What You Should Know About Gifts to Physicians from Industry Module 3: Professionalism and Gifts to

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What You Should Know About Gifts to Physicians
from IndustryModule 3 Professionalism and Gifts
to Physicians from Industry
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Authors

• 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.

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Disclosure 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.

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Module 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

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Topic 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

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Gifts and Residents

• What percentage of residents surveyed were
  carrying items with a pharmaceutical company logo
  or product brand?
• a) 79
• b) 88
• c) 97

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Gifts 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.

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Gifts and Residents

• What percentage of residents surveyed
  acknowledged that gifts and meals influenced
  their prescribing patterns?
• a) 79
• b) 87
• c) 91

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Gifts 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.

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Gifts and Perception

• Studies found that compared to physicians,
  patients were _________ to find gifts acceptable.
  
• a) less likely
• b) more likely
• c) just as likely

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Gifts 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.

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Gifts 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

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Gifts 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.

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Gifts 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

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Gifts 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

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Gifts and Prescribing Practices
Neslin, S. ROI. Analysis of Pharmaceutical
Promotion RAPP An Independent Study.
Accessed at http/www.rappstudy.org (May 2001)
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Gifts 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

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Gifts 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

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Gifts 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

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Gifts 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.

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Research 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

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Topic 2 Professionalism Physicians Obligations
and Privileges

• Do physicians have special roles in society?

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Professionalism 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.

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Professionalism 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

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Professionalism 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

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Social 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.

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Obligations 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

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Obligations 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

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Obligations 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

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Obligations and Privileges
Obligation associated with control over knowledge

• Competence
• Appropriate knowledge and its application
• Knowledge is current
• Seeking and transmitting knowledge to others

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Obligations 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

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Obligations 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

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Obligations 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

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Obligations 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

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Obligations 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

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Societys 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

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Societys 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

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Societys Evolving Expectations of Physicians

• How can physicians follow high professional
  standards when societal priorities
• are constantly evolving?

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Societys 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

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Concepts of Professionalism Summary
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Topic 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

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Differences 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

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Differences 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?

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Differences between Commercial and Professional
Activities
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Differences between Commercial and Professional
Activities

• How do the obligations of commercial entities and
  physicians differ in their obligations regarding
  information about a drug?

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Differences between Commercial and Professional
Activities
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Differences 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

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Differences 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

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Marketing, 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

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Marketing, 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

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Marketing, 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

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Marketing, 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?

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Marketing, 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

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Marketing, 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

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Marketing, 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?

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Marketing, Gifts, Professional Obligations, and
AMA Ethical Guidelines
Gifts and professional obligations
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Quick 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?

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Quick 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?

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Quick 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

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Case 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

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Marketing, 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

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Marketing, 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
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Quick 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?

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Quick 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?

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Quick 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

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Quick 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

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Quick 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

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Quick 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?

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Quick 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?
  

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Quick 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

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Quick 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

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Quick Case 4
Conflicts between professional obligations and
gifts

• According to CEJA Ethical Guidelines
• Decline excessive compensation
• If cannot control content, decline the invitation
  altogether

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Quick 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?

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Quick 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?

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Quick 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

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Quick 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

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Quick Case 5
Conflicts between professional obligations and
gifts

• According to CEJA Ethical Guidelines
• Conditions all appear to be met
• May choose to participate

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Quick 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

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Quick 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

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Quick 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

81
Conflicts 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

82
Topic 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)

83
Topic 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

84
Module 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

85
Module 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

86
What 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

87
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