Commercial supporters may not take the role of a non-accredited partner or participate in a joint sponsorship relationship.

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Continuing Pharmacy Education Office Commercial Support Policy Revised January 2014

The University of Arkansas for Medical Science College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of Continuing Pharmacy Education. As such, the UAMS College of Pharmacy is responsible for the design and implementation of CPE activities and requires all educational activities to strictly adhere to ACPE’s Standards for Commercial Support. The UAMS College of Pharmacy’s Continuing Pharmacy Education Office has developed the following policies and procedures as instructional guidelines for activities.

Commercial Support Policy & Procedures Policy 18.0 - Independence

Continuing Pharmacy Education activities must be planned independently or “free” from the control of a commercial interest. A commercial interest is defined as any entity producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients. Providers of clinical service directly to patients are not ‘commercial interests.’

Commercial supporters may not take the role of a non-accredited partner or participate in a joint sponsorship relationship.

Procedures 18.0 – Independence

The CPE Office will ensure all activities will be planned without control from a commercial interest. Commercial interests will not be allowed to take part in any planning of an educational activity. The CPE Office will have final authority in all aspects of educational activity planning which includes: • Identification of CPE needs;

• Determination of educational objectives; • Selection and presentation of content;

• Selection of all persons and organizations that will be in a position to control the content of the CPE;

• Selection of educational methods; • Evaluation of the activity.

Policy 18.1 - Conflict of Interest Identification

Planners, speakers, authors, and all other individuals who are in a position to control the content of an educational activity must disclose all relevant financial relationships they (and/or an immediate family member) have with any commercial interest. ‘Relevant financial relationships’ are defined as

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of interest. Disqualification

An individual in a position to control the content of an educational activity refusing to disclose relevant financial relationships will be disqualified from being a planner, a teacher, or an author and cannot have control of, or responsibility for, the development, management, presentation, or evaluation of the CPE activity.

Resolution

The UAMS College of Pharmacy Continuing Pharmacy Education Office has an identification mechanism and processes in place to resolve all conflicts prior to the education activity being delivered to learners.

Procedures 18.1 - Conflict of Interest Identification

All planners, teachers, authors, or other individuals in a position to control the content of an

educational activity must complete a Biographical & Conflict of Interest Form no less than 30 days in advance of the CPE activity.

Appendix L: Biographical & Conflict of Interest Form Disqualification

Individuals, who refuse or, for some other reason choose not to complete this form, will be disqualified from taking part in the activity. In such case the CPE Director or Course Director must inform the individual that the CPE requirements cannot be met and that he/she may not participate in the activity until this requirement is met. Failure to complete and return a biographical & conflict of interest form is the same as refusing to disclose and requires disqualification from participation. Resolution

The Continuing Pharmacy Education Director is responsible for resolving conflicts of interest. The forms must be reviewed for identification of relevant financial relationships with commercial interest(s) prior to the educational activity. The following mechanisms for resolving conflicts of interest may be used to bring a successful resolution to the conflict:

A. Peer Review

The conflict can be resolved by an effective peer review of content prior to educational activity to ensure the content is free from bias. Educational content can be peer reviewed by commercially disinterested peers (namely members of the CPE Committee).

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Appendix S: Online Conflict of Interest Resolution Form (http://pharmcollege.uams.edu/coir/) B. Altering financial relationships

An individual may change his/her relationships with commercial interest(s), e.g. discontinue contracted services. In doing so, no duty, loyalty, or incentive remains to introduce bias into the CPE content. When an individual divests himself/herself of the relationship, it is

immediately no longer relevant and resolves the previous conflict of interest. However, ACPE requires that the existence of the former relationship be disclosed to the learners during any CPE activity in which that individual influences CPE content during the 12 months following the divestiture.

C. Altering control over content

An individual’s control of CPE content can be altered in several ways to remove the opportunity to affect content related to the products/services of a commercial interest. These include:

• Choosing someone else to control that part of the content – If a proposed teacher/author has a conflict of interest related to the content, choose someone else who does not have a relationship to the commercial interest(s) related to the content.

• Change the focus of the CPE activity – The CPE provider can change the focus of the activity so that the content is not relevant to the products/services of the commercial interest that is the basis of the conflict.

• Change the content of the person’s assignment – The role of a person with a conflict of interest can be changed within the CPE activity so that he/she is no longer teaching about issues relevant to the products/services of the commercial interest.

• Limit the content to a report without recommendations – If an individual has been funded by a commercial company to perform research, the individual’s presentation may be limited to the data and results of the research. Someone else can be assigned to address broader implications and recommendations.

• Limit the sources for recommendations – Rather than having a person with a conflict of interest present personal recommendations or personally select the evidence to be presented, limit the role of the person to reporting recommendations based on formal structured reviews of the literature with the inclusion and exclusion criteria stated (evidence-based). For example, the individual could present summaries from the systematic reviews of a peer-reviewed source.

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bias). The Continuing Pharmacy Education Office and CPE Committee Members share the responsibility to evaluate the perception of bias by the learners in any CPE activity. The CPE director will be responsible for communicating any evidence of bias to those who created the impression of bias. Documentation of the evidence, and any actions taken based on the evidence, must be kept on file by the Continuing Pharmacy Education Office.

E. Elimination

All planners, teachers, authors, or other individuals in a position to control the content of an educational activity who are perceived as either manifesting conflicts of interest or being biased may be eliminated from consideration as resources (committee members, teachers, authors, etc.) in subsequent accredited CPE activities.

Policy 18.2 - Appropriate Use of Commercial Support

Definition of Commercial Support: Financial or in-kind contributions given by a commercial interest used to pay all or part of the costs of a CPE activity.

As the accredited provider, UAMS College of Pharmacy will make all decisions about the disposition and disbursement of commercial support.

A commercial interest may not require acceptance of advice or services from teachers, authors, or participants or other education matters, including content as a condition of the commercial support.

All requests for commercial support associated with any CPE activity, whether directly or jointly sponsored, must be submitted with full knowledge and approval of the UAMS College of Pharmacy Continuing Pharmacy Education Office.

Written Agreements Documenting Terms of Support

All educational grants from commercial supporters must be documented by a written agreement between UAMS College of Pharmacy (the ACPE-accredited provider) and the commercial supporter even if the support is given directly to an educational partner or cosponsor.

The written agreement must remain in compliance with the guidelines set forth in the ACPE Standards for Commercial Support.

The written agreement must list the commercial interest providing the commercial support. The written agreement must be signed and dated by both the commercial supporter and the provider, UAMS College of Pharmacy.

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Expenditures for an individual providing CPE

Payment of honoraria to planners, speakers, or authors must be consistent with the CPE Office’s Honorarium Policy. See procedure for policy.

Expenditures for Learners

Meals and social events at CPE activities must be modest and not take precedence over the educational activity.

Commercial support may not be used to pay for travel, lodging, honoraria, or personal expenses for non-teacher or non-author learners at a CPE activity.

Commercial support may be used to pay for travel, lodging, honoraria, or personal expenses for bona fide employees and volunteers of the provider, cosponsor, or educational partner.

Accountability

The UAMS College of Pharmacy Continuing Pharmacy Education Office is responsible for documentation of all CPE activities.

Procedures 18.2 - Appropriate Use of Commercial Support

The UAMS College of Pharmacy Continuing Pharmacy Education Office will maintain all control regarding any commercial support.

The CPE Office will monitor closely to ensure commercial interests refrain from the following: • Offering advice or services regarding teachers, author, or participants or other education

matters, including content, as a condition of support.

• Require acceptance of advice or services from teachers, authors, or participants or other education matters, including content as a condition of the commercial support.

Requests for commercial support of a CPE activity must be made to the UAMS College of Pharmacy Continuing Pharmacy Education Office. Requests will be reviewed and must be approved before they can be accepted for support.

Written Agreements Documenting Terms of Support

All funds received from commercial interests to support UAMS College of Pharmacy sponsored CPE activities must be given in the form of an unrestricted educational grant made payable to UAMS College of Pharmacy, the University of Arkansas for Medical Sciences, or the joint sponsor or educational partner as designated by the UAMS College of Pharmacy. Educational grants must be unrestricted without any expectation from the commercial supporter for special acknowledgements,

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A written agreement between the commercial interest and the UAMS College of Pharmacy must be created which includes the following:

• UAMS College of Pharmacy (ACPE-accredited provider), even if the support is given directly to a designated educational partner or cosponsor,

• Educational partners (when applicable),

• The commercial interest that is the source of commercial support,

• The terms, conditions, and purpose of the educational grant consistent with the guidelines set forth in the ACPE Standards for Commercial Support,

• Signatures from the commercial supporter and the provider.

As long as the written agreement is consistent with the ACPE guidelines, it can be initiated by the commercial supporter.

In cases where grants are obtained through an electronic system, electronic signatures are

permissible. The appropriateness of the electronic signature should be cleared and/or verified by the UAMS College of Pharmacy Continuing Pharmacy Education Office.

Expenditures for an individual providing CPE

Honorariums will be paid in accordance with the Continuing Pharmacy Education Office Honorarium Policy.

See Appendix T: Honorarium Policy

The Continuing Pharmacy Education Office will not allow the Commercial Supporter to make any direct payments to planners, speakers, or authors for services related to the CPE activity for which the support is given.

Additional payments will not be given to the course director, planning committee members, teachers or authors, cosponsor, or any others involved with the supported activity.

Teachers or authors listed on the agenda as facilitating or conducting an educational activity, but participating in the remainder of the educational event as a learner, may be reimbursed and honoraria can be paid for the teacher or author role only.

Expenditures for Learners

The Continuing Pharmacy Education Office will monitor social events and meals to ensure they are modest and will not take priority over the educational activity. Meals will not be provided during an educational activity and will be in a location separate from the educational activity.

The Continuing Pharmacy Education Office will not allow commercial support to be used to pay for travel, lodging, honoraria, or personal expenses for non-teacher or non-author learners at a CPE

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activity.

The Continuing Pharmacy Education Office will allow commercial support to be used to pay for travel, lodging, honoraria, or personal expenses for bona fide employees and volunteers of the provider, cosponsor, or educational partner.

Accountability

All documentation for a CPE activity will be maintained by the UAMS College of Pharmacy Continuing Pharmacy Education Office. Departmental sponsors or joint sponsors who are managing the CPE activities must provide the Continuing Pharmacy Education Office with accurate documents detailing the receipt and expenditures for all commercial support upon completion of the CPE activity. This documentation requires a detailed budget summary to be completed and returned with the activity’s final closing report. The CPE Office must maintain accurate documentation detailing the receipt and expenditure of the commercial support.

Policy 18.3 - Appropriate Management of Associated Commercial Promotion

Arrangements for commercial exhibits or advertisements cannot be a condition of the provision of the support for the activity, nor can they influence planning or interfere with the presentation. Commercial promotional materials or product specific advertisement of any sort is prohibited in or during the CPE activities.

Educational materials that are part of the CPE activity; e.g., slides, abstracts, and handouts; must not contain advertising, trade names, or a product-group message.

Print or electronic information distributed about the non-CPE elements of the CPE activity that are not directly related to the transfer of education to the learner may include product promotion material or product-specific advertisement; e.g., schedules and content descriptions.

A commercial interest cannot be utilized as the agent providing a CPE activity to learners; e.g., arranging for electronic access to CPE activities or distributing of self-study CPE activities. Procedures 18.3 - Appropriate Management of Associated Commercial Promotion

The CPE Office will not allow promotion of products or services inside the classroom or in obligate pathways to educational sessions.

All promotional materials will be reviewed by the CPE Office to ensure the following guidelines are followed:

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the CPE content given these materials are not related to the CPE content they face and are not paid for by the commercial supporters of the CPE activity.

• Computer based:

Advertisements and promotional materials will not be allowed on the screen at the same time as the CPE content and will not be interleafed between computer screens of the CPE content.

• Audio and video recording:

There will be no commercial breaks or advertising and promotional materials included in the CPE recording.

• Live:

Advertisements and promotional materials cannot be presented or dispersed in the space designated for the educational activity immediately before, during, or after a CPE activity. Representatives of Commercial Interests cannot engage in sales or promotional activities while in the area designated for the CPE activity.

Non-educational materials distributed about the non-CPE elements of the CPE activity to the learner may include product promotion material or product-specific advertisement; e.g., schedules and content descriptions but they must be previewed by the CPE Office to ensure compliance before they are distributed.

The CPE Office will not allow a commercial interest to be utilized as the agent providing a CPE activity to learners; e.g., arranging for electronic access to CPE activities or distributing of self-study CPE activities.

Policy 18.4 - Content and Format without Commercial Bias

Educational activities must be presented to promote improvements in the quality of healthcare and not a specific proprietary business or commercial interest.

All presentations must give a balanced view of therapeutic options using generic names of products discussed. When trade names must be used, those from more than one manufacturer should be mentioned.

Procedures 18.4 - Content and Format without Commercial Bias

The CPE Office will review presentations prior to the educational activity to assure the presentation is focused in promoting improvements in the quality of healthcare and not to promote a branded business or commercial interest.

Generic names will be utilized for all drugs. A list of brand name drugs may be included if all drugs in that class are indicated on the list.

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Policy 18.5 - Disclosures Relevant to Potential Commercial Bias

Relevant financial relationships of those with control over CPE content

An individual must disclose to learners any relevant financial relationship.

An individual without a relevant financial relationship but still inform learners that no relevant financial relationship exists.

Commercial Support for the CPE Activity

The audience must be informed about the source(s) of all commercial support before the activity begins. When the support is ‘in-kind’, the nature of the support must be acknowledged.

This acknowledgement must not include the use of a trade name or product group message. Timing of disclosure

The audience must be informed about the source(s) of all commercial support before the activity begins.

Procedures 18.5 - Disclosures Relevant to Potential Commercial Bias

All disclosures will be made prior to the educational activity in written or verbal format; written format will be encouraged. Disclosures cannot include the use of a trade name or product group message.

Disclosures must include the following information: o Existence of relevant financial relationships:

 The name of the individual(s) who has(have) such a financial relationship(s);  The name of the commercial interest(s);

 The nature of the relationship that person has with each commercial interest. o No existence of relevant financial relationships:

 The individual(s) reported that no relevant financial relationship(s) exist. The UAMS COP CPE Office strongly encourages a written method of disclosure be used. When a verbal disclosure is made it will be documented through a Disclosure Attestation Statement by someone present during disclosure. Disclosure information may be presented to the audience in a written format or verbally by the moderator or speaker.

Written disclosure can be:

• Included in handouts or syllabus

• Presented on a slide before the activity begins • Posted on a sign at the door

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If the disclosure information is presented to the audience verbally, it must be documented, in writing, by someone present at the time of the disclosure. A Disclosure Attestation Statement will be used for this purpose.

The attestation statement must include: • the name of the presenter(s),

• the name of the company with which the financial relationship(s) exist, • the nature of the financial relationship and

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