Problematic Promotion of Medications by Nurse Ambassadors—Legal and Ethical Issues

Abstract

A number of pharmaceutical companies offer nurse ambassador programs that typically involve companyemployed registered nurses who interact with patients to help facilitate the use of complicated medications that have been prescribed for the patient. However, some of these companies have been the subject of lawsuits alleging that their programs are inappropriately blurring the line between caregiver and marketer. In August 2020, the pharmaceutical company AbbVie agreed to pay California $24 million to settle a whistleblower case that involved its nurse ambassador program for adalimumab (Humira), while not admitting any wrongdoing. 1 Nurse ambassador programs in part aim to ensure that patients continue the use of costly medications and have provided incentives to physicians and other clinicians to prescribe the medication. The programs continue to be largely unregulated by the federal government, with US Department of Justice guidance suggesting that the program could have an important role in patient interactions in some cases. 2 Nurse ambassador programs are not confined to AbbVie. 3 Companies such as Lilly, Gilead Sciences, Bayer, Amgen, AstraZeneca, Vanda Pharmaceuticals, Berlex, Pfizer, and EMD Serono have similar programs and sometimes refer to the nurses as patient or clinical "educators." 4 Although it is not known how many nurse ambassadors are currently employed in the United States or how many AbbVie employs, the company has nurse ambassador programs for 2 other medications (risankizumab-rzaa and glecaprevir/pibrentasvir). According to a report from 2018, one nurse reported that the company had 400 nurse ambassadors when she left the nurse ambassador program that year. 5 The AbbVie-California settlement provides guidance at the state level and suggests that the programs can continue with some changes, but legal and ethical concerns remain.

Branded Care: The Policy Implications of Pharmaceutical Industry-Funded Nursing Care Related to Specialty Medicines

“…Following this report, a 2009 law formalized industry patient support programs, requiring approval by the health regulator and prohibiting the involvement of sales representatives; programs could instead be implemented by industry-employed clinicians (La loi HPST, 2009). However, these preliminary findings and details released through US legal action raise important questions for professional and health product regulators about the ways that interactions between patients and industry-employed clinicians stand-in for those they would typically have with their healthcare team, creating misaligned incentives and risks to patient interests (Yang & Mason, 2021).…”

Industry influence in healthcare harms patients: myth or maxim?

“…An example of this is the "ambassador" nurses hired by AbbVie to teach patients how to administer adalimumab (Humira), complete related paperwork, answer questions and promote adherence [71]. A lawsuit filed in 2018 alleged that such ambassadors provided unbalanced information especially around downplaying serious side-effects [72]. These ambassadors saved time and resources for the prescribing physician, but were only available for those patients who were prescribed AbbVie's drug [71].…”

“…These ambassadors saved time and resources for the prescribing physician, but were only available for those patients who were prescribed AbbVie's drug [71]. The case was settled out of court with AbbVie paying California USD 24 million but with no admission of wrongdoing [72]. Other pharmaceutical companies with paid nurse roles include, amongst others, AZ, Lilly, Gilead Sciences, Bayer, Pfizer, and more recently, to support with commencement of CFTR modulators, "Patient Support Specialists" from Vertex.…”

Prevalence and nature of manufacturer-sponsored patient support programs for prescription drugs in Canada: a cross-sectional study

“…In 2020, AbbVie settled a California suit in which the state alleged that the patient care and insurance authorization assistance provided by the nurses of the patient support program constituted a kickback because it provided "free and valuable professional goods and ser vices to physicians," contingent upon prescription of the drug. 17,18 Overall, industrysponsored patient support programs and the extent or nature of the services provided are not well under stood, 17 making it difficult to assess their value to patients or their impact within health systems. Canada offers a useful case study to conduct a national survey of industrysponsored patient sup port programs.…”