Rules & Guidelines - Meritcare - Sample Policy

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08.00 Medication Samples

Approved By: Pharmacy & Therapeutics Committee; John Leitch, Chairman

Written By: R. Keel, Pharmacy Operations Coordinator

Original Date: 11-98

Revised Date: 7-00

Policy
All handling of drug samples within MeritCare Health System must follow the requirements of the Prescription Drug Marketing Act and standards TX 3.3 to TX 3.5 of the Joint Commission on Accreditation of Health Care Organizations "Comprehensive Accreditation Manual for Hospitals".
This mandates the maintenance of sample medications to prevent the dispensing of outdated medications including the recording of lot numbers to allow for recall of previously dispensed medications.
Sample medications are intended for patient use only. "Legend" drug samples, by law, may be dispensed only by prescription or written order in the patient chart and proper documentation must be maintained. The dispersal of these drugs in any other manner may be considered drug diversion and is considered grounds for discipline.
Sample medication records will be kept for a period of one year.

Purpose

  1. To provide a consistent and safe method of receiving, storing, and dispensing of medication samples.
  2. To provide a system that allows for the recall of any medication in a timely manner.
  3. To ensure the supply of samples is secured and safe.
  4. To ensure compliance with all State, Federal, and JCAHO regulations and laws.
  5. To ensure samples are dispensed safely by authorized personnel according to laws and regulations.

Procedures

Receiving

  1. Pharmaceutical "Sample Log Sheets" will be provided to those areas where samples are used.
  2. Samples will be delivered by the pharmaceutical representative to the designee at each area utilizing sample medications.
  3. Upon receipt, all samples will be logged into the "Log Sheet" indicating date, drug name, lot number, expiration date, quantity received, and initials of person receiving the samples.
  4. Mailing of drug samples is strongly discouraged.
  5. No controlled substances will be accepted as samples. This includes Schedule II, III, IV, and V.
  6. No samples are to be left unattended anywhere in the system. Failure to comply with this provision may result in suspension of detailing privileges for the representative.

Dispensing

  1. Only physicians, pharmacists, physician assistants, or nurse practitioners may dispense sample medications. Nursing personnel may, under the direction of the prescriber; obtain the sample medication, do the necessary paperwork, and deliver to the prescriber. The prescriber must give the samples to the patient. State regulations dictate that medication may not be "dispensed" by the nurse. Samples are intended for patient use only and are not to be diverted for use by others, including employees, unless prescribed by employee's physician as part of employee's treatment. In order for samples to be used by employees, all procedures must be followed, including "dispensing" only by personnel legally able to do so.
  2. When dispensing samples, the following information must be indicated in the patient chart:
    - drug name, strength, dosage form, dose, and frequency of administration
    - an indication that samples were given to the patient.
  3. Labels for dosage instructions shall be applied to samples (JCAHO recommendation).
  4. When dispensing samples, indicate date dispensed, patient name, drug name, quantity dispensed, and initial of person dispensing the sample.

Monitoring

  1. Sample drugs must be monitored monthly by a designee of the service area.
  2. Outdated medications shall be subtracted from the inventory log and properly packaged for incineration/destruction or may be returned to Pharmacy Services for disposal.
  3. All manufacturer recalls must be brought to the attention of the service area designee. The "Receiving Log" must be checked to see if any of the recalled drug/lot number was received into stock. If so, all recalled medication will be pulled from the sample inventory and subtracted from the log. All patients who received samples of the recalled drug must be contacted. It should be documented in the chart that the patient was notified of the recall. Recalled medications may be returned to the manufacturer or returned to Pharmacy Services for disposal.
  4. Once per month a random reconciliation must be done on two medications at each clinic area to assure ongoing compliance with the "Sample Medication Policy" (per JCAHO). Enter results on log and address potential problems.

Storage

  1. All samples will be stored in a lockable area following the storage specifications from the manufacturer.
  2. Access will be limited to physicians and their designees.

MeritCare Hospital Requirements
The use of drug samples for patients of MeritCare Hospital is not permitted except in emergency situations when routine sources of supply are interrupted.

NOTE: Pharmaceutical representatives who provide samples should refer to the respective departmental policies for any specific procedures unique to that service area.

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