The Second Drug Problem

The Big Asthma Lie

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How is it possible that modern medicine still does not provide care of known benefit sufficiently and correctly? Quite simply, deficiencies in medical quality are due to inadequacies of organization, delivery, and financing systems.

Bernard Bloom

Drug therapy may be the most common modality of therapy in the industrialized world. In the United States, just under two thirds of all physician office visits include one or more prescriptions. The frequency of prescription use increases slightly with age (Figure 1.1).1

Doctors and patients intend drug therapy to improve the quality of peoples' lives, by curing or controlling disease. However, this is too often not the outcome of drug therapy. Research data show that preventable injury and death from drug therapy are major public health problems in most industrialized nations. Their costs, both human and financial, are major burdens on everyone. The billions of dollars that are spent to correct preventable drug-related morbidity (PDRM) could be used to prevent it, thereby gaining not only better quality of care but also reduced costs and improved access.

Adverse effects of drug therapy may be the fourth leading cause of death in the United States, according to a literature review in the Journal of the American Medical Association.2 Lazarou et al. estimated that in 1994 there were from 76,000 to 137,000 deaths from adverse drug reactions (ADRs) in U.S. hospitals. Even with the lower estimate, ADRs would be the sixth leading cause of death. This ranks mortality rates from ADRs among those caused by heart disease, cancer, stroke, and accidents. A recent report of the Institute of Medicine (IOM) reviewed the prevalence and significance of human error in health care and its implication for patient safety. The report found that medication-related errors are "one of the most common types of errors ... substantial numbers of individuals are affected, and it accounts for a sizeable increase in health care costs."3

Chapter 2 will show that the prevalence of preventable hospital admissions caused by drug therapy rivals those from myocardial infarctions, cancer,

1 200

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Under 15 15-24 25-44 45-64 65-74 75 and Patients age in years over

FIGURE 1.1

Number of prescriptions (mentions) per 100 physician office visits in the United States in the year 2000 (National Ambulatory Medical Care Survey).

diabetes mellitus, and asthma. Comparisons to diabetes and asthma are ironic, by the way, because drug therapy is such an important part of their management, and we know that mismanagement of drug therapy is a cause of hospital admission for patients with those diseases.

The money spent to correct preventable office visits, emergency department visits, hospital days, etc., may approximate $100 to $300 annually for each man, woman, and child in the United States. The news media now refers to the intentional abuse of drugs as "the drug problem." Preventable drug-related morbidity is then the industrialized world's "second drug problem." It lags drug abuse in popular coverage but may well cause more human misery and waste more money than drug abuse. Clearly, we should prevent adverse outcomes of drug therapy from a clinical and humanitarian viewpoint. Moreover, by preventing them, we may make health care much more efficient.

Stories about real people add human meaning to the statistics. When we consider the tragedy of Katherine's death (see Preface) in the context of research, we see that it is not a rare occurrence. There are many more stories of avoidable injury and death from mismanaged drug therapy. They shock and offend, and make many people seek simple explanations and quick solutions. Katherine LaStima's death is shocking and offensive, but is actually one of the less dramatic and more commonplace examples. Her story is rather a tragic symbol of how ordinary this problem really may be in community health care.

The death of Katherine is a symbol of a pervasive and major public health problem — adverse outcomes from the mismanagement of routine drug therapy. Although people die of asthma, nearly all asthma deaths are pre-ventable.4,5 If Katherine had been murdered or killed by a drunk driver, we would be outraged. We should be even more outraged by a death due to

Under 15 15-24 25-44 45-64 65-74 75 and Patients age in years over

FIGURE 1.1

Number of prescriptions (mentions) per 100 physician office visits in the United States in the year 2000 (National Ambulatory Medical Care Survey).

inadequate medical care. The mismanagement that killed Katherine LaStima exemplifies many important points found in research literature, but perhaps most of all, her death illustrates the banality of evil and the wisdom of Edmund Burke's admonition, "The only thing necessary for the triumph of evil is for good men to do nothing."

Two reports from the IOM on the quality of medical care in America produced a flurry of activity recently and some continuing effort to correct the problem.3,6 But still, there is no consensus to improve the overall system of medication use.

Preventing PDRM should be directed at root causes. The sheer number of potentially significant root causes, however, suggests that preventing PDRM by separate, specific remedies might be impossibly complicated, especially considering the thousands of drug products available. Furthermore, few studies show that changing one element in medications use affects outcomes. Theoretically, reengineering the medications use system could address many root causes for many drugs, providers, and patients. This has in fact been confirmed by several studies that improved outcomes and reduced total costs, as described in Chapter 8.

Dramatic improvements in patient outcomes are possible when physicians, patients, and pharmacists cooperate in systematically managing outcomes. This promising research has been accumulating for nearly 20 years, yet somehow it has not yet been followed up by many health care professionals and researchers, and continues to be ignored by many new mandarins of managed care. Meanwhile, literally thousands of lives and millions of dollars are wasted by PDRM. So, there are two problems: the basic problem of PDRM, and the secondary problem that society has been so slow to respond to the primary problem.

This situation should provoke strong motives to do whatever is needed to make drug therapy safer and more effective. Health professionals and managers in North America and Europe are among the best educated in the world. Given the significance of the problem, their response has been absurdly inadequate. A preventable disease is endemic to most or all of the industrialized world. Its prevalence and cost rank with major diseases like diabetes and heart disease. We have some evidence about how to prevent or at least ameliorate this disease, but we do very little with it. This is surely not the way the world of health care is supposed to work.

Most citizens of the United States, Canada, U.K., and other countries known to have high prevalence of PDRM seem to take great pride in the quality of their medical care, but seem to accept such failure. Many are shocked by the facts. We could not have the PDRM problem some people say. It must be confined to subpopulations like the elderly, poor, or teaching hospital patients or rural backwaters. Furthermore, people have faith in their doctors and pharmacists. If we had the PDRM problem, would not the doctors, pharmacists, and hospitals know about it and fix it? The short answer is no.

Why Do These Problems Persist?

These problems exist, and persist, because the technology of drug therapy has far outstripped society's traditional ways of thinking about it and customary arrangements to control it. The United States and many other Western societies have demanded that marketed drug products be safe and effective. Then, in effect, they have sent those safe and effective drug products into an unsafe and ineffective system of use.

In the days of tinctures and fluid extracts (roughly until the 1940s), the list of effective drug products was shorter and, the rate of pharmaceutical innovation was slower than today. Professionals and patients had time to develop experience with drugs. Concerns involved drug purity, potency, and consistency. The pharmacist's job was to obtain high-quality crude drugs and to prepare them properly. A pharmacy smelled like, and in many ways was, an apothecary shop. One-way communications from physician to pharmacist through a prescription were sufficient.

Making drug products has now been taken over mainly by the pharmaceutical industry. This has led to many new drug products, safer and more effective. Drugs, dosage forms, and their potency are now standardized. Most nations closely regulate the pharmaceutical industry. Manufacturers have to prove the safety, effectiveness, purity, potency, and consistency of drug products.

Drug products make billions of dollars for their manufacturers. Consequently, they are articles of commerce as much as professional instruments of care. The industry has become a powerful force. It advertises directly to consumers. It contributes to political campaigns and funds research. Only the naive would believe that the industry does not influence the interpretation of research results.7

Consumers and purchasers, especially third-party payers like insurance companies, are keenly aware of drug products as expensive articles of commerce. Total expenditures for drugs are rising rapidly. Higher prices and higher total expenditures for drug products are a real worry, but they must not be allowed to draw attention away from how well those expensive medicines are used. The proper use of medications can lower total costs of care, and misuse can increase it by more than the cost of the drugs themselves.

The list of drug products numbers into the thousands, and innovation (real or apparent) is rapid. The complexities of dosages, drug interactions, and allergies are mind-boggling. Nonetheless, the family physician is expected to manage therapeutics single-handedly. Communication to the pharmacist is still mostly one-way, through a prescription, although the biggest questions now may concern the effect that the prescription is having on the patient. Community pharmacists, freed from drug preparation, have become part of a commercial distribution system.

In short, reality today is quite different from when drug controls were set up. Traditional thinking about drug therapy, however, has outlived the galenical era. The concepts and language that stakeholders* use to talk about drug therapy, adverse effects, and treatment failures may be the basic problems. How we think about medications use surely determines how speak about it and what we do about it.

The medications use system is poorly understood. The conventional wisdom about how to provide safe, effective, and efficient drug therapy sometimes lacks a basis in fact, and is therefore often wrong. For example, unsafe drug products and inappropriate prescribing are not the leading cause of patient injury in ambulatory care, and sometimes have nothing to do with causing injury. Yet managed care organizations spend more money to influence prescribing than on any other aspect of medications use.

Like many others, Katherine LaStima did not die of an adverse drug reaction, toxicity, or side effect. Despite being in the care of a specialist, she died of the natural course of her disease, asthma. She died in part from exposure to an overload of allergens at the county fair and in part because her doctor, pharmacist, parents, and even Katherine herself did not control her drug therapy, and therefore did not control her asthma.

Overuse of albuterol, an asthma "rescue" medicine, is rarely harmful and did not kill (or even directly harm) Katherine. Frequent inhaler use, however, is a useful marker to show that asthma is slipping out of control. The extra albuterol helped Katherine to breathe while her disease was getting worse. Also, she was using too little "preventer" medicine (a steroid-like cortisone) that fights the cause of asthma symptoms. In effect, Katherine was fighting her symptoms instead of her disease. When she went to the fair, she may have been extremely vulnerable to the allergens that she encountered there.

Many people seem to focus on the drug product instead of the manner of its use. Perhaps some patients and providers value convenience and reassurance more than competent care and a disciplined, full understanding of how to use medicines. The effects of the preventer medication would not have been apparent to them, so perhaps Katherine and her parents did not fully understand that it was essential.

We have to change the normal arrangements of community practice. These arrangements do not permit enough coordinated attention to drug therapy. In particular, interprofessional cooperation is usually inadequate. A patient, physician, or pharmacist cannot manage drug therapy alone. Katherine's pharmacist obviously emphasized his function as a dispenser of medicines rather than his potential role as a co-therapist in the management of Katherine's asthma.

When something goes wrong and a patient is injured, the tendency is to look for simple solutions: the drug product itself or the people involved. While professional errors cause some heart-wrenching injuries, very few patient

* Many kinds of people have an interest in how medications are used: regulators, purchasers, providers, professionals, patients, and family members.

injuries are caused by errors, at least as most people would understand the term. In this instance, the physician and pharmacist were sued.

People like Katherine are not supposed to die of asthma, so it would have seemed that somebody must have made a mistake, for example, the doctor or pharmacist who treated Katherine. She had been repeatedly hospitalized in the past, and her pattern of medication use just before she died showed that she probably was beginning another exacerbation. Court records show that Dr. Michael and the pharmacist, Mr. Merchant, knew the possible adverse consequences of her medication use pattern. They said that they had warned her mother, Joanne, more than once. Her death could have been prevented by any of the participants in her care, even by Katherine herself.

The point is not to exculpate the doctor or pharmacist. Of course people should be held accountable when they fail to meet their responsibilities. Accountability, with or without punishment, seems just and may provide some measure of meaning and closure to a tragic event. Nevertheless, there are two problems with the approach of blame and liability. The first is that apportioning blame among all the participants in drug therapy, given their rights to defend themselves, can be cumbersome and expensive at best. Since blame is retrospective, the second problem is that blame seldom leads to preventative measures. Risk management may emphasize money rather than causes.

Long court battles are likely, one case at a time. Some, perhaps most, will be settled with no finding of blame and with confidential agreements. Possibly, professionals can be sanctioned by their regulatory boards. Neither outcome is likely to reduce the risk of the next tragedy. No penalty that a court could have imposed on Dr. Michael, Mr. Merchant, or the LaStimas would have reduced the likelihood of another patient being injured by inadequate management. Such tragedies are repeated again and again by different people.

Perhaps more importantly, changing our view from blame toward prevention would allow us to think about this problem more productively. More sophisticated, professional practice standards in Massachusetts might have prevented her death. Hale Hospital should have known the significance of Katherine's prior admissions for asthma. A computer at the insurance company could have flagged her inappropriate prescription refill patterns. The mass media could have done a better job of informing the public about the dangers of medications use. None was to blame. Outside the structure of error and blame, however, each of them could have contributed to a safer system of medication use. (As it happened, the insurance company that paid for Katherine's albuterol might have objected to her overuse, had it known about it. Mr. Merchant concealed the timing of some refills so that the LaStimas would not have to pay for them out of pocket. But the insurance company did not object to Katherine's underuse of preventer medication, which probably contributed as much to her death as her overuse of albuterol.)

Instead of apportioning blame through litigation, our legal system could have interpreted Katherine's long-standing misuse of medications as demonstrating systems' failure. Perhaps failure of a single component or participant could have been detected and corrected before her final asthma attack.

We must question the basic arrangements for providing therapy.

Most Western medical systems tacitly hold that the doctor will be responsible for "everything," but PDRMs are invisible to many physicians. For example, a California study of drug-related hospital readmissions found that fewer than a fifth of the drug-related admissions identified by medical audit had been coded as drug related by the admitting physician. The magnitude of this problem is hidden from the very people who are expected to detect it.

Health care programs lack adequate mechanisms for assessing, directing, and controlling actual medications use (as contrasted to drug prescribing, which is often used as a surrogate measure). Without valid and reliable feedback on performance, consistent improvement is impossible.

Some health care policies may worsen the problem. For example, efforts to control expenditures include pressure on professional fees. To maintain their incomes, physicians and pharmacists may feel pressure to see more patients and fill more prescriptions. Pharmacists are not held to standards requiring them to participate in managing drug therapy outcomes. High prescription volumes and low professional service expectations may further degrade system performance.

Finally, many pharmaceutical and medical societies have addressed the problem, but no professional or consumer body has made this problem its major priority or taken the responsibility to solve it.

Thesis — A Systems Approach

A systematic response to the PDRM problem would recognize that most adverse outcomes are caused by system failures — for example, a combination of nonresponse to symptoms, inappropriate prescribing, basic pharmacology, insurance provisions, package labeling, dispensing errors, inadequate patient cooperation, and idiosyncrasy. Real improvement will not be possible by blaming parts of the system or by removing a few scapegoats. Real improvement will be possible only by changing how the delivery of drug therapy is organized, provided, regulated, and financed and how individuals behave in specific cases.

The professionals, academics, and consumers of the industrialized world need to evaluate the safety and effectiveness of medications use in their respective populations and to change their assumptions about drug therapy. They need to develop more systematic ways of providing drug therapy. Consistent with recommendations from the IOM, this will mean:

• Reengineered care processes: more information and faster flow among patients, physicians, and pharmacists

• Fuller use of information technology in planning care and in evaluating quality

• More focused and frequent attention to practice-wide and population-wide results

• Development of effective teams: more responsible cooperation among patients, physicians, and pharmacists

• Coordination of care across patient conditions, and type and location of service

• More management of outcomes

This would increase the efficiency of drug therapy and consequently of medical care itself. The problems that killed Katherine LaStima are endemic. We need a new way to understand the safe and effective use of safe and effective medicines. And then we need to construct new, cost-effective systems. But most of all, we need to act.

The primary care marketplace is evolving too slowly and painfully. Insurance companies and managed care organizations are preoccupied with minimizing the cost of specific services, e.g., physician visits and drug product costs. This must be replaced by a marketplace in which payment conditions require all providers to participate in delivering coordinated, cost-effective care.

At present, disease management is a familiar idea of how to coordinate care. Disease management is often an important and welcome step toward "vertically" integrating the steps in medication use. However, disease management appears incomplete from a medication systems perspective. Disease management should be seen as an intermediate stage on the path toward pharmaceutical care, that is, patient-centered medication use management. A patient may have more than one disease that affects his quality of life and his consumption of health care resources. If one imagines a disease management program for many diseases, one arrives at the idea of "horizontal" integration — coordinated care of multiple patient problems.

Further, disease management may emphasize objective aspects but minimize a patient's subjective "illness" experience. It might then fall short of improving a patient's overall health-related quality of life and may therefore not sufficiently influence demand for health care services or patient satisfaction.

The Way Forward

We can see the health care system in a four-level framework.8 Improving the quality and increasing the overall cost-effectiveness of drug therapy requires change on all four levels:

1. Patient-centered pharmaceutical care by individual health professionals to individual patients.

2. Pharmaceutical care in microsystems. Drug therapy is often necessary, difficult, and dangerous. Therefore:

a. Direct patient care microsystems should include pharmaceutical care subsystems. These are described in detail in Chapter 10 and elsewhere in this book.

b. Pharmaceutical care systems require cooperation by a pharmacist and physician, as well as other caregivers and the patient. This cooperation can be left to chance. However, it also can be structured by developing collaborative practice agreements among pharmacists, physicians, and clinical nurses, and by explaining the collaborative practices to patients in a way they can understand. In short, health professionals can construct specific systems for their own practices and their patients.

3. Organizational medications management systems.

a. Professional practices, hospitals, nursing homes, and other provider organizations should institute appropriate practice management systems, including a formative performance appraisal and quality improvement (QI) systems. These are described in Chapters 5, 7, and 11.

4. Environment that supports medications use management. To sustain safe and effective medications use, professionals should promote changes in professional standards and regulations. Professional organizations should promote quality standards for themselves and managed care organizations.

a. Cost management (e.g., drug product cost control) should optimize the costs of outcomes. Minimizing payments for components like drugs, professional services, etc., may lead to higher total costs and poorer quality. Influential purchasers of health care services, e.g., employers and governmental agencies, have the sophistication to demand total value for cost. Often, quality of drug therapy is free.

b. Managed care organization (broadly speaking, whether private or governmental) should routinely collect, organize, and interpret data on the safety and effectiveness of the medications use systems under their influence. They should encourage pharmaceutical care system development, e.g., through reimbursement policies.

The "sharp end" is level 1. Levels 2 to 4 have value — and deserve support — only to the extent that patients receive the best outcome possible. At the same time, the environmental realities (level 4) powerfully influence the behavior of institutions (level 3) and practice groups (level 2). The merits of laws, policies, and rules must be judged by their ability to encourage appropriate patient care and acceptable patient experience.

References

1. Cherry, D.K. and Woodwell, D.A., 2000 Summary Advance Data from Vital and Health Statistics, 328, 6-5-0002.

2. Lazarou, J., Pomeranz, B.H., and Corey, P.N., Incidence of adverse drug reactions in hospitalized patients, JAMA, 279, 1200, 1998.

3. Kohn, L.T., Corrigan, J.M., and Donaldson, M.S., To Err Is Human: Building a Safer Health System, National Academy Press, Washington, D.C., 2000.

4. Fletcher, H.J., Ibrahim, S.A., and Speight, N., Survey of asthma deaths in the Northern region, 1970-85, Arch. Dis. Child, 65, 163, 1990 [see comments].

5. Hindi Alexander, M.C. and Middleton, E., Jr., Asthma deaths: are they preventable? N. Engl. Reg. Allergy Proc., 7, 462, 1986.

6. Institute of Medicine, Crossing the Quality Chasm: A New Health System for the 21st Century, National Academy Press, Washington, D.C., 2001.

7. Mundy, A., Dispensing with the Truth: The Victims, the Drug Companies, and the Dramatic Story behind the Battle over Fen-Phen, St. Martin's Press, New York, 2001.

8. Berwick, D.M., A user's manual for the IOM's Quality Chasm Report, Health Aff, 21, 80, 2002.

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