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Single Patient Controlled Substances Case Packs for the Operating Room (7.7)

Single Patient Controlled Substances Case Packs for the Operating Room (7.7) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Controlled Substances

7.7






Effective Date:

September 2002
Pharmacy Policy Manual
Chapter: Controlled Substances

Chapter

Policy #: 7.7

Original
 Revision 4-15

Page 1 of 8


Title: Single patient controlled substances
case packs for the operating room

I. Purpose: To establish a safe, reliable and uniform method of ordering, storing, dispensing,
returning, and wasting Drug Enforcement Agency (DEA) controlled substances (CS) in the
University of Wisconsin Hospitals and Clinics (UWHC) Inpatient Operating Room (OR),
Outpatient Surgery Center (OSC) and American Family Children’s Hospital Operating Room
(AFCH OR) and to ensure compliance with federal and state laws governing controlled
substances.

II. Policy: Controlled substances used in the OR, OSC, AFCH OR, and anesthesia blockrooms
are obtained by anesthesia staff from the pharmacy technician or by accessing a limited number
of CS in the night drawers. Documentation of use and waste of narcotics in the ORs are to be
completed by the anesthesia staff on the designated accountability form (UWH # 1280210).


III. Forms:
A. OR CS sign out sheet(UWH # 1280210).: triplicate form used to document dispensing,
administration, return, and waste of CS within the ORs
B. OR CS testing log : triplicate form used to document CS being sent to the clinical lab for
discrepancy testing
C. OR narcotic accountability form: form used by pharmacy technicians to document
location of all CS dispensed, returned, and wasted during their shift
D. OR daily narcotic packet checklist: form used by pharmacy technicians to ensure all CS
audits are completed each day
E. Pharmacy night drawer check sheet: form used by pharmacy technicians to account for
all night drawer CS

IV. Procedure:
A. CS Dispensing Systems
1. Anesthesia Providers (AP) request medications on triplicate CS sign out sheets
(indicating the number of each CS desired for that case)
2. The Pharmacy Technician (PT) fills the request by placing all medications in a plastic
bag, including a second bag to place subsequent waste syringes
a. The white copy of the triplicate form is used by pharmacy to track what was
issued for the case
b. The yellow and pink copies of the triplicate form are given to the AP for
documentation of use, return and waste of CS
c. Both PT and AP will verify the quantities of each item dispensed at the time of
issue and will sign the CS sign out sheet
3. Any additional CS needed during the case are obtained from the PT
a. This addition is documented by the PT on the white copy of the CS sign out sheet






Effective Date:

September 2002
Pharmacy Policy Manual
Chapter: Controlled Substances

Chapter

Policy #: 7.7

Original
 Revision 4-15

Page 2 of 8


Title: Single patient controlled substances
case packs for the operating room

b. The AP will indicate the quantity received & initial the additions on the
yellow/pink copies of the sign out sheet
4. As drugs are used during the case, the AP will record the appropriate information on
the pink/yellow copies of the sign out sheet including amount used, amount returned,
and amount to be wasted
a. The AP is required to reconcile the quantity documented on the sign out sheet as
administered with the documentation in Health Link before returning the CS to
the pharmacy
b. No routine wastage will be done by the AP in the OR - if a drug is wasted during
the case due to breakage or spillage, this waste will be documented on the waste
form in the area provided, and a licensed witness will cosign
5. After the case, all unused, unopened medications are returned to the OR medication
room with the pink copy of the sign out sheet
a. When PT is not present, medications are placed in a locked drop box in the OR
medication room
6. Medications requiring wasting will be labeled with drug name and concentration,
drawn up into a syringe and capped, placed in a second (provided) separate bag with
the yellow copy of sign out sheet, and dropped into the locked CS waste medication
box
B. Block medication box dispensing
1. The pharmacy department will supply a secure, single patient-block medication box
which will contain the commonly used CS and non-controlled medications for block
procedures
a. Four secure block medication boxes will be stocked in drawers for each
anesthesia block cart
b. The anesthesia block carts are located in the following places
i. Blockroom for both inpatient and OSC OR’s or may be relocated to the
respective recovery room locations (2 carts in each OR)
ii. AFCH OR pharmacy room
2. The AP will obtain a single patient block medication box from the block cart, with a
triplicate OR CS sign out sheet and a second plastic bag to place subsequent waste
syringes
a. The white copy is kept in the pharmacy to track what was issued for the block
medication box
b. The yellow/pink copies are kept by the AP for documentation of use, return and
waste of CS
c. The AP will verify the quantities of each CS item in the block medication box
when they obtain the box from the block cart and sign the “CS received by” blank
on the sign out sheet






Effective Date:

September 2002
Pharmacy Policy Manual
Chapter: Controlled Substances

Chapter

Policy #: 7.7

Original
 Revision 4-15

Page 3 of 8


Title: Single patient controlled substances
case packs for the operating room

3. Any additional CS needed during the case are obtained from the PT or the acudose
cabinet
a. This addition is documented by the PT on the white copy of the CS sign out sheet
(if received from the PT)
b. The AP will indicate the quantity received & initial the additions on the
yellow/pink copies of the sign out sheet
4. As CS medications are used for the patient case, the AP will record the appropriate
information on the yellow/pink copies of the sign out sheet including amount used,
amount returned, and amount to be wasted
a. The AP is required to reconcile the quantity documented on the sign out sheet as
administered with the documentation in Health Link before returning the CS to
the pharmacy
b. No routine wastage will be done by the AP in the OR - if a drug is wasted during
the case due to breakage or spillage, this waste will be documented on the waste
form in the area provided area provided, and a licensed witness will cosign.
5. After the case, all unused, unopened medications are returned to the OR pharmacy
room with the pink copy of the sign out sheet
a. Medications are placed in a locked drop box in the OR medication room
b. Medications requiring wasting will be labeled with drug name and concentration,
drawn up into a syringe and capped, placed in a second (provided) separate bag
with the yellow copy of sign out sheet, and dropped into the locked CS waste
medication box
C. Night drawer CS dispensing
1. During hours when there is no PT, an AP may obtain CS from the supplies located in
the night drawer
2. The charge nurse has access to the pharmaceutical room and a segregated CS drawer
inventory including pre-filled packs, with standard items and will fill the request for
cases
3. The AP will obtain the CS medications and sign out sheet from the charge nurse in a
plastic bag, including a second bag to place subsequent waste syringes
a. The CS sign out sheet is signed by the charge nurse with the white copy left in the
drawer and is used by pharmacy to track what was issued for the case
b. The yellow/pink copies are kept by the AP for documentation of use, return and
waste of CS
c. The AP will verify the quantities of each item dispensed when they receive the CS
medications from the charge nurse
4. Any additional CS needed during the case are obtained from the charge nurse (extra
medications are located in another night drawer) and this addition is documented by
the charge nurse on the white copy of the CS sign out sheet in the night drawer






Effective Date:

September 2002
Pharmacy Policy Manual
Chapter: Controlled Substances

Chapter

Policy #: 7.7

Original
 Revision 4-15

Page 4 of 8


Title: Single patient controlled substances
case packs for the operating room

a. The AP will indicate the quantity received & initial the additions on the
yellow/pink copies of the sign out sheet
5. As drugs are used during the case, the AP will record the appropriate information on
the pink/yellow copies of the sign out sheet including amount used, amount returned,
and amount to be wasted
a. The AP is required to reconcile the quantity documented on the sign out sheet as
administered with the documentation in Health Link before returning the CS to
the pharmacy
b. No routine wastage will be done by the AP in the OR - if a drug is wasted during
the case due to breakage or spillage, this waste will be documented on the waste
form in the area provided, and a licensed witness will cosign.
6. After the case, all unused, unopened medications are returned to the OR pharmacy
room with the pink copy of the sign out sheet
a. Medications are placed in a locked drop box in the OR medication room
7. Medications requiring wasting will be labeled with drug name and concentration,
drawn up into a syringe and capped, placed in a second (provided) separate bag with
the yellow copy of sign out sheet, and dropped into the locked CS waste medication
box
D. Destruction of CS waste from the OR
1. At all times during the waste review and destruction process, at least two individuals
will be present with the waste from the time of collection to the time of final
destruction
2. Keys for the waste medication boxes in the OR medication rooms will be kept locked
in the Key Watcher system when not in use and signed out of the system when
picked up, and signed back in to Key Watcher when returned
3. The central pharmacist, with a central pharmacy technician as witness, will remove
the CS waste daily from the locked waste medication boxes in the medication rooms
for verification and destruction of waste
4. A central pharmacist will compare the returned waste with corresponding waste
documentation to validate accuracy of waste documentation
a. For situations where the contents of the bag to be wasted do not match the yellow
copy of CS sign out sheet, the pharmacist will complete the following:
i. Note on the CS sign out sheet what was actually wasted and sign
ii. Write a discrepancy report noting the patient name and MR# with description
of the issues (wrong dose, wrong drug, incomplete documentation, etc.)
iii. Photocopy the CS sign out sheet and attach to discrepancy report
iv. Provide discrepancy form to PT in ORs for identification of the AP involved
and documentation on the discrepancy report
v. PT will return the report to the designated pharmacy manager






Effective Date:

September 2002
Pharmacy Policy Manual
Chapter: Controlled Substances

Chapter

Policy #: 7.7

Original
 Revision 4-15

Page 5 of 8


Title: Single patient controlled substances
case packs for the operating room

vi. The pharmacy manager will forward a copy of discrepancy report to the
director of perioperative services (or designee) and the OR pharmacist for
follow up with staff involved
5. After reconciliation of the contents of the bag with the CS sign out sheet has been
completed, the central pharmacist will waste the medication in the presence of
another licensed pharmacist and both will initial the yellow copy of the CS sign out
sheet
6. The yellow copies will then be returned to the appropriate PT
E. Reconciliation of used, returned and wasted CS
1. The PT will match each yellow copy to the original white and pink completed CS
sign out sheets and staple the forms together
a. If one of the copies (yellow or pink) of the CS sign out sheet is missing, the PT
will review the situation with the AP and central pharmacist to find the missing
form
b. If after discussion with both the AP and pharmacist the form is still missing a
discrepancy report must be completed and individuals involved are listed on the
report
2. The PT will reconcile the white, pink and yellow copies of the CS sign out sheet
ensuring that there is a complete accounting of the CS issued to the AP
a. The amount received by AP must equal the sum of the amount administered,
returned, and wasted
3. For situations where accounting is incomplete, the PT will review the documentation
on CS sign out sheet with the AP to determine the cause of the discrepancy and
correct any errors
a. If after review by the PT and AP, the accounting for CS remains incomplete a
discrepancy report must be completed and individuals involved listed on the
report
b. A copy of the discrepancy report will be forwarded to the AP involved, the
director of perioperative services, and the pharmacy manager
F. Sampling of CS waste
1. The OR pharmacist will select random syringes from the locked waste box for
sampling of syringe contents (both drug and concentration) by the UWHC clinical
laboratory
a. The sample will be labeled with a Bar Tender label
i. Labels are generated by the OR Pharmacist
ii. Labels have title “OR Waste Sample” and a unique tracking #
b. The following information will be recorded onto the corresponding triplicate OR
CS testing log form by the pharmacist:
i. Unique tracking #






Effective Date:

September 2002
Pharmacy Policy Manual
Chapter: Controlled Substances

Chapter

Policy #: 7.7

Original
 Revision 4-15

Page 6 of 8


Title: Single patient controlled substances
case packs for the operating room

ii. Date
iii. Medical record number
iv. Anesthesia provider
v. Faculty member
vi. Drug and concentration
vii. Volume submitted to UWHC Clinical lab
viii. Initials of pharmacist submitting sample
2. The date and notation “sent for testing” will be recorded on the yellow copy of the CS
sign out sheet in addition to the initials of the pharmacist who sent the product for
testing
3. The log and samples will be conveyed to the clinical laboratory by the OR pharmacist
a. The OR pharmacist should call the toxicology lab (263-7029) before taking
samples to lab to ensure the appropriate staff are available to take the samples
b. If one of the appropriate individuals is available to take samples, they should be
taken to the main toxicology lab (C5/230)
c. Staff will ask pharmacist to go with them to room D4/245 where the samples are
locked up
4. The Clinical Laboratory personnel receiving the samples will initial the log form
(acknowledging receipt of each of the samples)
a. The white copy of the log form will be forwarded to the narc station in pharmacy
by the OR pharmacist
b. The pink/yellow copies will be left with the clinical lab
5. The samples will be secured in a double locked area in the clinical lab before and
after testing (a locked box in a locked cabinet)
6. Results for which the assayed amount of drug is not consistent with waste
documentation will be automatically repeated and confirmed by clinical laboratory
personnel before initial reporting
7. Test results will be recorded on the OR CS testing log by the clinical laboratory
personnel using the unique control # as identifier
8. Unused sample drug will be returned from the clinical laboratory to the OR
pharmacist and documented on the OR CS testing log
a. Clinical lab staff will initial “returned to pharmacy” box on yellow/pink duplicate
forms
b. The pharmacist will initial “returned to pharmacy” box on yellow/pink duplicate
forms
c. Clinical lab will keep pink copy
9. The remaining sample will then be wasted by two licensed pharmacists with
documentation of waste recorded on the yellow copy of the OR CS testing log and
forwarded to the narcotic control coordinator






Effective Date:

September 2002
Pharmacy Policy Manual
Chapter: Controlled Substances

Chapter

Policy #: 7.7

Original
 Revision 4-15

Page 7 of 8


Title: Single patient controlled substances
case packs for the operating room

a. The narcotic control coordinator will match white copy to yellow copy and
investigate missing yellow copies as needed
10. Results of laboratory analysis will be reviewed by the narcotic control coordinator
and relayed to the director of perioperative services and pharmacy manager when
analysis reveals unexpected results
G. Storage and replenishment of CS medications in the OR medication rooms
1. CS inventory will be maintained in locked drawers in the OR medication rooms
2. Standard quantities of CS medications will be kept in the locked drawers
3. CS medications will be ordered from the narc station technician daily and the
amounts replenished will be documented on the OR narcotic accountability form
4. Amounts restocked to OR medications rooms will be audited by AM and PM OR
technicians and the narc station technician for accuracy
H. Daily accountability audits
1. Two pharmacy technicians (the AM OR and PM OR technician) will complete the
OR accountability form and inventory count and review of the CS sign out sheets to
verify authenticity of transactions completed by previous shift
2. Details of audits are documented on the daily narcotic packet checklist
3. The narc station technician will verify that audits were completed and that
documentation matches issue documentation from narc station
I. Rules for CS waste
1. Each drug returned as waste must have drug name and concentration on the syringe
a. If drugs are diluted AP must indicate new concentration
2. The contents of each drug must be drawn into a syringe and capped
a. AP must verify amount wasted matches amount documented on CS sign out sheet
3. Amount to be wasted must be documented using the units listed on the CS sign out
sheet
4. All needles must be removed from syringes
5. Waste documentation will be recorded in appropriate section of CS sign out sheet
6. The AP returning the waste will record name and pager number in appropriate section
of the CS sign out sheet
J. Charging
1. Pharmacy personnel run Health Link OR charging reports each day
2. The reports identify patients that had an OR procedure on the previous calendar day
3. Pharmacy personnel selects each patient from the report and reviews both the
anesthesia medication report and the OR medications report
4. Pharmacy personnel bulk charge, in Health Link, the total dose of each medication
documented on the reports according to the OR medication charging procedures








Effective Date:

September 2002
Pharmacy Policy Manual
Chapter: Controlled Substances

Chapter

Policy #: 7.7

Original
 Revision 4-15

Page 8 of 8


Title: Single patient controlled substances
case packs for the operating room

V. REFERENCES AND RELATED POLICIES, PROCEDURES: none

VI. COORDINATION:
A. AUTHORED BY: OR pharmacy manager
B. REVIEWED BY: Pharmacy manager of business operations
C. COMMITTEE APPROVAL BY: UWHC Pharmacy Operations Committee

Approved By:
__________________________________________
Director of Pharmacy Services

Date:
____________________