Ampule-Based Preparations

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Chapter 10Ampule-Based

Preparations

2012 Paradigm Publishing

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Learning Objectives Gain an awareness of the history of ampules. Understand the identifying characteristics of ampules and their

purpose in sterile compounding procedures. Identify the USP Chapter <797> procedures that must be

performed during the compounding of ampule-based preparations.

Demonstrate excellent aseptic technique in the compounding of ampule-based preparations.

Recognize the safety issues associated with the opening of ampules.


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Topics Learning Objectives Introduction Opening of Ampules Contents of Ampules Administration of Ampule-Based Preparations Properties of Ampule Medications Risks of Parenteral Preparations USP Chapter <797> Guidelines

for Ampule-Based Preparations Understand the Resources and Supplies Preview the Lab Procedure Chapter Summary


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Introduction

Ampules are made from thin, medical-grade glass tubing and are manufactured as sterile containers for specific medications, many of which are incompatible with the rubber or PVC components found in most vials


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Opening of Ampules

An ampule is designed so that the neck is either scored or made of thinner glass, called a break ringan IV technician applies

pressure to either the scored area or the break ring of the tapered neck, which breaks off the head of the ampule


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Opening of Ampules…/2

Once the ampule is opened, and prior to injecting the medication into the compounded sterile preparation (CSP), the solution must be filtered by passing it through a single-direction filter needlethis specialty needle removes any minute glass fragments

that may have fallen into the ampule’s fluid during the opening process


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Contents of Ampules

Ampules most often contain sterile medications, such as promethazine or epinephrine, for parenteral administrationoccasionally, ampules contain a sterile powdered

medication that requires the IV technician to reconstitute the powder with a sterile diluent prior to drawing it up into a syringe for parenteral administration


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Contents of Ampules…/2

In general, ampule medications range in volume from as little as 1 mL to as much as 20 mLthe fragile nature of the glass ampule renders it incapable

of safely storing larger fluid volumesfor the most part, the medication contained within a single

ampule is sufficient to provide the necessary dose for a single intravenous piggyback (IVPB) or IV drip


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Administration of Ampule-Based Preparations

Ampule-based preparations may be administered by intramuscular (IM) injection or, more often, intravenouslyadministered by piggybacking them through IV tubing

attached to a primary IV solution, or through a heparin lock

the pharmacy must consider the physical and chemical properties of ampule medications, including compatibility and stability, when determining the appropriate IVPB base solution and volume


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Properties of Ampule Medications

The physical and chemical properties of ampule medications vary widelysome ampule medications have an acidic pH value, a

higher osmotic pressure, or a higher tonicityhowever, as is the case with vial medications, once the

ampule medication is injected into an IVPB base solution, the resulting CSP has physical and chemical properties that are generally isotonic, isoosmotic, and pH neutral


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Properties of Ampule Medications…/2

In some circumstances, a parenteral medication that is neutral despite being diluted in an IVPB base solution will be administered over a long period to avoid any and all potential problems related to phlebitis or other administration risksfor instance, the medication gentamicin, which is generally

isotonic and pH neutral, is administered by IVPB over a period of at least 60 minutes to avoid potential problems due to ototoxicity or nephrotoxicity, which may result from rapid administration of the medication


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Risks of Parenteral Preparations

Preparation Risks A preparation risk unique

to ampule-based preparations is the presence of broken glass during the opening of an ampule


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Risks of Parenteral Preparations…/2

Preparation Risks…continued Broken glass can create a hazardous situation for

both the patient and the IV technicianduring the breaking process, minute shards of glass are

commonly deposited in the contents of the ampuleall ampule medications must be passed through a filter

needle so that glass particles do not transfer into the CSP


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Preparation Risks…continued Opening an ampule

may also cause injury to the IV technician or create a dangerous work environment under the hood


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Administration Risks All patients receiving parenteral fluids should be

monitored for the following complications:nosocomial infectionallergic reaction (including anaphylaxis)phlebitistissuingembolismextravasationcellulitisStevens-Johnson syndromenephrotoxicity


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Administration Risks…continued CSPs prepared from ampules have similar

preparation and administration risks as those prepared from vialsas is the case with all CSPs, the most common risks

associated with ampule medications include phlebitis, allergic reaction, nosocomial infection, and medication-specific side effects, such as GI upset or drowsiness


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USP Chapter <797> Guidelines forAmpule-Based Preparations

During preparatory and compounding procedures of ampules, the IV technician must adhere to the overarching principles set forth in USP Chapter <797>these guidelines are reinforced in each facility’s P&P

manualin accordance with these guidelines, sterile compounding

personnel must pay strict attention to aseptic technique protocol both in the anteroom and clean room


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Your Turn


1) An ampule is designed so that the neck is either scored or made of thinner glass, called aa. back tube.b. break tube.c. back ring.d. break ring.

2) This specialty needle removes any minute glass fragments that may have fallen into the ampule’s fluid.a. regularb. ventedc. filterd. sheath

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Understand the Resources and Supplies

Essential Supplies The vast majority of 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 Ampule

the base of the ampule, called the ampule body, is the largest portion of the ampule, and it is the area that contains the sterile fluid

the uppermost part of the ampule body, just before it starts to narrow, is sometimes referred to as the ampule shoulder

the narrowest portion of the ampule is the ampule neck, which must be broken in order to access the fluid within


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Procedure-Specific Supplies Ampule…continued

the ampule head is the small glass bulb located above the neck

once the neck has been broken and the ampule head removed, the ampule is then considered to be an open container and should, therefore, be treated as a single-use container


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there are a number of methods that IV technicians use to open an ampule safely

while employing these methods may seem to provide a certain degree of protection to the worker, these techniques may create more problems than they solve

some IV technicians slip small plastic caps called ampule breakers over the heads of the ampules to safely open them


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many IV technicians prefer to simply open an ampule with their gloved hands

provided the ampule is opened using proper aseptic technique, this method is safe, efficient, and cost effective


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Procedure-Specific Supplies Filter Needle and Filter

Strawthere are a number of

different filters—including filter needles, filter straws, and filter discs—that may be used during sterile compounding procedures


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Procedure-Specific Supplies Filter Needle and Filter Straw…continued

when working with ampules, the type of filter most commonly used is a 5-micron filter needle


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when withdrawing a large amount of fluid (a volume greater than 5 mL) from an ampule, some IV technicians use a single-direction filter straw

this sterile, hollow, plastic tube attaches to a syringe and contains a 5-micron filter

as the IV technician withdraws fluid from the ampule through the filter straw into a syringe, glass shards are trapped in the filter


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a filter needle is always used in conjunction with a regular (nonfilter) needle when compounding ampule-based preparations

the choice of whether to first use the regular needle to withdraw the fluid from the ampule and then use the filter needle to inject the fluid from the syringe into the IVPB—or vice-versa—is dependent upon the viscosity of the fluid within the ampule and the directives set forth within a facility’s P&P manual


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Procedure-Specific Supplies IVPB Base Solution

for ampule-based preparations, the IV technician uses an IVPB base solution bag with a tail injection port


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Critical Sites of Essential Supplies and Ampules The IV technician must

recall the critical sites of the supplies


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Preview the Lab Procedure

Anteroom Preparatory Proceduresverifying the CSP label against the

medication orderperforming 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 Procedurescleansing hands with

sterile, foamed 70% IPAdonning sterile glovescleaning the hood


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Ampule-Based Compounding Procedurepick up the ampule and gently

tap or swirl the containerswab the neck of the ampule prepare the syringehold the body of the ampule

firmly but gently in your nondominant hand


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Ampule-Based Compounding Procedure…continuedalways snap the ampule away

from youremove the regular needle cappull back on the flat knob of the

plunger with the thumb or forefinger of your dominant hand


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Ampule-Based Compounding Procedure…continuedhold the barrel of the syringe with the capped needle

pointing upward, and tap the syringe barrel to force bubbles up toward the syringe tip


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Your Turn


3) This is the name for the base of the ampule. a. shoulderb. neckc. bodyd. head

4) When withdrawing a large amount of fluid, some IV technicians use this. a. filter needleb. filter tubec. filter strawd. filter breaker

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Ampule-Based Preparations

Health & Medicine

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