Pharmacy Technician Review. Pharmacy Technician Review. Program Disclosure. Program Disclosure. Parenteral Routes of Administration

(1)

Pharmacy Technician Review

Presented by:

Aseptic Technique: Handling Sterile Products

Presented by:

P a m e l a G r i m m , C P h T

Pharmacy Technician

Manager

University of Iowa

This program was originally presented and recorded live as part of the Pharmacy Technician Review, October 16-17, 2008, in Des Moines, Iowa and sponsored by The Collaborative Education Institute.

P a m e l a G r i m m , C P h T

P h a r m a c y Te c h n i c i a n M a n a g e r U n i v e r s i t y o f I o w a H o s p i t a l s a n d C l i n i c s I o w a C i t y, I A

Program Disclosure

yThis program was recorded live as part of the Collaborative

Education Institute’s Technician Review in October 2008. CEI and its staff take full responsibility for the program planning. This presentation is owned solely by CEI. Requests for permission to utilize any part of this presentation should be directed to Jennifer Moulton, jmoulton@iarx.org.

yPamela Grimm indicated that she had no actual or potential conflicts of interest in relation to this program. The speaker has indicated that off-label use of medications will not be discussed during this presentation.

yThe program is delivered in this online format by the Collaborative Education Institute (CEI).

Pharmacy Technician Review

Presented by:

P a m e l a G r i m m , C P h T

Aseptic Technique: Handling Sterile Products

P a m e l a G r i m m , C P h T

P h a r m a c y Te c h n i c i a n M a n a g e r U n i v e r s i t y o f I o w a H o s p i t a l s a n d C l i n i c s I o w a C i t y, I A

This program was originally presented and recorded live as part of the Pharmacy Technician Review, October 16-17, 2008, in Des Moines, Iowa and sponsored by The Collaborative Education Institute.

Program Disclosure

yThis program was recorded live as part of the Collaborative

Education Institute’s Technician Review in October 2008. CEI and its staff take full responsibility for the program planning. This presentation is owned solely by CEI. Requests for permission to utilize any part of this presentation should be directed to Jennifer Moulton, jmoulton@iarx.org.

yPamela Grimm indicated that she had no actual or potential conflicts of interest in relation to this program. The speaker has indicated that off-label use of medications will not be discussed during this presentation.

yThe program is delivered in this online format by the Collaborative Education Institute (CEI).

Parenteral Routes of Administration

y

Today

Parenteral routes only

●Intravenous (IV) - Vein

●Intramuscular (IM) - Muscle

●Subcutaneous (SC or SQ) - Beneath the skin( Q)

●Intradermal (ID) - Top layer of the skin

●Intra-arterial - Artery

●Intrathecal (IT) - Spinal canal

●Intraarticular - Joint

●Many others - Intraperitoneal, intrapleural, etc

Parenteral Routes of Administration

y

Advantage

Quick onset

Amount of drug administered = amount of drug available in the body

Does not undergo first-pass metabolism by the intestine

Does not undergo first pass metabolism by the intestine and the liver

(2)

Parenteral Routes of Administration

y

Disadvantage

Once administered, it’s hard to stop the effect

●More chance of overdose in case of mistakes

Local reactions at injection sites

P

Pyrogens

Risk of infection at injection sites and blood

●Must use aseptic technique

●Human touch is the most common source of contamination

Sterilization

y

Sterile?

Absence of all living microorganisms

Does not mean absence of pyrogens or viruses

Sterilization

y

Filtration

The most common method of sterilization in a

pharmacy

●A filter must have a pore size less than 0.3 microns

y

Method of sterilization

y

Method of sterilization

Cold sterilization by chemicals

●Ethylene oxide gas

●Radiation

●Ultrasonic

Heat sterilization by steam and pressure

●In an autoclave

●In a hot air oven

Handling Sterile Products

y

Pyrogen

Any substance that can cause a fever

Can be a bacterial endotoxin or an exotoxin

●An endotoxins is a large molecule that consists of sugar chains and a lipid

E d t i ll th f th i ti it f

●Endotoxins are usually the cause of the pyrogenic activity of a contaminated drug

Does not get filtered by a 0.2 micron filter

Not destroyed by an autoclave

Contaminated products must be discarded

Handling Sterile Products

y

Aseptic Technique

Handling without contamination

Should be used for compounding sterile products

Handling Sterile Products

y

Anyone preparing sterile products should

undergo aseptic technique training by

experienced personnel

y

Aseptic technique training should include:

Instructional video

Professional publications

Hands on aseptic technique manipulation training

(3)

Preparation Areas

y

Avoid contamination of the air

No jewelry

No makeup

No Artificial nails

No fingernail polish

Scrub properly

●Scrub nails, fingers, hands, wrists, and forearms for at least 30 seconds.

●Use a low lint towel to dry hands or use a hand dryer

Wear a hair cap, a knee-length gown, gloves, and shoe

covers (important to gown from your head

downwards)

Preparation Areas

y

Categorized by the air quality

ISO Class 5 Area

●For sterile product preparation

No more than 3520 particles 0 5 microns or larger per cubic

●No more than 3520 particles, 0.5 microns or larger, per cubic meters of air

●Equivalent to the Class 100 area, which has a count of no more than 100 particle, 0.5 microns and larger per cubic foot of air

Preparation Areas

y

Categorized by the air quality

ISO Class 6, 7, 8 Areas

●For non-sterile product preparation

●Respectively 1000 10000 and 100000 particles per cubic

●Respectively 1000, 10000, and 100000 particles per cubic foot of air

Preparation Areas

y

Buffer area

The compartment in which the laminar flow workbench is located

Separate from other pharmacy operations

The second cleanest space in a pharmacy

Must maintain a positive air pressure

No cardboard box should enter this area

Preparation Areas

y

Anteroom

Highly clean

A separate compartment between the buffer area

and other pharmacy operation

Keep hand wash equipments and other supplies

Keep hand-wash equipments and other supplies

such as gowns, gloves, and hair caps.

Positive pressure - Less pressure than the buffer

area

The dirty side and the clean side are separated by a

line

Preparation Areas

y

Surfaces of the preparation areas

Smooth

Non-shedding

Easily cleaned/disinfected

No seams and cracks

(4)

Preparation Areas

y

Critical Site

Opening or surface of any sterile product that can come in contact with the product in preparation

i e. Needle cap, the tip of the syringe, open neck of an ampoule, the top of the vial closure

Handling Sterile Products

y

Laminar Flow

Air in a confined area moving with uniform speed along parallel lines

Laminar flow workstations can filter out all particles that are 0.3 microns or larger in diameterg

Horizontal Flow

Outward air flow towards the operator

Vertical flow

Downward

air flow toward the bench

Handling Sterile Products

y

Using the Laminar Flow Workbench

Know that the LFW only keeps sterile products sterile

It does not remove contamination already present on the items placed inside the workstation

Handling Sterile Products

y

Using the Laminar Flow Workbench

Cleaning the LFW

●General rule

Use non-shedding wipes and 70% isopropyl alcohol

Do not spray the sanitizing agent directly on the hood

Start at the end closest to the filter

Move outward from the top edge of the side to the bottom

Wipe from side to side

Wipe from the filter to the outside

(5)

Handling Sterile Products

y

Using the Laminar Flow Workbench

Working in the LFW

●Wipe down any products not in a sealed package with 70% alcohol

●Remove the protective packaging right at the edge of the hood

●Keep a syringe in a protective wrap until right before its use. It should be placed 6 inches inside the edge

●All work must be done 6 inches inside the hood

●Nothing should block the airflow to another object in the hood

●Do not block the airflow with your hands or body

Handling Sterile Products

y

Using the Laminar Flow Workbench

Working in the LFW

●Minimize movement while working in the hood

●All materials should be kept 6 inches inside the hood

●The items to be discarded should be placed no more than 6 p inches into the hood

●Needles and other sharp objects must be discarded into a designated container

Handling Sterile Products

y

Syringes

Plastic or glass

Plastic is used most often

Examine the package carefully for any signs of puncture or contamination

Th ib f th l d th ti f th i th

The ribs of the plunger and the tip of the syringe are the critical sites

Use the smallest syringes possible

●For example, use a 5 ml syringe instead of 10 ml to transfer 4 ml of drug

Remove the package inside the hood

Handling Sterile Products

y

Needle sizes

The larger the gauge, the thinner the needle

●Use 18G for a large volume transfer

●Use 21G for a small volume transfer

The needle length are specified by inches

The needle tip and the hub located above the needle are critical sites

Handling Sterile Products

y

Putting the needle on a syringe

Examine the package carefully for any signs of puncture or contamination

Remove the packaging inside the hood

Do not tear the paper packaging when removing a needle or a syringey g

●May generate paper particles

Do not touch the needle and keep the paper wrap on the syringe -Grab the needle over the paper wrap

Hold the needle with the thumb and first finger of your non-dominant hand and the syringe with your non-dominant hand

Assemble them together by twisting the needle

Handling Sterile Products

y

Drawing up the right volume

With the needle cap on, push the plunger all the way down to unlock the syringe

Pull back the syringe up to the volume you are about to draw up and inject the air into

h l l

1 NOT here

the vial to equalize pressure

Draw up the drug to the desired volume

Tap the syringe to remove air before removing the syringe from the vial

Readjust the volume as necessary

2

Right

(6)

Handling Sterile Products

y

Ampoules

Wipe the ampoule with a 70%-alcohol swab and let it

dry

Use caution when opening the ampoule

●Use only enough amount of force

Break the ampoule away from you toward the side of

the hood

Never break it toward the HEPA filter

Use an ampoule opener if you experience difficulties

Do not push air into an ampoule

Use a filter when you draw up the drug

You must cannot use one filter needle to draw up and

to inject - It should be used only in one direction

Handling Sterile Products

y

Vials

Flick the top off

Wipe the top of the vial with a 70% alcohol swab and let it dry

A single-dose vial cannot be entered more than once

●Once out of the hood, it must be discarded A multi dose vial can be entered multiple times

A multi-dose vial can be entered multiple times

●Multi-dose vials contain preservatives

●Multi-dose vials exp 28 days after the vial has been punctured Insert the needle at an angle of 50-60 degrees with the bevel of

the needle up

Once penetrated, hold the needle in a vertical position

Remember not to block the airflow to the syringe and to the vial

Handling Sterile Products

y

Reconstitution of a powder

Some drugs cannot stay stable in a solution form so they are available in a powder form

They need to be reconstituted with a diluent before use

●Diluent

A fluid solvent used to dissolve the powder

Most drugs specify how much diluent to mix with

Handling Sterile Products

y

Reconstitution of a powder

Note that powders also take up a certain amount of

volume

Withdraw the pre-specified amount of the correct

diluent using aseptic technique

Inject the diluent into the vial of powder

Let the air re-enter the syringe to equalize pressure

Shake the vial well until all powder is dissolved

Hold the vial in the light for visual inspection of

particles

Use filtering if instructed to do so or when a particle

exists in the vial after a vigorous shaking

Handling Sterile Products

y

Double-check your work

Is everything correct?

●Label

Complete and error-free?

●Correct drug and strength of the drug

dd d h f h dd

●Correct additive and strength of the additive

●Correct quantity

Visual inspection

●Make sure no precipitation has occurred

●Make sure the admixture is clear and free of particulate matters

●May use a black sheet of paper to identify a particle

Chemotherapeutic Agents

y

Handling these agents may pose an

occupational hazard

Anyone who is pregnant, nursing or trying to become

pregnant should not prepare chemotherapy.

Minimize unnecessary exposure

y

p

Must receive special training

All chemo agents should be prepared in a biological

safety cabinet designated for preparing cytotoxic

drugs

(7)

Chemotherapeutic Agents

y

In order to avoid exposure to chemo agents:

Wear protective clothing

Place an absorbent drape on the work surface

●Must be after spillage

Lower the window as low as possible

U

i

h i

l

d

Use negative pressure technique or a closed system

device such as PhaSeal® when using chemo agents

Be sure to vent the vial to avoid positive pressure

Discard anything that may potentially have come in

contact with into a hazardous material waste

container

Review

The pore size of a sterilizing filter is:

A.

0.1 microns

B.

0.2 microns

C.

0.5 microns

D.

0.75 microns

E.