Institutional Policy Roundtable

Nuts and Bolts SymposiumSeptember 14, 2007

NEJM Survey of Physician-Industry Relationships

3167 physicians in six specialties Anesthesiology Cardiology Family practice General surgery Internal medicine Pediatrics

NEnglJMed 2007;356:1742-50

Survey Results Summary 94% Relationship with pharmaceutical

industry 83% Receiving food in the workplace 78% Receiving drug samples 35% Reimbursed cost for professional

meeting or CME 28% Consulting, lecturing

American Medical Student Association2007 PharmFree Scorecard

Ranking of reporting US medical schools’ policies on pharmaceutical company access and influence 5 schools have comprehensive policy 8 schools have limited policy 44 schools are drafting or discussing policies 40 schools have no policy

40 schools did not respond and were not graded

ACGME Institutional RequirementsJuly 1, 2007 GMEC Responsibilities: Must establish and

implement policies and procedures regarding the quality of education and the work environment for residents in all programs. These must include:

Vendor interactions: Provision of a statement or institutional policy (not necessarily GME-specific) that addresses interactions between vendor reps/corporations and residents/GME programs.

How do we best manage? What is our current practice? What policies/regs are in place? How do those impact your ability to practice and

teach? What recommendations do you propose for follow

up? Create new policy? Revise? OK as is?

Four targets today General Principles and Faculty Guidelines

(including primary mission of UT COMC clinical training programs)

Industry Access to Physicians in the Hospital and Outpatient Settings

Industry Access to Residents Industry Support of Research

Institutional Policy

General PrinciplesFaculty Guidelines

GME Principles #1 Physicians’ conflicts of interest generated

by pharmaceutical and other health-related industry marketing activities should be resolved consistent with obligations to patient care and medical education

GME Principles #2 Attending faculty and house staff are

committed to intellectual rigor and objectivity in all transmittal of medical information.

GME Principle #3 The primary mission of UT COMC’s clinical

training programs is to prepare physicians in training and student physicians to render patient-focused, competent, evidence-based, and responsible clinical care.

This training involves 3 components Acquisition of basic & advanced knowledge of

pharmaco-therapeutics Ability to critically evaluate the continuous stream

of developing therapeutic information from academic and commercial sources

The ability to identify various commonly employed marketing strategies intended to influence physician practice.

Principle #4 Pharmaceutical detailing should not

inappropriately bias physician practice.

Principle #5 For purposes of this policy,

“pharmaceutical” shall include pharmaceutical, biomedical devices, equipment, and other health-related entities.

Faculty Guidelines Faculty should model behavior consistent

with ethical guidelines developed by responsible professional organizations* regarding relationships between physicians and industry. Faculty comprises any and all physicians engaged in teaching house staff, whether salaried or voluntary.

*American Medical Association, Accreditation Council for Continuing Medical Education

Faculty Guidelines Regardless of venue or sponsorship,

faculty must present only objective & fairly balanced materials

Faculty Guidelines Faculty may not receive honoraria for

activities given on campus or at UT COMC-affiliated ambulatory sites during usual working hours or in the course of usual working responsibilities.

Faculty Guidelines Faculty may serve as consultants to

pharmacy or proprietary companies for clearly defined professional services.

Faculty Guidelines Faculty must disclose to peers and

residents relevant financial or other relationships between faculty and industry that might constitute conflict of interest, when involved in pharmaceutical sponsored programs.

Institutional Policy

Industry Access to PhysiciansHospital and Outpatient Setting

Vendor access to hospital EHS

Pharm reps are not permitted to see any physician in the hospital except by appointment

Pharm reps are not permitted in any pt care area except by specific appts, including nursing units, surgical units, diagnostic units, treatment areas of ER. General visiting or detailing is not allowed

UT COMC Proposed Policy Reps must comply with the

Hospital Dept of Pharmacy Policy regarding pharmacy detailers/vendors

Reps may not use hospital infrastructure for promotion of programs not accredited by the ACCME, eg, dinner/show

Reps may not loiter in the Medical Library or elsewhere on campus for the purpose of contacting physicians

Vendor access to hospital--cont Members of the hospital

staff will report directly to the Director of Pharmacy any violations of the above rules or misconduct of Pharm Sales Reps.

The first offense will result in a written warning. Future infractions or abuse will result in withdrawal of privileges for a minimum of 6 months. The rep’s company will be notified regarding the violations and consequences.

Reps may not engage in any detailing, promotional, or educational activities on the inpatient floors. Any rep found in a patient care area, without prior approval from the hospital or the training program will be removed and repeat offenders will be denied access to UT COMC.

Vendor access to hospital--cont Pharm reps are not

permitted to conduct in-services or luncheons in the hospital unless approved by the Pharmacy prior to the event.

Reps may attend conferences when company sponsors a speaker. No specific drug products may be promoted, only acknowledgement of sponsoring company allowed.

Reps may meet with the chief of service or designee by appointment, given approval by the department leadership

Reps may provide lunch meals and leave promotional materials, only with prior authorization of the chair of the dept of his/her designee. Under no circumstances are reps to address assembled attendees.

Vendor access to hospital--cont Pharm reps are not

permitted to detail non-formulary drugs to any employee until approved

Pharm reps not permitted to round or conduct preceptorships with any service excluding private physician offices

Device in-services and related programs conducted by industry reps must be attended by at least one faculty physician.

Reps may attend, but not participate in, any general educational programs.

Reps may not offer scholarship, grants or funds directly to any house staff member.

Vendor access --Samples Pharmaceutical reps are

permitted to give free samples to individual physicians for their personal or office use when these are specifically requested by the physician; however, hospital policy prohibits use of samples in patient care areas.

Medication and other product sampling are promotional activities and should be limited among hospital’s clinical depts and faculty practices.

Sample products may be helpful to pts who have financial difficulty in obtaining needed meds. Prescribing and distributing branded meds solely because of gratis availability is inappropriate.

Samples--cont JCAHO standards, TN law,

federal law state all drug samples will be controlled by the pharmacy

Drug samples are not to be dispensed to inpatients

All outpatient dispensing of samples should be documented in pt’s chart

Log to track receipt and distribution of each drug sample should be in place

It may be acceptable to distribute a specific branded medication sample to treat a condition provided: 1) the quality of care to

the patient is no way compromised by selection of the medication (eg, efficacy, risk profile, compliance or cost), and

2) no acceptable generic alternatives exist.

Samples--cont Policy violations by

individual clinics may result in loss of sample dispensing privileges.

Physicians should not accept from pharmaceutical detailers conditions of face-to-face interaction in order to procure samples

The physician (or designee) responsible for a clinical dept or faculty practice determines the specific medication or product samples to be accepted for distribution.

Samples--cont Consistent with AMA

guidelines, faculty and trainees may accept gratis meds for personal or family use for a trial to assess tolerance or efficacy, or for treatment of acute conditions requiring short courses of therapy. Neither faculty nor trainees may accept gratis pharmaceuticals for long term treatment of chronic conditions.

Samples--cont Faculty or trainees should

not receive, for personal use, medication or other product samples (eg infant formula) of monetary value greater than $50

UT COMC PolicyOutpatient Settings

Presentations by pharmaceutical reps may have specific value in terms of assisting faculty in educating trainees in analysis of promotional material and in recognizing marketing techniques.

Presentations by pharm reps and attended by trainees in either inpatient or outpatient practice settings, must conform to the following:

Outpatient settings--cont All campus presentations by pharm reps must be

organized & directed by dept chair or designee Attendees must include at least 1 faculty MD Rep must make promotional materials to be used

during a meeting available to faculty preceptor prior to meeting in a time frame acceptable to the preceptor

Outpatient settings--cont A faculty member should be prepared to discuss

the promoted material in an objective and evidence-based fashion or assign this responsibility to a trainee.

This preparation may include critical review of the promotional material, presentation of additional or refuting studies, referencing the promoted information with consensus panel statements, position papers, etc.

Outpatient settings--cont The rep may remain for the discussion portion

of the meeting at the discretion of the faculty physician in attendance.

Institutional Policy

Industry Access to Residents

Vendor access to residents EHS

Pharmaceutical reps are permitted to speak with the residents between 8:00 - 4:00 pm by appointment only made previously with a chief resident

UT COMC PolicyPhysicians in Training (including medical students)

May not organize or promote (on or off campus) non-CME accredited, industry-driven activities

May organize product or vendor fair

May not attend detailing lunches off campus or at ambulatory sites during work hours without faculty

UT COMC PolicyPhysicians in Training (including medical students)

May not engage in detailing activities (including computer-based) for which they receive gifts or payment

May not receive payment for lectures, advisory boards, dinners, etc.

May accept gifts related to professional activities less than $100

UT COMC PolicyPhysicians in Training (including medical students)

May attend social events associated with education activities only if:

the value is modest, and the education portion accounts for substantial

majority of total time

Institutional Policy

Industry Influence in Research

Los Angeles TimesAugust 6, 2007

Under the Influence From fundings to findings Doctor, just a little something for you Next step: create the demand In short, marketing works

$1 advertising in med journals = $5 drug sales $1 CME sponsorship & professional meetings= $3.56 drug sales $1 physician detailing = $1.72 drug sales on average $1 the most aggressively marketed drugs = $10.00+

And now, a push for change

UT/EHS IRB No specific policy or procedures regarding conflict

of interest review

Should we adopt language from UT HSC? If so, who is responsible for COI review? What is IRB’s role in reviewing budgets,

contracts? (Are contract, protocol, and consent form consistent?)

New EHS policy re COI disclosure?

UT COMC/EHS IRB Policy Conflict of Interest

Yes No Is there a potential conflict of interest for the Principal Investigator or key research personnel?

If “Yes” check all that apply Compensation whose value could be affected by the study outcome. A proprietary interest in the tested product, including but not limited to, a

patent, trademark, copyright or licensing agreement, or the right to receive royalties from product commercialization.

Any equity interest in the sponsor or product whose value cannot be readily determined through reference to public prices (e.g., ownership interest or stock options).

Any equity interest in the sponsor or product that exceeds $10,000, or 5%. Significant payments or other sorts with a cumulative value of $10,000

made directly by the sponsor to any of the investigators as an unrestricted research or educational grant, equipment, consultation, or honoraria.

UT System Fiscal Policy Employees involved in research (ie

investigators) must have disclosed outside interests that may be affected by the research before proposals are submitted to funding agencies.

UT System Fiscal Policy--cont “Investigator” means the principal investigator,

co-principal investigators, graduate assistants, and any other person at the university who is responsible for the design, conduct, or reporting of research activities funded or proposed for funding.

UT System Fiscal Policy--cont Such employees must keep their disclosures

updated for the duration of the project.

Examples of such interests include, but are not limited to, receiving payments for services exceeding $10,000, having equity interest exceeding 5% or $10,000, and holding IP rights.

UT HSCDefinitions Significant financial interest—anything of

monetary value, including but not limited to:

Salary for services or other payments from a single source (eg consulting fees or honoraria) when aggregated over 12 months are expected to exceed $10,000

Equity interest (stocks, options, gifted stock) Intellectual property rights (patents, copyrights, royalties)

Allowable Not allowable Faculty whose U-related

entrepreneurial activities resulted in commercial entity, once all significant financial interests are disclosed.

University & commercial entity shall be reviewed by COI Committee & reviewed by campus Chief Business Officer or other designated official

Faculty may not participate in a sponsored program if s/he has significant financial interest in sponsoring organization

U may not participate in a sponsored program if Dean, Chair in that College has a significant financial interest in sponsoring organization.

UT HSC Managing Conflict of Interests

When developing a University-supervised plan with oversight procedures, the following are some examples of how financial COI may be addressed:

UT HSC Conflict of InterestsManaging COI Public disclosure of significant financial interests Monitoring of research by independent reviewers Modification of the research plan Disqualification from participation in all or a

portion of the research funded by the sponsoring organization

Divestiture of significant financial interests Severance of relationships that create actual or

potential conflicts

Should we adopt language from UT HSC policy?

Would need to expand definition of principal investigator to include non-UT employees (not just faculty, eg EHS physician, physician from outpatient clinic; volunteer faculty)

Who is responsible for COI management?

Options could include: UT/EHS IRB UT/EHS Scientific review committee UT HSC COI committee in Memphis UT/EHS COI committee Other?

What is the process? What is IRB’s role in reviewing budgets &

contracts? How do we determine if contract, protocol,

and consent form are consistent? How is billing process facilitated to insure

protection of research subject?

EHS Prior to adding patients to research, contract

between a principal investigator (PI) and Erlanger must be signed …

Patient Financial Services will set up insurance plan for project with PI as guarantor

Coordinator identifies subjects and contacts registrar…

EHS & UT COMC New Research Compliance Working

Committee Sixth Sigma project to target research

billing Monitoring new CMS billing regs

News via the UT COMmunicator Coordinator Forum, research & compliance conf Look for new CME offerings