IV Service

Practice Basics

Aseptic Technique, Sterile Compounding, and IV Admixture Programs

Parenteral Drug Administration

Parenteral drug administration refers to the delivery of medication by injection, bypassing the digestive tract. The main methods of parenteral drug administration include:

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  1. Intravenous (IV)

  2. Intramuscular (IM)

  3. Intrathecal (IT)

  4. Epidural

  5. Intraarticular

  6. Intraarterial

  7. Intraocular

  8. Intraperitoneal

  9. Subcutaneous (SQ, SC, SubQ)

Risks of Intravenous Therapy

IV therapy has several associated risks, which include:

  • Infection: Introduction of pathogens through the catheter or IV line.

  • Air embolus: Air entering the bloodstream, which can cause serious complications.

  • Bleeding: Potential for bleeding at the insertion site or internally.

  • Allergic reaction: Adverse reactions to medications administered.

  • Incompatibilities: Chemical reactions between drugs that can render them ineffective or harmful.

  • Extravasation: Leakage of IV fluids into the surrounding tissues, causing damage.

  • Particulate Matter: Tiny particles that can cause adverse effects when infused.

  • Pyrogens: Fever-inducing substances that may contaminate IV solutions.

  • Phlebitis: Inflammation of the vein due to irritation from the IV line or medication.

Types of IV Administration

There are two main types of IV administration:

  1. Infusions:

    • Continuous: Administering IV fluids or medications over a continuous period.

    • Intermittent: Administering IV medications at scheduled intervals.

IV Containers

IV administration typically utilizes several types of containers, including:

  • Large Volume Parenterals (LVPs): Used for continuous IV fluid administration, often containing dilute solutions.

  • Small Volume Parenterals or "Piggyback" Systems: Used for intermittent infusions.

  • Add-Vantage® Vial Spike Systems: For adding medications to LVPs.

  • Flexible Plastic Bags: Often used for IV solutions due to their ease of use.

  • Glass Containers: Less common, but used for certain medications.

Basic Continuous IV Therapy

In a typical setup for large volume parenteral (LVP) therapy:

  • The LVP is hung on an IV pole at a height of 36 inches above the patient’s bed.

  • Flow is maintained by gravity, utilizing sterile tubing attached to the primary IV set.

  • A catheter is inserted into the patient’s vein for administration.

LVP Solutions and Techniques

Typically, LVP solutions consist of simple combinations like dilute dextrose and sodium chloride.

  • Preparation:

    • Swab the rubber stopper with alcohol and allow it to dry.

    • Inject the drug into the fluid and then remove the bottle, ensuring proper vacuum integrity.

Non-coring Technique

When preparing IV admixtures, the non-coring technique is critical. This technique involves:

  • Proper manipulation of the needle bevel and pressure to prevent the removal of pieces of the vial stopper, which could contaminate the preparation.

Administration Systems

The methods of administering IV fluids and medications can be categorized into:

  • Continuous Infusions: These are more effective and less toxic than intermittent doses. Such methods are used for:

    • Basic fluid and electrolyte therapy

    • Blood products

    • Drugs requiring tight administration control

  • Intermittent Injections: This allows for periodic administration to increase efficacy and decrease toxicity.

Pre-Mixed Admixtures

These are commercially manufactured LVPs that contain stable additives, available in several sizes (e.g., 250 mL, 500 mL, 1000 mL).
Examples of common additives include:

  • Lidocaine

  • Potassium

  • Nitroglycerin

  • Dopamine

  • Aminophylline

Electronic Infusion Devices

Electronic infusion devices enhance the precision and accuracy of infusions, especially in fluid-restricted patients.

  • Smart pumps: Alert users to issues such as infusion settings outside the recommended range.

  • Users may receive updates on settings, and pump logs can be sent to information systems for records.

Patient Controlled Analgesia

A patient-controlled analgesia (PCA) method is highly effective for managing pain. The setup includes:

  • The patient can administer medication as soon as pain is felt, reducing nursing workload.

  • The pump may have:

    • A programmed basal rate

    • A bolus dose when the patient pushes a button

    • An example would be a maximum of 1 mg of morphine every 15 minutes. If the patient pushes the button after 10 minutes, the drug is not administered but logged to track pain control.

Unique Infusion Devices

Some infusion methods involve specialized devices:

  • Implanted Pumps: Used for continuous low-dose chemotherapy.

  • Elastomeric Infusion Device (EID): Functions as its own pump, using the pressure of a container to force drugs through tubing.

Administration Sets

The primary IV set connected to the LVP may be one of several varieties:

  • Drip Chamber: Used to estimate administration rate by counting drops; can be macrodrip or minidrip.

    • Drip Set Parameters:

    • Macro-drip sets deliver 10-20 drops per 1 mL.

    • Minidrip sets deliver 60 drops per 1 mL.

  • Control infusion rates using a roller clamp or electronic infusion device.

Venous Access Devices

Venous access devices for IV therapy can be categorized as follows:

  • Peripheral Catheters:

    • Most commonly used, but have limitations on what can be infused and at what rate.

  • Central Catheters:

    • More complex and riskier, but offer fewer restrictions regarding concentration and administration rates.

    • Can remain in place for longer periods.

Peripheral Catheters

  • Typically made of plastic for flexibility and comfort.

  • Steel needles with short tubing may be left in place if flushed properly.

Central Catheters

  • These can be temporary or permanent and provide access to veins with high blood flow.

Catheter Examples

  • Permanent Catheters:

    • Hickman®, Broviac®, Port-a-cath®.

  • PICC (Peripherally Inserted Central Catheter):

    • Inserted peripherally and threaded through the venous system, with the tip ending near the heart, allowing for high blood flow administration.

Aseptic Preparation

The program for preparing admixtures includes several essential components:

  1. Development and maintenance of strong aseptic technique among personnel.

  2. Creation and upkeep of sterile compounding areas with sterilized equipment and supplies.

  3. Continuous development of skills for effectively using a Laminar Airflow Workbench (LAFW) or laminar airflow hood.

Aseptic Technique

Aseptic technique focuses on manipulating sterile products to prevent contamination:

  • Use of the LAFW must be followed by strict aseptic practices and conscientious habits.

Sterile Compounding Area

Compounded sterile products (CSPs) must be free of:

  • Living microorganisms

  • Pyrogens

  • Visible particles

To achieve this, it is important to:

  • Minimize airborne particles by avoiding cardboard in clean rooms

  • Regularly clean work surfaces and floors

Segregation and Air Quality

  • Segregate the compounding area to minimize traffic and contamination.

  • Remove trash regularly and filter incoming air using ultraviolet irradiation and air-lock entry portals with sticky mats for additional protection.

Anteroom Utilization

  • Use an anteroom for non-aseptic activities such as:

    • Order processing

    • Gowning

    • Handling stock

  • The sterile compounding area achieves an ISO Class 5 environment, meaning no more than 100 particles per cubic foot of air that are 0.5 micron or larger. LAFWs help maintain this standard.

Laminar Airflow Workbenches (LAFWs)

Principle of LAFWs

LAFWs function by continuously sweeping the work area with filtered laminar air to prevent the ingress of contaminating room air. There are two main types:

  1. Horizontal Flow:

    • Air moves from the back to the front of the cabinet.

  2. Vertical Flow:

    • Air descends from the top.

IV Hoods

Vertical Hoods

  • Designed for the preparation of hazardous medications, protecting the preparer from exposure.

Horizontal Hoods

  • Commonly used for sterile preparation of IV solutions.

Horizontal LAFW

  • An electrical blower draws room air through a prefilter to remove gross contaminants.

  • Prefiltered air progresses through a final filter, leading to a HEPA filter that removes 99.97% of particles that are 0.3 microns or larger.

Vertical LAFW

  • Air emerges from the top to minimize exposure to airborne particulates.

  • These are typically referred to as biological safety cabinets (BSCs) and are critical for preparing antineoplastic agents.

  • The space between the HEPA filter and the sterile object is vital as it is a critical area to prevent downstream contamination, known as the zone of turbulence.

LAFW Principles

  • Position LAFWs away from high traffic areas, doors, and air vents.

  • When turned off, they must run for at least 15-30 minutes before being used again.

  • All surfaces inside should be cleaned with a 70% isopropyl alcohol solution or another disinfecting agent on a clean, lint-free cloth.

Cleaning LAFWs

To ensure the effectiveness of LAFWs, they must be cleaned regularly:

  • Frequency of Cleaning:

    • At the beginning of each shift

    • Before each batch

    • Not greater than every 30 minutes during ongoing compounding

    • After any spills or contamination is suspected

Additional LAFW Instructions

  • No items should come into contact with the HEPA filter.

  • Only essential items should be present in the hood during IV preparation; avoid items like paper, pens, labels, or trays.

  • Jewelry should not be worn on hands or wrists, and one should speak and cough away from the LAFW.

Aseptic Environment

Proper attire must be adhered to in the aseptic environment:

  • Wear covered shoes, head and facial hair, and face masks or eye shields.

  • Gowning must occur when leaving the pharmacy.

Personal Hygiene

  • Handwashing is the most common source of contamination and should be done thoroughly—scrub hands, nails, wrists, and forearms to elbows for at least 30 seconds with a brush, warm water, and bactericidal soap.

  • Gloves are considered sterile only until touching something unsterile.

Equipment & Supplies

Syringes

Essential components of syringes include:

  • Final edge of the plunger piston

  • Luer-lock tip

  • Calibration marks on the barrel

  • Top collar of the plunger

  • Flat end (lip)

Syringe Usage

When measuring volume:

  • Fill the syringe to 1/2 to 2/3 of its capacity.

  • Ensure the final edge lines up with the calibration mark on the barrel.

Needles

Components of needles are:

  • Bevel heel

  • Bevel tip

  • Hub

  • Shaft

Vials

Vial preparation involves:

  • Swabbing the rubber stopper with 70% isopropyl alcohol to normalize pressure and avoid coring.

  • Understanding reconstitution and preservative implications.

Ampules

To utilize ampules:

  • Move fluid to the body of the ampule, swab the neck, break at the neck, and ensure the needle bevel faces down while tilting to draw fluid.

Prefilled Syringes

These are ready-to-inject syringes that are convenient for emergency administration, commonly used for IM, IV, or subcutaneous application. Most often stored in patient care areas.

Preparation of IV Admixtures

The preparation process includes the following steps:

  1. Inputting the order into the computer system.

  2. Assembling all necessary materials and visually inspecting them.

  3. Cleaning the hood and placing only needed products within.

  4. Disinfecting all injection surfaces before proceeding.

  5. Withdrawing and measuring the drug fluid while ensuring no air bubbles remain in the syringe.

  6. Discarding syringes and uncapped needles as recapping is generally considered unsafe; use the one-handed scoop method if recapping is essential.

Automated Compounding

The manual preparation of sterile products can be complex with potential verification challenges.

  • Automation can help reduce preparation errors, and robotics can be utilized in high-volume operations or for specific patient doses.

Labeling of IV Preparations

Labeling should contain:

  • Patient’s full name, identification number, and room number.

  • Bottle or bag sequence number.

  • Name and amount of drugs added.

  • Name and volume of admixture solution.

  • Total volume of admixture and prescribed flow rate (in mL/h).

  • Schedule for scheduled administration along with preparation date, time, expiration date, and initials of the person who prepared/checked the IV admixture.

  • Including auxiliary labeling and bar coding is recommended.

Beyond Use Date (BUD)

Every label and final sterile product must indicate a BUD. This date should be:

  • Validated by a registered pharmacist and based on stability studies, sterility, and professional judgment in line with established policies and procedures.

Cytotoxic & Hazardous Drugs

Handling hazardous agents requires special procedures, including:

  • Precise labeling, storage, and transport protocols.

  • Specific clothing for handling, and measures for spill & waste management.

  • Further resources are available in the ASHP Technical Assistance Bulletin concerning cytotoxic and hazardous drugs.

Protective Apparel

Recommended apparel includes disposable coveralls or solid front gowns made of low-permeability, lint-free fabric suitable for hazardous drug handling.

  • Proper gloves are vital, with at least one pair worn under the gown's cuffs and the other pair over the cuffs.

  • Hand hygiene is essential before and after glove usage.

First Aid

  • Facilities must have eyewash fountains and appropriate first aid resources within areas where hazardous drugs are handled.

  • Established procedures for addressing injuries should be followed immediately, with medical attention sought without delay.

Biological Safety Cabinet (BSC)

A BSC is a specific type of vertical LAFW set to safeguard workers from hazardous agents.

  • BSCs are required to meet standards set by the NSF (National Sanitation Foundation Standard 49) and should not be used interchangeably with horizontal LAFWs for hazardous drug preparation.

BSC Specifications

The front air barrier in BSCs protects handlers from contact with drug dust and aerosols.

  • Class II BSC Types:

    • Type A

    • Type B

  • These cabinets must operate continuously and be inspected and certified every 6 months. Regular cleaning is essential for maintaining safety.

Preparing Hazardous Drugs

Preparation protocols for hazardous drugs are the same as those for regular drugs; however, additional precautions must be taken:

  • Attach and prime IV sets before integrating the hazardous drug.

  • Maintain slight negative pressure inside the vial and utilize chemotherapy dispensing pins and locking fittings on syringes and IV sets.

  • Clearly label the IV bag accordingly and place it in sealable bags to contain leaks.

Waste Disposal & Spill Cleanup

For spills, it is critical to use spill kits comprised of:

  • Protective gear, eye protection, respirators, utility and latex gloves, and disposable coveralls.

  • Clean-up procedures must follow established guidelines, including proper disposal of shards and absorbent materials.

Total Parenteral Nutrition (TPN)

TPN, also known as hyperalimentation, provides comprehensive nutritional support containing:

  • Carbohydrates

  • Proteins

  • Fats

  • Water

  • Electrolytes

  • Vitamins

  • Trace elements

TPN Therapy

TPN serves patients who are unable to eat due to various medical conditions and meets their enhanced nutritional needs.

Components of TPNs

Base components typically include:

  • Dextrose (Carbohydrates):

    • Common concentrations of 50% or 70%, max 10-12.5% for peripheral administration.

  • Amino Acids (Proteins):

    • Concentration standards are 8.5%, 10%, or 15%; customized solutions may be necessary for pediatrics or specific medical conditions.

  • Fats (Lipids):

    • Emulsions of 10% or 20% provided separately or added within a 3-in-1 solution.

Additional Components

  • Water: Essential for overall metabolic function.

  • Electrolytes: Include sodium, potassium, chloride, acetate, phosphate, magnesium, calcium prepared as specific salts.

  • Vitamins: Such as a multi-vitamin infusion (MVI) and trace elements vital for enzymatic reactions.

Example of TPN Order

A sample TPN order might include the following:

  • Dextrose 250 g

  • Amino acids 42.5 g

  • Sodium chloride 60 mEq

  • Potassium chloride 40 mEq

  • Potassium phosphate 20 mEq

  • Calcium gluconate 1 g

  • Magnesium sulfate 1 g

  • Trace elements 2 mL

  • MVI 10 mL

  • Total volume: 1000 mL

  • Infusion rate: 100 mL per hour with Vitamin K given intramuscularly weekly.

TPN Form

Using preprinted order forms can help minimize errors, and are often required in various healthcare settings, designed as per the institution’s standards.

Preparation of TPN Solutions

TPN solutions may be compounded using automated devices which provide two primary preparation options:

  1. Separate compounders for base solutions and electrolytes.

  2. One compounder to infuse all components.

Administration of TPN

  • Central line administration: Provides immediate dilution of concentrated solutions due to high blood flow.

  • Peripheral Parenteral Nutrition (PPN): Contains the same components but may not meet all nutritional needs.

Pediatric IV Drug Administration

Doses must be personalized and calculated based on the patient’s body weight.

  • Intermittent doses may be given via syringe through a volume control chamber or syringe pump to ensure accuracy while minimizing excess fluid.

  • All calculations must be thoroughly double-checked to ensure safe administration.

Epidural Administration

An epidural involves placing a special catheter in the epidural space of the spine to administer medications at the nerve endings for significant pain relief.

  • All solutions used must be preservative-free, and patient-controlled analgesia can be implemented with continuous infusions or bolus injections as needed.

Admixture Programs

An effective admixture program requires:

  • Policies and procedures, designated space, trained personnel, appropriate equipment, and systems for standard and non-standard preparations, labeling, and handling.

Quality Assurance Program

Per the ASHP’s Technical Assistance Bulletin concerning quality assurance for pharmacy-prepared sterile products, important elements include:

  • Preparation validity, expiration dating, labeling, and facility standards including equipment and personal training.

USP Chapter 797

Refers to the standards outlined in USP Chapter 797, which governs pharmaceutical compounding and sterile preparations. It provides recommendations concerning IV admixture programs, including risk classifications and policies on training, aseptic techniques, process validation, and end-product evaluation.