Pharmacists, Ethics, Professional Integrity, and Conflicts of Interest

From UBC Wiki
 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:


Then:

  1. Read and reflect on the first 8 scenarios below.
  2. 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.

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.

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.

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.

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.
Probing questions:
  • Are there problems here? What? Why exactly is it a problem?
  • Is it ever appropriate to advocate on behalf of your hospitalized loved one?
  • If so, what strategies or mechanisms to do so might be more appropriate than what happened here?
  • Are there policies at your institution which govern these sorts of scenarios?

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.”

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).
Probing questions:
  • What are the potential risks to your professional integrity by agreeing to such a thing?
  • What if they didn’t ask you in advance and you found out upon arrival?
  • What if the sponsorship was from a company not so directly linked to the therapeutics you’re talking about?
  • Does the conference organizer have a policy that governs such things? Do you wish you’d know this was permissible beforehand? Does this experience change how you approach future talk invitations?
  • Is there a potential CONFLICT OF INTEREST involved here? If so, what EXACTLY is the potential conflict between?

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.

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.
Probing questions:
  • What are some of the reasons why you might describe forming such a relationship as BENEFICIAL? Who benefits?
  • What are the potential risks to your professional integrity by forming such a relationship?
  • Is there a potential CONFLICT OF INTEREST involved here? If so, what EXACTLY is the potential conflict between?
  • Are there ways to get the benefits of the relationship while minimizing the risks? (i.e., can the risks be MANAGED here?)
  • Does giving them the information but not taking the money and/or the meal help?
  • Does your institution have policies which would forbid you from sharing information about your formulary approval process?
  • Does whether or not you are a member of the formulary committee (or a consultant to it) matter?
  • If you do enter this relationship, what implications might it have for your future involvement in formulary decision-making? Will this relationship be a “declarable conflict” for other committees (eg, government, legal work) in which you do or might participate in the future?

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.

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.
Probing questions:
  • What ethical or legal obligations of the investigator are involved here? What does the sponsorship agreement/contract say about this? Did your university approve a contract that permits this sort of thing (suppression of dissemination of findings)?
  • Was the study registered?
  • Since you’ve already made the study expenditures, of course you expect them to give you the full funds promised. Does accepting such funds, under the new circumstances, have any professional integrity implications?
  • Since this wasn’t a “therapeutic” study (ie, there was no intended benefit to any subjects involved), is this “just business” and no big deal?
  • What if it was an RCT of a promising therapeutic intervention that didn’t show positive results? Revealed worrying toxicities?
  • Does your agreement (or not) with their assertion that the methodology was flawed have relevance?
  • Does the fact that grad students were involved, who need/expect to get publications (as do you) influence your reaction to the sponsor’s objection?

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.

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.
Probing questions:
  • This is tricky because, without your explicit consent, you’ve received a benefit from someone. You didn’t have the opportunity to decline beforehand.
  • Since nobody is likely to find out that this transaction occurred, does it even matter?
  • If you’re bothered by it, what would “fixing it” even look like?
  • If you’re troubled by it, what choices do you have? Do you act in the moment and try to pay for your own room and have the charge to the rep reversed? Do you call the rep and thank him/her? chastise him/her politely? Say, “I owe you one.”? [P.S., this is probably exactly what they want you to think/say.] There’s a sense of powerlessness here.
  • If you do nothing about it (except send a thank you email), what are the potential risks to your professional integrity?

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.
Probing questions:
  • What are some of the reasons why you might describe forming such a relationship as BENEFICIAL? Who benefits?
  • What are the potential risks to your professional integrity by forming such a relationship?
  • Is there a potential CONFLICT OF INTEREST involved here? If so, what EXACTLY is the potential conflict between?
  • Does the fact that the company/product involved is not a DRUG MANUFACTURER/DRUG make a difference? How exactly?
  • What exactly is this meeting about? Is it a legitimate “issues discussion”, or a junket? Does it matter?

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.

Bottom Lines

  1. What value you place on maintaining your professional INTEGRITY and the TRUST of your patients/colleagues.
  2. LEARN about the sometimes-unforseen consequences of certain courses of action you take, so they’re no longer unforseen.
  3. WEIGH the pros and cons of each relationship/situation. Don’t just REACT to things reflexively.
  4. Think of COI as merely a part of the broader issue of BIAS, and bias as part of the broader issue of INTEGRITY.
  5. 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

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