In his inaugural address as 1999 president of the American Pharmaceutical Association, J. Lyle Bootman, Ph.D., noted that many issues facing pharmacists at the turn of this millennium were present in the year 1000. Four major issues, as recorded in The History of Pharmacy, were the "development of formularies or compendia of medicaments, herbal products and the materia medica that served as references for their use, toxicology reports detailing the adverse consequences of using poisons and other substances, and the relationship between nutrition, health status, and disease."
But, Bootman notes, in 1000, the separation of medicine and pharmacy had yet to occur. Easing the friction that has resulted from that professional divergence is one of Bootman's goals as APhA president.
Bootman is dean and professor of pharmacy practice at the University of Arizona College of Pharmacy in Tucson. He also founded, and is executive director of, the college's Health Outcomes and PharmacoEconomic Research Center (HOPE Research Center). His current research efforts include outcomes and pharmacoeconomics, pharmacoepidemiology, and international pharmacy systems. Bootman also serves with the National Academy of Sciences' Institute of Medicine.
A Californian by birth, he received a bachelor's degree in 1974 from Arizona, and his master's and Ph.D. from the University of Minnesota. He is a member of Managed Care's editorial advisory board. APhA was founded in 1852 as the first professional association of pharmacists in the United States, and now has 53,000 members. Bootman spoke with Senior Contributing Editor Patrick Mullen.
MANAGED CARE: What are the prospects for President Clinton's Medicare prescription-drug coverage proposal? What are your thoughts on his approach to adding coverage?
J. LYLE BOOTMAN, Ph.D.: When one understands the true economics of drug use and the impact on the economics of health care, the key question becomes whether we can afford not to cover drugs. It makes little medical or logical sense to continue down the river of third-party payment and not pay for prescription drugs. If a restaurant were run like our health care system, one person would order from the menu, a second person would eat what that person ordered, a third person would pay the bill, while a fourth person would provide the money to pay the bill. Those are the functions of the physician, patient, health plan, and employer — respectively.
MC: And the plan is telling the employer, "I wouldn't pay for that dessert if I were you."
BOOTMAN: Yes, the fourth person is asking why we're having lobster every night. The third person tries to switch to monkfish instead of lobster. Administrators of the whole situation like to think about marketing and management and sometimes they lose track of the fact that health care is unique. Let's assume that we're going to stay with the four-player scenario, even though it doesn't make a lot of sense. With Medicare, the fourth player is the taxpayer, and the third player is the Health Care Financing Administration. First, we have to keep in mind where drugs are as a treatment. Drugs are not used to diagnose disease; drugs are used to treat or prevent disease and, in theory, to increase productivity and quality of life for those who use them. When the FDA approves a drug, it's relatively safe and it's shown to be efficacious. Inherently, the FDA approves drugs because it identifies a value associated with drugs. Value is a slightly different term from efficacy. The value of a drug is that its benefits outweigh its costs, mainly in terms of adverse effects. We pay physicians to diagnose and monitor the extent of the disease. Then, when it comes to drug treatment, we tell the patient, have a good life, you pay for it because we don't pay for diabetic care. That makes no sense. We end up paying over and over again for emergency room visits, urgent care visits, hospitalizations, and additional physician visits because treatment was not dealt with adequately. There are numerous patients who can't afford the drugs so they just don't get them, they don't take them, or they don't take them correctly. Medicare should either pay for the whole package for treatment of that diabetic — including drug treatment — or not pay for any of it.
MC: If "health care as restaurant" doesn't make sense, then how should care be paid for in this country? Should it be a market-driven system?
BOOTMAN: The root question is whether health care is a right or a privilege. If it's a right then we need to go down one path, and if it's a privilege it's another path. I don't know how we answer that question. This country is still grappling with that choice.
MC: What's your view?
BOOTMAN: I don't have a view on which would be the best way, because I don't think we should offer what are, in effect, royal edicts. If we want health care to operate as a market, the solution is providing economic incentives in the right direction for all parties to coordinate and work in a rational way. We probably would achieve more efficiency if we went to a more market-driven situation. But would that have an impact on research and development of new technologies? Would research continue to grow? A more market-driven approach might also precipitate some other questions that I'm not prepared to answer.
MC: How long will it be before this country defines health care as a right or a privilege?
BOOTMAN: We're answering it now, slowly but surely, over time. Most other countries have decided that it's a right. In Canada, health care is considered a right. Can they have all the heart transplants they want? No. They don't have enough specialists or resources to provide the high level of care that we offer. Many patients come to America for their specialty care.
MC: Do you see a future where we as a society decide that a certain amount of health care is a right, but beyond that it's a privilege?
BOOTMAN: Yes. That's what I call the menu approach. If you have this condition, we'll provide this treatment. We're already implementing such policies in some plans.
MC: Even as the Clinton administration proposes to add a drug benefit to Medicare, many managed care plans are deciding that they're not getting enough out of Medicare as it is to make a profit.
BOOTMAN: We just had a front-page headline today in our paper that our medical center is dropping senior care for 3,000 patients.
MC: Does that mean that offering a prescription drug benefit is less relevant, given that a growing number of physicians and health plans don't want to be part of Medicare because they're not getting paid enough?
BOOTMAN: It may actually stimulate more non-managed care involvement, depending on how you define managed care. Some people define managed care as HMOs only, while others include Blue Cross/Blue Shield plans that include price controls on fee-for-service medicine as managed care. Even if HMOs drop Medicare, that doesn't necessarily mean that Blue Cross/ Blue Shield or other insurance companies will not continue to administer the benefit under some type of Medicare+Choice plan. It happens that HMOs that are collecting capitated rates right now are not able to cover drugs for the elderly, so they're dropping them.
MC: Let's talk about some of the broader questions that you raised in your inaugural speech as APhA president. You talked about the need to bring health care full circle, back to when pharmacists and doctors worked together, the implication being that the circle has been broken.
BOOTMAN: The circle's been broken not just between physicians and pharmacists, but also with patients. In the 1800s, medicine wasn't very sophisticated. A lot of people abused it. Medicine regrouped, and since about 1910, when it got its act together, medicine started to advance. At the same time, pharmaceuticals were moving to another stage of development. The passage of the 1906 Food and Drug Act primarily concentrated on making sure that when someone said there's 100 milligrams in the capsule, it was 100 milligrams. Since World War II, we've seen the development of many technologically advanced drugs. Prior to all of those changes, pharmacy and medicine worked more closely together. Of course, everyone paid cash for health care, and there wasn't a lot of insurance and certainly not managed care. With the changes came the administrators. Not to downgrade the value of the MBAs, but they have never been on the front line in taking care of patients. They've never had to take care of patients' concerns at the community level as pharmacists have, or interfaced with physicians when medical care was needed. As a result of many forces, pharmacists and physicians have moved in different directions, not to the benefit of patient care. We spend a lot of money on health care in this country, more than any other country in the world, whether measured per capita or as a percentage of gross domestic product. Still, we have growing indicators that we're not doing so well in terms of overall outcome. When 50 percent of the diabetics in this country haven't even been diagnosed, and of those who have been diagnosed, 50 percent are not being treated appropriately, that's not a good sign. When the immunization rate in this country is well below 75 percent, while it's above 95 percent in any other developed country, that's not a good ratio for quality.
MC: Where do you see the roots of these problems?
BOOTMAN: Again, I see a lack of coordinated effort and incentive to do the right thing. Even within managed care plans that claim they're managing care, we all know that they're actually managing costs. The dynamic will always be balancing access, quality, and cost. Even the employers who pay the bills are confused with the business of health care. Imagine the position of the CEO responsible for a computer company or an automobile manufacturing company. If he changes the alloy of the metal he uses to make the products, he can tell you in a short time what effect that will have on the cost of manufacturing that good. Change drug A to drug B, and we can't determine what impact that will have on the cost of diagnosing and treating asthma. I am not referring to only treatment costs, but total costs. We often don't even know what was spent last year to diagnose and treat a specific disease such as asthma or diabetes. Part of the problem is the mentality that we have that costs are isolated silos. You've got the laboratory silo, the M.D. silo, the hospital silo, and the drug silo. Those silos are actually connected, but few organizations are aware of the interactions. One can make the case that we ought to be spending more on drugs, which might cause us to spend much less for other silos.
MC: Offering a drug benefit isn't very helpful if people don't take the drugs correctly. How can compliance be increased?
BOOTMAN: It is estimated that noncompliance may cost us an additional $35 billion. Drugs are much more complex than they were in the '40s and '50s. Today's drugs are much more potent and much more defined for specific disease states. We've also got patients who are taking over-the-counter medications, herbal medications, and other treatments along with their prescribed drug therapies. This combined therapy may precipitate more problems. Noncompliance is a huge problem. For example, it has been stated that the average course of therapy for a hyperlipidemic agent may be 40 to 50 days. Obviously, one needs to take it much longer in order for it to have any impact on cholesterol, which ultimately impacts upon the progression of heart disease. If they're only going to take it for 40 to 50 days, we might as well just throw the pills in the river. It becomes a wasted resource.
MC: How would you characterize relations these days between pharmacists and physicians?
BOOTMAN: Improving, because many pharmacy schools have retooled their educational programs. Here at the University of Arizona, and at the University of California San Francisco, for example, physicians and pharmacists train together, so they learn new ways of practicing and coordinating care for patients in a cost-effective manner. Our goal is to identify ways to maximize quality relative to costs.
MC: Isn't balancing costs and quality what pharmaceutical care is all about?
BOOTMAN: Pharmaceutical care is a practice paradigm in which the ultimate goal is to maximize the outcome of drug treatment and to minimize — if not prevent — any problems related to drug therapy. Drug related problems, including dosage problems where patients are getting too large or too small a dose, adverse drug reactions, drug interactions, prescribing an unneeded drug like an antibiotic, result in unnecessary expenditures. What does it cost the health care system when we don't adequately treat disease? My research estimates that we spend approximately $76 billion in health expenditures when drug-related problems occur. Our goal for pharmaceutical care is to minimize if not prevent drug-related problems. One such example of pharmaceutical care is the situation in which your pharmacy called you to remind you to get your refill. For you, that might work. Others need more involvement. One key to solving the problems of successfully delivering pharmaceutical care is a much more sophisticated database system than we have now. Many companies are trying to improve their database so that practitioners can make better decisions. In pharmacy, we utilize computers heavily. We know, for the most part, every drug that a patient's on, as long as he goes to the same pharmacy. And with chains, such as Walgreens, you don't even have to go to the same pharmacy. However, much of what the doctor does never finds its way into a database. He's still handwriting his notes on a chart. I have heard physicians who tell me that they'll never use a computer to record their actions. That's a major problem if we are to advance to a truly integrated health system that achieves cost-effective health care.
MC: Those doctors eventually will retire, and the ones coming in behind them will not, one would hope, have that sort of technophobia.
BOOTMAN: Exactly. I'm a firm believer that economics drives change and behavior will change as a result of economic incentives. Also, let me clarify that pharmaceutical care is not solely a pharmacist-driven practice paradigm. The pharmacist, the physician, and the patient all have to participate. The pharmacist and physician can do all they want for the hyperlipidemic but the patient may still decide not to take the medicine.
MC: I'm sure there will be legal cases in years to come where people end up with diseases that could have been prevented had they taken the course of treatment that was recommended.
BOOTMAN: Already I'm paying through Medicare and my insurance premium today for people who are not complying and taking their medication correctly. It's already happening.
MC: How much of an obstacle to pharmaceutical care, if any, is the fact that the pharmacy business is now more and more in the hands of a small number of large chains?
BOOTMAN: That's true for many businesses, correct? Much of health care has become corporate. There are three dimensions to the corporatization of health care. Many of our practitioners — our physician graduates and our pharmacist graduates — have become employees as opposed to employers. Second, corporations are providing health care as opposed to small businesses. Third, corporations have become the major purchasers of health care. I'm not saying these are problems, but they're facts. Corporations are part of every aspect of American life. Is it good or bad? I'm not sure. Some could give reasons why it's a negative situation. But the corporatization of the pharmaceutical world has lowered the price of some drugs, maintained costs, allowed for a certain consistency in delivery, and achieved a high level of quality. So there are advantages to it.
MC: What's the biggest challenge facing community pharmacies?
BOOTMAN: The next challenge for the community pharmacy world, which is dominated by chains, is adoption of technology — robotics and computers to automate the actual dispensing process — so we can fulfill our pharmaceutical care role as practitioners. There are a variety of programs that can be implemented to bring more efficiency to drug distribution. Drug distribution is complex in itself. Getting the drug from Merck on a truck to local pharmacies all over the U.S. efficiently, and to the patient, is a very complex process. Some would claim that it's still not as efficient as it should be. I believe that market forces will eventually correct this situation.
MC: Some folks are also saying that they could just go on the Internet, and then buy whatever drugs they want that way.
BOOTMAN: That may be one way to bring about more efficiency. It is certainly another element of competition.
MC: Does that also risk cutting out pharmacists and other caregivers who watch out for drug interactions and other problems?
BOOTMAN: Positively. I'm not opposed to systems that bring efficiency to the distribution of the product, as long as we don't eliminate the caregiving aspects that need to go along with ensuring quality patient outcomes.
MC: But that's exactly what some folks are doing now, getting drugs that haven't been approved here online from other countries.
BOOTMAN: Absolutely. We are globalizing more quickly than we realize.
MC: Another piece of the corporatization of health care is the move toward direct-to-consumer advertising of drugs, which is a billion-dollar marketing effort. What effect is that having?
BOOTMAN: There are federal laws guiding how these ads are worded: "We have developed a drug and it is available for the treatment of X. Ask your physician to find out if it's appropriate for your condition." I think it would be hard for us to say that we could outlaw those types of situation.
MC: I'm not saying we should. My question is, how does that change the relationship between a pharmacist or physician and a patient? Whoever has the biggest marketing gun can drive demand for a particular agent, even among people for whom that agent is inappropriate.
BOOTMAN: This is the future. It will become easier and cheaper to get information on any drug that is available. You won't necessarily need a lot of money to place such info on a Web site. There's only 30 drug companies that conduct probably 90 percent of all drug development. It would be easy to link all 30 of them to my Web site. I probably already have them bookmarked. They probably all have a monthly update about the drugs that they've developed and have been approved by the FDA and for what conditions.
MC: How optimistic or pessimistic are you about the changes taking place in health care delivery?
BOOTMAN: I'm optimistic from a global view. Change is occurring, and consumers are becoming wiser as to their needs relative to quality. Consumers want the highest level of quality. They don't want to pay directly for the level that they want, but that issue will surface as well. When consumers gripe about their HMO not covering a drug, I say, "Why don't you write a check?" No doctor and no pharmacist I know of will refuse cash. I'm reminded of a study of the use of copayments with drugs. Patients had three choices: a $5 copayment for a product that was most likely a generic, a $10 copayment for a restricted number of trade name products, or a $20 copayment for any product the patient wanted. Only 2 percent chose the $20 copayment. I went in the other day to have a skin condition examined by a dermatologist. I was going out of the country, and melanoma is very common in Arizona. I didn't think it was melanoma, but I wanted a dermatologist to tell me it wasn't. I belong to an HMO, but I didn't want to wait for an appointment or go through its referral process through my primary care physician. I asked how much it was going to cost. The office said $50 for the visit. So I set up the appointment. The clerk couldn't believe I agreed to pay cash. "You're not going to get reimbursed by the HMO," she told me. I told her I didn't care. She said, "You don't understand, we can't do this." I asked her if she was telling me she wouldn't take my money. She was just completely befuddled that I'd give her my credit card and pay $50. I was able to see the doctor immediately.
MC: Instead of waiting for a referral.
BOOTMAN: I would hope that HMOs eventually will learn that waiting for a referral and going to a primary care doctor is a waste of time in some cases. However, to get back to your question: Overall, things are indeed moving in the right direction. We're beginning to see some changes. I am optimistic that these changes will lead to more positive outcomes. To that end, consumers are going to have to compromise, and so are pharmacists, physicians, and insurers. We have to work toward the day when we're all organized and integrated, and not working in separate camps. The marketplace should provide the incentive to accomplish this end.
MC: Thank you.