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Narcotic Control in Sterile Products Area (7.15)

Narcotic Control in Sterile Products Area (7.15) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Controlled Substances

7.15






Effective Date:

March 2010

Chapter: Controlled
Substances

Chapter:

Policy #: 7.15

Original
 Revision 12/14

Page 1
of 6

Title: Narcotic Control in Sterile Products
Areas

I. PURPOSE: To establish a safe, reliable method of ordering, storing, dispensing, returning,
and wasting of Drug Enforcement Agency (DEA) controlled substance medications in the
University of Wisconsin Hospitals and Clinics (UWHC) Sterile Products Areas (SPA)
located in both the main inpatient pharmacy and the AFCH inpatient pharmacy. To be
compliant with federal and state laws governing controlled substances. To describe systems
in place for identifying and preventing possible controlled substance diversion.

II. POLICY:
A. All DEA controlled substance medications (CS) will be kept locked with accountability
records maintained for each CS documenting all transactions including two signatures for
each addition and subtraction from inventory.
B. The key to the locked CS medications will be held by the pharmacist at all times or a badge
reader will limit access to the pharmacist or an AFCH pharmacy technician on the night
shift.
C. Shift Counts will be completed at the start of each shift by the pharmacist and a discrepancy
report will be completed for any missing or surplus medications (see P&P 7.4 Controlled
Substance Discrepancy Reporting).

III. FORMS
A. SPA Narcotic Accountability Record
B. SPA Returned CS Infusion Record

IV. PROCEDURE:
A. Ordering of CS Medications
1. The Pharmacist will request CS medications from the NarcStation Technician or sign
out medications from the NarcStation following appropriate procedure (see P&P 7.1
NarcStation Operations).
2. The Pharmacist will add the amount of CS medications received from the NarcStation
to the appropriate SPA Narcotic Accountability Record and initial the entry.
3. The Pharmacist will lock the medications in the CS cabinet for secure storage.
4. A second staff member will initial the SPA Narcotic Accountability Record verifying
that the amount of product removed from NarcStation matches the amount added to the
SPA Narcotic Accountability Record.
5. On the night shift an AFCH Pharmacy Technician may obtain drugs from the AFCH
NarcStation if a pharmacist is not available and medication is required and complete
steps 1-3 above.
a. The AFCH pharmacist will verify entries on the SPA Narcotic Accountability
Record and cosign the entry as outlined in step 4 above.







Effective Date:

March 2010

Chapter: Controlled
Substances

Chapter:

Policy #: 7.15

Original
 Revision 12/14

Page 2
of 6

Title: Narcotic Control in Sterile Products
Areas

B. Overfill
1. Some CS medications contain a volume greater than the stated volume on the dosage
form.
2. To account for the overfill, during the checking process the pharmacist will record an
entry on the SPA Narcotic Accountability Record stating “Correction for Overfill” and
the amount remaining may be adjusted to account for the overfill. This will always
result in extra medication being added to the records.
3. A second staff member will initial the SPA Narcotic Accountability Record verifying
that the overfill adjustment is valid.

C. Preparation of Patient Specific CS Infusions and Syringes (CS Infusions)
1. CS medications for preparation of CS Infusions will be signed out on the
appropriate SPA Narcotic Accountability Record by a SPA technician or
pharmacist.
a. The technician or pharmacist will record the date, patient name and
medical record number (MR#), patient location or unit, the complete bag
number (all digits), dose and volume required.
b. The amount of drug used will be subtracted from the previous inventory
balance to determine the current inventory of the ingredient which will be
recorded on the SPA Narcotic Accountability Record.
2. The pharmacist will issue the appropriate amount of CS medications from the SPA
inventory to the technician to prepare the CS infusion.
a. On the night shift when a pharmacist is not available, an AFCH pharmacy
technician may obtain drugs from the AFCH SPA inventory.
3. The technician will then prepare the item using the CS medication from the SPA
inventory.
a. After product preparation is completed, the Patient Specific CS Infusion
and CS medication container (including any remaining CS medication) is
provided to the pharmacist during the checking process.
b. A second staff member will initial the entry on the SPA Narcotic
Accoujntability Record verifying that information recorded is accurate.
4. After the product is checked, the pharmacist will return any remaining CS product
to the locked storage area and completes the following:
a. Verify that the entry on the log form matches the product checked
(patient name, drug, dose, volume used).
b. Verify the calculation of the remaining volume of the CS medication on
the SPA Narcotic Accountability Record .
c. Verify that the physical quantity remaining in the locked storage cabinet is
what is listed on SPA Narcotic Accountability Record and sign his/her






Effective Date:

March 2010

Chapter: Controlled
Substances

Chapter:

Policy #: 7.15

Original
 Revision 12/14

Page 3
of 6

Title: Narcotic Control in Sterile Products
Areas

initials verifying that the remaining quantity and log entry is correct for the
product prepared.
1. A discrepancy report will be completed for any missing or surplus
medications (excluding overfill) (see P&P 7.4 Controlled Substance
Discrepancy Reporting).
5. The CS infusion will then be locked in the narcotic cabinet or kept under constant
supervision until picked up by an authorized individual.
a. Alternatively, the product may be given to a pharmacy technician for
immediate secure transaction tubing (see P&P 3.34 Delivery of
Medications via Pneumatic Tube System).
6. When the product is picked up, the following information will be recorded on the
SPA Narcotic Accountability Record.
a. Last name and employee badge number of the individual who picked up
the CS infusion legibly recorded.
b. For CS infusions sent via pneumatic tube, the sending technicians name
and badge number must also be legibly recorded
c. The pharmacist must verify that this documentation is completed correctly
after the transactions are completed. If missing elements are noted by the
pharmacist, he/she will work with the technicians involved to ensure
documentation is completed.
7. The person who picks up the drip or receives via secure tube is responsible for
signing narcotic sterile product in to the Acudose cabinet or other manual system for
narcotic accountability.
a. The addition of the CS infusion to the AcuDose cabinet will be double
checked by the assigned pharmacy technician during the following days
narcotic audits.

D. Return of Patient Specific CS Infusions and Syringes (CS Infusions)
1. Upon termination of CS infusions, the pharmacy technician will expire the infusion
from the AcuDose cabinet and bring the infusion to the SPA.
2. The technician will record the following information on the SPA Returned CS Infusion
Record
a. Date, patient name, order number, unit location, the complete bag number (all
digits), drug and dose.
b. Technician’s initials.
3. The technician will give possession of the infusion to the pharmacist and verify that the
pharmacist initials the appropriate line of the SPA Returned CS Infusion Record.
a. The technician may not leave the drip with the SPA unless a pharmacist will take
possession of the drip and sign the SPA Returned CS Infusion Record.






Effective Date:

March 2010

Chapter: Controlled
Substances

Chapter:

Policy #: 7.15

Original
 Revision 12/14

Page 4
of 6

Title: Narcotic Control in Sterile Products
Areas


E. Re-use of Patient Specific CS Infusions and Syringes (CS Infusions)
1. Pharmacy Technician will review inventory of CS items that have been returned that
may be re-used.
2. If an item can be reused, the technician will obtain the CS infusion and record the
following information on the SPA Returned CS Infusion Record.
a. New patients name, order number and bag number, date reused, and unit of patient.
b. Technician’s initials.
3. The technician will then remove the label from the CS infusion and attach it to the
documentation label for the new CS infusion being prepared.
4. The Pharmacist will complete the following:
a. CS infusion re-used matches the order for the new CS infusion (appropriate drug,
dose, diluent) and the dating of the re-used CS infusion is acceptable.
b. Verifies that the information recorded by the technician on the SPA Returned CS
Infusion Record is accurate.
c. Initials the SPA Returned CS Infusion Record for the reuse of the CS infusion.
5. The CS infusion will then be locked in the narcotic cabinet with the narcotic inventory
until picked up by an authorized individual.
a. Alternatively, the product may be given to the triage technician for immediate
secure transaction tubing (see P&P 3.34 Delivery of Medications via Pneumatic
Tube System)
6. When the product is picked up, the following information will be recorded on SPA
Returned CS Infusion Record
a. Last name and employee badge number of the individual who picked up the CS
infusion legibly recorded.
b. For CS infusions sent via pneumatic tube, the sending technicians name and badge
number must also be legibly recorded
c. The pharmacist must verify that this documentation is completed correctly after the
transactions are completed. If missing elements are noted by the pharmacist, he/she
will work with the technicians involved to ensure documentation is completed.

F. CS Stock Preparation
1. CS medications for preparation of CS Stock Items will be signed out on the appropriate
SPA Narcotic Accountability Record by a SPA technician.
a. The technician will record the date, stock dose, lot number, and quantity being
prepared, and the volume of drug required to prepare the batch.
b. The amount of drug used will be subtracted from the previous inventory balance to
determine the current inventory of the ingredient which will be recorded on the SPA
Narcotic Accountability Record .






Effective Date:

March 2010

Chapter: Controlled
Substances

Chapter:

Policy #: 7.15

Original
 Revision 12/14

Page 5
of 6

Title: Narcotic Control in Sterile Products
Areas

c. The technician will initial the entry and then request the CS medications from the
Pharmacist.
2. After review of the entry, the pharmacist will issue the appropriate amount of CS
medications from the SPA inventory to the technician to prepare the CS Stock.
3. The technician will then prepare the stock items using the CS medication provided by
the pharmacist.
a. After product preparation is completed, products prepared and the CS medication
container (including any remaining CS medication) is provided to the pharmacist
during the checking process
4. After the products are checked, the pharmacist will return any remaining CS product to
the locked storage area and completes the following:
a. Verify that the entry on the log form matches the product checked (drug, dose, Lot
number and volume used).
b. Verify the calculation of the remaining volume of the CS medication on the SPA
Narcotic Accountability Record .
c. Verify that the physical quantity remaining in the locked storage cabinet is what is
listed on SPA Narcotic Accountability Record and sign his/her initials verifying that
the remaining quantity is correct.
i. A discrepancy report will be completed for any missing or surplus medications
(excluding overfill) (see P&P 7.4 Controlled Substance Discrepancy Reporting).
5. The preparation of CS stock items listed on the SPA Narcotic Accountability Record
will be double checked by the NarcStation Technician during the following days
narcotic audits and the technician will initial the entry to verify the accuracy of the
transaction.
a. Verification will include
i. Matching the number of items prepared with the amount of drug used and any
documentation of waste.
ii. Matching the quantity added to NarcStation or SPA Narcotic Accountability
Record
b. A discrepancy report will be completed for any missing or surplus medications
(excluding overfill) (see P&P 7.4 Controlled Substance Discrepancy Reporting).

G. Special Dilutions
1. From time to time, special dilutions may be required in the preparation of CS stock
medications.
2. Only enough special dilution product will be prepared to meet the need of the stock
preparation. Any remaining production will be wasted.

H. Waste documentation






Effective Date:

March 2010

Chapter: Controlled
Substances

Chapter:

Policy #: 7.15

Original
 Revision 12/14

Page 6
of 6

Title: Narcotic Control in Sterile Products
Areas

1. If during the preparation of CS products, medication is contaminated, a small residual
results, or in other ways some quantity of CS medication should be wasted the
following will be completed.
a. Documentation of waste may be completed on either the SPA Narcotic
Accountability Record or on the CS Stock production record.
b. All waste documentation must be witnessed by two licensed pharmacists with their
initials recorded where the waste is documented.
c. Large amounts of waste should be recorded on a discrepancy report (see P&P 7.4
Controlled Substance Discrepancy Reporting) in addition to documentation above.

I. Shift Counts
1. At the beginning of each shift the Pharmacist will verify the following:
a. The amount listed on each SPA Narcotic Accountability Record matches the amount
in the locked cabinet.
i. To document this verification, the pharmacist will record the date and time of
the audit, the amount on hand, and the pharmacist’s initials.
2. Verify that all returned CS infusions recorded on the on SPA Returned CS Infusion
Record which have not been re-used or wasted are present.
3. A discrepancy report will be completed for any missing or surplus medications
(excluding overfill) (see P&P 7.4 Controlled Substance Discrepancy Reporting).




Approved By____________________________
Director of Pharmacy

Date:____________