By Victoria Stern

Earlier this year, JosÉ Baselga, MD, the physician-in-chief and chief medical officer at Memorial Sloan Kettering Cancer Center in New York City, resigned after failing to report millions of dollars in payments from drug and device companies.

According to the federal Open Payments database, Dr. Baselga had received close to $3.5 million from Genentech and other drugmakers from August 2013 through 2017. But, as The New York Times and ProPublica found, he did not disclose those financial ties in the majority of his research papers.

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Dr. Baselga’s resignation comes at a time of increased scrutiny of conflicts of interest in medicine. However, the majority of this scrutiny has fallen on physicians.

More than a decade ago, several prominent physicians were found to have failed to report millions of dollars in payments from drug and device companies. The scandals, which raised concerns about lax disclosure policies and the influence of financial ties on medical practice, spurred the federal government to enhance its scrutiny of these relationships.

Since 2013, the Physician Payments Sunshine Act has required drugmakers and device companies to report payments to doctors, dentists, chiropractors, optometrists and podiatrists. The law, however, had a notable blind spot: It failed to include payments to nurse practitioners and other clinicians who can prescribe medications.

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But that will change soon. In October, President Donald Trump signed a bill aimed at combating the opioid epidemic, which will also expand the Sunshine Act reporting requirements to nurse practitioners, physician assistants and other advanced practice nurses by 2022.

Understanding nurses’ interactions with pharmaceutical and device companies has become increasingly relevant as nurses’ roles in health care continue to expand. Nurse administrators, nurse managers or clinical nurse specialists may be involved in their hospital’s purchasing decisions, and nurse practitioners can prescribe medications, order tests and recommend treatments. According to data from the Medicare Part D prescription drug plan, nurse practitioners wrote about 11% of almost 1.5 billion prescriptions in the program in 2016.

Although expanding Open Payments would help publicize the extent of nurses’ financial ties to industry on a national level, reporting payments to health care professionals alone does not paint a complete picture of these relationships. Such payments do not capture the role that industry plays in advancing patient care and fostering innovation. Additionally, payment information neither reflects day-to-day interactions in the clinical setting, nor determines how industry-led education on drugs and devices might blur the boundary between support and marketing.

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“Nurse–industry relationships were something that we generally did not need to think about as an ethical issue that affected nursing practice; but today, we do,” said Connie M. Ulrich, RN, PhD, the Lillian S. Brunner Chair in Medical and Surgical Nursing and a professor of bioethics and nursing at the University of Pennsylvania School of Nursing, in Philadelphia.

“Nurses are in constant contact with patients and their families on clinical units and are in a prime position to interface with industry as advancements in technology and the growth of different types of treatment options (medical devices, pharmaceuticals) are presented to patients and their families.”

A Lack of Data

Still, data on industry payments to nurses in the United States and how these payments may affect practice remain limited.

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“In the U.S., no formal data on nurse–industry payments exist at the national level,” said Quinn Grundy, PhD, RN, a postdoctoral research fellow at the University of Sydney.

Washington, D.C. and several states require pharmaceutical companies to report their expenditures on marketing to health care prescribers, which include nurse practitioners and physician assistants. According to 2015 data, for instance, advanced practice nurses in D.C. received $317,118 and registered nurses received $122,312 in gifts—significantly less than the $13.5 million in payments to general physicians, although an increase from the previous year.

A 2017 analysis found that in 2013, gifts to D.C. nurses from pharmaceutical companies were associated with more prescriptions per patient and more costly prescriptions (PLoS One 2017;12[10]:e0186060). Nurse practitioners who accepted gifts tended to have a higher average cost per claim ($180 vs. $86), although not a significantly higher proportion of branded claims.

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The most comprehensive data on nurse–industry payments, however, come from Australia, where companies that manufacture prescription medicines are required to report payments to all health care professionals. In Australia, data show pharmaceutical companies gave more than $1.7 million AUD to nurses and nurse practitioners in 1,635 individual payments between 2016 and 2017. It’s unclear, however, whether the data from D.C. and Australia reflect industry payments in the United States more broadly.

Struck by how little is understood about nurse–industry interactions, Dr. Grundy set out to clarify the nature and extent of these relationships. In a 2016 analysis, published in Annals of Internal Medicine (2016;164[11]:733-739), Dr. Grundy and her colleagues at the University of Sydney interviewed 56 registered nurses and 16 other health care professionals at four U.S. institutions.

All the registered nurses reported interacting with industry in the past year. In addition to attending sponsored events and receiving gifts, product samples or consulting fees, some nurses described daily interactions with industry representatives in the OR as well as efforts to coordinate staff training about new products. Most nurses noted the benefits of working with industry, and more than 25% said it “would be impossible to do their jobs without industry resources.”

But, Dr. Grundy noted, because these day-to-day interactions typically began in an official capacity, they often flew under an institution’s radar.

“I wasn’t surprised by the extent of the relationship we found,” said Dr. Grundy, who is also the author of the new book, “Infiltrating Healthcare: How Marketing Works Underground to Influence Nurses” (Johns Hopkins University Press, 2018). Dr. Grundy said, “I was more surprised by the disconnect—the idea that nurses do not have industry relationships or are not subject to the same conflicts as doctors, despite interacting with sales reps on a daily basis.”

According to the Annals analysis, more than one-third of the nurses were members of their hospital’s purchasing committees. Although nurses typically evaluated smaller ticket items, such as wound care products, infusion kits and gowns, those purchases could add up to multimillion-dollar contracts for companies. Even so, most of the nurses interviewed did not identify as decision makers, often characterizing their influence as more indirect (Adv Nurs Sci 2017;40[2]:E28-E43).

“Many nurses may have internalized the idea that only prescribers make treatment and purchasing decisions,” Dr. Grundy said. “But forging relationships with nurses can give sales reps that foot in the door quite literally because they have to get past nurses to be in the OR space, and more metaphorically, because nurses know hospital policy and how to bring products into the OR.”

But given the study’s limited scope, Dr. Grundy’s team could not draw more sweeping conclusions about the prevalence or impact of these interactions—a challenge in earlier research as well, which has suggested that nurses represent a “soft target” for pharmaceutical marketing (PLoS Med 2008;5[2]:e5) and nurse practitioner prescribers have frequent interactions with pharmaceutical reps (Am J Manag Care 2010;16[12]:e358-e362).

“These studies are generally difficult to generalize, so we need much more research with larger samples and with different types of nursing specialties to better understand the ethical issues that nurses are experiencing in their day-to-day interactions with industry and how this affects patient care,” Dr. Ulrich said.

Andrew Wright, MD, the director of the University of Washington Medicine Hernia Center at Northwest Hospital, in Seattle, explained that when device reps are in the OR to troubleshoot equipment, they often offload a lot of work from nursing staff. “We rely on industry for such services, though it may complicate the dynamic or introduce subtle influences.”

Part of that complexity is that device reps serve the dual function of product support and salesperson, which may create an ethical gray area (J Med Ethics 2018;44[9]:589-592). Managing this potential conflict is something that current nursing guidelines may not address explicitly.

“Introducing someone into the OR whose loyalty is ultimately to their company brings in another dynamic,” Dr. Grundy said. “Although these interactions in the OR may be typical, they may not always be in the patient’s best interest, which leads to a bigger conversation about the appropriate role for reps in providing educational support.”

Increasing Transparency

Despite the various analyses and ongoing debates focused on physician conflicts of interest, “there’s still a lot of disagreement,” Dr. Wright said. “Most people don’t want to think of themselves as being influenced. There’s resistance to the idea that an industry relationship can change the way you think.”

And when it comes to nurse–industry relationships, even less is known about influence. Including nurses in Open Payments would be one step toward greater transparency. Joyce Marth Knestrick, PhD, C-FNP, APRN, FAANP, the president of the American Association of Nurse Practitioners (AANP), supports expanding Open Payments to nurses.

“AANP is committed to a transparent health care system,” Dr. Knestrick, a family nurse practitioner at Wheeling Health Right in Wheeling, W.Va., told OR Management News. “We stand ready to work with our members to comply with the Open Payments provisions.”

Dr. Ulrich agreed that nurses should be included in Open Payments. “Patients and their families have the right to know whether an industry relationship is potentially a conflict that could influence the provision of care to patients and their families.

“Nurses’ primary commitment is to their patients, families and community,” Dr. Ulrich said, “but they are also challenged with so many other competing interests, including industry relationships, as they work day to day to provide quality care in whatever setting they might find themselves.”

Fostering Nurse–Industry Relationships

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Instead of shying away from industry, the Association of periOperative Registered Nurses encourages nurses to become more involved.

“Industry relationships are invaluable to nurses,” said Lisa Spruce, DNP, RN, the director of evidence-based perioperative practice at AORN. “We work very closely with industry, and our nurses rely on industry to understand new devices and products.”

As end users of products, nurses play a key role in evaluating tools and equipment and providing information on safety and user experience. Sales reps are often already present in the OR and interacting with nurses, Dr. Spruce said, so getting nurses more involved can help lead to better products.

To foster nurse–industry relationships, AORN plans to host its first reverse trade show at the upcoming Global Surgical Conference & Expo in Nashville, Tenn. “The reverse trade show is a great opportunity for nurses to see new products, test them and ask questions, and for industry to connect one-on-one with perioperative nurses who are key purchasing decision makers,” Dr. Spruce said.

But with more interactions comes more opportunities for conflicts of interest to arise. To help nurses navigate these relationships in the OR setting, AORN created guidelines in 2014 that delineate a device rep’s role in the OR and how nurses can ensure reps provide necessary support without overstepping their boundaries—for example, providing technical assistance and education but not direct patient care. The guidelines also stipulate that nurses ensure the patient has provided written consent for the rep to be present during surgery and act as advocates for the patients’ safety during a procedure.

“In my experience, the role of the sales rep is to show all aspects of the product, but after that, industry needs to step away and let the OR team independently evaluate it,” Dr. Spruce said.