Title: What You Should Know About Gifts to Physicians from Industry Module 3: Professionalism and Gifts to
1What You Should Know About Gifts to Physicians
from IndustryModule 3 Professionalism and Gifts
to Physicians from Industry
2Authors
- Beverley D. Rowley, PhD
- R. Van Harrison, PhD
- Andrew M. Thomas, MD, MBA
- Reviewers for this module included AMA staff and
Kenneth V. Iserson, MD, MBA, Director, Arizona
Bioethics Program, University of Arizona. - In collaboration with the Working Group for the
Communication of Ethical Guidelines on Gifts to
Physicians from Industry and its Educational
Advisory Committee chaired by R. Van Harrison,
PhD, University of Michigan Medical School. (See
http//www.ama-assn.org/ama/pub/category/8405.html
for information about the Working Group) - Project Manager Beverley D. Rowley, PhD, Medical
Education and Research Associates, Inc., Tempe,
Arizona.
3Disclosure of Conflict of Interest
- Authors have no relationship with companies who
provided unrestricted educational grants to this
program. - The content of this CME publication does not
contain discussion of off-label uses.
4Module Goals and Objectives
- Present research findings regarding the impact of
gifts on physicians behavior - Introduce the privileges and obligations of
physicians as members of a unique profession in
our society - Examine the potential for conflicts between
professional obligations to patients and personal
gifts from commercial companies - Introduce professional codes and other
regulations that guide professional behavior
5Topic 1 Research on the Effects of Gifts to
Physicians
- This topic addresses the impact of gifts on
- Residents
- Physician and public perception of prescribing
practices - Prescribing practices (actual impact)
- Formularies
6Gifts and Residents
- What percentage of residents surveyed were
carrying items with a pharmaceutical company logo
or product brand? - a) 79
- b) 88
- c) 97
7Gifts and Residents
- What percentage of residents surveyed were
carrying items with a pharmaceutical company logo
or product brand? - 97 of residents surveyed were carrying items
with a pharmaceutical company logo or product
brand on them. - 98 of residents surveyed had also eaten at least
one pharmaceutical company-provided meal sometime
in the previous 12 months.
8Gifts and Residents
- What percentage of residents surveyed
acknowledged that gifts and meals influenced
their prescribing patterns? - a) 79
- b) 87
- c) 91
9Gifts and Residents
- What percentage of residents surveyed
acknowledged that - gifts and meals influenced their prescribing
patterns? - 91 of residents surveyed acknowledged that gifts
and meals influenced their prescribing patterns. - As gifts influence prescribing patterns, they
decrease objectivity and increase the possibility
of prescribing based on decisions other than the
best interests of the patient.
10Gifts and Perception
- Studies found that compared to physicians,
patients were _________ to find gifts acceptable.
- a) less likely
- b) more likely
- c) just as likely
11Gifts and Perception
- Studies found that compared to physicians,
patients were _________ to find gifts acceptable.
- Less likely. Compared to physicians, patients
were more likely to find gifts inappropriate.
12Gifts and Perception
- Other studies found that compared to physicians,
patients were _________ to believe that gifts
from industry biased physicians decisions about
prescriptions. - a) less likely
- b) more likely
- c) just as likely
13Gifts and Perception
- Other studies found that compared to physicians,
patients were _________ to believe that gifts
from industry biased physicians decisions about
prescriptions. - More likely. Compared to physicians, patients
were more likely to believe that gifts from
industry biased physicians decisions about
prescriptions or that the physician may not have
the patients best interests in mind.
14Gifts and Prescribing Practices
- Is there a positive association between meetings
of pharmaceutical industry representatives and
physicians, and a change in prescribing
practices? - a) Yes
- b) No
15Gifts and Prescribing Practices
- Is there a positive association between meetings
of pharmaceutical industry representatives and
physicians, and a change in prescribing
practices? - Yes. A positive association was noted between
- meetings of pharmaceutical industry
representatives and physicians, and a change in
prescribing practices - accepting funding for travel or lodging and
prescribing practices
16Gifts and Prescribing Practices
Neslin, S. ROI. Analysis of Pharmaceutical
Promotion RAPP An Independent Study.
Accessed at http/www.rappstudy.org (May 2001)
17Gifts and Formularies
- Physicians who had accepted money from industry
to attend a conference, speak at a meeting, or
participate in a research project were __________
to request that drugs be added to a formulary. - a) less likely
- b) more likely
- c) just as likely
18Gifts and Formularies
- Physicians who had accepted money from industry
to attend a conference, speak at a meeting, or
participate in a research project were __________
to request that drugs be added to a formulary. - More likely. Physicians who requested that drugs
be added to a formulary were more likely to have
accepted money from industry to - attend a conference
- speak at a meeting
- participate in a research project
19Gifts and Formularies
- Physicians who requested that drugs be added to a
formulary were more likely to request that
_________ be added to the formulary. - a) any drug in the class
- b) generic equivalent drugs
- c) specific drugs by brand name
20Gifts and Formularies
- Physicians who requested that drugs be added to a
formulary were more likely to request that
_________ be added to the formulary. - Specific drugs by brand name. Physicians who
requested that drugs be added to a formulary were
more likely to request that specific drugs by
brand name be added to the formulary.
21Research on the Effects of Gifts to Physicians
Summary
- Studies and literature reviews show that gifts
from industry influence - prescribing patterns of residents and physicians
- formulary requests by physicians
- Accepting gifts may interfere with
physicianpatient relationships - These influences are recognized by the CEJA and
reflected in the Ethical Guideline on Gifts to
Physicians from Industry
22Topic 2 Professionalism Physicians Obligations
and Privileges
- Do physicians have special roles in society?
23Professionalism Physicians Obligations and
Privileges
- Do physicians have special roles in society?
- Yes! And understanding those special obligations
and privileges helps explain how gifts may
influence physicians is ways that conflict with
physicians special roles in society.
24Professionalism Physicians Obligations and
Privileges
- This topic explores the concept of
professionalism in terms of - The concept of a social contract between
physicians and society - An overview of the obligations and privileges of
physicians as a profession - The continuing evolution of societys
expectations of physicians
25Professionalism Physicians Obligations and
Privileges
- Organization statements of principles and
responsibilities - Principles of Medical Ethics of the AMA
- Declaration of Professional Responsibility
Medicines Social Contract with Humanity by the
AMA - Medical Professionalism in the New Millennium A
Physician Charter of the American Board of
Internal Medicine Foundation, ACP Foundation, and
European Federation of Internal Medicine
26Social Contract Between Society and the Medical
Profession
- Social contract? What contract? I never signed
- any contract! Resident quote
- Being part of a profession entails a societal
contract. The profession is granted a monopoly
over the use of a body of knowledge and the
privilege of self-regulation and, in return,
guarantees society professional competence,
integrity, and the provision of altruistic
service. - Cruess, SR, Johnston, S, Cruess, RL.
Professionalism for medicine opportunities and
obligations. Med J Aust. 2002177(4)208-211.
27Obligations and Privileges
- Physicians have the obligation to be competent in
their knowledge, its application, and its
integrity. - Failure to do so can endanger patients lives.
- IN RETURN,
- Physicians are given certain privileges
- Control over knowledge
- Considerable autonomy
- Prestige
- Financial rewards
28Obligations and Privileges
- Privileges or Rights
- Are not free
- Come with expectations of certain behavior on the
part of the physician - Obligations
- Competence
- Responsible actions
- Integrity and morality
- Altruism
- Accountability
- Service to others
- Regulation in profession
- Professional associations
29Obligations and Privileges
Privilege Control over a body of knowledge
- Laws, contracts, and customs give physicians
special privileges with the use of medical
knowledge - Physicians can view and touch individuals in ways
that could be a criminal violation if done by
others - The practice of medicine without a license is
illegal - Health insurance companies require that
healthcare be performed by or under the
supervision of physicians
30Obligations and Privileges
Obligation associated with control over knowledge
- Competence
- Appropriate knowledge and its application
- Knowledge is current
- Seeking and transmitting knowledge to others
31Obligations and Privileges
Privilege Considerable autonomy
- Within customary practice, physicians
- Apply medical knowledge with great latitude
- Exercise considerable individual judgment
- Prescribe FDA-approved medications, whether or
not labeled for the use intended by the PI - Remain largely unquestioned in their medical
judgments
32Obligations and Privileges
Obligations associated with professional autonomy
- Physicians accept certain obligations for their
actions - Integrity and morality Be honest and uphold
moral standards - Altruism Place needs of patients ahead of
personal self-interests - Accountability Be able and willing to explain
reasons for professional behavior to patients and
peer review committees - Service to others Work for the general health
of all people, placing the welfare of society
above your profession - Self-regulation within the profession Establish
mechanisms for professional accountability,
education, and discipline - Operate professional associations Establish and
support professional organizations to govern
standards of practice
33Obligations and Privileges
Obligations associated with professional autonomy
- The privilege of professional autonomy is
associated with physicians - Individually and jointly working in the best
interests of patients and society - Maintaining an infrastructure that assures
obligations are met now and in the future
34Obligations and Privileges
Privilege Prestige
- In a 2002 Harris Poll Survey, occupations were
publicly ranked according to their level of
prestige - Physicians and scientists topped the list of
professions considered to have very great
prestige - http//vr.harrispollonline.com/register/main.a
sp
35Obligations and Privileges
Privilege Financial rewards
- Physicians are able to maintain a standard of
living that is well above average - In 1998, a physicians median income was 4.5
times greater than the average worker - In 1999, the median physician income was 150,000
36Societys Evolving Expectations of Physicians
- Factors that affect societys on going
discussions and priorities regarding health care - Health care rights
- Governmental responsibility to provide health
care - Health care improvements that increase its cost
- Management of health priorities
- Expenditures, with limited resources
37Societys Evolving Expectations of Physicians
- As concerns shift, the boundaries of physician
obligations and privileges also shift. - Laws can be written to narrow/expand physician
latitude of autonomy - Professional codes of ethics are often updated to
incorporate new factors and situations - When societal change is rapid, misalignment
between ethics and law can occur, thereby causing
frustration
38Societys Evolving Expectations of Physicians
- How can physicians follow high professional
standards when societal priorities - are constantly evolving?
39Societys Evolving Expectations of Physicians
- Physicians should use their core professional
obligations as guides to assure that - Patients and society are benefited
- The profession continues to fulfill its societal
obligations
40Concepts of Professionalism Summary
41Topic 3 Conflicts between Professional
Obligations and Personal Gifts
- This topic will
- Contrast professional obligations with commercial
obligations - Identify how personal gifts from commercial
sources may conflict with physicians
professional obligations - Explain how the AMA Ethical Guidelines on Gifts
to Physicians from Industry helps physicians
avoid conflicts with their professional
obligations - Examine cases illustrating potential conflicts
42Differences between Commercial and Professional
Activities
- Societys assumptions about commercial
transactions do not always apply to health care
transactions - Physicians have obligations to patients in
recommending health care purchases - Special laws govern health care purchases
involving Medicare and Medicaid - practices that may be common or longstanding in
other businesses are not necessarily acceptable
or lawful when federal health care programs are
involved - OIG for the U.S. Department of Health and Human
Services
43Differences between Commercial and Professional
Activities
- What are some examples of the differences between
professional and commercial entities in relation
to the previously discussed professional
obligations and privileges?
44Differences between Commercial and Professional
Activities
45Differences between Commercial and Professional
Activities
- How do the obligations of commercial entities and
physicians differ in their obligations regarding
information about a drug?
46Differences between Commercial and Professional
Activities
47Differences in Professional and General
Commercial Standards
- An extensive marketing campaign may result in
physicians ordering a specific product more
frequently than they would a lesser known, but
more effective product. - From a general commercial perspective, the
marketing campaign would be a great success - From the professional perspective, this
commercial success could result in a transmission
of biased or incomplete knowledge to individual
physicians
48Differences in Professional and General
Commercial Standards
Summary points
- Professional and commercial activities can have
different standards - Although physicians are involved in commercial
transactions, their professional obligations
require that they have a higher standard of
behavior - Failure to recognize that different standards of
behavior apply to people in different roles can
result in confusion, misunderstanding, and
conflict - Recognizing that different standards legitimately
apply can help individuals work respectfully with
others
49Marketing, Gifts, Professional Obligations, and
AMA Ethical Guidelines
- Acting on behalf of patients, physicians as a
profession authorize the majority of national
health care expenditures. - In 2000, personal health care expenditures in the
U.S. totaled over a trillion dollars - Hospital care, physicians services and
prescription drugs accounted for 73 of
expenditures - Prescription drugs accounted for 11 of the total
50Marketing, Gifts, Professional Obligations, and
AMA Ethical Guidelines
- In general, marketing efforts
- Provide information about products and services
- Gain the attention of physicians, making them
aware of the information - Gain the good will of physicians, prompting them
to react favorably to the company
51Marketing, Gifts, Professional Obligations, and
AMA Ethical Guidelines
Effects of gifts and other inducements
- Inducements for a potential buyer
- Money or gift certificates
- Objects, such as books or computers
- Special meals
- Tickets to events
- Paid travel
- Overpayment for services
52Marketing, Gifts, Professional Obligations, and
AMA Ethical Guidelines
Effects of gifts and other inducements
- A pharmaceutical representative gives a physician
a pair of tickets to a sold-out athletic event.
What might be the pharmaceutical representatives
intentions for giving this gift?
53Marketing, Gifts, Professional Obligations, and
AMA Ethical Guidelines
Effects of gifts and other inducements
- The giving of a gift can
- Provoke feelings of goodwill toward the giver
- Provoke a feeling of indebtedness to the giver
- Raise the value/importance of the giver
- Enhance/further the relationship between the two
parties - Extend the duration of the relationship
- Imply compensation for services rendered
54Marketing, Gifts, Professional Obligations, and
AMA Ethical Guidelines
- In typical commercial transactions
- The recipient of a gift is usually also the
potential buyer - Gifts are intended to positively influence the
recipient - The buyer receives the benefit of the gift and
bears the consequences of purchasing decisions,
payment, and personally receiving the
product/service - Physicians
- Make buying decisions on behalf of patients
- Do not bear the consequences of cost,
inconvenience, or quality - Are open to special scrutiny
55Marketing, Gifts, Professional Obligations, and
AMA Ethical Guidelines
Gifts and professional obligations
- How might gifts and other inducements from
commercial companies compromise the professional
obligations of physicians - as discussed in Topic 1?
56Marketing, Gifts, Professional Obligations, and
AMA Ethical Guidelines
Gifts and professional obligations
57Quick Case 1
Patient and society perceptions
- A drug company has a catering company prepare an
expensive dinner for a group of physicians. The
catering manager sees her physician at the
dinner. At her next visit, her physician
prescribes the companys product. - What might the patient think?
- How could that affect the physicians ability
- to fulfill professional obligations?
58Quick Case 2
Patient and society perceptions
- A company pays for a physician to go to a resort
for two days, which includes a half-day meeting
to consult about ways to market a companys drug.
The physician returns home and asks the hospital
formulary committee to add the companys drug to
the formulary. Two colleagues on the committee
are aware that the company paid for the
physicians trip, including the extended personal
stay. - What might the colleagues think?
- How could that affect the physicians ability
- to fulfill professional obligations?
59Quick Cases 1 and 2
Patient and society perceptions
- The individual who is aware of the inducement has
good reason to wonder if the physicians
professional judgments are being influenced by
the companys personal inducements - Individuals may begin to distrust the physicians
statements and actions, lowering the physicians
ability to work with others with regard to
meeting professional obligations
60Case Summary
Patient and society perceptions
- Gifts and other personal inducements have the
potential to bias a physician's actions when
performing professional obligations - By accepting gifts or other personal inducements,
physicians can create the impression that they
are biased when performing professional
obligations
61Marketing, Gifts, Professional Obligations, and
AMA Ethical Guidelines
AMA Ethical Guidelines on Gifts
- Based on physicians underlying professional
obligations, the AMA CEJA operational guidelines
specify four conditions that should all be met
before a physician accepts a personal gift from a
commercial source - Primarily benefits patients
- Not of substantive value
- If an educational activity, unbiased and
legitimate - No strings or conditions
62Marketing, Gifts, Professional Obligations, and
AMA Ethical Guidelines
- AMA CEJA guidelines set a high standard that
excludes most gifts and inducements commonly
offered - Even if all four CEJA conditions are met,
physicians must use professional judgment and may
choose not to accept a gift
AMA Ethical Guidelines on Gifts
63Quick Case 3
Conflicts between professional obligations and
gifts
- A dermatologist receives an invitation from a
pharmaceutical company to attend an educational
symposium featuring a thought leader in the
latest management trends for skin disorders. The
symposium will be held at a ski resort. There is
no cost for the conference registration and the
physician will receive 1500 towards travel and
lodging expenses. - Should the physician accept the invitation?
64Quick Case 3
Conflicts between professional obligations and
gifts
- As the physician considers this invitation, which
professional obligations and CEJA guidelines are
supported, uncertain, or potentially compromised?
65Quick Case 3
Conflicts between professional obligations and
gifts
- This case raises concerns about the following
professional obligations - Competence
- Uncertain content and control over it must be
determined - Integrity and morality
- Potentially compromised substantial personal
inducements - Altruism
- Potentially compromised personal benefit could
affect decision
66Quick Case 3
Conflicts between professional obligations and
gifts
- The CEJA Ethical Guidelines provide guidance
- Primary benefit to patients
- Questionable substantial personal benefit
- Not of substantial value
- Very substantial value
- If an educational activity, unbiased and
legitimate - Is program without bias?
- No conditions
- None evident
67Quick Case 3
Conflicts between professional obligations and
gifts
- According to CEJA Ethical Guidelines
- At least one condition is not met (value is
substantial) - Decline the invitation
68Quick Case 4
Conflicts between professional obligations and
gifts
- XYZ pharmaceutical invites a physician to give a
one-hour speech on recent research findings about
drugs at a meeting in a large metropolitan area.
The honorarium will be 5,000 plus all expenses
paid for the physician and a guest. The
pharmaceutical company will supply the physician
with the slides and the statistical information
on their newly released product. - Should the physician accept the invitation?
69Quick Case 4
Conflicts between professional obligations and
gifts
- As the physician considers this invitation, which
professional obligations and CEJA guidelines are
supported, uncertain, or potentially compromised?
70Quick Case 4
Conflicts between professional obligations and
gifts
- Professional obligations are
- Competence
- Potentially compromised control over
information - Integrity and morality
- Potentially compromised high personal benefits
- Altruism
- Potentially compromised high personal benefits
71Quick Case 4
Conflicts between professional obligations and
gifts
- The CEJA Ethical Guidelines provide guidance
- Primary benefit to patients
- Questionable high personal benefit
- Not of substantial value
- Very substantial high honorarium guest
expenses - If an educational activity, unbiased and
legitimate - High probability of bias toward the companys
product - No conditions
- None evident
72Quick Case 4
Conflicts between professional obligations and
gifts
- According to CEJA Ethical Guidelines
- Decline excessive compensation
- If cannot control content, decline the invitation
altogether
73Quick Case 5
Conflicts between professional obligations and
gifts
- All of the nephrologists in a state receive an
e-mail inviting them to participate in an online
educational program about new clinical
developments in nephrology sponsored by XYZ
Pharmaceutical Company. The author for the
program is someone who has done substantial
research in the field. - Each person who registers for the program is
entitled to receive a 100 gift certificate to
Amazon.com toward the purchase of a medical book.
A nephrologist is wondering about the offer. - Should she participate in the program?
- Should she accept the gift certificate?
74Quick Case 5
Conflicts between professional obligations and
gifts
As the physician considers this invitation, which
professional obligations and CEJA guidelines are
supported, uncertain, or potentially compromised?
75Quick Case 5
Conflicts between professional obligations and
gifts
- Regarding program participation, professional
obligations are - Competence
- Potentially supported useful information if
unbiased - Integrity and morality
- Supported no special favor to individual since
all invited - Altruism
- Supported attending will benefit patients
76Quick Case 5
Conflicts between professional obligations and
gifts
- The CEJA Ethical Guidelines provide guidance
regarding whether or not to participate - Primary benefit to patients
- Beneficial to patients
- Not of substantial value
- Not substantially valuable
- If an educational activity, unbiased and
legitimate - Uncertain bias toward the companys product
- No conditions
- No condition placed on decision to attend
77Quick Case 5
Conflicts between professional obligations and
gifts
- According to CEJA Ethical Guidelines
- Conditions all appear to be met
- May choose to participate
78Quick Case 5
Conflicts between professional obligations and
gifts
- Regarding gift acceptance, professional
obligations are - Competence
- Uncertain gift may determine participation in
company activity - Integrity and morality
- Potentially compromised gift may influence
physicians decisions - Altruism
- Supported book is for patient care
79Quick Case 5
Conflicts between professional obligations and
gifts
- The CEJA Ethical Guidelines provide guidance
regarding whether or not to accept the gift
certificate - Primary benefit to patients
- Beneficial to patients
- Not of substantial value
- Approaching substantial value
- If an educational activity, unbiased and
legitimate - Self-selected text likely unbiased and legitimate
- No conditions
- Must attend companys program to receive gift
certificate
80Quick Case 5
Conflicts between professional obligations and
gifts
- According to CEJA Ethical Guidelines
- The gift certificate has a condition controlled
by the company, therefore decline - If certificate had been offered as a gift with no
condition, could accept
81Conflicts between Professional Obligations and
Gifts Summary
- When physicians interact with commercial entities
on behalf of patients, their obligations are
different than when acting for themselves - Gifts and other personal inducements can put a
physicians personal interests ahead of their
professional obligations - By accepting personal inducements, physicians may
be perceived as not fulfilling their professional
obligations appropriately and fairly - Physicians should only accept a gift when all of
the following conditions have been met - Primarily beneficial to patients
- Not of substantial value
- If an educational activity, unbiased and
legitimate - No strings or conditions
82Topic 4 Written Standards Related to
Professionalism and Gifts to Physicians
- The American Medical Association (AMA) and the
AMAs Council on Ethical and Judicial Affairs
(CEJA) - The Accreditation Council for Continuing Medical
Education (ACCME) - The Accreditation Council for Graduate Medical
Education (ACGME) - The Association of American Medical Colleges
(AAMC) - American College of Physicians (ACP)
- Veterans Administration (VA)
- The Pharmaceutical Research and Manufacturers
Association (PhRMA) - The Office of the Inspector General of the
Department of Health and Human Services
(OIG-DHHS)
83Topic 4 Written Standards Related to
Professionalism and Gifts to Physicians
Looking to the future
- As health care changes, ethical guidelines will
be updated - Rapid changes require review of professional
obligations and their application to current
circumstances - The future success of physicians depends on their
understanding and fulfillment of their special
obligations
84Module Review
- Key points
- Physicians have special obligations and receive
special privileges in our society - Accepting personal gifts from commercial
companies can result in conflicts with
professional obligations - Physicians first obligation is to the patient
- In commercial interactions related to healthcare,
expectations for physicians are higher than those
for commercial companies and their representatives
85Module Review
- More key points
- Physicians should generally NOT accept gifts from
industry and consider accepting only those that - Primarily entail a benefit to patients
- Are not of substantial value
- If involving an educational activity, are
unbiased and legitimate - Have no strings or conditions
- Professional organizations provide guidance
concerning interactions with industry and other
professional issues - Understanding professionalism and physicians
special obligations will help physicians address
future changes
86What You Should Know about Gifts to Physicians
from Industry
- Module 1 Overview of Ethical, Professional, and
Legal Issues for Physicians Relationships with
Industry - Module 2 Physician Expectations of Industry and
Sales Personnel - Module 4 AMA Ethical Guidelines on Gifts to
Physicians from Industry
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