1. Compounding Sterile Products and Hazardous Drugs
Chapter 11
Created by Jennifer Majeske, Mineral Area College

2. Learning Objectives
Identify the role and function of equipment used in intravenous preparation and administration, including syringes, needles, intravenous sets, catheters, infusion pumps, and filters.
Identify the components of an intravenous administration set.
Describe common characteristics of intravenous solutions, including pH value, osmolarity and osmolality, tonicity, compatibility, and stability.
Created by Jennifer Majeske, Mineral Area College

3. Learning Objectives
Summarize the steps necessary for aseptic technique in a hospital pharmacy.
Describe the correct procedure used in preparing compounded sterile preparations from vials and ampules for hazardous and nonhazardous agents.
Discuss the preparation of total parenteral nutrition.
Differentiate between expiration dating and beyond-use dating.
Created by Jennifer Majeske, Mineral Area College

4. Learning Objectives
Understand the types of premade parenteral products, including vial-and-bag systems and frozen intravenous solutions, and their handling requirements.
Calculate intravenous flow rate.
Discuss the importance of and techniques for preparing, handling, and disposing of hazardous agents.
Define the purpose and list examples of quality assurance programs in the hospital.
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5. Introduction
Hospitals carry out unique activities, such as the preparation, handling, and disposing of hazardous drugs.
A major responsibility of the pharmacy tech involves compounded sterile products (CSPs).
Aseptic technique – the processes and physical preparation methods used by sterile compounding personnel to avoid introducing pathogens, into parenteral products.
Compliance with sterile compounding and aseptic technique standards established by USP. Reflected in Chapter <797> standards.
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6. Sterile Supplies for IV Preparation and Administration
Syringes and Needles: used for withdrawing or injecting solutions during the preparation of CSPs.
IV push (IVP) – bolus administration; rapid injection of a medication.
Syringes: made of glass or plastic; glass – limited use, expensive; plastic – less expensive, supplied in sterile packaging, disposable.
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7. Parts of a Syringe Main components: Syringe tip
Barrel – contains calibration marks
Rubber-tipped piston plunger
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8. Syringe Selection and Measurement
Technicians should choose the smallest syringe that is able to hold the desired volume; at least ¾ full.
Technicians should count the number of marks between labeled measurement units, to get the most accurate dose.
The volume of solution is measured at the point of contact between the rubber-tipped piston plunger and the inside of the barrel.
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9. Needles Needles are made of stainless steel or aluminum.
Needle size is determined by length and gauge.
Lengths range from 3/8 inch to 6 inches.
Gauge refers to the diameter of the opening; the larger the gauge number the smaller the opening (or size of the lumen).
31-gauge (smallest bore)
13-gauge (largest bore)
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10. Needles Parts of a Needle: Handling of the Needle-and-Syringe Unit:
Needle tip
Bevel
Heel
Needle shaft
Needle lumen
Needle hub
Handling of the Needle-and-Syringe Unit:
A syringe comes from the manufacturer in sterile packaging.
Sterile compounding personnel must not touch the sterile parts or critical sites of the syringe or needle.
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11. Handling of the Needle-and-Syringe Unit
Critical site – the part of
the supply item that
includes any fluid-
pathway surface or
opening that is at risk
for contamination
by touch or
airflow interruption.
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12. IV Administration Sets
IV administration set – a sterile, disposable device used to deliver IV fluids and injectable medications directly into a patient’s vein.
IV sets do not have expiration dates, but do contain “Federal law restricts this device to sale by or on the order of a physician.”
An IV infusion pump is nondisposable, reusable equipment often referred to as durable equipment.
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13. Components of an IV set
Universal spike adaptor (tubing spike or spike)
Pierces the rubber stopper or port of the IV
Drip chamber
Allows healthcare personnel to view and count drops of IV fluid
Roll clamp
Adjust flow rate
Flexible tubing
Delivers the fluid
Needle adaptor
Attaches a needle or catheter to the patient
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14. Components of an IV set
Universal Spike Adaptor: spike – used to pierce the IV’s tubing port; some IV sets have an air vent.
Drip chamber – hollow drip chamber; allows any air bubbles to rise to the top of the IV fluid.
Drop set – number of drops it takes to make 1 mL; also know as the tubing’s drop factor.
Macrodrip set: 10, 15, 20 gtts/mL
Microdrip or minidrip set: 60 gtts/mL
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15. Components of an IV set
Roll Clamp – a hard, plastic clip that contains a smaller roller allowing control of the flow of fluid.
Flexible tubing – IV tubing, molded from pliable PVC and other plasticizers.
Needle adaptor – usually located at the distal end of the IV set, close to the patient.
Additional Components of an IV set:
Y-site injection port – allows medication to be added to the IV solution
In-line filter – provides protection against particulates
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16. Preparation of an IV Set
Length of IV sets vary, ranging from 6 to 120 inches.
What determines length of IV tubing?
Priming – the action of flushing out the small particles in the tubing’s interior lumen before medication administration.
The amount of fluid needed to prime the tubing depends on the length of the set – 3 to 15 mL.
In-line filters has reduced the need for flushing the line with IV fluid before administration.
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17. Medication Delivery with an IV Set
Nurses typically administer IV solutions to patients by attaching the IV tubing to the fluid container, establishing flow rate, and managing overall regulation.
Catheter – tube, implanted in the patient and affixed to the patient’s skin.
IV sets are changed every 24 – 96 hours to minimize the risk of infection.
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18. Pharmacy Personnel and IV Sets
Changes in the scope of pharmacy practice make it necessary for pharmacy personnel to have a complete understanding of IV sets and their operations.
Pharmacist may:
Select IV sets
Serve on CPR or code teams
Provide in-service training
Use IV sets when transferring fluids
Prime IV sets
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19. Filters
Filter – a device used to remove contaminants such as glass, fibers, and tiny bits of rubber that may have inadvertently entered the CSP during sterile compounding.
Depending on size, filtration should protect the patient.
Filters do not remove virus particles or toxins.
Common filter sizes:
0.5 micron: random path membrane
0.45 micron: in-line filter
0.22 micron: removes bacteria to produce a sterile solution
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20. IV Solutions
Most IV preparations are comprised of ingredients added to a sterile water medium or base solution.
Certain chemical properties or characteristics are needed of these preparations so damage does not occur to the patients blood cells or vessels or alters the chemical properties of blood.
CSPs must possess chemical characteristics similar to blood serum.
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21. Chemical Properties of IV Solutions
Beyond-use date – the date and time after which a CSP is no longer sterile, stable, or effective.
pH Value – the degree of acidity or alkalinity of a solution.
Less than 7.0 = acidic
Greater than 7.0 = basic (alkaline)
Blood plasma pH 7.4
IV solutions should have a pH that is neutral (near 7.0) so they don’t adversely affect the pH of the blood.
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22. Osmolarity and Osmolality
Osmolarity – a measure of the number of milliosmoles of solute per liter of solution (mOsm/L).
Blood plasma = 285 mOsm/L
Osmotic pressure – the pressure required to maintain equilibrium, with no net movement of solution across body membranes.
Osmolality – a measure of the number of milliosmoles of solute per kilogram of solvent.
An IV preparation must be isoosmotic, meaning the solution should have the same number of particles in solution per unit volume and the same osmotic pressure as blood.
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23. Chemical Properties of IV Solutions
Hypotonic solution – hypoosmolar solution; fewer number of dissolved particles than blood cells; water is drawn into cells, causing cells to swell.
0.45% normal saline (NS)
Hypertonic solution – hyperosmolar solution; greater number of dissolved particles than blood cells; water is drawn out of cells, causing cells to shrivel.
50% dextrose or 3% sodium chloride
Isotonic solution – similar number of dissolve particles as blood.
0.9% NS
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24. Chemical Properties of IV Solutions
Compatibility – the ability to combine two or more base components or additives within a solution, without resulting in changes to the physical or chemical properties of the additives.
Stability: is affected by storage conditions; some IV medications need to be refrigerated or frozen after compounding; amber-colored bags protect the drug from exposure to light.
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25. Types of IV Solutions Multiple IV solutions are available.
Most common used IV infusions are dextrose in water, normal saline, or dextrose in saline.
Table 11.1 pg. 444 Commonly Used IV Products and Abbreviations
Technicians typically compound two types of CSPs:
Large-volume parenterals
Primary source of hydration
Small-volume parenterals
“piggybacked”
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26. Large-Volume Parenterals
Large-volume parenteral (LVP) – is used to replenish fluids and to provide drugs, electrolytes, and nutrients such as vitamins, minerals, and glucose.
LVPs commonly available:
250 mL, 500 mL, and 1000 mL
Potassium chloride is the most common additive.
Lactated Ringer’s Solution – IV solution that contains a specific mixture of electrolytes.
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27. Small-Volume Parenterals
Small-volume parenteral (SVP) – a CSP that is dispensed in a minibag; over a short time period 10 minutes to an hour.
SVPs commonly available:
25 mL, 50 mL, 100 mL, 150 mL, or 250 mL
IV piggybacks (IVPBs) – majority of SVPs prepared; small volume (50 to 100 mL) of a base solution (D5W) and a medication.
Special SVP solutions include frozen IV solutions, premade IVPBs, and vial-and-bag systems.
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28. Preparation of Labels for LVPs and SVPs
A CSP label should contain the following:
Patient’s name and id #
Room number
Medication name and dose
Base solution and amount
Infusion period
Flow rate
Beyond-use date
Signature or initials
Additional information
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29. Aseptic Preparation of IV Products
Sterile preparations of IV medications by pharmacy personnel include single- and multi-dose vials, ampules, and other containers that must be transferred to an LVP or SVP.
CSPs must be prepared in an ISO Class 5 laminar airflow hood.
Table 11.2 pg. 447 Summary of Procedures to Maintain Aseptic Technique During Sterile Compounding
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30. Specialized Sterile Compounding Procedures
Vials – a sealed, sterile, plastic or glass container that has a hard plastic cap; sizes range from 1 mL to 250 mL.
Types of vials:
Single-dose vials (SDV)
do not contain a preservative
one-time use
used within 1 hour or discarded
Multi-dose vials (MDV)
do contain a preservative
stable for 28 days
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31. Withdrawing Fluid from a Vial
First disinfect the rubber stopper with 70% isopropyl alcohol.
Pierce the rubber top with a needle-and-syringe unit.
Bevel up; penetrate at an angle; straightened to 90 degrees.
Coring – the inadvertent introduction of a small piece of rubber top into the solution.
A milking technique must be used to release negative pressure within the vial.
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32. Reconstituting Powdered Medication in a Vial
Some medications come freeze-dried (lyophilized), and need to be reconstituted with a diluent such as sterile water or NS before being injected into the IV.
Vented needle – allows the diluent to be injected into the vial while simultaneously venting the positive pressure that has built up within the vial.
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33. Preparing a CSP with a Vial’s Contents
The technician should arrange the vial, filled syringe, and the IV or IVPB base for a pharmacists final check.
The pharmacist then verifies the technicians work.
After verification the technician can proceed with preparing the CSP; checking for leaks and signs of incompatibility and labels the CSP for delivery.
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34. Ampules Ampule – a small, hermetically sealed
container that has a distinct,
elongated neck.
Contains no preservative
Some drugs are only available in an
ampule because of incompatibility with rubber
or PVC components of vials
Parts of an Ampule:
head, neck, shoulder,
and body.
Break ring – a scored area on the neck that marks the site where a technician will break the glass to access the ampule’s contents.
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35. Ampules
Opening an Ampule: safe opening of an ampule can be done with a piece of gauze, sterile 70% IPA swab or a ampule breaker a small plastic cap, placed over the head of an ampule.
Hold the ampule upright, clear the medication from the head and neck.
Clean the neck of the ampule.
Hold the ampule in the non-dominant hand, grasping the head of the ampule with the dominant hand.
Exert firm but gentle pressure on the break ring to snap the ampule’s neck.
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36. Ampules
Withdrawing Medication from an Ampule: hold the ampule upright; bevel down in the corner near the opening.
When the ampule is nearly empty, tilt the ampule slightly to allow easier access to the remainder of the medication.
A filter needle should be used when drawing medication out of an ampule to avoid glass fragments.
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37. Ampules
Preparing a CSP with an Ampule’s Contents: similar to the process of preparation for a vial so that it can be checked by the pharmacist.
The pharmacist verifies the technicians work.
After verification the technician may proceed with the making of the CSP.
Lastly, the technician will need to check for leaks and signs of incompatibility and label the CSP for delivery.
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38. Total Parenteral Nutrition Solutions
Total parenteral nutrition (TPN) – IV solutions that provide long-term nutritional support for a specific patient population.
Why might a patient need a TPN?
TPN Components: approximately 15 components including:
Sterile water for hydration
Dextrose for calories and energy
Amino acids for protein synthesis
Fatty acids for chemical processes and energy
Additives: electrolytes, vitamins, and minerals
Medication for treatment of a disease or disorder
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39. Total Parenteral Nutrition Solutions
Preparing a TPN: 1,000 to 2,000 mL to provide nutritional support for 12 – 24 hours.
Automated compounding device (ACD) – for the preparation of large volumes of TPN solutions.
IV fat emulsion is known as a 3-in-1 TPN solution.
Administering TPN: central venous catheter (CVC) – central line, into the subclavian vein – is required form the administration of a TPN.
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40. Created by Jennifer Majeske, Mineral Area College

41. Premade Parenteral Products
Premade parenteral products benefits the hospital pharmacy, the nursing staff and the patients.
These commercially available products come as:
Vial-and-bag systems
Frozen sterile IV solutions
The expiration date varies compared with standard beyond-use dating.
The expiration date is based on scientific studies and can be found on the product, and can be found on the vial or in the product package insert.
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42. Vial-and-Bag Systems
Vial-and-bag system – provides both a single vial of powdered medication with an adaptor and a specified IV solution that acts as the diluent.
Types of Vial-and-Bag Systems: ADD-Vantage (Hospira), MINI-BAG Plus (Baxter Healthcare); not considered CSPs.
Stability and expiration date varies with the type and concentration of the drug, diluent, storage conditions, and activation.
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43. Benefits of Vial-and-Bag Systems
Some of the benefits of vial-and-bag systems include less wastage, improved safety, efficiency, and cost-effectiveness.
Safety: admixing errors are minimized; risk of contamination is also minimized.
Efficiency: doses are premeasured for rapid reconstitution and easy assembly.
Cost-effectiveness: no admixing is necessary and no additional supply costs.
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44. Assembly and Activation of Vial-and-Bag Systems
Each vial-and-bag system differs somewhat, but the concept is similar.
The vial of drug – that is not reconstituted – is coupled (with or without an adaptor) with an appropriate volume of IV solution.
Assembly: the technician is responsible for assembly; performed in the hood to maintain sterility.
Activation: nursing staff is responsible for activation.
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45. Frozen IV Solutions
Commercially available products and are not considered CSPs.
Most are antibiotics and are manufactured as SVPs in a premixed frozen state.
Handling of Frozen IV Solutions: kept in the freezer until an order is received; the product is then thawed at room temp. or in the refrigerator.
Expiration date varies with the drug and storage conditions.
Ancef – expiration date of 48 hours at room temp., 30 days in the refrigerator
Zosyn – expiration date of 24 hours at room temp., 14 days in the refrigerator
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46. Hospital Pharmacy Calculations
Certain calculation skills are necessary by a pharmacy technician who prepares CSPs.
Most dosage calculations are done by the pharmacy technician.
IV flow rate is used to calculate days supply for IVs and IVPBs.
Calculation and verification differs for chemotherapy agents, neonatal IV medications and certain TPN preparations.
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47. Determining IV Administration Flow Rates
Daily IV run or batch – preparation of all CSPs needed for all patients during a specific period.
Calculations address the following questions:
What is the infusion rate in mL/hour?
Divide total volume by the number of hours: TV/H = x
How long will this bag last?
Divide the total volume by the infusion rate: TV/IR = x
What time will the next bag be needed?
Add the number of hours calculated, (x) calculated in the previous step to the current standard time
How many bags will be needed for the patient in a 24-hour period?
Divide 24 by the number of hours calculated in the previous step (x).
Examples 1-4
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48. Adding Electrolytes
Electrolyte solution – IV fluid containing dissolved mineral salts.
What is the most common electrolyte additive?
Electrolyte solutions are measure in milliequivalents (mEq).
Pharmacy technicians must use pharmacy math formulas to determine the amount of additive that must be drawn up to provide a prescribed dosage.
Example 5
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49. Hazardous Agents
Hazardous agents require special handling and preparation by pharmacy personnel.
Cytotoxic drug – any drug that destroys cancer cells.
Antineoplastic drug – reduces or prevents the growth of cancer cells.
Before 1980, there were few safety standards for handling of hazardous drugs.
There exists persistent contamination in both preparation and patient care areas.
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50. Risks of Exposure to Hazardous Agents
Trauma or injury: accidentally prick oneself with a needle or cut from a broken container
Inhalation of the hazardous substance: releasing a fine mist of medication and inadvertently inhaling the substance
Ingestion: ingest minute powder when crushing an oral tablet or cleaning a tray
Direct skin contact: accidental spill
Asparaginase can cause skin irritation
Doxorubicin can cause tissue death and sloughing
Nitrogen mustards can cause irritation of the eyes, mucous membranes, and skin
Steptozocin is a potential carcinogen if it comes into contact with skin
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51. Risks of Exposure to Hazardous Agents
Healthcare workers with exposure to hazardous agents can suffer acute, chronic and long-term health consequences.
Risks should be understood by a woman of reproductive age who routinely works with hazardous agents.
Incorrect aseptic technique may result in contamination and potential infection.
Closed-system transfer devices (CSTDs) are increasingly being used to prepare and administer hazardous drugs.
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52. Protective Clothing
USP Chapter <797> indicates the donning of protective clothing when working with hazardous agents.
The gown should be a disposable, lint-free, impervious, and closed-front.
Hair cover and shoe covers; eye protection, face mask, chemotherapy gloves worn over sterile disposable gloves (double gloving).
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53. Receipt and Storage of Hazardous Agents
Gloves need to be worn when preparing hazardous agents, as well as when receiving, stocking, inventorying, and disposing.
Storage areas should be labeled: “Caution: Hazardous Agents.”
Refrigerated hazardous agents should be stored separately from other drugs.
Access to hazardous materials should be limited to trained personnel.
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54. Equipment for Preparing Hazardous Agents
Strict aseptic techniques should be used in the preparation of CSPs that contain hazardous agents.
Biological Safety Cabinet (BSC) – a specialized hood that is used to prepare chemotherapy drugs and other hazardous compounds.
Compounding Aseptic Containment Isolator – a vertical airflow hood that is used in the preparation of hazardous drugs.
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55. Supplies Used in Hazardous Drug Preparation
Specialized Supplies:
Closed-System Transfer Devices – a double internal needle transfer with duel membranes to provide a tight seal connection.
Chemotherapy Compounding Mat – a thin mat whose side is made of absorbent material to soak up potential fluid spills within the BSC.
Chemotherapy Dispensing Pin – chemo pin – small plastic device that has a spike at one end and an adaptor at the other end.
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56. Hazardous Agents in Vials
Hazardous CSPs may need to be prepared from a vial.
If a CSTD is not available, a vented chemotherapy dispensing pin may be used to safely withdraw fluid from a hazardous drug vial.
Negative pressure techniques: no introduction of air into the vial or by introducing a volume of air that is less than the solution volume to be withdrawn.
Never inject into a hazardous drug vial more than 75% of the volume that you plan to withdraw.
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57. Hazardous Agents in Ampules
The process of withdrawing a hazardous drug from an ampule is the same as with a non hazardous drug.
A 5 micron filter needle should be place on the syringe to withdraw the solution from the ampule.
A standard needle is then used to inject the fluid into an IV or IVPB.
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58. Hazardous Oral Drugs
Hazardous oral drugs can be handled in community, home healthcare, long-term care and hospital pharmacies.
Counting and pouring of these medications should be done carefully, and counting trays should be immediately cleaned after use.
Crushing of hazardous drugs should be done by placing the medication in a small, sealable plastic bag and crushing with a spoon or pestle.
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59. Radioactive Pharmaceuticals
Occasionally prepared in a nuclear pharmacy by a specially trained and certified nuclear technician.
Handling, preparation, and disposal of radioactive agents are beyond the scope of this class and text.
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60. Priming, Labeling, and Administering Hazardous Agents
Priming and IV Administration Set:
Wipe with sterile 70% IPA
Transported in a sealed plastic bag
Priming should be done in the BSC or CACI
Labeling Hazardous Agents:
Patient’s name and room number, solution name and volume, drug name(s) and dosage, CSP administration information and storage requirements
Administering Hazardous Agents:
A nurse must wear a mask, gloves and a special gown
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61. Hazardous Agent Spills
Pharmacy personnel, in the event of a hazardous agent spill, must be aware of proper cleanup procedures and disposal.
Spill kits
Why when cleaning up a spill should you work from the outside in?
Spill, cleanup and personnel exposure must be documented.
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62. Procedures in Case of Exposure
Material Safety Data Sheet (MSDS) or Safety Data Sheet (SDS) outlines specific recommendations on how to handle exposure to a hazardous substance.
Skin exposure – flush affected area immediately; cleanse area with soap and water.
Eye contact – flush the eyes with large amounts of water.
Remove contaminated garments; wash hands; go to the emergency room.
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63. Final Inspection and Delivery to the Patient Care Unit
Inspection of CSP: accuracy; technique; packaging; labeling; physical appearance.
When combining one than more drug there is the likelihood of physical incompatibility.
Combining an acidic and alkaline salt may result in a solid precipitate.
Reference for physical drug incompatibility is Trissel’s Stability of Compounding Formulations.
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64. Delivery and Administration of CSP
Delivery of a CSP must be done without damage to the package.
Proper storage conditions must be met.
IV administration times must be documented by the nurse in the medication administration record (MAR).
Proper labeling and storage of CSPs is necessary if to be administered at a later time.
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65. CSP and Manufactured Product Returns
What if a CSP is returned? When can a CSP be re-dispensed?
CSP storage conditions must be met by the nursing unit, what happens if they are not?
What about the return of vial-and-bag systems?
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66. Quality Assurance
Quality assurance (QA) program – detect and correct errors; identify problems and try to correct them so they do not recur.
What can occur if there is a breakdown in accuracy?
The QA program is to be outline in the hospital pharmacies P&P manual.
Following appropriate aseptic technique minimizes microbial contamination.
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67. Quality Assurance in Handling Hazardous Agents
Personal training and proper handling of CSPs and hazardous agents documentation is required by USP Chapter <797> and Joint Commission standards.
What areas of training must be covered for hazardous agents?
Training must be documented and repeated each year.
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