Patients who don't take their medication as prescribed is a billion-dollar problem, reports pharmacy benefit manager Express Scripts in its 2011 Drug Trend Report. Nonadherence to prescription medication cost the U.S. health care system $317.4 billion in 2011. And that's just for treating medical complications - not the cost of lost productivity - that could have been avoided if patients had taken their medication as prescribed. The report shows that for many therapy classes, less than 50% of patients take their medication as prescribed.

"If you think about nonadherence as a $317 billion condition, it becomes the most expensive condition out there in the United States," says Sharon Frazee, vice president of research and analysis with Express Scripts.

Not only is it costly, nonadherence is dangerous - even lethal. "When we look at the leading cause of accidental death now in the United States, it's death by poisoning, and [that's] primarily prescription drugs at this point," says Dr. Leland McClure, director of pain management with Quest Diagnostics. "Over 20,000 Americans die each year because of prescription drug abuse. It's been a huge increase."

Interestingly, according to the Express Scripts data, 89% of people who are nonadherent actually believe they are adherent.

Misuse of any type is a health concern because it puts the patient's health at risk, says McClure. "At worst, it may signal you've got an addiction or illegal activity and, potentially, lethal drug interactions," he says. "At best, though, it signifies the patient isn't taking the medication that's indicated to treat a medical condition, and that's something that's very important."

According to a 2012 Quest Diagnostics study, 63% of patients tested were taking the medication inconsistently with a physician's orders. "Many of the patients combined drugs without physician oversight and that could be risking potentially dangerous drug interactions," says McClure. "A significant number didn't take their medications, suggesting there could be diversion or, at the very least, health care waste and medical conditions being untreated."

Dr. Donald Pittman, national practice leader for Express Scripts' cardiovascular therapeutic resource center, is the lead researcher on a number of studies that have looked at adherence rates for statins (cholesterol lowering drugs) and antihypertensives (blood pressure lowering drugs).

"We know that, in general, with cardiovascular medications, patients will drop their adherence rates over 50% in the first year of taking it," he says. "That's true with hypertensives and statins as a general rule."

In a 2010 study of adherence among patients taking antihypertensive medications, Pittman's research found that high adherence to the prescribed drugs reduced total health care costs up to $813 per patient annually, compared to those patients with low or moderate adherence to their drugs.

"Even when you have a small population, if they have hypertension, each patient not taking their medication costs you an additional $800 per year," says Pittman. "That adds up quickly."


Behavioral, cost, clinical concerns

Express Scripts surveyed more than 600,000 prescription drug plan members in a pilot program and determined the reasons for noncompliance fall into three main buckets: behavioral issues, cost concerns and clinical reasons.

Behavioral issues - forgetting to take the medication, for example, or procrastinating on getting a refill - account for 69% of the total nonadherence problem, according to the Express Scripts research. Cost concerns - patients who may have trouble affording their medication - accounts for 16% of nonadherence, while clinical - patients who don't understand how to take their medication properly or who don't take it because of concerns about side effects, for example - accounts for 15%.

The PBM is preparing to launch a new product, ScreenRx, which uses predictive modeling to screen patients for nonadherence. Those deemed likely to be nonadherent can then be offered appropriate interventions - whether it's a timer to remind them to take their medication, or a referral to a patient assistance program to help them pay for their medication, or a referral to a clinical pharmacist who can talk the patient through any concerns about side effects.

"We build predictive models that have about 400 variables in them - and it's disease-specific - that can predict which types of patients are likely to become nonadherent in the future," explains Frazee. "So, you can help them proactively, rather than wait for a bad habit to be ingrained."

Plan sponsors should look at pharmacy costs in conjunction with medical costs, notes Kristi Rudkin, senior director of product development and adherence at Walgreens.

"If a patient fills their prescription and takes their medication appropriately you might see an increase in the pharmacy costs, but that should be more than offset by savings on the medical side," she says. "One does impact the other; so, how do we make that connection, and are employers looking at it from that perspective?"


Retail increases compliance

In a study released earlier this year, data from Walgreens showed a 15% increase in medication adherence when patients were offered a 90-day retail option compared to a 30-day retail option, which is "very significant," says Gerry Gleeson, divisional vice president for bio-pharmaceutical development and market access with Walgreens. "When we do other types of adherence programs - telephonic or letter-writing programs - we see single-digit increases in adherence. When we see a 15% increase overall, that's a pretty sizeable rate."

Part of the problem with nonadherence is that there's no one-size-fits-all solution. "I've talked to a number of health plans and payers, and while the numbers are alarming, they're not entirely surprised," says Laure E. Park, executive director, prescription medication monitoring, Quest Diagnostics. "We're an employer of 42,000 ourselves ... we're educating our employees on this topic much like we would educate them on exercise and appropriate diet."




Online resources Online resources

A list of websites with more information on the topic of prescription drug abuse and/or noncompliance:

* Centers for Disease Control and Prevention

* National Institute on Drug Abuse

* Office of National Drug Control Policy

* National Rx Drug Abuse Summit

* National Council on Patient Information and Education

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