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Educao e Informao aos Profissionais Prescritores e Usurios como Instrumento para o Uso Racional Prom

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Title: Educao e Informao aos Profissionais Prescritores e Usurios como Instrumento para o Uso Racional Prom


1
Educação e Informação aos Profissionais
Prescritores e Usuários como Instrumento
para o Uso RacionalPromoting Quality Use of
Medicines via Education and Information for
Health Professionals and Consumers
Brasilia 6 April 2005
  • Dr Peter R Mansfield
  • peter.mansfield_at_adelaide.edu.au
  • Healthy Skepticismwww.healthyskepticism.org

2
Topics
  • The current situation in AustraliaInformation
    provision
  • How to increase resistance to misleading
    promotion Overcoming overconfidence
  • AdWatch website
  • Teaching healthy skepticism
  • Policy recommendations for education about drug
    promotion

3
1.The current situation in Australia
4
National Medicines Policy
  • Quality, Safety and Efficacy
  • Therapeutic Goods Administration (TGA)
  • Access
  • Pharmaceutical Benefits Scheme (PBS)
  • Viable pharmaceutical industry
  • Dept of Industry ?PBS
  • Quality Use of Medicines (no govt dept)
  • Missing Health Professionals, Consumers, Health

5
Quality Use of Medicines
  • National Prescribing Service
  • Australian Prescriber
  • Drug and Therapeutics Information Service
  • Educational visiting
  • Therapeutic Guidelines
  • Australian Medicines Handbook
  • Healthy Skepticism

6
Providing information works when people know that
they dont know.(doctors often dont)
7
Information for consumers
8
  • Adverse Medicines Events Line
  • Consumer product information
  • NPS Telephone Information Service
  • Health Insite (www)

9
2. How to increase resistance to misleading
promotion
10
  • And if, indeed, candor, accuracy, scientific
    completeness, and a permanent ban on cartoons
    came to be essential for the successful promotion
    of prescription drugs, advertising would have
    no choice but to comply.
  • Garai PR. Advertising and Promotion of Drugs.
    in Talalay P. Editor. Drugs in Our Society.
    Baltimore John Hopkins Press 1964.

11
  • The best defense doctors can muster against
    this kind of advertising is a healthy skepticism
    and a willingness, not always apparent in the
    past, to do homework. Doctors must cultivate a
    flair for spotting the logical loophole, the
    invalid clinical trial, the unreliable or
    meaningless testimonial, the unneeded improvement
    and the unlikely claim. Above all, doctors must
    develop greater resistance to the lure of the
    fashionable and the new.
  • Garai PR. Advertising and Promotion of Drugs.
    in Talalay P. Editor. Drugs in Our Society.
    Baltimore John Hopkins Press 1964.

12
Improving health care decision making
  • Hypothesis 1. Promotion might improve to match
  • Hypothesis 2. Promotion might become more subtle
    but stay harmful.
  • Even if hypothesis 1 is correct, there is a limit
    to how much humans with limited resources can be
    expected to improve.

13
Educated
  • Mr Brindell corporate affairs manager, Pfizer
    Australasia said doctors, who were obviously
    highly educated, could sort the chaff from the
    wheat.
  • Riggert E. Doctors seduced by drug giants Drug
    companies tactics spark rethink by doctors. The
    Courier Mail. Brisbane 1999July 261-2

14
Intelligence
  • Doctors have the intelligence to evaluate
    information from a clearly biased source.
  • - Dr Rob Walters, ADGP chair
  • Richards D. Guess whos coming to dinner. Aust
    Dr. 200423 Jan19-21

15
  • I believe I may have the ability to think for
    myself. I know there is a large percentage of
    people (esp. in this class) who would easily be
    sucked in as you put it but I am confident this
    doesnt apply to me.
  • - 2nd year medical student 2004
  • The illusion of unique invulnerability

16
The illusion of unique invulnerability
  • Many people believe that others may be vulnerable
    but not themselves.
  • Some doctors believe no doctor is vulnerable.
  • Consequently education about misleading
    promotional techniques is not applied to the self
    and thus not effective.
  • Thus the key is to dispel the illusion of unique
    invulnerability.

17
Dispel the illusion of invulnerability
  • Attempts to confer resistance to appeals will
    likely be successful to the extent that they
    install 2 conceptual features perceived undue
    manipulative intent of the source of the appeal
    and perceived personal vulnerability to such
    manipulation.
  • Sagarin, B. J. Cialdini, R. B. Rice, W. E.,
    and Serna, S. B. Dispelling the illusion of
    invulnerability the motivations and mechanisms
    of resistance to persuasion. J Pers Soc Psychol.
    2002 Sep 83(3)526-41.

18
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19
  • Fascinating way to learn.
  • www.healthyskepticism.org/adwatch.php
  • Illuminates the logical, psychological and
    pharmacological techniques in drug ads.
  • Evidence based recommendations.
  • Feedback for the AdWatch team, the company and
    regulatory agencies.

20
Feedback to AdWatch and to the company
  • To AdWatch re Nexium Unfortunately had me
    sucked in for a period but no longer.
  • To the company re Micardis Plus You have misled
    me into a false understanding of the response to
    telmisartan Hcl.

21
When people know that they dont know or know
they are vulnerable to being misled then they
will want to use more reliable information
sources.
22
4. Teaching healthy skepticism
23
perceived undue manipulative intent of the
source of the appeal

24
Put yourself in their shoes
  • You are responsible for promotion of a new drug
    that is no better than the old ones but will be
    sold at a higher price.
  • If you do not succeed you will lose your job.
    Because you will not be able to get such a well
    paid job elsewhere you and your family will loose
    your house.
  • What promotional methods will you use?

25
Did you plan to tell
  • the truth?
  • (without ambiguity)
  • the whole truth?
  • and nothing but the truth?

26
Drug companies know how to manipulate our main
motivations
  • Burnt out Dodo
  • Caring Bunny
  • Conservative Sheep
  • Entrepreneurial Wolf
  • Branthwaite A, Downing T. Marketing to doctors
    the human factor. Scrip Magazine 1995 March32-5

27
(No Transcript)
28
perceived personal vulnerability to such
manipulation
29
Educated
  • Mr Brindell corporate affairs manager, Pfizer
    Australasia said doctors, who were obviously
    highly educated, could sort the chaff from the
    wheat.
  • Riggert E. Doctors seduced by drug giants Drug
    companies tactics spark rethink by doctors. The
    Courier Mail. Brisbane 1999July 261-2

30
Intelligence
  • Doctors have the intelligence to evaluate
    information from a clearly biased source.
  • - Dr Rob Walters, ADGP chair
  • Richards D. Guess whos coming to dinner. Aust
    Dr. 200423 Jan19-21

31
Shuttle pilots
32
Your ability to cope with potentially misleading
promotion depends on your understanding of
  • Medicine
  • Pharmacology, Epidemiology, Public Health,
    Evidence Based Medicine, Drug Evaluation,
    Pharmacovigilance
  • Social sciences
  • Psychology, Semiotics, Economics, Sociology,
    Anthropology, Management, History, Politics,
    Communication Studies,
  • Humanities
  • Logic, Rhetoric, Epistemology, Linguistics,
    Literature, Art
  • Marketing
  • Product Management, Advertising Account Planning,
    Public Relations
  • Statistics

33
Studies of influence of promotion on prescribing
find more harm than good.
  • Becker MH, Stolley PD, Lasagna L, McEvilla JD,
    Sloane LM. Differential education concerning
    therapeutics and resultant physician prescribing
    patterns. J Med Educ 197247118-27.
  • Linn LS, Davis MS. Physicians orientation
    toward the legitimacy of drug use and their
    preferred source of new drug information. Soc
    Sci Med 19726199-203.
  • Mapes R. Aspects of British general
    practitioners prescribing. Med Care
    197715371-81
  • Haayer F. Rational prescribing and sources of
    information. Soc Sci Med 1982162017-23.
  • Ferry ME, Lamy PP, Becker LA. Physicians
    knowledge of prescribing for the elderly a
    study of primary care physicians in Pennsylvania.
    J Am Geriatr Soc 1985 33616-21.
  • Blondeel L, Cannoodt L, DeMeyeere M, Proesmans H.
    Prescription behaviour of 358 Flemish general
    practitioners. Paper presented at the
    International Society of General Medicine
    meeting, Prague, Spring 1987.
  • Bower AD, Burkett GL. Family physicians and
    generic drugs a study of recognition,
    information sources, prescribing attitudes, and
    practices. J Fam Pract 198724612-6.
  • Cormack MA, Howells E. Factors linked to the
    prescribing of benzodiazepines by general
    practice principals and trainees. Family
    Practice 19929466-71.
  • Berings D, Blondeel L, Habraken H. The effect of
    industry-independent drug information on the
    prescribing of benzodiazepines in general
    practice. Eur J Clin Pharmacol 199446501-505.
  • Caudill TS, Johnson MS, Rich EC, McKinney WP.
    Physicians, pharmaceutical sales representatives,
    and the cost of prescribing. Arch Fam Med
    19965201-6.
  • Powers R. Time with drug reps affects
    prescribing. Paper presented at the Society of
    General Internal Medicine meeting, 1998
  • Wazana A. Physicians and the pharmaceutical
    industry is a gift ever just a gift? JAMA. 2000
    Jan 19283(3)373-80

34
Benzodiazepine prescribing in Flanders
  • Years since graduation positive views about
    commercial information seeing more reps
    accounted for 26 of the variation in
    prescribing.
  • Berings D, Blondeel L, Habraken H. The effect
    of industry-independent drug information on the
    prescribing of benzodiazepines in general
    practice. Eur J Clin Pharmacol 199446501-505.

35
Until we can fix the system the best we can do
is avoid all contact with drug companies
36
Results
  • A 90 minute session with 19 General Practice
    registrars on 25 February 2005.
  • 5 questions asked before and after the session
    about beliefs and plans
  • Answers on 1 to 7 Likert like scales

37
1) Is it ethically acceptable for doctors to
receive gifts from drug companies?
  • 1 Completely acceptable
  • 7 Completely unacceptable
  • median mean range
  • Before 4 3.68 1-6
  • After 6 5.53 2-7
  • Wilcoxon signed-rank test p

38
2) Will you accept visits from drug company
representatives?
  • 1Never
  • 7At every opportunity
  • median mean range
  • Before 5 4.37 1-7
  • After 3 3.26 1-7
  • Wilcoxon signed-rank test p 0.0119

39
3) Will you accept gifts from drug companies?
  • 1 Never
  • 7 At every opportunity
  • median mean range
  • Before 5 5 2-7
  • After 4 3.74 1-7
  • Wilcoxon signed-rank test p 0.0034

40
4) How often is information from drug companies
reliable?
  • 1 Never reliable
  • 7 Always reliable
  • median mean range
  • Before 4 3.68 2-5
  • After 2 2.47 1-5
  • Wilcoxon signed-rank test p 0.0006

41
5) Will you be vulnerable to being misled by drug
companies?
  • 1 Completely vulnerable
  • 7 Completely invulnerable
  • median mean range
  • Before 4 3.79 2-6
  • After 3 3.42 1-7
  • Wilcoxon signed-rank test p 0.2377

42
5. Policy recommendations
  • Recommendations for educating health
    professionals about pharmaceutical promotion. 1
    April 2005
  • Healthy Skepticism
  • No Free Lunch (www.nofreelunch.org)

43
  • Dr Peter R Mansfield, Founder, Healthy Skepticism
    Inc / Research Fellow, Dept of General Practice,
    University of Adelaide, Australia
  • Dr Bob Goodman, Founder, No Free Lunch, New York,
    USA
  • Prof Allen F. Shaughnessy, Professor of Family
    Medicine, Tufts University, USA
  • Prof Jerome Hoffman, Professor of Medicine and
    Emergency Medicine, University of California Los
    Angeles, USA
  • Jen Edelman, Medical Student, Columbia
    University, USA
  • A/Prof Joel Lexchin, Professor, School of Health
    Policy Management, York University, Canada
  • Dr Luisella Grandori, Coordinator, No grazie pago
    io, Italy
  • Dr David Neely, Director Undergraduate Education,
    Dept of Medicine, Northwestern University, USA
  • Dr Des Spence, Founder, No Free Lunch (UK),
    Glasgow, UK
  • Dr Jon Jureidini, Chair, Healthy Skepticism Inc /
    Head, Dept of Psychological Medicine, Women's and
    Children's Hospital, South Australia, Australia
  • A/Prof Leonore Tiefer, Associate Clinical
    Professor of Psychiatry, New York University, USA
  • Carol Kushner, Health Policy Analyst, Ontario,
    Canada
  • A/Prof Amy Brodkey, Clinical Associate Professor
    of Psychiatry, Univ of Pennsylvania, USA
  • Dr Mark McConnell, Internal Medicine, LaCrosse,
    Wisconsin, USA
  • Dr. Simon Ahtaridis, Dept of Internal Medicine
    Cambridge Health Alliance, Massachusetts,USA
  • A/Prof Christopher Doecke, Associate Professor of
    Pharmacy Practice, University of South Australia,
    Australia
  • Dr Andrew Herxheimer, Emeritus Fellow, UK
    Cochrane Centre, Oxford, UK
  • Prof Dan Mayer, Professor of Emergency Medicine,
    Albany Medical College, New York, USA
  • Dr. Ken Harvey, School of Public Health, La Trobe
    University, Australia

44
(No Transcript)
45
  • The role of drug promotion in the heavy death
    toll from COX2 selective drugs illustrates the
    reality that misleading drug promotion is a major
    health threat.
  • The World Health Assembly resolution 52.19 urges
    member states to
  • "integrate the rational use of drugs and
    information on commercial marketing strategies
    into training for health practitioners at all
    levels."

46
  • Healthy Skepticism Inc and No Free Lunch
    recommend the following 4 objectives for
    education about pharmaceutical promotion for
    health professionals at all levels of training
    and practice.
  • Pharmaceutical promotion includes any activity
    that can increase pharmaceutical sales.
  • Education should use methods that are effective
    for changing behavior, such as involvement of
    influential peers.
  • Education for health professionals should never
    be funded by vested interests.

47
  • 1. Health Professionals should avoid
    pharmaceutical promotion
  • Exposure to pharmaceutical promotion correlates
    with harmful and wasteful use of
    pharmaceuticals.
  • There are no proven methods for enabling health
    professionals to gain more benefit than harm from
    exposure to drug promotion.
  • Consequently, education for health professionals
    should increase the understanding that all health
    professionals have a professional fiduciary
    responsibility to patients to take all practical
    steps to avoid pharmaceutical promotion.

48
  • This responsibility includes refusing to accept
    gifts and one to one visits from drug company
    representatives both at the personal and
    organisational levels.
  • Meetings of groups of doctors with drug company
    representatives may be less harmful than one to
    one meetings but it is highly unlikely that this
    type of activity will be found to do more good
    than harm compared to no such meetings.

49
  • 2. Health Professionals should be educated about
    decision making
  • Education for health professionals should
    include teaching the psychology and illogic of
    misleading arguments and appeals with the aim of
    improving the quality of medical decision making
    in response to evidence.

50
  • 3. Health professionals should be warned that
    they are vulnerable to pharmaceutical promotion
  • Knowledge of misleading arguments and appeals
    does not reliably protect people from being
    misled by promotional techniques.
  • The key to reducing vulnerability to being
    misled by promotion is helping people move from
    overconfidence in their abilities to
    understanding that they are vulnerable.
  • Consequently, education for health professionals
    should explain that whilst knowledge of
    misleading promotional techniques may increase
    their resistance to being mislead, it is unlikely
    to enable them to reach a level of resistance
    where they would gain more benefit than harm from
    exposure to drug promotion.

51
  • An effective way to reduce dangerous
    overconfidence is to expose participants to
    misleading promotion, allow them to express
    incorrect beliefs and then debunk those beliefs
    and explain the misleading techniques used so
    that participants can understand that they are
    personally vulnerable.
  • 4. Health professionals should be educated about
    more reliable sources of information
  • Health professionals should receive education
    about the availability and strengths and
    weaknesses of the least biased useful sources of
    information.

52
  • 1. Lomas J, Enkin M, Anderson GM, Hannah WJ,
    Vayda E, Singer J. Opinion leaders vs audit and
    feedback to implement practice guidelines.
    Delivery after previous cesarean section. JAMA.
    1991 May 1265(17)2202-7.1
  • 2. Rogers WA, Mansfield PR, Braunack-Mayer AJ,
    Jureidini JN. The ethics of pharmaceutical
    industry relationships with medical students. Med
    J Aust. 2004 Apr 19180(8)411-4.
  • 3. Steinbrook R. Commercial support and
    continuing medical education. N Engl J Med. 2005
    Feb 10352(6)534-5. 4. Schafer A. Biomedical
    conflicts of interest a defence of the
    sequestration thesis-learning from the cases of
    Nancy Olivieri and David Healy. J Med Ethics.
    2004 Feb30(1)8-24.
  • 5. Dana J, Loewenstein G. A social science
    perspective on gifts to physicians from industry.
    JAMA 2003 290 252-255.
  • 6. Katz D, Caplan AL, Merz JF. All gifts large
    and small toward an understanding of the ethics
    of pharmaceutical industry gift giving. Am J
    Bioethics 2003 3 39-46.
  • 7. Katz D, Mansfield P, Goodman R, Tiefer L, Merz
    J. Psychological aspects of gifts from drug
    companies. JAMA. 2003 Nov 12290(18)2404-5
  • 8. Becker MH, Stolley PD, Lasagna L, McEvilla JD,
    Sloane LM. Differential education concerning
    therapeutics and resultant physician prescribing
    patterns. J Med Educ 197247118-27.
  • 9. Linn LS, Davis MS. Physicians' orientation
    toward the legitimacy of drug use and their
    preferred source of new drug information. Soc Sci
    Med 19726199-203.
  • 10. Mapes R. Aspects of British general
    practitioners' prescribing. Med Care
    197715371-81
  • 11. Haayer F. Rational prescribing and sources of
    information. Soc Sci Med 1982162017-23.
  • 12. Ferry ME, Lamy PP, Becker LA. Physicians'
    knowledge of prescribing for the elderly a study
    of primary care physicians in Pennsylvania. J Am
    Geriatr Soc 1985 33616-21.
  • 13. Bower AD, Burkett GL. Family physicians and
    generic drugs a study of recognition,
    information sources, prescribing attitudes, and
    practices. J Fam Pract 198724612-6.
  • 14. Cormack MA, Howells E. Factors linked to the
    prescribing of benzodiazepines by general
    practice principals and trainees. Family Practice
    19929466-71.

53
  • 15. Berings D, Blondeel L, Habraken H. The effect
    of industry-independent drug information on the
    prescribing of benzodiazepines in general
    practice. Eur J Clin Pharmacol 199446501-505.
  • 16. Caudill TS, Johnson MS, Rich EC, McKinney WP.
    Physicians, pharmaceutical sales representatives,
    and the cost of prescribing. Arch Fam Med
    19965201-6.
  • 17. Mansfield PR, Lexchin J. Scepticism and
    beliefs about new drugs. Healthy Skepticism
    International News 2001191-6
  • 18. Caamano, F. Figueiras, A., and Gestal-Otero,
    J. J. Influence of commercial information on
    prescription quantity in primary care. Eur J
    Public Health. 2002 Sep 12(3)187-91.
  • 19. Watkins, C. Harvey, I. Carthy, P. Moore, L.
    Robinson, E. Brawn, R. Attitudes and behaviour of
    general practitioners and their prescribing costs
    a national cross sectional survey. Qual Saf
    Health Care. 2003 Feb 12(1)29-34.
  • 20. Mansfield PR, Henry D. Misleading drug
    promotion-no sign of improvements.
    Pharmacoepidemiol Drug Saf 2004 Nov13(11)797-9.
  • 21. Brody H. The company we keep why physicians
    should refuse to see pharmaceutical
    representatives. Ann Fam Med. 2005
    Jan-Feb3(1)82-5.
  • 22. Scott DK, Ferner RE. "The strategy of desire"
    and rational prescribing.Br J Clin Pharmacol
    199437 217-9.
  • 23. Shaughnessy AF, Slawson DC, Bennett JH.
    Separating the wheat from the chaff identifying
    fallacies in pharmaceutical promotion. J Gen
    Intern Med. 1994 Oct9(10)563-8.
  • 24. Mansfield PR. Healthy Skepticism's new
    AdWatch understanding drug promotion. Med J
    Aust. 2003 Dec 1-15179(11-12)644-5.
  • 25. Sagarin BJ, Cialdini RB, Rice WE, Serna SB.
    Dispelling the illusion of invulnerability the
    motivations and mechanisms of resistance to
    persuasion. J Pers Soc Psychol 200283 526-41.
  • 26. Mansfield P. Accepting what we can learn from
    advertising's mirror of desire. BMJ. 2004 Dec
    18329(7480)1487-8.
  • 27. Wilkes MS, Hoffman JR. An innovative approach
    to educating medical students about
    pharmaceutical promotion. Acad Med 2001 76
    1271-1277.

54
Healthy Skepticism
  • Countering misleading drug promotion

www.healthyskepticism.org
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