The Ohio University College of Osteopathic Medicine (OU-HCOM) and University Medical Associates (UMA) share a goal to improve the healthcare of those in the Appalachian Ohio region through the creation and dissemination of medical knowledge, and through the delivery of caring, effective and efficient clinical care. To accomplish this mission, faculty, students, trainees, and staff of the (OU-HCOM) and employees of (UMA) must interact and build relationships with representatives from the pharmaceutical, biotechnology, medical device, and hospital equipment supply industries (here after referred to as “Industry”), in a manner that will allow for further advancements in evidence-based medicine, new medical technologies and enhanced patient care. While interactions with Industry can be beneficial, Industry influence can also result in unacceptable conflicts of interest that may lead to increased costs of healthcare, compromise of patient safety, negative socialization of students and trainees, bias of research results, and diminished confidence and respect among patients, the general public and regulatory officials. Because provision of financial support or gifts, even in modest amounts, can exert a subtle but measurable impact on recipients’ behavior, OU-HCOM and UMA have adopted the following policy to govern the interactions between Industry and OU-HCOM and UMA personnel.
A.
Scope of Policy
This policy applies to all
faculty, staff, and students of OU-HCOM, and to all healthcare
professionals and staff employed and/or contracted by UMA.
Ohio University Policy 01.003: Exceptions to or Restrictions of University Policies In all cases where this policy is more restrictive than Ohio University conflict of interest policies, this policy shall supersede University documents. This policy applies to interactions with all sales, marketing, or other product-oriented personnel of Industry, including those individuals whose purpose is to provide information to clinicians about company products, even though such personnel are not classified in their company as “sales or marketing.”
B. Statement of Policy It is the policy of OU-HCOM and UMA that clinical decision-making, education, and research activities be free from influence created by improper financial relationships with, or gifts provided by, Industry. Regardless of their size, delivery or type, clinicians and their staffs, OU-HCOM faculty, medical students and administrative staffs should not be the recipients of commercial incentives or inducements. These general principles should guide all potential relationships or interactions between OU-HCOM and UMA personnel and Industry representatives. The following specific limitations and guidelines are directed to certain specific types of interactions. For other circumstances, OU-HCOM and UMA personnel should consult in advance with their dean, department chairs or their administrators to obtain further guidance and clarification. Charitable gifts provided by industry in connection with fundraising done by or on behalf of OU-HCOM or UMA shall be subject to other Ohio University or UMA fundraising or foundation policies.
C. Specific Activities
1. Gifts and Provision of Meals
OU-HCOM and UMA personnel shall not accept or use personal gifts (including food) from representatives of Industry, regardless of the nature or dollar value of the gift.
Although personal gifts of nominal value may not violate professional standards or anit-kickback laws, such gifts do not improve the quality of patient care and may subtly influence clinical decisions. Gifts from industry that incorporate a product or company log on the gift (e.g., pens, notepads or office items such as clocks) introduce a commercial, marketing presence that is not appropriate to a non-profit educational institution and its affiliated healthcare system. Meals or other hospitality funded directly by industry may not be offered or accepted in any facility owned and operated by OU-HCOM or UMA.
It is permissible to receive items bearing Industry logos provided as part of an off-site educational program or professional society meeting such as name tags, lanyards, totes, etc., provided that they are incidental to meeting attendance, nominal in value and not used on OU-HCOM or UMA premises.
OU-HCOM and UMA personnel may not accept meals or other hospitality funded by Industry, whether on-campus or off-campus, or accept complimentary tickets to sporting or other events or other hospitality from industry. Modest meals provided incidental to attendance at an off-campus event that complies with the provisions of subsection 6, below may be accepted.
Industry wishing to make charitable contributions to OU-HCOM or UMA may contact the Ohio University Foundation or other charitable foundations legally organized to support UMA. Such contributions shall be subject to any applicable policies maintained by Ohio University or UMA.
2. Consulting Relationships OU-HCOM and UMA recognize the obligation to make the special knowledge and intellectual competence of its clinical and academic faculty members available to government, business, labor, and civic organizations, as well as the potential value to the faculty member, Ohio University and UMA. However, consulting arrangements that simply pay OU-HCOM or UMA personnel a guaranteed amount without any associated duties shall be considered gifts and are consequently prohibited.
In order to avoid gifts disguised as consulting contracts, where OU-HCOM or UMA personnel have been engaged by Industry to provide consulting services, the consulting contract must provide specific tasks and deliverables, with payment commensurate with the tasks assigned. All such arrangements between individuals or units and outside commercial interests must be reviewed and approved prior to initiation in accordance with appropriate Ohio University or UMA policies.
For OU-HCOM personnel, consulting relationships with industry may be entered into only with the prior permission of a faculty member’s dean, department chair, or administrator. In addition, prior review and written approval from the faculty member’s dean is required if consulting relationships with any one company (including the parent and subsidiary companies) will pay the faculty member in excess of $10,000 in any twelve-month period. OU-HCOM and/or UMA reserves the right to require faculty and employees to request changes in the terms of their consulting agreements to bring those consulting agreements into compliance with OU-HCOM and/or UMA policies.
3.
Drug or Device Samples The provision by manufacturers of “free” samples of prescription drug or device products is a marketing practice designed to promote the use of these products and to gain access to prescribers to influence their behavior. At the same time, this practice provides invaluable assistance to some patients to quickly begin a course of treatment or to determine which therapeutic option is most beneficial for that patient. Free samples also have been responsibly incorporated into the evidence-based decision making of some individual and group practices. While societal benefits result from the availability of medications at the point of care, sampling is also accompanied by regulatory and security concerns, poses potential safety risks for patients, and encourages prescribing of new, high cost medications whose safety and efficacy may not be different from existing treatments. In addition, the manufacturers’ cost of producing the specially packaged samples and distributing them to physicians via company representatives, introduces a substantial expense into the overall consumer drug cost. In addition, the costs to the physician's practice associated with managing the inventory and storing the samples may increase provider and overall healthcare costs.
Application of the dual guiding principles given above in the Statement of Policy suggests the need to examine a more structured and less costly approach to providing medications to patients who, in their physicians’ judgments, have requirements, both medical and financial, that cannot be fulfilled by the usual pathways.
In order to create alternatives to providing samples, a representative, multidisciplinary Sample Policy Ad-hoc Committee, composed primarily of practitioners, will be appointed by the Dean of OU-HCOM and UMA administration and charged with the responsibility of examining this issue and to propose a revised Drug or Device Samples section to this policy, with a goal of implementing a comprehensive policy regarding samples to be effective by February 28, 2011. This ad-hoc committee will determine whether alternative methods (such as vouchers or requirements to prescribe generic medications) are feasible and can meet legitimate needs in those cases where use of samples may be justified. 4. Site Access
As non-profit institutions dedicated to advancing the public interest, OU-HCOM and UMA should not allow use of their facilities or other resources for marketing activities by Industry. Ohio University always reserves the right to refuse access to their facilities or to limit activities by Industry representatives consistent with their non-profit mission.
However, interaction with representatives of Industry is appropriate as it relates to exchange of scientifically valid information and other data, interactions designed to enhance continuity of care for specific patients or patient populations, as well as training intended to advance healthcare and scientific investigation. To balance these interests, OU-HCOM’s Office of Administration and Finance and UMA’s appropriate scheduling/room rental office will develop a registry to assist in the management of site access by Industry representatives for appropriate purposes.
Sales or marketing representatives of Industry may access OU-HCOM and/or UMA facilities only if the company with which they are associated has registered with the OU-HCOM Office of Administration and Finance and/or the appropriate UMA office, or, where Industry representatives have been specifically invited to meet with an individual healthcare provider or a group of healthcare providers for a particular purpose.
Representatives without an appointment as outlined above are not allowed to conduct business in patient care areas (inpatient or outpatient), in practitioners’ office areas, or other areas of OU-HCOM or UMA clinical or academic facilities.
All Industry personnel seeking sales or vendor relationships must work directly with the OU-HCOM Office of Administration and Finance, Ohio University Office of Procurement Services and/or appropriate UMA office. While in OU-HCOM or UMA facilities, all Industry representatives must be identified by name and current company affiliation in a manner determined by such department, as applicable.
On-campus vendor fairs intended to showcase Industry products may be
permitted if approved by the appropriate OU-HCOM or UMA departments, but
only in campus buildings in which no clinical care is delivered or in
which no research is conducted. Such events must comply with the “no
gifts” provisions of Sections 1 and 3 of this policy. In such
situations, vendors would not be permitted to distribute free samples,
free meals, raffle tickets, or any other gifts to attendees.
5.
Support of Continuing Medical Education Industry support of continuing medical education (“CME”) can provide benefit to patients by ensuring that the most current, evidence-based medical information is provided to healthcare practitioners. In order to ensure that potential for bias is minimized and that CME programs are not a guise for marketing, all CME events hosted or sponsored by OU-HCOM or UMA must comply with the AOA or ACCME Standards for Commercial Support of Educational Programs (or other similarly rigorous, applicable standards required by other health professions), whether or not CME credit is awarded for attendance at the event. All such agreements for Industry support must be negotiated through and executed by the OU-HCOM Continuing Medical Education Office and/or appropriate UMA office and must comply with all policies for such agreements. Any such educational program must be open on equal terms to all interested practitioners, and may not be limited to attendees selected by the company sponsor(s).
Industry funding for such programming should be used to improve the quality and delivery of the education provided and should not be used to support hospitality, such as meals, social activities, etc., except at a modest level. Industry funding may not be accepted for social events that do not have an educational component. Industry funding may not be accepted to support the costs of internal department meetings or retreats (either on- or off-campus).
Funding support by Industry sponsors can be acknowledged in the text of
program announcements, brochures, and handouts by using phrases such as
“This program was made possible in part by an educational grant from
______.” OU-HCOM or UMA facilities (clinical or non-clinical) may not be rented by or used for Industry funded and/or directed programs, unless there is a CME agreement for Industry support that compiles with the policies of OU-HCOM or UMA. Dedicated marketing and training programs designed solely for sales or marketing personnel supported by Industry are prohibited. 6. Industry Sponsored Meetings or Industry Support for Off-Campus Meetings OU-HCOM faculty, staff, or students or UMA physicians or staff may participate in or attend Industry-sponsored meetings, or other off-campus meetings where Industry support is provided, so long as: (a) the activity is designated to promote evidence-based clinical care and/or advance scientific research (b) the financial support of Industry is prominently disclosed; (c) if the OU-HCOM or UMA representative is an attendee, Industry does not pay attendees’ travel and/or attendance expenses: (d) attendees do not receive gifts or other compensation for attendance; (e) meals provided are modest (i.e., the value of which is comparable to the Standard Meal Allowance as specified by the United States Internal Revenue Service) and consistent with the educational or educational or scientific purpose of the event.
In addition, if an OU-HCOM or UMA representative is participating as a speaker: (a) all lecture content is determined by the OU-HCOM or UMA speaker and reflects a balanced assessment of the current science and treatment options, and the speaker makes clear that the views expressed are the views of the speaker and not OU-HCOM or UMA; (b) compensation is reasonable and limited to reimbursement of reasonable travel expenses and a modest honorarium not to exceed $2,500 per event.
7.
Industry Support for Scholarships or Fellowships or Other Support of
Students, Residents, or Trainees OU-HCOM and UMA may accept Industry support for scholarships or discretionary funds to support trainee or resident travel or non-research funding support, provided that all of the following conditions are met:
(a) Industry support for scholarships and fellowships must comply with all Ohio University or UMA requirements for such funds, including the execution of an approved budget and written gift agreement through each entity’s respective Foundation, and be maintained in an appropriate restricted account, managed at the department as determined by the Dean or senior UMA administration. Written documentation of the selection process will be maintained. (b) Industry support for other trainee activities, including travel expenses or attendance fees at conferences, must be accompanied by an appropriate written agreement and may be accepted only into a common pool of discretionary fund, which shall be maintained under the direction of the Dean or UMA department as specified in the funding agreement for the relevant entity. Industry may not earmark contributions to fund specific recipients or to support specific expenses. Departments may apply to use monies from this pool to pay for reasonable travel and tuition expenses for residents, students, or other trainees to attend conferences or training that have legitimate educational merit. Attendees must be selected by the department based upon merit and/or financial need, with documentation of the selection process provided with the request. Approval of particular requests shall be at the discretion of the department head.
8. Medical School Curriculum With regard to physicians-in-training, departmental curricula will include discussion and reflection on managing encounters with Industry representatives where appropriate, and faculty and teaching staff will be briefed by the Assistant Dean for Predoctoral Education, or his/her designee, on how promotional activities may influence judgment in prescribing decisions and research activities. OU-HCOM will continue to encourage and develop interdisciplinary instructional programs that will help students understand the conflicts that may arise between industry representatives and health care professionals and how to develop and sustain productive and ethical relationships with Industry. Educational programs will continue to include evidence-based medicine education, literature search strategies and critical appraisal of the healthcare literature.
9.
Frequent Speaker Arrangements (Speakers Bureaus) and Ghostwriting While a common way for OU-HCOM and UMA clinicians and academicians to disseminate new knowledge is through lectures, “speakers bureaus” sponsored by Industry may serve as little more than an extension of the marketing department of the companies that support the programming. Before committing to being a speaker at an Industry-sponsored event, careful consideration should be given to determine whether the event meets the criteria set forth in Section 6 of this policy, relating to Industry Sponsored Meetings. OU-HCOM or UMA personnel may not participate in, or receive compensation for, talks given through a speakers bureau or similar frequent speaker arrangements if: (a) the events do not meet the criteria of Section 6; or (b) if the content of the lectures given is provided by Industry or is subject to any form of prior approval by either representatives of Industry or event planners contracted by Industry; or (c) the content of the presentation is not based on the best available scientific evidence; or
(d) the company selects the individuals who may attend or provides any
honorarium or gifts to the attendees. Under no circumstance may OU-HCOM and/or UMA personnel be listed as co-authors on papers ghostwritten by Industry representatives. In addition, OU-HCOM and UMA personnel should always be responsible for the content of any papers or talks that they give, including the content of slides. Speaking relationships with company or company event planners are subject to review and approval of the participant's administrator, department chair, or dean as delineated in Section 2, Consulting Relationships.
10. Other Industry Support for Research Ohio University and OU-COM have established policies and contract forms to permit Industry support of basic and clinical research in a manner consistent with the non-profit mission of the University. True philanthropic gifts from Industry may be accepted through the Ohio University Foundation or a UMA foundation.
D. Reporting and Enforcement All faculty members must submit to the chair of the respective department, and all chairs must submit to the Dean of the College of Osteopathic Medicine an Assurance of Compliance and Disclosure of Information form (http://www.research.ohiou.edu/compliance/index.php?section=265&page=14) annually and any time he or she enters into a new or revised industry-sponsored activity that potentially affects his/her role as administrator, teacher, researcher, or clinician in the Ohio University College of Osteopathic Medicine. A signed statement is reviewed and commented upon by the department chair and then forwarded to the Dean of the College of Osteopathic Medicine. Details about conflicts that potentially affect a faculty member’s professional activities are made available on the web sites of the Ohio University Vice President for Research and Research Compliance (http://www.research.ohiou.edu/compliance/index.php). If, in the opinion of the Dean of the Ohio University College of Osteopathic Medicine, the conflict of interest adversely affects the faculty member’s professional role or if the faculty member fails to report or incompletely or inaccurately reports a potential conflict of interest, then the faculty member may be subject to disciplinary action.
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