Purpose of Policy - AMSA Scorecard

guiltlesscyanΒιοτεχνολογία

3 Δεκ 2012 (πριν από 4 χρόνια και 11 μήνες)

211 εμφανίσεις


1


Policy: Conflict of Interest with Industry


Purpose of Policy


The purpose of this policy is to establish
rules

for interactions with Industry and Industry
representatives throughout Wake Forest University Baptist Medical Center and its component
institutions, Wake Forest University Health Sciences and North Carolina Baptist Hospital

and their
controlled
affiliates
.
These institutions carry out a joint mission of patient care, education, research and
community service, and are committed

to ensuring that faculty, employees
, students, trainees and
volunteers strive for the highest degree of professional and ethical st
andards and integrity in carrying
out this mission.

Often, Wake Forest University Baptist Medical Center engage
s

in effective and
principled interactions and relationships with representatives of pharmaceutical, biotechnology,
medical device, and hospital

and research
equipment supply companies in order to advance patient
care, education, research
,

and community service.
While many of these interactions and relationships
may benefit the Medical Center, its individual members, patients and the community,
t
hey also
have

the
potential
to create
actual and perceived conflicts of interest, as well as other
adverse consequences.

In addition, the federal Anti
-
Kickback laws prohibit knowingly receiving anything of value
from
vendors
that induces a clinician to use

or purchase products or services which are reimbursed by
Government programs such as Medicare or Medicaid.
Therefore, Wake Forest University Baptist
Medical Center has adopted the following policy to govern interactions and relationships with
Industry.


S
tatement and Scope of Policy


It is the policy of Wake Forest University Baptist Medical Center, including Wake Forest University
Health Sciences and North Carolina Baptist Hospital, that interactions with Industry be free from
improper influence by Indust
ry
,

conducted so as to avoid or minimize
actual or perceived
conflicts of
interest
,

and compliant with federal and state laws and regulations, including the Anti
-
Kickback law
.


This policy applies to all faculty, employees, students, trainees and volunteers of Wake Forest
University Baptist Medical Center, Wake Forest University Health Sciences and North Carolina
Baptist Hospital.


For purposes of this policy, “Industry” is def
ined as all pharmaceutical manufacturers, and
biotechnology, medical device, and hospital and research equipment supply
I
ndustry entities and their
representatives
, as well as any other vendor that provides goods or services for use in patient care,
educat
ion or research
.


This policy also supplements existing WFUBMC, WFUHS and NCBH policies, including but not
limited to:
WFUHS Authorship Guidelines; WFUHS Policy on Conflicts of Interest and Disclosure;
NCBH Policy on Conflicts of Interest; and WFUBMC Pol
icies for Medical Service Representatives for
Pharmaceutical Products and for Medical Service Representatives for Medical Devices and Products.


In all cases where this policy is more restrictive than a
nother

WFUBMC, WFUHS or NCBH policy,
this policy shall

control.



2


P
rocedures for the implementation and oversight of this policy shall be developed by
the Conflict of
Interest Oversight Committee
with membership representing
WFUBMC, WFUHS and NCBH
.



This policy incorporates the following types of interactio
ns with Industry:


I.

Certified Continuing Education (CCE) Activities

and Noncertified Continuing Education
(non
-
CCE) Activities

II.

Ghost Writing and Guest Authorship

III.

News Releases and News Media Contact

IV.

Committee Participation

V.

Industry Sponsored Research

VI.

Consulting and Speakers’ Bureau Agreements

VII.

Payments for Attending Professional Meetings

VIII.

Vendor Fairs

IX.

Personal Gifts from Industry

X.

Institutional Gifts from Industry

XI.

Free Meals

XII.

Advertising Materials

XIII.

Access of M
edical Service Representatives (MSRs)

XIV.

Free Sampl
es

XV.

Free Services

to
Clinical

Departments





Unless
specified otherwise herein, penalties for violations of this policy will be imposed in accordance
with applicable policies of WFUBMC, WFUHS and NCBH. Possible penalties may include:
reimbursement to
WFUBMC, WFUHS or NCBH for misused resources; formal reprimand for
placement in employee or student file; ineligibility to participate in grant applications or on
committees; or other disciplinary action up to and including termination of employment or dism
issal
from an educational or training program.

Reports of suspected violations may be made to any of the
individuals listed below, or anonymously through the WFUBMC hotline.
Suspected violations will be
referred to the following for investigation and sanc
tioning as appropriate:



Student
s:

Associate
Dean
for

Student Services


Staff:

Human Resources


Faculty:

President of WFUP
, WFUHS President and Dean of the School of Medicine
,

or
Senior
Associate Dean


House Staff:

President of WFU
HS or Associate Dean
for GME


Policy


I.

Certified Continuing Education (CCE) Activities and Noncertified Continuing
Education (non
-
CCE) Activities


Industry support of continuing education (“CE”) can provide benefit to patients by ensuring
that the most current, evidence
-
based medical information is provided to healthcare

3


practitioners. In order to ensure that potential for bias is minimized and that

CE programs are
not a guise for marketing or off
-
label promotions, all CE events receiving
I
ndustry support or
I
ndustry sponsorship that are hosted, sponsored, or jointly sponsored by the Medical Center
must comply with the
2004 Updated Accreditation Coun
cil for Continuing Medical Education
(ACCME) Standards for Commercial Support of CME: Standards to Ensure the Independence
of CME Activities

[
http://www.accme.org/dir_docs/doc_upload/68b2902a
-
fb73
-
44d1
-
8725
-
80a1504e520c_uploaddocument.pdf
]
(or other similarly rigorous, applicable standards required
by other health professions), whether or not CE credit is awarded for attendance at the event.
Al
l such agreements for
I
ndustry support must comply with the Wake Forest University School
of Medicine (“WFUSM”) Office of Continuing Medical Education (“CME”) policies. Any
such educational activity must be open on equal terms to all interested practition
ers, and may
not be limited to attendees selected by the company supporter(s). The same standards shall
apply to
I
ndustry
-
supported non
-
CCE activities as apply to
I
ndustry
-
supported CCE activities.
A Medical Center committee shall be established to revie
w applications for
I
ndustry
-
supported
non
-
CCE activities, and this committee will also manage logistics, including finances, of these
programs.


II.

Ghost Writing and Guest Authorship



Faculty, staff, and students may not be listed as authors on any material
s ghostwritten by
Industry representatives

or someone acting on behalf of Industry
. Faculty, staff, and students
must always be responsible for the content of any publications or presentations, including
slides.

See also WFUHS Authorship Guidelines
, Page
IV
-
70 of Operations and Policy Manual

http://infinet.wfubmc.edu/depts/deansoffice/msophandbook/2005%20Revised%20Section
s/Section%20IV%20July%202008.pdf
, which
provides guidance

for scholarly publications
.



III.

News Releases and News Media Contact


It is the

policy of Wake Forest University Baptist Medical Center to disclose
any

potential
or
actual conflict

of interest
(COI)
related to an

individual’s financial interest in the sponsor of
his/her research or in the ownership of a related entity or intellectual property, such as
new
or
experimental
drugs, devices or therapies
, or of a start
-
up business. All
such disclosures must
comply with

the policy on
Conflict
-
of
-
Interest Procedure for News Releases and News
Media Contact, (Public Relations & Marketing (PR&M), January 2010).


IV.

Committee Participation


WFUBMC, WFUHS and NCBH faculty members and employees may serve on Medical Center
committe
es that recommend purchases and utilization of pharmaceuticals or medical devices.
In order to ensure that all actions of these Committees are free from the appearance of conflict
of interest, each voting member of a Committee will annually complete a Dis
closure of
Potential Conflicts of Interest form. Additionally, Committee members are required to verbally
update any new potentially conflicting relationships
in open meeting
prior to each vote during
the year.



4


Any voting member with an actual or potenti
al conflict of interest shall recuse himself or
herself from participation in voting events and similar decision
-
making processes when the
decision or discussion may pose a conflict of interest.

In addition, the Chair of a Co
mmittee
may remove a member fr
om the Committee in the event the Chair reasonably determines that
the member cannot substantially contribute to and participate in the work of the Committee due
the member’s actual or potential conflict(s) of interest.



V.

Industry Sponsored Research


Any WFUBMC, WFUHS or NCBH faculty member or employee
acting as a Principal
Investigator, Clinical Investigator (co
-

or sub
-
investigator), or otherwise
conduct
ing

Industry
-
sponsored research
in any way that could bias the design, conduct or implementation,
management and reporting of research data,
must comply with all institutional and federal
requirements regarding management of conflicts of commitment and conflicts of interest.
Specifically, each employee must comply with the “Overview and Summary of Con
flict of
Commitment and Conflict of Interest” Policy, revised in April, 2009
, and as amended from
time to time

(WFUSM Organization and Policies Handbook IV, pp. 46
-
55)
.


VI.

Consulting
Agreements
and Speakers’ Bureau
s
Agreements


For purposes of this policy
c
onsulting agreements are personal contracts between
a

faculty
member
or employee
and a separate

Industry

Entity,
and do not include Wake Forest
University Baptist Medical Center,
Wake Forest University Health Sciences,
or
North Carolina
Baptist Hospital
a
s

a party to the consulting agreement
. Nor
does
WFUBMC, WFUHS or
NCBH

provide review
or insurance coverage
for such contracts. Any faculty member
or
employee
considering entering into a consulting arrangement may wish to seek the advice of an
attorney

reta
ined at the faculty member’s or employee’s expense
.



The purpose of this policy on personal consulting is to
ensure that

the first commitment of the
faculty
or employee
is to
WFUBMC
,

WFUHS and NCBH,

and that no conflict between a
faculty member’s
or emplo
yee’s
employment exists when that faculty member
or employee
enters into a personal consulting relationship with an outside entity.


Faculty members are permitted to enter into consulting arrangements upon
advance
notification
to

the appropriate department

chair and receipt of necessary approvals.

Such notification shall
specify the company the faculty member will be consulting with, the expected duration of the
consulting, and the amount of money or other compensation the faculty member expects to earn
or

receive from the consulting. The department chair is responsible for maintaining
documentation of all consulting arrangements for faculty members in his or her department for
the duration of the consulting arrangement and for two years after the arrangem
ent has
terminated.


Faculty
members
and
staff

may consult with Industry to provide scientific advice, provided any
compensation for consulting services is
reasonably related to specified services and is
at fair
market value; the arrangement is governed by

written agreement specifying the service(s) to be

5


provided;

the consultant’s duties are based on relevant expertise; the consultant is free to
provide advice and services that reflect his or her expertise and judgment;

and the arrangement
complies with ap
plicable Medical Center policies on conflicts of interest and commitment.


The following paragraph (adapted to the particular agreement) should be included in any and
all personal consulting agreements:

The Entity acknowledges that Consultant's primary
obligation is to
WFUHS or NCBH
. It is
the intent of the parties that efforts and specific responsibilities under this Agreement be
separate and distinct from those duties performed for
WFUHS or NCBH
. In the event of
any conflict between this Agreement and
any terms of employment between the Consultant
and
WFUHS or NCBH
, including work responsibilities and ownership of any resulting
intellectual property, the terms and conditions of the Consultant’s employment with
WFUHS or NCBH

will take precedence unless specific written arrangements have been
made in advance between the Entity and
WFUHS or NCBH


In principle, f
aculty and staff

may
not
participate in
Industry sponsored
Speakers’ Bureaus and
promotional speaking events
.



Faculty members may participate in extramural programs funded by unrestricted educational
grants from industry, and may receive honoraria for these speaking engagements provided the
content of the faculty member’s presentation is his/her own and is not pro
vided by the sponsor
.

For any presentation that an employee expects to receive compensation or support
,

the
employee must disclose the name of the
entity

providing the support and the nature of it. This
disclosure must be
submitted
in writing to the empl
oyee’s Chair or supervisor

for approval
.


Faculty members may fulfill speaking obligations to which they have committed themselves,
provided such agreements precede the effective date of this policy and are completed by
December 31, 2010.



The phased im
plementation of this policy will be directed and monitored by the Conflict of
Interest Oversight Committee.


VII.

Payments for Attending Professional Meetings


WFUBMC, WFUHS, and NCBH faculty and employees may attend Industry sponsored or
supported educational
meetings, lectures and conferences
when such meetings, lectures and
conferences are limited to

objective scientific and educational information that promotes
evidence
-
based medicine and scientific research. The following standards shall apply when
attendi
ng Industry sponsored or supported educational meetings:


A.

Faculty and employees attending educational meetings may not accept any payments or
reimbursements, either directly or indirectly, from Industry for costs and expenses
related to the meeting, inc
luding registration fees, transportation, lodging, meals or
other incidental expenses. In addition, payments or reimbursements may not be

6


accepted for costs or expenses related to the cost of a spouse or other guest of the
faculty or staff member attending

the meeting.


B

The main reason for attending the Industry sponsored or supported educational
meetings should be to further the faculty member’s or employee’s knowledge on the
subject(s) presented. Faculty and employees should ensure that such meetings
are
inclusive of and led by those who are qualified to present a program that is aimed at
promoting evidenced
-
based medicine and scientific research. Meetings led by
marketing representatives would not qualify as a legitimate educational meeting.


C.

Gift
s may be accepted only in accordance with this policy. (See Section on Personal
Gifts from Industry, below.)


D.

Faculty and employees may attend receptions and accept meals of modest value
provided in connection with the
educational meeting

when provided or sponsored by
Industry and when related to the educational meetings

and available for all attendees
.
The receptions and meals should promote discussions among those attending the
educational meeting, and should be incidental to the educat
ional content of the
meetings. Faculty and employees may not attend the reception and accept the meal if
the faculty or employee will not be attending the educational component of the meeting.


E.

In principle, f
aculty and employees may not attend e
ducatio
nal programs sponsored by
Industry
when such meetings are

structured to improperly influence purchasing or
prescribing decisions.


F.

If a faculty member or employee attends the meeting and participates as a presenter or
speaker, acceptance of payments or
reimbursements shall be in accordance with this
policy. (See Section on Consulting and Speaker’s Bureaus, above.)


G.

A faculty
member
or
employee

must
complete the appropriate request form and
obtain
approval of his/her Chair or supervisor prior to attend
ing an educational meeting, and
such approval may be granted only in accordance with this
p
olicy.



This policy is not intended to prohibit unrestricted educational grants provided by Industry.
Departments may establish a departmental education fund

where

all such grants from Industry
may be deposited. Awards from the departmental fund

may not be made, conditioned upon or
relate
d to any pre
-
existing or future

business relationship with
any company that has
contributed to the fund

or any business or other
decisions WFUHS, NCBH or WFUBMC has or
may make relating to
any such

company or its products or services
.
In addition, the
departmental fund may not be used to cover expenses for or related to attendance at an Industry
organized meeting. Documentation of

expenditures from the departmental fund and the
purposes for such expenditures must be maintained by the department chair for as long as
required by WFUBMC.




7


VIII.

Vendor Fairs


Vendor fairs shall be prohibited at Wake Forest University Baptist Medical Cente
r. A vendor
fair is an event intended to promote drugs, devices, or other products to be prescribed for/used
in the care of patients.

This policy is not intended to preclude the NCBH Material
s
Management Department or

the WFUHS Purchasing Department from

coordinating vendor
displays where several brands of medical devices or medical materials are displayed
simultaneously for key decision makers to compare them in order make purchasing or
standardization decisions.


IX.

Personal Gifts from Industry


Personal gifts from Industry may not be accepted by faculty, staff, students or volunteers.
Examples of personal gifts include off
-
campus meals, pens, notepads, food baskets, flowers,
gift cards, and entertainment, regardless of the value. Limited except
ions are permissible for
items designed solely to educate patients, if individually valued at $100.00 or less. Examples
include books related to healthcare such as
The Premature Baby Book
, diabetic cookbooks,
general education booklets, and educational DV
Ds. Existing non
-
educational gifts branded
with Industry logos must be removed from the Medical Center.


X.

Institutional Gifts from Industry


Gifts
and loans
to WFUBMC, WFUHS and NCBH of equipment, devices, supplies and similar
items from Industry for use i
n education, research or clinical care must be consistent with
institutional guidelines and procedures
, including the sourcing of potential equipment prior to
the acceptance of such gifts.
. The gift
or loan
transaction will be documented, and such gifts
w
ill be unrestricted in the sense that the donor
-
company will have no expectation of return
benefit, or “quid pro quo”.



XI.

Free Meals


Effective July 1,
201
0
, Industry supplied or supported food and drinks shall be prohibited at
WFUBMC, WFUHS and NCBH.


XII.

Adv
ertising Materials


Advertising materials (for example, print, radio, and television) designed to promote physician
practices or clinical services that are funded directly or indirectly by Industry and include
advertising for Industry or Industry products
may not be purchased or accepted.


Industry advertising and
I
ndustry advertising materials are prohibited at Wake Forest
University Baptist Medical Center and at Medical Center programs
.
For purposes of this
policy, Industry advertising does not include
advertisements for clinical trials or Industry
sponsored patient education materials such as those permitted under Section
IX
, Personal Gifts
from Industry.



8


XIII.

Access of
M
edical Service Representatives (MSRs)


Industry access to
the M
edical
C
enter

occurs primarily through Medical Service
Representatives (MSRs), including, but not limited to, pharmaceutical products MSRs and
medical device MSRs. Pharmaceutical products MSRs are defined as vendors’ representatives
who promote pharmaceutical products

and provide information and services to health care
providers on behalf of manufacturers and suppliers.


Medical device MSRs are defined as
vendors’ representatives who promote medical devices and products and provide information
and services to health ca
re providers and researchers on behalf of manufacturers and suppliers,
but do not include health science associates or liaisons, who do not act in the capacity of
MSRs.




Faculty, staff, and student interactions with MSRs must comply with the Medical
Center
policies on MSR for Pharmaceutical Products and Medical Devices and Products
,

which
require MSRs to properly register and prohibits their access to patient care areas.


The Policy on Medical Devices and Products makes a
limited exception for MSRs i
nvited to
provide in
-
service assistance regarding devices or equipment. MSRs providing in
-
service
assistance must be accompanied by Medical Center staff or faculty at all times and patient
consent for the MSRs attendance must be obtained. In these limited
circumstances, an MSR
may be allowed to offer technical advice to a surgical team regarding their equipment or
devices but may not give advice concerning patient care. MSRs are restricted from
manipulating their equipment or devices while in use on a patie
nt and MSRs are not to touch
patients at any time, nor may they scrub on any procedures. Exceptions to this restriction are
extenuating circumstances (e.g., equipment malfunction) or specialized training (e.g.,
pacemaker representatives) under the directi
on of a Medical Center physician and in
accordance with the applicable departmental policy.


MSRs must have an appointment with a specified individual
in
order to visit Medical Center
staff or faculty.


XIV.

Free Samples


Individual Medical Center faculty, st
aff, students and trainees may not accept medications and
pharmaceutical samples from
I
ndustry
.

Further, individual faculty, staff, trainees and students
at the Medical Center may not accept medications and pharmaceutical samples from
I
ndustry
representati
ves on behalf of the Medical Center. The only exception
s

to this rule
are

that the
NCBH Pharmacy may continue to accept pharmaceutical samples, as it has previously done,
for
select transplant and cardiology patients

and that samples will be permitted whe
n provided
for patient education (for example education in the use of inha
led drugs for pediatric asthma)
.


Should the elimination of medication samples negatively impact the quality of patient care
within an individual clinic, the section or department may request an exception to this policy.
Specific criteria will be established for such exceptions, and the r
equest will be reviewed by the
Medical Center Committee.



9


A voucher system will be established for the distribution of pharmaceuticals to meet the needs
of indigent
and other selected
patients at the medical Center. The Outpatient Prescription Drug
Subco
mmittee shall develop
the procedures for implementation of this policy, including
a list
of drugs that are acceptable for free distribution to indigent patients via the voucher system.



X
V
.

Free Services

to Clinical Departments


Clinical departments may
not accept free services provided by Industry representatives.

Examples include Industry representatives
obtaining insurance preauthorizations

for their drugs
or devices
,
conducting
coding audits
, and appealing

denied claims

or reimbursing
departments

fo
r denied claims
.
Exceptions may be appropriate if the primary purpose of the service is to
benefit the patient, and the benefit to the clinical department is de minimus.

For example,
frequently providing a free service that is ordinarily performed by depar
tment staff is not
acceptable.

Requests for exceptions should be made to
the
WFUHS
and

NCBH Compliance
Office as appropriate.