Policies:

UMHHC Policy 07-01-045 Drug Samples in UMHHC

Date Issued: 11/1989; Last Reviewed: 7/2007; Last Revised: 7/2007

I. POLICY STATEMENT
Drug samples, while convenient for patients, entail regulatory concerns, safety risks for patients, and encourage prescribing of high cost, non-preferred medications. Therefore, with limited exceptions, sample medications are not permitted in UMHHC facilities. Vouchers for starter medications approved by the Ambulatory Formulary Committee may be dispensed to patients as an alternative. Non-approved vouchers are not permitted in UMHHC facilities.

Drug samples shall not be made available for use by inpatients.

The policy regarding the distribution of drug samples shall be controlled by the Executive Committee on Clinical Affairs. Visitation of Ambulatory Care Site personnel and control of drug samples/vouchers shall be monitored jointly by the site personnel and the Department of Pharmacy Services.

II. POLICY PURPOSE
This policy and these procedures have been developed to provide:
A. Guidelines restricting the use of samples in ambulatory clinic sites.

B. A mechanism for enforcement of these guidelines

III. DEFINITIONS
Drug Samples: Prescription and non-prescription medications which are provided to the sites by pharmaceutical representatives for complimentary distribution to patients, as starter doses.
UMHCC Sites: Applicable to all UM Hospitals and Health Centers where care is provided to patients.
Pharmaceutical Sales Representatives (PSR): A representative of a pharmaceutical manufacturer who visits the ambulatory care sites for the purpose of soliciting the use of, or providing information about, pharmaceutical products. Representatives who visit UMHHC facilities for the sole purpose of initiating or monitoring research studies are exempt from these guidelines.

IV. POLICY STANDARDS
A. Sample medications are not permitted in UMHHC facilities except as noted below. This includes both patient care and non-patient care areas.

B. Vouchers approved by the University of Michigan Health System's Ambulatory Formulary Committee may be distributed by Pharmacy Services to UMHHC ambulatory care sites in order for patients to receive complimentary starter medications from a pharmacy of their choice. The Ambulatory Formulary Committee will determine a formulary of UMHS-preferred medications, which then may be available through vouchers. Only vouchers approved by the Ambulatory Formulary Committee are permitted to be used by UM clinicians at UMHHC.

C. Non-approved vouchers may not be distributed by PSRs to UMHHC ambulatory care sites, nor dispensed by UMHHC personnel at UMHHC sites.

D. Under special circumstances in which there is a legitimate clinical need, with the approval noted below, sample medications may be permitted in UMHHC. Specific requests to have physical samples in a UMHHC clinic must be made on the Special Cause Sample Request Form (Exhibit A), and be approved by the Ambulatory Formulary Committee and the Site Medical Director.

V. PROCEDURE ACTIONS
A. Participating pharmaceutical companies, through their pharmaceutical representatives, should provide available vouchers to the Drug Information Service for review by the Ambulatory Formulary Committee. A list of approved vouchers will be posted on the UMHS intranet.

B. UMHS Ambulatory Formulary Committee-approved vouchers will be distributed to UMHHC clinics, upon request by the clinic, through a centralized voucher distribution program run through the Drug Information Service. These vouchers are for generic medications or brand drugs that are designated as "preferred" by the Ambulatory Formulary Committee. Clinics wishing to obtain approved vouchers should contact the Drug Information Service by email (druginfo@med.umich.edu) or by phone (936-8200). A list of approved vouchers will be posted on the UMHS intranet (http://ummcpharmweb.med.umich.edu/i/docs?xsdid=317&file=vouchers.pdf

C. PSRs may not distribute vouchers directly to clinics. They also are not to distribute non-approved vouchers or coupons within UMHHC sites, or to UMHS clinicians.

D. If a clinic medical director believes there is a clinical need to maintain some physical samples, a request will be made to the Ambulatory Formulary Committee and Site Medical Director using the Special Cause Sample Request Form (Exhibit A). If the request is approved, the succeeding steps must be followed:

  • A formulary of approved sample products must be approved for the clinic. Samples of only those products are permitted at the site.
  • The approved products must be reviewed annually by the medical director.
  • Samples must be stored in a locked secure area. PSRs are not authorized to have access to drug sample storage areas.
  • When samples are received from the manufacturer, they must be recorded on the Sample Drug Log-in Form (Exhibit B).
  • The sample drugs must be inspected by the clinic medical director or designee monthly, and a copy of this review sent to the Department of Pharmacy Services (Exhibit C).
  • In the event of a drug recall, the Department of Pharmacy Services will notify the clinic. The clinic medical director or designee must review sample inventory and return recalled drugs to the pharmacy.
  • When dispensing a sample medication to a patient, the physician must select the drug, dose and quantity of medication to be dispensed. This must be recorded in the patient's medical record. The physician must review the dose-pack and patient label with written instructions prior to the medication being dispensed to the patient. Distribution of sample medications for purposes other than starter doses is prohibited by the Michigan Public Health Code.
  • The physician may delegate to a medical assistant or nurse the following steps:
    • Complete the Sample Drug Sign-Out Log (Exhibit D)
    • Complete the Sample Medication Label (Exhibit E)
    • Document the patient waiver of a child-proof container
    • Obtain final approval from the physician before dispensing
    • Provide patient education regarding the medication

E. The Department of Pharmacy Services will inspect the sample medication storage, log, and dispensing process at least annually. If adherence to this policy is not being met, the privilege of maintaining samples will be revoked.
F. If PSRs distribute non-approved samples or vouchers to a UMHHC site, the UMHHC reserves the right to take disciplinary action against the representative and/or company including prohibition from visiting UMHHC facilities.


VI. EXHIBITS
Exhibit A: Special Cause Sample Request Form
Exhibit B: Sample Drug Log-In Form
Exhibit C: Monthly Ambulatory Medication Area Form
Exhibit D: Drug Sample Sign-out Log
Exhibit E: Sample Medication Label

Authors: John E. Billi, M.D.
Arthur Poremba, MS
James Stevenson, PharmD
Jeoffrey Stross, M.D.
Gundy Sweet, PharmD
Approved: Ambulatory Formulary Committee, June 26, 2002; November 26,2003; June 27, 2007
Pharmacy & Therapeutics Committee, July 16, 2002
Executive Committee on Clinical Affairs, July 23, 2002
Director and Chief Executive Officer, UMHHC, September 20, 2002; March 31, 2004; November 19, 2007

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