National and Institutional Guidelines on Conflict of Interest in Physician-Industry Relationships Rev. 10/21/2014 APGO Interaction with Industry: A Medical Student Guide

Objectives List the agencies that regulate industry and identify relationships that are of importance in our field Describe the common features of conflict of interest guidelines regarding physicians’relationships with the pharmaceutical industry Summarize your own institutional guidelines Become familiar with the websites where you can go for more information on physician relationships with industry

Guidelines on Physician Interaction with Industry In recent years, there has been an increase in regulatory guidelines in the area of conflict of interest with a focus on physician relationships with the pharmaceutical industry Reasons for this increase include: – Potential influence of pharmaceutical marketing on patient care – Bias in research and results reporting – Rising costs of health care – Fraud and abuse

Guidelines on Physician Interaction with Industry American Medical Association (AMA) Association of American Medical College (AAMC) Accreditation Council for Continuing Medical Education (ACCME) American College of Obstetricians and Gynecologists (ACOG) Association of Professors of Obstetrics and Gynecology (APGO) Pharmaceutical Research and Manufacturers of America (PhRMA) Advanced Medical Technology Association (AdvaMed Code) Physician Payments Sunshine Act (CMS)

AMA (hyperlinks will be active in presentation mode) The American Medical Association (AMA) has an extensive code of ethics. It includes several sections concerning conflicts of interest: Opinion Gifts to Physicians from Industry Opinion Opinion Financial Relationships with Industry in CME Opinion Opinion COI in Biomedical Research Opinion Opinion Managing Conflicts of Interest in Clinical Trials Opinion

AAMC (hyperlinks will be active in presentation mode) Offers a number of resources for members regarding conflicts of interestnumber of resources Conflicts of Interest in Research AAMC Report on Institutional Approaches to Implementing the Final NIH Rule on Financial Conflicts of Interest (2012) AAMC Report on Institutional Approaches to Implementing the Final NIH Rule on Financial Conflicts of Interest Conflicts of Interest in Medical Education Report of the AAMC Task Force on Industry Funding of Medical Education (2008) Report of the AAMC Task Force on Industry Funding of Medical Education Reviewed on next slide Conflicts of Interest in Clinical Care In the Interest of Patients” Recommendations for Physician Financial Relationships and Clinical Decision Making (2010) In the Interest of Patients” Recommendations for Physician Financial Relationships and Clinical Decision Making Science Behind Conflicts of Interest AAMC Symposium on the Scientific Basis of Influence and Reciprocity (2007) AAMC Symposium on the Scientific Basis of Influence and Reciprocity

AAMC (cont’d) (hyperlink will be active in presentation mode) Goal of the task force report, Industry Funding of Medical Education (June 2008), was to examine the benefits/pitfalls associated with industry funding of medical education and offer principles, recommendations, and guidelines to assist in refashioning industry relationships to better conform to high standards of medical professionalismIndustry Funding of Medical Education Recommendations – Academic medical centers should establish a central CME office where support and funds for CME activity are coordinated and overseen – Pharmaceutical samples (if permitted) should be centrally managed with vouchers for low- income patients. – Site access by pharmaceutical representatives restricted to non-patient care areas and by appointment only – Site access by devise manufacturers in patient care requires appointments, credentialing, and disclosure and consent by patients – Exclude professionals with financial relationships with drug manufacturers from Pharmacy and Therapeutic Committees and the FDA Advisory Committees. – Faculty should not serve as members of speakers’ bureaus.

ACCME (hyperlink will be active in presentation mode) The ACCME Standards for Commercial Support describes practices considered appropriate for accredited providers to ensure CME activities are independent, free of commercial bias and beyond the control of persons or organizations with an economic interest in influencing the content of CMEACCME Standards for Commercial Support Six standards are enumerated, each with subsections Standard 1: Independence Standard 2: Resolution of Personal Conflicts of Interest Standard 3: Appropriate Use of Commercial Support Standard 4: Appropriate Management of Associated Commercial Promotion Standard 5: Content and Format without Commercial Bias Standard 6: Disclosures Relevant to Potential Commercial Bias

ACOG (hyperlink will be active in presentation mode) Professional Relationships with Industry (November 2012) Professional Relationships with Industry Comprehensive recommendations for practicing physicians on structuring relationships that will enhance, rather than detract from, their obligations to their patients in the following areas: Product promotion to individual physicians by advertising, personal communication, and provision of samples Support of educational activities for individual physicians Industry-sponsored device training Industry sponsorship of research Importance of physicians acting as consultants to industry

APGO (hyperlink will be active in presentation mode) Policy on Ob-Gyn Educators’ Interaction with Industry Policy on Ob-Gyn Educators’ Interaction with Industry (March 2012) APGO promotes the responsible education of teachers and leaders in women’s health care with respect to their interactions with industry. APGO recognizes that continuing instruction is paramount in appropriate and ethical interactions during and after training as part of life-long learning. APGO is dedicated to providing the tools and materials necessary to connect educators with the most current innovations in medicine and industry, as well as updates to regulatory guidelines.

APGO (cont’d) (hyperlink will be active in presentation mode) APGO recognizes that some advancements in medical and surgical care originate from collaborations with industry. APGO is committed to fostering responsible relationships with our industry partners so that medical educators can become proficient in teaching the skills necessary to allow learners to safely and effectively employ innovations in medical therapy. An artificial and ambiguous divide exists when interaction is forbidden, which then prevents and/or prohibits bringing important and improved technologies and treatments to our patients. Adaptation and integration of these improvements may be further delayed because of barriers in access to the leaders and teachers who should disseminate skills and information. APGO support policies and forums that foster a fair and unbiased exchange of information. APGO has adopted guidelines for appropriate disclosure of all conflicts of interest.guidelines

PhRMA (hyperlink will be active in presentation mode) Guidelines on Physicians’ Interactions with Industry “Ethical relationships with health care professionals are critical to our mission” The Pharmaceutical Research and Manufacturers of America (PhRMA) represents research-based pharmaceutical and biotechnology companies which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA members alone invested an estimated $50.3 billion in 2008 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.2 billion in Developed and published “Code on Interactions with Health Care Professionals” which took effect Jan 2009.

PhRMA Guidelines on Physician Interactions with Industry (hyperlink will be active in presentation mode) “Ethical relationships with healthcare professionals are critical to our mission of helping patients by developing and marketing new medicines. An important part of achieving this mission is ensuring that healthcare professionals have the latest, most accurate information available regarding prescription medicines, which play an ever-increasing role in patient healthcare. This document focuses on our interactions with healthcare professionals that relate to the marketing of our products.” professionals professionals

AdvaMed (hyperlink will be active in presentation mode) AdvaMed Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code) (2009) facilitates ethical interactions between MedTech companies and healthcare professionals to ensure that medical decisions are based on the best interests of the patient. AdvaMed Code of Ethics on Interactions with Health Care Professionals It clarifies and distinguishes appropriate activity between health care professionals and representatives of AdvaMed member companies.

Physician Payment Sunshine Act (hyperlink will be active in presentation mode) Physician Payments Sunshine ActPhysician Payments Sunshine Act - Center for Medicare & Medicaid Services (CMS) (2013) This program is a national resource for beneficiaries, consumers, and providers to better understand relationships between physicians, teaching hospitals, and industry. Collaboration among physicians, teaching hospitals, and industry manufacturers can contribute to the design and delivery of life-saving drugs and devices. However, while some collaboration is beneficial, payments from manufacturers to physicians and teaching hospitals can also introduce conflicts of interest. Open Payments is a national disclosure program that promotes transparency by publishing the financial relationships between the medical industry and healthcare providers (physicians and hospitals) on a publicly accessible website developed by CMS. Physicians have the right to review their reports and challenge reports that are false, inaccurate or misleading

Physician Payment Sunshine Act (cont’d) (hyperlinks will be active in presentation mode) The program requires that the following information is reported annually to CMS: Applicable manufacturers of covered drugs, devices, biologicals, and medical supplies to report payments or other transfers of value they make to physicians and teaching hospitals to CMS. Applicable manufacturersphysiciansteaching hospitals Applicable manufacturers and applicable group purchasing organizations (GPOs) to report to CMS certain ownership or investment interests held by physicians or their immediate family members.applicable group purchasing organizations (GPOs) Applicable GPOs to report to CMS payments or other transfers of value made to physician owners or investors if they held ownership or an investment interest at any point during the reporting year.

Do you know your own institutional guidelines?

AMSA Scorecard (hyperlink will be active in presentation mode) AMSA Scorecard: Conflict of Interest Policies at Academic Medical Centers The Scorecard is an institution-specific evolving tool that uses letter grades to assess schools’ performance in fourteen potential areas of conflict of interest. It offers a comprehensive look at the changing landscape of conflict- of-interest policies across US medical education, as well as in-depth assessments of individual policies that govern industry interaction between students, faculty, and the pharmaceutical and medical device industries.

Know your responsibilities for reporting potential or actual conflicts of interest.

Understand how to manage relationships with potential conflicts at your institution. Avoiding those relationships is not the answer.

“The key to success is collaboration. Industry cannot do this alone, physicians cannot do this alone, medical and communications companies can’t do this alone.” Mike Saxton Director of Clinical Education, Pharmacia