Pharmacists, Ethics, Professional Integrity, and Conflicts of Interest
It is difficult to get a man to understand something when his salary depends upon him not understanding it. -Upton Sinclair (1878-1968)
Facilitator: Dr. Peter Loewen | Assistant Professor | UBC Faculty of Pharmaceutical Sciences
Background
By virtue of their specialized knowledge and skills, pharmacists are in a privileged position to make decisions which affect the health of other people. Patients, therefore, expect that pharmacists’ decisions are based primarily on what is in their best interests. In our complex healthcare environment, pharmacists have the opportunity to form many different kinds of professional and personal relationships with a wide variety of people. Each of these relationships has the potential to positively or negatively affect the professional integrity of the pharmacist involved. As such, pharmacists who are interested in maintaining a high degree of professional integrity are well served by appreciating the implications of each relationship from this viewpoint.
Objectives
After the session and upon personal reflection, participants should be able to
- Articulate a personal vision for what professional integrity means to them
- Weigh the benefits and risks of entering relationships which may have implications for their professional integrity.
Preparation
Read, think about, and come prepared to talk about the following:
- Is THIS a conflict of interest?
- “I’m OK, You’re Biased” (NYT 16APR06)
- Confluence, Not Conflict of Interest JAMA. 2015;314(17):1791-1792
- The Impact of Disclosing Financial Ties in Research and Clinical Care Arch Intern Med. 2010;170(8):675-682
Then:
- Read and reflect on the first 8 scenarios below.
- Come prepared to speak to scenarios on which you're named, commenting on:
- What are the ethical, professional integrity and/or potential conflict of interest issues here?
- how you think the situation should be managed
Scenarios
Scenario 1 - Leanne
You attend a small-group industry-sponsored dinner/talk at Chambar, and receive a token gift of a Cross pen emblazoned with Effient®. You were invited because you are considered to be a local opinion leader. You carry this pen on rounds the next day. |
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Scenario 2 - Jenny
While in patient care rounds, discussion ensues regarding a difficult therapeutic issue. You haven’t read any recent literature on this topic, however you did attend an “educational dinner cruise” last night at which this was discussed. You provide a drug recommendation based upon your recollection of last night’s discussions. While the drug isn’t on formulary, you assure the team that you will be able to arrange to bring supplies in. |
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Scenario 3 - Lucas
You’re chair of a provincial drug benefits committee, composed of a lay-member plus a bunch of clinicians, researchers, lawyer, etc. At this week’s meeting while reviewing an expensive MS drug for coverage status, the person beside you whispers that they know the lay member’s wife has severe MS. |
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Scenario 4 - Laura
You’re a clinical pharmacist just assigned to work in the new “CV Risk Reduction Clinic” at your institution. You’re aware that the clinic is funded through an “unrestricted grant” from the makers of perindopril. In return, perindopril was added to the instutution’s formulary. |
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Scenario 5 - Renée
You are visiting your grandmother at the hospital. She was admitted yesterday for management of myocardial infarction including coronary artery stenting. You sneak a peek at her chart when no one is around, and notice that she is on ASA, clopidogrel, metoprolol, ramipril, simvastatin and warfarin. She is on warfarin for hypomotility of the left ventricle. These medications look appropriate to you, except that she is not on a heparin (the warfarin can’t possibly be therapeutic yet). Armed with this information, you confront the cardiology resident about the absence of heparin from her medication regimen. |
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Probing questions:
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Scenario 6 - Stacey
In trying to make a treatment decision for a patient with CAP, you decide that several antibiotics are viable (and have equivalent efficacy/safety). You seek, therefore, to use the least costly one. You notice that the costs of all but two are displayed in your pocket formulary. Upon inquiring with your director about the costs of the other two, you’re told that, “that information is confidential, per the contract we signed with the manufacturers.” |
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Scenario 7 - Leanne
You’re looking forward to speaking at a pharmacists CE conference next month. The conference is sponsored in the usual way by industry money laundered through a university’s CE division. The conference organizer asks whether you’d mind if your talk about statins was shown on the program as “supported by an unrestricted educational grant from Pfizer” (maker of one of several statins available). |
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Probing questions:
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Scenario 8 - Jenny
Your hospital pharmacist colleague tells you that he has a “side consulting business” where he takes fees from drug manufacturers to counsel them on the processes involved and gives tips for getting their drugs favourably reviewed and approved by regional, provincial, and national formulary committees. |
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Scenario 9 - Lucas
As the CCU pharmacist, you are invited by Ipsos Reid (contracted by the manufacturers of a new innovative CHF drug) to their offices to participate in an informal focus group. These questions would relate to your opinions about “approaches to managing CHF”. It may also involve discussion of the barriers that would may impede formulary approval of the drug at a hypothetical hospital. In return for your time, you would be provided with a $1000 honorarium for your valuable time and a complementary meal during the question period. |
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Probing questions:
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Scenario 10 - Laura
While in a community pharmacy, a visit from an OTC drug rep brings in samples for Aerius – which I pass on to my allergy prone, impoverished university student brother. I have notified him that all non-sedating antihistamines are the same and that these are only free because the drug rep was feeling generous toward me. |
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Scenario 11 - Renée
You have acted as a principal investigator for an industry-sponsored bioequivalence trial. Preliminary results do not favour the sponsor’s drug. The sponsor isn’t happy. They inform you that they now believe the study methodology was flawed and do not wish the data to be published. They also inform you that you will receive the full grant funds promised. |
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Probing questions:
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Scenario 12 - Stacey
You are an attractive young female PharmD on the Drugs and Therapeutics committee at your hospital. A new antibiotic is being considered for formulary status and you have been asked to provide the committee with an evidence-based review of the drug. The sales rep for this particular antibiotic happens to be an attractive young male and when you meet to ask for information the two of you hit it off and he asks you out. You have dinner in Yaletown and then watch America's Next Top Model at his place. |
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Additional Scenarios for Discussion
Scenario 13
You are at a conference. The registration was paid for by your institutional education fund, and you are planning on paying for your hotel. When you go to check out on the last day, the hotel informs you that your bill has already been paid for. When you ask for details, the hotel gives you the name of a pharmaceutical rep you have met with several times as the owner of the credit card who paid. |
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Probing questions:
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Scenario 14
A manufacturer that you have been doing business with on infusion pumps invites you to a users group meeting in which all expenses are paid but no honorarium - smart infusion pumps are used in about 50% of your hospital at the current time. |
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Probing questions:
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Scenario 15
You are a PharmD working for a drug company. You are responsible for the development of educational/ promotional material for a new drug. In your review of the literature you noticed flaws in the studies and you are not convinced that your drug did show an advantage over the comparator. Meanwhile, your performance evaluation is coming up. You are the sole source of income for your family. |
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Bottom Lines
- What value you place on maintaining your professional INTEGRITY and the TRUST of your patients/colleagues.
- LEARN about the sometimes-unforseen consequences of certain courses of action you take, so they’re no longer unforseen.
- WEIGH the pros and cons of each relationship/situation. Don’t just REACT to things reflexively.
- Think of COI as merely a part of the broader issue of BIAS, and bias as part of the broader issue of INTEGRITY.
- Only presume there’s a CONFLICT when the sway in judgment that’s involved is such that it’s a COMPROMISE in judgment.
Useful Concepts
Resources and Further Reading
- BMJ editor Fiona Godlee takes on corruption in science
- Retraction Watch
- Beauty Council wants cities to regulate hair salons and more
- On the Psychology of Pharmaceutical Industry Gifts to Physicians J Gen Intern Med 2009;25:7–8
- Shnier A, Lexchin J, Mintzes B, Jutel A, Holloway K. Too Few, Too Weak: Conflict of Interest Policies at Canadian Medical Schools. PLoS ONE 2013;8:e68633.
- Effect of Reminders of Personal Sacrifice and Suggested Rationalizations on Residents’ Self-Reported Willingness to Accept Gifts. JAMA. 2010;304(11):1204-1211.
- Wesson DE. An Organizational Approach to Conflicts of Interest: Lessons From Non-Health Care Businesses. JAMA Internal Medicine 2013;
- CBS Bans SodaStream Ad
- CBC Tamiflu probe sparks drug policy review
- B.C. health ministry fires four, calls RCMP to investigate conflict allegations | Research Stopped by Ministry Might Have Cut Big Pharma Profits | UBC drug researchers appeal for access to crucial data
- The power of transparency
- UBC Policy 97: Conflict Of Interest and Conflict Of Commitment
- GUIDELINES FOR PHYSICIANS IN INTERACTIONS WITH INDUSTRY-CMA
- Managing Financial Conflict of Interest in Biomedical Research-JAMA
- Times curbs Pogue’s P.R. appearances
- Toward More Uniform Conflict Disclosures - The Updated ICMJE Conflict of Interest Reporting Form
- Pharmacists and Industry: Guidelines for Ethical Interactions