This document provides an overview of topics related to preparing narcotic compounded sterile preparations. It discusses the legal regulations for controlled substances, properties of narcotic CSPs, potential complications of parenteral therapy, storage and record keeping of controlled substances, guidelines for preparing patient-controlled analgesia, and USP Chapter <797> procedures. The objectives are to understand regulations and demonstrate proper technique for preparing narcotic CSPs.

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Chapter 11
Narcotic Preparations
2012 Paradigm Publishing

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Learning Objectives
 Gain an awareness of the history of narcotic medications.
 Understand the legal regulations and procedures that must be
followed when preparing various controlled substances for
parenteral administration.
 Identify the USP Chapter <797> procedures that must be
performed when preparing narcotic compounded sterile
preparations (CSPs).
 Demonstrate correct technique in the preparation of narcotic
CSPs.
2012 Paradigm Publishing

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Topics
 Learning Objectives
 Introduction
 Drug Schedules
 Properties of Narcotic CSPs
 Potential Complications of Parenteral Therapy
 Controlled Substance Storage
 Controlled Substance Record Keeping
 Patient-Controlled Analgesia
 USP Chapter <797> Guidelines for Controlled
Substance CSPs
 Understand the Resources and Supplies
 Preview the Lab Procedure
 Chapter Summary
2012 Paradigm Publishing
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Introduction
 The CSA classifies
controlled substances
according to their
potential for abuse and
addiction
most narcotic CSPs
prepared by IV
technicians are
comprised of a C–II
narcotic mixed with a
base solution
2012 Paradigm Publishing

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Drug Schedules
 The CSA organizes controlled
substances into five drug schedules
or classes based on their potential
for abuse and addiction
in addition to these federal
regulations enforced by the DEA, each
individual State Board of Pharmacy
provides guidelines and oversight
regarding the prescribing and
dispensing of controlled substances
2012 Paradigm Publishing

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Drug Schedules…/2
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Drug Schedules…/3
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Drug Schedules…/4
 Community or retail pharmacies often stock C–III
through C–V medications on the shelf along with
noncontrolled substance medications
in this type of environment, C–II controlled substances
must be tracked using a perpetual inventory system
 Most institutional or hospital pharmacies store all
classes of controlled substances under a double-lock
system
2012 Paradigm Publishing

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Properties of Narcotic CSPs
 The physical and chemical properties of narcotic
medications vary widely
most narcotics have chemical properties that are generally
isotonic, isoosmotic, and pH neutral
occasionally, narcotics have an acidic pH value or are
hypertonic or hyperosmotic
in those instances, the narcotic must be injected into an IV
or IVPB base solution; the resulting CSP has physical and
chemical properties that are generally isotonic, isoosmotic,
and pH neutral
2012 Paradigm Publishing

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Potential Complications of
Parenteral Therapy
 All patients receiving parenteral therapy should be
monitored for the following complications:
nosocomial infection
allergic reaction (including anaphylaxis)
phlebitis
tissuing
embolism
extravasation
cellulitis
Stevens-Johnson syndrome
nephrotoxicity
2012 Paradigm Publishing

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Potential Complications of
Parenteral Therapy…/2
 Patients with end-stage cancer or other terminal
diseases sometimes build up a narcotic tolerance to
the narcotic medications used to control their pain
the IV technician may be required to prepare an LVP
preparation by injecting a C–II narcotic, such as
hydromorphone or morphine into an IV base solution
 In the hospital, hospice, or home healthcare setting,
nursing personnel typically administer the
compounded preparation to the patient
2012 Paradigm Publishing

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Potential Complications of
Parenteral Therapy…/3
 Patients receiving high-
dose narcotics face a
heightened risk from
central nervous system
(CNS) depression
must be closely monitored
to prevent a potentially
fatal reduction in their
respiratory or cardiac
functions
2012 Paradigm Publishing

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Controlled Substance Storage
 Controlled substances carry various levels of risk with
regard to their potential for drug abuse and
controlled substance diversion, or narcotic diversion
proper controlled substance storage is essential in
mitigating these risks
2012 Paradigm Publishing

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Controlled Substance Storage…/2
 In the institutional setting,
all controlled substances
within the pharmacy are
kept in the narcotic room
under a double-lock system
2012 Paradigm Publishing

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Your Turn
2012 Paradigm Publishing
1) Most narcotic CSPs prepared by IV technicians are comprised of this
narcotic mixed with a base solution.
a. C–I
b. C–II
c. C–III
d. C–IV
2) Most institutional or hospital pharmacies store all classes of
controlled substances under this system.
a. no-lock
b. single-lock
c. double-lock
d. triple-lock
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Controlled Substance Record
Keeping
 Proper controlled substance
record keeping is also critical
for reducing the possibility of
drug abuse and controlled
substance diversion
there is one aspect of controlled
substance record keeping that
all sterile compounding
personnel should know: the use
of a perpetual inventory record
2012 Paradigm Publishing

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Controlled Substance Record
Keeping…/2
Perpetual Inventory Log Book
 The perpetual inventory log book is an official, legal
record with pages titled “Perpetual Inventory
Record” or “Controlled Substance Record”
is kept in the narcotic room or vault and is a record of all
activity relating to the medications in the narcotic room
2012 Paradigm Publishing

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Controlled Substance Record
Keeping…/3
Perpetual Inventory Log Book…continued
2012 Paradigm Publishing

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Controlled Substance Record
Keeping…/4
Perpetual Inventory Log Book…continued
 Every controlled substance that leaves the narcotic
room—for example, to fill floor stock, prepare an
epidural cassette, or compound a PCA syringe—must
be signed out and subtracted from the perpetual
inventory record
this process is referred to as a narcotic sign-out, or a
controlled substance sign-out
2012 Paradigm Publishing

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Controlled Substance Record
Keeping…/5
Perpetual Inventory Log Book…continued
2012 Paradigm Publishing

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Controlled Substance Record
Keeping…/6
Error Correction in the Perpetual Inventory Log Book
 In most facilities, pharmacy personnel will record an
entry or addition to the log in black ink, and record
withdrawals or negative balances in red ink
personnel should never erase, scribble over, or use
correcting tape or fluid to cover transcription errors
instead, technicians should note an error by drawing a
single line through the entire entry and placing their
circled initials next to the text with the strike-through line
2012 Paradigm Publishing

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Controlled Substance Record
Keeping…/7
Security and Disposal of Controlled Substances
 To provide the utmost security, sterile compounding
personnel should always ensure that the narcotics,
the keys to the narcotic room, and all narcotic
records are kept in their control
if a discrepancy is discovered while creating a record in the
perpetual inventory log book, IV technicians must
immediately report it to their instructor or pharmacist
2012 Paradigm Publishing

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Controlled Substance Record
Keeping…/8
Security and Disposal of Controlled
Substances…continued
 IV technicians must also properly dispose of unused
controlled substance solutions after completing
sterile compounding procedures
 In order to prevent narcotic diversion, all narcotic
waste procedures must be recorded in the perpetual
inventory record and must be observed by a narcotic
waste witness
2012 Paradigm Publishing

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Patient-Controlled Analgesia
 IV technicians need to be
familiar with several
different controlled
substance CSPs and their
preparation, including
LVPs used for chronic,
severe pain control as
well as epidurals and
patient-controlled
analgesia (PCA)
2012 Paradigm Publishing

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Patient-Controlled Analgesia…/2
 A PCA provides narcotic pain control, or narcotic
analgesia, for hospitalized patients
allows a patient to self-administer a dose of the
medication intravenously by pressing a handheld
controller
is preprogrammed to lock out the patient if a dose is
requested before the scheduled time
experience has shown that patient control of analgesia
leads to less narcotic use and, therefore, less potential for
issues related to drug tolerance or side effects
2012 Paradigm Publishing

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USP Chapter <797> Guidelines
for Controlled Substance CSPs
 In addition to the detailed record-keeping mandates
for controlled substances, there are a number of
other procedures that must be carefully followed
while compounding controlled substance
preparations
these procedures are presented in USP Chapter <797> and
are reinforced in each facility’s P&P manual
sterile compounding personnel must pay strict attention to
aseptic protocols both in the anteroom and clean room
2012 Paradigm Publishing

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Understand the Resources and
Supplies
Essential Supplies
 Most sterile compounding procedures require the
same essential supply items to be available for use in
both the anteroom and the clean room
2012 Paradigm Publishing

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Understand the Resources and
Supplies…/2
Procedure-Specific Supplies
 Controlled-Substance
Perpetual Inventory
Log Book
 PCA Supply Items
a Luer-to-Luer connector is
a small plastic device used
to join the tips of two
syringes
2012 Paradigm Publishing

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Understand the Resources and
Supplies…/3
Procedure-Specific
Supplies…continued
 PCA Supply Items…continued
need to attach a sterile, plastic
cap, called a syringe cap, to the
tip of the PCA syringe
an IVA syringe seal is an
adhesive seal that is often
affixed to a syringe cap to
provide evidence of tampering
2012 Paradigm Publishing

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Understand the Resources and
Supplies…/4
Procedure-Specific Supplies…continued
 IVPB Base Solutions
the same type of bag used for other vial-based IVPBs: a
bag with a tail injection port
insert the needle directly into the injection port of an IVPB
without regard to the position of the needle bevel and
without creating any bend to the needle
2012 Paradigm Publishing

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Understand the Resources and
Supplies…/5
Critical Sites of Essential Supplies and PCA Supplies
 Before beginning preparatory procedures in the
anteroom or clean room, the IV technician must
recall the critical sites of the supplies
identifying the critical site of each supply item helps you to
determine the proper procedure for handling the supply
item once you enter the clean room and begin working in
the hood
2012 Paradigm Publishing

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Preview the Lab Procedure
 Anteroom Preparatory
Procedures
verifying the CSP label against the
medication order
performing correct pharmacy
calculations to determine type, size,
and number of supply items needed
gathering and cleaning of supplies
performing aseptic garbing and
hand washing
donning a sterile gown
2012 Paradigm Publishing

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Preview the Lab Procedure…/2
 Clean Room Preparatory Procedures
when preparing controlled substance preparations for
patient administration, sterile compounding personnel
must diligently follow established pharmacy clean room
protocols as well
once the preparatory steps have been completed, narcotic
PCA syringe compounding procedures may begin
2012 Paradigm Publishing

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Preview the Lab Procedure…/3
 Narcotic PCA Syringe
Compounding Procedure
after the verification check,
aseptically remove the
needle from the narcotic
syringe and carefully attach
one end of a Luer-to-Luer
connector to the tip of the
filled narcotic syringe
2012 Paradigm Publishing

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Your Turn
2012 Paradigm Publishing
3) This log book is an official, legal record.
a. perpetual account
b. perpetual stash
c. perpetual inventory
d. perpetual stock
4) This is often affixed to a syringe cap to provide evidence of tampering.
a. IVA syringe capsule
b. IVA syringe tube
c. IVA syringe seal
d. IVA syringe cap
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