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Marcus, S. J. (ed.) (2002). Neuroethics: Mapping the Field, Conference Proceedings. New York: Dana Foundation.

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Mayberg, H. S., Lozano, A. M., Voon, V., et al. (2005). Deep brain stimulation for treatment-resistant depression. Neuron 45: 651–60.

New York State Task Force on Life and the Law (2005).

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Olson, S. (2005). Brain scans raise privacy concerns. Science 307: 1548–50.

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Racine, E., Bar-Ilan, O., and Illes, J. (2005a). fMRI in the public eye. Nat Rev Neurosci 6: 159–64.

Racine, E., Waldman, S., and Illes, J. (2005b). Ethics and scientific accuracy in print media coverage of modern neurotechnology. In Proceedings of the 2005 Annual Meeting of the Society for Neuroscience, Washington.

Racine, E., Gareau, I., Doucet, H., et al. (2006). Hyped biomedical science or uncritical reporting? Press coverage of genomics (1992–2001) in Que´bec. Soc Sci Med 62: 1278–90.

Racine, E., Van der Loos, H. Z. A., and Illes, J. (2007). Internet marketing of neuroproducts: New practices and healthcare policy challenges. Camb Q Healthc Ethics 16: 181–94.

Risk, A. and Petersen, C. (2002). Health information on the Internet: Quality issues and international initiatives. JAMA 287: 2713–15.

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Terzian, T. V. (1999). Direct-to-consumer prescription drug advertising. Am J Law Med 25: 149–67.

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A pharmacist at a drug store has been presented with prescriptions for two drugs that the pharmacist knows are being prescribed ‘‘off-label’’ or ‘‘off-list’’ (meaning, for a non-approved use) for obesity. The patient presenting the prescription appears to be somewhat overweight but not obese. The pharmacist knows that the medical literature has recently contained reports that patients on this drug combination have developed severe cardiac problems and some have died from the condition. Since the reports are anecdotal in nature and not supported by scientifically controlled research studies, the consensus opinion among healthcare providers is that there is no proof that the drugs cause cardiac problems but there is cause to be alarmed about the risk. For this reason, some physicians have stopped prescribing the combination for their overweight patients. When the pharmacist asks the patient about the prescriptions, he learns that the patient has been on the drugs for months and has lost a considerable amount of weight, a fact that he says has ‘‘turned his life around.’’ He reports, improved blood lipid chemistries, better mobility, and a tremendous boost in his self-esteem. The patient also discloses that his usual physician has stopped prescribing the drugs because of the side effect reports, forcing the patient to locate another willing prescriber. In the midst of this prescription intake session with the patient, the pharmacy supervisor calls the pharmacist aside and tells him that there is a backlog of prescriptions that need filling immediately.

What is pharmacy ethics?

With regard to the basic biomedical ethical responsibilities – benefiting the patient, supporting a patient’s right to self-determination/autonomy, refraining from harming the patient, assisting and

advocating on behalf of the patient to ensure effective and safe healthcare, protecting the patient’s medical privacy, and maintaining professional competency and knowledge – pharmacists are no different to any other healthcare professional. However, the role that pharmacists play in healthcare creates unique situations in which these ethical duties occur. This singularity arises from four aspects of pharmacy practice: a pharmacist is expected to dispense medications but also now has responsibilities to provide clinical services; a pharmacist is at least one step removed from a patient’s primary encounter with a physician, who diagnoses illness and prescribes treatment; in the outpatient setting, the pharmacist is the last healthcare professional encountered by a patient before drug treatment commences; and pharmacists often control the drug formulary at healthcare institutions. These four features of the profession generate most of the ethical conflicts in pharmacy practice. These are in the areas of (i) allocation of time between dispensing and clinical services; (ii) patient advocacy responsibilities; (iii) social, moral, or religious objections to certain drug uses; (iv) conflicts of interest with pharmaceutical companies; (v) drug diversion and abuse; and (vi) healthcare resource stewardship. This chapter discusses these ethical issues in pharmacy ethics in practice.

Why is pharmacy ethics important?

Pharmacy ethics is important to the same degree that drug therapy is important to a patient’s

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health and well-being. That is, they are both often fundamental. A pharmacist’s primary responsibility is to benefit patients and prevent harm by dispensing the right drug in the right amount and with complete use information. Failure to fulfill these responsibilities can lead to loss of disease control, disability, and/or death. Adherence to both professional standards and a code of ethics is imperative if these problems are to be avoided. According to the American Hospital Association and the US Food and Drug Administration, the most common medication errors stem from incomplete patient information (such as allergies to drugs or use of other medications), unavailable drug information (such as up-to-date warnings), miscommunication of drug orders (such as misuse of zeros or decimal points), lack of appropriate labeling, environmental factors that degrade drugs (such as temperature), and distractions that lead to dispensing errors. Medication errors such as these cause at least one death every day and injure approximately 1.3 million people annually in the USA (US Food and Drug Administration, 2006). Many of these kinds of error were involved recently when patients died from a 20-fold overdose of morphine when a certain concentrated oral solution was prescribed in milliliters (ml) instead of milligrams (mg) (US Food and Drug Administration, 2003). This and the other causes of medication error can be avoided by the careful intervention of a pharmacist.

How do I approach pharmacy ethics in practice?

This section contains brief discussions of the most common ethical dilemmas faced by pharmacists.

Conflicts between dispensing and clinical services

A primary source of ethical tension in pharmacy practice stems from the current transition of

professional focus from the drug product to the patient. So-called dispensing pharmacists spend much of their professional time interpreting, filling, and dispensing prescriptions. These functions require that the pharmacist reviews the prescription for proper drug use and dosage. Either because it is required by law or because it is considered standard professional practice, some pharmacists also review the list of the other drugs dispensed to a patient to ensure that no dangerous contraindications or interactions exist. For instance, a pharmacist who receives a propranolol prescription for a patient who is already using an inhaled b2-adrenoceptor agonist would be alert to the fact that the beta blocker could trigger an asthma attack. Prescription problems such as this are rectified by contacting the physician, who can then modify the drug order if needed. For all of these dispensing services, pharmacists receive a fee, and the number of prescriptions filled becomes the primary measure of the pharmacist’s income, especially in a chain drug store setting.

Other pharmacists spend a significant part of their time focusing on patient health. These so-called clinical pharmacists perform a number of non-dispensing functions: obtaining drug histories from patients so that drug duplication and interactions are avoided and to determine if any current medical problem has been caused by an untoward drug effect; monitoring for drug compliance, side effects, and interactions between drugs; and counseling patients about proper and safe drug use. More advanced clinical pharmacists also monitor for drug effects (taking blood pressure, testing blood glucose levels, monitoring drug levels) and advise physicians on drug choice, dosing, and toxicity. A clinically oriented pharmacist such as this is most often found in a hospital setting. Since there is usually no reimbursement for clinical pharmacy services, this group must secure a non-traditional source of income for their clinical services and so are often paid as faculty at medical and pharmacy teaching hospitals.

In the middle of the pharmacy practice spectrum is the largest group of pharmacists, who both dispense and provide some limited clinical service, usually counseling patients about a new prescription medicine. This group is often challenged by a situational pressure since time spent counseling interferes with the income-producing dispensing function. The time pressures can, in turn, impinge on the quality of the services provided. The conflict has both legal and ethical dimensions. Some pharmacists are legally required to offer counseling to all patients (Scott and Wessels, 1997). However, even with no legal obligation, many pharmacists believe that patient counseling is ethically required since, especially for complicated drug regimens, counseling can reduce drug administration mistakes and patient morbidity.

This kind of income versus dispensing versus patient health conflict can be resolved with advance planning, triage systems, and staffing adjustments. The planning should identify the priority of obligations that are owed to patients. For instance, a group of pharmacists can determine that counseling services are almost always a priority unless a patient is in acute medical need of a prescription (for pain, asthma, infection, etc.). Communication systems can be developed to alert pharmacists when service priorities need to shift, and staffing adjustments can be made to accommodate the priorities. Notices in the waiting areas that educate patients about professional service priorities can lessen patient stress when delays occur. When patients perceive a benefit from medication counseling, they can more easily tolerate disruptions in dispensing services.

Patient advocacy

It can be difficult to decide how far the scope of a pharmacist’s duty to serve patient interests should extend. For instance, most pharmacists acknowledge a duty to recommend generic substitution – when available and if the generic is well formulated – in the interest in benefiting patients (some of whom

cannot afford the cost of branded prescription drugs and might go without) and in the interest of rational healthcare resource allocation. However, other situations are not so clear. Pharmacists are not simply a conduit through which a patient receives a prescription drug. Training and specialized knowledge should be put to use to determine if the prescription is valid, beneficial, and safe. Yet pharmacists, especially those in retail settings, are limited by several circumstances in their ability to make these determinations. If, for example, a physician has written a prescription for one medication but a similar drug for the same indication has a better efficacy:safety profile, should the pharmacist attempt to intervene in the interest of rational prescribing and patient safety? As an example, a growing number of cases of violent agitation in the elderly treated with triazolam (Halcion) led pharmacists and medical payors to reject prescriptions for the drug in aged patients (Hensley, 2006). Also, some drugs (propoxyphene [Darvon] is one) come to be recognized as lacking a reliable risk–benefit profile, leading pharmacists to contact prescribers with a request that another drug be selected. The difficulty in questioning a physician’s drug choice stems from the fact that the medical data may not be clear about the attributes of various medicines. A pharmacist also lacks the medical information that the physician has about the patient, and pharmacists often cannot take the time to inquire about the prescribing choices of a busy physician who may, in turn, resent the interference. Circumstances can also influence what choice to make. Is the physician known to be prescribing outside of his or her specialty, so prescribing advice may be welcome? Is there credible medical evidence that the prescription drug is inferior to the alternative? Two guiding principles may help the pharmacist in cases such as this: (i) the more severe the potential harm to the patient, the more the pharmacist should be motivated to intervene, and (ii) informing patients of any concern and advising them to seek further advice from their physician is always advisable.

Pharmacists are also always better positioned to promote rational drug use when they have kept abreast of the clinical pharmacology literature.

Refusal to fill a prescription on the basis of social, moral, or religious objections

Pharmacists can have moral objections to the use of medications in many circumstances. The use of drugs for physician-assisted suicide is one such circumstance, and debates exist about whether pharmacists should fill these prescriptions, both in jurisdictions where the practice is legal and those in which it is not (Veatch, 1989; Canadian National Association of Pharmacy Regulatory Authorities, 1999; Catholic News Agency, 2005). Some pharmacists who deplore drug abuse do not wish to participate in the treatment of addicts by dispensing drugs such as buprenorphine. Other pharmacists object to the use of medications to combat obesity. Use of medication, they believe, undermines personal responsibility for discipline, self-restraint, and healthy living. In other cases, pharmacists have objected on moral grounds to filling prescriptions for contraception for unwed women or medications that act as emergency contraception or abortifacients (McClain, 2005). Once having arrived at these conclusions, pharmacists must determine how their moral principles should be balanced against the rights of patients seeking access to medication. The laws and ethics guidelines can be divided on the issue (National Conference of State Legislatures, 2005). Some state that, despite personal objections, pharmacists have a duty to fill legal prescriptions and sometimes even to counsel patients on appropriate use. In other jurisdictions, pharmacists are legally allowed to refuse to fill morally objectionable prescriptions but some laws further require (so that the patient is not abandoned medically) that the pharmacist then refer patients to another willing dispenser. What is not condoned in most countries is a pharmacist refusing to return the prescription to the patient or telling a patient that it is morally forbidden to use the medication for the intended purpose.

Pharmacists have been known to do both (Greenberger and Vogelstein, 2005; Stein, 2005). As communities become increasingly pluralistic, these kinds of conflict are inevitable. They require accommodations (such as a timely referral) that recognize the legitimate personal beliefs of the pharmacist and preserves as much as possible the ethical underpinnings of the patient–pharmacist relationship: a patient’s autonomy and right to treatment and the duty of the pharmacist to benefit the patient and to refrain from harming someone seeking medication.

Using prescription records to assist the marketing activity of pharmaceutical companies

Some large pharmaceutical companies pay US pharmacies to mail material or call patients about company drugs or competing products. The materials and messages urge patients to do such things as continue taking a currently prescribed drug, switch to a new form of the drug, or switch from a competitor’s drug. Theses programs ostensibly do not invade a patient’s medical privacy and are not illegal, since the company does not have access to the list of patients taking its drugs. Although viewed by many as promotional material directed to patients taking selected drugs, companies call such material ‘‘patient education,’’ ‘‘patient compliance,’’ or ‘‘disease management’’ programs. However they are characterized, these programs raise several troubling ethical questions (O’Harrow, 1998). Are such actions by a pharmacist an improper invasion of the privacy of patients’ prescription records? Is there a conflict of interest when pharmacists are paid to urge patients to take a particular brand of drug? Is this interfering with the patient–physician relationship when the material advises a patient to take a drug other than one prescribed by the physician? These programs have been challenged in lawsuits brought by US pharmacy customers against major chain pharmacies for invasion of privacy, and in investigations by attorneys general in different

states and the Federal Trade Commission for possible violations of laws prohibiting unfair and deceptive trade practices. The US Congress and the Department of Health and Human Services have also considered new privacy laws and regulations to stop the practice (Zimmerman and Armstrong, 2002). Leaving aside the merits of the claims against the companies and pharmacists, which have not been resolved, this is a classic example of how ethically questionable but legal activity can lead to censure, litigation, regulation, and loss of trust in the profession. Pharmacists who are approached to participate in these programs need to place primary emphasis on protecting patients’ privacy interests and should only convey information clearly intended to promote health interests.

Drug diversion and abuse

Surveys indicate that prescription drug abuse has been rising over a number of years to what is now considered epidemic proportions (National Center on Addiction and Substance Abuse at Columbia University, 2005). Pharmacists increasingly suspect that when a patient presents a prescription for a controlled drug, it is for the purpose of diversion or abuse. Professional responsibilities in such a case often conflict. Pharmacists have a duty to dispense opioid analgesics when the drug has been legally prescribed and is therapeutically appropriate for the patient. Determining if both of these requirements have been met can be difficult, and errors in judgement can have dire consequences. Refusal to fill a legitimate prescription can withhold pain relief from a suffering patient, and pharmacists have been sued and disciplined for refusals to fill these prescriptions based on the mistaken belief that abuse or diversion was occurring (Simonsmeier, 2005). Alternatively, filling a narcotic prescription that is used abusively increases the risk of harm to the patient and perpetuates a dangerous threat to the public health. Since most pharmacists will face this kind of challenge, all should receive training that focuses equally on decision-making

skills to detect drug abuse and diversion and also on the recognition of valid and appropriate prescriptions for controlled substances. Armed with these skills, pharmacist are less likely to err in either direction. The second task for the pharmacist is to recognize and avoid any tendency to make decisions in these cases based on racial or other biases, fear of liability or other personal harm, lack of reimbursement, or other extraneous considerations. Finally, when faced with an ambiguous situation and contacting the prescriber or questioning the patient and others, pharmacists must be diligent, appropriately timely, and considerate of the patient’s need.

Medical resource stewardship

No system of healthcare is free of the burdens of cost and the fair and rational allocation of constrained resources. Pharmacists play a central role in these matters since they control or manage institutional drug formularies, which are systems designed to limit the choice of drugs that can be prescribed based on cost-effectiveness determinations. A typical drug formulary decision involves selecting the least expensive among a class of drugs that provide the same or similar therapeutic benefit and risk. At times, however, the decision can involve whether or not to stock a particularly expensive drug. Assessing the cost effectiveness of drugs in these cases often requires an economic analysis involving calculations based on factors such as cost per life year and cost per qualityadjusted life year. However important these numbers are to the economic viability of healthcare systems, they are considered unfair by patients in desperate need of treatment and by physicians who want to do everything possible for their patients. An example is drotrecogin alfa (Xigris), a drug approved in 2001 for the treatment of sepsis, a condition with a high risk of death and for which there is no consistently effective treatment. Some hospital pharmacies did not want to stock the drug, however, since it is not uniformly effective; costs it over $6800 per treatment in the USA (£5000 in the

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UK); and, at least at first, was inadequately reimbursed by insurers or the government. This combination meant that pharmacy budgets could be depleted to save only a relatively few patients. Of the hospitals that did offer the drug, many limited patient eligibility to severe sepsis in an attempt to improve the cost–benefit ratio (Regalado, 2003; Green et al., 2006). Rationing of scarce or expensive medical care raises very contentious issues especially when patients learn that they may not be offered (or cannot afford) the most advanced treatments. Hospital politics also enters the picture when the request to add the drug to the formulary comes from a highly valued physician who controls a department and/or admits a large number of patients. Institutional pharmacists often find themselves in the middle of these dilemmas and need to study carefully and objectively all the available drug and cost data and balance equality and fairness so that formulary decisions that limit access to treatments will be accepted by physicians, patients, and the community. Periodic reassessment and physician and patient education will reinforce the viability of these decisions (Bochner et al., 1996). For more on issues related to resource allocation, see Ch. 33.

The case

The case at the beginning of this chapter is loosely based on the early reports of death and disability from pulmonary and cardiac disease attributed to the diet pill combination of fenfluramine and phentermine (called fen-phen; Connolly et al., 1997). The case represents a conflict between a pharmacist’s duty to act in the best interests of a patient’s health and the duty to respect the autonomy rights of patients to make their own personal and medical decisions. In many Western countries particularly, respecting a patient’s autonomy is a highly valued medical ethics obligation, supported by laws and medical ethics codes that require healthcare professionals to provide

full information to patients about the benefits and risks of medical treatment options and otherwise assist patients in making their own medical decisions. Since ignorance undermines autonomy, the first duty of the pharmacist in this case is to ascertain whether the patient has been informed of the potential drug risks. If the answer is ‘‘yes,’’ a second question for the patient is whether the physician intends to monitor for the cardiovascular risk. With a second affirmative response, the pharmacist has more assurance that both the physician and the patient understand the potential consequences of the choice to medicate. If either one of these conditions does not exist, the patient needs more information. The patient can be informed about the medical literature reports and then referred back to the prescribing physician to address questions about potential adverse effects and monitoring. Promoting patient safety may require that the pharmacist notifies the physician that the patient has been so advised and that continuing the drugs can be harmful. The patient should also be told to inform his primary care physician of the choice to continue taking the medication so that medical care can proceed in as safe a manner as possible. Some may disagree with these proposed courses of action as unwarranted intrusions into the physician–patient relationship but, when potentially lethal side effects are possible and when refraining from drug treatment presents no immediate risk, a pharmacist’s advocacy duties should err on the side of preserving patient health.

The case also raises the issue of ‘‘off-label’’ or ‘‘off-list’’ prescribing and dispensing, that is, using a drug for a purpose other than its labeled indication. In most jurisdictions, physicians are not prevented from prescribing off-label; this is considered the practice of medicine and subject only to professional standards. Pharmacists are likewise not prevented from dispensing drugs intended for off-label use. The question here is whether physicians have the sole responsibility for determining what off-label uses are appropriate. Even if

dispensing pharmacists are free from a legal duty to act, do they have an ethical obligation to intervene if they think that this prescribing is irresponsible? Again, pharmacists may not know the medical situation that prompted the off-label prescription. But sometimes this information is available to the pharmacist, either from patient disclosures or because the use is obvious. This situation existed with Genentech’s recombinant human growth hormone, approved and labeled initially for use in children with a rare form of dwarfism caused by lack of natural growth hormone. After the product was launched, physicians began prescribing the drug to short healthy children to help them to grow taller, to adults to improve athletic performance, to obese patients for weight loss, and for other off-label uses. Little was known about the efficacy or safety of the product for these other uses, and concerns existed about the potential for harm, especially in children. Although off-label uses can be bring beneficial treatments to patients faster than if all new uses were first researched, the lack of prior data leaves both healthcare providers and patients in the dark about the consequences of this kind of drug use. It can also invite the kind of criticism that undermines trust in the healthcare system. In the recombinant human growth hormone situation, both Genentech and the prescribing physicians were said to be profiting from purposefully ignoring and/or engaging in irresponsible prescribing that could harm children (Veatch, 1983; Kolata, 1994). The same question could have been directed to pharmacists who dispensed this product. The guidelines stated above concerning the duty of advocacy can guide a pharmacist when dealing with off-label prescribing. It is advisable that physicians who prescribe drugs off-label in their medical practice (i.e., they are not collecting data in a research setting) should institute a monitoring program that would allow them to detect drugrelated problems and then disseminate that information. Pharmacists can do likewise by asking patients about possible adverse effects during

drug-refill counseling sessions and alerting the physician if indicated.

REFEREN CES

Bochner, F., Burgess, N. G., and Martin, E. D. (1996). Approaches to rationing drugs in hospitals. An Australian perspective. Pharmacoeconomics 10: 467–74.

Canadian National Association of Pharmacy Regulatory Authorities (1999). Model statement regarding refusal to provide products or services for moral or religious reasons. Ottawa: Canadian National Association of Pharmacy Regulation Authorities (http://www.napra.org/docs/0/95/ 157/165/179.asp).

Catholic News Agency (2005). Catholic pharmacists in Spain refuse to sell condoms. Rome: Catholic News Agency (http://www.catholicnewsagency.com/new.php? n=5187).

Connolly, H. M., Crary, J. L., McGoon, M. D., et al. (1997). Valvular heart disease associated with fenfluraminephentermine. N Engl J Med 337: 581–8.

Green, C., Dinnes, J., Takeda, A., et al. (2006). Evaluation of the cost-effectiveness of drotrecogin alfa (activated) for the treatment of severe sepsis in the United Kingdom. Int J Technol Assess Healthc 22: 90–100.

Greenberger, M. D. and Vogelstein, R. (2005). Pharmacists’ refusals: a threat to women’s health. Science 308: 1557–8.

Hensley, S. (2006). As drug bill soars, some doctors get an ‘‘unsales’’ pitch. Wall Street Journal 13 March, A1.

Kolata, G. (1994). Selling growth hormone for children: the legal and ethical questions. New York Times, 15 August, A2.

McClain, C. (2005). Rape victim: ‘‘morning after’’ pill denied. Arizona Daily Star, 23 October. (http://www. azstarnet.com/dailystar/dailystar/99156.php.) [This article cited a 2004 survey of more than 900 Arizona pharmacies that found less than half kept emergency contraception drugs in stock, with most citing low demand as a reason but some pharmacists cited moral reasons. The article also featured the story of a 20-year- old rape victim who spent three days attempting to find a Tucson pharmacy to dispense the medication, which is most effective the earlier it is taken.]

National Center on Addiction and Substance Abuse at Columbia University (2005). Under the Counter: The

Diversion and Abuse of Controlled Prescription Drugs in the US. New York: Columbia University Press (http:// www.casacolumbia.org).

National Conference of State Legislatures (2005).

Pharmacist Conscience Clauses: Laws and Legislation. Denver, CO: National Conference of State Legislatures (http://www.ncsl.org/programs/health/conscienceclauses.htm).

O’Harrow, R. (1998). Plan’s access to pharmacy data raises privacy issue. Washington Post, 27 September, A1.

Regalado, A. (2003). To sell pricey drug, Lilly fuels a debate over rationing. Wall Street Journal 18 September, A1.

Scott, D. M. and Wessels, M. J. (1997). Impact of OBRA ’90 on pharmacists patient counseling practices. J Am Pharmaceut Assoc 4: 401–406. [OBRA ’90 is the US Omnibus Budget Reconciliation Act of 1990. OBRA ’90 also requires Medicaid pharmacy providers to offer prescription drug-use counseling to patients at the time that drugs are dispensed. However, laws are sometimes insufficient to change professional practice. The Scott and Wessels study showed that, six years after OBRA ’90 passed, fewer than half of retail pharmacists reported that time devoted to patient counseling increased as a result of the law.]

Simonsmeier, L. M. (2005). False imprisonment alleged when patient is detained with suspicious Rx. Pharmacy Times, March, 96.

Stein, R. (2005). Pharmacists’ rights at front of new debate.

Washington Post, 28 March, A1.

US Food and Drug Administration (2003). MedWatch; 2003 Safety Alert: Roxanol (morphine sulfate) Concentrated Oral Solution. Washington, DC: Food and Drug Administration (http://www.fda.gov/medwatch/SAFETY/2003/ roxanol.htm).

US Food and Drug Administration (2006). Medication Errors. Washington, DC: Food and Drug Administration

(http://www.fda.gov/cder/drug/MedErrors/default.htm). Veatch, R. M. (1983). Ethics of drugs for non-approved

uses. US Pharmacist 8: 69–72.

Veatch, R. M. (1989). Pharmacist’s refusal to dispense diethylstilbestrol for contraceptive use. Am J Hosp Pharm 46: 1413–16.

Zimmerman, A. and Armstrong, D. (2002). Use of pharmacies by drug makers to push pills raises privacy issues. Wall Street Journal, 1 May, A1.

Resources

Codes of ethics

American Pharmacists Association Code of Ethics for Pharmacists. http://www.aphanet.org/ pharmcare/ethics.html

Model Standards of Practice for Canadian Pharmacists. http://www.napra.org/docs/0/ 95.asp

Royal Pharmaceutical Society of Great Britain

Code of Ethics and Standards. http://www. rpsgb.org.uk/members/ethics/index.html

Smith, M., Strauss, S., Baldwin, J. H., and Alberts, K. T. (eds.) (1991). Pharmacy Ethics. Binghamton, NY: Haworth Press.

Veatch, R. M. and Haddad, A. (1999). Case Studies in Pharmacy Ethics. New York: Oxford University Press.

Wingfield, T. and Badcott, D. (2007). Pharmacy Ethics and Decision Making. London: Pharmaceutical Press.

Ms. M, a patient with a rare skin condition who has failed all relevant conventional therapies, asks her dermatologist, Dr. N, about treatment options involving complementary and alternative medical (CAM) therapies. Dr. N mentions a homeopathic remedy commonly available in pharmacies and health food stores; Ms. M tries the remedy, and the skin condition quickly resolves. She is elated by this success and tells her best friend, a neurologist, who promptly files a complaint with the state medical board, noting that few, if any, physicians of any subspecialty in the state ever recommend homeopathy for any condition. The board holds a hearing at which there is no evidence that Dr. N has ever harmed a patient or acted unskillfully or incompetently in any way. Indeed, several dozen patients testify that Dr. N is a skilled, caring healthcare professional. The board nonetheless decides to revoke Dr. N’s license based on a state statute defining professional misconduct as ‘‘any departure from acceptable and prevailing medical standards.’’ Subsequently, Ms. M sues Dr. N for malpractice, alleging that he failed to adequately discuss the risks and benefits of a different CAM therapy – acupuncture – for her condition, and, in the alternative, that by inducing her to rely on homeopathy he neglected conventional dermatological treatment.

What are complementary and alternative medical therapies?

Complementary and alternative medical (CAM) therapies refer to those modalities and whole systems of healing that historically have not been part of the dominant system of medical practice in the West. These CAM therapies include acupuncture and traditional oriental medicine, chiropractic,

herbal medicine, massage therapy, and ‘‘mindbody’’ therapies (such as hypnotherapy and guided imagery) (Institute of Medicine of the National Academies, 2005). Integrative healthcare refers to clinical practice that judiciously combines conventional medical therapies and evidence-based CAM therapies, focusing on patient-centered, relationship-driven care (Institute of Medicine of the National Academies, 2005).

This chapter discusses the ethical, legal, and policy aspects of clinical integration of CAM therapies. Legal and ethical rules suggest that inquiry into patient use of CAM therapies, disclosure and discussion of risks and benefits of potentially beneficial CAM therapies, and appropriate warnings as to possible contraindications, adverse reactions, and interference with conventional care, as applicable, should be standard practice. Such conversations will enhance shared decision making, help to balance non-maleficence and patient autonomy interests, and improve the therapeutic alliance, thus reducing the possibility of medical malpractice liability. Guidelines for liability risk management are explored.

Why are complementary and alternative medical therapies important?

Ethics

Like conventional care, clinical integration of CAM therapies implicates major ethical principles such