- The Washington Times - Tuesday, August 5, 2003

Lost in the highly charged debate over Medicare prescription-drug benefits is a significant story that has been largely ignored to date: the fact that tens of thousands of senior citizens will never benefit from the drugs they receive because they can’t, won’t or just don’t take them properly.

There is nothing government can do about this. There are more than 40 million seniors in the United States — and an additional 77 million baby-boomers right behind them. While Washington can create a new prescription drug entitlement, it can’t make a bad-tasting medicine taste good or provide round-the-clock reminders that it’s time to take your pills.

What we need are more user-friendly medicines that will enable or encourage the elderly — who even without a Medicare drug benefit account for approximately 42 percent of the more than $175 billion in annual prescription-drug sales — to take their medications. Only the pharmaceutical industry can solve this problem, and we need to take on the challenge with the same enthusiasm as our search for the next blockbuster drug.

The problem of prescription “noncompliance,” as it is called, cuts across age groups and demographics. As the authoritative “Merck Manual of Diagnosis and Therapy” notes, children are even “less likely than adults to follow a treatment plan.” A study of children prescribed 10-day courses of penicillin for streptococcal infections, for example, showed that 56 percent had stopped taking the drug by the third day, 71 percent by the sixth day and 82 percent by the ninth day. “Compliance is worse with chronic diseases requiring complex, long-term treatment,” the Merck manual noted.

There are many reasons. Some patients won’t take their medicines because they taste bad, or dosage instructions are too complicated. One pill three times a day for 10 days doesn’t seem like rocket science. But to a senior citizen already taking medication for arthritis, thyroid problems and high blood pressure, one more prescription can induce drug-instruction overload.

Indeed, a 2002 survey by the American Association of Retired Persons indicated that 35 percent of Americans age 45 and older now take two or three prescription medicines every day, 24 percent take four or five daily, and 19 percent take six or more each day. So, if you’re already taking one pill three times a day, another twice a day, a third once a day, and a fourth every four hours, you might have a problem (at any age) if the doctor prescribes still another.

Bad taste and overlapping or complicated medication timetables are not the only reasons patients fail to take prescribed medicines. Some patients quit taking their medicines when they start feeling better, figuring that they will save a few pills in case the condition returns. Others complain of side effects, such as nausea, or have difficulty swallowing pills. And others just can’t remember what to take when.

A study published in the Archives of Internal Medicine in July 2000 showed a 76 percent “discrepancy rate” between the medicines patients were prescribed and the medicines they took. Of the discrepancies, 58 percent were the result of patients not taking prescribed medications or taking the wrong dosages.

The problem exacts a high cost. According to academic and government experts, prescription noncompliance results in 125,000 deaths, adds more than $100 billion to the national health-care tab, and results in 10 percent of all hospital admissions and 23 percent of nursing home admissions each year in the United States.

The point is that the United States can spend $400 billion over the next decade on a new prescription drug benefit for seniors — or 10 times that amount — and the compliance problem will still exist. Only the pharmaceutical industry can solve it.

Many medicines used today were developed and approved years ago. We can now take some of these products and make them better. For example, we can create extended-release formulations. If a patient could take one pill a day, instead of three or four, or a single pill on Day 1, instead of three or four pills a day for 10 days, compliance rates would improve.

We could also develop more “smart pills,” such as controlled-release formulations that enter the blood stream after they pass through the stomach, minimizing unpleasant side effects. There are new rapid-dissolve formulations that begin providing relief the instant the medication hits your tongue. We can do a better job of taste “masking.” And we can produce various forms of medications now available only in tablet form for those who have difficulty swallowing pills.

The pharmaceutical industry needs to understand that the government will eventually “discover” the noncompliance problem and elevate it into a “crisis.” The industry can prevent this by making the needed investments in new formulations now.

Eugene T. Haley is chief executive officer of Wilmington Pharmaceuticals, Wilmington, N.C.

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