Effective April 9, 2009

Purpose
Definitions
Gifts & Meals, Samples, and Site Access
USF Health and Continuing Professional Education
Consulting Relationships with Industry
Informational Presentations on Behalf of Industry (Speaker's Bureau Relationships)
Relations with Pharmaceutical and Industry Representatives in Educational Settings
Recommendations for USF Health Internal Referrals for Action

Quick Reference Guide

Purpose

This guideline governs interactions between USF Health Community Members with Industry and recognizes the benefit of such interactions in contributing to quality patient care and the advancement of knowledge.

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Definitions

• Industry - pharmaceutical representatives, device representatives and other vendors
• USF Health Community Members - USF Health faculty, staff, residents, fellows, students and other trainees, and other workforce members
• PHI – Protected Health Information as defined by the HIPAA Privacy Rule: any health related information that can be used to identify an individual

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Gifts & Meals, Samples and Site Access

Gifts and Meals from Industry

USF Health through its members does not accept gifts or meals provided by Industry which may be viewed as creating a potential to bias objective professional judgment and clinical decision making.

Gifts may be accepted only on an occasional basis when of a modest value and directly related to professional education or patient care/education.   USF Health does not accept items from Industry that may be perceived as marketing materials, such as pens, notepads and other items with company or product logos.  Gifts in the form of entertainment or recreational activities/items, cash, or cash equivalents (such as gift certificates), and items for personal benefit may not be accepted, regardless of value.

Informational presentations by and discussions with Industry can provide valuable educational benefits.  In connection with such, occasional meals may be offered to attendees.  Meals from Industry may be accepted only when of modest value as judged by local standards and in connection with an informational/educational presentation by Industry.  For the protection of the privacy of our patients, all on-site meals must be scheduled in advance and held in non patient care areas wherein PHI is not seen or overheard.

Quick Reference

• Occasional gifts from Industry acceptable when of modest value and directly related to professional education or patient care/education.
• Marketing materials not acceptable.
• Gifts of entertainment, recreation, cash or cash equivalents, personal benefit never acceptable.
• Meals from Industry acceptable only when of modest value and in connection with educational presentation.
• Meals scheduled in advance and held in non patient care areas.

Pharmaceutical Samples

Pharmaceutical samples can benefit patient care by allowing patients to try a medication for effectiveness and absence of side effects prior to incurring a related cost, and by expediting the patient’s medical intervention.  With these benefits comes responsibility for managing the medications to ensure security of medication inventory, prevent dispensing of expired medications, and recording of all dispensed medications in the respective patient records.

USF Health does not accept remuneration of any kind for either receiving or dispensing sample medications.  Sample medications are to be signed for by a physician and stored in a locked central location with a designated clinic manager responsible for security of access.  Any Schedule II or III medications are to be kept in a separate locked storage space/cabinet.  Sample medications may be dispensed only under the written order of a licensed practitioner legally authorized to prescribe medications, and must be recorded in the patient’s medical record along with the corresponding written order for the medication.  The medical record documentation should include the order date, medication dispensed and dosing instructions, which should be provided to the patient.  USF Health Community Members are not authorized to request, take or dispense sample medications without a written order.  Sample medications are to be checked by the designated clinic manager for expiration dates on a monthly basis.  Expired medications are to be disposed of as hazardous waste and not distributed or dispensed for use by anyone.  The medication inventory is to be updated whenever medications are received, dispensed or disposed of.

Quick Reference

• No remuneration for accepting or dispensing sample medications.
• Sample medications must be signed for by a physician and logged in as received and out as dispensed or disposed of.
• Samples are to be kept in a secure central locked area and managed by designated clinic management.
• Any Schedule II or III medications are to be kept in a separate locked storage.
• Sample medications may be dispensed only under written order of a physician or other licensed practitioner authorized to prescribe.
• Record all dispensed sample medications in the patient medical record, including written order for such, date, medication dispensed and related dosing instructions, which should be provided to the patient.
• Expired samples to be disposed of as hazardous waste and not distributed or dispensed for use by anyone.

USF Health Site Access by Industry Representatives

The HIPAA Privacy Rule requires protection of the privacy of PHI.  This rule allows unrestricted use and disclosure of PHI only for treatment purposes.  All other uses and/or disclosures, including many involving interactions with Industry, are restricted.

Industry representatives are required to schedule an appointment to meet with a physician and limit their interaction to that physician.  Industry representatives are to check in at a designated area to sign in as a visitor at a USF Health site; receive a visitor pass to be worn throughout their visit; and return the visitor pass upon signing out when leaving the site.  On their initial visit to a USF Health site, Industry representatives are to be notified of related USF Health policies and sign an agreement acknowledging their commitment to comply with such.  Industry representatives are not allowed access to patients or PHI unless authorized by the treating physician and patient for involvement in patient care in accordance with appropriate patient consent or in accordance with an IRB/Privacy Board approved research authorization or waiver.

Educational materials, products or product information that may be useful to patients may be directly accepted by the physician and designated clinic staff.  Industry representatives are not permitted to place educational material in patient care areas or waiting areas.  Any educational sessions presented by Industry representatives are to be held away from patient care areas wherein PHI is not viewed or heard.

Quick Reference

• Industry representatives must schedule appointments with physicians and limit their interactions to that physician.
• Industry representatives must sign in and out, and wear a visitor ID.
• Industry representatives are not to have access to patients or PHI unless authorized by the treating physician and patient for patient care.
• Industry representatives are to provide any educational materials, products or product information only to a physician or designated clinic staff.  They may not place materials in patient care areas or waiting areas.
• Educational sessions are to be held away from patient care areas wherein PHI is not viewed or heard.

USF Health and Continuing Professional Education

Industry Compensation/Reimbursement for Basic Attendance at Educational (CPE) or Professional Meetings

Attendance by Medical Professionals at conferences or meetings where objective scientific and/or educational activities are the primary focus of the conference or meeting (“Professional Meetings”) is encouraged.  Payment of expenses for attendance at Professional Meetings for Medical Professionals associated with USF Physicians Group shall be governed by policies and procedures of the unit with which the Medical Professional is associated (e.g., the USF Physicians Group Travel Expense Policy, the USF College of Nursing Travel Guide, etc.)

Direct payment or reimbursement to a Medical Professional by Industry of travel or other expenses associated with the Medical Professional’s attendance at Professional Meetings is not permitted.  However, Industry contributions may be made to a Departmental resident education fund maintained within the USF Foundation for the purpose of defraying costs and expenses of attendance at Professional Meetings for residents and fellows (“trainees”). Distribution of funds for trainee attendance at professional meetings shall be exercised at the discretion of the institution independent of Industry direction or influence⁽¹⁾.

Quick Reference

• Costs of attendance at professional meetings may not be paid for by Industry.
• Industry may contribute to a general departmental fund controlled by the institution for the benefit of trainees.

1 AMA Gifts to Physicians, AMA website, January 2007.

Industry Compensation/Reimbursement for Professional Speaking and Lecturing at Educational (CPE) or Professional Meetings

Participation by faculty as speakers and/or thought leaders at Professional Meetings is encouraged. Such participation enhances the national reputation of the University, of USF Health and of the individual faculty member.  The University recognizes that faculty spend time and effort apart from their regular University duties in preparing for such engagements, and that compensation based on the faculty member’s expertise, experience, regional/national/international reputation, and specialty  by the sponsor or organizers of the Professional Meeting for the faculty member’s time, expertise and the expenses of attendance may be offered.

Faculty participation as speakers or thought leaders at Professional Meetings where compensation/honoraria is offered shall normally be conducted as an outside activity.  On rare occasions, other arrangements may be made with the Department Chair to conduct the activity as part of the faculty member’s assignment or with professional leave (e.g., where a faculty member is asked to be keynote speaker at a conference of national repute).  The determination of whether the activity will qualify for professional leave or can be done as part of a faculty member’s assignment rather than as an outside activity shall be made by the Department Chair in consultation with the faculty member.

If the faculty member participates in the Professional Meeting as an outside activity, then the faculty member must disclose the activity via the outside activity process (Reporting Outside Activities Database).  Approval will not be unreasonably withheld, but will be dependent upon whether the faculty member is meeting his or her departmental assignments/expectations.  The faculty member must also submit a request for annual leave if the participation will take place during University business hours (8am-5pm).

If conducted as an outside activity, the honorarium may be made directly to the faculty member and should be fair and reasonable compensation. The actual costs of travel, lodging and other reasonable expenses of attending the event may also be paid or reimbursed by the sponsor or organizer of the meeting.

Faculty participating as speakers at Professional Meetings for which continuing professional education (CPE) credit is offered will be subject to the CPE policies and procedures of the ACCME accredited CME provider.  Honorarium and payment or reimbursement of expenses for lecturing at CPE events should be paid by the ACCME accredited CME provider to the faculty member and should not be paid directly to the faculty member by Industry⁽²⁾.  Accredited CPE activities are an appropriate forum for discussion of unapproved or off-label uses of products/devices.

USF Health-Sponsored CPE Events

For USF Health-Sponsored CPE events, the policies and procedures of USF Health's Office of Continuing Professional Development (OCPD) Office will apply.  Faculty organizing Professional Medical Conferences/Meetings for CPE credit must use USF Health’s OCPD as the organizing unit.

CPE Events Sponsored by Nationally Recognized Professional Organizations

Occasionally, faculty members will be invited to lecture at conferences sponsored by nationally recognized professional organizations (e.g. AAMC).  In these situations, the professional organization will be the credentialing body for the event and will require faculty to follow its CPE policies and procedures.

Medical Education Company (MEC) CPE Events

Faculty are permitted to speak in commercially-sponsored CPE events developed by MECs; however, such activity must always be conducted as an outside activity with the approval of the Department Chair.  Such participation should not compete or conflict with USF Health CPE events on similar topics.

Quick Reference

• Faculty lecturing at professional meetings for compensation must be disclosed through ROAD as an outside activity (see full text for exceptions).
• Faculty must take annual leave for participation in outside activity during University business hours.
• Reasonable compensation may be paid to the faculty member for the speaking activity.
• Actual costs of travel, lodging and other reasonable expenses of attending the event may be paid by the sponsor or organizer of the meeting.
• For CPE events, the policies and procedures of the ACCME accredited provider apply and honoraria/expenses should be paid by the ACCME accredited provider⁽²⁾.

2 ACCME Standards for Commercial Support, standards 3.7 – 3.9, revised 2007.

Consulting Relationships with Industry

The University expects that its faculty will be sought after as consultants to industry and agrees that such relationships can lead to medical innovation, better medical and surgical products, and can ultimately promote better patient care.  However, such consulting relationships must not:

• interfere with university duties;
• compromise professional ethics;
• have elements that may be construed by the government as an illegal kickback, resulting in criminal charges; or
• be used as a vehicle for direct payment to faculty aimed at convincing them to use a company's products.

Accordingly, consulting relationships with industry are permitted under the following conditions:

• the relationship must be disclosed via the outside activity process (Reporting Outside Activities Database); and approved by the Department Chair, unless other arrangements are made with the Department Chair to conduct the activity as part of the faculty member’s assignment; and
• the faculty member must submit a request for annual leave if the participation will take place during University business hours (8am-5pm); and
• the relationship must be based on a written agreement which documents the specific, legitimate tasks and deliverables; and payment amount must be commensurate with the tasks performed considering the faculty member’s specialty, expertise and regional/national/international reputation.
• A copy of the final, fully-executed contract must be submitted to the Department Chair for the department file, and a copy also should be provided to the USF Health Office of Faculty Affairs.

On occasion, a company will ask for a release letter from the University indicating that the University has approved the activity in question.  The faculty member may provide the approved outside activity form in response to this request.

For a faculty member who is engaged in research involving the company with whom the consulting relationship is proposed, the faculty member must complete and submit a Financial Relationships Disclosure Form to the Division of Sponsored Research (c/o COI Administrator, ADM 200) for sponsored research, or to the USF Health Office of Research Compliance (c/o COI Administrator, MDC 02) for non-sponsored research for additional review and approval of a management plan per the process for review of conflicts of interest in research.

Quick Reference

• Faculty consulting relationships must be defined by a written agreement that specifies the specific legitimate tasks and deliverables; payment must be commensurate with the tasks performed considering the faculty member’s specialty, expertise and regional/national/international reputation.
• A copy of the executed agreement must be provided to the Department Chair and to USF Health Office of Faculty Affairs.
• Faculty consulting relationships must be disclosed through ROAD as an outside activity, unless otherwise agreed by the Department Chair.
• Faculty must take annual leave for participation in outside activity during University business hours..
• Faculty who are engaged in research involving the company with whom the consulting relationship is proposed must complete a Financial Relationships Disclosure Form and follow the process for review of conflicts of interest in research.

Informational Presentations on Behalf of Industry (Speaker's Bureau Relationships) 

The University recognizes that its faculty may be sought after as speakers to present information relevant to a company’s products and recognizes that such speaking opportunities may serve to provide necessary scientific and educational information to the medical and health care provider community. The University recognizes that faculty spend time and effort apart from their regular University duties in preparing for such presentations, and that compensation by the company for the faculty member’s time is appropriate.

Faculty participation as speakers on behalf of industry products must be conducted as an outside activity.  The faculty member must disclose the activity via the outside activity process (Reporting Outside Activities Database). Approval will not be unreasonably withheld, but will be dependent upon whether the faculty member is meeting his or her departmental assignments and obligations.  The faculty member must also submit a request for annual leave if the participation will take place during University business hours (8am-5pm).

Payment to faculty members must be reasonable and fair compensation for the work performed based on the faculty member’s expertise, experience, regional/national/international reputation, and specialty.  The gathering where the information is presented must be primarily dedicated to informing healthcare professionals about a product or treatment, providing scientific information, and promoting educational discourse on the topic presented.  The venue must be conducive to informational communication and meals (a) are modest as judged by local standards; (b) are not part of an entertainment or recreational event; and (c) are provided in a manner conducive to informational communication.    In addition, inclusion of a healthcare professional’s spouse or other guest in a meal accompanying an informational presentation made by or on behalf of a company is not appropriate⁽³⁾.

Presentation materials on drug products must follow pharmaceutical guidelines and present information on the FDA-approved use of the drug product and may not promote the “off-label” use of a drug product.

Participation in an industry sponsored speaker’s bureau may create a conflict of interest for the faculty if invited to speak on a similar topic for a Professional Meeting certified for CPE credit.

Quick Reference

• Faculty participation as speakers on behalf of industry products must be disclosed through ROAD as an outside activity.
• Faculty must take annual leave for participation in speaker’s bureau activities during University business hours.
• Reasonable compensation may be paid to the faculty member for the speaking activity based on the faculty member’s expertise, experience, regional/national/international reputation, and specialty.
• A meal may be provided as long as such meal is “modest as judged by local standards.”
• The gathering must be primarily for the purpose of informing healthcare professionals about a product or treatment, providing scientific information, and promoting educational discourse on the topic presented and the venue conducive to informational communications.
• Presentation materials on drug products must follow pharmaceutical guidelines and present information on the FDA-approved use of the drug product and may not promote the “off-label” use of a drug product.

3 Pharma Code (Revised) page 4, effective January 1, 2009.

Relations with Pharmaceutical and Industry Representatives in Educational Settings 

1. Representatives are allowed to provide educational materials and presentations to resident physicians only if the interaction is approved by the relevant residency director.
   1. Interactions must only involve presentation of published literature and FDA approved indications.
   2. Time allowed for open questions shall be not greater than 10% of the allocated presentation time.
   3. The representative may not provide promotional items to the medical students or resident physicians, regardless of value.
2. Pharmaceutical representatives shall not have access to patient information nor be allowed to observe examinations or therapeutic discussions of patients.
3. Device representative’s access to patient information, examinations, and therapeutic discussion shall be limited only that which is necessary for appropriate education of the medical staff during planned or active use of the represented device.

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Recommendations for USF Health Internal Referrals for Action

Recommendations to the Curriculum Committee:

1. Students should be provided a comprehensive education regarding the roles that outside commercial interests play in the medical profession and the importance of responsible, critical decision making when interacting with representatives of those companies.
2. A gradated level of education should be provided as students progress through their medical education.  A minimal level must be attained before students begin their MS1 LCE assignment.  A further level is expected prior to the MS3 clinical year, during which students are frequently exposed to representative from pharmaceutical and device industries.  A system should be implemented to allow students to demonstrate and certify their competency at each level.

Recommendations to the Honor Council:

1. Students should limit their professional interactions with commercial representatives to those that occur during their clinical duties.
2. Students should refrain from displaying commercial promotional materials during their clinical duties.
3. Students should at all times adhere to those guidelines set forth by their honor code as they pertain to interactions with representatives.

Recommendations to the Student Council:

1. Establish an award which annually recognizes a faculty member who has contributed to educational discussions regarding the role of pharmaceutical and device industries in the business of medicine. Note: This award would not be intended to recognize “pharm-free” physicians, but rather those physicians who foster open conversations and mentor students regarding responsible decision making during interactions with representative from pharmaceutical and device industries.

Recommendations to the Faculty Council:

Recommendations to the Vice President of USF Health:

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There shall be a one year grace period for implementation of the policies and procedures enunciated. Effective 1 Jan 2010, failure to abide by the principles enunciated and modifications as subsequently adopted shall be cause for disciplinary action in accordance with relevant University Policy.

It is proposed that this document serve as a vehicle for discussion and referral for consideration as noted which should conclude in early 2009.

Edited 1/2/2009
Date of adoption 4/9/2009

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