From: Michael E. Coughlin, President and CEO, ScriptPro
Date: July 26, 2002
Re: Food and Drug Administration (FDA), HHS, Public Meeting
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Barcode Label Requirements for Human Drug
Products
July 26,
2002, from 9 a.m. to 5 p.m.
Natcher Auditorium, Building 45
National Institutes of Health, Bethesda,
MD
RECOMMENDATIONS
FOR THE DEVELOPMENT OF A REGULATION ON BARCODE LABELING FOR
HUMAN DRUG PRODUCTS, INCLUDING BIOLOGIC PRODUCTS
APPENDIX
A - PRESCRIPTION DISPENSING PROCESS
1. Most prescriptions
are filled using countable tablets and capsules. In robotic
dispensing of countable tablets and capsules, they are poured
into the robot’s dispensing cell and then automatically counted
out into prescription vials by the robot as needed.
a. When refilling
the dispensing cell, the barcode on the drug product (stock
bottle) is scanned and matched to the barcode on the cell. A picture of the tablet or capsule is displayed for further
verification.
Scanning Stock
Bottle, SP 200
Scanning Cell,
SP 200
Drug Pill Information,
SP 200
Drug Stock Information,
SP 200
Pouring Pills
into Cell, SP 200
b. Prescriptions
are then transmitted to the robot and queued for dispensing.
Pending Script
Queue, SP 200
c. The robot verifies
the barcode on the dispensing cell before it counts out the
drug.
Robot Scanning
Cell Before Dispensing, SP 200
d. Then the robot
counts the tablets or capsules into the vial.
Counting Pills
Into Vial, SP 200
e. Next the robot
prints and applies the prescription label. The label contains
a barcode, a picture of the drug, descriptive information regarding
the drug and auxiliary labels.
Label, SP 200
Label Being
Applied, SP 200
f. The operator
scans the label barcode and the system displays an image of
the drug for final verification by a pharmacist.
Operator Scanning
Vial, SP 200
Verification
Display, SP 200
There are more
than 2,000 systems of this type in use today. Pharmacists using
these systems have claimed that it is almost impossible to dispense
the wrong drug or strength, or attach the wrong label.
“I could tell immediately
that with the barcode technology, the SP 200 would improve
our error rate. The time-saving features of the ScriptPro system
are evident as well.”
--Danny Cottrel
President, Brewton Medical Center Pharmacy,
Brewton, AL
With barcode scanning,
the SP 200 is virtually foolproof. It is extremely accurate
on making sure the patient gets the right drug.”
--Dan Brown
Director of Pharmacy, San Joaquin General
Hospital, French Camp, CA
2. Prescriptions
that are not filled using countable tablets and capsules are
typically filled using prepackaged items such as inhalers, birth
control packs, etc. These are often called "unit-of-use
medications" or "patient packs." In robotic
dispensing of patient packs, they are presented to the robot
and automatically stored. They are then picked by the robot
for dispensing as needed.
a. When presenting
a patient pack to the robot for storage, the barcode on the
drug product (patient pack) is scanned. This identifies the
drug to the robot so that it can be stored and tracked automatically.
Scanning Patient
Pack for Input, SPUD
Placing Patient
Pack on Conveyor, SPUD
b. Prescriptions
are then transmitted to the robot and queued for dispensing.
Pending Script
Queue, SPUD
c. The robot then
picks the patient pack for dispensing.
Patient Pack
Being Picked from Conveyor, SPUD
Patient Pack
on Outfeed Conveyor, SPUD
d. The operator
then scans the barcode on the patient pack, again verifying
its identification.
Patient Pack
Being Scanned for Labeling, SPUD
e. Next the robot
prints the prescription label and presents it to the operator
for application to the patient pack. The label contains a bar
code identifying the drug, a picture of the drug, descriptive
information regarding the drug and auxiliary labels.
Label, SPUD
Label Presented
for Peeling, SPUD
Label Being
Applied, SPUD
f. The operator
scans the label barcode and the system displays an image of
the drug for final verification by a pharmacist.
Operator Scanning
Label & Verification Display, SPUD
The robotic systems
described above support efficient and accurate dispensing of
most prescription drugs. There are also systems that support
the manual dispensing of prescriptions. These systems use the
barcode labels on drug products as well to prevent basic dispensing
errors.
3. For manual dispensing,
the prescriptions are queued on the screen at a prescription
filling station. The operator uses the station to manually
fill and label the prescriptions.
a. The screen display
shows the operator which prescriptions are to be filled.
Pending Script
Queue, SP Station
b. The operator
fills a prescription by picking the required drug product and
scanning its barcode at the station. The filling is aborted
unless the barcode scan confirms that the correct drug product
has been selected.
Drug Product
Being Scanned for Labeling, SP Station
c. The station
then prints the prescription label and presents it to the operator
for application to the drug product. The label contains a bar
code, a picture of the drug, descriptive information regarding
the drug and auxiliary labels.
Label, SP Station
Label Presented
for Peeling, SP Station
Label Being
Applied, SP Station
d. The operator
scans the label barcode and the system displays an image of
the drug for final verification by a pharmacist.
Operator Scanning
Label, SP Station
Verification
Display, SP Station
There are other
dispensing errors that can occur:
·
Wrong
prescription in bag provided to patient.
·
Wrong
bag provided to patient.
·
Failure
to provide all prescriptions.
·
Failure
to provide counseling to patient.
Again, barcodes
are used to prevent errors:
1. When filling
the bag.
a. The station
prints a barcode label for the bag that is to be given to the
patient. This barcode is unique and associates all prescriptions
for the patient with the bag.
Bag Barcode
Label Printed, SP Station
Bag Barcode
Label Applied to Bag, SP Station
b. Barcodes on
prescription labels are then matched to the barcode on the
bag. The bag is not considered complete until all prescriptions
for the patient have been scanned and matched.
Prescription
Barcode Scanned, SP Station
Prescriptions
Into Bag, SP Station
2. When providing
the bag to the patient.
a. Patient presents
card (or other document) with identifying barcode.
Patient Presents
Card
b. Scan of patient
card prompts display of bag(s) to be provided.
Patient Card
Scanned, SP Checkpoint
Display of Bags
for Patient, SP Checkpoint
c. Bag labels
are scanned for match to patient.
Bag Barcode
Scanned, SP Checkpoint
d. Patient is prompted
to obtain counseling and sign for receipt of prescription via
electronic signature device.
Patient Prompted
for Counseling, Electronic Signature Device
Patient Counseling
Information, Electronic Signature Device
Patient Signature,
Electronic Signature Device
SP 200
