Watkins, Raquel S. MD; Kimberly, James Jr. MD
Debate over appropriate physician–pharmaceutical industry interaction (PPII) is intensifying. During 2000, pharmaceutical companies spent 16 billion dollars on promotion and marketing,1 more than the amount of money spent on undergraduate and graduate medical education annually. The goal of pharmaceutical industry marketing is to change physicians’ behaviors. Recent literature shows that gifts influence the prescribing patterns of physicians; can have a negative impact on physicians’ knowledge, attitudes, and behaviors; and results in increasing costs.2 Although position statements,3–5 national guidelines,3 and recent research2,6 have addressed PPII, published reports suggest physicians are not knowledgeable about these guidelines and literature. Many physicians find gifts from industry acceptable and believe they are not influenced by them,2,7 in effect disregarding the old adage “there is no such thing as a free lunch.”
Little is known about the knowledge, skills, or attitudes that internal medicine residents need to interact appropriately with pharmaceutical industry representatives.
Internal medicine residents have frequent contact with these representatives (PRs), attend grand rounds given by pharmaceutical industry-sponsored speakers, receive samples in clinics, and receive gifts from industry.2 Many educators believe that this interaction should be restricted or at least be addressed by training programs.2,8 A survey of internal medicine program directors showed that only 25% of programs had formal instruction on how to interact with PRs.9 Few curricula exist that address the PPII,10–13 and none have focused on this relationship in depth. In addition we found no published reports of an assessment to identify the specific learning needs of internal medicine residents on this topic. Given new national efforts to address the effect of pharmaceutical marketing on physicians’ prescribing patterns and professional behavior, formal curricula that address PPII is warranted.
Our residency program is a large university-based program in western North Carolina. We have 88 internal medicine residents (36 interns, 27 second-year residents, and 25 third-year residents). Eight of the interns are in preliminary year positions, 14 residents are in the primary care tract, and the remaining are in categorical positions. Currently our residents can interact with pharmaceutical industry representatives in public and administrative areas (e.g., offices, conference rooms, administrative locations in ambulatory patient care areas)14 and freely after-hours (dinners and sporting events). Additionally, pharmaceutical industry representatives can interact with residents in patient care areas by appointment.14 Samples are also allowed in patient care areas but are limited to medications that are on formulary.
We have 109 clinical faculty in the Department of Internal Medicine. Faculty can also interact with pharmaceutical industry representatives in administrative areas and freely after-hours. Some faculty members are paid pharmaceutical company speakers.
Two years ago, we asked our residents to complete a questionnaire that helped us explore their attitudes about the pharmaceutical industry and its sales representatives.15 Most residents believed that PR contact did not affect their prescribing practices, did ensure adequate availability of samples, and did not create any ethical conflict of interest. Subsequently, we formed a focus group of residents to learn more about their perceptions on this issue. Because of feedback from this group and new national attention about PPII, we conducted a needs assessment of current knowledge and preferences to assess the need for a more structured educational initiative.
To develop our needs assessment questionnaire, we searched Medline for articles published from 1966–2001 using a combination of the terms drug industry, needs assessment, internship, and residency. We found no articles. We searched Medline again for articles published during the same dates using the terms physicians, conflict of interest, drug industry, and interprofessional relationships and attitudes. We found four articles, one of which was a recent systematic review. We reviewed the bibliographies of these articles as well. We also searched the World Wide Web and found guidelines from the American Medical Association (AMA) as well as the “No Free Lunch” Web site. In total, we reviewed the guidelines from three professional organizations.
Based on the literature review, we created a two-page questionnaire using a five-point ordinal scale. The questionnaire was pilot-tested with educators for clarity and relevance.
We mailed the questionnaire to all internal medicine residents and clinical faculty at Wake Forest University Health Sciences (School of Medicine) in Fall 2001. The questionnaires were number-coded to maintain respondents’ anonymity. Nonresponders received two follow-up mailings. We asked residents and faculty to assess their knowledge of formal position statements and research concerning PPII (existing guidelines, recent literature on PPII) and other aspects of the pharmaceutical industry (process of new drug development, drug marketing costs, industry-sponsored research at academic centers and independent research centers, training of pharmaceutical industry representatives, and trends in direct-to-consumer marketing in both television and printed ads). We also asked residents and faculty to assess the importance of including the following components in residency education: familiarity with formal position statements, literature exploring the impact of marketing strategies on prescribing patterns, economics of pharmaceutical marketing, familiarity with pharmaceutical companies’ speakers’ bureaus, efficient and critical interpretation skills of drug promotional materials, familiarity with marketing techniques, potential for conflicts of interest, and patients’ perceptions of physician–pharmaceutical industry relationships. Additionally, we asked responders to rate the importance of the following venues for teaching: lecture series, small-group discussions, web-based modules, information flyers sent to mailboxes, department grand rounds, critical-reading skills seminars, morning report, spending a day with a pharmaceutical industry representative, and panel discussion with residents, pharmaceutical industry representatives, and pharmacists.
Analysis included the Wilcoxon two-sample test.
Response rates were 97% (85/88) for residents and 79% (86/109) for faculty. Very few responders reported being knowledgeable about formal position statements and research concerning PPII, knowledge of industry sponsored research by independent research companies, drug marketing costs, or training of pharmaceutical industry representatives (see Table 1). Most responders felt that residents should learn to critically interpret drug promotional materials, recognize potential for conflicts of interest, and consider how patients perceive the physician–pharmaceutical industry relationship (see Table 2). Concerning other curricular components, more faculty than residents valued including familiarity with formal position statements and literature exploring the impact of marketing strategies on prescribing patterns (see Table 2).
No significant differences existed in the responses from generalist and subspecialty faculty. A few trends did emerge where generalists were more likely to value inclusion of critical interpretation skills of drug promotional materials (85% versus 70%, p = .05), literature exploring the impact of marketing strategies on prescribing patterns (86% versus 67%, p = .06); and patients’ perceptions of the physician–pharmaceutical industry relationship (75% versus 63%, p = .09).
Of all responders, only half or fewer favored small-group discussions, lecture series, critical-reading skills seminars, or panel discussions. Even fewer desired Web-based modules, flyers in mailboxes, or spending a day with a pharmaceutical industry representative.
Despite the 2001 AMA initiative on the ethics of gifts to physicians from industry, internal medicine residents and faculty in this sample reported low levels of knowledge about position statements and guidelines. Additionally, residents and faculty in our study reported low levels of knowledge about literature exploring the impact of marketing strategies on prescribing patterns. This is concerning given published data that gifts from industry can affect health care costs and can have a negative impact on physicians’ knowledge, attitudes, and behaviors.2
We found that both housestaff and faculty want residency curricula to include efficient and critical interpretation skills of drug promotional materials, potential for conflicts of interest, and patients’ perceptions of physician–pharmaceutical industry relationships. Faculty and residents’ opinions on the importance of including policy statements and literature on the impact of marketing strategies on prescribing in residency education differed significantly. In addition, residents consistently reported wanting less education overall than did faculty. We found this particularly interesting given that a consistent finding in the literature is that residents, relative to faculty, are more vulnerable to persuasion by industry and they appreciate their vulnerability less.7,19–21
We found that faculty and residents have more knowledge of actual advertising practices than of professional guidelines, suggesting that pharmaceutical advertising has significant impact. Although residents may have more fundamental educational goals, we were surprised that so few faculty were familiar with PPII guidelines that have been published in medical journals with wide appeal. This is troubling given what we know about the potential for conflicting interests between physicians and the pharmaceutical industry.
Our needs assessment has several limitations. We surveyed residents and faculty at one academic center, raising questions on the generalizability of our results. However, this academic center is similar in size to many midsize internal medicine programs and we believe that residency and faculty opinions here are generalizable. Additionally, although our questionnaire asked residents and faculty to report their perceptions about knowledge and importance, we did not actually test their levels of knowledge.
Based on our findings, we decided to develop, evaluate, and implement a curriculum that focuses on the five key areas that most residents or faculty identified as important components for residency education (see Table 2). We reasoned that to enable informed decision making, all physicians should be cognizant of the potential for conflict of interest in PPII. Thus the overall goal for our curriculum is to teach internal medicine residents about the ethics and effects of PPII. The curriculum is composed of four units integrated throughout the residency program (see Figure 1). The course is conducted in both small- and large-group one-hour seminars open to interns and residents. All seminars are conducted in scheduled noontime slots when most educational conferences at our institution take place.
Given the controversial nature of this topic, our introductory unit of the curriculum was, “Increasing Awareness of Patients’ Perceptions and Potential for Conflict of Interest.” We chose this as our first unit because the primary responsibility of a physician is to the patient, and we hoped that seeing and hearing their patients’ comments on PPII would motivate residents to participate in the other units in our curriculum. Because published data on patients’ perceptions on PPII are limited,16,17 our first unit included an eight-minute collection of digitized interviews of clinic patients seen by our residents. These patients were all asked to respond to questions pertaining to the appropriateness of gifts to physicians from the pharmaceutical industry and to describe their experiences with medication costs. Their responses were videotaped, edited, and then shown to the residents during Unit 1. This presentation without commentary was followed by a 20-minute discussion. Subsequently, we asked the residents to define conflict of interest in the professions, and after the group reached a consensus on a definition, we described the four ethical principles of nonmaleficence, beneficence, autonomy, and justice. We then provided examples of pharmaceutical industry gifts to physicians and asked residents to consider whether these gifts were acceptable given their patients’ perceptions, our definition of conflict of interest, and the four ethical principles.
Because many physicians use information provided by pharmaceutical representatives in their clinical practice, both during and after residency training,18 our rationale for the second and third units of our curriculum, “Applying Critical Interpretation Skills to Promotional Materials” and “Applying Information on Cost to Prescribing Decisions and Increasing Familiarity with Marketing Strategies,” was to provide an opportunity for the residents to gain practical skills for use when interacting with industry representatives. These units included information on the importance of differentiating between relative risk, relative risk reduction, and number needed to treat. We also reviewed promotional strategies used by pharmaceutical representatives such as appealing to emotion, authority, or celebrity figures. Additionally, we identified electronic references on drug information such as Micromedex22 and the Medical Letter on Drugs and Therapeutics.23
Our last unit included a component that only a minority of residents in our study favored: familiarity with statements from professional organizations. We reasoned that it was important for residents to be aware of formal position statements, but given their low level of interest on our needs assessment, we decided to couple this information with senior faculty's perceptions. We hoped that after learning about patients’ perceptions and gaining practical skills, residents would be poised to review and discuss position statements with senior faculty members.
The evaluation of the curriculum consisted of both external expert review and pilot testing to document the effectiveness of achieving the learning objectives. One national content expert and one educational design expert reviewed the curriculum for accuracy and consistency and improvements were made based on their suggestions. The first unit was pilot tested in April 2002 with residents who provided direct feedback regarding content and process. Data on the curriculum's effectiveness on knowledge and attitudes were collected from pre- and postintervention evaluations. We asked residents to evaluate the curriculum on a four-point ordinal scale (1 = yes; 4 = not at all). All residents responded “yes” to having an increased awareness of patients’ perceptions, how to identify conflict of interest, and feeling as if they would be able to interact in a more informed manner with the pharmaceutical industry. To assess the effect on knowledge, we administered a pre- and postintervention test. We asked questions on patients’ perceptions, effect of PPII on prescribing patterns, and cost to the pharmaceutical industry for promotion and marketing. Additionally, we asked them to define widely accepted principles of ethics. The mean score on the pretest was 33% and on the posttest 86%. To assess residents’ attitudes toward PPII, we plan to compare precurriculum implementation opinions to postcurriculum implementation opinions. A questionnaire was distributed at the beginning of the 2002 academic year, and we plan to redistribute this questionnaire in October of 2003 after Unit 4 of the curriculum is implemented.
Although we do not know the long-term effects of our curriculum, we contend that the findings in our needs assessment indicate there is an educational need for a curriculum to teach the ethics and effects of PPII. In our opinion, as educators we should consider what role we have played in identifying and assessing the learning needs of resident–physicians about PPII. Also, what role can we play in teaching our residents about the risks and benefits of pharmaceutical industry gifts to physicians? The results from our work in progress suggest a compelling need for innovative approaches to teach our learners that there is “no free lunch.”
The needs assessment was presented as a poster at the Society of General Internal Medicine annual meeting in April 2002. The curriculum was presented orally at the Primary Care Faculty Development conference at Michigan State University in June 2002. We wish to acknowledge mentors, Dr. Rebecca Henry and Dr. Gary Ferenchick from Michigan State University Office of Medical Education, Research and Development, and Dr. Mark Wilson from The University of Iowa School of Medicine. We also wish to acknowledge the Michigan State University Primary Care Faculty Development Fellowship
1.Prescription Drugs and Mass Media Advertising, 2000 〈http://www.nihcm.org
〉. Accessed February 2004. National Institute for Health Care Management Foundation, November 2001.
2.Wazana A. Physicians and the pharmaceutical industry. JAMA. 2000;283:373–80.
4.Canadian Medical Association. Physicians and the pharmaceutical industry (update 2001). CMAJ. 2001;164:1339–44.
5.Coyle SL. Physician-industry relations. Part 1: individual physicians. Ann Intern Med. 2002;136:396–404.
6.Angell M. Is academic medicine for sale? N Engl J Med. 2000;342:1516–8.
7.Steinman MA, Shlipak MG, McPhee SJ. Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical industry promotions. Am J Med. 2001;110:551–7.
8.McCormick BB, Tomlinson G, Brill-Edwards P, Detsky AS. Effect of restricting contact between pharmaceutical company representatives and internal medicine residents on posttraining attitudes and behavior. JAMA. 2001;286:1994–9.
9.Lichstein PR. Impact of pharmaceutical company representatives on internal medicine residency programs. Arch Intern Med. 1992;152:1009–13.
10.Anastasio G, Little J Pharmaceutical marketing: implications for medical residency training. Pharmacotherapy. 1996;16:103–7.
11.Shaughnessy A, Slawson D, Bennett J. Teaching information mastery: evaluating information provided by pharmaceutical representatives. Fam Med. 1995;27:581–5.
12.Hopper JA, Speece MW, Musial JL. Effects of an educational intervention on residents’ knowledge and attitudes toward interactions with pharmaceutical representatives. J Gen Intern Med. 1997;12:639–42.
14.Small R, Pegram S. Policy and procedure regarding medical service representatives. Winston-Salem, NC: Wake Forest University Baptist Medical Center, 2001.
15.Hulgan T, Wilson MC, Applegate WB. Is there free lunch? Resident and faculty perception at the turn of the century. J Gen Intern Med. 2000;15(suppl 1):35.
16.Mainous AG, Hueston WJ, Rich EC. Patient perceptions of physician acceptance of gifts from the pharmaceutical industry. Arch Fam Med. 1995;4:335–9.
17.Gibbons RV, Landry FJ, Blouch DL, et al. A comparison of physicians’ and patients’ attitudes toward pharmaceutical industry gifts. J Gen Intern Med. 1998;13:151–4.
18.Caudill TS, Johnson MS, Rich EC, McKinney WP. Physicians, pharmaceutical sales reps and the cost of prescribing. Arch Fam Med. 1996;5:201–6.
19.Hodges B. Interactions with the pharmaceutical industry: experience and attitudes of psychiatric residents, interns and clerks. CMAJ. 1995;153:553–9.
20.Orlowski JP, Wateska L. The effects of pharmaceutical firm enticements on physician prescribing patterns. Chest. 1992;102:270–3.
21.Chren MM, Landefeld CS. Physician behavior and their interactions with drug companies. JAMA. 1994;271:684–9.