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Barcode Packaging of Medications using the Robot and Bulk Packager (4.2)

Barcode Packaging of Medications using the Robot and Bulk Packager (4.2) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Central Unit Dose (CUD)

4.2

POLICY & PROCEDURE





Effective Date:

February 2004
⌧Pharmacy Policy Manual
Chapter: Central Unit Dose (CUD)
Operations Procedure Manual
Chapter:

Policy: 4.2

Original
⌧ Revision 9/10
Page 1
of 6
Title: Barcode Packaging of Medications
using the Robot and Bulk Packager


I. PURPOSE: To outline proper procedures for packaging medications using the Robot
Packaging Machine.

II. POLICY: All pharmacy personnel working in packaging work areas will have appropriate
knowledge and skill to execute operation of automated packaging equipment and prepare
medications using established quality assurance procedures.

III. FORMS:
A. Barcode Packaging Report – Appendix 4.2a
B. Daily Packaging Report – Appendix 4.2b

IV. PROCEDURE:
A. Prepare the medication for packaging.
1. The Inventory Control technician will bring complete boxes of medication to the
packaging area.
2. Do not use single doses from the manual stock area. This must be avoided
because mistakes that are made putting returns away could potentially carry over
to packaging errors (i.e.: mislabeling).
3. Detach the medication into the desired number of individual units to be packaged.
4. Individual units may mean tearing into single units, two tablets per unit, or
whatever is appropriate for the given dose.
5. Refer to the “Daily Packaging Report” to prepare packaging machine for the
packaging process.

B. Prepare the packaging machine.
1. The print head and roll bars on the machine must be cleaned. Teflon strip must
be changed at the beginning of each shift.
2. Turn on the packaging machine.

C. Robot Packaging Machine adjustment.
1. Check the last operator’s “Work Notes” to learn about possible problems
encountered and to learn about changes done to overcome these problems.
2. Set the sealing time potentiometer to the value between 0.8-1.0 on the 0-10
scale range depending on your most comfortable and effective working speed
(the recommended value is 1.0). If you change the value write it down in your
work notes and explain the reasons.


POLICY & PROCEDURE





Effective Date:

February 2004
⌧Pharmacy Policy Manual
Chapter: Central Unit Dose (CUD)
Operations Procedure Manual
Chapter:

Policy: 4.2

Original
⌧ Revision 9/10
Page 2
of 6
Title: Barcode Packaging of Medications
using the Robot and Bulk Packager

3. Set the air pulse duration potentiometer to 0.1 on the 0-10 scale range. If you
change the value write it down in your work notes and explain the reasons.
4. If for any reason while you are working the bags are not sealed correctly,
change the value in 3.2 until the bags are sealed properly. A lower sealing time
is desired when bags are getting burned and higher value when they do not seal
properly.
5. If for any reason while you are working the bags are not opening properly,
change the value in 3.4 until the bags open correctly. A higher air pulse
duration is desired when bags are not opening correctly and lower value when
the air pushes the medication out of the bag.
6. Adjust the packaging machine for the appropriate bag size and for the position
and print of the barcode label on the package.

D. Product Computer Setup.
1. Select “Packaging” from the computer menu.
2. Type the NDC number of the drug to be packed. Always use the NDC number
that is on the individual package, if the individual package does not have an
NDC number, use the one that is on the box.
3. Type the correct manufacturer information.
a. Manufacturer name is the name imprinted on the drug to be packaged.
Enter the name by typing it in or by selecting it from the pull-down
menu.
b. Manufacturer lot number is the lot number on the drug to be packaged.
4. Type the correct repackaging lot number.
a. Lot number is the date packaged in the following format (YY/MM/DD-
Line item from packaging sheet).
Example: Lot number of March 27, 2002-Line # 1 = 020327-01.
5. Type the correct expiration date (month/year) for the product.
a. If the day of the month that the product expires equals the last day of the
listed month, then use the listed month and year.
b. If the day of the month that the product expires does not equal the last
day of the month, then click on the Expiration Date Format Change Box
and enter in the full month/day/year expiration date.

E. Packager Pre-packaging Quality Assurance Check – This QA check is designed to ensure
that the packaging tech follows correct procedures before packaging medication.
1. Ensure that the correct bag size is being used

POLICY & PROCEDURE





Effective Date:

February 2004
⌧Pharmacy Policy Manual
Chapter: Central Unit Dose (CUD)
Operations Procedure Manual
Chapter:

Policy: 4.2

Original
⌧ Revision 9/10
Page 3
of 6
Title: Barcode Packaging of Medications
using the Robot and Bulk Packager

2. Clear old labels from the packager by hitting the foot pedal until a bag appears with
the correct drug information.
3. Verify the package label by inspecting the medication bag to make sure:
a. Alignment of label on bag is correct.
b. Label is correct and legible.
c. Barcode is of good quality.
4. Attach the first repackaged dose to a bin that will contain all repackaged doses.
5. Record the name of the drug in the medication description column of the robot
packaging report
6. Record the actual quantity that will be packaged in the actual amount column of the
“Barcode Packaging Report”.
7. Record the manufacturer and lot number of the medication packaged in the “MFG
Lot #” column of the “Barcode Packaging Report”.
8. Record CUD packaging technician initials in the PKG Tech column of the
“Barcode Packaging Report”.
9. Take the item to be packaged (this includes ALL the drug and any related
packaging such as cardboard boxes), the first dose repackaged bag, and the robot
packaging report to a “Certified QA Technician” for completion of the QA check.

F. Quality Assurance (QA) Check -- The QA check is designed to ensure that the
repackaging process is being done accurately.
1. A technician certified to perform packaging quality assurance must do this
mandatory check.
2. A list of technicians who are certified to check will be posted in the packaging
area.
a. Technicians who do not appear on this list are not allowed to complete this
check.
b. In the absence of a technician who is certified, a pharmacist may complete
the QA check.
3. The following Q.A. steps must be completed as part of this check.
a. Review the robot package and verify that the following information is
correct, and that the text and bar code are of high readability.
i. Drug Name, Dose, and Dosage Form.
ii. Lot Number.
iii. Expiration Date.
iv. NDC number
v. All drug that is to be packaged matches the label of the robot bag.

POLICY & PROCEDURE





Effective Date:

February 2004
⌧Pharmacy Policy Manual
Chapter: Central Unit Dose (CUD)
Operations Procedure Manual
Chapter:

Policy: 4.2

Original
⌧ Revision 9/10
Page 4
of 6
Title: Barcode Packaging of Medications
using the Robot and Bulk Packager

vi. Verify that no other drug is on the top shelf of the robot packaging
cart.
4. Physically inspect packaging machine to verify that next bag is correct.
a. For the Robot Packager look at next bag on machine for verification.
b. For the Bulk Packager and/or Red Barron the Packaging Technician must
advance a package to be inspected in the presence of the Q.A. Technician.
5. Technicians will be certified upon completion of training with the area supervisor
and successful completion of a quality assurance competency assessment. Those
staff members that have completed this certification will be included on a list
posted in the packaging area.

G. Robot Packager will package medications using the robot packager
1. Hit the bag count button to make the count is zero before beginning packaging
(hit bag count button then hit zero then hit reset and hit enter to make the count
zero)
2. Place the medication product in the bag and then press the foot pedal to seal the
bag. Be careful to never put your hands between the bag sealer and the bag.
This area is very hot and there is danger of burning.
3. If bag does not open you must first take foot off the pedal and then open the bag
by hand.
4. If medication does not fall inside the bag, pick up medication immediately and
place it again.
5. If after pressing the foot pedal the bag is not sealed correctly refer to procedure
6. If the bag is not opened or the meditation is being pushed out of the bag after
the air pulse report the problem to McKesson Help Desk (1-800-700-8737).
7. When finished packaging, the counter should match the number of medications
to be packaged.
a. If the counter reaches the number of medications to be packaged and
there are medications left to be packaged, then there are empty bags in
the system.
i. Count the medications you have left to package. This is the
amount of empty bags in the bin.
ii. Sort through the bin to locate the number of empty bags.
b. If the number on the counter is smaller than the number of medications
to be packaged, and there are no medications left to be packaged, this
means that there are wrong doses in some bags.
i. Sort through the bin to find these bags. Repackage the doses.

POLICY & PROCEDURE





Effective Date:

February 2004
⌧Pharmacy Policy Manual
Chapter: Central Unit Dose (CUD)
Operations Procedure Manual
Chapter:

Policy: 4.2

Original
⌧ Revision 9/10
Page 5
of 6
Title: Barcode Packaging of Medications
using the Robot and Bulk Packager

c. If the machine prints bad bar code labels, do not fill those bags.
Immediately remove the bags from the bin and discard.
d. Hit the enter key or click on “Package Next Drug”. When the computer
asks for confirmation of the Qty Packaged click on YES to confirm the
quantity or NO to re-enter the amount.
e. To complete packaging operation, remove excess plastic tailings from
all doses.

H. Pharmacist check of repackaging.
1. Check the first dose packaged to ensure label and medication are correct.
2. Verify that Drug Name, Dose, and Dosage Form, Lot Number, Exp Date, and
NDC number is correct on package compared with all packaging materials
provided (all drug boxes, bottles and materials used must be provided by
packaging technician).
3. Verify that QA check is completed by “Certified QA technician.”
4. Randomly inspect approximately 10% of medications looking for double drugs,
missing drugs, wrong doses, or other random errors.
5. Record pharmacist initials in the “RPh” column of the “Barcode Packaging
Report”.

I. Complete “Barcode Packaging Report” at the end of the shift.
J. Robot Packaging Machine Maintenance schedule
1. Every shift
a. Clean machine
i. Print head
ii. Roll bars
iii. Sealer area
b. Change forward Teflon Strip on the sealer at the beginning of each shift.
This is the strip on the moving bar closer to the operator.
c. Turn the Teflon sheet to a clean surface as needed. Contact McKesson if
the Teflon sheet needs to be changed.
d. Oil machine: air cylinder rods.

2. McKesson will perform routine maintenance
a. During a scheduled maintenance visit the McKesson Engineer should check
the following:
b. Complete machine operation.
c. Air system.

POLICY & PROCEDURE





Effective Date:

February 2004
⌧Pharmacy Policy Manual
Chapter: Central Unit Dose (CUD)
Operations Procedure Manual
Chapter:

Policy: 4.2

Original
⌧ Revision 9/10
Page 6
of 6
Title: Barcode Packaging of Medications
using the Robot and Bulk Packager

d. Bag sealer (temperature and time control).
e. Printing system.
f. Oil internal mechanisms.
g. Other preventive maintenance as needed.

V. REFERENCES AND RELATED POLICIES, PROCEDURES – None

VI. COORDINATION:
a. AUTHORED BY: Brad Ludwig
b. REVIEWED BY: Steve Rough
c. COMMITTEE APPROVAL BY: PPIRC



Approved By: ____________________________
Director of Pharmacy Services

Date: ________________