MD-Pharma interactions & the U of T Standards

MD-Pharma interactions & the U of T Standards

MD-Pharma interactions & the U of T Standards Jeannette Goguen, MD, FRCPC DOM Program Director IM New Faculty Orientation September 15, 2016 Disclosure Relevant relationships with commercial entities:

None Potential for conflicts within this presentation: None Steps taken to review and mitigate potential bias: N/A 02/22/2020

Disclosure Relevant relationships with commercial entities: List industry company names you have relationships with Potential for conflicts within this presentation: List the drugs from those companies that you will be discussing. Steps taken to review and mitigate potential bias: State that (1) you will clearly identify any time a recommendation you make with respect to one of these drugs is off-label and/or does not

adhere to recognized national/international guidelines OR (2) you will not be discussing any off-label use of the medications, and will be adhering to national/international guidelines. 02/22/2020 Objectives Outline 1. Review the big picture:

Background to the development of the standards Existing Policies/Standards 2. Review highlights from the U of T Relations with Industry document Actions on your part

Background to the development of the standards Why is this an issue? Doctors work to advance their patients interests, whereas industry works to advance their stockholders interests Industry does have positive effects on patients health Conflict of interest arises if inappropriate influence Trust of the public Is it possible to handle/control the conflict of interest when doctors interact with pharma?

Many contexts for potential influence

Pharma sales representative visits Drug detailing Samples Journal advertisements & prescribing software Attendance at pharma-sponsored meetings Participation in speakers bureaus Participation in sponsored clinical trials Acceptance of gifts Pharma-sponsored literature/ guidelines

How can we understand this topic? Behavioural economics/psychology vs Ethics/Professionalism Cialdinis Six Key Principles of Influence Reciprocity People tend to return a favour. Liking People are easily persuaded by other people that they like Commitment and Consistency If people commit, orally or in

writing, to an idea or goal, they are more likely to honour that commitment because of establishing that idea or goal as being congruent with their self-image. Social Proof People will do things that they see other people are doing. Authority People will tend to obey authority figures. Scarcity when perceived, generates demand Cialdini RB Influence: The psychology of persuasion 1993 Sales savvy

Food Food is the most commonly used technique to derail the judgment aspect of decision making Flattery We are receptive to compliments even when we recognize the sources transparent agenda Friendship Engendering goodwill

Encourage reciprocation for gifts received Katz D et al. Am J Bioethics 2003;3:39-46 Influence of drug detailing on physicians Impact on physicians knowledge improved ability to identify treatment for complicated illnesses inability to identify wrong claims about medication

Impact on physicians attitude positive attitude toward pharma rep awareness, preference and rapid prescription of new drug Lexchin J Canadian Medical Association Journal 1993;149:1401-1407 Wazana A Journal of the American Medical Association 2000;283:373-380 Influence on physicians: Studies show Impact on behaviour formulary requests for medications

non-rational prescribing behaviour increasing prescription rate prescribing fewer generics prescribing more expensive, newer meds at no demonstrated advantage Lexchin J Canadian Medical Association Journal 1993;149:1401-1407 Wazana A Journal of the American Medical Association 2000;283:373-380 Information from Pharmaceutical Companies and the

Quality, Quantity, and Cost of Physicians Prescribing: A Systematic Review Marketing impact on scripts:Quality, Quantity, Costs* *66% showed an effect, 21% no effect, 13% mixed 58 studies: 2 RCT, 3 controlled cohort or case-controlled studies Association, not causation Bidirectional? Possible bias in both directions (publication, ideological, financial conflict) Spurling G et al PLOS Medicine 2010 http://journals/plos/org/plosmedicine/article?

id=10.1371/journal.pmed.1000352 The effects and role of Direct-to-Physician Marketing in the Pharmaceutical Industry: An Integrative review Not only is detailing an important source of information, it affects physician prescription behavior in a positive and significant manner. More important, this seems to occur over the length of the drugs life cycle. This is puzzling considering that over a drugs life cycle, most information about the drug is likely to be disseminated early ona fact confirmed by physician surveys.Based on our analysis and industry observations, our

explanation is that in addition to providing a reminder effect, constant interaction builds a stock of goodwill between a detailer and the physician, translating into positive physician prescribing behavior. This goodwill is not based on purely objective and rational factors but on social and cultural norms. Its character changes from informative to more persuasive in the later stages of the drug life cycle. The evolution of goodwill in this manner reflects the deepening relationship between the physician and the pharmaceutical sales representative. Manchanda P. Yale J Health Policy, Law & Ethics 785 2005

Can this influence be a good thing? American Journal of Bioethics 2010 Huddle: behavioural economics view of the inevitability of unconscious influence is not proven Morreim: physician as fiduciary imposes a higher standard of behaviour (burden of proof on the doctor that no abuse) Rubin: it is good for the public for new drugs to be used Brody: unprofessional to spend time with detailers because there are other sources of information, and detailers are

giving you gifts, setting up a conflict of interest etc Ethical issues Benevolence fiduciary nature of patient-physician relationship Conflict of interest exists when the MDs primary responsibility to the patient is influence by secondary competing

considerations such as personal gain patient perception of physicians receiving gifts from patients Physicians and the pharmaceutical industry (update 2007) www.cma.ca Ethical issues Autonomy the physician should always maintain professional autonomy, independence and commitment to the scientific method

Justice Costs involved for: pharmaceutical industry doctors

patients public Physicians and the pharmaceutical industry (update 2007) www.cma.ca Key Standards / Guidelines http://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf http://www.ucsfcme.com/news/IndustryFundingMedicalEduation.pdf

Interactions with Pharmaceutical Representatives Policy Oct 30, 2015 (SMH Intranet) What do we need to know about the U of T Standards? Principles: The interests of our patients are paramount We are role models for trainees: Rules apply to all of us, at all times

U of T Relationship with Industry & the Educational Environment in UME & PGME Sales Representatives: Meetings between industry product or sales representatives and students or trainees should occur only in educational settings and when a faculty member is present. The faculty member has a responsibility to ensure that any discussion about specific products is

medically and scientifically sound, balanced and includes alternatives. \ U of T Relationship with Industry & the Educational Environment in UME & PGME Student or trainee contact information must not be provided to industry representatives.

U of T Relationship with Industry & the Educational Environment in UME & PGME Faculty members should consider the educational value of meeting with representatives of industry and recognize that in doing so they model such interactions for trainees. Meetings with representatives should be by appointment. Meetings with industry representatives should not

normally take place in the presence of patients unless the representatives are specifically needed for patient care. Gifts must not be accepted from industry. This includes food and entertainment, which are considered gifts. Educational events and programs Address the educational needs of learners

Are Hands off from sponsor(s) Openly acknowledge sponsor(s) Properly disclose potential COI Properly display commercial information Ghostwriting When publishing as an author, faculty members must insist that contributions written by industry are clearly disclosed and acknowledged.

Food - Offering food/hospitality may be appropriate at events, but engenders obligation and entitlement Use of unrestricted educational grants for refreshments - Modest food - No reps in attendance - Hospitality for full day programs: no direct link to the sponsor Industry-sponsored dinner = accepting gifts - Attend at your own expense!

Funding for Postgraduate Programs: Unrestricted educational grant (ideally from multiple donors) Publically acknowledged Managed centrally by PD or DDD with financial statements Donor plays no role selecting trainees for funding No quid pro quo

Consultation to industry: CAN do (with reasonable compensation and disclosure): - Teach company personnel at education sessions - Consultation for advocacy, health promotion, better products - Industry-funded public education with no brand product CANNOT do: - Speakers bureau (paid to give company talks) - Participate in industry sales program/ marketing Drug Samples:

- Ideally with central depository and pharmacists - Not used by doctors or their families - Proper records, storage, dispensing - Declare COI if on hospital drug/devices selection committee Disclosure What to disclose: Salary support, consultancy fees, honoraria, research support, ownership interest, financial interest (not amounts)

When to disclose: At all lectures/seminars, held anywhere All manuscripts submitted for publication Consulting to government, public or private agencies Interacting with the media Questions?

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