Capítulo 2 Marco de Referencia
2.7 Tema de la investigación
It might appear that ethical and other value problems arise infrequently for the pharmacist. Although the physician is increasingly seen as confronting such issues—in decisions about abortion, euthanasia, test-tube baby cases, and genetics, for example—the pharmacist’s day may, to the layperson, seem less fi lled with such controversial issues. In fact, there are pharmaceutical dimensions to almost all of the dramatic ethical problems in health care. Abortion can involve decisions about the use of abortifacient agents; euthanasia, about the use of barbiturates and narcotic analgesics to hasten death; pharmaceutical agents are used in producing superovu-lation that precedes in vitro fertilizations; and genetic engineering includes many pharmaceutical applications in drug manufacturing and decisions about alternative therapies.
Thus almost every dramatic and controversial issue in health care ethics can pose problems directly related to pharmacy. Nevertheless, many of the day-to-day ethical dilemmas faced by the pharmacist arise not in the context of these dramatic, ethically exotic cases, but in much more normal, routine pharmacy practice. Every prescription raises issues about informed consent, assessment of risks and benefi ts, and the ethics of determining a fair price. Many patients will be faced with diffi cult choices about the wisdom of using drugs their physicians have prescribed. Other patients will turn directly to the pharmacist for medical advice, raising questions not only about the ethics of informing patients, but also about the moral limits on the pharmacist’s role as health care practitioner.
Before turning to specifi c topics, such as the ethics of informed consent, pric-ing, and the dispensing of morally controversial medications, some preliminary work must be done. Having developed a fi ve-step model for analyzing ethical cases,
we now need to examine the ethical and other value judgments in pharmacy deci-sions (the focus of this chapter) and the problem of where moral judgments are grounded (the topic of the next chapter).
Identifying Value Judgments in Pharmacy
Normative judgments (or evaluative judgments) occur constantly in all health care decisions. It is impossible to get to a clinical conclusion—to prescribe a drug, use an over-the-counter medication, substitute a generic, check the accuracy of a dosage with the physician, include a medication in a formulary, or report a suspected drug abuser—without making a normative judgment. Whenever someone decides to act (or refrain from acting), some evaluation has taken place. A decision is made that a particular course is the right one. It is better than available alternatives. It is what one ought to do.
One key to learning to recognize that evaluative judgments have taken place is to watch for value terms. Words like right, better, and ought all signal a process of evaluation. It is the nature of a clinical science like pharmacy that these evaluations take place constantly.
Case 2-1 does not raise a dramatic or grave ethical issue. It may not raise any ethical issue at all. It does involve a number of evaluations, however. In deciding how the pharmacist should respond to the patient/customer in this case, one has to be able to identify what value judgments are being made. In reading through this case, note all the words signaling that an evaluation is taking place.
CASE 2-1 Over-the-Counter Diet Pills
Although it was still the middle of winter, Bess Williams noticed that the new swimsuits were on display in the department store window. As she admired the latest in swimwear, she made a fi rm resolution to lose weight. Ms. Williams had tried numerous diets over the years but always seemed to lose only a few pounds and then gain back even more.
Also, she really hated exercise, so a quick-and-easy way to lose weight was what she had in mind. She stopped by the pharmacy she often patronized during her lunch hour. She found the “diet aids” section of the pharmacy and scanned the products until she found one she had seen advertised on the Internet. Ms. Williams remembered that the product, sold in several different forms, helps “curb your appetite” when you need it most and increases metabolism to “burn fat.”
Since the drugstore wasn’t busy, Steven Krause, Pharm.D., also the pharmacy owner, rang up Ms. Williams’s purchases. Dr. Krause noticed the weight control pills and looked up to see if the buyer was truly overweight. He had noticed a seasonal increase in the sales of these pills following the holidays and leading into swimsuit season. Ms. Williams looked to be at least 50 pounds overweight for her height.
Ms. Williams asked Dr. Krause, “How do these diet pills work? I’ve just never had the willpower to stick to a diet, but I really want to lose weight this time.”
Dr. Krause explained, “The main ingredients in these pills are herbs and other prod-ucts. They contain chitosan, which binds to dietary fat and purportedly has an effect on
Values in Health and Illness 31
Commentary
At fi rst this case may appear to raise no evaluative issues at all. The customer wanted the diet pills, and the pharmacist was in a position to provide her with some informa-tion about them.
Searching for the value terms, however, reveals a number of judgments that are clearly in the realm of values. According to this pharmacist the pills should be used on a short-term basis along with reduced caloric intake. Two judgments are implied here. First, longer use would produce an unacceptable risk of bad results, in the pharmacist’s judgment. But, second, it is acceptable to use them only in the short term. Both of these evaluations are controversial.
They rely in part on assessments of what the case refers to as side effects.
The term is an interesting one. It is, in fact, a value judgment that certain effects are unintended and bad. (It would be quite odd to speak of a “good” side effect.) The pharmacist lists several such effects: nervousness, restlessness, insomnia, dizzi-ness, headache, and possible increase in blood pressure and heart rate. The judg-ment that these are bad effects is relatively noncontroversial. It is a value judgjudg-ment nonetheless. Moreover, these effects are worse for some people than for other people. Someone suffering from hypotension might be less concerned than a hypertensive.
We already see how such evaluations take the pharmacist beyond what pharmacological science can provide. The move becomes even more significant when the pharmacist and patient begin to compare the risks of these harmful side effects with the possible benefits of using the diet pills. In deciding to use
CASE 2-1 Continued.
reducing the absorption of fat. The formula also contains some bitter orange that will suppress your appetite to a certain degree. There is also guarana, and that has an effect similar to caffeine. These pills should be used on a short-term basis along with reduced caloric intake and exercise. The amount of weight reduction usually is small.”
“You mean I have to be on a diet, too?” Ms. Williams groaned. Looking somewhat disappointed she said, “Oh well, it’s worth a try. The worst thing that can happen is that I won’t lose all the weight I want.”
Dr. Krause replied, “Actually, other things could happen with these pills. Even though you don’t need a prescription there are still some side effects you should know about.
They have a stimulant effect, which can result in nervousness, restlessness, insomnia, diz-ziness, and headache. There is also the possibility of an increase in blood pressure and heart rate.”
Ms. Williams was getting more and more discouraged. “I can’t even drink coffee without getting all jumpy and irritable.”
Ms. Williams stood in the checkout line with the diet pills in her hand, tapping them lightly on the counter as she decided what would be worse: being irritable and tired or not being able to wear a swimsuit again this summer.
any drug, the critical question is always how valuable the expected benefit is going to be. Normally that is not a medical issue. In this case, the critical ques-tion is how important it is to Ms. Williams to lose weight through the use of the drug. In order to answer that question we need to know not only how she values weight loss, but also how she compares the harms from the possible side effects with what she perceives as the disadvantages of other ways of losing weight (and of not losing weight at all). If every alternative is very unattractive, then (assuming continued use has at least some additional weight-loss effect) she might be willing to take on the risks of using the drug for a longer period.
However, if losing weight is not as important, or if other methods are not ter-ribly burdensome, then even short-term use of the substances commonly found in diet pills would make little sense. The evaluations are key, and it is hard to see how being trained as a pharmacist (or any other health professional) makes one an expert in making them.
What then is the pharmacist’s role when educating patients about the so-called risks and benefits of pharmaceutical agents? Is it this pharmacist’s duty to tell Ms. Williams what his personal opinions are about how one set of effects compares to another? Or is he simply charged to give her the facts?
It seems strange that he would be expected to give her his personal value judgments. However, giving her just the facts would create serious problems as well. In the case of nonprescription products, such as herbs and vitamins, it may be very difficult for the pharmacist to know what the facts really are, since there is little convincing, scientific evidence about the benefit of any ingredient in weight-loss products. Also, stocking these products in the phar-macy implies a value of sorts, and that sends a message to patients when they look for assistance from the pharmacist. Moreover, in order to fully evaluate the risks, the pharmacist would have to know other important facts about the case, such as what products Ms. Williams had tried in the past and why she is worried about losing weight. Then, too, how can the pharmacist know exactly which medical facts to give her? Surely, more could be said about diet pills than is reasonable to tell to a patient. In addition, this particular patient may be unusually interested in certain relatively rare risks that would not be of concern to most.
Many interesting questions lie beneath the surface of this case, questions hav-ing relevance not only for over-the-counter medications, but also for value judg-ments made about the risks and benefi ts of medicinal agents as part of patient education. Learning to recognize value judgments is a crucial fi rst step. Only after these issues are confronted can we turn to more directly ethical questions, such as whether patients should be permitted to take medicinal risks based on their own judgment and whether patients have the right to know about the risks and benefi ts in the fi rst place.
Case 2-2 presents another opportunity to identify the evaluations taking place in a conversation between a pharmacist and a patient. In this case try to identify the value judgments made by the prescribing dentist, the pharmacist, and the patient.
Values in Health and Illness 33
Commentary
As in Case 2-1 there appear to be possible differences in value judgments about how to treat pain from a tooth extraction. Similar questions arise about what constitutes a side effect and how to determine just how bad the side effects could be. Mr. Rudolph seems to believe he will not need what he considers to be strong pain medication. Of course, the anesthetic has not worn off yet, but he may well know from past experi-ence that he can tolerate the anticipated level of pain. The judgment that he will not need the codeine is actually a judgment that he prefers the risk of pain controlled only with nonnarcotic analgesics to pain controlled by a narcotic.
Dr. Jones apparently views these trade-offs differently. He believes he is in a posi-tion to know not only how much pain Mr. Rudolph is likely to experience, but also whether the risks of the narcotic would be justifi ed in his case.
Attitudes about pain vary tremendously from one culture to another and from one individual to another. Some people are averse to using “strong,” or narcotic, medication in part because of the psychological connotations of using narcotics. They may believe that the risk of addiction, no matter how small, is not worth it. They may also ground their judgments in even deeper cultural attitudes about the meaning of pain and its control. Moreover, in some cultures pain is perceived as affording some advantage, as a warning of an underlying problem or as a character-building experi-ence in which the sufferer learns to cope. For other cultures and ethnic groups, pain is something to be expressed openly. This generates an attitude of sympathy while providing a rationale for explaining unusual behaviors related to pain.
In addition, there are those who hold the worldview that pain makes no sense (other than, perhaps, as a signal of a potential medical problem). According to this
CASE 2-2 Managing Dental Pain
Ian Jones, Pharm.D., could tell just by looking at Jerry Rudolph’s face that he had just been to the dentist. Mr. Rudolph and Dr. Jones knew each other not only as pharmacist and patient, but as members of the same health club. Mr. Rudolph’s speech was slightly slurred as he presented a prescription to Dr. Jones. Mr. Rudolph stated, “I just had a root canal, and my mouth is still numb. I can’t talk very well yet. The dentist said the stuff he used to numb my mouth will last a long time, maybe up to 6 hours. What’s the prescription for anyway? I wasn’t paying much attention when I left the dentist’s offi ce.”
Dr. Jones replied, “The prescription is for Tylenol #40, which is a combination of Tylenol and codeine, a narcotic analgesic. It’s for pain relief.”
Mr. Rudolph remarked, “I didn’t ask for anything for pain. I’m not sure about taking strong pain medication when I really don’t need it. Would aspirin or something else over-the-counter work just as well? Are there any side effects from codeine?”
Dr. Jones believes that pain and pain relief are completely subjective. Yet he doesn’t like to encourage the use of narcotic analgesics until it is clear that the pain will not be relieved by nonopiate analgesics. He feels this is especially true in the case of dental patients who have received local anesthetic agents with a long duration of action. Should Dr. Jones encourage Mr. Rudolph to try aspirin, acetaminophen, or ibuprofen to relieve the pain?
point of view, humans should have dominance over nature and make use of technol-ogy to suppress suffering. The dentist in this case seems to gravitate toward this view, while the patient is more cautious.
In effect, Dr. Jones is being asked to arbitrate a debate about which of these two worldviews is more appropriate for treating someone experiencing dental pain.
Surely, there is no reason why the dentist’s view is necessarily the more correct. Some would be inclined to say that these issues are simply matters of taste, that there is no
“right” answer. In that case, the pharmacist is being asked as a friend to give counsel on a matter of personal preference, a role he might want to take on as a friend but surely not as a pharmacist. Even if we want to view the question of whether or not to fi ght pain aggressively as having a correct answer, it is not the sort of issue about which any medical professional—dentist, physician, or pharmacist—can really claim to have expertise. It is a question of aesthetics, of what kind of lifestyle is best. It may also be a question of what kind of lifestyle is ethical. This raises the question of the relationship between ethical judgments and other kinds of evaluative judgments, a question we address in the second half of this chapter.
CASE 2-3 Use of Generic Drugs
Sandra Kelly, Pharm.D., was impressed with the professionalism of her new employer, Mark Pierce, the pharmacist/owner of Midtown Pharmacy. Dr. Pierce took the time to counsel patients about the side effects of medications and often stepped out from behind the counter to assist a customer in selecting a nonprescription drug product. However, Dr. Kelly noted that Dr. Pierce seldom asked patients if they preferred generic or brand-name medications. Dr. Kelly had strong negative feelings about the bioequivalence of some generic drugs to innovator drugs, in particular, drugs with a narrow therapeutic index. Her suspicions had been fostered by several pharmacy school instructors who emphasized their personal biases against using generics for critical-dose drugs, such as immunosuppressive agents. One instructor went so far as to say, “A good pharmacist would not dispense generic drugs for critical-dose drugs.”
Dr. Kelly asked Dr. Pierce why patients weren’t routinely given the option to choose between generic and brand-name drugs. Dr. Pierce stated, “There is a sign on the cash register in the pharmacy that tells patients to ask about generic drugs. If they don’t request one, I’m not going to encourage the patient to choose a brand-name product. We make a larger profi t on generics, so I prefer dispensing them whenever I can.” In addition to her general concerns about the effectiveness of generics, Dr. Kelly is uncomfortable with the specifi c practice of not giving patients a real choice. The sign on the cash register is not very large. Should she comply with the pharmacy’s informal policy that encourages the use of generics, or should she let patients know they have a choice?
Commentary
Once again the problems of this case may appear to raise questions of medical science. Dr. Kelly and her instructors in pharmacy school have been impressed by
Values in Health and Illness 35
the pharmacological data reportedly showing inconsistent bioequivalence of generic drugs as compared with name-brand medications. Furthermore, Dr. Kelly’s instruc-tors went so far as to make a value judgment on the quality of the pharmacist, sug-gesting that a bad pharmacist dispenses generics for critical-dose drugs. However, even if one assumes that there is less consistency in generic compounds as well as a greater risk of getting an ineffective dose, it does not automatically follow that the patient should prefer the brand name compound.
If through careful consideration of the pertinent research on the effi cacy of generic drugs Dr. Kelly concludes that one can buy greater reliability by paying a higher price, she still must consider whether it is wise to spend more money for the extra margin of advantage from the brand name drug. The answer will depend on how one perceives the value of the extra benefi t from a brand-name drug as
If through careful consideration of the pertinent research on the effi cacy of generic drugs Dr. Kelly concludes that one can buy greater reliability by paying a higher price, she still must consider whether it is wise to spend more money for the extra margin of advantage from the brand name drug. The answer will depend on how one perceives the value of the extra benefi t from a brand-name drug as