Authors

  1. Erlen, Judith A.

Abstract

Conflict of interest as it relates to healthcare is gaining increasing attention. Pharmaceutical companies and manufacturers that produce medical devices are coming under greater scrutiny because of the influence that their marketing practices may have on the patient management decisions made by healthcare professionals. The result is that healthcare agency administrators are developing conflict of interest policies and procedures for their professional employees. The driving force behind many of these policies is the need to maintain the trust of the public by refraining from questionable professional conduct. This article presents 2 hypothetical cases to provide nurses with an understanding of the concept of conflict of interest and the ethical considerations this issue raises, and describes the subtle and not-so-subtle influences on professional practice decisions. Recommendations are offered to help nurses avoid conflict of interest and preserve their professional integrity. It is incumbent upon nurses to become cognizant of the types of situations that may present a conflict of interest for them and to take the necessary steps to avoid such professional impropriety.

 

Article Content

Conflict of interest is gaining increasing attention in the professional and lay literature and the popular press; several articles discussing the pharmaceutical industry and nursing have recently been published in the nursing literature (Ashmore, Carver, & Banks, 2007; Crigger, 2005; O'Malley, 2006). A 2006 article by Brennan and colleagues in the Journal of the American Medical Association, "Health industry practices that create conflicts of interest: A policy proposal for academic medical centers," called for policies that would reshape the healthcare provider-industry relationship and eliminate the potential of conflicts of interest in current practice. The result has been that healthcare organizations and academic medical centers that include the various schools of the health sciences are developing policies and procedures for their professional employees, which include nurses. The driving force behind many of these policies is the need to maintain the trust of the public by refraining from questionable professional conduct. While the patient's best interest seems to be served because of the new drugs or devices, the healthcare professional or the pharmaceutical or manufacturing company is also deriving financial benefit. Prescribing the new drugs or using the new devices when existing ones provide similar benefits raises questions such as: Is the new drug or device actually better? Why is this drug being prescribed? Who bears the additional costs? New products often have significantly higher costs; in the case of new drugs, there may not be a lower priced generic version available. Or, healthcare professionals may be led to believe that the generic drug may not deliver the same benefit to their patients as the brand name drug.

 

Nurses' belief that they are immune to these conflict of interest issues and that physicians are the only target of pharmaceutical and device companies is incorrect; nurses' decisions in matters related to patient care are also influenced (Crigger, 2005). The same healthcare industries that have been sponsoring physician continuing education programs also sponsor continuing education programs for nurses, giving the sales representatives opportunities to provide a service, as well as to "pitch their products" (O'Malley, 2006). These manufacturing companies know that nurse practitioners, one portion of the program's audience, have prescriptive privileges and need to document attendance at continuing education activities. Nurses engaged in other aspects of nursing practice, for example, office nurses, may also unsuspectingly serve as emissaries of the drug and device companies' sales representatives. These nurses hear the sales pitches and receive brochures describing the products. Should they be involved in the decision-making process regarding which patient products to purchase, these nurses may find that they are recommending the new drug or device that had been advertised at a recent meeting that they had attended. Additionally, office nurses might be enablers for industry allowing the sales representative to meet with the physician although office hours have begun and there is a waiting room full of patients.

 

Thus, it is incumbent upon nurses to become cognizant of the types of situations that may present a conflict of interest for them and to take the necessary steps to avoid such professional impropriety. This article presents hypothetical cases to provide nurses with an understanding of the concept of conflict of interest and the ethical questions this issue raises and describes the subtle and not-so-subtle influences on professional practice decisions. Additionally, there are recommendations that nurses need to consider to avoid conflict of interest and preserve their professional integrity.

 

Hypothetical Cases

Two hypothetical cases are presented that describe common situations involving conflict of interest. At the end of each case, there is a question asking what the nurse should do. As you read the case, consider what you would do if you were the nurse. Quite possibly, you will find yourself thinking about your own professional practice and your own relationships with patients and whether your decisions regarding care have been influenced by drug and/or device manufacturers.

 

HYPOTHETICAL CASE 1: TAMMY

Tammy is a nurse practitioner employed in a clinical practice that provides care to older adults. Many of her patients have diagnoses such as hypertension, hypercholesteremia, and osteoarthritis of the knee; these diagnoses are quite common among this patient population. The management goals for patients with these conditions are to reduce the blood pressure, reduce the cholesterol level, and decrease the pain. Each of these goals may be achieved by prescribing specific medications along with other therapies such as diet and exercise.

 

Tammy recently met with the representative from a pharmaceutical company who regularly visits this practice to discuss the company's latest product line. At the end of the visit, the sales representative provided samples of various medications for distribution to patients seen by the healthcare professionals in the practice. Tammy has been distributing the samples to her patients. Quite often, the patients have financial constraints. Tammy believes that she is helping these patients have the latest drug that they may not otherwise be able to afford because of their health insurance coverage or their limited incomes. Should Tammy continue to meet with the sales representatives and distribute the samples they provide to her patients?

 

HYPOTHETICAL CASE 2: GARY

Gary is a psychiatric-mental health clinical nurse specialist in an outpatient mental health facility. The regulations governing licensure in the state in which Gary resides require that nurses acquire a specified number of continuing education units at a minimum for renewal of one's license. One of the opportunities available to Gary for obtaining continuing education units is an update on mental health practices. The program includes sessions in which the latest evidence to support the use of these practices is being discussed. Gary notices that the brochure states that the all-day session that will provide him with 8 contact hours is partially supported by a pharmaceutical company that manufactures medications commonly prescribed for patients with mental health disorders. There is also an optional free lunch sponsored by this company at which a presentation will be made by someone from that pharmaceutical company.

 

Recently, Gary has read some articles about how healthcare providers can be influenced by the sales pitches and the advertisements of pharmaceutical companies. However, he thinks about the other side of the equation and says to himself, "These companies play an important role in healthcare through the development of new and more effective drugs. They need to advertise. They are a business; businesses make money so that they can return dividends to their shareholders. What's the harm in my attending this program? I need the information that is being presented by the speakers so that I use evidence-based therapies in my care of patients." The question for Gary is: Should he attend this conference and the optional lunch knowing that more than evidence-based practice will be discussed?

 

In each of these cases, the nurses are potentially at risk for conflict of interest situations. One could argue that Tammy is providing a benefit to her patients should she decide to continue to distribute samples to her patients. In effect, she might say that she is serving their best interests. In Gary's case, the argument might be that attending the continuing education program will help him fulfill the requirements for renewing his nursing license. Additionally, becoming knowledgeable about the latest evidence to support mental health practices will help him serve the best interests of his patients. It seems that the benefits to his patients outweigh the possible risks, or do they?

 

Conflict of Interest

Conflict of interest occurs when two competing interests clash (Brody, 2005). There is a need to make a decision; however, the person making the decision could be influenced to choose one alternative over another. The ethical issue occurs when the choice becomes self-serving, rather than serving the best interests of the other, and the choice results in moral compromise (Crigger, 2005; Tonelli, 2007).

 

The Code of Ethics for Nurses (American Nurses Association, 2001) offers guidance on making decisions regarding the ethical issues that arise when there is a conflict of interest that affects the nurse-patient relationship. The code describes nurses' relationships with and accountability to patients. Patients are the nurses' first priority and their interests are critically important. Whenever nurses engage in professional practice, they are to ensure that their other relationships do not take precedence over their relationships to patients. To do otherwise is to compromise the integrity of the nurse-patient relationship.

 

Conflicting Goals

The case of Tammy demonstrates a situation involving conflicting goals. As Tammy considers the appropriate action to take in regard to meeting with and listening to sales representatives and distributing their free samples to patients, she needs to identify the goals that are at stake and to whom she is accountable. The pharmaceutical representative is responsible and accountable to the company, which, in turn, is responsible to its shareholders. Therefore, the representative is marketing a product that has the potential to increase the company's profits and is using various ways to meet this goal such as colorful brochures, sales pitches about the drug's effectiveness, free samples, and possibly bringing the staff lunch when making the visit to the practice (Brody, 2005; Wall & Brown, 2007). Tammy is responsible and accountable to her patients and how she can best serve their interests. Will she now write a prescription for this latest drug although the current drug her patients are taking may be effective in controlling their health problem? Along with the prescription, she could give her patients some of the samples of the new drug, thinking that this will help the patients with the cost of this drug. Ultimately, though, Tammy's patients and other patients will bear the additional costs for this new drug.

 

Although patients' interests are being served and their health problems addressed, has this been done on the basis of the evidence for the best practice and having all of the information necessary to make an informed decision regarding the use of the new drug? If the representative is "pushing the product," then the information that Tammy receives may be biased toward the benefits of the medication, rather than any possible risks to the patient that may occur when taking the drug and therefore unduly influencing her decision (Campbell, 2007). Additionally, the patient's best interests may not be served by prescribing a higher cost medication that may place a financial burden on the patient although some free samples are provided. There is no guarantee that the patient will always be able to rely on having free samples as a way to reduce the costs of the prescribed medications.

 

Gary's situation is one that many nurses have encountered. Nurses may have attended conferences where pharmaceutical companies have underwritten the costs or provided lunch or dinner that was not included as part of the conference fee; participants are free to choose the meal option and attend a presentation that the manufacturer is offering (Wall & Brown, 2007). On the surface, this may seem rather harmless. In fact, nurses have been heard to say, "Why not get a free meal? I'm only going to attend because I want to eat; I don't care about the presentation." In addition to underwriting the meals, the drug and/or device companies will often have "giveaways" available to participants who choose to take these free items that actually market a product. These items are not necessarily expensive; however, they do have the name of the manufacturer on them or the name of that company's latest product. Once the nurse takes these items, such as pens and notepads, they will continue to serve as a reminder of the product. The gifts and the presentations at the meals have the potential to influence a nurse's patient care decisions (Campbell, 2007; Crigger, 2005).

 

The question for Gary is whether he should attend this optional free lunch at this conference, given that there are limited options for lunch near the conference site or seek some other continuing education offering that will be independent of industry influence? The conflicting goals in this case involve Gary's need to have ongoing continuing education for maintaining his nursing license and the role of continuing education in updating nurses' knowledge to enable them to provide the best practices versus industry's need to advertise its latest products to what might be described as a "captive" audience attending a sponsored lunch at a conference. Gary's best interests, and ultimately his patients' best interests, may not be served by his attending this lunch because of the potential for the biased approach in at least this one presentation and the gifts that he receives (O'Malley, 2006). All of these things could ultimately influence future decisions that he makes or encourages his fellow healthcare professionals to make when they are considering the latest treatments for their patients.

 

However, unless information regarding the latest products is provided through advertising and marketing, how will healthcare providers learn about the newest medications and devices? Are these practices wrong? The answer to this question is most likely "no." The ethical questions arise in regard to how much influence the marketing will have on decision making and whether healthcare professionals will examine other alternatives in a systematic way before making a decision regarding which product to use (Brody, 2005; Crigger, 2005; Tonelli, 2007).

 

Transparency

As these two cases illustrate, nurses' decisions may be influenced by their interactions with representatives from the pharmaceutical and device industries. However, this influence has recently come under renewed scrutiny by healthcare professionals and ethicists (Brennan et al., 2006; Brody, 2005; Campbell et al., 2007). The current health practices are that healthcare professionals are required to disclose any financial relationships with industry as a way to protect the interests of patients and that accepting small gifts is considered as not providing undue influence on patient care. However, these practices are now being strongly questioned; Brennan et al. (2006) state that the assumptions underlying these practices are actually myths.

 

Despite their minimal cost, small gifts can serve to influence another's behavior (Crigger, 2005). As noted earlier, the gifts often have slogans or some type of information that serve as an ongoing advertisement of a product. For example, when one uses the notepad or the pen, the product name is there serving as a reminder to the nurse of an earlier presentation about a new drug or device. Full disclosure does nothing to reduce or eliminate a potential conflict of interest. The issues regarding full disclosure of a financial interest by healthcare professionals that are not addressed by the current practice include what counts as a conflict of interest, who verifies this conflict, and can others recognize biased information in a presentation (Brennan et al., 2006).

 

The present focus is on ensuring transparency regarding interactions with industry and the removal of any sense of impropriety (Brennan et al., 2006). The goal is to make certain that policies are clear to healthcare professionals and industry representatives and free of pretense. Healthcare organizations, academic medical centers, and schools of health sciences are developing and implementing very specific policies for the faculty and healthcare professionals who provide patient care in these organizations (Fahy, 2008; Tregaskis, 2008). These policies also regulate the activities of the industry representatives who are making presentations about their products to faculty and healthcare professionals in clinical settings. For example, industry representatives may not distribute gifts such as pens and notepads or provide food when describing their companies' products within healthcare organizations.

 

Relevant Ethical Considerations

As individuals within healthcare organizations and academic medical centers discuss professional-industry relationships and develop and implement policies and procedures, they need to be cognizant of the ethical precepts that form the foundation of the healthcare professions. Nurses and other healthcare professionals care for their patients; this provision of care is by its very nature a moral action (Bishop & Scudder, 1990).

 

Nurses and other healthcare professionals must make autonomous, informed, and deliberate decisions when choosing a particular management approach to their patients' conditions. They need accurate, complete, and unbiased information regarding potential treatment options. Similar to the informed consent process, the critical elements for selecting a therapeutic modality requires being fully informed and then making choices without feeling any pressure or undue influence to choose otherwise (Beauchamp & Childress, 2001; Bryan, Brett, Saunders, Khushf, & Fulton, 2004). When healthcare professionals do not feel compromised or manipulated as they make decisions about patient care, they are able to maintain their own integrity, as well as the integrity of the healthcare professional-patient relationship.

 

Another ethical consideration is that trust is the foundation of healthcare professionals' relationship with their patients. Not violating this trust is of the utmost importance (Beauchamp & Childress, 2001). Patients expect that healthcare professionals are concerned about their well-being and that their best interests are at the center of the treatment plan. However, outside influences can compromise or erode this trust relationship. Healthcare professionals must avoid any indication of impropriety; they cannot breach the trust of the public.

 

Promoting the patient's rather than another's welfare becomes the key goal; the patient's best interest is paramount. Reducing risks and preventing harm are important considerations when considering what is in the patient's best interest (Beauchamp & Childress, 2001). Nurses need to choose those management therapies that will offer the most benefit to their patients.

 

Providing free samples of medications that have been supplied by a pharmaceutical company can benefit, at least, some patients. However, given that the supply of samples is limited, not all of a healthcare provider's patients who may require a particular drug will be able to benefit. Therefore, distributing samples of medications in an equitable manner is essential; identifying the criteria for a fair distribution system is difficult (Beauchamp & Childress, 2001). Yet, which criteria are the most relevant? The goal of the distribution system is that some patients should not benefit at the expense of others because those others would have an undue burden placed upon them.

 

Recommendations

What can nurses do to avoid a potential conflict of interest and maintain their professional integrity? The following recommendations will assist nurses as they come to understand the impact that conflict of interest can have on their own professional practice.

 

Nurses need to understand conflict of interest and its far-reaching effects. Therefore, nurses need to engage in continuing education activities that address conflict of interest. Faculty need to include a discussion on conflict of interest in ethics courses at all levels of nursing education.

 

Nurses need to recognize that they are not immune from conflict of interest situations. They are just as easily influenced by the marketing practices of industry as other healthcare professionals. Nurses need to create opportunities to discuss the marketing practices of sales representatives and the impact of these practices on patient care decisions.

 

Nurses need to be involved with developing organizational conflict of interest policies. These policies must address such topics as the healthcare professional-industry relationship, the limits on the marketing practices, sponsoring of continuing education programs, dispensing of free samples, and sanctions for violating these policies.

 

Nurses need to examine their own professional practice for any activities that may be or suggest this type of impropriety. Nurses need to examine their feelings about accepting small gifts and free lunches. Introspection may be painful because of what one may learn; however, without this soul searching nurses will not change the way they conduct their practice. Given that patients are at the core of nursing practice, nurses must ensure that patients' interests are uppermost when making management decisions.

 

REFERENCES

 

American Nurses Association. (2001). Code of ethics for nurses. Washington, DC: Author. [Context Link]

 

Ashmore, R., Carver, N., & Banks, D. (2007). Mental health nursing students' relationships with the pharmaceutical industry. Nurse Education Today, 27, 551-560. [Context Link]

 

Beauchamp, T. L., & Childress, J. F. (2001). Principles of biomedical ethics (5th ed.). New York: Oxford University Press. [Context Link]

 

Bishop, A. H., & Scudder, J. R., Jr. (1990). The practical, moral, and personal sense of nursing: A phenomenological philosophy of practice. Albany: State University of New York Press. [Context Link]

 

Brennan, T. A., Rothman, D. J., Blank, L., Blumenthal, D., Chimonas, S. C., Cohen, J. J., et al. (2006). Health industry practices that create conflicts of interest: A policy proposal for academic medical centers. Journal of the American Medical Association, 295, 429-433. [Context Link]

 

Brody, H. (2005). The company we keep: Why physicians should refuse to see pharmaceutical representatives. Annals of Family Medicine, 3(1), 82-85. [Context Link]

 

Bryan, C. S., Brett, A. S., Saunders, D. E., Khushf, G., & Fulton, G. B. (2004). Medical ethics and professionalism: A synopsis for students and residents. Columbia: University of South Carolina Center for Bioethics and Medical Humanities. [Context Link]

 

Campbell, E. G. (2007). Doctors and drug companies-Scrutinizing influential relationships. New England Journal of Medicine, 357, 1796-1797. [Context Link]

 

Campbell, E. G., Gruen, R. L., Mountford, J., Miller, L. G., Cleary, P. G., & Blumenthal, D. (2007). A national survey of physician-industry relationships. New England Journal of Medicine, 356, 1742-1750. [Context Link]

 

Crigger, N. J. (2005). Pharmaceutical promotions and conflict of interest in nurse practitioner's decision making: The undiscovered country. Journal of the American Academy of Nurse Practitioners, 6, 207-212. [Context Link]

 

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O'Malley, P. (2006). Pharmaceutical advertising and clinical nurse specialist practice. Clinical Nurse Specialist: A Journal for Advanced Nursing Practice, 20(1), 13-15. [Context Link]

 

Tonelli, M. R. (2007). Conflict of interest in clinical practice. Chest, 132, 664-670. [Context Link]

 

Tregaskis, S. (2008, Spring). A new diet for docs. No free lunches. No swag. And patients have everything to gain. PITTMED, 10(1), 17-19. [Context Link]

 

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