PAMEAS Code of Ethics
Introduction

The Patient Medical Association (PAMEAS) was founded to reduce medical errors and to make patients safer. We strive to reach that goal through our publications, educational programs, products, and grant and scholarship foundation programs.

PAMEAS has a history of producing high-quality educational programs for the healthcare community. As a non-profit, 501(c)(3) a patient advocate educational organization, PAMEAS is dedicated to maintaining the highest standards of professional ethics and transparency in its educational programs. The purpose of these educational programs is to reduce errors made in patient care and it is the responsibility of PAMEAS to assure that the educational activities we produce are designed primarily for that purpose.

PAMEAS often receives financial and other support from commercial organizations. Such support can contribute significantly to the quality of educational activities. However, commercial support from industry does not influence educational content, faculty selection, and/or product usage during demonstrations and, therefore, does not compromise the ethical or scientific integrity of PAMEAS programs.

This Educational Code of Ethics focuses on interactions with healthcare professionals that relate to commercial support during educational activities produced by PAMEAS. The purpose of this Code is to describe appropriate behavior of faculty, staff, and commercial supporters in participating in PAMEAS educational activities for which commercial support is received. Its content is based on our own standards and those developed by the Accreditation Council for Continuing Medical Education (ACCME), the Code on Interactions with Healthcare Professionals, , adopted by the Pharmaceutical Research and Manufacturers of America (PhRMA), the Code of Ethics adopted by the Advanced Medical Technology Association (AdvaMed), and other organizations and institutions. PAMEAS will continually review and update this Code to best serve the needs of patients, and the latest version can always be found online at http://pameas.org/code.

PAMEAS appreciates that effective marketing of healthcare products ensures that patients have access to the products they need and that these products must be used correctly for maximum patient benefit. PAMEAS recognizes that an appropriate relationship between commercial supporters and the healthcare professional is critical to:

  1. Inform healthcare professionals about the benefits and risks of medical products,

  2. Provide scientific and educational information,

  3. Support medical research and education, and

  4. Obtain feedback and advice about products through consultation with medical experts.

However, in interacting with the medical community, PAMEAS also believes that commercial supporters must be committed to following the highest ethical standards, as well as all regulatory requirements, and that interactions between commercial entities and healthcare professionals not be perceived as inappropriate by patients or the public at large, particularly in instances where physicians are called upon to be objective clinical experts. This Code is intended to provide a framework to reinforce our intention that commercial interactions with healthcare professionals are to benefit patients and to enhance the practice of medicine and are based on the principle that a healthcare professional’s care of a patient should only be based upon each patient’s medical needs and the healthcare professional’s medical knowledge and experience.

PAMEAS does not exist to help commercial supporters sell product. We exist to improve patient safety and reduce medical errors.

This Code addresses interactions between commercial supporters and healthcare professionals during PAMEAS educational activities with respect to marketed products and related pre-launch activities.

Code Details
  1. BASIS OF INTERACTIONS
    The relationships between commercial supporters and healthcare professionals are intended to benefit patients and to enhance the practice of medicine. Commercial interactions should be focused on informing healthcare professionals about products, providing scientific and educational information, and supporting medical research and education.

  2. BASIC PRODUCTION REQUIREMENTS FOR EDUCATIONAL ACTIVITIES
    In producing educational activities, PAMEAS will assure that educational activities are free of commercial bias for or against any product. If the activities are concerned with commercial products, they will present objective information about those products, based on scientific methods generally accepted in the medical community.

  3. INDEPENDENCE OF PAMEAS
    The design and production of educational activities shall be the ultimate responsibility of PAMEAS, the course directors, and faculty associated with each program. Commercial supporters of such activities shall not control the planning, content, or execution of the activity. To assure compliance with this standard, the following requirements will be adhered to.

    1. Assistance with Preparation of Educational Materials
      The content of slides and reference materials will remain the ultimate responsibility of the faculty selected by PAMEAS. A commercial supporter may be asked to provide support of conference-related educational materials, but these materials shall not, by their content or format, advance the specific proprietary interests of the commercial supporter.

    2. Assistance with Educational Planning
      PAMEAS may obtain information that will assist in planning and producing an educational activity from any outside source whether commercial or not. However, acceptance by PAMEAS of advice or services concerning speakers, invitees, or other educational matters, including content, shall not be among the conditions of providing support by a commercial organization.

    3. Marketing Educational Activities
      Only PAMEAS may authorize a commercial supporter to disseminate information about an educational activity to the medical community. However, the content of such information is the responsibility of PAMEAS, and any such information will identify the educational activity as produced by PAMEAS.

    4. Educational Activities or Materials Prepared by Proprietary Entities
      When PAMEAS offers educational activities consisting of concepts or materials prepared by proprietary entities, such activities will adhere to this Code in all respects, especially with regard to the provisions concerning the independence of PAMEAS in planning, designing, delivering, and evaluating such activities.

  4. IDENTIFYING PRODUCTS, REPORTING ON RESEARCH, AND DISCUSSING UNLABELED USES OF PRODUCTS
    1. Generic and Trade Names
      Presentations must give a balanced view of therapeutic options. Faculty use of generic names will contribute to this impartiality. If trade names are used, those of several companies should be used rather than only that of a single supporting company.
       
    2. Reporting Scientific Research
      Objective rigorous scientific research conducted by commercial companies is an essential part of the process of developing new medical products or devices. It is desirable that direct reports of such research be communicated to the medical community. An offer by a commercial entity to provide a presentation reporting the results of scientific research shall be accompanied by a detailed outline of the presentation, which shall be used by PAMEAS to confirm the scientific objectivity of the presentation. Such information must conform to the generally accepted standards of experimental design, data collection, and analysis.
       
    3. Unlabeled Uses of Products
      When an unlabeled use of a commercial product, or an investigational use not yet approved for any purpose, is discussed during an educational activity, PAMEAS shall require the speaker to disclose that the product is not labeled for the use under discussion or that the product is still investigational. Off-label product usage is not endorsed by PAMEAS.
       
  5. EXHIBITS AND OTHER COMMERCIAL ACTIVITIES
    1. Exhibits
      When commercial exhibits are part of the overall program, arrangements for these should not influence planning or interfere with the presentation of educational activities. Exhibit placement should not be a condition of support for an educational activity.
       
    2. Commercial Activities During Educational Activities
      No commercial promotional materials shall be displayed or distributed in the same room immediately before, during, or immediately after an educational activity certified for credit.
       
    3. Commercial Supporters at Educational Activities
      Representatives of commercial supporters may attend an educational activity, but may not engage in sales activities while in the room where the activity takes place.
       
  6. MANAGEMENT OF FUNDS FROM COMMERCIAL SOURCES
    1. Independence of PAMEAS in the Use of Contributed Funds
      The ultimate decision regarding funding arrangements for educational activities will be the responsibility of PAMEAS. Funds from a commercial source should be in the form of a restricted educational grant made payable to PAMEAS for the support of programming and management. The terms, conditions, and purposes of such grants will be documented by a signed agreement between the commercial supporter and PAMEAS. All support associated with an educational activity, whether in the form of an educational grant or not, will be given with the full knowledge and approval of PAMEAS. No other funds from a commercial source shall be paid to the director of the activity, faculty, or others involved with the supported activity.
       
    2. Payments to Faculty
      Payment of reasonable honoraria and reimbursement of out-of-pocket expenses for faculty is customary and proper and will be made solely by PAMEAS.
       
    3. Educational and Practice-related Items given to Faculty
      Items primarily for the benefit of patients may be offered to faculty if they are not of substantial value. All items must be evaluated by PAMEAS for compliance with this Code prior to being distributed to faculty.
       
    4. Commercially Supported Social Events
      Commercially supported social events at educational activities will be fully produced and coordinated by PAMEAS and will not compete with, nor take precedence over, educational activities. Occasional meals may be offered but will be modest as judged by local standards and occur in a venue and manner conducive to informational communication and provide scientific or educational value.
       
    5. Acknowledgment of Commercial Support
      Commercial support will be acknowledged in writing; however, reference will not be made to specific products.
       
    6. Accountability for Commercial Support
      Following the educational activity, upon request, PAMEAS will be prepared to report to each commercial supporter, and other relevant parties, information concerning the expenditure of funds each has provided.
       
    7. Balance of Funds
      Any remaining grant funds not expended for an educational activity may be used for other PAMEAS educational activities.
       
  7. DISCLOSURE OF FACULTY AND PROVIDER RELATIONSHIPS
    1. Disclosure Policy for All Educational Activities
      PAMEAS shall have a policy requiring disclosure of the existence of any significant financial interest or other relationship a faculty member or the provider has with the manufacturer(s) of any commercial product(s) discussed in an educational presentation. All PAMEAS educational activities shall conform to this policy.
       
    2. Disclosure in Conference Materials
      PAMEAS and its faculty relationships with commercial supporters shall be disclosed to participants prior to educational activities in brief statements in conference materials such as websites, email, brochures, syllabi, exhibits, poster sessions, and post-meeting publications.
       
    3. Disclosure for Regularly Scheduled Activities
      In the case of regularly scheduled events, such as grand rounds, the moderator of the activity shall make disclosure after consultation with PAMEAS, the faculty member, or a representative of the supporter.
       
  8. FINANCIAL SUPPORT FOR PARTICIPANTS IN EDUCATIONAL ACTIVITIES
    1. Expenses of Non-Faculty Attendees
      PAMEAS will generally not use funds originating from a commercial source to pay travel, lodging, registration fees, honoraria, or personal expenses for non-faculty or non-staff attendees. Subsidies for hospitality should not be provided outside of modest meals or social events that are held as part of the activity.
       
    2. Scholarships for Medical Students, Residents, Fellows, and other Special Cases
      Scholarship or other special funding to permit medical students, residents, fellows, or others to attend selected educational programs may be provided, as long as the selection of recipients who will receive the funds is made by PAMEAS and not any commercial supporter.
       
    3. Items for the benefit of Patients
      Items primarily for the benefit of patients may be offered to participants during a PAMEAS educational program. These activities must be coordinated and approved by PAMEAS prior to the educational program.
  9. INDEPENDENCE OF DECISION MAKING
    Commercial support from industry does not influence educational content, faculty selection, and/or product usage during demonstrations and, therefore, does not compromise the scientific integrity of PAMEAS programs. No grants, scholarships, subsidies, support, consulting contracts, educational, or practice related-items will be provided or offered to a faculty member, staff, or other participants of a PAMEAS educational program without coordination and involvement of PAMEAS. Nothing should be offered or provided in a manner or on conditions that would interfere with the independence of a faculty or staff member during an educational activity.
     
  10. ADHERENCE TO CODE
    Each faculty member, staff, and commercial supporter of PAMEAS educational activities must agree to adopt procedures to assure adherence to this Code.