Department of
Pharmacy Policies & Procedures
Number: 5:15
Effective Date:
January, 1992
Revisions: 6/99,
3/07, 4/08, 2/09
Reviewed: 9/09
Approval: 8/11/99
Subject: DRUG SAMPLES
A.
POLICY
Drug samples are
complimentary medications provided to UAMS licensed physicians free of charge
by pharmaceutical manufacturers. Samples
of prescription drugs will not be used on inpatients at the
The Outpatient
Pharmacy may also store and dispense the samples upon the request of a
physician, or at the discretion of the pharmacy. The Outpatient Pharmacy will
not charge patients for any samples that are dispensed.
Absolutely no samples
of Controlled Substances will be allowed.
B. PROCEDURES FOR MANAGING SAMPLES IN THE
OUTPATIENT AREA
Ordering & Receipt of Drug Samples
Each
clinic must notify the Director of Pharmacy by email of their intent to stock
sample medications.
Drug
samples may be obtained from the manufacturer either directly from the
pharmaceutical sales representative or via the mail.
It
is the responsibility of the practice director to decide which sample
medications will be stocked in their respective clinics.
The
pharmaceutical drug representative must sign the Product Integrity Statement. This
statement is maintained on file by the practice director.
Each
drug sample received is logged in on the UAMS Medication Sample Log. The person placing the drug into inventory
must complete all fields on the inventory log sheet.
Received
drug samples are securely stored in accordance with the Storage
of Medications in Patient Care Areas Policy 5:32.
Storage and Security
of Drug Samples
Storage
Drug
samples must be stored in a locked area (e.g. cabinet, drawer, or room).
Drug
samples are stored under temperature conditions consistent with the product
label.
The
drug storage area is kept clean and organized at all times.
The
drug storage area must be evaluated for proper lighting, humidity, and
temperature.
A
single central storage location is preferable to decentralized storage.
Stock
must be rotated whenever items are added to inventory to insure that drugs with
the shortest expiration dates are issued first.
Security
Access
to drug storage areas and possession of the key to those areas is restricted to
persons authorized by the practice director.
Drug
storage areas are to be locked at all times.
Drug
representatives are not permitted access to the drug sample storage area.
UAMS Drug Storage Policy
All
other aspects of drug sample storage must be in accordance with the Storage of Medications in Patient Care Areas Policy 5:32.
Inventory Requirements
In
order to facilitate inventory inspection, accountability, and drug recall
procedures, a perpetual inventory system is used whereby the inventory log
displays the running on-hand balance for each medication.
Records and Documentation Requirements
All drug records must be kept such that all
data is readily available, and shall be retained for at least two years.
Drug Records Binder
The following medication-related documents
will be maintained in the clinic, filed together in separate sections:
Drug Sample Inventory Log sheets, filed
alphabetically by brand name.
Medication Quality Assurance Checklist,
submitted to the pharmacy.
The binder will be maintained by the practice
director or designee.
It must be kept up to date and must be made
available to the Outpatient QA nurse or inspecting pharmacist.
All drug samples that are going to be
dispensed to patient must have an inventory log sheet.
The purpose of this log is to document all
additions and removals from inventory, and to maintain a perpetual count of the
inventory on hand.
A separate inventory log sheet is used for
each medication.
The inventory log sheets are maintained in a
ring binder, filed alphabetically by drug name.
This log sheet is maintained as follows:
a. Column-A (DATE): Enter the date of the
addition or removal from inventory.
b. Column-B (PATIENT’S NAME AND MEDICAL
RECORD #) When removing product from inventory enter the patient’s name and
medical record number the product is dispensed to. The patient’s label may be used here.
c. Column-C (PRESCRIBER) Enter
the prescriber’s name who is ordering the product to be dispensed.
d. Column-D (LOT NO.) When
adding or removing product from inventory, enter the lot number of the product.
e. Column-E (EXPIRATION DATE) When adding or
removing product from inventory, enter the expiration date of the product.
f. Column-F (DISPENSED/REC’D BY) When adding
or removing product from inventory, enter the person’s name issuing/receiving
the product.
g. Column-G (QUANTITY REC/DISP): Enter the
number of dose units added or removed from inventory. Place a plus sign (+)
before the number when the product is added to inventory (e.g. +12). Place a
minus (-) sign before the number when the product is removed from inventory
(e.g. –12).
h. Column-H (BALANCE ON HAND): This is a
running balance of the inventory on hand. It is calculated by adding the
quantity placed in inventory, or subtracting the quantity removed from
inventory, to the most recent “balance on hand” entry.
ISSUING DRUG SAMPLES TO PATIENTS
Drug samples may be issued to patients only
when prescribed by UAMS physicians and practitioners within the scope of their
practice specialty.
Sample medications may not be dispensed to
any individual not seen by one of the clinic medical staff.
Drug samples may only be prescribed for the
patients of the prescriber’s UAMS practice location.
A record of the prescription order must be
documented in the patient medical record. At a minimum, this record must
include: drug name; strength; dosage form; directions; the quantity prescribed
and clearly state samples were given to the patient.
By law, only pharmacists and physicians can
dispense drugs. Other Practitioners may dispense drugs if so delegated by the
supervising physician. Advanced practice nurse practitioners may dispense drugs
in accordance with Arkansas Nursing Board.
Other Practitioners may dispense drugs if so
delegated by a supervising physician.
Staff can only give a patient a sample at the direction a physician once
they have validated the accuracy of the medication and its use directions. This
must occur each time samples are provided to a patient.
Drugs may only be issued to the patient or
the patient’s legal representative.
Drug samples or other medications issued to patients
must be labeled with the patient’s name, prescriber’s name, date, name of
medication, strength, and directions and cautionary statements, if required by
law (A medication patient education sheet may be substituted for the cautionary
statements).
Prior to issuing the drug to the patient, the
expiration date is checked to insure that expired medications are not given to
patients.
Sample drugs must be provided free of charge
to patients.
Each drug sample removed from inventory is
logged-out on the Drug Sample Inventory Log.
Unless otherwise delegated by the practice director, the person removing
the drug must complete all fields on the inventory log. See the Records
& Documentation Requirements section above for log completion and maintenance
instructions.
RECALLS
AFFECTING DRUG SAMPLES
In
the event of a sample drug recall, all patients listed on the log as receiving
a drug from the affected lot number or for a period of 6 months prior to the
recall shall be called to discover if they have any samples remaining. When
applicable, the patient shall be instructed to refrain from taking the drug and
to return their supply to the clinic at their earliest convenience.
Arrangements for additional supplies of drug shall be made if needed.
Any
expired drugs or recalled medications are to be taken to the out-patient
pharmacy or the inpatient pharmacy for proper disposal according to Pharmacy policy 6:08 Returned Goods.
MONITORING COMPLIANCE
OF SAMPLE POLICY
The
clinic will assign one individual to monitor the distribution of the samples
and to insure the policy is followed.
All
clinic stocking samples will be monitored on a routine basis by the OP QA nurse
and/or by pharmacy.
The
OP QA nurse and/or pharmacy will inspect for compliance of the following
items: documentation, labeling of
medications, security of medications, and expiration dates.
Each
clinic will have 10 sample drugs audited each month by the practice director or
designee during their Medication Quality Assurance Checklist.
If
the clinic fails the inspection, the practice director, clinic manager,
Director of Pharmacy and Associate Hospital Director for Ambulatory Services
will be notified immediately. The clinic
will be inspected again within one month, if the clinic still does not comply
with the policy samples will pulled from that clinic.
Samples in the
Outpatient Pharmacy
A
physician may sign for samples which can then be sent to outpatient pharmacy
for management.
A
physician may write on a patient’s prescription, please fill with sample if
available. The Outpatient fill will the prescription with samples if they are
available.
The
Pharmacy will not maintain a list of samples nor keep samples for an individual
provider.
Pharmacy
reserves the right to refuse samples.
All
appropriate Department of Pharmacy Policies and Procedures, and Arkansas Board
of Pharmacy regulations will be applied to the dispensing of sample medication
from the Outpatient Pharmacy