PHARMACEUTICAL REPRESENTATIVE GUIDELINES



PHARMACEUTICAL REPRESENTATIVE GUIDELINES

The guidelines below were extracted from the Department of Pharmacy, Policies & Procedures, Policy #10-002 – Pharmaceutical Representative Guidelines. Go to to view the policy in its entirety.

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PURPOSE:

To establish guidelines for the appropriate conduct of Pharmaceutical Representatives who conduct business at Cleveland Clinic (CC).

DEFINITIONS:

Pharmaceutical Representative (PR): Any individual employed by a pharmaceutical company who has business to conduct at any CC facility. This includes but is not limited to personnel in sales, marketing, education, and account management. Individuals employed by pharmaceutical companies whose responsibilities are restricted solely to research activities are exempt from this policy.

POLICY:

The Cleveland Clinic Foundation is a private, not for profit institution. Facilities are for the use of employees, patients and patient visitors. Pharmaceutical Representatives (PRs) shall conduct their business activities within the guidelines of CC to promote safe, efficacious and cost effective drug therapy with due consideration for CC personnel time expenditure. All activities must be consistent with and promote CC’s mission and formulary activities.

APPOINTMENTS:

1. PRs are not permitted in CC facilities without an appointment.

2. All appointments are to be scheduled through the physician's office, the Nursing office, the Center for Continuing Medical Education, or through the pharmacy offices (or with individual Pharmacy personnel).

3. For visits to the Main Campus, the physician's office, nursing office or pharmacy personnel must call the Department of Pharmacy (extension 4-6498) prior to a scheduled appointment to register the appointment and authorize the issuance of a vendor badge.

4. At the Family Health Centers, PR’s are not required to call the Department of Pharmacy and no badges will be issued. Appointments with Nursing personnel at the Family Health Centers are limited to the Clinical Nurse Manager.

5. PRs are prohibited from scheduling individual appointments at CC with house staff physicians. House staff physicians include Residents, Fellows, Medical Students and other physicians in training. PRs may meet with house staff physicians at conferences approved by the Foundation's Educational Program Director or Department Chairman.

6. PRs are prohibited from scheduling individual appointments with hospital or Family Health Center administrators.

7. Physicians (including house staff), nurses and pharmacists are not to be contacted by the paging system or at home unless requested to do.

RESTRICTED AREAS:

1. PRs are guests of CC and may not be present in any CC buildings or areas without an appointment.

2. After the appropriate appointment and registration procedure, PRs are to proceed immediately to a scheduled appointment. They are to wait in a public waiting area until called/escorted to the requesting person's office.

3. PRs are prohibited from marketing, detailing, or loitering in the following areas:

a. Halls and lobbies

b. Hospital cafeterias or restaurants

c. Medical Library (photocopying is also prohibited)

d. PRs are prohibited from visiting the following areas without an appointment

e. Physician offices. This includes dropping off samples.

f. Work areas (Pharmacy, Microbiology, Laboratory)

g. Education areas (including the old Education and Lerner Buildings)

h. Research Areas (including the Research and Lerner Buildings)

i. Administrative areas

j. Patient care areas (examining rooms, patient rooms, nursing units)

4. The PR may enter patient care areas only to access offices for scheduled business appointments or approved educational meetings only upon the specific invitation of a staff physician, pharmacy manager or nursing manager.

RESTRICTED ACTIVITES:

1. Patient Contact

a. The formulation of treatment plans for patients at CC requires a confidential, candid exchange and assessment of confidential patient and treatment information among health care professionals, without the potential appearance of outside influence, especially from vendors. As such, Pharmaceutical Representatives are prohibited from participating in physician, nursing, or other health professional rounds, whether or not direct patient contact occurs.

b. Furthermore, PRs will not be permitted to observe or have direct contact with patients at CC. Examples of contacts prohibited by this policy include making rounds on the inpatient units (including the intensive care units), being present when examinations are conducted in the outpatient setting, and observing surgical and non-surgical procedures.

c. The only exception to this is as follows:

i. Pharmaceutical Representatives may be permitted to participate in patient rounds as part of a formalized preceptorship performed under the guidance of the Center for Continuing Medical Education. Under these circumstances, representatives may have patient contacts only after the expressed written consent of each patient to be observed.

2. Drug Product Provision

a. Samples

i. Samples are not permitted at CC. This includes the hospital, clinic areas, and Family Health Centers.

b. Free Goods

i. All drug products must be procured and distributed through the Department of Pharmacy in order to comply with all applicable legislative, regulatory, and accreditation issues.

c. Drugs for Clinical Investigation or Informal Evaluation

i. All drug products used for clinical investigation or informal evaluation, whether commercially available or investigational must be procured and distributed through the Department of Pharmacy. Drugs used in this manner may require an IRB approved protocol.

d. Food and Beverages

i. Food and beverages may not be provided by PR’s and/or their companies to any employee (including physicians, nurses, pharmacists) at any CC facility. PR’s may sponsor educational conferences through CC Department or Division Chairmen. If food is part of the educational conference it must be arranged and provided through CC department. The PR may not make food arrangements, orders or deliveries. The hotels may not be used for pharmaceutical company sponsored educational programs during business hours (7am-5pm) unless part of a program coordinated through the Center for Continuing Medical Education.

e. Patient Educational Materials

i. A Staff Physician must authorize the availability of pharmaceutical company provided patient educational materials in public areas. Material must be placed in these areas by authorized CC personnel.

f. Displays

i. Displays are permitted only as a part of programming approved by the Center for Continuing Medical Education and only during the time specified by that program.

g. Presentations/Education

i. Any company sponsored presentation must be approved by the Department or Division Chairman. Provision of food is prohibited.

Org. Policy Date: 8/27/04 (Pharmacy policy)

Policy Extraction for GPM: 5/1/07

GMEC Approval for Information Only: 7/2007

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