MICHIGAN STATE UNIVERSITY MSU HEALTH TEAM POLICIES AND PROCEDURES

MICHIGAN STATE UNIVERSITY
MSU HEALTH TEAM
POLICIES AND PROCEDURES
SUBJECT: Sample Drugs
SCOPE: All HT Clinics
AUTHOR: Susan Dolby, Risk Manager
FINAL APPROVAL: 12/2008
EFFECTIVE DATE: 12/1/2008
REVIEW/REVISE DATE: 12/2010
NO: CP - 4
Page: 1 of 4
Policy
An effective and safe medication management process for receipt, storage and
dispensing of sample pharmaceuticals will be maintained.
A practice may accept only those pharmaceuticals that are routinely or reasonably
used within that practice.
No schedule II, III, IV, or V medications will be accepted as samples. Exceptions may
be allowed if Governing Board approval is received in advance.
Samples may be provided to patients as a starter or trial supply. Supplying a complete
course of a medication is allowed if deemed necessary by the provider based on cost or
availability.
The use of samples is restricted to patients of licensed independent practitioners of the
HealthTeam.
Definitions
Adverse Drug Reaction: An unintended, undesirable, or unexpected effect of a
prescribed medication that requires discontinuing the medication or modifying the
dosage and results in a patient outcome of any of the following:
 Initial or prolonged hospitalization
 Disability in body function, structure, physical activities or quality of life.
 Treatment with a prescription medication to prevent damage or impairment
 Life-Threatening
 Death
 Offspring with congenital anomalies
Process
1. Receipt:
a. Before any medications are accepted, a staff physician is required to
approve all medication samples. A licensed staff person of the
HealthTeam will sign for receipt of samples.
b. Pharmaceutical company representatives may stock and record delivered
samples if assisted by a designated nursing staff member or pharmacist.
c. The Sample Drug Log (attachment #1) Section A will be completed at the
time of delivery of samples.
2. Storage:
Revised 9/2009
a. Samples will be stored appropriately with regard to light, temperature,
and humidity in a locked area accessible only to authorized staff.
b. Medications that look-alike or the names sound-alike will be physically
separated as much as possible in the secure storage area.
3. Labeling:
a. Sample medications are to be labeled with pertinent information if not
displayed on packaging.
i. Drug name
ii. Strength
iii. Amount
iv. Drug expiration date
v. Patient name
vi. Written administration instructions
vii. Provider name
4. Dispensing:
a. Dispensing is controlled by the licensed independent practitioner.
b. Should be in amounts to minimize diversion yet consistent with patient
needs.
c. Will be in ready-to administer form from the manufacturer if feasible or
unit dose if repackaged by pharmacist or a licensed repackager.
d. Dispense package inserts if required.
e. The Sample Drug Log (attachment #1) Section B will be completed when a
sample is distributed to a patient. For clinics not utilizing the electronic
prescribing, they should handwrite the necessary information. For clinics
utilizing electronic prescribing, a weekly report of samples dispensed may
be attached to the log sheet.
f. The Sample Drug Log (attachment #1) will note items sent back to
pharmacy for disposal.
g. Written administration instructions are given and reviewed with the
patient or caregiver.
5. Documentation:
a. Documentation in the patients medical record is standard in both the
paper and electronic record and will include drug, strength, lot number,
amount dispensed and the prescribing method will be noted as ‘samples
given’. For clinics utilizing electronic prescribing, the lot # of the sample
must be entered into the area for instructions.
b. The patient’s medical record shall reflect appropriate instructions
provided.
c. Maintain log sheets for ten years.
6. Quality Control
a. Samples will be inspected monthly for expiration date, damage and or
contamination. Cross check with the log book will be done to ensure
accurate inventory. The day of the monthly inspection will be determined
by the clinic.
b. Samples that have expired, appear damaged, or contaminated will be
removed from storage and sent to the clinical center pharmacy for
disposal per ORCBS regulations.
Revised 9/2009
i. Removal of expired medications will necessitate updating in log to
note ‘expired’ and disposition of medications.
ii. Transport of expired medications will be via the courier system,
c. Adverse reactions to sample medications should be reported to the clinic
medical director and clinical center pharmacy for review and follow up.
Page 2 of 4
Removal of samples for safety reasons from clinical areas based on
pharmacy review is under the direction of the chief pharmacist in
consultation with the clinical medical director. A decision to report to the
FDA MedWatch will be made by the clinical medical director.
d. Adverse drug reactions and medication errors will be reported to risk
management using the occurrence reporting system (see Policy ADM-16)
Revised 9/2009
ATTACHMENT #1
Sample Drug Log
Section A
Medication Brand Name:
Lot Number:
Medication Generic Name:
Expiration Date:
Date Received:
Manufacturer Name:
Rep. Name/Phone #
Section B
Date
MRN
Patient Name
Strength:
Quantity Received:
Provider Name
Do Not Discard. Maintain a copy of drug log in department
Revised 9/2009
Amount
dispensed