"Former President Bill Clinton… was prescribed a statin for high cholesterol when he left office. But he stopped taking it at some point. And at age 58, he had to have quadruple bypass surgery because of severely clogged arteries that doctors said put him in danger of a heart attack."

Associated Press, 9/26/06

What's going on here? How is it possible that Bill Clinton, an intelligent man with few economic constraints and a host of people with an enormous investment in his ongoing good health, could fall into noncompliance?

It's a good question, and one that would seem to poke a hole in the popular notion that noncompliance is the result of economic hardship, lack of physician concern, or patient incompetence. Indeed, Mr. Clinton's experience is by no means the exception. According to an article in the November 2006 issue of PharmaVOICE, 15–25% of patients never fill the prescription, 30–40% fill it only once, and a staggering 50% of patients discontinue therapy entirely by month six!

	Taken together, these statistics represent not just an enormous loss in revenue to your brand, but a staggering economic expense to all of us, in the form of increased health care costs and lost worker productivity.

The old standbys are not enough.

Helping patients adhere to a treatment regimen — whether that involves filling a prescription, staying on a diet or exercise program, modifying environmental factors, or some combination of all — is easier said than done. And it's not for lack of trying… it's simply because the people and tactics we've turned to up until this point are not enough:

• The doctor can't ensure compliance. I love my doctor. He spends time with me and works hard to explain how, when and how often any medication he prescribes should work, including letting me know about possible side effects. But he was hard to find and is unique, and I know that our mutual connection as industry insiders buys me more of his time and attention than the average patient.

  Physicians have enormous influence (good or bad), but they generally don't have the time or energy that's necessary to explain the disease, the medication, the ramifications, the side effects and the other factors necessary to build the foundations of a good, compliant patient. Like a priest or rabbi who doesn't call when you stop coming to services (even if he welcomes you with open arms when you return), today's doctors don't have the bandwidth to keep track of patients when they leave the office.

• The patient can't ensure compliance. Unfortunately, human nature works against compliance. We're all creatures of habit, and even with pharmacy reminders and similar external prompts, once someone has made the decision (consciously or not) to stop taking a given medication, it's extremely difficult to bring them back into the compliance zone. Shockingly, even patients with life-threatening conditions such as HIV/AIDS, cancer and diabetes stop taking their medication in large numbers.
• DTC can't ensure compliance. Here as well, mass market advertising has not demonstrated an ability to move the compliance needle. Yes, awareness of particular drugs and conditions may cause someone to recognize a need and request a prescription. But DTC is aimed almost entirely at the start of the prescription-writing process; it does little to help a patient stay within a treatment regimen.

What's the solution?

The approaches used to date don't work, plain and simple. We can keep on doing the same, watching market share and patient health steadily erode, or we can take a different tack. Specifically, programs need to be developed which include:

• Early patient contact. Once the patient leaves the doctor's office the clock is ticking. Clearly, preventing non-compliance is much more manageable than trying to fix noncompliant patients after the fact. Effective programs reach out to patients quickly.
• Frequent patient contact. Every day represents a new opportunity for a given patient to fall off treatment. One time, one way information transfer is not enough. Effective programs are interactive, and remain in contact with the patient over the duration of the treatment regimen.
• Automated feedback to the physician. Programs which give physicians insight into patient understanding and compliance — particularly if done on an individual patient basis — allow the doctor to monitor her effectiveness in keeping the patient on treatment. A correct diagnosis and prescription is of no use if treatment is not followed, and doctors need an automated feedback loop which lets them know whether or not what they've recommended is working. Effective programs provide useful information, and take the burden of check-in off the doctor's calendar.

Lack of compliance hurts all of us… as patients, as pharmaceutical professionals and as citizens who in the end shoulder the burden of mounting healthcare costs. The challenge is to develop new ways and new approaches which help patients (from former presidents on down) receive the often readily available solutions they so desperately need.

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Compliance Management… Not All Patients Are Created Equal

It's often useful to speak of compliance in macro terms (e.g. "50% of patients discontinue therapy entirely by month six."). In practice, however, all that matters to the individual patient is his or her own results.

Traditionally, these individual results have been measured "after the fact," with patients being asked, "Did you take your medicine as instructed?" Unfortunately, because this information is inherently retrospective, it's of no value to the patient in question.

Much more beneficial, is to engage the patient in a conversation at baseline — before any treatment has begun.

Using as few as four key questions — all supported by the literature as being highly predictive, and all focused on how the patient has behaved in prior treatment situations — we are able to establish a Treatment Adherence Predictor (TAP); a measure of how well a given patient will comply with a treatment regimen.

Patients can then be reliably classified into three levels of risk (high, medium, low), and supplied information based on their individual TAP. So, for example, those who are low risk, receive information which supports their good, past behavior. As we move up the risk scale on the other hand, we give more attention, and gently, but firmly, include information regarding the consequences of noncompliance (e.g. morbidity and the impact on quality of life), and even specific snippets of support (e.g. "Keep your pills next to your toothbrush to help remember.").

Why does it matter? Because "one size fits nobody" treatment programs are in danger of offering too little information to some, too much information to others, and the perfect amount of the wrong information to still others. The more we can customize the experience before the fact, the better we'll be at helping patients stay compliant.

InfoMedics was thrilled to be the Gold Sponsor of this year's Patient Education and Disease Awareness Summit, held for two days earlier this week in Pennsylvania. Our own Paul Le Vine (Vice President, Analytic Services) served as Conference Co-Chair, and Dr. Stanley Wulf (Vice President and Chief Medical Officer) delivered a presentation on building market share and increasing brand loyalty.

Some of the other critical topics covered in this in-depth and interactive event were, "Patient-Centric Marketing — The New Alternative to DTC," "Motivating Healthy Behavior with 360 Degree Educational Programs," and "New Technologies Link Patients, Physicians and Brands."

It was a great opportunity to share stories and tactics, make new friends and meet old ones, and refocus our collective energies for the coming year. Thanks to those of you who attended!

"The patients can spend as long as they need on the phone talking to someone who can answer all of their questions in these [InfoMedics] programs . I don't have that kind of time to spend with them."

— Doctor of Internal Medicine, InfoMedics Research, Fall, 2006

How compliant are you? What percent of the time do you follow your doctor's treatment regimen as instructed?

InfoMedics creates an interactive, real-time means for helping patients and physicians better communicate about a diagnosed condition or prescribed treatment.

This results in improved health outcomes and consistent increases in prescribing levels for new prescriptions and refills.

December 2006

November 2006