narcotic preparations

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Chapter 11Narcotic 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.


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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


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Introduction

The CSA classifies controlled substances according to their potential for abuse and addictionmost narcotic CSPs

prepared by IV technicians are comprised of a C–II narcotic mixed with a base solution


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Drug Schedules

The CSA organizes controlled substances into five drug schedules or classes based on their potential for abuse and addictionin 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


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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 medicationsin 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


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Properties of Narcotic CSPs

The physical and chemical properties of narcotic medications vary widelymost narcotics have chemical properties that are generally

isotonic, isoosmotic, and pH neutraloccasionally, narcotics have an acidic pH value or are

hypertonic or hyperosmoticin 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


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Potential Complications of Parenteral Therapy

All patients receiving parenteral therapy should be monitored for the following complications:nosocomial infectionallergic reaction (including anaphylaxis)phlebitistissuingembolismextravasationcellulitisStevens-Johnson syndromenephrotoxicity


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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 painthe 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


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Potential Complications of Parenteral Therapy…/3

Patients receiving high-dose narcotics face a heightened risk from central nervous system (CNS) depressionmust be closely monitored

to prevent a potentially fatal reduction in their respiratory or cardiac functions


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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 diversionproper controlled substance storage is essential in

mitigating these risks


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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


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Your Turn


1) Most narcotic CSPs prepared by IV technicians are comprised of this narcotic mixed with a base solution.a. C–Ib. C–IIc. C–IIId. C–IV

2) Most institutional or hospital pharmacies store all classes of controlled substances under this system.a. no-lockb. single-lockc. double-lockd. 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 diversionthere is one aspect of controlled

substance record keeping that all sterile compounding personnel should know: the use of a perpetual inventory record


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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


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Perpetual Inventory Log Book…continued


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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 recordthis process is referred to as a narcotic sign-out, or a

controlled substance sign-out


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Perpetual Inventory Log Book…continued


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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 inkpersonnel should never erase, scribble over, or use

correcting tape or fluid to cover transcription errorsinstead, 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


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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


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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


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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)


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Patient-Controlled Analgesia…/2

A PCA provides narcotic pain control, or narcotic analgesia, for hospitalized patientsallows 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


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USP Chapter <797> Guidelinesfor 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 preparationsthese procedures are presented in USP Chapter <797> and

are reinforced in each facility’s P&P manualsterile compounding personnel must pay strict attention to

aseptic protocols both in the anteroom and clean room


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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


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Understand the Resources and Supplies…/2

Procedure-Specific Supplies Controlled-Substance

Perpetual Inventory Log Book

PCA Supply Itemsa Luer-to-Luer connector is

a small plastic device used to join the tips of two syringes


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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


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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


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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 suppliesidentifying 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


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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 suppliesperforming aseptic garbing and hand

washingdonning a sterile gown


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Preview the Lab Procedure…/2

Clean Room Preparatory Procedureswhen 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


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Preview the Lab Procedure…/3

Narcotic PCA Syringe Compounding Procedureafter 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


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Your Turn


3) This log book is an official, legal record.a. perpetual accountb. perpetual stashc. perpetual inventoryd. perpetual stock

4) This is often affixed to a syringe cap to provide evidence of tampering. a. IVA syringe capsuleb. IVA syringe tubec. IVA syringe seald. IVA syringe cap

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narcotic preparations

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