The Pharmacy The Pharmacy Technician 4ETechnician 4E

Chapter 8Chapter 8Preparing Sterile Preparing Sterile

FormulationsFormulations

Chapter 8: OutlineChapter 8: Outline

• Parenterals: Sterile Formulation

• LVP Solutions• SVP Solutions• Special Solutions• Laminar Flow Hoods• Biological Safety Cabinets• Clean Rooms• Aseptic Techniques in Hoods

& Cabinets

Working with vialsWorking with vials Working with ampoulesWorking with ampoules Syringes & needlesSyringes & needles FiltersFilters Administration devicesAdministration devices Parenteral incompatibilitiesParenteral incompatibilities Quality assurance & Infection Quality assurance & Infection

ControlControl Units of measurementUnits of measurement

Parenterals: Sterile FormulationsParenterals: Sterile Formulations

The IV route of administration is used: The IV route of administration is used: To reach appropriate drug serum levels. To reach appropriate drug serum levels. To guarantee compliance.To guarantee compliance. For drugs with unreliable gastrointestinal (GI) For drugs with unreliable gastrointestinal (GI)

absorption. absorption. For the patient who can have nothing by mouth .For the patient who can have nothing by mouth . For the patient who is unconscious or uncooperative.For the patient who is unconscious or uncooperative. For rapid correction of fluid or electrolytes.For rapid correction of fluid or electrolytes.

IV SolutionsIV Solutions The vehicles most commonly used for IV infusions are: The vehicles most commonly used for IV infusions are:

Dextrose in water.Dextrose in water. NS solution.NS solution. Dextrose in saline solution.Dextrose in saline solution.

The two main types of IV solutions are: The two main types of IV solutions are: Small-volume parenterals (SVPs)Small-volume parenterals (SVPs) of 50 or 100 Ml. of 50 or 100 Ml. Large-volume parenterals (LVPs) Large-volume parenterals (LVPs) of more than 100 of more than 100

mL.mL.

Characteristics of IV PreparationsCharacteristics of IV Preparations

Intravenous (IV) preparations are either: Intravenous (IV) preparations are either: Solutions (in which ingredients are dissolved). Solutions (in which ingredients are dissolved). Suspensions (in which ingredients are suspended).Suspensions (in which ingredients are suspended).

Most parenteral preparations are made of ingredients Most parenteral preparations are made of ingredients in a in a sterile water . sterile water .

Some parenteral preparations may be oleaginous Some parenteral preparations may be oleaginous (oily). (oily).

Intravenous PreparationsIntravenous Preparations Most parenterals are introduced Most parenterals are introduced directlydirectly into the into the

bloodstreambloodstream Must be Must be free of air bubbles free of air bubbles or or particulate matter.particulate matter. Have many characteristics including solubility, Have many characteristics including solubility,

osmolality, and Ph.osmolality, and Ph. The solution must be stable for its intended use.The solution must be stable for its intended use. Must be Must be PYROGENPYROGEN free. free.

Chemicals that are produced by microorganisms.Chemicals that are produced by microorganisms. Soluble in water and Soluble in water and NOT NOT removed by sterilizing or removed by sterilizing or

filtering the solutions.filtering the solutions.

Characteristics of IV PreparationsCharacteristics of IV Preparations An An isotonic solutionisotonic solution is a solution in which body cells can is a solution in which body cells can

be bathed without a net flow of water across a be bathed without a net flow of water across a semipermeable membrane.semipermeable membrane. 0.9% normal saline (NS).0.9% normal saline (NS).

A A hypertonic solution hypertonic solution has more number of particles than has more number of particles than the blood cells themselves.the blood cells themselves. 50% dextrose or 3% sodium chloride. 50% dextrose or 3% sodium chloride.

A solution of less than normal tonicity is A solution of less than normal tonicity is hypotonic,hypotonic, which which has fewer numbers of particles than blood cells. has fewer numbers of particles than blood cells. 0.45% NS.0.45% NS.

Intravenous FormulationsIntravenous Formulations

Osmotic PressureOsmotic Pressure The characteristics of a solution determined by The characteristics of a solution determined by

the number of disserved particles in it. the number of disserved particles in it. OsmolalityOsmolality

A unit of measure of osmotic pressure.A unit of measure of osmotic pressure. Blood has 300 mOsmol per liter.Blood has 300 mOsmol per liter. Both NS and D5W solutions have a similar Both NS and D5W solutions have a similar

osmolarity.osmolarity.

Characteristics of IV PreparationsCharacteristics of IV Preparations TheThe pH valuepH value is the degree of acidity or alkalinity of a is the degree of acidity or alkalinity of a

solution. solution. Acidic solution: pH of less than 7.Acidic solution: pH of less than 7. Alkaline solution: pH value more than 7.Alkaline solution: pH value more than 7.

Human blood plasma has a pH of 7.4.Human blood plasma has a pH of 7.4. Slightly alkaline.Slightly alkaline. Parenteral IV solutions should have a pH that is neutral Parenteral IV solutions should have a pH that is neutral

(near 7).(near 7).

Methods of InjectionMethods of Injection The The bolus,bolus, or or injectioninjection, is one of the most common , is one of the most common

routes of IV administration.routes of IV administration. The injection is performed using a The injection is performed using a syringe.syringe.

Prepackaged in the form of filled, disposable plastic Prepackaged in the form of filled, disposable plastic syringes.syringes.

Injectable drug must be taken up into the syringe Injectable drug must be taken up into the syringe from a single or multi-dose glass or plastic vial, or from a single or multi-dose glass or plastic vial, or from a glass ampule.from a glass ampule.

Sometimes the solid drug in the vial has to be Sometimes the solid drug in the vial has to be reconstituted by addition of a liquid before use.reconstituted by addition of a liquid before use.

Methods of InjectionMethods of Injection

IV infusions IV infusions deliver:deliver: Large amounts of liquid into the Large amounts of liquid into the

bloodstream over prolonged periods of bloodstream over prolonged periods of time.time.

IV infusion is used to deliver: IV infusion is used to deliver:

Large Volume SolutionsLarge Volume Solutions Packaged in containers holding Packaged in containers holding 100 ml or more.100 ml or more. The most common sizes:The most common sizes:

100, 250, 500, and 1,000 ml.100, 250, 500, and 1,000 ml. Common LVP solutions:Common LVP solutions:

Sodium Chloride, Dextrose Solution, Ringers Solution.Sodium Chloride, Dextrose Solution, Ringers Solution. Containers:Containers:

Plastic bags:Plastic bags:Weight less, less storage space, disposable.Weight less, less storage space, disposable. Glass bottle: Glass bottle: (with or without air vent tube).(with or without air vent tube).

Good for drugs that interact with plastic bags.Good for drugs that interact with plastic bags. E.g. Nitroglycerine, amiodarone.E.g. Nitroglycerine, amiodarone.

Large Volume Large Volume SolutionsSolutions

PortsPorts- Administration port- Administration port- Medication port- Medication port

Regulatory RequirementsRegulatory Requirements

Both USP and FDA have regulations.Both USP and FDA have regulations. Chapter of USP <797>: Chapter of USP <797>:

Pharmaceutical Compounding Sterile Preparations Pharmaceutical Compounding Sterile Preparations established requirements for the aseptic preparing established requirements for the aseptic preparing of sterile dosage forms. of sterile dosage forms.

Intent is Intent is to prevent infection and contamination.to prevent infection and contamination. Provides guidelines for development of policies and Provides guidelines for development of policies and

procedures for the safe preparation of sterile procedures for the safe preparation of sterile preparation.preparation.

Common LVP SolutionsCommon LVP Solutions

Four common solutions used either as LVP solutions Four common solutions used either as LVP solutions or as the primary part of an admixture solution are:or as the primary part of an admixture solution are: sodium chloride solutionsodium chloride solution dextrose solutiondextrose solution Ringer's solutionRinger's solution Lactated Ringer's solutionLactated Ringer's solution

Various combinations of different strengths of Various combinations of different strengths of sodium chloride and dextrose solutions are also sodium chloride and dextrose solutions are also available.available. E.g., 5% dextrose and 0.45% sodium chloride, or E.g., 5% dextrose and 0.45% sodium chloride, or

5% dextrose and 0.225% sodium chloride.5% dextrose and 0.225% sodium chloride.

Small Volume SolutionsSmall Volume Solutions

SVP solutions SVP solutions are 100 ml or less.are 100 ml or less.• Primarily used for delivering medications.Primarily used for delivering medications. Ampules, Prefilled syringes, Single or Multi dose Ampules, Prefilled syringes, Single or Multi dose

vials.vials. AdditiveAdditive: a drug that is added to a Paternal solution.: a drug that is added to a Paternal solution. Admixture: Admixture: the resulting solution when a drug is added the resulting solution when a drug is added

to a Parenteral solution.to a Parenteral solution.

Small Volume SolutionsSmall Volume Solutions Lypholizied Lypholizied – freeze dried powders– freeze dried powders Diluent Diluent – solvent used to reconstitute a powdered drug– solvent used to reconstitute a powdered drug Ready-to-mix systemsReady-to-mix systems - Add-Vantage®, Add-a-Vial®, - Add-Vantage®, Add-a-Vial®,

Mini-Bag Plus®Mini-Bag Plus®

Total Parenteral Nutrition (TPN) SolutionsTotal Parenteral Nutrition (TPN) Solutions Provide Provide nutritional support nutritional support to patients who are to patients who are

unable to take in adequate nutrients through their unable to take in adequate nutrients through their digestive tract.digestive tract.

Contains Contains macro and micro nutrients.macro and micro nutrients. MacronutrientsMacronutrients: dextrose, fat, and protein.: dextrose, fat, and protein. Micronutrients: Micronutrients: electrolytes, vitamins, and trace electrolytes, vitamins, and trace

elements.elements. Lipid emulsion Lipid emulsion may be added.may be added.

Available in 2 or 3 Litter sizes.Available in 2 or 3 Litter sizes. Administered via the Administered via the subclavian vein subclavian vein over 8-24 hours.over 8-24 hours.

Dialysis SolutionsDialysis Solutions

DialysisDialysis - the passage of small particles through - the passage of small particles through membranes.membranes.

Renal dialysis Renal dialysis – artificial kidney– artificial kidney Peritoneal dialysis Peritoneal dialysis – a solution placed in and – a solution placed in and

emptied from the peritoneal cavity to remove toxic emptied from the peritoneal cavity to remove toxic substance from the body.substance from the body.

Irrigation SolutionsIrrigation Solutions

Administered directly into the venous system but are Administered directly into the venous system but are subject to the same stringent controls as IV fluids .subject to the same stringent controls as IV fluids .

Container size, usually larger than 1 liter.Container size, usually larger than 1 liter. Surgical irrigation Surgical irrigation solution used.solution used.

To bath and moisten body tissue, dressing, or To bath and moisten body tissue, dressing, or wash instruments.wash instruments.

Urological irrigation solution Urological irrigation solution usedused To maintain tissue integrity or remove blood to To maintain tissue integrity or remove blood to

maintain a clear file of vision.maintain a clear file of vision. E.g. Glycine 1.5%, Sorbitol 3%E.g. Glycine 1.5%, Sorbitol 3%

Laminar Flow HoodsLaminar Flow Hoods

Carefully enclosed work area designed to prevent Carefully enclosed work area designed to prevent contamination. contamination.

Air is drawn through a high efficiency particulate air Air is drawn through a high efficiency particulate air (HEPA)(HEPA) filter that removes particles larger than 0.5 filter that removes particles larger than 0.5 microns.microns.

The purified air then flows over the work surface at a The purified air then flows over the work surface at a uniform velocity (i.e. uniform velocity (i.e. laminar flow) laminar flow) of 80-100 ft./min. of 80-100 ft./min.

The cabinet is usually made of stainless steel with no The cabinet is usually made of stainless steel with no gaps or joints where spores might collect.gaps or joints where spores might collect.

The surfaces of the The surfaces of the hood's work area are CLEAN, but hood's work area are CLEAN, but NOT NOT

sterile.sterile.

It is necessary to use techniques which maintain the It is necessary to use techniques which maintain the sterility of all sterile items called sterility of all sterile items called aseptic techniques.aseptic techniques.

Laminar Flow HoodLaminar Flow Hood

HEPA filter

intake filter

laminar flow from above

blower

air in

PT 8-2:2

air out

Vertical Flow HoodVertical Flow Hood

Horizontal Flow HoodHorizontal Flow Hood Hoods exist in bothHoods exist in both horizontal and vertical horizontal and vertical

configurations. configurations.

HorizontalHorizontal Blows air toward the operator.Blows air toward the operator.

Used for preparing Used for preparing IVs, TPNs, compounding, eye solutions, and any drug that is IVs, TPNs, compounding, eye solutions, and any drug that is

not hazardous.not hazardous.

Vertical Flow Hood & Biological Safety Vertical Flow Hood & Biological Safety HoodHood

Protects personnel and the environmentProtects personnel and the environment Air is passed into a Air is passed into a HEPAHEPA filter and directed down filter and directed down

toward the work surface and is pulled through vents at toward the work surface and is pulled through vents at the front, back and sides of the hood.the front, back and sides of the hood.

Used for Used for chemotherapy and mixing live viruses.chemotherapy and mixing live viruses. Two typesTwo types

Class 2, Type A Class 2, Type A Class 2, Type BClass 2, Type B

Cleaning Hoods or CabinetsCleaning Hoods or Cabinets Turn the hood or cabinet on and Turn the hood or cabinet on and let it operate for at least 30 let it operate for at least 30

minutes minutes before use. before use. Clean the inside of the hood with a suitable disinfectant. Clean the inside of the hood with a suitable disinfectant. First clean the metal pole used to hang the containers.First clean the metal pole used to hang the containers. Then the sides of the hood are cleaned using up and down Then the sides of the hood are cleaned using up and down

motions moving from the back of the hood toward the front.motions moving from the back of the hood toward the front. Then the bottom of the hood is cleaned using side-to-side motions Then the bottom of the hood is cleaned using side-to-side motions

moving from the back of the hood toward the front.moving from the back of the hood toward the front. If using a spray bottle to dispense the disinfectant, be sure not to If using a spray bottle to dispense the disinfectant, be sure not to

spray the HEPA filter.spray the HEPA filter.

Clean RoomsClean Rooms Clean rooms are rooms that have a Clean rooms are rooms that have a controlledcontrolled level of level of

contamination and are used to prepare sterile contamination and are used to prepare sterile preparations.preparations.

Need to follow the regulations under Need to follow the regulations under USP/NF <797>.USP/NF <797>. Only Only designated personnel designated personnel should enter the space.should enter the space. ISO Class 7 environment ISO Class 7 environment means any air flow unit used means any air flow unit used

in the clean room is capable of producing an in the clean room is capable of producing an environment containing no more than 10,000 air born environment containing no more than 10,000 air born particles of a size 0.5 microns or larger per cubic food particles of a size 0.5 microns or larger per cubic food of air.of air.

Aseptic TechniquesAseptic Techniques Aseptic Techniques are the sum total of Aseptic Techniques are the sum total of

methods and manipulations required methods and manipulations required to to minimize the contamination of sterile minimize the contamination of sterile products. products.

Contaminants are microorganisms and/or Contaminants are microorganisms and/or particulate material.particulate material.

Working in a laminar flow hood Working in a laminar flow hood DOES DOES NOTNOT, , by itself, guarantee a sterile formulation.by itself, guarantee a sterile formulation.

IV Preparation IV Preparation

Preparing IV’s Preparing IV’s should always be done should always be done under the supervision of a licensed under the supervision of a licensed pharmacist.pharmacist.

Medication that is prepared by the Medication that is prepared by the technician must always be reviewed and technician must always be reviewed and approved by the pharmacist. approved by the pharmacist.

Preparing IVsPreparing IVs Pharmacists and technicians prepare drugs and IV Pharmacists and technicians prepare drugs and IV

solutions in a form ready to be administered to a solutions in a form ready to be administered to a patient.patient.

IV push IV push (i.e., bolus) and IV infusion dose forms (i.e., bolus) and IV infusion dose forms should be prepared in laminar airflow hoods using should be prepared in laminar airflow hoods using aseptic techniques .aseptic techniques . Products used during the preparation must Products used during the preparation must

always be always be sterilesterile and handled in such a manner and handled in such a manner as to prevent contamination.as to prevent contamination.

IV Preparation GuidelinesIV Preparation Guidelines Begin all IV preparations by Begin all IV preparations by washing your hands washing your hands

thoroughly. thoroughly. All jewelry All jewelry should be removed from the hands and should be removed from the hands and

wrists before scrubbing and while making a sterile wrists before scrubbing and while making a sterile product. product.

Wear Wear glovesgloves during all procedures. during all procedures. Laminar airflow hoods are normally Laminar airflow hoods are normally kept running.kept running. Eating, drinking, talking, or coughing is prohibited in the Eating, drinking, talking, or coughing is prohibited in the

laminar airflow hood. laminar airflow hood. Working in the laminar flow hood should Working in the laminar flow hood should be free from be free from

interruptions.interruptions.

IV Preparation GuidelinesIV Preparation Guidelines Before making the product, thoroughly clean all interior

working surfaces. Gather all the necessary materials for the operation and make

sure they are: Not expired. Free from particulate matter such as dust. Check for leaks by squeezing plastic solution containers.

Only essential objects and materials necessary for product preparation should be placed in the airflow hood.

IV Preparation GuidelinesIV Preparation Guidelines Work in the center of the work area within the Work in the center of the work area within the

laminar airflow hood.laminar airflow hood. At least At least six inchessix inches inside the edge of the hood inside the edge of the hood Make sure nothing obstructs the flow of air from Make sure nothing obstructs the flow of air from

the high-efficiency particulate air (HEPA) filter the high-efficiency particulate air (HEPA) filter over the preparation area.over the preparation area.

Nothing should pass behind a sterile object and Nothing should pass behind a sterile object and the HEPA filter in a horizontal airflow hood or the HEPA filter in a horizontal airflow hood or above a sterile object in a vertical airflow hood.above a sterile object in a vertical airflow hood.

Aseptic TechniqueAseptic Technique

Put on non-shedding coats, gowns, or coveralls Put on non-shedding coats, gowns, or coveralls (hospital scrubs), head and facial hair covers, face (hospital scrubs), head and facial hair covers, face masks, and shoe covers. Note that it is important to masks, and shoe covers. Note that it is important to follow the sequence of items indicated in this step.follow the sequence of items indicated in this step.

Clean the laminar flow hood Clean the laminar flow hood with with isopropyl alcohol. isopropyl alcohol. The alcohol must remain in contact with the surface The alcohol must remain in contact with the surface for 30 seconds prior to compounding any sterile for 30 seconds prior to compounding any sterile product.product.

IV Preparation GuidelinesIV Preparation Guidelines Follow proper procedure for handling sterile devices Follow proper procedure for handling sterile devices

and medication containers.and medication containers. Remember that Remember that the plunger the plunger and the and the tip of the syringe tip of the syringe

are sterile and are sterile and must not be touched.must not be touched. For greatest accuracy, use the smallest syringe that For greatest accuracy, use the smallest syringe that

can hold the desired amount of solution.can hold the desired amount of solution. Complete a Complete a quality check quality check of the product for container of the product for container

integrity and leaks, solution cloudiness, particulates, integrity and leaks, solution cloudiness, particulates, color of solution, and proper preparation of product.color of solution, and proper preparation of product.

Working with VialsWorking with Vials

Vials are closed systems.Vials are closed systems. The amount of air introduced should be equal The amount of air introduced should be equal

to the volume of fluid removed .to the volume of fluid removed . An exception to this guideline is the An exception to this guideline is the

withdrawal of cytotoxic drugs from vialswithdrawal of cytotoxic drugs from vials There are two types:There are two types:

The drug already in the solution.The drug already in the solution. A powder that must be dissolved in a dilute to A powder that must be dissolved in a dilute to

make a solution.make a solution. Powders are reconstituted by introducing a diluent Powders are reconstituted by introducing a diluent

(e.g., sterile water for injection).(e.g., sterile water for injection).

CoringCoring

Coring is when a needle damages the rubber closure Coring is when a needle damages the rubber closure of a Parenteral container causing fragments of the of a Parenteral container causing fragments of the closure to fall into the container and contaminate its closure to fall into the container and contaminate its contents.contents.

To prevent coring:To prevent coring: Place the vial on a flat surface and position the Place the vial on a flat surface and position the

needle point on the surface of the rubber.needle point on the surface of the rubber. Put downward pressure on the needle while Put downward pressure on the needle while

gradually bringing the needle to an upright gradually bringing the needle to an upright position.position.

Vial Containing SolutionsVial Containing Solutions

1. Choose the smallest gauge needle appropriate for the task. 1. Choose the smallest gauge needle appropriate for the task. 2. Attach the needle to the syringe.2. Attach the needle to the syringe.3. Draw into the syringe an amount of air equal to the amount 3. Draw into the syringe an amount of air equal to the amount

of drug to be drawn from the vial.of drug to be drawn from the vial.4. Swab or spray the top of the vial with alcohol before entering 4. Swab or spray the top of the vial with alcohol before entering

the laminar flow hood; allow the alcohol to dry. the laminar flow hood; allow the alcohol to dry. 5. Puncture the rubber top of the vial with the needle bevel up. 5. Puncture the rubber top of the vial with the needle bevel up. 6. Then bring the syringe and needle straight up, penetrate the 6. Then bring the syringe and needle straight up, penetrate the

stopper, and depress the plunger of the syringe, emptying stopper, and depress the plunger of the syringe, emptying the air into the vial.the air into the vial.

Vial Containing SolutionsVial Containing Solutions

7.7. Invert the vial with the attached syringe.Invert the vial with the attached syringe.8. Draw up from the vial the amount of liquid 8. Draw up from the vial the amount of liquid

required.required.9. 9. Withdraw the needle from the vial. In the case of a Withdraw the needle from the vial. In the case of a

multi-dose vial, the rubber cap will close, sealing multi-dose vial, the rubber cap will close, sealing the contents of the vial.the contents of the vial.

10. Remove and properly dispose of the needle, and 10. Remove and properly dispose of the needle, and cap the syringe. A new needle will be attached at cap the syringe. A new needle will be attached at the time of injection into a patient.the time of injection into a patient.

Vials Contain Lyophilized PowderVials Contain Lyophilized Powder

Determine the correct volume of diluents.Determine the correct volume of diluents. Transfer the diluent into the vial.Transfer the diluent into the vial. Remove the volume of air into the syringe once the Remove the volume of air into the syringe once the

diluents is added.diluents is added. Swirl the vial until the drug is dissolved.Swirl the vial until the drug is dissolved. Using a new needle and syringe, transfer the Using a new needle and syringe, transfer the

reconstituted solution to the final container.reconstituted solution to the final container.

Ampules Ampules

An An ampule ampule is a single-dose-only drug container.is a single-dose-only drug container.

The glass ampule offers a challenge because one must The glass ampule offers a challenge because one must first break the top off the ampule before withdrawing first break the top off the ampule before withdrawing the medication.the medication.

Ampules Ampules

Gently tap the top Gently tap the top of the ampule to bring the of the ampule to bring the medication to the lower portion of the ampule.medication to the lower portion of the ampule.

Clean the neck Clean the neck with an alcohol swab, then grasp the with an alcohol swab, then grasp the ampule between your thumb and index finger at the ampule between your thumb and index finger at the neck with the swab still in place.neck with the swab still in place.

Forcefully snap Forcefully snap the neck away from you.the neck away from you.

AmpulesAmpules To withdraw To withdraw from an ampule, tilt the ampule, place from an ampule, tilt the ampule, place

the needle bevel of a filter or the tip of a filter straw in the needle bevel of a filter or the tip of a filter straw in the corner near the opening, and withdraw the the corner near the opening, and withdraw the medication. medication.

Use a needle equipped with a filter for Use a needle equipped with a filter for filtering out filtering out any tiny glass particles, fibers, or paint chips that may any tiny glass particles, fibers, or paint chips that may have fallen into the ampule.have fallen into the ampule.

AmpulesAmpules Before injecting the contents of a syringe into an IV, Before injecting the contents of a syringe into an IV,

the the needle must be changed needle must be changed to avoid introducing to avoid introducing glass or particles into the admixture.glass or particles into the admixture.

A standard needle could be used to withdraw the A standard needle could be used to withdraw the drug from the ampule; it is then replaced with a filter drug from the ampule; it is then replaced with a filter device before the drug is pushed out of the syringe..device before the drug is pushed out of the syringe..

Filter needles are for one directional use only.Filter needles are for one directional use only.

Equipment Used in IV PreparationEquipment Used in IV Preparation Pharmacies use Pharmacies use plastic disposable plastic disposable products to:products to:

Save time and money. Save time and money. Provide the patient with an inexpensive sterile product. Provide the patient with an inexpensive sterile product.

Often the entire system sent out to the patient is Often the entire system sent out to the patient is composed of plastic.composed of plastic. Thin, flexible plastic catheters are replacing metal shafts Thin, flexible plastic catheters are replacing metal shafts

that deliver the medication into the vein.that deliver the medication into the vein. In many cases the only durable, non-disposable product In many cases the only durable, non-disposable product

used to deliver IV medication is the IV pump or used to deliver IV medication is the IV pump or controllercontroller..

Syringes and NeedlesSyringes and Needles Syringes are used for IV push and in the Syringes are used for IV push and in the

preparation of infusions; they are made of glass or preparation of infusions; they are made of glass or plastic. plastic.

Glass syringes Glass syringes are more expensive.are more expensive. Use limited to medications that are absorbed by Use limited to medications that are absorbed by

plastic plastic Plastic syringesPlastic syringes

Less expensive.Less expensive. Disposable. Disposable. Arrive from the manufacturer sterile.Arrive from the manufacturer sterile.

Syringes & NeedlesSyringes & Needles

Basic parts of a syringeBasic parts of a syringe Barrel is a tube that is open at one end and tapers Barrel is a tube that is open at one end and tapers

into a hollow tip at the other end.into a hollow tip at the other end. Plunger is a piston-type rod with a slightly cone-Plunger is a piston-type rod with a slightly cone-

shaped stopper that presses the barrel.shaped stopper that presses the barrel. Tip provides the point of attachment for a needle.Tip provides the point of attachment for a needle.

Common types: Slip-Tip®, Luer-Lock®, and Eccentric Common types: Slip-Tip®, Luer-Lock®, and Eccentric tips®.tips®.

Syringes and NeedlesSyringes and Needles

Needles are made of stainless steel or aluminum. Needles are made of stainless steel or aluminum. Needle lengths range from 3/8 of an inch to 6 inches. Needle lengths range from 3/8 of an inch to 6 inches. Needles come in gauges ranging from 30 to 13 (higher the gauge, smaller Needles come in gauges ranging from 30 to 13 (higher the gauge, smaller

the lumen). the lumen). After use, needles must be discarded in a designated sharps container.After use, needles must be discarded in a designated sharps container.

Syringes and NeedlesSyringes and Needles

Various types & have several Various types & have several characteristicscharacteristics Graduation marksGraduation marks SizesSizes GaugesGauges

SyringesSyringes

Needle

Tip

Barrel

Plunger

Different size needles

PT 8-1:3

hub

shaft

bevel

Filters Filters

Filters are devices used to remove contaminants Filters are devices used to remove contaminants such as glass, paint, fibers, and rubber cores.such as glass, paint, fibers, and rubber cores. Will not remove virus particles or toxins.Will not remove virus particles or toxins. Occasionally become clogged, thus slowing Occasionally become clogged, thus slowing

expected flow rates.expected flow rates.

FiltersFilters Depth filters Depth filters Inside the hub of a filtered needle Inside the hub of a filtered needle - 5 - 5

micronmicron Membrane filters.Membrane filters. FFilter solution when being expelled from ilter solution when being expelled from

the syringe. the syringe. 0.22 micron.0.22 micron. Final filterFinal filter Used immediately before it enters the Used immediately before it enters the

patient’s vein.patient’s vein.

FiltersFilters

Membrane filter Filter needle

Using a membrane filter

PT 8-1:4

IV SetsIV Sets

An An IV administration setIV administration set Sterile, pyrogen-free disposable.Sterile, pyrogen-free disposable. Device used to deliver IV fluids to patients. Device used to deliver IV fluids to patients.

The set mayThe set may Be sterilized before use by means of radiation or ethylene Be sterilized before use by means of radiation or ethylene

oxide.oxide. Come in sterile packaging and a sealed plastic wrapCome in sterile packaging and a sealed plastic wrap

Sets do not carry expiration dates. Sets do not carry expiration dates. Sets carry the legend Sets carry the legend

““Federal law restricts this device to sell by or on the order of a Federal law restricts this device to sell by or on the order of a physician.”physician.”

IV SetsIV Sets IV sets are sterile and nonpyrogenic.IV sets are sterile and nonpyrogenic. Each unit is supplied in packaging that ensures the Each unit is supplied in packaging that ensures the

maintenance of sterility.maintenance of sterility. Most of the length of the tubing is molded from a Most of the length of the tubing is molded from a

pliablepliable polyvinyl chloride (PVC). polyvinyl chloride (PVC). PVC sets should not be used for: PVC sets should not be used for:

NitroglycerinNitroglycerin, which is absorbed by the tubing., which is absorbed by the tubing. IV fat emulsionsIV fat emulsions, which may leach out of the , which may leach out of the

tubing.tubing.

IV SetsIV Sets The The length of sets length of sets varies from 6-inch extensions up to varies from 6-inch extensions up to

110- to 120-inch sets used in surgery.110- to 120-inch sets used in surgery. The priming of tubing depends on the length of the The priming of tubing depends on the length of the

setset Standard sets have a lumen diameter of 0.28 cm.Standard sets have a lumen diameter of 0.28 cm.

Varying sizes of the lumen diameter achieves Varying sizes of the lumen diameter achieves different flow rates.different flow rates.

Regulation of flow rates is critical in neonates and Regulation of flow rates is critical in neonates and infants.infants.

IV SetsIV Sets A A spikespike to pierce the rubber stopper or to pierce the rubber stopper or

port on the IV container.port on the IV container. A A drip chamber drip chamber for trapping air and for trapping air and

adjusting flow rate.adjusting flow rate. A A control clamp control clamp for adjusting flow rate for adjusting flow rate

or shutting down the flow.or shutting down the flow. Flexible tubing to convey the fluid.Flexible tubing to convey the fluid.

IV SetsIV Sets A needle adapter for attaching a needle or a catheter.A needle adapter for attaching a needle or a catheter. A A catheter, or tubecatheter, or tube, may be implanted into the patient , may be implanted into the patient

and fixed with tape to avoid having to repuncture the and fixed with tape to avoid having to repuncture the patient each time an infusion is given.patient each time an infusion is given.

Most IV sets contain Most IV sets contain a Y-site,a Y-site, or injection port and or injection port and used for adding medication to the IV. used for adding medication to the IV.

Some IV sets also contain Some IV sets also contain resealable in-line filtersresealable in-line filters to to protect the patient against particulates, including protect the patient against particulates, including bacteria and emboli.bacteria and emboli.

IV SetsIV Sets Clamps allow for adjusting the rate of flow and for Clamps allow for adjusting the rate of flow and for

shutting down the flow.shutting down the flow. Clamps may be located at any position along the Clamps may be located at any position along the

flexible tubing.flexible tubing. Usually a clamp moves freely, allowing its location to Usually a clamp moves freely, allowing its location to

be changed to one that is convenient for the health be changed to one that is convenient for the health professional administering the medication.professional administering the medication.

Pumps and ControllersPumps and Controllers Fluids and drugs are often delivered to catheters by Fluids and drugs are often delivered to catheters by

some form of device, including electronic devices, to some form of device, including electronic devices, to control the infusion rate.control the infusion rate.

The first system to deliver a drug IV was the The first system to deliver a drug IV was the syringe syringe system. system.

The syringe system is very nurse labor-intensive and The syringe system is very nurse labor-intensive and pharmacy labor-intensive.pharmacy labor-intensive.

Pumps and ControllersPumps and Controllers The The Buretrol or Soluset Buretrol or Soluset were in use before infusion were in use before infusion

pumps and replaced the syringe system and has a built-pumps and replaced the syringe system and has a built-in graduated cylinder. in graduated cylinder. Fluid is run into the cylinder.Fluid is run into the cylinder. Nurses can add a drug in the top of the cylinder Nurses can add a drug in the top of the cylinder

injection port for dilution and mixing before it is injection port for dilution and mixing before it is infused.infused.

Safer than the syringe system because the drug is Safer than the syringe system because the drug is being diluted in the cylinder and it can be infused over being diluted in the cylinder and it can be infused over a long period of time.a long period of time.

Pumps and ControllersPumps and Controllers Infusion pumps are preferred by both nurses Infusion pumps are preferred by both nurses

and physicians. and physicians. Produce a positive pressure of 10 to 25 psi.Produce a positive pressure of 10 to 25 psi. More accurate than controllers.More accurate than controllers. Have fewer flow interruptions.Have fewer flow interruptions.

Infusion pumps control the flow of IV Infusion pumps control the flow of IV medications.medications.

Maximum flow is 999 mL/hr.Maximum flow is 999 mL/hr. Provides a higher rate of infusion.Provides a higher rate of infusion. Higher pressure increases possibility Higher pressure increases possibility

of infiltration. of infiltration.

Pumps and ControllersPumps and Controllers

A patient-controlled analgesia (PCA) A patient-controlled analgesia (PCA) device is a type of device is a type of medication delivery that uses a parenteral route and medication delivery that uses a parenteral route and allows the patient to administer analgesics by pressing allows the patient to administer analgesics by pressing a button.a button. Controls the medication so the patient cannot Controls the medication so the patient cannot

overdose or give the medication too soon after the overdose or give the medication too soon after the previous dose.previous dose.

Often, after surgery or severe injuries, a physician will Often, after surgery or severe injuries, a physician will order a PCA for the patient for 24 to 72 hours.order a PCA for the patient for 24 to 72 hours.

CathetersCatheters IV administration for fluids and drug therapy can be IV administration for fluids and drug therapy can be

accomplished through needle-like devices called catheters. accomplished through needle-like devices called catheters. CathetersCatheters are devices inserted into veins for direct access are devices inserted into veins for direct access

to the blood vascular system and are used in two primary to the blood vascular system and are used in two primary ways: ways: Peripheral venous cathetersPeripheral venous catheters are inserted into a vein are inserted into a vein

close to the surface of the skin. close to the surface of the skin. Central venous catheters Central venous catheters are inserted deeper in the are inserted deeper in the

body.body.

IV SolutionsIV Solutions A A piggyback piggyback isis a small-volume parenteral admixture that is a small-volume parenteral admixture that is

attached to an existing IV line .attached to an existing IV line . The piggyback solution is infused into the tubing of the running The piggyback solution is infused into the tubing of the running

IV.IV. Usually over a short time, from 30 minutes to 1 hour.Usually over a short time, from 30 minutes to 1 hour.

Heparin Locks Heparin Locks – is a short piece of tubing attached to a needle – is a short piece of tubing attached to a needle or IV catheters used to prevent blood from clotting in the tube. or IV catheters used to prevent blood from clotting in the tube.

Preparing a Label for an IV AdmixturePreparing a Label for an IV Admixture

Labels for IV admixtures should bear the following Labels for IV admixtures should bear the following information:information: Patient’s name and identification numberPatient’s name and identification number Room numberRoom number Fluid and amountFluid and amount dDug name and strength (if appropriate)dDug name and strength (if appropriate) Infusion periodInfusion period Flow rate (e.g., 100 mL/hr or infuse over 30 min)Flow rate (e.g., 100 mL/hr or infuse over 30 min) Expiration date and time Expiration date and time Additional information as required by the Additional information as required by the

institution or by state or federal guidelines.institution or by state or federal guidelines.

Parenteral IncompatibilitiesParenteral Incompatibilities

NOTNOT all drugs are compatible with each other all drugs are compatible with each other IncompatibilitiesIncompatibilities

When two or more drugs react that are When two or more drugs react that are incompatible with each other, one drug can cause incompatible with each other, one drug can cause the degradation of the other drug.the degradation of the other drug.

Characteristics Characteristics of incompatibilities:of incompatibilities: Color changeColor change Hazy appearanceHazy appearance PrecipitationsPrecipitations

Parenteral IncompatibilitiesParenteral Incompatibilities

NOTNOT all incompatibilities are dangerous, some are normal. all incompatibilities are dangerous, some are normal. Color change Color change

Imipenem-cilastatin or dobutamine may show some color Imipenem-cilastatin or dobutamine may show some color change but NOT a sign of incompatibility.change but NOT a sign of incompatibility.

Hazy Appearance Hazy Appearance When ceftazidime is reconstituted, carbon dioxide gas is When ceftazidime is reconstituted, carbon dioxide gas is

released.released. Precipitation Precipitation

The precipitate that forms when paclitaxel is refrigerated The precipitate that forms when paclitaxel is refrigerated dissolves at room temperature.dissolves at room temperature.

Incompatibilities – Contribution FactorsIncompatibilities – Contribution Factors

Light Light Amphotericin B, cisplatin, metronidazole must be Amphotericin B, cisplatin, metronidazole must be

protected from light.protected from light. Temperature Temperature

Cefazolin stable at room Temp for 24 hrs but under Cefazolin stable at room Temp for 24 hrs but under refrigeration for 96 hrs.refrigeration for 96 hrs.

Dilution Dilution Up to 15 mEq of Calcium can be added to a liter of Up to 15 mEq of Calcium can be added to a liter of

solution containing 30mEq of PO4.solution containing 30mEq of PO4. Buffer capacity, pH, and TimeBuffer capacity, pH, and Time

Incompatibilities – Contribution FactorsIncompatibilities – Contribution Factors

FiltersFilters Inline filter cause 90% reduction in nitroglycerin.Inline filter cause 90% reduction in nitroglycerin.

Solutions Solutions Ampotericin B is not compatible in NS.Ampotericin B is not compatible in NS.

Chemical ComplexationChemical Complexation Ca reduces tetracycline activity.Ca reduces tetracycline activity. Needle or filter containing aluminum should not be Needle or filter containing aluminum should not be

used with Cisplatin-AQ.used with Cisplatin-AQ. Plastics Plastics

Albumin should be used in glass bottle because it binds to PVC Albumin should be used in glass bottle because it binds to PVC plastics.plastics.

Quality Assurance (AQ) & Infection ControlQuality Assurance (AQ) & Infection Control

USP/NF <797> requires that every compounding USP/NF <797> requires that every compounding facility has to have a QA program.facility has to have a QA program.

Major componentsMajor components Semi-annual testing and certification.Semi-annual testing and certification. Routine monitoring of environmental airborne.Routine monitoring of environmental airborne. Routine monitoring of operating temperature.Routine monitoring of operating temperature. Maintaining continuous positive pressured.Maintaining continuous positive pressured. Continuous HEPA filtered air.Continuous HEPA filtered air.

Hazardous Waste RegulationsHazardous Waste Regulations

The Resources Conservation and Recovery Act The Resources Conservation and Recovery Act (RCRA) regulates handling hazardous waste from its (RCRA) regulates handling hazardous waste from its generation to disposal.generation to disposal.

Hazardous waste must be collected and stored Hazardous waste must be collected and stored according to specific EPA and DOT requirements.according to specific EPA and DOT requirements.

Hazardous materials classificationHazardous materials classification P-list waste includes epinephrine, NTG, and P-list waste includes epinephrine, NTG, and

physostigmine.physostigmine. U-list wastes includes toxic, flammable, corrosive, U-list wastes includes toxic, flammable, corrosive,

or reactive and cyclophosphamide. or reactive and cyclophosphamide.

Sharps DisposalSharps Disposal

SharpsSharps An object that might puncture or cut the skin of anyone An object that might puncture or cut the skin of anyone

who handles them.who handles them. Needles, jagged glass, or metal objects.Needles, jagged glass, or metal objects.

Sharp containers Sharp containers should be easily indentified, leak proof, puncture proof, should be easily indentified, leak proof, puncture proof,

and be able to be sealed permanently.and be able to be sealed permanently.

Hazardous Waste Regulations Hazardous Waste Regulations

• Protective Clothing Protective Clothing • A disposable, lint-free, nonabsorbent, closed-A disposable, lint-free, nonabsorbent, closed-

front gown with cuffed sleeves should be worn. front gown with cuffed sleeves should be worn.

• Hair and shoe covers should be worn to reduce Hair and shoe covers should be worn to reduce the potential for particulate contamination.the potential for particulate contamination.

• Eye protectionEye protection• MaskMask• Use of latex gloves when disposing of damaged Use of latex gloves when disposing of damaged

packages.packages.

Units of MeasurementUnits of Measurement

MolarityMolarity A mole is the number of grams numerically equal to A mole is the number of grams numerically equal to

the the molecular weightmolecular weight of the drug. of the drug. OsmolesOsmoles

Equal to the molecular weight of the drug divided Equal to the molecular weight of the drug divided by the number of by the number of ionsions formed when a drug formed when a drug dissolves in solution.dissolves in solution. Osmole = Osmole = molecular weightmolecular weight

# of ions# of ions

Units of MeasurementUnits of Measurement

EquivalentsEquivalents Expression for an amount of drug is the equivalent Expression for an amount of drug is the equivalent

weight (Eq).weight (Eq).

Equilvalent weight = Equilvalent weight = molecular weightmolecular weight valencevalence

Units of MeasurementUnits of Measurement

Percentage weight per volumePercentage weight per volume Refers to the drug’s weight per 100 ml if the drug Refers to the drug’s weight per 100 ml if the drug

is a solidis a solid The drug’s volume per 100 ml if the drug is a liquid.The drug’s volume per 100 ml if the drug is a liquid.

Solid: % = Solid: % = weight (gm)weight (gm) 100 ml100 ml

Liquid: % = Liquid: % = volume (ml)volume (ml) 100 ml100 ml

Terms to RememberTerms to RememberTerms to RememberTerms to Remember

1. Horizontal flow hood1. Horizontal flow hood2. Hub2. Hub3. Hypertonic3. Hypertonic4. Hypotonic4. Hypotonic5. Ions5. Ions6. Irrigation solution6. Irrigation solution7. Isotonic7. Isotonic8. Laminar flow8. Laminar flow9. Lumen9. Lumen10. Lyophilized10. Lyophilized11. Membrane filter11. Membrane filter

12. Molecular weight12. Molecular weight13. Omsosis13. Omsosis14. Osmotic pressure 14. Osmotic pressure 15. Peritoneal dialysis solution15. Peritoneal dialysis solution16. Piggybacks16. Piggybacks17. Pyrogens17. Pyrogens18. Ready-to-mix18. Ready-to-mix19. Shaft19. Shaft20. Sharps20. Sharps21. Slip-tip®, luer-lok®, eccentric, oral21. Slip-tip®, luer-lok®, eccentric, oral22. Total nutrient admixture (TNA) solution22. Total nutrient admixture (TNA) solution

Terms to RememberTerms to RememberTerms to RememberTerms to Remember

23. Total parenteral23. Total parenteral nutrition nutrition (TPN) solution(TPN) solution

24. Additive24. Additive25. Admixture25. Admixture26. Ampules26. Ampules27. Anhydrous27. Anhydrous28. Aseptic techniques28. Aseptic techniques29. Bevel29. Bevel30. Compounded sterile30. Compounded sterile31. Preparation (CSP)31. Preparation (CSP)32. Coring32. Coring33. Depth filter33. Depth filter

34. Dialysis34. Dialysis35. Diluent35. Diluent36. Equivalent weight36. Equivalent weight37. Final filter37. Final filter38. Flashball38. Flashball38. Flow rate38. Flow rate40. Gauge40. Gauge41. HEPA filter41. HEPA filter42. Heparin lock42. Heparin lock