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The Value of Pharmaceutical Representative Visits and Medication Samples in Community-Based Family Practices
METHODS: We collected detailed descriptive field notes of the direct observations of 53 primary care clinicians and 1588 patient encounters in 18 purposefully selected Nebraska family practices. We used a comparative case study design, that used depth interviews of clinicians and office staff, and included details of the interactions with pharmaceutical representatives and the use of samples in clinical encounters.
RESULTS: Individual providers and practices displayed noticeable variation in their approaches to drug representatives and samples. We found formal strategies and policies in a minority of practices. Generally there was little structure in the organization and distribution of sample medications at the office level, and detailed patient education regarding these drugs was rarely observed in patient encounters. Nevertheless, samples were used in almost 20% of observed encounters, at times as starter dosages, but often as complete courses of treatment. The benefits derived from contact with the pharmaceutical industry varied substantially, but most often included free medication samples, meals, and patient education materials.
CONCLUSIONS: Clinicians have a complex symbiosis with the pharmaceutical industry and need to critically evaluate their handling of samples and their contact with pharmaceutical representatives to optimize this relationship and ensure quality patient care. Clinics with specific policies for interactions with drug companies appear to derive more satisfaction from their encounters.
The world of medicine is permeated by the influence of the pharmaceutical industry, which spends an estimated $10 billion (more than $13,000 per physician) each year on drug promotion.1 This industry’s influence extends from medical education to clinical research and patient care.2 For example, medical journals and medical conferences are supported by pharmaceutical advertising or depend on financial contributions from pharmaceutical companies to offer their programs. Pharmaceutical companies grant a variety of scholarships and subsidies. The pharmaceutical industry also reinvests a portion of its profits to support new research and development, including hundreds of clinical trials reported each year in the scientific literature.3 Up-to-date drug detailing and continuing medical education (CME) is offered to clinicians, and patient education materials are frequently made available to practices. Patients, especially those with a lower income, benefit from receiving free medication samples donated by pharmaceutical companies.
Pharmaceutical companies, health care providers, and patients represent unique interests that may at times overlap. How the interactions between physicians and pharmaceutical representatives influence prescribing habits, decision making, and physician behavior in general is a contestable topic that has not been well studied or thoroughly understood. In the last several years, medical organizations in the United States and Canada have released discussion papers and policy statements about the relationship between the medical profession and the pharmaceutical industry.3 Whether the influence of the pharmaceutical industry is ultimately beneficial or detrimental remains a contentious and complex topic shrouded in much controversy.4-15
The interactions between the pharmaceutical industry and physicians have been discussed in a plethora of publications. Several of these articles have focused on the ethical implications of these interactions and the potential for exploitation; however, they have commonly been based on surveys and self-reporting and have often been limited to providers in academic or residency training contexts.3,16-21 Brotzman and Mark16 encourage the development of more comprehensive policies for residency training purposes. Kelcher and coworkers19 promote the concept of a structured educational program to prepare residents for future contact with the pharmaceutical industry. Lexchin9 discusses the need for critical comparison when evaluating drug information received from pharmaceutical representatives.
So how do family practice clinicians approach this challenging relationship? Through direct observation of these interactions within the private practice context, we attempted to add a new and vital dimension to the assessment of this rather complex symbiosis. We describe the approaches and reactions of individual family physicians and their practices to pharmaceutical representatives.
Methods
The Prevention and Competing Demands in Primary Care Practice study was designed to examine the organizational contexts that support or inhibit the delivery of preventive services in family medicine practices. Eighteen practices were studied using a multimethod ethnographic design that involved extensive observational field notes of the office system and the clinical encounters. These notes were collected by a researcher who spent at least 4 weeks in each practice. A total of 44 physicians and 9 other clinicians were shadowed, and approximately 1600 patient encounters were directly observed. Individual depth interviews were conducted with each clinician and many of the practice staff to obtain their perceptions.
Sampling
The comparative case study design began with an initial phase of purposefully selecting practices that included both urban and rural settings and those with different intensities of preventive services delivery, (n=10) followed by a sample to confirm or refute evolving hypotheses (n=8). The practices were selected from those that had participated in the Centers for Disease Control and Prevention/Nebraska Department of Health–funded Tobacco Use Prevention in Physicians Offices study (Helen McIlvain, principal investigator). These high-volume practices had a wide variation in practice location (urban, suburban, and rural) and organizational structure (solo vs group, independent vs system affiliated). Because we noted some interesting variations among practices from different health systems in the early analyses, the replication sample ensured at least 2 practices from each of 4 major health systems, and 2 from those practices that were seen as struggling to provide preventive services in the tobacco study.
We solicited study participation by sending an invitation letter followed by a telephone call to one of the physicians in the practice. Participation was very high, requiring contact with 23 practices to obtain the 18 deemed necessary in the study design.
Data Collection
We sent a field researcher trained in qualitative methods to each practice where she used a variety of data collection methods to produce a comprehensive picture of the practice as a functioning organization. Data were collected through direct observation of the practice,22 the use of structured checklists of the office environment,23 direct observation of patient encounters supplemented with structured checklists, the use of patient pathways,24 individual depth interviews with physicians and other key staff members,25 and chart audits. It took from 4 to 12 weeks for the field researcher to complete the data collection in each practice, depending on its size.
The field researcher observed and jotted details of the physical environment and functioning of the practice, then dictated extensive field notes at the end of each day. These field notes contained detailed descriptions of the clinic location and environment, patient characteristics, nursing station, examination rooms, the waiting area, physician offices, bulletin boards, posters, and patient education materials. Photographs were taken of each room, including the reception area, waiting area, nurses’ station, nurse intake room, and the examination rooms. Existing practice personnel, their roles and duties, and their relationships and interactions with other staff members were characterized in a practice genogram.26 Physical office systems, including charts, flow sheets, and computer systems were described, as were functional office routines and procedures. The field researcher specifically noted the storage and organization of drug samples within the clinic, comments made by staff relating to pharmaceutical representatives, and any observed interaction between staff and representatives.
The field researcher attempted to observe 30 patient encounters for each clinician; because of patient volume and scheduling this was not always possible. Thirty or more patient encounters were observed in 42 of the 53 clinicians participating in the study, and 20 or more patient encounters were observed for all but 1 provider (who had 18 encounters). After obtaining written informed consent from the patient, the field researcher shadowed the clinician and jotted notes about each encounter for later dictation. The patient encounter field notes contained rich descriptions about any verbal patient education delivered and the context of that education, including the reason for the visit, how the visit unfolded, and how the clinician and patient interacted. The patient encounter dictation captured the distribution of drug samples, discussion between the clinician and patient regarding drug samples, prescriptions written by physicians, and instructions given by physicians.
Using the depth interviewing technique, the field researcher interviewed all family physicians within the practice, the office manager, head nurse, and other significant persons within the practice.25 Questions asked by the field researcher related to overall views of medicine, general practice characteristics, the systems in place for the delivery of preventive medicine, and perceived rates of delivering preventive medicine. These interviews were tape-recorded and transcribed verbatim.
Additional data such as photographs and chart audits were collected as part of the larger study but were not included in our analysis.
Data Analysis and Interpretation
Qualitative data were transcribed, checked for accuracy by having the field worker review the manuscript, and entered into FolioViews 4.11, an infobase software package.27 We began our analysis by immersing ourselves in all the data from 2 practices to understand the function of the practices and the overall richness and variation of the data collected, and to identify any mention of drug samples or interactions with pharmaceutical representatives. Using this immersion/crystallization approach, we worked to formulate hypotheses and an initial organizational scheme.28 Group discussions led to the development of a codebook of key words.
Two investigators then performed computer word searches on the infobases of the 2 previously selected practices using the codebook. All relevant passages were tagged and printed, and the information retrieved was compared with data identified from an earlier in-depth reading of the transcripts from the 2 practices we initially studied. The word search technique and template organizing style was used to identify relevant portions of 4 more practices for secondary data analysis.29
Finally, segments of the selected field notes and patient encounter notes that described drug samples and pharmaceutical representatives were identified and organized into preliminary tables or matrices.30 After constructing matrices for the 6 selected practices we held discussions and further refined the organization and categories within the matrices. Once the matrices were refined they were used to organize relevant data identified by word searches for the rest of the 18 practices in the sample. The matrices served as the framework for data analysis, allowed the visualization of emergent patterns, and facilitated comparisons across physicians and practices.
Results
Individual clinicians and their practices displayed noticeable variation in their approaches to pharmaceutical representatives and the use of samples. Our analysis revealed patterns with respect to the types of contact they have with the pharmaceutical representatives, their use of sample medication, and the relative benefits obtained from the interactions.
Contact with the Pharmaceutical Representatives
All 18 practices had some form of contact with the pharmaceutical industry. This contact ranged from scheduled and well-organized meeting times to random interactions. Formal strategies and policies regarding drug representative interactions and the use of samples were in place in 8 of the 18 practices (44%). One other practice voiced a concern regarding the need for such a policy.
Most of the 8 clinics that had a formal plan or policy preferred a specific time (such as the lunch hour) during which the physicians and staff could meet with the representative. Some practices determined which days and times would be most convenient for their staff. One clinic made the clinician’s schedule available, thus allowing the representatives to schedule visits accordingly. One rural physician even allotted 30-minute patient appointment times to each representative to optimize the quality of these interactions. These lengthy visits facilitated more extensive drug detailing and CME, and generated an ample supply of samples, which were used to serve the needs of this particular rural community. A receptionist in another clinic was found to simply use a chalkboard to notify the staff whenever a representative had set up a presentation in the office. All of these measures appeared to be effective in minimizing confusion, distraction, and schedule disruption.
The remaining 10 practices displayed more haphazard dealings with drug representatives. These included brief hallway meetings that happened when clinicians were confronted by a representative as they exited the examination room. Other pharmaceutical representatives waited in medication sample rooms, hoping to catch the physicians as they searched for samples. These casual relationships were, at times, counterproductive. In one practice the physicians seemed oblivious to when “drug lunches” were scheduled, leading to frustration on the part of the pharmaceutical representatives; in another, the physician found herself rudely interrupted by an imposing representative during her own lunch.
Usage and Storage of Sample Medication
In the 18 practices, medication samples were used in 19.8% of the 1588 observed patient encounters. Multiple drugs were dispensed in 14.6% of the encounters in which samples were used. In only 5.1% of cases was a medication dispensed as a result of a patient’s specific request; the clinician usually initiated the distribution of samples. Drug samples were also offered to additional family members in 3.5% of encounters, sometimes even when these individuals were not accompanying the patient to the given appointment. This appeared to be particularly common in certain rural practices where the clinicians seemed sensitive to the needs of their patients and their families.
A review of the types of medication dispensed revealed noticeable trends and pointed to a prevalence of certain medication categories [Table 1]. The top 4 categories included asthma and allergy remedies, anti-infective agents, analgesics and anti-inflammatory medications, and antihypertensive drugs. These major categories accounted for more than 63% of all drugs dispensed.
The duration for which these medication samples were given varied from starter dosages (lasting 1-3 days) to complete courses of treatments (eg, a course of antibiotics) to amounts sufficient to supply the patients’ needs for several months (eg, antidepressants). The analysis of the clinician’s intent when dispensing samples identified that some were using samples to test for efficacy and tolerability while others were attempting to offer temporary relief or convenience to the patient. Also, certain physicians were clearly concerned about cost savings for their patients. The use of medication samples could be seen to represent tangible benefits to the individual patient.
Instructions accompanied the dispensing of samples in 150 (47.8%) of the cases and were predominantly verbal in nature. Dosing appeared to be the main focus, and little to no attention was given to more detailed information, such as whether the medication should be taken with meals. Drug interactions were not routinely discussed.
The majority of dispensing was done by physicians, physician assistants, and nurse practitioners. In some clinics, office staff had access to samples and were asked to consult with the physician before using these samples. Personal use of samples was documented in at least 4 practices, and in 2 of these the nurses were described as “helping themselves.” One particular clinic even voiced concerns about patients having unsupervised access and mentioned the need to develop a drug policy.
Dispensing patterns varied significantly among the clinics. Certain practices, especially those in rural, underserved communities, were found to dispense more liberally than others. These clinics appeared to be particularly sensitive to the needs of the individual patients and those of the greater community. In one practice, medication was handed out in 39.2% of encounters. On one occasion the physician waited until after the pharmaceutical representative had delivered an adequate supply of the necessary medication to give it to the patient. In contrast, clinicians in a particular suburban clinic only dispensed drugs 4.4% of the time.
However, even within a given practice, vast individual variances existed for each clinician in their approach to samples. In one clinic, 2 of the partners displayed disparate habits: One physician used samples regularly (in 41.9% of observed encounters), and the other only did so on rare occasions (in 3.2% of observed encounters). Of all the 18 sites, the physician who dispensed samples most frequently did so in 56.7% of observed encounters; the physician, however, at the other end of the spectrum dispensed medications in 2.4% of the observed patient encounters.
Of the 18 practices, 9 made use of specific closets or rooms for the storage of medication samples. One particular practice boasted an extraordinary and meticulously organized shelving system, complete with labeled bins and demarcated sections. The medical assistant in whose office these medications were stored was responsible for dispensing the ordered medications. In contrast to this efficient system, most clinics displayed very little structure in the organization and dispensing of samples. One clinic was described as having an overfilled, disorganized stack of shelves where medications were placed alongside vitamin supplements and herbal products. In this clinic staff spent vast amounts of time searching for the appropriate samples.
Only one clinic kept the sample room locked; another office had placed a notice on the door to keep it shut. It is important to note, however, that these storage places did not contain narcotics or similarly scheduled medications. In spite of Health Care Financing Administration regulations, we did not find any documentation to support which samples with which serial numbers had been distributed to patients, making effective recalls almost impossible. Stocks were most often replenished during routine drug representative visits. In one of the sites the head nurse kept in contact with the representatives and notified them when additional stocks were needed.
Benefits of These Interactions
We found that physicians and patients gained some advantage from their dealings with drug companies. The benefits the practices obtained from their contact with the pharmaceutical industry varied substantially. Other than medication samples, the most commonly observed benefits included the provision of meals, treats, and patient education materials [Table 2].
Patients also profited in a spectrum of ways. While samples represented tangible cost savings, immediate relief, and convenience to the individual patient (and occasionally to their family members), patient education materials facilitated further understanding of their diagnosis, potentially leading to a higher degree of satisfaction with their health care.
Discussion
Our study suggests that the relationship between the pharmaceutical industry and clinicians is symbiotic. It is a complex relationship that deserves objective analysis regarding its virtues and pitfalls.
Although it is essential to acknowledge the extent of the pharmaceutical industry’s influence, it is equally important to recognize and enhance the opportunities that clinicians have to direct this relationship. Our data suggest that clinics with existing policies for interactions with drug companies appear to derive more satisfaction and less frustration from their encounters. Formal meeting times eliminated unwanted interruptions and distractions from patient care and made the interactions more meaningful. Physicians who negotiated extensive and structured contact with drug representatives often received regular visits and generous supplies of both samples and patient education materials. Drug representative briefings, even though these needed to be viewed with healthy skepticism, also constituted a welcome form of CME for certain physicians.31
We found, however, that many offices do not have formal policies regarding pharmaceutical representatives and use questionable sample handling and storage practices. Interactions with pharmaceutical representatives can also be time consuming, potentially affecting the patient care schedule. Dispensing medications in the office setting may lead to increased responsibility and liability. We found that few clinicians provided extensive patient education about the samples they dispensed. Physicians need to be cognizant of the fact that they are bypassing the pharmacist. Directions to the patient need to be clear and comprehensive, addressing issues such as polypharmacy and drug-drug interactions. In addition, physicians should remain mindful of their own vulnerability with respect to the pharmaceutical industry’s influence over their prescribing habits. Drug detailing, even when insightful, may be biased.
Conclusions
The management of office visits with pharmaceutical representatives and the distribution of medication samples need to be addressed. Clinics with specific policies for interactions with drug companies appear to derive more satisfaction from their encounters. Practices should also maintain specific strategies when it comes to dispensing samples and should develop patterns of accountability for the handling of samples in the office.
Future research should include issues such as the impact of the pharmaceutical representative’s visit on patient finances, attitudes, disease management, and the physician-patient relationship. Further work is needed in the area of prescribing habits and the factors influencing physician decision making. More information on these topics may ultimately define and establish a relationship between the physician and the pharmaceutical industry that protects and promotes the interests of patients.
Acknowledgments
Our work was supported by a grant from the Agency for Health Care Policy and Research (1RO1 HS08776) to Benjamin Crabtree, PhD.
1. Westfall JM, McCabe J, Nicholas RA. Personal use of drug samples by physicians and office staff. JAMA 1997;278:141-43.
2. Newton W, Goldstein A, Frey J. There is no such thing as a free lunch: developing policies on pharmaceutical industry support. J Fam Pract 1992;34:32-34.
3. Lexchin J. Interactions between physicians and the pharmaceutical industry: what does the literature say? CMAJ 1993;149:1401-07.
4. Arkinstall WW. Interaction between physicians and the pharmaceutical industry. CMAJ 1995;153:398-99.
5. Brotzman GL, Mark DH. Policy recommendations for pharmaceutical representative-resident interactions. Fam Med 1992;24:431-32.
6. Chren M-M, Landefeld CS, Murray TH. Doctors, drug companies, and gifts. JAMA 1989;262:3448-51.
7. Forrest JB. Faculties of health sciences and the pharmaceutical industry: an effective partnership. CMAJ 1994;151:1320-22.
8. Gibbons RV, Landry FJ, Blouch DL, et al. A comparison of physicians’ and patients’ attitudes toward pharmaceutical industry gifts. J Gen Intern Med 1998;13:151-54.
9. Lexchin J. What information do physicians receive from pharmaceutical representatives? Can Fam Physician 1997;43:941-45.
10. Madhavan S, Amonkar MM, Elliott D, Burke K, Gore P. The gift relationship between pharmaceutical companies and physicians: an exploratory survey of physicians. J Clin Pharm Ther 1997;22:207-15.
11. Orlowski JP, Wateska L. The effects of pharmaceutical firm enticements on physician prescribing patterns: there’s no such thing as a free lunch. Chest 1992;102:270-73.
12. So AD. Free gifts: redundancy or conundrum? J Gen Intern Med 1998;13:213-15.
13. Squires BP. Physicians and the pharmaceutical industry. CMAJ 1993;149:1391-92.
14. Tiner R. Pharmaceutical representatives: guidelines exist on making effective use of time spent with representatives. BMJ 1996;313:881.-
15. Wolfe SM. Why do American drug companies spend more than $12 billion a year pushing drugs? Is it education or promotion? Characteristics of materials distributed by drug companies: four points of view. J Gen Intern Med 1996;11:637-39.
16. Brotzman GL, Mark DH. Policies regulating the activities of pharmaceutical representatives in residency programs. J Fam Pract 1992;34:54-57.
17. Chren M-M, Landefeld CS. Physicians’ behavior and their interactions with drug companies: a controlled study of physicians who requested additions to a hospital drug formulary. JAMA 1994;271:684-89.
18. Hodges B. Interactions with the pharmaceutical industry: experiences and attitudes of psychiatry residents, interns and clerks. CMAJ 1995;153:553-59.
19. Kelcher S, Brownoff R, Meadows LM. Structured approach to pharmaceutical representatives: family medicine residency program. Can Fam Physician 1998;44:1053-60.
20. McKinney WP, Schiedermayer DL, Lurie N, Simpson DE, Goodman JL, Rich EC. Attitudes of internal medicine faculty and residents toward professional interaction with pharmaceutical sales representatives. JAMA 1990;264:1693-97.
21. Sergeant MD, Hodgetts PG, Godwin M, Walker DMC, McHenry P. Interactions with the pharmaceutical industry: a survey of family medicine residents in Ontario. CMAJ 1996;155:1243-48.
22. Bogdewic SP. Participant observation. In: Crabtree BF, Miller WL, eds. Doing qualitative research. 2nd ed. Thousand Oaks, Calif: Sage Publications; 1999;37-70.
23. Stange KC, Zyzanski SJ, Jáen CR, et al. Illuminating the ‘black box’: a description of 4454 patient visits to 138 family physicians. J Fam Pract 1998;46:377-89.
24. Pommerenke FA, Dietrich A. Improving and maintaining preventive services part 1: applying the patient model. J Fam Pract 1992;34:86-91.
25. Miller W, Crabtree B. Depth interviewing. In: Crabtree B, Miller W, eds. Doing qualitative research. 2nd ed. Thousand Oaks, Calif: Sage Publications; 1999;89-108.
26. McIlvain H, Crabtree B, Medder J, Stange KC, Miller WL. Using practice genograms to understand and describe practice configurations. Fam Med 1998;30:490-96.
27. Ray LD. Qualitative data management using Folio VIEWS. Qual Health Res 1997;7:301-08.
28. Borkan J. Immersion/crystallization. In: Crabtree B, Miller W, eds. Doing qualitative research. 2 ed. Thousand Oaks, Calif: Sage Publications; 1999;179-94.
29. Crabtree B, Miller W. Using codes and code manuals: a template organizing style of interpretation. In: Crabtree B, Miller W, eds. Doing qualitative research. 2nd ed. Thousand Oaks, Calif: Sage Publications; 1999;163-78.
30. Miles MB, Huberman AM. Qualitative data analysis: an expanded sourcebook. 2nd ed. Thousand Oaks, Calif: Sage Publications; 1994;239-44.
31. Ziegler MG, Lew P, Singer BC. The accuracy of drug information from pharmaceutical sales representatives. JAMA 1995;273:1296-98.
32. Drake D, Uhlman M. Making medicine, making money. Kansas City, Mo: Andrews & McMeel; 1993;27.
METHODS: We collected detailed descriptive field notes of the direct observations of 53 primary care clinicians and 1588 patient encounters in 18 purposefully selected Nebraska family practices. We used a comparative case study design, that used depth interviews of clinicians and office staff, and included details of the interactions with pharmaceutical representatives and the use of samples in clinical encounters.
RESULTS: Individual providers and practices displayed noticeable variation in their approaches to drug representatives and samples. We found formal strategies and policies in a minority of practices. Generally there was little structure in the organization and distribution of sample medications at the office level, and detailed patient education regarding these drugs was rarely observed in patient encounters. Nevertheless, samples were used in almost 20% of observed encounters, at times as starter dosages, but often as complete courses of treatment. The benefits derived from contact with the pharmaceutical industry varied substantially, but most often included free medication samples, meals, and patient education materials.
CONCLUSIONS: Clinicians have a complex symbiosis with the pharmaceutical industry and need to critically evaluate their handling of samples and their contact with pharmaceutical representatives to optimize this relationship and ensure quality patient care. Clinics with specific policies for interactions with drug companies appear to derive more satisfaction from their encounters.
The world of medicine is permeated by the influence of the pharmaceutical industry, which spends an estimated $10 billion (more than $13,000 per physician) each year on drug promotion.1 This industry’s influence extends from medical education to clinical research and patient care.2 For example, medical journals and medical conferences are supported by pharmaceutical advertising or depend on financial contributions from pharmaceutical companies to offer their programs. Pharmaceutical companies grant a variety of scholarships and subsidies. The pharmaceutical industry also reinvests a portion of its profits to support new research and development, including hundreds of clinical trials reported each year in the scientific literature.3 Up-to-date drug detailing and continuing medical education (CME) is offered to clinicians, and patient education materials are frequently made available to practices. Patients, especially those with a lower income, benefit from receiving free medication samples donated by pharmaceutical companies.
Pharmaceutical companies, health care providers, and patients represent unique interests that may at times overlap. How the interactions between physicians and pharmaceutical representatives influence prescribing habits, decision making, and physician behavior in general is a contestable topic that has not been well studied or thoroughly understood. In the last several years, medical organizations in the United States and Canada have released discussion papers and policy statements about the relationship between the medical profession and the pharmaceutical industry.3 Whether the influence of the pharmaceutical industry is ultimately beneficial or detrimental remains a contentious and complex topic shrouded in much controversy.4-15
The interactions between the pharmaceutical industry and physicians have been discussed in a plethora of publications. Several of these articles have focused on the ethical implications of these interactions and the potential for exploitation; however, they have commonly been based on surveys and self-reporting and have often been limited to providers in academic or residency training contexts.3,16-21 Brotzman and Mark16 encourage the development of more comprehensive policies for residency training purposes. Kelcher and coworkers19 promote the concept of a structured educational program to prepare residents for future contact with the pharmaceutical industry. Lexchin9 discusses the need for critical comparison when evaluating drug information received from pharmaceutical representatives.
So how do family practice clinicians approach this challenging relationship? Through direct observation of these interactions within the private practice context, we attempted to add a new and vital dimension to the assessment of this rather complex symbiosis. We describe the approaches and reactions of individual family physicians and their practices to pharmaceutical representatives.
Methods
The Prevention and Competing Demands in Primary Care Practice study was designed to examine the organizational contexts that support or inhibit the delivery of preventive services in family medicine practices. Eighteen practices were studied using a multimethod ethnographic design that involved extensive observational field notes of the office system and the clinical encounters. These notes were collected by a researcher who spent at least 4 weeks in each practice. A total of 44 physicians and 9 other clinicians were shadowed, and approximately 1600 patient encounters were directly observed. Individual depth interviews were conducted with each clinician and many of the practice staff to obtain their perceptions.
Sampling
The comparative case study design began with an initial phase of purposefully selecting practices that included both urban and rural settings and those with different intensities of preventive services delivery, (n=10) followed by a sample to confirm or refute evolving hypotheses (n=8). The practices were selected from those that had participated in the Centers for Disease Control and Prevention/Nebraska Department of Health–funded Tobacco Use Prevention in Physicians Offices study (Helen McIlvain, principal investigator). These high-volume practices had a wide variation in practice location (urban, suburban, and rural) and organizational structure (solo vs group, independent vs system affiliated). Because we noted some interesting variations among practices from different health systems in the early analyses, the replication sample ensured at least 2 practices from each of 4 major health systems, and 2 from those practices that were seen as struggling to provide preventive services in the tobacco study.
We solicited study participation by sending an invitation letter followed by a telephone call to one of the physicians in the practice. Participation was very high, requiring contact with 23 practices to obtain the 18 deemed necessary in the study design.
Data Collection
We sent a field researcher trained in qualitative methods to each practice where she used a variety of data collection methods to produce a comprehensive picture of the practice as a functioning organization. Data were collected through direct observation of the practice,22 the use of structured checklists of the office environment,23 direct observation of patient encounters supplemented with structured checklists, the use of patient pathways,24 individual depth interviews with physicians and other key staff members,25 and chart audits. It took from 4 to 12 weeks for the field researcher to complete the data collection in each practice, depending on its size.
The field researcher observed and jotted details of the physical environment and functioning of the practice, then dictated extensive field notes at the end of each day. These field notes contained detailed descriptions of the clinic location and environment, patient characteristics, nursing station, examination rooms, the waiting area, physician offices, bulletin boards, posters, and patient education materials. Photographs were taken of each room, including the reception area, waiting area, nurses’ station, nurse intake room, and the examination rooms. Existing practice personnel, their roles and duties, and their relationships and interactions with other staff members were characterized in a practice genogram.26 Physical office systems, including charts, flow sheets, and computer systems were described, as were functional office routines and procedures. The field researcher specifically noted the storage and organization of drug samples within the clinic, comments made by staff relating to pharmaceutical representatives, and any observed interaction between staff and representatives.
The field researcher attempted to observe 30 patient encounters for each clinician; because of patient volume and scheduling this was not always possible. Thirty or more patient encounters were observed in 42 of the 53 clinicians participating in the study, and 20 or more patient encounters were observed for all but 1 provider (who had 18 encounters). After obtaining written informed consent from the patient, the field researcher shadowed the clinician and jotted notes about each encounter for later dictation. The patient encounter field notes contained rich descriptions about any verbal patient education delivered and the context of that education, including the reason for the visit, how the visit unfolded, and how the clinician and patient interacted. The patient encounter dictation captured the distribution of drug samples, discussion between the clinician and patient regarding drug samples, prescriptions written by physicians, and instructions given by physicians.
Using the depth interviewing technique, the field researcher interviewed all family physicians within the practice, the office manager, head nurse, and other significant persons within the practice.25 Questions asked by the field researcher related to overall views of medicine, general practice characteristics, the systems in place for the delivery of preventive medicine, and perceived rates of delivering preventive medicine. These interviews were tape-recorded and transcribed verbatim.
Additional data such as photographs and chart audits were collected as part of the larger study but were not included in our analysis.
Data Analysis and Interpretation
Qualitative data were transcribed, checked for accuracy by having the field worker review the manuscript, and entered into FolioViews 4.11, an infobase software package.27 We began our analysis by immersing ourselves in all the data from 2 practices to understand the function of the practices and the overall richness and variation of the data collected, and to identify any mention of drug samples or interactions with pharmaceutical representatives. Using this immersion/crystallization approach, we worked to formulate hypotheses and an initial organizational scheme.28 Group discussions led to the development of a codebook of key words.
Two investigators then performed computer word searches on the infobases of the 2 previously selected practices using the codebook. All relevant passages were tagged and printed, and the information retrieved was compared with data identified from an earlier in-depth reading of the transcripts from the 2 practices we initially studied. The word search technique and template organizing style was used to identify relevant portions of 4 more practices for secondary data analysis.29
Finally, segments of the selected field notes and patient encounter notes that described drug samples and pharmaceutical representatives were identified and organized into preliminary tables or matrices.30 After constructing matrices for the 6 selected practices we held discussions and further refined the organization and categories within the matrices. Once the matrices were refined they were used to organize relevant data identified by word searches for the rest of the 18 practices in the sample. The matrices served as the framework for data analysis, allowed the visualization of emergent patterns, and facilitated comparisons across physicians and practices.
Results
Individual clinicians and their practices displayed noticeable variation in their approaches to pharmaceutical representatives and the use of samples. Our analysis revealed patterns with respect to the types of contact they have with the pharmaceutical representatives, their use of sample medication, and the relative benefits obtained from the interactions.
Contact with the Pharmaceutical Representatives
All 18 practices had some form of contact with the pharmaceutical industry. This contact ranged from scheduled and well-organized meeting times to random interactions. Formal strategies and policies regarding drug representative interactions and the use of samples were in place in 8 of the 18 practices (44%). One other practice voiced a concern regarding the need for such a policy.
Most of the 8 clinics that had a formal plan or policy preferred a specific time (such as the lunch hour) during which the physicians and staff could meet with the representative. Some practices determined which days and times would be most convenient for their staff. One clinic made the clinician’s schedule available, thus allowing the representatives to schedule visits accordingly. One rural physician even allotted 30-minute patient appointment times to each representative to optimize the quality of these interactions. These lengthy visits facilitated more extensive drug detailing and CME, and generated an ample supply of samples, which were used to serve the needs of this particular rural community. A receptionist in another clinic was found to simply use a chalkboard to notify the staff whenever a representative had set up a presentation in the office. All of these measures appeared to be effective in minimizing confusion, distraction, and schedule disruption.
The remaining 10 practices displayed more haphazard dealings with drug representatives. These included brief hallway meetings that happened when clinicians were confronted by a representative as they exited the examination room. Other pharmaceutical representatives waited in medication sample rooms, hoping to catch the physicians as they searched for samples. These casual relationships were, at times, counterproductive. In one practice the physicians seemed oblivious to when “drug lunches” were scheduled, leading to frustration on the part of the pharmaceutical representatives; in another, the physician found herself rudely interrupted by an imposing representative during her own lunch.
Usage and Storage of Sample Medication
In the 18 practices, medication samples were used in 19.8% of the 1588 observed patient encounters. Multiple drugs were dispensed in 14.6% of the encounters in which samples were used. In only 5.1% of cases was a medication dispensed as a result of a patient’s specific request; the clinician usually initiated the distribution of samples. Drug samples were also offered to additional family members in 3.5% of encounters, sometimes even when these individuals were not accompanying the patient to the given appointment. This appeared to be particularly common in certain rural practices where the clinicians seemed sensitive to the needs of their patients and their families.
A review of the types of medication dispensed revealed noticeable trends and pointed to a prevalence of certain medication categories [Table 1]. The top 4 categories included asthma and allergy remedies, anti-infective agents, analgesics and anti-inflammatory medications, and antihypertensive drugs. These major categories accounted for more than 63% of all drugs dispensed.
The duration for which these medication samples were given varied from starter dosages (lasting 1-3 days) to complete courses of treatments (eg, a course of antibiotics) to amounts sufficient to supply the patients’ needs for several months (eg, antidepressants). The analysis of the clinician’s intent when dispensing samples identified that some were using samples to test for efficacy and tolerability while others were attempting to offer temporary relief or convenience to the patient. Also, certain physicians were clearly concerned about cost savings for their patients. The use of medication samples could be seen to represent tangible benefits to the individual patient.
Instructions accompanied the dispensing of samples in 150 (47.8%) of the cases and were predominantly verbal in nature. Dosing appeared to be the main focus, and little to no attention was given to more detailed information, such as whether the medication should be taken with meals. Drug interactions were not routinely discussed.
The majority of dispensing was done by physicians, physician assistants, and nurse practitioners. In some clinics, office staff had access to samples and were asked to consult with the physician before using these samples. Personal use of samples was documented in at least 4 practices, and in 2 of these the nurses were described as “helping themselves.” One particular clinic even voiced concerns about patients having unsupervised access and mentioned the need to develop a drug policy.
Dispensing patterns varied significantly among the clinics. Certain practices, especially those in rural, underserved communities, were found to dispense more liberally than others. These clinics appeared to be particularly sensitive to the needs of the individual patients and those of the greater community. In one practice, medication was handed out in 39.2% of encounters. On one occasion the physician waited until after the pharmaceutical representative had delivered an adequate supply of the necessary medication to give it to the patient. In contrast, clinicians in a particular suburban clinic only dispensed drugs 4.4% of the time.
However, even within a given practice, vast individual variances existed for each clinician in their approach to samples. In one clinic, 2 of the partners displayed disparate habits: One physician used samples regularly (in 41.9% of observed encounters), and the other only did so on rare occasions (in 3.2% of observed encounters). Of all the 18 sites, the physician who dispensed samples most frequently did so in 56.7% of observed encounters; the physician, however, at the other end of the spectrum dispensed medications in 2.4% of the observed patient encounters.
Of the 18 practices, 9 made use of specific closets or rooms for the storage of medication samples. One particular practice boasted an extraordinary and meticulously organized shelving system, complete with labeled bins and demarcated sections. The medical assistant in whose office these medications were stored was responsible for dispensing the ordered medications. In contrast to this efficient system, most clinics displayed very little structure in the organization and dispensing of samples. One clinic was described as having an overfilled, disorganized stack of shelves where medications were placed alongside vitamin supplements and herbal products. In this clinic staff spent vast amounts of time searching for the appropriate samples.
Only one clinic kept the sample room locked; another office had placed a notice on the door to keep it shut. It is important to note, however, that these storage places did not contain narcotics or similarly scheduled medications. In spite of Health Care Financing Administration regulations, we did not find any documentation to support which samples with which serial numbers had been distributed to patients, making effective recalls almost impossible. Stocks were most often replenished during routine drug representative visits. In one of the sites the head nurse kept in contact with the representatives and notified them when additional stocks were needed.
Benefits of These Interactions
We found that physicians and patients gained some advantage from their dealings with drug companies. The benefits the practices obtained from their contact with the pharmaceutical industry varied substantially. Other than medication samples, the most commonly observed benefits included the provision of meals, treats, and patient education materials [Table 2].
Patients also profited in a spectrum of ways. While samples represented tangible cost savings, immediate relief, and convenience to the individual patient (and occasionally to their family members), patient education materials facilitated further understanding of their diagnosis, potentially leading to a higher degree of satisfaction with their health care.
Discussion
Our study suggests that the relationship between the pharmaceutical industry and clinicians is symbiotic. It is a complex relationship that deserves objective analysis regarding its virtues and pitfalls.
Although it is essential to acknowledge the extent of the pharmaceutical industry’s influence, it is equally important to recognize and enhance the opportunities that clinicians have to direct this relationship. Our data suggest that clinics with existing policies for interactions with drug companies appear to derive more satisfaction and less frustration from their encounters. Formal meeting times eliminated unwanted interruptions and distractions from patient care and made the interactions more meaningful. Physicians who negotiated extensive and structured contact with drug representatives often received regular visits and generous supplies of both samples and patient education materials. Drug representative briefings, even though these needed to be viewed with healthy skepticism, also constituted a welcome form of CME for certain physicians.31
We found, however, that many offices do not have formal policies regarding pharmaceutical representatives and use questionable sample handling and storage practices. Interactions with pharmaceutical representatives can also be time consuming, potentially affecting the patient care schedule. Dispensing medications in the office setting may lead to increased responsibility and liability. We found that few clinicians provided extensive patient education about the samples they dispensed. Physicians need to be cognizant of the fact that they are bypassing the pharmacist. Directions to the patient need to be clear and comprehensive, addressing issues such as polypharmacy and drug-drug interactions. In addition, physicians should remain mindful of their own vulnerability with respect to the pharmaceutical industry’s influence over their prescribing habits. Drug detailing, even when insightful, may be biased.
Conclusions
The management of office visits with pharmaceutical representatives and the distribution of medication samples need to be addressed. Clinics with specific policies for interactions with drug companies appear to derive more satisfaction from their encounters. Practices should also maintain specific strategies when it comes to dispensing samples and should develop patterns of accountability for the handling of samples in the office.
Future research should include issues such as the impact of the pharmaceutical representative’s visit on patient finances, attitudes, disease management, and the physician-patient relationship. Further work is needed in the area of prescribing habits and the factors influencing physician decision making. More information on these topics may ultimately define and establish a relationship between the physician and the pharmaceutical industry that protects and promotes the interests of patients.
Acknowledgments
Our work was supported by a grant from the Agency for Health Care Policy and Research (1RO1 HS08776) to Benjamin Crabtree, PhD.
METHODS: We collected detailed descriptive field notes of the direct observations of 53 primary care clinicians and 1588 patient encounters in 18 purposefully selected Nebraska family practices. We used a comparative case study design, that used depth interviews of clinicians and office staff, and included details of the interactions with pharmaceutical representatives and the use of samples in clinical encounters.
RESULTS: Individual providers and practices displayed noticeable variation in their approaches to drug representatives and samples. We found formal strategies and policies in a minority of practices. Generally there was little structure in the organization and distribution of sample medications at the office level, and detailed patient education regarding these drugs was rarely observed in patient encounters. Nevertheless, samples were used in almost 20% of observed encounters, at times as starter dosages, but often as complete courses of treatment. The benefits derived from contact with the pharmaceutical industry varied substantially, but most often included free medication samples, meals, and patient education materials.
CONCLUSIONS: Clinicians have a complex symbiosis with the pharmaceutical industry and need to critically evaluate their handling of samples and their contact with pharmaceutical representatives to optimize this relationship and ensure quality patient care. Clinics with specific policies for interactions with drug companies appear to derive more satisfaction from their encounters.
The world of medicine is permeated by the influence of the pharmaceutical industry, which spends an estimated $10 billion (more than $13,000 per physician) each year on drug promotion.1 This industry’s influence extends from medical education to clinical research and patient care.2 For example, medical journals and medical conferences are supported by pharmaceutical advertising or depend on financial contributions from pharmaceutical companies to offer their programs. Pharmaceutical companies grant a variety of scholarships and subsidies. The pharmaceutical industry also reinvests a portion of its profits to support new research and development, including hundreds of clinical trials reported each year in the scientific literature.3 Up-to-date drug detailing and continuing medical education (CME) is offered to clinicians, and patient education materials are frequently made available to practices. Patients, especially those with a lower income, benefit from receiving free medication samples donated by pharmaceutical companies.
Pharmaceutical companies, health care providers, and patients represent unique interests that may at times overlap. How the interactions between physicians and pharmaceutical representatives influence prescribing habits, decision making, and physician behavior in general is a contestable topic that has not been well studied or thoroughly understood. In the last several years, medical organizations in the United States and Canada have released discussion papers and policy statements about the relationship between the medical profession and the pharmaceutical industry.3 Whether the influence of the pharmaceutical industry is ultimately beneficial or detrimental remains a contentious and complex topic shrouded in much controversy.4-15
The interactions between the pharmaceutical industry and physicians have been discussed in a plethora of publications. Several of these articles have focused on the ethical implications of these interactions and the potential for exploitation; however, they have commonly been based on surveys and self-reporting and have often been limited to providers in academic or residency training contexts.3,16-21 Brotzman and Mark16 encourage the development of more comprehensive policies for residency training purposes. Kelcher and coworkers19 promote the concept of a structured educational program to prepare residents for future contact with the pharmaceutical industry. Lexchin9 discusses the need for critical comparison when evaluating drug information received from pharmaceutical representatives.
So how do family practice clinicians approach this challenging relationship? Through direct observation of these interactions within the private practice context, we attempted to add a new and vital dimension to the assessment of this rather complex symbiosis. We describe the approaches and reactions of individual family physicians and their practices to pharmaceutical representatives.
Methods
The Prevention and Competing Demands in Primary Care Practice study was designed to examine the organizational contexts that support or inhibit the delivery of preventive services in family medicine practices. Eighteen practices were studied using a multimethod ethnographic design that involved extensive observational field notes of the office system and the clinical encounters. These notes were collected by a researcher who spent at least 4 weeks in each practice. A total of 44 physicians and 9 other clinicians were shadowed, and approximately 1600 patient encounters were directly observed. Individual depth interviews were conducted with each clinician and many of the practice staff to obtain their perceptions.
Sampling
The comparative case study design began with an initial phase of purposefully selecting practices that included both urban and rural settings and those with different intensities of preventive services delivery, (n=10) followed by a sample to confirm or refute evolving hypotheses (n=8). The practices were selected from those that had participated in the Centers for Disease Control and Prevention/Nebraska Department of Health–funded Tobacco Use Prevention in Physicians Offices study (Helen McIlvain, principal investigator). These high-volume practices had a wide variation in practice location (urban, suburban, and rural) and organizational structure (solo vs group, independent vs system affiliated). Because we noted some interesting variations among practices from different health systems in the early analyses, the replication sample ensured at least 2 practices from each of 4 major health systems, and 2 from those practices that were seen as struggling to provide preventive services in the tobacco study.
We solicited study participation by sending an invitation letter followed by a telephone call to one of the physicians in the practice. Participation was very high, requiring contact with 23 practices to obtain the 18 deemed necessary in the study design.
Data Collection
We sent a field researcher trained in qualitative methods to each practice where she used a variety of data collection methods to produce a comprehensive picture of the practice as a functioning organization. Data were collected through direct observation of the practice,22 the use of structured checklists of the office environment,23 direct observation of patient encounters supplemented with structured checklists, the use of patient pathways,24 individual depth interviews with physicians and other key staff members,25 and chart audits. It took from 4 to 12 weeks for the field researcher to complete the data collection in each practice, depending on its size.
The field researcher observed and jotted details of the physical environment and functioning of the practice, then dictated extensive field notes at the end of each day. These field notes contained detailed descriptions of the clinic location and environment, patient characteristics, nursing station, examination rooms, the waiting area, physician offices, bulletin boards, posters, and patient education materials. Photographs were taken of each room, including the reception area, waiting area, nurses’ station, nurse intake room, and the examination rooms. Existing practice personnel, their roles and duties, and their relationships and interactions with other staff members were characterized in a practice genogram.26 Physical office systems, including charts, flow sheets, and computer systems were described, as were functional office routines and procedures. The field researcher specifically noted the storage and organization of drug samples within the clinic, comments made by staff relating to pharmaceutical representatives, and any observed interaction between staff and representatives.
The field researcher attempted to observe 30 patient encounters for each clinician; because of patient volume and scheduling this was not always possible. Thirty or more patient encounters were observed in 42 of the 53 clinicians participating in the study, and 20 or more patient encounters were observed for all but 1 provider (who had 18 encounters). After obtaining written informed consent from the patient, the field researcher shadowed the clinician and jotted notes about each encounter for later dictation. The patient encounter field notes contained rich descriptions about any verbal patient education delivered and the context of that education, including the reason for the visit, how the visit unfolded, and how the clinician and patient interacted. The patient encounter dictation captured the distribution of drug samples, discussion between the clinician and patient regarding drug samples, prescriptions written by physicians, and instructions given by physicians.
Using the depth interviewing technique, the field researcher interviewed all family physicians within the practice, the office manager, head nurse, and other significant persons within the practice.25 Questions asked by the field researcher related to overall views of medicine, general practice characteristics, the systems in place for the delivery of preventive medicine, and perceived rates of delivering preventive medicine. These interviews were tape-recorded and transcribed verbatim.
Additional data such as photographs and chart audits were collected as part of the larger study but were not included in our analysis.
Data Analysis and Interpretation
Qualitative data were transcribed, checked for accuracy by having the field worker review the manuscript, and entered into FolioViews 4.11, an infobase software package.27 We began our analysis by immersing ourselves in all the data from 2 practices to understand the function of the practices and the overall richness and variation of the data collected, and to identify any mention of drug samples or interactions with pharmaceutical representatives. Using this immersion/crystallization approach, we worked to formulate hypotheses and an initial organizational scheme.28 Group discussions led to the development of a codebook of key words.
Two investigators then performed computer word searches on the infobases of the 2 previously selected practices using the codebook. All relevant passages were tagged and printed, and the information retrieved was compared with data identified from an earlier in-depth reading of the transcripts from the 2 practices we initially studied. The word search technique and template organizing style was used to identify relevant portions of 4 more practices for secondary data analysis.29
Finally, segments of the selected field notes and patient encounter notes that described drug samples and pharmaceutical representatives were identified and organized into preliminary tables or matrices.30 After constructing matrices for the 6 selected practices we held discussions and further refined the organization and categories within the matrices. Once the matrices were refined they were used to organize relevant data identified by word searches for the rest of the 18 practices in the sample. The matrices served as the framework for data analysis, allowed the visualization of emergent patterns, and facilitated comparisons across physicians and practices.
Results
Individual clinicians and their practices displayed noticeable variation in their approaches to pharmaceutical representatives and the use of samples. Our analysis revealed patterns with respect to the types of contact they have with the pharmaceutical representatives, their use of sample medication, and the relative benefits obtained from the interactions.
Contact with the Pharmaceutical Representatives
All 18 practices had some form of contact with the pharmaceutical industry. This contact ranged from scheduled and well-organized meeting times to random interactions. Formal strategies and policies regarding drug representative interactions and the use of samples were in place in 8 of the 18 practices (44%). One other practice voiced a concern regarding the need for such a policy.
Most of the 8 clinics that had a formal plan or policy preferred a specific time (such as the lunch hour) during which the physicians and staff could meet with the representative. Some practices determined which days and times would be most convenient for their staff. One clinic made the clinician’s schedule available, thus allowing the representatives to schedule visits accordingly. One rural physician even allotted 30-minute patient appointment times to each representative to optimize the quality of these interactions. These lengthy visits facilitated more extensive drug detailing and CME, and generated an ample supply of samples, which were used to serve the needs of this particular rural community. A receptionist in another clinic was found to simply use a chalkboard to notify the staff whenever a representative had set up a presentation in the office. All of these measures appeared to be effective in minimizing confusion, distraction, and schedule disruption.
The remaining 10 practices displayed more haphazard dealings with drug representatives. These included brief hallway meetings that happened when clinicians were confronted by a representative as they exited the examination room. Other pharmaceutical representatives waited in medication sample rooms, hoping to catch the physicians as they searched for samples. These casual relationships were, at times, counterproductive. In one practice the physicians seemed oblivious to when “drug lunches” were scheduled, leading to frustration on the part of the pharmaceutical representatives; in another, the physician found herself rudely interrupted by an imposing representative during her own lunch.
Usage and Storage of Sample Medication
In the 18 practices, medication samples were used in 19.8% of the 1588 observed patient encounters. Multiple drugs were dispensed in 14.6% of the encounters in which samples were used. In only 5.1% of cases was a medication dispensed as a result of a patient’s specific request; the clinician usually initiated the distribution of samples. Drug samples were also offered to additional family members in 3.5% of encounters, sometimes even when these individuals were not accompanying the patient to the given appointment. This appeared to be particularly common in certain rural practices where the clinicians seemed sensitive to the needs of their patients and their families.
A review of the types of medication dispensed revealed noticeable trends and pointed to a prevalence of certain medication categories [Table 1]. The top 4 categories included asthma and allergy remedies, anti-infective agents, analgesics and anti-inflammatory medications, and antihypertensive drugs. These major categories accounted for more than 63% of all drugs dispensed.
The duration for which these medication samples were given varied from starter dosages (lasting 1-3 days) to complete courses of treatments (eg, a course of antibiotics) to amounts sufficient to supply the patients’ needs for several months (eg, antidepressants). The analysis of the clinician’s intent when dispensing samples identified that some were using samples to test for efficacy and tolerability while others were attempting to offer temporary relief or convenience to the patient. Also, certain physicians were clearly concerned about cost savings for their patients. The use of medication samples could be seen to represent tangible benefits to the individual patient.
Instructions accompanied the dispensing of samples in 150 (47.8%) of the cases and were predominantly verbal in nature. Dosing appeared to be the main focus, and little to no attention was given to more detailed information, such as whether the medication should be taken with meals. Drug interactions were not routinely discussed.
The majority of dispensing was done by physicians, physician assistants, and nurse practitioners. In some clinics, office staff had access to samples and were asked to consult with the physician before using these samples. Personal use of samples was documented in at least 4 practices, and in 2 of these the nurses were described as “helping themselves.” One particular clinic even voiced concerns about patients having unsupervised access and mentioned the need to develop a drug policy.
Dispensing patterns varied significantly among the clinics. Certain practices, especially those in rural, underserved communities, were found to dispense more liberally than others. These clinics appeared to be particularly sensitive to the needs of the individual patients and those of the greater community. In one practice, medication was handed out in 39.2% of encounters. On one occasion the physician waited until after the pharmaceutical representative had delivered an adequate supply of the necessary medication to give it to the patient. In contrast, clinicians in a particular suburban clinic only dispensed drugs 4.4% of the time.
However, even within a given practice, vast individual variances existed for each clinician in their approach to samples. In one clinic, 2 of the partners displayed disparate habits: One physician used samples regularly (in 41.9% of observed encounters), and the other only did so on rare occasions (in 3.2% of observed encounters). Of all the 18 sites, the physician who dispensed samples most frequently did so in 56.7% of observed encounters; the physician, however, at the other end of the spectrum dispensed medications in 2.4% of the observed patient encounters.
Of the 18 practices, 9 made use of specific closets or rooms for the storage of medication samples. One particular practice boasted an extraordinary and meticulously organized shelving system, complete with labeled bins and demarcated sections. The medical assistant in whose office these medications were stored was responsible for dispensing the ordered medications. In contrast to this efficient system, most clinics displayed very little structure in the organization and dispensing of samples. One clinic was described as having an overfilled, disorganized stack of shelves where medications were placed alongside vitamin supplements and herbal products. In this clinic staff spent vast amounts of time searching for the appropriate samples.
Only one clinic kept the sample room locked; another office had placed a notice on the door to keep it shut. It is important to note, however, that these storage places did not contain narcotics or similarly scheduled medications. In spite of Health Care Financing Administration regulations, we did not find any documentation to support which samples with which serial numbers had been distributed to patients, making effective recalls almost impossible. Stocks were most often replenished during routine drug representative visits. In one of the sites the head nurse kept in contact with the representatives and notified them when additional stocks were needed.
Benefits of These Interactions
We found that physicians and patients gained some advantage from their dealings with drug companies. The benefits the practices obtained from their contact with the pharmaceutical industry varied substantially. Other than medication samples, the most commonly observed benefits included the provision of meals, treats, and patient education materials [Table 2].
Patients also profited in a spectrum of ways. While samples represented tangible cost savings, immediate relief, and convenience to the individual patient (and occasionally to their family members), patient education materials facilitated further understanding of their diagnosis, potentially leading to a higher degree of satisfaction with their health care.
Discussion
Our study suggests that the relationship between the pharmaceutical industry and clinicians is symbiotic. It is a complex relationship that deserves objective analysis regarding its virtues and pitfalls.
Although it is essential to acknowledge the extent of the pharmaceutical industry’s influence, it is equally important to recognize and enhance the opportunities that clinicians have to direct this relationship. Our data suggest that clinics with existing policies for interactions with drug companies appear to derive more satisfaction and less frustration from their encounters. Formal meeting times eliminated unwanted interruptions and distractions from patient care and made the interactions more meaningful. Physicians who negotiated extensive and structured contact with drug representatives often received regular visits and generous supplies of both samples and patient education materials. Drug representative briefings, even though these needed to be viewed with healthy skepticism, also constituted a welcome form of CME for certain physicians.31
We found, however, that many offices do not have formal policies regarding pharmaceutical representatives and use questionable sample handling and storage practices. Interactions with pharmaceutical representatives can also be time consuming, potentially affecting the patient care schedule. Dispensing medications in the office setting may lead to increased responsibility and liability. We found that few clinicians provided extensive patient education about the samples they dispensed. Physicians need to be cognizant of the fact that they are bypassing the pharmacist. Directions to the patient need to be clear and comprehensive, addressing issues such as polypharmacy and drug-drug interactions. In addition, physicians should remain mindful of their own vulnerability with respect to the pharmaceutical industry’s influence over their prescribing habits. Drug detailing, even when insightful, may be biased.
Conclusions
The management of office visits with pharmaceutical representatives and the distribution of medication samples need to be addressed. Clinics with specific policies for interactions with drug companies appear to derive more satisfaction from their encounters. Practices should also maintain specific strategies when it comes to dispensing samples and should develop patterns of accountability for the handling of samples in the office.
Future research should include issues such as the impact of the pharmaceutical representative’s visit on patient finances, attitudes, disease management, and the physician-patient relationship. Further work is needed in the area of prescribing habits and the factors influencing physician decision making. More information on these topics may ultimately define and establish a relationship between the physician and the pharmaceutical industry that protects and promotes the interests of patients.
Acknowledgments
Our work was supported by a grant from the Agency for Health Care Policy and Research (1RO1 HS08776) to Benjamin Crabtree, PhD.
1. Westfall JM, McCabe J, Nicholas RA. Personal use of drug samples by physicians and office staff. JAMA 1997;278:141-43.
2. Newton W, Goldstein A, Frey J. There is no such thing as a free lunch: developing policies on pharmaceutical industry support. J Fam Pract 1992;34:32-34.
3. Lexchin J. Interactions between physicians and the pharmaceutical industry: what does the literature say? CMAJ 1993;149:1401-07.
4. Arkinstall WW. Interaction between physicians and the pharmaceutical industry. CMAJ 1995;153:398-99.
5. Brotzman GL, Mark DH. Policy recommendations for pharmaceutical representative-resident interactions. Fam Med 1992;24:431-32.
6. Chren M-M, Landefeld CS, Murray TH. Doctors, drug companies, and gifts. JAMA 1989;262:3448-51.
7. Forrest JB. Faculties of health sciences and the pharmaceutical industry: an effective partnership. CMAJ 1994;151:1320-22.
8. Gibbons RV, Landry FJ, Blouch DL, et al. A comparison of physicians’ and patients’ attitudes toward pharmaceutical industry gifts. J Gen Intern Med 1998;13:151-54.
9. Lexchin J. What information do physicians receive from pharmaceutical representatives? Can Fam Physician 1997;43:941-45.
10. Madhavan S, Amonkar MM, Elliott D, Burke K, Gore P. The gift relationship between pharmaceutical companies and physicians: an exploratory survey of physicians. J Clin Pharm Ther 1997;22:207-15.
11. Orlowski JP, Wateska L. The effects of pharmaceutical firm enticements on physician prescribing patterns: there’s no such thing as a free lunch. Chest 1992;102:270-73.
12. So AD. Free gifts: redundancy or conundrum? J Gen Intern Med 1998;13:213-15.
13. Squires BP. Physicians and the pharmaceutical industry. CMAJ 1993;149:1391-92.
14. Tiner R. Pharmaceutical representatives: guidelines exist on making effective use of time spent with representatives. BMJ 1996;313:881.-
15. Wolfe SM. Why do American drug companies spend more than $12 billion a year pushing drugs? Is it education or promotion? Characteristics of materials distributed by drug companies: four points of view. J Gen Intern Med 1996;11:637-39.
16. Brotzman GL, Mark DH. Policies regulating the activities of pharmaceutical representatives in residency programs. J Fam Pract 1992;34:54-57.
17. Chren M-M, Landefeld CS. Physicians’ behavior and their interactions with drug companies: a controlled study of physicians who requested additions to a hospital drug formulary. JAMA 1994;271:684-89.
18. Hodges B. Interactions with the pharmaceutical industry: experiences and attitudes of psychiatry residents, interns and clerks. CMAJ 1995;153:553-59.
19. Kelcher S, Brownoff R, Meadows LM. Structured approach to pharmaceutical representatives: family medicine residency program. Can Fam Physician 1998;44:1053-60.
20. McKinney WP, Schiedermayer DL, Lurie N, Simpson DE, Goodman JL, Rich EC. Attitudes of internal medicine faculty and residents toward professional interaction with pharmaceutical sales representatives. JAMA 1990;264:1693-97.
21. Sergeant MD, Hodgetts PG, Godwin M, Walker DMC, McHenry P. Interactions with the pharmaceutical industry: a survey of family medicine residents in Ontario. CMAJ 1996;155:1243-48.
22. Bogdewic SP. Participant observation. In: Crabtree BF, Miller WL, eds. Doing qualitative research. 2nd ed. Thousand Oaks, Calif: Sage Publications; 1999;37-70.
23. Stange KC, Zyzanski SJ, Jáen CR, et al. Illuminating the ‘black box’: a description of 4454 patient visits to 138 family physicians. J Fam Pract 1998;46:377-89.
24. Pommerenke FA, Dietrich A. Improving and maintaining preventive services part 1: applying the patient model. J Fam Pract 1992;34:86-91.
25. Miller W, Crabtree B. Depth interviewing. In: Crabtree B, Miller W, eds. Doing qualitative research. 2nd ed. Thousand Oaks, Calif: Sage Publications; 1999;89-108.
26. McIlvain H, Crabtree B, Medder J, Stange KC, Miller WL. Using practice genograms to understand and describe practice configurations. Fam Med 1998;30:490-96.
27. Ray LD. Qualitative data management using Folio VIEWS. Qual Health Res 1997;7:301-08.
28. Borkan J. Immersion/crystallization. In: Crabtree B, Miller W, eds. Doing qualitative research. 2 ed. Thousand Oaks, Calif: Sage Publications; 1999;179-94.
29. Crabtree B, Miller W. Using codes and code manuals: a template organizing style of interpretation. In: Crabtree B, Miller W, eds. Doing qualitative research. 2nd ed. Thousand Oaks, Calif: Sage Publications; 1999;163-78.
30. Miles MB, Huberman AM. Qualitative data analysis: an expanded sourcebook. 2nd ed. Thousand Oaks, Calif: Sage Publications; 1994;239-44.
31. Ziegler MG, Lew P, Singer BC. The accuracy of drug information from pharmaceutical sales representatives. JAMA 1995;273:1296-98.
32. Drake D, Uhlman M. Making medicine, making money. Kansas City, Mo: Andrews & McMeel; 1993;27.
1. Westfall JM, McCabe J, Nicholas RA. Personal use of drug samples by physicians and office staff. JAMA 1997;278:141-43.
2. Newton W, Goldstein A, Frey J. There is no such thing as a free lunch: developing policies on pharmaceutical industry support. J Fam Pract 1992;34:32-34.
3. Lexchin J. Interactions between physicians and the pharmaceutical industry: what does the literature say? CMAJ 1993;149:1401-07.
4. Arkinstall WW. Interaction between physicians and the pharmaceutical industry. CMAJ 1995;153:398-99.
5. Brotzman GL, Mark DH. Policy recommendations for pharmaceutical representative-resident interactions. Fam Med 1992;24:431-32.
6. Chren M-M, Landefeld CS, Murray TH. Doctors, drug companies, and gifts. JAMA 1989;262:3448-51.
7. Forrest JB. Faculties of health sciences and the pharmaceutical industry: an effective partnership. CMAJ 1994;151:1320-22.
8. Gibbons RV, Landry FJ, Blouch DL, et al. A comparison of physicians’ and patients’ attitudes toward pharmaceutical industry gifts. J Gen Intern Med 1998;13:151-54.
9. Lexchin J. What information do physicians receive from pharmaceutical representatives? Can Fam Physician 1997;43:941-45.
10. Madhavan S, Amonkar MM, Elliott D, Burke K, Gore P. The gift relationship between pharmaceutical companies and physicians: an exploratory survey of physicians. J Clin Pharm Ther 1997;22:207-15.
11. Orlowski JP, Wateska L. The effects of pharmaceutical firm enticements on physician prescribing patterns: there’s no such thing as a free lunch. Chest 1992;102:270-73.
12. So AD. Free gifts: redundancy or conundrum? J Gen Intern Med 1998;13:213-15.
13. Squires BP. Physicians and the pharmaceutical industry. CMAJ 1993;149:1391-92.
14. Tiner R. Pharmaceutical representatives: guidelines exist on making effective use of time spent with representatives. BMJ 1996;313:881.-
15. Wolfe SM. Why do American drug companies spend more than $12 billion a year pushing drugs? Is it education or promotion? Characteristics of materials distributed by drug companies: four points of view. J Gen Intern Med 1996;11:637-39.
16. Brotzman GL, Mark DH. Policies regulating the activities of pharmaceutical representatives in residency programs. J Fam Pract 1992;34:54-57.
17. Chren M-M, Landefeld CS. Physicians’ behavior and their interactions with drug companies: a controlled study of physicians who requested additions to a hospital drug formulary. JAMA 1994;271:684-89.
18. Hodges B. Interactions with the pharmaceutical industry: experiences and attitudes of psychiatry residents, interns and clerks. CMAJ 1995;153:553-59.
19. Kelcher S, Brownoff R, Meadows LM. Structured approach to pharmaceutical representatives: family medicine residency program. Can Fam Physician 1998;44:1053-60.
20. McKinney WP, Schiedermayer DL, Lurie N, Simpson DE, Goodman JL, Rich EC. Attitudes of internal medicine faculty and residents toward professional interaction with pharmaceutical sales representatives. JAMA 1990;264:1693-97.
21. Sergeant MD, Hodgetts PG, Godwin M, Walker DMC, McHenry P. Interactions with the pharmaceutical industry: a survey of family medicine residents in Ontario. CMAJ 1996;155:1243-48.
22. Bogdewic SP. Participant observation. In: Crabtree BF, Miller WL, eds. Doing qualitative research. 2nd ed. Thousand Oaks, Calif: Sage Publications; 1999;37-70.
23. Stange KC, Zyzanski SJ, Jáen CR, et al. Illuminating the ‘black box’: a description of 4454 patient visits to 138 family physicians. J Fam Pract 1998;46:377-89.
24. Pommerenke FA, Dietrich A. Improving and maintaining preventive services part 1: applying the patient model. J Fam Pract 1992;34:86-91.
25. Miller W, Crabtree B. Depth interviewing. In: Crabtree B, Miller W, eds. Doing qualitative research. 2nd ed. Thousand Oaks, Calif: Sage Publications; 1999;89-108.
26. McIlvain H, Crabtree B, Medder J, Stange KC, Miller WL. Using practice genograms to understand and describe practice configurations. Fam Med 1998;30:490-96.
27. Ray LD. Qualitative data management using Folio VIEWS. Qual Health Res 1997;7:301-08.
28. Borkan J. Immersion/crystallization. In: Crabtree B, Miller W, eds. Doing qualitative research. 2 ed. Thousand Oaks, Calif: Sage Publications; 1999;179-94.
29. Crabtree B, Miller W. Using codes and code manuals: a template organizing style of interpretation. In: Crabtree B, Miller W, eds. Doing qualitative research. 2nd ed. Thousand Oaks, Calif: Sage Publications; 1999;163-78.
30. Miles MB, Huberman AM. Qualitative data analysis: an expanded sourcebook. 2nd ed. Thousand Oaks, Calif: Sage Publications; 1994;239-44.
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