Fixing Noncompliance

It is considered as a black mark on a patient’s chart.  Being labeled as a noncompliant patient basically sends the message that no matter what medical instructions a physician gives you, you will not abide.  A recent post by Dr. Danielle Ofri, associate professor of medicine at New York University School of Medicine and editor in chief of the Bellevue Literary Review, discusses what it truly means to be noncompliant and how the issue of noncompliance could be better handled. 

Dr. Ofri quotes the example that a hypothetical medical chart was constructed for a 67-year-old patient with diabetes, hypertension and high cholesterol.  In order to remain truly compliant, the patient would have more than 3,000 behaviors to tend throughout the course of a year!  These include anything from taking medication as prescribed to exercising three or four days a week to attending recommended checkups.  Day in and day out (for some reason medical issues do not like to take time off), the patient must turn instructions into habit so that they may remain compliant.

The question needs to be asked, what can we do as Healthcare and Pharma professionals to improve medical adherence?  This could potentially be a multi-billion dollar question as improved medical adherence would directly impact prescription drug sales and provide new avenues for healthcare companies to facilitate and monetize physician-patient dialogue.  Now that smartphones and apps seem to be within arms length of almost everyone, we believe one key strategy will be to develop apps that allow patients and physicians to monitor key stats such as daily caloric intake and provide the ability to set reminders to adhere to a prescribed plan (see Prescription Smartphone Apps for Medication Adherence). 

However, this is just the beginning.  Improving adherence will require input and effort by everyone involved.  It is important for the Healthcare and Pharma industries to understand that adherence can be a “complicated balancing act” for patients.  Particular issues in a patient’s therapy may trump others and professionals in Healthcare and Pharma need to recognize this so that a prioritized plan can be developed.  Together we can develop strategies that improve medication adherence, and with this improvement, everyone will be better off.

Industry-Physician Education: Walking in Patients' Shoes

Some industry critics have railed that any contact between physician and drug makers is akin to a mortal sin; the very thought sullies the purity of medical practice. We think extremism, in any form, shows poor judgment and lack of logical thought. Transparency is excellent, but contact between industry and physician is still necessary for medical advancement.

So we loved the piece we read in Pharmaceutical and Medical Packaging News about the pharmaceutical consulting firm that set up booths at a rheumatology conference which allowed physicians to experience what their RA patients deal with every day. The point: education for all stakeholders, and that includes the use of biologics. A Web-designed program also stresses the need for exercise and the importance of medication adherence.

The booths were equipped with a working faucet and sink; a laundry detergent container; and working taxi cab door. A pharma sales rep guided each physician through the booth, who was asked to turn on the faucet, and so on. The physician, who was measured on how difficult it was to perform the tasks, generally had no problem doing so.

Then the HCP put on specially made gloves (made by folks at George Tech University) that simulated the challenges the RA patient goes through; the physicians' decline in functionality was significant.

The doctors who went through the booth loved it; 92% said they would go through it again – 98% said the demonstration helped them understand what their patients dealt with every day.

Just think: Maybe the consulting firm that developed this tool, OneWorld, can design similar booths for neurologists, so they can appreciate what migraineurs live with, and for pulmonologists, so they can understand what it’s like to live with emphysema.

The VA Shouldn't Hold Its BREATH

What a mess. In 2009, the Department of Veterans Affairs abruptly halted a study called the BREATH study, designed to help 413 veterans manage their advanced COPD, because of unspecified safety concerns.

Apparently the deadly type of safety concerns.

The VA, keeping mum about what happened until it publishes in a peer-reviewed journal, had all the right intentions. It wanted to help the sick vets cope with this chronic lung illness by teaching them how to manage it–-with the hope of then keeping them out of the hospital.

But apparently the trial backfired. While the study’s researchers wouldn’t give details, one told the Pittsburgh Tribune-Review, “If someone were to start a disease management program, I would suggest they probably not do it just yet, until the information is available," said Dennis Niewoehner, a pulmonary doctor in Minneapolis, a co-chair for the trial.

Forgive us, Dr. Niewoehner, but we disagree. One, the VA should tell healthcare providers now what happened. There may be a clinical trial going on that could benefit from your knowledge. And two, stalling the start of a disease management program until a paper is published is not right. For those with chronic diseases, every minute has got to be torture.

What is ironic is that maybe the VA should have waited to start its study. Just recently, a review was published in Current Opinion in Pulmonary Medicine on COPD and older adults. The researchers looked at various areas, including comorbidities and disease management.


Older adults with this disease have an average of nine other comorbidities, including depression, cardiovascular diseases and chronic renal failure. What they found was that research suggests that “aging is a determinant of the progression of disease and that management of this population requires different metrics and strategies.” According to the summary information of the VA study, the study group received an education program, an “action manager," plus care. They also received telephone calls. The control group received standardized care.

Since we have no clue as to what went wrong with the study, we can only speculate, but the take-away message is that patient monitoring and management could have potentially signaled these problems sooner. While we think publishing what goes wrong is as important as publishing what goes right, we also believe the use of monitoring technologies like MedAdherence can help providers manage patients with many comorbitities remotely, and possibly better.

Let us know what you think.

Pharma: Know Thine Enemy

Mindless habitual behavior is the enemy of innovation. 
Harvard Business Professor Rosabeth Moss Kanter 

Might we suggest that pharma begin thinking about investing serious money into healthcare that does not only involve drugs? We keep tripping over stories and studies of how non-traditionalists are stepping into the healthcare space using social media.

We found this interesting.

One group of researchers has published two papers on smoking cessation; both papers involved the same number of subjects, 27. Another group took a look at the 47 apps, designed to help smokers quit smoking, all of which are currently sold for iPhones only.

The two groups of researchers found different results.

In the first paper  the researchers first used fMRIs on the subjects, all heavy smokers, to learn which parts of the brain were fighting, or giving in, to the urges to smoke. Their description of this battle: “A war that consists of a series of momentary self-control skirmishes.”

The researchers theorized that by mapping the brain areas where these skirmishes are fought, they could predict which of the subjects would have more success at quitting–-because these brain areas were more active. The motivation they used on these subjects was text messages, eight messages a day for three weeks.

“We are really excited about this result because it means that the brain activation we see in the scanner is predictive of real-world outcomes across a much longer time span than we thought,” said one researcher. “The tasks that we use in the laboratory are simplified models of these real-world processes–-but they seem to be valid models.”

In the apps paper, the researchers checked out the 47 smoking cessation apps, just to see how effective they might be. They looked at how each app approached smoking cessation and its adherence to the U.S. Public Health Service's 2008 Clinical Practice Guidelines for Treating Tobacco Use and Dependence.

The conclusions? The apps had “low levels of adherence to key guidelines in the index. Few, if any, apps recommended or linked the user to proven treatments such as pharmacotherapy, counseling, and/or a quitline.”

What an opportunity for pharma; it’s tailor-made.

Medication Adherence: Two Views

We have a friend who’s done a lot of research on medication adherence, and he says that healthcare professionals fall into two camps regarding how they see patients and their capacity to maintain their treatment regimens. In the one camp, he says, are those who think patients can't motivate themselves for their own betterment. It’s the doctors who have the answers, not the patients.

Those in the other camp think just the opposite. They say patients are smart enough to know they need to maintain their prescribed regimen – they just need a little help to stick with the program.

Is it possible both camps are right? A study of hypertensive Medicaid patients who used a pill phone app on their cell phone reminding them to take their meds is pointing that way. It was a small study – 50 patients -- so we’re loathe to do more than surmise.

In a nutshell, the 50 patients accepted the idea, and used the app throughout the seven-month study. The patients were “generally satisfied” with the software, and patients continued to have their scripts refilled. But – once the study was over, there was a “decrease” in refills “after the application was discontinued.”

So, the study’s sponsors and researchers, including George Washington University Medical Center, appreciated that the participants were smart enough to be taught how to use the technology. And these patients used it for the study's duration. But once they no longer had the phone, they stopped.

Why? It would be good if the researchers asked some follow-up questions of these study participants. Any insight into how patients feel about maintaining their treatment regimens can only help.

Nurse Practitioners: Should the Sun Shine, or Shadows Fall?

The other day, we wrote about a medication adherence study that ran in the American Journal of Managed Care. Pharmacists, the authors said, were second only to nurses – in the right milieu – in getting patients to stick to their medication game plan.

We bring this up because a second study in the same journal is also talking about nurses. But here, the study’s focus is on nurse practitioners. And the study’s topic is nurse practitioners and industry influence.The study’s authors are concerned that NP's see no conflict of interest with drug reps promotions.  The respondents to this study see no problem with handing out samples, learning about new drugs at industry-sponsored dinners, attending industry-sponsored CME, and so on.

The authors suggest, “Future research should assess influences of evidence-based academically sponsored continuing education programs on NP prescribers’ beliefs and practices.”

The researchers’ fears are based on the fact that these professionals are going to become more prominent in the delivery of patient care going forward. The number of physicians planning to enter general internal medicine is significantly dropping. Nurse practitioners, who now number at least 150,000 in this country, are allowed to prescribe most drugs in every state.

And now the reason we bring the med adherence study into this blog. Back in 1993, the Gallup people polled patients about their willingness to see a nurse practitioner. The results: 86% said yes, we like them. Why? Their communication skills and the way they promote health. Considering the scarcity of doctors and the little time they can give to patients -- there is no reason to presume that the 86% figure has decreased since then.

According to the nurse practitioners' study, the industry directed 20% more of its marketing efforts between 2004 and 2006 to these ancillary HCPs. We advise folks to proceed with caution here.  We believe that these healthcare professionals should be treated as the educated, intelligent individuals that they are.

And industry critics need to be careful here as well. The unintended consequences of taking away all industry-provided tools could be detrimental to patients’ welfare.

Talk to a Pharmacist: It's Good for Your Health

If pharmacists are up to the task, they could help save the U.S. healthcare system a lot of money – about $300 billion a year, to be exact.

Why? A recent study showed that of all the ways to try and get people to stay adherent to their medicines, pharmacists – talking to patients in the store – is the way to get the job done.

The runners up? Nurses – talking to patients who are leaving the hospital. Did everyone note that the words ‘talking to patients’ are in both paragraphs?

PMP News recently ran a story about a study in the American Journal of Managed Care. The study's researchers culled more than 6,000 articles before focusing on 168 of them.  The results: Of the 168 articles, 51 were reviewed and met the inclusion criteria for their analysis. Here is a summary of what the data suggest when there is person-dependent intervention:

• 83% of interventions done at the pharmacy, in-person with a pharmacist, are the most effective.
• 67% of interventions done at the time of hospital discharge with a trained professional were effective.
• 47% of interventions done at the clinic were deemed effective.
• 38% of interventions done over the phone were effective.

The researchers also found that “electronic interventions” – faxes, e-mails, and so on – can work too, but not as well. Among person-independent interventions, 56% of these types were successful, with electronic interventions being the most successful sub segment, representing 67%.

Obviously, people want meaningful contact – the opposite of what many patients may get in our country’s health care system.

We couldn’t agree more. The question is: What, if anything, will be done with the study’s results?

A look on Google showed that no major media outlet picked up on the study, which tells you that med adherence just isn’t sexy enough for the paparazzi, even with a $300 billion price tag. But it is for CVS.

A look at the company’s web site shows that medication adherence is a topic near and dear to its heart. Sure, for obvious reasons. But it’s also funding studies – check out the web site – to try and find answers to this huge issue. Which is more than others are doing.

We ask that you share these results with your colleagues, and consider developing an adherence initiative that motivates patients to adhere to their prescribed regimens. 

Medication Adherence: A Glance At PubMed

Do you need proof that certain treatment adherence programs can work?

Just plug in “patient adherence” and “cell phones” into PubMed. You'll likely see two Lancet articles on mobile phone use and HIV treatment adherence.  In the Chi and Stringer article, these researchers found that weekly text messages sent to HIV patients in sub-Saharan Africa improved adherence -- 62% versus 50% for the control group – and allowed for better rates of virological suppression (57% vs 48%). Patients who didn’t respond to the text message within 48 hours received a follow-up phone call.

Chi and Stringer raise interesting points in their article. They recognized that the calls were too spread out to actually remind patients to take their antiretrovirals; they speculated that “[p]ossibly the SMS [short message service] intervention worked by improving communication and rapport between health providers and patients.”

Two other points of discussion:  One, the cost. Chi and Stringer write that SMS costs less than $8 per patient.  “This intervention might prove cost effective, particularly when one considers the cost and complexity of second-line therapy. However, this aspect still requires formal analyses.”

The second point the researchers raise: Can cell phones be used to help other patients with other types of chronic diseases?  Chi and Stringer might find the answer to that question in other PubMed articles. In India, at the L.K. Diabetes Centre in Lucknow, diabetes specialists use videos made with mobile phones for diabetes education. They call them “mobi-films.” These mobi-films are used in multiple ways: patient to patient communication, doctor to doctor communication, doctor to patient communication, and patient to doctor communication. As to whether these films have helped improve patient care, the authors write, “Over the years, we have seen a sea change in the knowledge and day-to-day diabetes care skills of people visiting our center and benefiting from our diabetes education films.”

Some physicians are experimenting with cell phones for patients with hypertension; other researchers have seen success with patients with malaria.

And, by the way, Chi and Stringer aren't the only researchers who found that HIV patients are adherent when prompted with cell phone messages; a literature review by other researchers found similar findings.

To us, the travesty of patient non-adherence is that solutions to the problem exist and that people in this country are not adhering to physician recommendations. What is reassuring: That studies are suggesting that innovation can occur anywhere.

Patient Adherence: Money Can't Change Everything

Even if providers slash medication prices, some patients are not adherent. To wit: Patients’ decision not to get vaccinated during the current flu season.

It seems that some major retailers, like Rite Aid and Kroger, and smaller venues, like doctors’ offices, are awash in flu vaccine, and cutting vaccine prices to salvage their losses. The WSJ reports there aren’t enough takers for this year’s 163 million doses of flu vaccine.

Last year, there were 110 million doses manufactured, not enough to cover the demand for the potentially fatal H1N1 viral strain. Pharma ramped up production this year, hoping that the public’s demand would be the same as in the prior flu season, and because the CDC now says all people over six months old should get the shot.

During last year’s epidemic, in which 12,000 people died and millions were sickened in this country, you couldn’t turn to a media outlet without hearing about H1N1, the CDC, WHO, problems with the vaccines, and so on. If you’ll recall, there was even a huge stink involving the WHO and conflict of interest. This year, stories about the flu season have been perfunctory, found essentially on medical web sites.

But the general feeling about last year’s flu season was that the medical community, including pharma, cried wolf. One of the comments to the WSJ article was that “H1N1 was an overblown marketing effort for the most part.”  Said another: Of course it was overblown."  Comments such as these certainly help explain the public’s ambivalence to getting their flu vaccine – and to those in public health in trying to accurately forecast the reach of the flu.

This year's flu season is still early, January is just starting. It will be interesting to see what happens in the waning months of the winter. Imagine the public's outcry if the flu season gets really out of hand.

Which raises this point: Will industry and public health officials pay attention to how patients are reacting this year to getting their shots? We think that people choose not to  get vaccinated because there is no immediate value to them in doing so. We believe that focused efforts on adherence to medical evidence, providing reminders for vaccinations via text messages can help overcome the delicate balance of supply and demand for vaccines.

This is important public health work.  We believe those who are casting aspersions on the industry need to be educated to the real challenges industry faces in forecasting this often fatal disease.

Pharma's Brave New World -- Patient Adherence

And so it continues. The pharma world persists in shedding jobs, despite signs – admittedly wobbly signs -- that the economy is recovering.

Bayer recently joined the job-shedding queue, announcing it planned to eliminate 4,500 positions – but would recreate more than 2,000 jobs when it expanded into emerging markets, primarily in Asia.

Bayer’s announced reasons for eliminating the positions were spiraling research and development costs, competition from generics, and costs from health care reform.  Not really a surprise ….

Interestingly enough, pharma members expanding into China and India will face similar business challenges in those countries eventually.

It’s time for the 30,000-foot view. From our vantage point: America is no longer the glory market. The industry is undergoing a paradigm shift; members are looking for other places to make their fortunes. The huge markets of China, India and other Asian markets are exactly where they should be going. Shareholders will only put up with so much for so long.

So where does that leave the industry staffs in United States? Where should pharma members focus? Our answer: Patient medication adherence! More to follow.

Prescription Abandonment: Opportunities Lost

It’s a shame that industry’s rep is in tatters right now. Pharma should be delivering an important message to American businesspeople, but they likely won’t pay attention – one, because of the messenger, and two, because it would cost them money – initially -- to fix the problem.

We’re talking about prescription abandonment. A new Annals of Internal Medicine study confirms what common sense tells us: people with limited resources will not pay for prescriptions they cannot afford. The study – conducted in tandem with CVS Caremark over the summer – shows that if a co-pay hits the $40 and above range, people are more apt to forgo the drug, especially if it’s a new script.

An accompanying editorial  also notes the obvious: Someone who doesn’t fill a prescription undermines his treatment, faces increased healthcare costs down the road as well as potentially life-threatening results.

That someone also affects the workplace – in terms of days off, reduced productivity, and so on.

The Annals study isn’t the first. A WSJ blog, citing a Wolters Kluwer study, notes that nearly 10% of new scripts for brand-name drugs weren’t filled in the 2nd quarter of 2010 – an 88% hike over the same time period in 2006.  Comments to this WSJ blog were Scrooge-like. “The bottom line is that people are too unaware of what the actual costs are for health care,” wrote one. “If you don’t think your health is important enough to spend any of your own money [even when insurance is available to you], why should the taxpayers, your employer, or anyone else think it’s important?” wrote another.

Let’s look at a map. Folks at Kaiser Permanente figured out how many prescription drugs people take in the U.S. In two words, it’s stunning. In Tennessee, people between 19 and 64 take an average of 16 medications; in North Dakota, it’s 13, in California, less than 9. We argue that this map shows that people will fill their prescriptions – when they can.

But if big employers do what they’re threatening – shift more healthcare costs to workers – what will happen to those employees at the bottom of the payroll?

A little forethought is needed here. Think about those diseases that are relatively symptomless at first, like type 2 diabetes. Regular doctor’s visits and blood draws would show creeping A1C levels. Diabetes under control is cheaper than diabetes out of control.

Are employers and government agencies being penny wise, pound foolish? We’d say so! We’d also urge industry marketers -- despite pharma's current reputation -- to use these data to help solve the problems and focus on medication adherence solutions that work!

With Patient Non-Adherence, Use a Little Psychology

My mother always said to get resistant people to do what you want, use a little psychology. That’s exactly what MicroMass Communications says in a recent white paper that discusses patients with chronic diseases and their unhealthy habits. MicroMass says if you want these patients to lose weight, take their medications, adopt positive attitudes, and so on, then it’s essential to find what will motivate them to do just that.

In their white paper, called “Understanding and Changing the Metabolic Mindset” researchers at MicroMass interviewed 1,500 patients with type 2 diabetes, obesity, high cholesterol and hypertension. They started out wanting to know the differences among the patients, so they could understand how to sell to them more effectively. But in the interviews, MicroMass researchers began seeing similarities among these people – the patients’ barriers to changing their behaviors were not all that different.

The researchers organized the patients into four groups: those on cruise control; those who take charge; those who are disengaged; and those who are overwhelmed. The last group is the largest; in a video, MicroMass’s director of behavioral services says patients in this group lack confidence to do what they need to do -- healthcare providers often mistake this lack of confidence for indifference. Encouraging the completion of baby steps is important here, she says.

Healthcare providers who can identify which group their patients belong in will see more success with those patients, MicroMass says. “Programs built around behavioral models have been successful.”

Nobody in this reading audience needs the dollars lost to patient non-adherence repeated here. A few pilot studies certainly seem in order.  To my friends at Micromass, Great Work! Others in your business should be making similar investments in their marketing strategy recommendations as well.

Patient Non-Compliance, Revisited

The problem of patient adherence, an issue all too familiar to those in healthcare, was the subject of a recent Merck study. Researchers looked at 79 adherence studies, specifically on prescription non-fulfillment rates. (You can find the abstract on PubMed.)

PharmExec, which wrote about the report, (and sensibly talked to us about) said that Merck determined that 15% to 20% of patients do not get that first script filled. The drug maker classified non-adherence on four levels, from primary (not getting the script filled) down to secondary adherence (not taking medicines as prescribed.)

The report blamed non-adherence on three reasons. It said patients:

• had concerns about the drugs;
  
• didn’t think they needed the medicine;
  
• couldn’t afford the drugs.

It pooh-poohed the myth that patients forget to take their medicines as a reason for non-compliance. PharmExec cited a couple of industry programs that seem to be working.

One was the Pfizer-Walgreens collaboration. Here, Pfizer is leaning on Walgreens’ pharmacists to make sure patients understand what they’re taking, and why. In the study, researchers found that the physician-patient disconnect -- reason for the prescription not explained well enough, not enough time during the appointment to do so -- was a major risk for patients not getting their scripts filled.

Patients just want to understand what's being said to them. They want to speak with professionals who can help them understand what's being prescribed to them without being judged for their lack of adherence. Our friend Dr. Grant Corbett explains this as the "competency world view." 


Maybe we should all take the view that patients are competent and need some positive coaching to improve their adherence.

NY Times Articles-Medication Adherence

“Failure of patients to comply with therapeutic regimens is a continuing source of frustration to physicians and clinicians. Only recently, however, has it become the subject of special investigations.” See the NY Times & NY Times Blog

No, you haven’t missed a thing – W.L. Ball, MD, wrote those lines in 1974 in the Canadian Medical Association Journal.

The problem of patient noncompliance lingers, festers, metastasizes. Back in Dr. Ball’s time, only a handful of people didn’t fill a new script. A new Harvard study now shows that percentage has grown: More than 20 percent of patients do not even go to the pharmacy and get their prescriptions filled.

Reams have been written on why people won’t take their meds as prescribed: They don’t understand what they’ve been told to do; they don’t have the money to fill the script; it’s too inconvenient to go to the pharmacy; and most importantly, they don’t have the education to appreciate the severity of their disease. The latter, incidentally, was not considered a factor in Dr. Ball’s time, but health literacy is a big part of the growing healthcare problem in this country.

The stakeholders here – industry, physicians, retail pharmacists, pharmacy benefit managers, managed care organizations, employers and even the government – claim they want to see patients take their drugs as prescribed. But who’s problem is this really? No one seems to be willing to take the lead and help drive this change. That would mean claiming ownership, at least partial ownership, of the problem, and no one wants to do that. They want to know who is going to pay for it?

That short-term view might look a tad foolish, 10 years down the road, when all those people who haven’t taken their meds for all their chronic diseases start consuming a lot more of the healthcare dollars. What will happen then?

“Medication non-adherence undermines even the best cost-saving and clinical intentions of evidence-based care,” according to the NY times article. We think people should do something about it. Each stakeholder in the medication therapy management process has a responsibility. Only by working collectively can we really solve this problem. We have some ideas and have done some work with a lot of bright minds on this issue. However, there is room for more. Tell us your thoughts.