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Controlled Substance Control Systems in Patient Care Areas (6.1.13)

Controlled Substance Control Systems in Patient Care Areas (6.1.13) - Policies, Clinical, UW Health Clinical, Medications and Pharmacy

6.1.13


UW HEALTH CLINICAL POLICY 1
Policy Title: Controlled Substance Control Systems in Patient Care Areas
Policy Number: 6.1.13
Category: UW Health
Type: Ambulatory and Inpatient
Effective Date: October 20, 2017

I. PURPOSE

To establish a safe, reliable and uniform method of storing, supplying, dispensing, administering,
documenting, returning, and wasting controlled substance medications throughout all UW Health patient
care areas. 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 ELEMENTS

A. All use of Drug Enforcement Agency (DEA) scheduled controlled substances in patient cares areas will
follow the procedures outlined below.
B. UW Health will maintain adequate systems to minimize risk for diversion of DEA scheduled controlled
substances.
C. UW Health will have systems to detect diversion of DEA scheduled controlled substances in a timely
manner.
D. UW Health will have systems to ensure staff that dispense and administer DEA scheduled controlled
substances comply with all aspects of this procedure.
E. UW Health will ensure that staff who dispense and administer DEA scheduled controlled substances do so
in compliance with all state and federal laws and regulations.
F. UW Health will have training systems that ensure staff have a thorough understanding of policies and
procedures related to use of DEA scheduled controlled substances.
G. UW Health will have systems to investigate, resolve, and if necessary report any suspected diversion of
DEA scheduled controlled substances.

III. PROCEDURE

A. Storage of Controlled Substances.
i. Controlled substances will be maintained in Automated Dispensing Systems (ADS) on inpatient
units, the emergency department, pre-operative and post-operative care areas, as well as in some
clinics and procedural care areas. Anesthesia carts will be utilized at The American Center.
ii. Dedicated, locked storage cabinets are used to secure controlled substances in all other areas as
appropriate.
a. All storage cabinets will be reviewed and approved for use by the Department of
Pharmacy.
b. Access to room where cabinet is located should be locked with access to room limited to
only staff that perform necessary activities for the area including support activities.
c. Keys to locked cabinet will not be "hidden" in patient care area, but will be continuously in
the possession of area staff member authorized to administer controlled substances.
d. Combination or electronic locks may be used if access to cabinet is strictly controlled and
limited only to staff authorized to administer controlled substances.
iii. Some Schedule IV - V controlled substances may be distributed to inpatient areas in unit dose
medication drawers.
iv. A user should not put the controlled substance into their pocket or in any other unapproved and/or
unlocked storage location after dispensing (i.e. patient’s cassette drawers).
B. Restocking of Controlled Substances.
i. ADS Re-stock.
a. Cabinets are restocked once or twice daily to ensure appropriate levels are maintained.
High volume areas are restocked twice daily.
b. Cabinet restocking is completed by pharmacy staff using bar code scanning of delivered
item at the cabinet to ensure accurate stocking.
c. Accountability of restocking activity is maintained in the electronic ADS transactions
records.
d. A reconciliation is completed daily of items issued from pharmacy to cabinets with
restocking and follow up is completed when restocking discrepancies are discovered.



UW HEALTH CLINICAL POLICY 2
Policy Title: Controlled Substance Control Systems in Patient Care Areas
Policy Number: 6.1.13

ii. Operating Room Re-supply.
a. Operating Room inventories are re-supplied daily from central pharmacy inventory.
b. Where available, pharmacy operating room technician completes a double check of all
restocking from pharmacy.
iii. Manual Controlled Substance Re-supply.
a. Controlled substances for manual Controlled Substance inventories are re-supplied daily
by pharmacy staff.
b. Pharmacy staff additions to these inventories are recorded on the controlled substance log
form and co-signed by a designated clinic staff member.
c. A second pharmacy staff member double checks that issues to area are recorded on the
controlled substance log form and match the amount issued from pharmacy inventories.
C. Dispensing of Controlled Substances.
i. ADS Dispensing.
a. Dispensing of a controlled substance is performed using a secure log on with a unique
user ID and a secure password.
b. Activities that are performed under the log on ID are the responsibility of the individual that
has accessed that cabinet.
c. At no time should a user request another staff member to log on to the cabinet for him/her
or share their log on/password with anyone else.
d. If there is an issue with access, each unit has identified staff members that can perform
editing functions for users to give temporary access.
e. The user should verify the count of any Schedule II to Schedule V medication at the time
of dispensing and enter the correct count into the ADS.
f. Each dispense transaction should only be used for a single dose. Partial doses should not
be left in patient rooms, carried about, or stored in any location for multiple use to either
the same or a different patient (see section E for specific requirement for documentation of
waste). A controlled substance may be used for more than one administration during
procedures or acute situations where the individual who dispensed the medication
maintains possession of the medication, does not leave the patient, and the controlled
substance administration is intermittent during this specified period.
g. Controlled substances should be dispensed, and then promptly administered.
h. The user dispensing the controlled substance is responsible for its full accountability
through administration, waste and return documentation.
i. A user may not transfer possession of the controlled substance to another employee for
administration, waste or return except when it’s impossible for the administering
practitioner to dispense. Dispensing by another practitioner should not be used for
convenience.
ii. Operating Room and Procedure Area Dispensing.
a. Controlled substances used in the UW Health Operating rooms and procedure areas are
issued from secure inventories in the medication support areas.
b. A multiple-ply controlled substance accountability document is created with each dispense
of controlled substance medications outlining anesthesia staff member who received the
medications and quantities of each drug issued.
c. Accuracy of dispenses is verified by anesthesia staff at time receipt from inventory.
d. A copy of the multiple-ply form is kept in the medication support area as documentation of
what was issued to anesthesia staff.
iii. Manual Controlled Substance Dispensing.
a. Upon receiving an order for a controlled substance, the nurse shall write the following
information on the controlled substance log form for all dispenses
1. Patient name and medical record number (MR#).
2. Nurse's initials.
3. Number of doses used in the appropriate medication column.
b. Doses are removed from inventory and the resulting inventory count verified.
D. Return of Controlled Substances.
i. Only intact, undamaged and unopened controlled substances may be returned to inventory for use
by another patient (any damaged, partial, or opened controlled substance should be wasted as
outlined below).
ii. ADS Returns.



UW HEALTH CLINICAL POLICY 3
Policy Title: Controlled Substance Control Systems in Patient Care Areas
Policy Number: 6.1.13

a. Medications removed from automated dispensing cabinet which have not been
administered to the patient should be returned promptly (no more than 30 minutes after
the dispense) using the automated dispensing cabinet "RETURN" procedure.
iii. Operating Room Returns.
a. Medications issued for a case but not used should be returned to the operating room
medication support area or anesthesia cart.
b. The amount returned is documented on the multi-ply controlled substance accountability
document.
iv. Manual Controlled Substance Dispensing.
a. An entry onto the controlled substance log form will be made for all returns clearly
identifying any dispense entries subsequently returned.
E. Waste of Controlled Substances.
i. Any controlled substance not administered or returned should be promptly wasted (no more than
30 minutes after administration) and made non-recoverable.
a. For all controlled substances issued from an ADS, disposal should be completed using the
controlled substance waste management smart sink system.
b. For substances not issued from an ADS, and a controlled substance waste management
smart sink system is not readily available, the sink or sewer should be used to dispose of
the wasted product.
c. Controlled substances may only be wasted by individuals with legal authority to administer
or dispense controlled substances such as, but not limited to, a registered nurse,
pharmacist, or physician.
ii. All waste should be documented as witnessed by a second person who has legal authority to
administer or dispense controlled substances such as, but not limited to, a registered nurse,
pharmacist, or physician.
iii. ADS Waste Documentation.
a. In areas where ADS are used, waste should be documented using the ADS "Waste"
procedure (see section 5 of Pharmacy departmental policy #14.4, Automated Dispensing
Systems).
b. Documentation for waste of a controlled substance that was not dispensed from the ADS
on that unit should be documented in Health Link using the medication waste note type
with confirmation of note by witness.
iv. Non ADS Operating Room and Procedure Area Waste Documentation.
a. Medications issued for a case but not used during the case and not suitable for return
(partial doses, drawn up but not used, open items, etc.) will be placed in the OR Waste bin
in the medication support area along with a copy of the Controlled Substance
accountability form.
b. The amount wasted is documented on the multiple-ply controlled substance accountability
document.
c. A pharmacist will verify that items and quantities provided to be wasted match the items
and quantities listed on the multiple-ply controlled substance accountability document to
be wasted and discrepancies investigated and documented.
d. A pharmacist will waste the controlled substances and a second pharmacist will witness
the waste transactions with documentation of the destruction on controlled substance
accountability document.
e. For areas with anesthesia carts, clinicians should follow the process for ADS
documentation.
v. Clinic Waste Documentation.
a. Amount wasted due to defective, broken, contaminated syringes, or partially used doses
shall be documented by completing an entry on the Controlled Substance log form.
b. This entry shall be signed by the person wasting and co-signed by a witness
c. Additionally, a medication waste note may be entered into the electronic medical record as
supporting documentation.
vi. Unique Waste Requirements.
a. Procedure for wasting PCA, IV, and Epidural Infusions.
1. When the order is discontinued waste should be documented using the ADS
"Waste" procedure (see section 5 of Pharmacy departmental policy #14.4,
Automated Dispensing Systems).



UW HEALTH CLINICAL POLICY 4
Policy Title: Controlled Substance Control Systems in Patient Care Areas
Policy Number: 6.1.13

2. The volume wasted should be estimated as close as possible to the true amount
remaining and wasted, including excess tube volume.
b. Procedure for disposal of Controlled Substance Patches.
1. With gloves on, remove the patch from the patient.
2. After removal of the patch, the patch will be folded so the adhesive side of the
patch adheres to itself.
3. The patch will then be disposed in the controlled substance waste management
smart sink system or by flushing down the toilet if this system is not readily
available.
4. The destruction and disposal of the patch should be documented using the ADS
"Waste" procedure (see section 5 of Pharmacy departmental policy #14.4,
Automated Dispensing Systems).
5. Removal of the patch prior to or at the 72-hour limit will be witnessed,
documented, and disposed of as above.
6. When the dispense of the patch occurred on a unit other than the current patient
location, the patch removal will be witnessed and disposed of as above, and
documented in Health Link using the medication waste note type with
confirmation of note by witness.
7. If a patient is admitted wearing a patch, the patch removal will be witnessed,
documented, and disposed of as above, and documented in Health Link using
the medication waste note type with confirmation of note by witness.
8. If a deceased patient is wearing a patch, the patch will be removed and disposal
should be witnessed and documented prior to removal of the body from the
patient care unit. If it is determined to be a coroner's case (see UW Health clinical
policy #3.3.8, Disposition of the Body after Death), the patch should NOT be
removed.
9. If the gel from the drug reservoir accidentally contacts the skin, the area should
be washed with copious amounts of water. Do not use soap, alcohol, or other
solvents to remove the gel because they may enhance the drug's ability to
penetrate the skin.
F. Shift Counts.
i. End of shift counts will involve the comparison of actual amount of controlled substances on hand
with the perpetual inventory record. The intent is to assure counts are completed and accurate prior
to staff leaving duty.
ii. In addition to end of shift counts, inventory levels should be verified when performing dispensing
activities.
iii. End of shift counts for ADS .
a. End of shift counts will be required for ADS as determined by Nursing and Pharmacy
based upon workflows and the history of discrepancy activity in that area.
b. For areas that provide patient care services twenty four hours per day, end of shift counts
for should be completed minimally 2 times per day, approximately 12 hours apart, and
should be done at change of shift (before staff have left the unit after completing their
shift). If end of shift counts are done 3 times per day, these will be done approximately 8
hours apart, and should be done at change of shift (before staff have left the unit after
completing their shift).
c. For areas that do not provide patient care services twenty fours per day, (some procedure
areas and clinics) shift counts should be performed, at a minimum, at the beginning of the
shift on days the area is in operation.
d. Controlled Substance keys (epidural and PCA) should be a part of each end of shift
count. Discrepancies are to be handled the same as a Controlled Substance. Controlled
Substance keys (epidural and PCA) should be kept in ADS.
e. End of shift counts will be completed by two licensed practitioners using the ADS
"inventory" function.
iv. Shift counts for the operating room are completed by pharmacy staff multiple times during the shift
and are documented on the cart check off sheet.
v. End of shift counts in manual Controlled Substance areas are done at the end of each shift by
licensed practitioners and documented on the controlled substances log form.
vi. The form utilized for end of shift counts should include the date, time, and the signatures of the two



UW HEALTH CLINICAL POLICY 5
Policy Title: Controlled Substance Control Systems in Patient Care Areas
Policy Number: 6.1.13

licensed practitioners performing the count.
G. Discrepancy Documentation.
i. When ever inventory quantities do not match quantities in documentation systems (ADS counts or
manual logs), a discrepancy is created.
ii. ADS will prompt users to recount when an inventory quantity being entered does not match the
quantity expected.
iii. For manual systems, a discrepancy report (form #9039) should be completed for the following
circumstances (see Pharmacy departmental policy #7.4).
a. An item is missing or extra.
b. An established procedure has not been followed and documentation of the event is
desired.
c. Something suspicious has occurred concerning controlled substance distribution and
documentation of the event is desired.
H. Discrepancy Resolution.
i. ADS Discrepancies.
a. All discrepancies are investigated by the Nurse Manager or designee and resolved with a
witness as follows.
1. Review past transactions and identify root cause of discrepancy.
2. Enter discrepancy resolution in ADS cabinet that indicates the cause of the
discrepancy in accordance with the annual training received by the Internal
Auditor of Controlled Substance Control.
b. If it is suspected that pharmacy created the discrepancy because of a restocking error,
expiration activity, or other action, the nurse manager or designee will contact the
NarcStation Technician at 263-1275 or the Internal Auditor of Controlled Substance
Control at 265-0325.
1. If NarcStation Tech or the Internal Auditor of Controlled Substance Control can
verify that a pharmacy restocking error has occurred, they will resolve the
discrepancy.
2. If a restocking error did not occur, the NarcStation Tech or the Internal Auditor of
Controlled Substance Control will let nursing manager or designee know that it
was not a restock error.
c. Controlled Substance Internal Auditor of Controlled Substance Control reviews and
verifies all discrepancy resolutions daily and follows up with Nurse Managers as needed to
confirm appropriate resolutions are provided.
ii. Areas without ADS.
a. Individual who discovers discrepancy completes a discrepancy report (Form #9039).
b. Discrepancy report is forwarded to pharmacy.
c. Pharmacy staff investigate the discrepancy, review details and individuals involved, and
determine if further follow up is needed.
iii. For discrepancies for which diversion is suspected, the appropriate process should be
implemented.
I. Suspected Theft or Diversion.
i. Any staff member who suspects that a theft or diversion has occurred should report the
circumstances of the events to an appropriate manager for their area.
ii. The Manager will notify their director and implement the appropriate process when theft or
diversion is suspected.
J. Inadvertent possession.
i. Any staff member who inadvertently removes scheduled medication from inventories and takes
outside of UW Health should return the medication to UW Health immediately upon discovery and
report the circumstances to an appropriate manager of his/her area.
ii. The Manager will complete a discrepancy report and forward both report and medications to
pharmacy manager.
iii. Medication will not be used for care of patients and may be saved for follow up investigation if
necessary.
iv. Manager will work with Employee Relations to determine if an investigation is warranted and if
disciplinary action is appropriate.
K. Critical Care Transport Teams (MedFlight/CHETA)
i. Controlled substances previously dispensed to a patient by a referring provider may be controlled



UW HEALTH CLINICAL POLICY 6
Policy Title: Controlled Substance Control Systems in Patient Care Areas
Policy Number: 6.1.13

by the transport team during transport and documentation of acceptance, administration, and waste
will be clearly documented on appropriate accountability form.
L. Auditing and Surveillance.
i. On a regular basis, audits will be conducted and trended to verify compliance with this policy and to
monitor for and detect potential diversion.
M. Open, Damaged, or Suspicious Medication Packaging
i. All controlled substances damaged, opened or in some way altered from original packaging will be
documented on a discrepancy form and returned to the Central Pharmacy. These items should not
be wasted. A discrepancy form should be completed and may be returned to the central pharmacy
utilizing the automated dispensing system return bin process or at a designated secure pharmacy
location. The return bin process should only be used when the medication was originally dispensed
from the automated dispensing system
ii. The employee bringing the controlled substance to the Central Pharmacy should have the
pharmacy employee who takes possession of the controlled substance sign the discrepancy form
and should call the Internal Auditor of Controlled Substances at 265-0325 letting them know this
transaction has taken place.
iii. Pharmacy management will facilitate lab testing of the controlled substance to verify its contents.

IV. FORMS

Controlled Substance Discrepancy Report (# 9039)

V. COORDINATION

Author: Director, Pharmacy
Senior Management Sponsor: SVP/COO
Reviewers: VP/Chief Nursing Officer Inpatient, UW Health Legal Department
Manager, Clinical Staff Education
Approval committees: UW Health Clinical Policy Committee
UW Health Clinical Policy Committee Approval: October 16, 2017

UW Health is a cohesive, united and integrated academic medical enterprise comprised of several entities.
This policy applies to facilities and programs operated by the University of Wisconsin Hospitals and Clinics
and the University of Wisconsin Medical Foundation, Inc., and to clinical facilities and programs
administered by the University of Wisconsin School of Medicine and Public Health. Each entity is
responsible for enforcement of this policy in relation to the facilities and programs that it operates.

VI. APPROVAL

Peter Newcomer, MD
Chief Clinical Officer

J. Scott McMurray, MD
Chair, UW Health Clinical Policy Committee

VII. REFERENCES

Pharmacy departmental policy #7.4, Controlled Substance Discrepancy Reporting
Pharmacy departmental policy #7.6, Documentation of Controlled Substance Use in UWHC Clinics
Pharmacy departmental policy #7.7, Single Patient Controlled Substances Case Packs for the Operating
Room
Pharmacy departmental policy #14.4, AcuDose-Rx
Pharmacy departmental policy #15.6, Critical Care Case Pack Systems Supplied to Med Flight and CHETA
UW Health clinical policy #3.3.8, Disposition of the Body After Death
UWHC policy #8.17, Administration of Medications

VIII. REVIEW DETAILS




UW HEALTH CLINICAL POLICY 7
Policy Title: Controlled Substance Control Systems in Patient Care Areas
Policy Number: 6.1.13

Version: Revision
Last Full Review: October, 2020
Next Revision Due: October, 2020
Formerly Known as: UWHC #8.30, Controlled Substance Control Systems in Patient Care Areas