requires all health care workers to get both the seasonal flu vaccine and the H1N1 vaccine. The New York Civil Liberties Union is arguing that it’s unconstitutional for the state to require the shots — especially since both the WorldHealth Organization and the CDC haven’t called for mandatory vaccinations.

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