Attachment 6 PHARM-004 Policy Governing Pharmaceutical and Medical Industry Reps.pdf

June 30, 2022 MCP PHARM-004

PROMOTION OF DRUGS AND DRUG-RELATED SUPPLIES BY

PHARMACEUTICAL COMPANY REPRESENTATIVES

US Department of VA Nebraska Western Iowa Health Care System

Signatory Authority:

VA NWIHCS COS

VA NWIHCS Director

Responsible Owner:

Chief of Pharmacy

Rescinded Document:

PHARM-004, dated February 2019

Effective Date:

June 30, 2022

Recertification Date:

June 30, 2027

1. POLICY

This medical center policy (MCP) establishes policy and procedure regarding on-site, in-person promotional activities of drugs and drug-related supplies, including educational activities, detailing, patient and provider contact, and overall conduct in Nebraska-Western Iowa (NWI) facilities by Pharmaceutical Company Representative(s) (PCR).

2. JUSTIFICATION

VHA Directive 1108.10 Promotion of Drugs and Drug-Related Supplies by Pharmaceutical Company Representatives (PCR), dated June 13, 2018, provides policy on promotional activities of drugs and drug-related supplies and overall conduct in Department of Veterans Affairs (VA) facilities by Pharmaceutical Company Representatives (PCR) in VA medical facilities. This policy outlines the local policies and procedures that must be followed by all VA Nebraska-Western Iowa Health Care (NWIHCS) facilities to comply with VHA Directive 1108.10.

3. RESPONSIBILITIES

a. Medical Center’s Director (or designee), in concert with the Chief of Pharmacy. The Medical Center’s Director or designee, in concert with the Chief of Pharmacy is responsible for:

(1) Ensuring no drug samples or drug-related supplies are donated to NWI.

(2) Approving and ensuring compliance for all other donations to NWI.

(3) Levying limitations, suspension, or the permanent revocation of privileges of a Pharmaceutical Company Representative (PCR) or entire sales force of a given manufacturer when appropriate.

b. Chief of Pharmacy (or designee). The Chief of Pharmacy (or designee) is responsible for:

(1) Providing copies of VHA Directive 1108.10 and this policy to all PCR who seek access to NWI prior to initiating any activities, as well as communicating permissions to the PCR.

(2) Ensuring samples of drugs and drug-related supplies are not obtained from PCR.

Attachment 6

June 17, 2022 MCP PHARM-004

(3) Coordinating the review of on-site, in-person promotional activities, including educational activities by PCR at NWI.

(4) Ensuring educational programs or promotional materials presented by a PCR are reviewed within 60 calendar days of receipt prior to presentation or distribution.

(5) Reviewing all pre-scheduled PCR and guest speakers with on-site appointments prior to final approval.

(6) Maintaining and making available a list of individuals or departments that wish to be called on by PCR.

c. Service Chiefs (or designee). Each Service Chief or designee is responsible for:

(1) Ensuring staff education on VHA Directive 1108.10 and this policy.

(2) Providing the Chief of Pharmacy with a list of employees who wish to be called on by PCR at least annually.

(3) Working in concert with the Chief of Pharmacy to review any on-site, in-person promotional activities or promotional material specific for their Service.

d. VA Employees. Each VA employee is responsible for:

(1) Complying with the provisions of VHA Directive 1108.10, this policy and the “Standards of Ethical Conduct and Related Responsibilities of Employees.”

(2) Ensuring staff who wish to be called on by PCR are on the designated list. They shall preschedule and obtain approval by the Chief of Pharmacy or designee prior to meeting with PCR.

(3) Ensuring that PCR who present on-site without a pre-arranged appointment are directed to the Pharmacy Administration Office or Pharmacy for guidance and education on scheduling appointments with VA Staff.

e. Pharmaceutical Company Representative (PCR). The PCR is responsible for complying with NWI Policy PHARM-004 and VHA Directive 1108.10.

4. PROCEDURES

a. Pharmacy.

(1) Pharmacy will maintain and make available a list of individuals or Services that wish to be called on by PCR. A point of contact shall be identified for each Service on the list to assist in scheduling PCR.

(2) Pharmacy will contact Services annually to review the PCR contact list and update it as needed.

b. Pharmaceutical Company Representative (PCR).

(1) All PCR will review and accept the current policy in Reptrax. All PCR are required to obtain a PAID Reptrax account and keep all Reptrax account requirements up to date, including vaccinations. PCRs should contact Pharmacy for assistance with Reptrax.

(a) A list of Services and individuals that wish to be called on by PCR will be maintained by the Chief of Pharmacy or designee. Appointments may only be made with individuals that have notified Pharmacy that they wish to be called upon.

(b) PCR will ensure departments and/or staff are on the PCR contact list prior to contacting a NWI employee. Appointments may be made by either telephone or email but must be made in advance of visiting the medical center.

(c) Unsolicited Visits Are Prohibited. All PCR are prohibited from making unsolicited visits to medical center staff. A request by a VA employee for literature, medical information, education materials, and similar items should not be considered a reason for a PCR to visit a medical facility without a scheduled appointment. PCR should not attempt to make appointments with individuals who are not on the list supplied by Pharmacy.

(d) PCR visiting VA facilities for previously scheduled appointments may not initiate requests for impromptu meetings with other VA staff whom they may happen to encounter during their scheduled visit but may respond to requests for meetings initiated by VA staff during the visit.

(e) PCR are not allowed to attend medical care treatment facility conferences where patient-specific material is discussed or presented.

(2) PCR Must Sign In. Whenever PCR are in the medical center, s/he must sign in and out appropriately.

(a) Omaha: PCR visiting the Omaha facility must sign in and out utilizing Reptrax.

(b) Grand Island or Lincoln: PCR must sign in and out with the Pharmacy Office.

(c) Community Based Outpatient Clinic (CBOC): PCR are prohibited from visiting a CBOC unless accompanied by Pharmacy personnel.

(d) The log or electronic entry in Reptrax must list the name of the staff member(s) with whom the PCR will be meeting. Listing destinations such as “medicine” or “surgery” is not adequate. A vendor badge will be issued by VA Pharmacy or Reptrax.

The VA issued badge must be returned before the PCR leaves the building. The VA issued badge or Reptrax ID must be worn for the duration of the planned visit and be worn so as to be clearly visible and not obstructed by clothing such as suit jackets.

(3) Pharmaceutical Displays and Educational Materials.

(a) Pharmaceutical displays (advertising materials designed to promote pharmaceuticals to prescribers or patients) are not permitted at any VISN 23 facility.

(b) Drug-related educational materials such as journal articles may be provided;

however, the formulary status of the drug (e.g., formulary, formulary restricted, non-formulary or not yet reviewed by the VA PBM) must be clearly articulated and conspicuously identified as such by the PCR.

(c) Educational materials or literature regarding a new drug or a new therapeutic indication for a drug already on the VA National Formulary, but which has not been reviewed by the VHA Medical Advisory Panel (MAP) and the VISN Pharmacist Executives (VPE) Committees, must be identified as such prior to being displayed or discussed.

(d) Educational programs and materials focusing on Non-VA National Formulary drugs or drug-related supplies without Criteria-for-Use must receive prior approval from the Chief of Pharmacy or designee.

(e) Promotional materials are not to be placed in any patient care area. The determination of “promotional” will be made by Chief of Pharmacy or designee.

(4) On-Site Educational Programs. Pharmaceutical companies may sponsor educational programs that are approved by the Chief of Pharmacy or designee.

Educational pharmaceutical programs are on-site presentations sponsored by a company who pays a speaker an honorarium, provides travel, pays a consultant fee related to the presentation or provides the majority of the slides.

(a) If a pharmaceutical company is sponsoring a lecture, it must be disclosed at the beginning of the lecture. In addition, every printed or email announcement about the lecture must disclose what company is sponsoring the talk and list what product(s) the drug company makes that are relevant to the presentation.

(b) When industry-sponsored and non-sponsored sources of data/analytical information exist for FDA approved uses of a particular drug or drug-related supply, a direct comparison between the two sources must be disclosed in the introductory remarks and in the announcement brochure.

(c) PCR must notify the Chief of Pharmacy or designee of all sponsored on-site educational programs and provide a summary of the event at least 60 days before the scheduled event.

(d) All educational programs must be approved by the appropriate continuing education accreditation agency, such as the Accreditation Council for Pharmacy Education (ACPE) or the Accreditation Council for Continuing Medical Education (ACCME), when appropriate, before submission to the facility designee for review.

(5) Patient Educational Programs. Pharmaceutical company-sponsored patient educational programs must be approved in advance by the Chief of Pharmacy or designee. These programs may not solicit confidential patient and/or prescriber information. Promotional materials are not to be placed in any patient care area and must not contain the name or logo of the industry manufacturer or be used for the promotion of a specific medication.

(6) Food. Food and/or beverages may not be provided at any on-site VA sponsored event by a pharmaceutical company either directly (company purchases) or indirectly (grants, access fees, etc.) Food includes soft drinks, coffee, donuts, and meals of any kind. Any off-site interactions between VA employees and PCRs would be scrutinized under the “Gifts” and “Conflicting Interests” provisions of the published criteria. In egregious circumstances, the criminal provisions of federal law might apply. (See for example, 18 U.S.C. §§ 201(b), 208 and 209. In addition, the Standards of Ethical Conduct for Employees of the Executive Branch, 5 C.F.R. Part 2635 and Part I of Executive Order 12674, pertain.) Any questions from VA employees related to permissibility of attending a specific off-site event should be referred to the facilities regional counsel for an opinion.

(7) Detailing. Promotion of a drug or drug-related supplies must be approved by the Chief of Pharmacy or designee. It must have significant educational value and not inappropriately divert VA staff from other activities they would otherwise perform during duty hours, including patient care and other educational activities.

(8) Residents and Trainees. PCRs may not detail (promote products) to residents or other persons in training programs on VA premises in the absence of a VA staff physician or the trainee’s supervisor.

(9) Restricted Areas. PCRs are restricted from detailing activities in all wards, clinics, and patient care areas. PCRs may not wait for appointments in patient care areas, but may briefly travel through them, when necessary, to meet in a staff member’s office.

(10) Drugs and Drug-Related Supplies.

(a) Promotion of VA National Formulary and Non-VA National Formulary drugs and drug-related products must be in accordance with applicable FDA and VA guidelines, including PBM Criteria-for-Use or applicable prescribing restrictions, which exist for those products.

(b) Non-VA National Formulary drugs or drug-related supplies may be promoted but must be approved by the Chief of Pharmacy or designee and must meet the conditions outlined in VHA Directive 1108.10.

(c) Those drugs or drug-related supplies classified by VA as non-promotable must not be promoted.

(d) Drug and drug-related supplies that are discussed must be displayed and represented accurately. When meeting with prescribers, PCRs must clearly indicate to the prescriber any guidelines or restrictions that have been imposed on their product by the VISN or medical center.

(11) New Molecular Entities. New molecular entities may be promoted if specifically permitted by the Chief of Pharmacy or designee and must adhere to VHA Directive

1108.10 guidelines.

(12) Formulary Requests. PCRs will not ask prescribers to submit requests to add products to the formulary nor prepare such requests.

(13) Pricing Information. PCRs will not provide pricing information to prescribers.

Prescribers that require pricing information should contact Pharmacy Service.

(14) Medications with established VA Criteria-for-Use must be detailed with content that is consistent with either national or facility-specific criteria.

(15) Donation of Drug Samples and Drug-Related Supplies is not allowed at NWI.

(16) PCR Who Do Not Comply with This Policy.

(a) PCR who do not comply with this policy will be prohibited access to NWI employees for an initial period of six months for the first offense. During this same six-month period, educational programs sponsored by the suspended PCR’s company will also be prohibited.

(b) The Chief of Pharmacy will issue a written notice to the suspended PCR detailing the non-compliance and the suspension. The PCR will have 30 calendar days to respond to the notice; however, the suspension will be enforced effective the date of the notice. After the end of the 30-day response period, or after the Chief of Pharmacy receives a timely response, the Chief of Pharmacy will issue to the PCR and their supervisor a final written order either confirming the action taken as indicated in the notice or specifying another action to be taken. If the PCR fails to comply with this policy after being suspended for six months, additional action will be taken.

(c) During a suspension, the PCR’s employer will not be permitted to replace its suspended PCR with a different representative.

(d) Multiple occurrences of noncompliance may lead to permanent revocation of commercial visiting privileges for the PCR and/or their employer.

(e) Any sanctions imposed under this policy may be communicated to all VA medical facilities.

c. VA Employees

(1) Gift Solicitation. VA employees shall not solicit or accept any gift, gratuity, favor, entertainment, loan, or anything of monetary value from a PCR or any other person seeking to become involved or currently involved in business interactions with the VA.

(2) Education and Conflict of Interest. Employees conducting business outside of the VA medical care facility or engaged in activities that may be supported by an PCR’s employer must adhere to the “Standards of Ethical Conduct and Related Responsibilities of Employees”.

5. DEFINITIONS

a. Pharmaceutical Company Representative(s) (PCR). Pharmaceutical Company Representative(s) (PCR) refers to anyone employed or contracted to represent a pharmaceutical manufacturer, retailer, or its business partners for promoting the use of items managed under the VA formulary process. These items primarily include drugs, but also encompass vaccines, any drug-related supplies, medical supplies, nutritional supplements, and similar commodities managed under the VA formulary process.

b. Non-Promotable Drugs. Non-promotable drugs are drugs designated by VA as non-promotable on the Pharmacy Benefits Management website at http://www.pbm.va.gov . A list of drugs or drug-related supplies classified by VA as non-promotable may be requested by contacting the VA medical facility’s Chief of Pharmacy.

6. REFERENCES

a. Policy ASD-001 Records Management, April 2, 2020

b. VHA Directive 1108.10 Promotion of Drugs and Drug-Related Supplies By Pharmaceutical Company Representatives (PCR), dated June 13, 2018, VHA Publications (va.gov)

c. VHA Directive 1108.08(1) VHA Formulary Management Process, dated November 2, 2016, VHA Publications (va.gov)

d. American Medical Association (AMA) Principles of Medical Ethics: II, Gifts to Physicians from Industry, Code of Medical Ethics Opinion 9.6.2, Gifts to Physicians from Industry | American Medical Association (ama-assn.org)

7. RECORDS MANGAGEMENT

All records regardless of format (e.g., paper, electronic, electronic systems) created by this directive shall be managed per the National Archives and Records Administration (NARA) approved records schedules found in VA Records Control Schedule 10-1.

Questions regarding any aspect of records management should be addressed to the appropriate Records Manager or Records Liaison.

8. RESCISSION

MCP PHARM-004, Policy Governing Promotion of Drugs and Drug-Related Supplies by Pharmaceutical Company Representatives, dated February 2, 2019.

9. REVIEW

This policy must be reviewed, at minimum, at recertification and including when there are changes to the governing document (for example, national policy or a health care accreditation body mandate).

http://www.pbm.va.gov/ https://www.va.gov/vhapublications/publications.cfm?pub=1&order=asc&orderby=pub_Number https://www.va.gov/vhapublications/publications.cfm?pub=1&order=asc&orderby=pub_Number https://www.va.gov/vhapublications/publications.cfm?pub=1&order=asc&orderby=pub_Number https://www.ama-assn.org/delivering-care/ethics/gifts-physicians-industry https://www.ama-assn.org/delivering-care/ethics/gifts-physicians-industry

10. RECERTIFICATION

This MCP is scheduled for recertification on or before the last working day of June 2027. This MCP will continue to serve as local policy until it is recertified or rescinded.

In the event of contradiction with national policy, the national policy supersedes and controls.

11. SIGNATORY AUTHORITY

David A Williams, M.D., MBA Chief of Staff

Eileen Kingston, DNP, MPA, BSN, RN, NE-BC Director

NOTE: The signature remains valid until rescinded by an appropriate administrative action.

CONCURRING OFFICIALS

ACOS/EDUCATION

ACOS/PRIMARY CARE

CHIEF OF STAFF

DENTAL SERVICE

GERIATRICS/EXTENDED CARE

MEDICINE/PRIMARY CARE

MENTAL HEALTH AND BEHAVIORAL SCIENCE

NUTRITION

PATIENT CARE SERVICES

SURGERY

ACOS/RESEARCH AND DEVELOPMENT

PHARMACY AND THERAPEUTICS (P&T) COMMITTEE

PRIVACY OFFICER

PROSTHETICS

DISTRIBUTION: Emailed to the VHANWI Leadership-Supervisor Team VHANWINebraskaSupervisors@med.va.gov and the VHANWI Pharmacy Managers VHANWIPharmacyManagers@va.gov on June 17, 2022. MCPs are available at:

Policies - By Policy Type (sharepoint.com) mailto:VHANWINebraskaSupervisors@med.va.gov mailto:VHANWIPharmacyManagers@va.gov https://dvagov.sharepoint.com/sites/VHANWI/SiteDirectory/policies/Documents/Forms/AllItems.aspx