IV Admixture: Parenteral Products and Total Parenteral Nutrition

IV Admixture: Parenteral Products and Total Parenteral Nutrition

Required Reading Thompson, Chapters 7, 32, 33

Objectives:

IV Admixture

1. Compare the mechanisms and utility of

Laminar Flow Hood

aka Laminar Flow Workbench (LAFW)

A multi fliter system designed to provide a uniform, continuous flow of particle (and baterium) free air across a worksurface, creating an aseptic environment. The first filter removes large particles (dust, etc). Then the flow of air is standardized and run through a high efficiency particulate air (HEPA) filter.

Class 100 environment

Protects pharmacist and product using a controlled air flow

Horizontal Flow from the back of the work surface toward the front

Masks required for horizontal flow

Vertical Flow from the top to the bottom

Extra protection from chemotherapy agents

More difficult to work with, but safer

Barrier Isolation Devices

Class 100 environment

Provides a sterile environment using solid walls instead of laminar air flow

Uses a HEPA filtration System

Protects product and pharmacist

AKA Glove box

Hood Descriptions

2. Describe USP 797 Requirements for the preparation of sterile products

. Identify criteria of and preparations in Low, Medium, and High risk categories.

All levels require

Class 100 work environment (See above)

LAFW re-certification every 12 months

Anteroom

Should be "Clean" but not necessarily Class 100

Non-shedding dress

Positive Air Pressure

Written monitoring plan

Low Risk (LR)

Sterile products provided by a mfg

Closed system transfers

Buffer Room Class 100,000

less than three products

High Risk I (HRI)

Numerous manipulations

Multiday infusions or pumps

Automated Total Parenteral Nutrition

Buffer Room Class 10,000

30 hours room temp, 7 days cold storage

High Risk II (HRII)

Buffer Room Class 10,000 or 100

Non-Sterile starting materials

24 hours room temp, 3 days cold storate

3. Demonstrate proper placement of items in a given hood.

Horizontal LAFW requires items be at least 6 inches from the edge

Vertical LAFW requires items be at the air flow split point on the table and stay behind the shield

4. Demonstrate aseptic formulation techniques

Do not touch the critical surfaces of the delivery devices

Do not obstruct laminar flow

Pay particular attention to position of hands. Make sure hands are not blocking critical surfaces when handling objects

Grab neck of bottle grasped between two fingers

Do not work in turbulence zones create by products or devices

Dont allow vials/objects to block work

Always work in the most direct flow of air

4. Turn on hood and let it run for a minimum of 30 minutes

5. Perform all calculations

6. Gather supplies

7. Wash, Glove and Gown

7. Dry hands w/ none particulate towels

8. Wipe down LAFW with alcohol and sterile gauze

8. Wipe from the back to the front in a long, smooth and continuous motion

9. Must work at least 6 inches into hood

10. Spread supplies out with thought

10. Make sure and maximize the number of surfaces exposed

10. e.g. turn needle into flow of air. Turning needle against air flow blocks an entire side of the needle from flow of air.

10. Dont leave free paper lying around it will blow off unless prevented

10. Do not block objects

10. e.g. do not put one vial in front of another vial

10. remove all possible wrappers with care

10. e.g the needle wrapper, syringe wrapper

11. Swab the vial diaphragm, injection ports with alcohol

12. Penetrate

12. With beveled needle penetration should be done at ~45o until the bevel heel has passed through the diaphragm the quickly but gently straighten needle to 90o vertical

12. This technique will prevent coring of the diaphragm

13. Push an equal amount of air into the container before attempting to withdraw anything

13. Vial/object should be on table when inserting needle and during equalizations of atmospheres

13. Pay attention to air flow and hand position so air flow is maximized around all objects in hood

13. Grasping neck of vial with the V of two fingers and the syringe with other hands fingers on the syringes top collar and the flat end of the plunger pick up the connected syringe and vial turning both over with the bottom of the vial pointed up 13. This technique will maximize air flow around the objects being grasped by the hands

13.

14. Withdraw product

14. With an even pressure on the flat end of the plunger and resistance on the top collar.

14. Pay attention to the fluid level in the vial; drawing vial liquid not the vial air14. Since atmospheres have been equalized can push fluid in and pull fluid out w/o consequence.

14. If air bubbles acquired two methods to remove14. Flick the needle barrel with one hands forefinger while supporting needle and vial in other hand

14. Push fluid back into vial

14. take a slower pull on the plunger stopping incrementally to allow needle barrel vacuum to pull fluid into the needles barrel

14. tap needle barrel to remove any bubbles

14. if pressure not equalized between needle and vial you will create a friggin mess when removing the needle shaft from the vial14. however much air volume placed into vial, then must remove the same volume of liquid

14. if injecting into sealed container, must remove equal volume of air to compensate for the increased pressure added by injecting volume of fluid

15. Label Product (should have at least the following information)15. For px specific products15. px name, any other pertinent px i.d info, batch prepared products should have control or lot number

15. all solution and ingredient names, amounts, strengths, and concentrations (when applicable)

15. expiration date and time, when applicable (half-life on cancer drug)

15. prescribed administration regimen, when appropriate (including rate and route of administration)

15. Appropriate auxiliary labeling (including precautions)

15. Storage requirements

15. Identification (e.g. intials) of the responsible pharmacists and tech

15. Device specific instructions (drip rate)

15. Any other additional information in accordance with state or federal requirements

16. If any adjustments made to parent solutions must make proper note of adjustments on parent product

16. If unsure of parent product status must dispose of parent product

16. If parent vial should be in powder form, but is in its liquid form without any notification of solution concentration must dispose of parent product.

17. Dispose of waste

17. Sharps go to sharps container

17. Do not need to recap needle if giving needle and syringe directly to sharps container

17. Regular waste can into designated waste receptacle

Recognize syringe and needle differences and be able to choose an appropriate syringe and needle for a given procedure.

Always take the lowest error route

Injecting 8mL sterile water into vial to remove 2mL solution choose the 10mL syringe

E.g using a five mL will require two injections of sterile water increasing the error factor

E.g using a 20mL will increase error factor as the 20mL will not be as accurate when drawing a 2 and 8mL volume as compared to a 10mL syringe

Needles distinguished by length and gauge, with various sizes for various routes

Intradermal25-28 gauge 3/8 to 5/8 length Syringe 0.02-0.5mL

Subcutaneous30-32 gauge 1/2 to 5/8 length Syringe 1-3 mL

Intramuscular20-22 gauge1/2 to 1-1/2 length Syringe up to 5mL

Intravenous20-22 gauge1/2 to 1-1/2 length Syringe up to 60mL

Critical Parts of the syringe

Needle This a sterile surface keep it that way

Easy to dull the tip

exposed plunger touching this can directly contaminate the inside of the syringes barrel

Determine therapeutic, physical, and chemical incompatabilities for a given formulation.

MicroMedix

United States Pharmacopoeia/National Formulary (USP/NF);

American Hospital Formulary Service;

Trissel's Handbook on Injectable Drugs

King's Guide to Parenteral Admixtures

Identify the major components of a parenteral prescription label

Pharmacy Name and location

Rx Number

Control number

Patient name and ID

Additives

Solvent

Administration Rate

Prep Date/Signature

Check Date/Signature

Calculate the amount of a drug solution to be added to a given IV prescription.

Powders requiring addition of liquid usually indicate the concentration of the final product

Develop skills necessary to prepare a sterile product for IV administration.

1. Washes hands: removes jewelry/watch, scrubs hands vigorously including nails, forearms, between fingers, rinses, dries

2. Dons gown, head cover, gloves. Avoids touching contaminated objects henceforth

3. Cleans work area starting at the back and working forward (away from the filter)

4. Cleans all supplies or removes all outer wraps as they are placed in the hood

5. Inspects all materials for integrity and expiration dating prior to using

6. Cleans all septa and injection ports with alcohol

7. Withdraws content of vial: inserts needle at an angle with opening acing up, injects HEPA air into vial and withdraws ___mls solution.

8. Removes air bubbles from syringe

9. Transfers solution: Vials: inserts needle at an angle with opening facing up, Ports: inserts needle straight through port. Injects solution

10. Performs all operations at least 6 inches inside the hood

11. Does not touch critical sites: needle shaft, opening of hub, syringe tip, or stem of plunger

12. Does not place items or allow fingers to come between the clean air source (HEPA filter) and critical sites

13. Inspects the solution for particles against light and dark backgrounds

14. Does not reach out of the hood to discard trash until finished

15. Disposes of sharps and glass in appropriate containers

Total

Demonstrate the ability to calculate IV rates and component quantities.

Identify the information required on an IV admixture label.

For px specific products

px name, any other pertinent px i.d info, batch prepared products should have control or lot number

all solution and ingredient names, amounts, strengths, and concentrations (when applicable)

expiration date and time, when applicable (half-life on cancer drug)

prescribed administration regimen, when appropriate (including rate and route of administration)

Appropriate auxiliary labeling (including precautions)

Storage requirements

Identification (e.g. intials) of the responsible pharmacists and tech

Device specific instructions (drip rate)

Any other additional information in accordance with state or federal requirements

Information on injectable drugs

United States Pharmacopoeia/National Formulary (USP/NF);

American Hospital Formulary Service;

Trissel's Handbook on Injectable Drugs

King's Guide to Parenteral Admixtures

Exercises:

IV Admixture

1. Calculate the volumes of solutions you will need to prepare the assigned IV order. Write out your calculations on the IV order.

2. Prepare the assigned IV order using aseptic technique. Have the TA or instructor observe your technique and check your calculations.

3. Prepare a complete label for the finished product and attach it to the IV order.

4. Write your name on the order and turn it in to your instructor.