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CPS-1.01 COM Business Relationships with Industry

POLICY NUMBER: CPS-1.01
EFFECTIVE DATE: July 1, 2014
RESPONSIBLE OFFICER: Chief Compliance Officer

I. PURPOSE

The Drexel University College of Medicine (CoM) provides patient-oriented care, medical education and research enhanced by technological and medical innovations. CoM healthcare professionals, faculty, and staff can be required to interact with representatives of pharmaceutical companies, medical device manufacturers, equipment, and service providers. In order to avoid conflicts of interest and maintain a culture of professionalism consistent with the report “Industry Funding of Medical Education” by The Association of American Medical Colleges, the purpose of this policy is:

  • To ensure that the relationship between Academic Medicine and Industry remains principled.
  • To sustain public trust in the proposition that we are fundamentally dedicated to the welfare of our patients and the improvement of public health.
  • To minimize undue influence of pharmaceutical and medical device manufacturers, equipment and service providers on practice patterns, prescribing and purchasing decisions of CoM healthcare professionals, faculty and staff.

II. DEFINITIONS

“Professionals” are CoM faculty and professional staff members (including full-time faculty who are Tenet employees), residents, fellows and students.

“Industry” is pharmaceutical and medical device manufacturers, equipment and service providers.

“DUP” shall mean “Drexel University Physicians.”

III. SCOPE

These guidelines apply to all CoM Professionals. They apply to all venues and activities on and off campus. If this Policy is more restrictive than other CoM conflict of interest policies and procedures, this Policy shall control. They apply to non-full-time, non-compensated faculty, when representing CoM.

IV. RESPONSIBLE OFFICER

The Chief Compliance Officer is the responsible officer for implementation, interpretation and enforcement.

V. PROCEDURE

A. Gifts

  1. Professionals shall not accept gifts or meals from Industry salespeople. “Gift” is defined as anything of value more than $25. Gifts cannot be accepted by third parties.
  2. Gifts for Continuing Medical Education (“CME”) Activities: All support for CME activities must be included in an educational grant made directly to either the CoM Office of CME or an outside accredited Office of CME. It must be preceded by a Letter of Agreement.
  3. Gifts for Non-CME Activities: Industry representatives can provide educational grants for non-CME programs through departments. At the discretion of the Chair, such support can be used for medical education purposes (e.g. honoraria and expenses for extramural lecturers and the provision of modest meals) The Department Chair will require full transparency and disclosure by any funded presenter.

B. Pharmaceutical Samples

  1. Medication samples from Industry representatives must be logged-in and logged-out. They should be available for distribution by all department members. Log-in and log-out controls will be audited periodically by the CoM Office of Quality Management.

C. Industry Access to Professionals and Patients

  1. Industry representatives can only interact with Professionals by appointment, outside of patient care hours.
  2. Industry representatives must wear identification badges while on CoM premises.
  3. Industry representatives must not interact directly with patients, review any part of the medical record, go on rounds, or attend surgery without patient authorization or Business Associate Agreement.
  4. Industry representatives cannot attend Professionals’ conferences unless invited or serving as the sponsor of a conference.
  5. Industry representatives cannot use the resources of educational or administrative offices of CoM clinical departments to inform Professionals of promotional Industry-sponsored events.

D. Participation in Lectures, Consulting, Advisory Boards and Conferences

  1. Speakers Bureaus: Participation by CoM Professionals in industry sponsored speakers bureaus are highly discouraged by CoM and the AAMC. “Speaker’s Bureau” is defined as the delivery of an FDA approved slide deck for the purpose of marketing a specific product. There may be certain circumstances where CoM faculty have legitimate reasons to participate. Written prior approval from the department chair is required.
  2. Other Lectures: Professionals can give lectures of their own material, sponsored or reimbursed by Industry. Academic investigators may present results of their Industry-sponsored studies to peers in settings where there is an opportunity for critical exchange.
  3. Medical School lectures: Faculty shall disclose their COIs prior to each lecture to the medical students.
  4. Financial reporting: Each lecture, advisory board or consulting assignment for Industry which renders fees in a calendar year that exceed $300 shall be reported. Direct company ownership that exceeds $10,000 or a 2% interest in the sponsor (whichever is lower) shall also be reported using the conflict of interest form per CPS-2. A plan to manage the conflict will be developed by the Department Chair. If research for the Industry sponsor is to be conducted, the plan will be approved by the DUCoM Vice Dean for Research.
  5. Contracts: Each advisory board membership or consulting assignment for industry must be described in a contract that sets forth compensation that is fair market value for services described. The contract must be filed with the Department Chair. If the consulting involves research, the contract must be filed with the Vice Dean for Research.
  6. Reimbursement of Expenses: Professionals may accept reimbursement (of travel, meals and other expenses) for presenting one’s own research findings at a meeting, procedural training or consulting provided that the expenses are reasonable in relation to the services provided (fair market value). Such presentation and reimbursement shall be approved in advance by the Department Chair.
  7. CoM Professionals shall not accept funds directly from Industry for the purpose of attending conferences or meetings in a passive capacity.
  8. Professionals-in-training or other trainees: Grants can be accepted by clinical departments or divisions for Professionals-in-training or other trainees to attend conferences provided that department faculty (and not the company) chooses the trainee to receive the funds for attending the meeting. The CoM Office of CME shall use funds from an educational grant in compliance with ACCME guidelines, to reimburse expenses for bona fide faculty, employees, volunteers, joint sponsor, or educational partners involved in an accredited activity.

E. Ghostwriting

  1. Consistent with the CoM Faculty Handbook section on research policy and procedures and the AAMC guidance, professional presentations and works of any kind, oral or written are not to be ghostwritten by any party, industry or otherwise. For more information, visit the Conduct of Research website.

F. Formulary and Purchasing

  1. CoM Professionals who participate in decision-making roles regarding the selection of pharmaceuticals, devices and other purchases by CoM must not have conflicts of interest. Professionals who are consultants to such selections must disclose their financial relationships with the Industry that provides the product prior to participation in the selection process, in accordance with the Conflict of Interest and Commitment Policy OGC-01. Professionals shall recuse themselves from the selection process if necessary.

G. Professionalism Education for Professionals and Trainees

  1. Each clinical department within CoM will educate its Professionals in prescribing practices at least annually.
  2. House staff shall be instructed on how promotional activities can influence judgment in prescribing decisions and research activities. Training on the influence of physician-Industry representative interactions will be included for house staff at least annually.

H. CoM/DUP Training Programs for Industry Representatives

  1. Occasionally physicians, pharmacists, nurses, or other professionals are asked by Industry to provide training about new drugs or procedures. Programs will be arranged through the respective Department Chair or Division Chief. A brief outline of the project that includes the intent, scope and time line of the educational program will be filed and retained in the office of the Chair.

I. Lectures to Medical Students and Residents

  1. Faculty will disclose their conflicts prior to all formal lectures.

J. Use of Animals

  1. All use of industry sponsored animal education problems will fall under the jurisdiction of ULAR and the ALSET Program (Animal Lab Surgical Education Training Program).

K. Other Activities

  1. For interactions and activities not specifically addressed in this policy, CoM Professionals are expected to conduct themselves consistent with the spirit of this policy.

L. Review

  1. This policy shall be assessed and reviewed periodically.

M. Sanctions

  1. Those not complying with this policy will be subject to sanction as outlined in the Code of Conduct.