PHARMACEUTICAL
and NUTRITIONAL VENDORS
POLICY and PROCEDURES and
FAQ’s
Approved P&T Committee:
Effective:
Revised:
This document is posted at http://pharmacy.mc.duke.edu/PT/index.htm
PURPOSE:
To ensure that clinical
staff and physicians provide high quality, uninterrupted patient care, and to
maintain the highest degree of patient confidentiality, all vendor
representatives will adhere to applicable laws and regulations of the State of
North Carolina, federal government, HIPAA Privacy Rule, JCAHO, AORN and other
applicable regulatory standards. In addition,
all vendor representatives will abide by the underlying principles set forth in
the Pharmaceutical Research and Manufactures of
Vendor representatives do not
have clinical privileges and will not engage in any type of clinical activity
while at Duke University Health System. Professionals who work for vendors
(e.g. MD’s, RN’s, Pharm. D’s.) may hold clinical
appointments under existing Duke assurances for confidentiality, conflicts,
disclosures and other credentialing/appointment guidelines and safeguards.
Appropriate
activities of pharmaceutical and nutritional industry representatives within
the medical center include:
1.
supporting continuing medical education and sponsoring
educational activities of trainees and house officers;
2.
providing medications through sampling and "special
access" programs to low income populations seen in the medical center;
3.
disseminating peer reviewed information about new products and
therapies.
It is the position of the
Pharmacy and Pharmacy & Therapeutics Committee that all interactions
between the pharmaceutical and nutritional products industry and all trainees
at Duke (including graduate medical education trainees, housestaff,
all health-affairs students) and Duke staff should
be guided by the principle of support for educational endeavors as outlined in
the White Paper on the Relationship of Graduate Medical Education and Industry
(http://www.acgme.org/). It is
acknowledged that pharmaceutical and nutritional industry representatives
should have the opportunity of discussing their products with physicians and
pharmacists as long as the information is objective, based on scientific
evidence and conforms to acceptable standards of promotional activities, when
it is promotional, or legitimate CME standards, when it is in fact, CME.
DEFINITION:
Pharmaceutical vendor representative – a person associated with a company soliciting/promoting the use of any drug, medical food, drug-related product, or devices and equipment used to prepare or administer medications or medical foods. These include persons in sales, marketing, research, management, and scientific liaison professionals.
Protected Health Information- identifiable health information as defined in the HIPAA Privacy Rule.
PROCEDURE:
Appointments,
registration and identification:
For each visit, vendor
representatives will sign in at designated vendor kiosks or at the Business Office for Procurement Services during normal business
hours of
The following information will be required:
·
Name of Duke
employee or physician whom they will be visiting
·
Time of scheduled
appointment - all appointments will be scheduled in advance
·
Purpose of the
visit
Vendors will arrange
approval for visits by the relevant Department or Clinic manager prior to
presenting for appointments in the respective area. When presenting for an appointment, the
vendor will check in with the nurse manager or clinic practice manager for each
visit.
Note: Exceptions to normal business hours will be
coordinated with the appropriate person applicable to the business transaction
or visit. Vendor
representatives, who have an appointment to visit Duke’s Operating Rooms, may
go directly to that area, sign in, and will abide by their vendor policy and
procedures.
Passes are good for the
pre-scheduled appointment only. Should
a need arise to visit another department after signing-in, an additional pass
will need to be issued by Procurement Services.
All meetings should be held
in accordance with the policy or guidelines of that specific area.
Confidentiality and
compliance agreements:
Vendor representatives will
be required to sign the Duke University Health System confidentiality form
which includes strict standards for maintaining confidentiality at all times
including information relating to patients, physicians, and staff. Vendor representatives will also be required
to sign that he/she understands and agrees to abide by the Vendor Policy and
Procedures and DUHS Corporate Compliance Policy
while visiting
Vendor representatives will
be issued a name tag at sign in, which will serve as a pass for the time period
of the scheduled appointment. The name
tag should be prominently displayed above the waist, along with their company
issued name badge. Vendor
representatives will wear the Duke name tag and corporate name badge at all times while in the facility.
Each Duke Facility (e.g.
Private Diagnostic Clinics - PDC), or specific departments within each
facility, may have additional vendor policies and procedures that are more
specific than Hospital policy. Vendor
representatives will receive such information from the department
representative, upon their initial visit and periodically thereafter, and will
be expected to abide by the specific area’s policy.
Vendor Representatives’ access to patient-specific information in any clinical setting will be managed through approved Business Associate Agreements in accordance with the HIPAA Privacy Rule.
Vendors may not contact nor
hold discussions with any Duke patient, family member or visitor.
Displays, exhibits,
promotional materials:
Displays and exhibits may
not be assembled in public areas, staff work rooms, teaching stations or
patient care areas. Displays may be used
only within structured educational sessions that are approved by the area manager
and conducted in designated and approved locations, consistent with ACCME
standards.
Educational conferences:
Representatives
may sponsor or attend educational
conferences with Duke faculty, trainees, nursing, pharmacy, nutrition and/or food services,
and respiratory care staff upon prior approval by the program director,
clinic director or conference organizer.
Representatives may not participate in any way in the actual educational conference. Representatives may have informal individual
discussions with faculty members, clinical supervisors, or staff before or
after conferences at which time residents or students may be present. Representatives are prohibited from initiating discussions regarding products or therapies with
residents or students unless faculty or
supervisors are present.
Promotional materials (e.g.
all branded office supplies, personal items such as coffee mugs, bags,
calendars, note
pads) and other devices will not be
distributed within
No advertisements should be posted on walls, doors,
windows, and cabinets or placed in reception area(s). Any bona
fide educational items to be posted on bulletin boards (e.g. for
lectures) should be left with the charge nurse or practice manager for display
in employee-only areas, i.e. break room.
Refreshments:
Food, drinks and
refreshments may not be delivered to any hospital or clinic area unless it is
directly related to a valid educational session that has been approved by the
area manager. Quantities should be
limited to staff who attend the educational session. Valid educational sessions include CME and
non-CME functions, conferences or seminars that present topics that advance
knowledge that is beneficial to improving care.
For CME, the educational content will be consistent with ACCME standards
for education and vendors will refrain from
promotional activities.
Financial support:
Financial support directly
to housestaff, fellows and students is
prohibited. Donations consistent with
applicable standards should be directed to Departments for distribution.
Locations and access
within Duke facilities for travel, meetings, and appointments:
Two vendor representatives
per company will be permitted to visit a patient care area at one time; however,
more than two representatives per company may visit under the following
circumstances; support is required for pre-approved trials, or in-service
training is needed. More than two vendor
representatives per company are permitted to visit at one time, providing the
meeting is held in an academic or administrative office area.
Vendor representatives may
be present in common areas of the facilities.
Initiating unsolicited contact with clinicians and facility employees is
prohibited.
Vendor representatives may
visit in patient care areas only when
an appointment has been scheduled and the
person (or their designee) with whom they have scheduled the appointment
escorts them. Vendor Representatives
will provide documentation of the scheduled appointment at the time of sign in
at Procurement Services.
Vendor Representatives will
park their private or company vehicles in appropriate visitor parking
areas. Vehicles parked in unauthorized
areas will be towed at the expense of the drivers.
Medication samples and
devices, equipment and supplies used to prepare or administer medications
All Non FDA
approved Investigational Devices (Class A or B) will have Duke IRB approval and
a FDA IDE number. Clinical trials of FDA
approved equipment for labeled and off-label uses will be approved by the Duke
IRB before initiating the trial.
All incoming products and
equipment will be covered by a Duke University and Duke
University Health System
purchase order, which is issued by Procurement Services. Medical equipment will be inspected and
approved by Clinical Engineering prior to use.
Vendors will assume all responsibility of the equipment on loan or
evaluation for proper operation or suitability.
Vendor representatives may not introduce products to any facility prior
to meeting with the appropriate Procurement Services representative and/or Duke
Committee liaison. Products and
equipment that are delivered without a valid purchase order may be considered a
donation to Duke, or may be returned at the vendor’s expense.
Sample medications or medical
foods will not be distributed within
Sample medications, medical
foods, products or equipment, when given to the patients, are free and no
charge will be submitted or collected for the free sample. Sample medications or medical foods will not
be provided to physicians or staff for their personal use or for family,
coworkers or friends.
Complaints and
Violations:
Vendor representatives will
not be given access, other than incidental disclosures that may occur as a
result of their presence in the clinic, to any protected health information
(PHI). Notwithstanding any other
provision in this Policy, or any other written or oral agreement between the PDC
and the Vendor representative or Vendor, Duke will immediately terminate a
Vendor’s access to all sites for any violation relating to the use, access, or
disclosure of patients’ PHI.
Failure to comply with this
Policy and Procedure will result in the loss of Vendor’s privileges, and
exclude the Vendor representative from further transactions with Duke
University Health System as determined by the Director of Pharmacy and the
Chair of the P&T Committee. Vendor representatives
visiting departments within the facility without first signing in and obtaining
a nametag will be asked to leave the premises. In addition,
the incident will be reported to the Asst. Vice President, Procurement and
Supply Chain Management and the Director of Pharmacy for review and appropriate
action.
PRECEPTORSHIPS and RELATED TRAINING OPPORTUNITES:
The following principles guide medical center staff, departments and divisions when organizing Pharmaceutical and Nutritional Industry Preceptorships:
1. All participants (“observers”) will sign a patient confidentiality agreement, approved by Risk Management.
2. If the Preceptorship includes disclosure of PHI (e.g. patient identification) or direct patient contact, the patient will be asked to provide written consent and/or authorizations as specified in HIPAA. Consent and/or authorizations will be obtained by the patient’s primary attending physician.
3. Patients may refuse to participate in the Preceptorship or refuse disclosure of their PHI at which time no further attempts to obtain consent or authorization will be made.
4.
The attending-level physician precepting the
observers is responsible for assuring patient privacy and confidentiality.
5.
No
promotional discussions may be held in the presence of any patient,
family or visitor.
PRIVATE DIAGNOSTIC CLINICS
(PDC) and
COMMUNITY PRIVATE DIAGNOSTIC
CLINICS (CPDC)
Vendor Representative Policy
Date:
I have read and understand the Vendor representative
Policy for the
Signature
Print
Name:
Company:
Address:
Phone Number:
Pager:
Email
Address:
Product(s)
Represented:
Please leave/attach a business card for our files.
___________________________________________
Frequently asked questions about the Pharmaceutical
and Nutritional Vendor Policy
Q. How does the Pharmaceutical and Nutritional Vendor Policy
(PNVP) relate to other Duke policies for Vendors? (updated 9/24//2004)
A. The PNVP
is a layered policy that adds additional standards and
expectations to representatives of selected products or
services. The PNVP does not replace any
requirement or expectation found in other DUHS policies. Representatives should contact the Pharmacy
Office if there are any questions about the applicability of this policy to
your situation or circumstance.
Q. Where can I look for updates to the Pharmaceutical and
Nutritional Representative Vendor Policy and the FAQ’s?
A. Procurement
Services, the Department of Pharmacy and the following website will have the
most updated information. (http://pharmacy.mc.duke.edu\PT\index.htm)
Q. Do vendors have to sign in at Procurement Services (or at a
future kiosk) to manage sample inventories within Duke Hospital and the PDC
clinics?
A. Yes. DUHS policy requires vendors to sign-in while
conducting business on Duke Hospital and PDC clinic premises. Visits must be in accordance with the
appointment/standing-time policy of the individual clinic.
Q. Tell me more about the
vendor kiosk for signing in.
A. Presently, the vendor kiosk for daily
sign-in are not installed. This option
was included as concept in the policy at the time of policy approval in
anticipation of future implementation, obviating the need to revise the policy
and seek new approval. Technology staff
and others are presently developing the features and functions of the
kiosk. The kiosk locations, procedures
and implementation date will be announced.
Q. How many forms do I need
to sign? (updated
A. Three
at the first visit and one thereafter. (1) Pharmaceutical and Nutritional
Vendor Policy (PNVP) (2) DUHS Confidentiality and Compliance Agreement (3)
Appointment log. Each representative
must only sign the PNVP once. Each
representative must sign the confidentiality agreement at the first visit and
annually thereafter. Each representative
must sign the appointment log at each visit. For more info, please visit the
Procurement website @ http://www.procurement.duke.edu All policies and forms are online for your
review. Signed forms, agreements and logs are kept on file in the Procurement
Office and your visit is recorded in a database.
Q. Do vendors have to sign in at Procurement Services (or at a
future kiosk) to appointments at outlying DUAP and C-PDC Practices (e.g. Roxoboro Road, Pickett Road, and other locations throughout
Durham and adjacent counties)?
A. At the present time, vendors do not have to sign in
at Procurement Services for appointments (including appointments to manage
sample inventories) with outlying clinics such as DUAP and C-PDC
Practices.
Q. Is Procurement the only
place I can check in? It says in the policy that there are other check in
places and a vendor kiosk?
A. If
you are visiting only the Cardiology Cath Lab, the OR, Radiology, or the Ambulatory Surgery Center, then you
may sign in at those places. If you will be in any other area of the hospital
or the clinics, you must come to Procurement to obtain your badge, and to sign
in. The caveat to the foregoing
is that if the vendor has to go anywhere else in the hospital, they need to go
to Procurement to get another badge for DUH.
Q. Does this policy apply to research personnel from
pharmaceutical vendors or their agents who are conducting research-related
business at Duke Hospital and PDC clinics?
A. Yes. The policy specifically includes research
personnel of the vendor (and any agent of the vendor, e.g. CRO). FDA and regulatory/accreditation personnel
are not included in this policy.
Q. Does a vendor have to sign-in for each appointment?
A. Yes. Vendors must
return to Procurement Services (or other approved location) to sign-in for each
appointment for each day. There are no
“standing orders”.
Q. What if I'm here for
several weeks inservicing for product introduction?
A. Provide
a note from the department being inserviced and
Procurement will issue one badge for the entire time, providing that there is a
signed confidentiality agreement from you on file.
Q. Do I have to sign in
only if I'm dropping off samples?
A. Yes.
You need to sign in whenever you visit Duke Hospital and Clinics in a
professional capacity, representing your company.
Q. I am sponsoring a conference at times before the Procurement
Services office is open or after it is closed.
How do I sign-in?
A. Representatives
should sign-in on a day when Procurement Services is open, before the conference to receive post-dated name tags to be
displayed by the sponsor(s). When
representative are not on the Duke campus immediately prior to a conference,
they are expected to sign-in immediately after the conference is
concluded. Representatives must sign-in
at Procurement Services before they close at 5pm on the day of an after-hours
conference. Conferences must be
pre-arranged with the approval of the area manager.
Q. What if I have to check
with my company before signing the confidentiality agreement?
A. You
are allowed to visit three times without signing the confidentiality agreement.
If for any reason, you can't sign the confidentiality agreement at the 4th
visit, you will not be allowed in Duke Hospital and Clinics for purposes of
representing your company.
Q. Do I have to wear the
vendor badge as well as my company badge?
A. Yes.
Both badges must be prominently displayed above the waist.
Q. Can vendors provide “goody-bags/incentives” for patient care?
A. Valid
educational tools (e.g as information leaflets,
diaries, anatomic models, video’s, medication compliance aids) may be provided for
patient care purposes. Sticky pads,
pens, toys, magnets and similar non educational gifts are not permitted.
Q. Am I allowed to bring
food with inservices?
A. If
you are inservicing or providing educational
information regarding an incumbent product, you may provide food. However, no
food or gratuities of any kind can be provided during the RFP process, or when
attempting to secure business. If there is a product trial, then only minimal
food may be provided, but company paraphernalia is not allowed at that point.
Q. What was updated with the April 2004
revisions?
A. The
first paragraph in the Purpose statement was revised to indicate that
representatives are signing agreement to abide by the underlying principles
of the PhRMA Code and OIG Guidelines. The original intent of this section did not
change.
Q. What was updated with the September 2004
revision to the FAQ (revised again
A. Links to supporting documents from the Duke Office of
Continuing Medical Education (DOCME) were added to the FAQ page. These include:
·
Independence
& Disclosure Policy & Procedure
·
Faculty Honoraria
& Travel Reimbursement Policy & Procedure
·
Joint/
Co-Sponsorship Policy & Procedure
http://docme.mc.duke.edu/Policies%20&%20Procedures/Joint%20&%20Co%20Sponsorship%20P&P.pdf
·
Policy and
Procedure on Regularly Scheduled Conferences and CME
http://docme.mc.duke.edu/Policies%20&%20Procedures/RSC%20P&P.pdf
If you would like to submit a question to the FAQ page, please
reply to:
FAQ page last
updated