Compounding Sterile Products

Study Unit
Compounding of Sterile Products 1

By Deborah Berlekamp, R.Ph. Reviewed By Gary Mead, R.Ph., M.H.A.
About the Author

Deborah Berlekamp, R.Ph., graduated cum laude with a five-year bachelor of science degree in 1981 from the University of Toledo College of Pharmacy in Toledo, Ohio. After graduation, she worked in a variety of pharmacy practice settings, including retail, hospital, and nursing home facilities. She has worked with and trained many pharmacy technicians while on the job. Berlekamp was the original coordinator of the Pharmacy Technology Program at Mercy College of Northwest Ohio. She also supervised the pharmaceutics laboratory in the Pharmacy Practice Department at the University of Toledo. Deborah has been a member of the Pharmacy Technician Educators Council, the American Society of Health System Pharmacists, the Ohio Society of Health System Pharmacists, and the Ohio Pharmacists Association. She is a past president of the Toledo Area Society of Hospital Pharmacists and a past president of the University of Toledo College of Pharmacy Alumni Association. She has been active at local and state levels of pharmacy organizations and maintains an enthusiastic interest in the pharmacy profession and the formal education of pharmacy technicians. Deborah currently manages the pharmacy department at The Pharm in Bowling Green, Ohio. This study unit was reviewed by Gary Mead, R.Ph., M.H.A.
This unit describes the methods used to prepare injectable drugs and parenteral admixtures in a hospital pharmacy setting. Youll be introduced to IV systems, packaged parenterals, devices and equipment, and methods of IV administration. Youll become familiar with the appearance and purpose of both small- and large-volume containers found in the IV therapy room. Youll also learn about aseptic technique and the devices, equipment, and methods used for preparation and labeling of intravenous fluids. Youll learn appropriate terminology and master necessary mathematical calculations. Examples of the most commonly made IV solutions will also be presented. When you complete this study unit, youll be able to
Explain the differences between ampules, vials, and prefilled syringes, and other container systems Describe the types of base solutions most often used in making IVPBs and LVPs Explain the labeling requirements for a final IV admixture Identify the concepts of microbial contamination and aseptic technique Explain how to use and care for the equipment and supplies used in the IV room Describe how to locate and use the practical information in package inserts for IV products Explain how to properly store medications in the IV area Discuss the differences between intermittent and continuous infusions Explain how to reconstitute and add drugs to larger volumes Describe how needles and syringes are used and identify their basic components Explain when and why to use final filtering devices
Preview
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PACKAGED PARENTERALS
Small-Volume Containers Larger Container Systems and Components Labeling of Containers
1
2 6 9
Contents
METHODS OF INTRAVENOUS ADMINISTRATION

Intravenous (IV) Infusions Intermittent Therapy Hookups Irrigations
14
14 17 19 20
DEVICES
Syringes Needles Final Filtering Devices
22
22 24 26
EXTEMPORANEOUS IV PREPARATION
Parenteral Preparation in Hospital and Home Care Settings Environmental Control Aseptic Technique
28
28 29 38
TERMINOLOGY IV CALCULATIONS
Concentrations of Solutions Reconstituted Vials Concentrations as Percentages Rate Problems Metric Conversions
47 54
54 57 59 61 63
COMMON PARENTERAL ADMIXTURES

Antibiotic Solutions Nonantibiotic Admixtures
67
67 72
SELF-CHECK ANSWERS
75

PACKAGED PARENTERALS
Youll recall from earlier study units that parenteral refers to injectable medications and fluids. The subject of injectable and intravenous fluids and medications might sound intimidating, but by the end of this study unit, youll be comfortable with the types of packaging, systems, equipment, and methods used to prepare injectable medications. In this first section well discuss the way that injectable medications are packaged. Remember that injectable medications may be given by different injectable routes of administration, depending upon the medication. Intramuscular (IM), subcutaneous (SC or SQ), intradermal (ID), and intravenous (IV) medications may come in ampules, vials, and prefilled syringes. These and all other injectable solutions must be sterile, or free from microorganisms. If microorganisms enter the bloodstream, an infection can result, causing great harm and even death to the patient. Its absolutely essential that great care in the practice of aseptic technique be used when preparing and administering parenterals, especially intravenous drugs. Aseptic technique is a special way of handling containers and supplies that prevents contamination of the final product. This technique will be discussed in detail later in this unit.
Small-Volume Containers
Ampules
Ampules are made entirely of glass and contain sterile medication in solution. The drugs contained in ampules are always in a solution. (Remember that solutions are liquids that contain completely dissolved ingredients.) These sealed glass containers are used for drugs that will interact with plastic, because the reaction can destroy the effectiveness of the drug. Ampules must be handled with great care because theyre made of such thin glass. They break easily when dropped. The shape of an ampule is similar to that of an hourglass. It has a cylindrical base that curves into an indentation that creates a narrow neck and curves out again to form an elongated cone-shaped top. The glass is very thin around the indentation, or neck, of the ampule, and all ampules must be broken at the neck area to access the medication. After the neck of the ampule is broken, the solution is then drawn into a syringe for use. Ampules are available in a variety of sizes, ranging from about 1 ml to 20 ml. The smaller 1 ml or 2 ml sizes are the most common. Ampules may be made of clear, colorless glass or of amber (brown) glass. Amber-colored glass is used frequently for medication packaging to protect the contents from light, because many drugs are affected by light.
Vials
Vials look different from ampules. Whereas ampules are made entirely of glass, vials are available in plastic or glass. The top of the vial is sealed with a rubber stopper thats held in place by a metal band (Figure 1). A needle may be inserted through the rubber stopper to either withdraw the contents or add solution to the vial (Figure 2). When the vial is packaged by a drug company, a small plastic lid is attached to the top of the vial, which must be removed before use. The lid protects the rubber stopper from damage and contamination during shipping. This lid also serves to indicate whether the vial has been tampered with.
FIGURE 1The top of a vial is sealed with a rubber stopper thats held in place by a metal band.
FIGURE 2A needle is inserted through the rubber stopper of a vial to either withdraw the contents or add solution to the vial.
Glass vials, like ampules, may be clear, or amber to protect the drug from light. Vials come in many sizes that range from 2 ml to over 100 ml (Figure 3). The most common sizes seen in the pharmacy are between 5 ml and 30 ml. Medications in vials may be in solution or in a powder form. If the medication is in a powder form, then it must be reconstituted, or mixed with a solvent (diluent) before use. The diluent dissolves the powder, and the reconstituted powder
FIGURE 3A 500 ml Size Vial
then becomes a solution. Powdered medications are usually reconstituted with sterile water or sterile normal saline thats injected into the vial. Solutions are then drawn into a syringe before use.
Prefilled Syringes
Prefilled disposable syringes contain medication in a liquid form thats ready to use. In some cases, the medication may be administered directly to the patient without any further preparation. In other cases, the medication may need to be ejected from the syringe into a larger volume of sterile fluid before administration to the patient. Prefilled syringes are useful in emergency situations because they come ready to use, so no time needs to be spent in the preparation of IV admixtures. Crash carts (emergency carts) contain medications that are needed in emergencies, and many of the drugs on a crash cart are available in prefilled syringes.
Prefilled syringes often have an outer package and may come in a box. Because the solutions have already been prepared in a prefilled syringe, this type of container is more expensive than an ampule or vial. Examples of medications that are available in prefilled syringes include sodium bicarbonate, 50% dextrose, epinephrine, atropine, isoproterenol, and phenytoin.
Larger Container Systems and Components

Ampules, vials, and prefilled syringes all contain a relatively small amount of medication in solution or in powdered form. As mentioned, some of these must be added to larger amounts of sterile fluids before use. There are three basic kinds of larger volume containers to which drugs from ampules or vials may be added: Large-volume parenterals (used for IV infusion) Small-volume parenterals (used for IVPB administration) Irrigations (used for rinsing or washing wounds or infections)
Large-Volume Parenterals (LVPs)

You already know that parenteral means injectable. The large part of the term large-volume parenteral (LVP) refers to the size of the glass bottle or plastic bag thats used to contain the injectable medication. Large volumes of solutions for injection come in a variety of sizes and types of containers. LVPs are available in the following sizes: 250 ml, 500 ml, 1000 ml, 2000 ml, and 3000 ml. The 250, 500, and 1000 ml are the most common. The containers may be made of polyvinyl chloride (PVC), a soft, flexible, yet strong plastic substance. These particular containers are referred to as bags. Viaflex bags are an example of this type of packaging. Solutions that come in Viaflex and other PVC bags must be stored in an outer wrap, or outer sleeve, until just before use. This outer sleeve provides protection from tampering, contamination, and evaporation. Youll
encounter LVPs in plastic bags made by different companies. The appearance of the bags may be slightly different, but the basic function is the sameto deliver IV fluids to the patient. As common as they are, PVC bags should not be used when the drug being addedsuch as cyclosporineis capable of solutionizing components of the bag. In these instances, a container made of ethylene vinyl acetate (EVA) should be used. The plastic bags have a hole at the top that allows them to be hung from a pole during preparation and use. There are two projections called ports located at the bottom of the bag. One port has a small rubber tip through which IV drugs may be added with a needle. The other port is covered by a small piece of blue plastic. This is where the IV administration tubing, or any transfer tubing, can be attached. The small piece of plastic protects against tampering and is removed just before tubing is attached. (Well discuss tubings later in this section.) LVPs may also come in glass or hard plastic containers. Glass containers are used when adding drugs that interact with plastic, which would destroy the effectiveness of the drug. The glass bottle has a wire at the bottom that allows it to hang from a pole for administration. Glass containers may or may not be vented. A tube inside the container acts as a vent, allowing air to flow back into the container as the medication is being administered to the patient. As fluid leaves a flexible plastic container, the bag collapses, as when a balloon loses air. Glass containers obviously cant collapse, and a vacuum is formed when the solution leaves the bottle. The vacuum becomes stronger as more solution leaves the bottle. If the glass container doesnt have a vent, vented administration tubing can help prevent a vacuum from forming. Plastic and glass containers are also available empty, without any solution in them. These empty containers are sterile and are used for special preparations. Empty glass containers called evacuated containers already have a vacuum created inside the bottle, so that solutions are easily transferred into them.
Small-Volume Parenterals (Piggybacks)

Intravenous piggyback (IVPB) containers have the same general appearance as LVPs except that theyre smaller in size. Most IVPBs are either 50 ml or 100 ml in size. Theyre sometimes referred to as minibags. Some piggybacks are 25 ml and a few are 250 ml. The containers used most often are made from PVC, as are the larger bags that we discussed. Minibags also have a plastic hole at the top so they can hang on a pole, and two ports at the bottom. Again, one port is used for adding drugs with a needle, and the other is sealed with a plastic covering thats removed immediately before attaching the administration tubing. See Figure 4 for types of solutions available in the containers. IVPB solutions are available as base solutions or as premixed solutions. The base solutions dont contain any active medication. Theyre intended to dilute the medication from a vial or ampule. (Well discuss the technique for doing this later.) The premixed IVPB solutions already contain active medication. Premixes are convenient but are more expensive than base solutions and may require special storage conditions. Many premixes must be kept frozen until use and take up storage space.
Type of Solution
Dextrose 5% in water
Synonyms
5% dextrose 5% glucose in water D5 D5W
Sizes Available
Large volume: 250, 500, 1000 ml Piggyback: 25, 50, 100 ml
0.9% sodium chloride
Normal saline 0.9% NaCl
Large volume: 250, 500, 1000 ml Piggyback: 25, 50, 100 ml Large volume: 250, 500, 1000 ml
Dextrose 5% & 0.9% sodium chloride
D5 & 0.9 D5/NS
Dextrose 5% & 0.45% sodium chloride Dextrose 5% & 0.33% sodium chloride Lactated Ringers solution Dextrose 5% & Lactated Ringers solution
D5 & D5 & LR D5LR
1/2 1/3
Large volume: 250, 500, 1000 ml Large volume: 250, 500, 1000 ml Large volume: 250, 500, 1000 ml Large volume: 250, 500, 1000 ml
FIGURE 4Common Base Solutions Used for Large- and Small-Volume Parenterals for Intravenous Use
Labeling of Containers
All ampules, vials, prefilled syringes, and other packages containing drugs or fluids for injection will have the following items on the label from the manufacturer: The generic name of the medication or fluid (The brand name shouldnt be used; however, if it is used, it should be placed in parentheses following the generic name.) The strength and amount of medication or solute The lot number and expiration date of the product Precautionary comments such as For IM use only or Not for IV use Directions for proper storage of the medication The federal caution labelCaution: Federal law prohibits dispensing without prescription. (Nearly all injectable drugs require a prescription or physicians order for use.) The directions for mixing and dilution, either on the label itself or in the package insert
Brand and Generic Name

You should recall from previous study units that all medication containers must be labeled with the name of the medication. This is also true for ampules, vials, and larger volumes of fluids. The name of the manufacturer or distributor of the medication must also be on the package. The manufacturer is the company that actually makes the drug, and the distributor is the company that markets, or sells, the drug.
Strength and Amount

All drug packages, including those in solution in ampules, vials, and other fluids for IV use, must be labeled with the strength and amount of medication. If the drug is in powder form, the label will state how much drug is contained in the vial, expressed in metric weights such as grams or milligrams. If the drug is in solution form, the drug strength can be expressed in the following ways:
Weight of drug per volume of solution (e.g., mg/ml) Percentage (e.g., 5%) If the drug is in solution, the total volume, or amount, of liquid is also given on the label. Remember that the strength, or weight of drug per volume, still remains the same even if the total volume of liquid may change.
Lot Number and Expiration Date

For safety and the protection of the public, the lot number and expiration dates must be listed on the container of the product. You may have already learned that a lot number is the number assigned to a batch of product when its made. If the need arises, the exact date and time of manufacture of a drug may be determined from the lot number. This identification can be important if a question arises as to the safety or effectiveness of a drug. Drug recalls can occur when doubts about safety, strength, effectiveness, or contamination have been expressed. The recall order will identify specific lot numbers of products that are being recalled. Drugs are very seldom recalled, but the ability to do so accurately and quickly is extremely important when public safety is at stake. An expiration date is assigned to every packaged drug product. This date is similar to the use by date on food products. Drugs can lose their potency over time. Nothing in the pharmacy should be used past its expiration date.
Precautionary Comments
Precautionary comments are frequently seen on injectable containers. You might assume that a drug contained in a vial or ampule may be given IV, but this assumption is extremely dangerous. Many drugs contained in vials or ampules are for intramuscular (IM), subcutaneous (SC or SQ), or other use. These drugs should not be given intravenously, and would cause harm to the patient if given that way. Bold lettering that declares Not for IV use or For IM use only is a helpful reminder that prevents accidents.
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Directions for Proper Storage

All drugs, including those in vials and ampules, have specific storage requirements. These directions are explicit about the temperature range and light sensitivity of the medication. Most drugs kept in the IV room are stored at controlled room temperature, which is defined as 5986F (1530C). Some drugs must be kept refrigerated or frozen between 3646F (28C).
Federal Caution Label

The law requires that the following warning appears on drug containers: Caution: Federal law prohibits dispensing without prescription. Injectable drugs, with few exceptions, require a prescription or physicians order before theyre administered to a patient.
Directions for Mixing and Dilution

Sometimes the package label contains brief directions for the reconstitution and further dilution of the drug contained in a vial. If the instructions are too long or complicated to place on the label, a package insert will provide detailed instructions for dilution and use. A package insert is a separate piece of paper that describes the characteristics, uses, prescribing recommendations, precautions, mixing and dilution instructions, compatibilities, and available sizes and strengths of that drug. A package insert comes with every medication product. With parenteral medications, the technician will be concerned mostly with the mixing, dilution, and compatibilities of the drug with various solutions.
The Final Pharmacy Label

The final pharmacy label is placed on the container before the container is distributed to a patient. The final label, which can be typed or computer generated, should contain the following information: Patient name and room number (or home-care location) Name and concentration, amount, or strength of drug(s) used
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The name of the base solution the drug has been placed in The final volume of the preparation Date and time preparation was made The expiration date and other storage information (such as stable for seven-day refrigeration) The rate at which the IV fluid is to be administered Any other special instructions that will be helpful for proper administration The labels on the large-volume containers obviously are able to contain quite a bit of information. Labeling on vials and syringes can be more difficult. If all of the necessary information wont fit on a small label, at least the name, room number, drug, strength, amount, and date should be placed on the label thats attached to the syringe or vial. The syringe or vial can then be placed in a zippered plastic bag, which may be labeled with more complete information for administration. Its important to note that the expiration date of the final product will be different from the expiration dates assigned by the manufacturer to the individual drugs or solutions used. Once a container has been manipulated or entered by a needle, the expiration date of the final product becomes close to the date it has been prepared. The actual date depends upon the type of final product (ranging from less than one day to approximately one month). The final expiration date also depends on how the product will be stored after preparation. Many IV fluids made in the pharmacy must be refrigerated, and may even be frozen, after preparation. Take a few moments now to complete Self-Check 1.
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Self-Check 1
At the end of each section of Compounding of Sterile Products 1, youll be asked to pause and check your understanding of what youve just read by completing a Self-Check exercise. Answering these questions will help you review what youve studied so far. Please complete Self-Check 1 now. 1. Which of the following best fits the description of a large-volume parenteral? a. b. c. d. A A A A glass container with a cylindrical base and an elongated top containing a drug in solution plastic container that holds a solution or powder for reconstitution glass bottle in the 50100 ml size Viaflex container in the 2501000 ml size
2. Which of the following best fits the description of an intravenous piggyback solution? a. b. c. d. A A A A glass container with a cylindrical base and an elongated top containing a drug in solution plastic container that holds a solution or powder for reconstitution PVC container in the 50100 ml size Viaflex container in the 2501000 ml size
3. Explain the differences between vials, ampules, and prefilled syringes.
__________________________________________________________
4. Explain what kind of information is found in a package insert. Which parts of the package insert will a pharmacy technician most likely use?
__________________________________________________________
5. What kind of information is found on the manufacturers label of a larger-volume container (piggybacks and large volumes)?
__________________________________________________________
6. What kind of typed or computer-generated information should be placed on the final IV container before dispensing to a patient?
__________________________________________________________
Check your answers with those on page 75.
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METHODS OF INTRAVENOUS ADMINISTRATION

Intravenous (IV) Infusions
Intravenous infusions are fluids or solutions that drip into a patients vein through a needle and tubing at a constant rate. Special solutions are needed for intravenous administration. To prevent serious health complications, the fluids must have the following characteristics: Be sterile, or free from microorganisms Have approximately the same pH as body fluids (This refers to the acidity of a solution.) Have approximately the same concentration of particles, or solutes, that human blood and body fluids contain These solutions are isotonic; that is, they usually have the same isotonicity (concentration of particles) as body fluids. Some solutions are hypertonic, and others are hypotonic, as compared to body fluids. Hypertonic fluids have a higher concentration of particles dissolved than body fluids, whereas hypotonic solutions have a lower concentration of particles than body fluids. IV fluids are used to treat patients for a variety of conditions. This treatment is called both infusion therapy and intravenous therapy. Intravenous infusions are normally used in the following situations: When patients need rehydration When patients need electrolyte replacement When patients need drugs that require larger volumes for dilution When patients need additional nutrition
Infusions for Patients Needing Rehydration

Dehydration is a serious condition. The blood in the body cant circulate properly without an adequate amount of
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fluids. When the body is dehydrated, it has lost much of the fluid it needs to function. If a patient is unable to drink enough water or other fluids to maintain proper function, intravenous fluids can help. There are several ready-made solutions used for rehydrating the body.
Infusions for Electrolyte Replacement

Our bodies need many electrolytes (which are salts) in the right amounts in order to function properly. Our nerves, our heart, and our brains use electricity, and the electrolytes provide the electricity our bodies need. If a patient cant obtain the necessary electrolytes through normal eating and drinking, electrolytes can be given by the IV infusion route. (Some examples of common electrolytes can be found in Figure 23 in the last section of this unit.)
Infusions for Drug Dilution

So far weve discussed infusion therapy for basic rehydration and electrolyte replacement. Intravenous infusion also may be needed to further dilute drugs before administering them to a patient. Two reasons drugs may need further dilution are that (1) the drug causes irritation in a more concentrated form and (2) the drug may even be poisonous if not further diluted. If a drug usually causes redness or pain when its given, further dilution will help prevent the irritation. A toxic, or poisonous, drug may be more safely administered when given very slowly. Dilution in a large volume of fluid allows the slow administration of the drug, preventing unwanted side effects that may occur during more rapid administration.
Infusions for Nutrition

Patients who either cant eat or are underweight need to receive nutrition in other ways besides eating and drinking. Specialized IV solutions referred to as total parenteral nutrition, or TPN, solutions can be made that provide all the nutrients a body needs to survive if the patient cant or wont eat. These solutions are complicated and arent available ready to use. Many micronutrients must be added to a base solution, including carbohydrates, proteins, fats, vitamins, minerals, and electrolytes. (These additives will be discussed in depth in another study unit.)
Compounding of Sterile Products 1 15
Rate of Infusion
Intravenous infusions, as youve learned, are sterile solutions, usually in large volumes, that drip into a patients vein at a constant rate. This procedure is referred to as a continuous infusion. The patients physician knows the needs of the patient and will decide why the infusion is needed, which fluids to use, and how much is needed. The infusion rate is the rate at which an infusion is given to a patient through the IV tubing. The rate is determined by the physician. The rate of infusion depends upon the drug, the solution, and the needs of the patient. Infusion rates are usually expressed in milliliters per hour, abbreviated as ml/hr. IV infusion rates can range from about 10 ml/hr to over 200 ml/hr, depending on the solution or medication thats being used. See Figure 5 for an example of a physicians order for an IV infusion. In Figure 5, the rate at which the dextrose 5% in water is administered to the patient is 40 ml/hr.
PHYSICIANS ORDER FORM Jones, Mary
Room 4111
#961271030
Age 70
10-24-96 11:00 A.M.
Begin D5W 1000 ml at 40 ml/hr
FIGURE 5Physicians Order Form
Dr. John Smith
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Intermittent Therapy
Intermittent intravenous therapy is the opposite of continuous intravenous infusion. Intermittent means from time to time or at regular intervals. This implies that the IV isnt running continuously into the patients vein, but that the solution is given periodically. As with oral and other routes of administration, intermittent intravenous medications are given on a schedule. The drug may be given one time only, once a day, every 6 hours, every 8 hours, every 12 hours, and so on. Intermittent therapy may even be given once a week or once a month, depending on the drug and the patient. Both intravenous piggybacks and IV push (IVP) drugs are given intermittently. These two types will be discussed next.
Piggyback Method
Weve discussed the package size of intravenous piggybacks already. IVPBs arent used for continuous infusion; theyre given by intermittent infusion. The entire contents of an IVPB are usually given to, or infused into, a patient over a 15- to 60-minute period. This is done to avoid vein irritation or to give the drug at a slower rate than IV push. Some drugs require a longer period of administration. When the entire contents of the bag have been given, the dose is complete for the time being. Another IVPB is given to the patient at a later time, depending on how often the drug must be administered. IVPBs are used to dilute drugs that come in ampules and vials before giving them to the patient. Once a drug is added to an IVPB solution in an institutional setting, its sent to the nursing unit and administered to the patient according to the physicians prescription. Its usually piggybacked into, or given to the patient through the port at the Y-site of the primary tubing from the large-volume parenteral. (This setup is considered to be a little bit like giving a piggyback ride to a youngster, hence the name IV piggyback.) The drug from the ampule or vial is added by a pharmacist or technician to the base IVPB solution. Base IVPB solutions are either 5% dextrose in water (D5W) or 0.9% sodium chloride (NS). The fluids in IVPB containers, either D5W or NS, must be compatible with, that is, must not react with, any
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drug thats added to it. D5W and NS are isotonic, have the approximate pH of human body fluids, and are also compatible with most drugs. The most common sizes of IVPBs are 50 ml or 100 ml, but they also come in 25 ml or 250 ml. The type and size of IVPB solution chosen depends on the drug and the strength that will be diluted, and can be determined from reading the package insert. For ease and efficiency of preparation, many IV therapy rooms in hospitals provide charts that show the sizes and types of IVPB solutions used for the most common IV drugs. Figure 6 is an example of a basic chart that may be used. When looking at this table, keep in mind that most of the drugs made in the IV therapy area of the pharmacy are antibiotics, which come as powders in vials. These powders must be reconstituted before further dilution in the piggyback container.
FIGURE 6Some Common IVPB Drugs, Solutions, and Sizes
Drug and Strength Ampicillin 500 mg Ampicillin 1 g Cefazolin 1 g Cefazolin 2 g Erythromycin 500 mg Erythromycin 1 g
Type of Solution 0.9% NaCl (NS) 0.9% NaCl (NS) 5% Dextrose (D5W) 5% Dextrose (D5W) 0.9% NaCl (NS) 0.9% NaCl (NS)
Size of Piggyback 50 or 100 ml 100 ml 50 ml 100 ml 50 or 100 ml 250 ml
In home care, the type and size of IVPB solution also depends on the stability of the drug. Often, a seven-day supply of medication or more can be sent to the patients home. Systems are used to mix the drug in the home without compromising sterility. Examples of these include the ADDVantage System and the MINI-BAG Plus Container. These are then administered by the caregiver according to the physicians prescription.
Direct IV Push
Some drugs need no further dilution before IV administration to a patient. The drug solution is drawn up into a syringe and may be injected into the port on the primary tubing, as mentioned earlier. The nurse pushes the plunger of the
18 Compounding of Sterile Products 1
syringe, thereby expelling the contents of the syringe into the IV tubing. IV push drugs may be in solution in ampules, vials, or prefilled syringes. They may also be in powder form in a vial, which must be reconstituted with normal saline or sterile water before being given IV push by the nurse.
Hookups
Even though the pharmacy is concerned mainly with supplying intravenous medications, its a good idea for you to know how IV infusions are given to a patient. When an IV infusion is given to a patient, its first hung on an IV pole. The pole is constructed to keep the IV bag elevated. One end of an administration tubing is attached to the IV solution. The other end of the tubing has a needle thats placed in the patients vein by a nurse. IVs are hooked up to the patient using IV tubing. There are different types of tubings available, but all have some basic components. Every type of tubing has a spike, a small pointed plastic end thats inserted into the IV bag. A small piece of plastic may cover the udder (port) on the bag that receives the spike. Spiking the bag allows the fluid from the bag to flow through the tubing. A needle is attached to the opposite tip of the tubing. Tubings are often referred to as sets, because they contain several components: spike, tubing, needle, and hanger. These sets are stored in boxes until use. Tubings are also referred to as lines. Anytime you hear IV line, youll know that it refers to the tubing that connects an IV bag to a patient. Although there are hundreds of different kinds of tubings, the pharmacy is concerned with only a few types. The tubings used in the pharmacy for product preparation are used to transfer solutions from one large container to another container when necessary. These are called transfer sets or tubings. Patient administration tubings are different from the transfer tubings used in the IV room. Each type of tubing used for patients has a different-sized opening at the end. The opening at the end of the tubing determines the size of the drops of fluid that come out. Each tubing delivers a different number of drops per milliliter. Some drugs, like morphine or heparin,
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Subcutaneous infusionThe injection of fluid into tissue just beneath the skin.
are given by subcutaneous infusion. These require a special port (called a Sub-Q port) as well as special tubing. Pharmacy technicians dont need to be concerned with the size of the tubings, except when the pharmacy is the supplier of tubing to the hospital. If this is so, be sure to read the box correctly to supply the right type of tubing. The basic tubings used for patients are either primary or secondary tubings. The tubings used for LVPs that will be given by continuous infusion are called primary tubings or primary sets because the tubing carries fluids from the primary, or main, solution to the patient. Secondary tubings, or secondary sets, are designed for IVPB use. These tubings also have a spike that enters the piggyback container at the udder. The other end will have a needle that will enter a port located on the primary tubing called the Y-site. The port at the Y-site on the primary set can receive the needle from the tubing on the secondary set. This allows the solution from the IVPB to flow into the same tubing thats attached to the patient.
Irrigations
Although irrigations arent given intravenously, all irrigations must be made under sterile conditions in the hospital. An irrigation is used to wash something. Irrigations arent injected into the vein, but should be free from microorganisms. Irrigations may be made of plain sterile water or normal saline, or medications may be added to the sterile water or normal saline. In healthcare situations, sterile irrigations are often used to wash wounds or infected areas of the skin, eye, bladder, or other parts of the body. Irrigation containers have labels that state that they may only be used for irrigation. Irrigation solutions may not be used for injection. Other labels may be placed on irrigation bottles to make sure that the irrigation isnt used for injection.
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Self-Check 2
1. How is the rate of an IV infusion usually expressed? a. In milliliters b. In hours c. In milliliters per hour d. In milligrams
2. Which of the following choices best describes the characteristics that a fluid for IV administration should have? a. It must have a small volume, be sterile, and match approximate isotonicity and pH of the human blood and body fluids. b. It must have a secondary set, be sterile, and always be given IV push. c. It must be sterile and match approximate isotonicity and pH of the human blood and body fluids. d. It must always be given IV push and match approximate isotonicity and pH of the human blood and body fluids. 3. The tubing used to administer LVPs to a patient is called a. primary tubing. b. secondary tubing. c. a transfer set. d. a needle set.
4. The tubing used to administer IVPBs to a patient is called a. primary tubing. b. secondary tubing. 5. Explain in general terms what an electrolyte is. c. a transfer set. d. a needle set.
__________________________________________________________ __________________________________________________________
6. What two methods are used to administer intermittent IV therapy to a patient?
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DEVICES
Specific equipment is required to prepare and administer injectable drugs. Various types of syringes, needles, and filtering devices are used when working with parenterals.
Syringes
Syringes are needed to both prepare and administer IV medications. The pharmacy is concerned with the preparation of IV medications, and personnel who work in the IV admixture area must be familiar with the different kinds of syringes used to prepare the drugs in that area.
General Description
Syringes are made of hard plastic or glass, and come in many sizes. There are three basic parts to a syringe: the barrel, the plunger, and the tip (Figure 7). The barrel of the syringe holds the liquid. The plunger may be pulled to draw up fluid into the barrel and pushed to expel the contents of the barrel into an IV tubing or into another container. The tip of the syringe is where the needle is attached. Some types of syringes already have the needle attached, and some dont.
FIGURE 7A syringe consists of three basic partsthe barrel, the plunger, and the tip.
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The tip of the syringe may be a catheter tip or a luer lock tip. A catheter tip syringe is a straight and smooth cone that comes to a point. A needle is attached only by firmly pushing the needle and syringe together. Friction helps to keep the needle attached. A luer lock tip syringe has threads like those found on a screw or a jar lid. The needle is attached by twisting it onto the syringe tip until it locks in place. (Well discuss types of needles a little later in this section.) Every syringe has markingscalled increments or graduations on its side that indicate the volume of solution that it may contain. These markings make it possible to measure volumes in milliliters and fractions of milliliters. If the syringe is large, the heavier marks designate the 5 ml or 10 ml points and the lighter marks measure single milliliters. On smaller syringes, the heavy marks measure the single milliliters and the lighter or smaller marks measure fractions of a milliliter. Each smaller increment usually designates 0.1 ml or 0.2 ml, depending on the syringe. These markings allow very precise measurements of small volumes of solution. Even more precise measurement can be obtained from insulin and tuberculin syringes. (Insulin and tuberculin syringes will be discussed separately.) Syringes range in size from 0.5 ml to 60 ml. The syringe you choose to use when making IV admixtures will depend on the volume of solution that youll be reconstituting. Most syringes are packaged in blister or bubble packs. This familiar type of packaging looks like a plastic bubble or blister firmly attached to a thick paper backing. The backing is labeled to indicate the size and type of syringe. The blister pack protects the syringe from contamination before use, so the syringes should always be stored in their original packaging. Syringes shouldnt be opened until immediately before theyre ready to be used. Once a fluid is drawn up into a syringe, the fluid is usually transferred to another container, such as a large-volume parenteral (LVP) or an intravenous piggyback (IVPB). Sometimes, medications are drawn up into syringes and sent to the patient care area for use by a nurse. In essence, the pharmacy creates a prefilled syringe for the nurse. When this is done, the syringe must be capped. All syringes come with a cap. The
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syringe may be capped, or, if the needle is attached, the needle is capped. There are different types of syringe caps, but they all perform the same functionto protect the contents from contamination.
Insulin and Tuberculin Syringes

Insulin syringes are small syringes (1 ml or less in size) with very small attached needles. These syringes are given to patients along with the drug insulin, which is used to treat the blood sugar condition called diabetes. Many diabetics know how to give themselves insulin injections and must use these very small syringes to measure the correct amount of insulin. The syringe helps the patient to know how many units of insulin to inject. Tuberculin syringes are also very small syringes with needles attached to them. Theyre often used in patient care areas of the hospital and in doctors offices. Tuberculin syringes are used to inject a very small volume of tuberculin test solution under the skin. This test will show if the patient has, or has had, tuberculosis. In addition to their primary intended use, insulin and tuberculin syringes are also used in the IV admixture area when very small volumes of other drugs need to be measured.
Needles
Cannulae are very small tubes that aid in the administration of intravenous medication. Needles belong to this category of devices. There are other types of cannulae that will be discussed after youre introduced to needles. Needles are the only cannulae that are used in preparation of IV fluids, but other types of cannulae are available for administering IV fluids to patients. Needles are placed at the end of a syringe or tubing. The needle can be described as having a shaft, a bore (or lumen), and a hub. The shaft of the needle is the long metal part. The tip of the shaft is cut at a slant, or beveled. This beveled tip allows the needle to easily pierce the surface of the skin or rubber stopper on a vial. The hub of the needle is the part that attaches to the syringe.
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The bore (or lumen) of the needle is the hole that the solution travels through. There are several different sizes of bores. Some are very large to make it easy to draw up thicker liquids into the syringe or expel them from the syringe. Midsized-bore needles are the kind that are usually used in the IV admixture area. Some needles are very slender, like a thin straight pin, with bores that are very small. Small-bore needles are used to minimize pain upon injection into the patient. Small-bore needles are rarely used in the pharmacy. Sizes of needles are expressed in gauge size and length. The larger the gauge size, the smaller the bore. The smaller the gauge size, the larger the bore. The smallest gauge (largest bore) needle is around 12 gauge, and the largest gauge (smallest bore) is around 24 gauge. The length of a needle shaft ranges from about 1/2 inch to over 3 inches. As a pharmacy technician, youll use syringes and needles to prepare IV admixtures. The bore size of the needle used is usually between 16 and 19 gauge. This size allows most fluids to flow freely from the vial to the syringe, or from the syringe into a larger volume. Smaller-bore needles make it difficult to transfer drugs in solution. Larger-bore needles, however, can be a source of coring. Coring is what happens when a piece of a rubber stopper (a core) is removed by the needle and contaminates the solution. Coring can also be caused by inserting the needle through the rubber stopper of a vial at an improper angle. Any solution being admixed in the pharmacy must always be checked for cores, even if care has been taken not to cause coring. Like syringes, needles are packed individually in blister packaging to protect them from contamination. The needle should be kept in this package until just before use. Additional measures for protecting against contamination include the use of needleless systems, which help minimize the risk of hepatitis or HIV transmission.
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Final Filtering Devices

A final filtering device is a needle, disk, tube, or administration device thats used to remove particulate matter from a solution. Particulate matter refers to any substance in an IV solution thats undissolved. Filtering devices are occasionally needed to remove unwanted particles from the solution. Filter needles are used after removing solution from an ampule. When breaking open ampules, tiny particles of glass may get into the solution. The filter needle is used to withdraw the solution from the ampule. Its then replaced with another needle before the solution is expelled from the syringe. Its important to note, however, that some drugs should never be used with filtered needles. Filter tubes or straws are like needles, except that theyre plastic and cant be used to transfer the solution into a larger volume. These are rarely used but are available for special uses. A filtering disc, such as a 0.22 micron filter, may be attached to a syringe or tubing to remove microscopic particles, including most bacteria. This type of disk has two openings. One opening attaches to the syringe, and the other end may be left open or have another needle attached. The solution from the syringe is expelled through the disk and may be injected into another container. This process is frequently used to sterilize, or remove bacteria from, intravenous products. Some intravenous administration tubings have in-line filters built into them. These are useful when nurses administer solutions that tend to react easily with other solutions. An in-line filter is the final checkpoint for intravenous fluid administration, and there are some drug package inserts that specifically state to use an in-line filter with the drug. The pharmacist should be familiar with the few drugs that have this requirement in order to alert the nurse to be adequately prepared.
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Self-Check 3
1. Name the three parts of a syringe.
__________________________________________________________
2. How is the volume in a syringe measured?
__________________________________________________________
3. Describe a catheter tip syringe.
__________________________________________________________
4. Besides their intended use to measure insulin and tuberculin tests for patients, what else are insulin and tuberculin syringes used for?
__________________________________________________________
5. Name the parts of a needle.
__________________________________________________________
6. How is the size of the bore of a needle expressed?
__________________________________________________________
7. Name four kinds of final filtering devices.
__________________________________________________________
8. What size of filtering disc is needed to remove bacteria from a solution?
__________________________________________________________
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EXTEMPORANEOUS IV PREPARATION
Parenteral Preparation in Hospital and Home Care Settings
Now that youre familiar with the basic types of supplies and products used in the making and administration of intravenous therapy solutions, youre ready to learn how to use these products to make IV admixtures. Making IV admixtures is sometimes referred to as extemporaneous IV preparation. Extemporaneous preparation basically refers to anything thats made or compounded outside the walls of the manufacturing plant. In this section youll be introduced to the supplies, equipment, and sterile technique used to prepare IV preparations . Youll learn the specific methods of diluting drugs, withdrawing the drugs, and adding the drugs to other containers. An important thing to remember is that a medication in an ampule or vial is sometimes given directly to the patient after being drawn up into a syringe with a needle. The pharmacy may be asked to prepare only the syringes containing medication withdrawn from ampules or vials. The pharmacy will also use contents from ampules and vials to add to larger volumes of solution as required. Pharmacists and technicians preparing intravenous medications in a hospital pharmacy work in the IV therapy room where IV admixtures are prepared. Because drugs in ampules and vials are added to larger volumes of solutions in the IV therapy room, its sometime referred to as the IV-add area. Intravenous admixtures are those preparations that result after careful addition of drugs to larger volumes of solution. These products must be free from microorganisms and other contaminants, and are therefore called sterile products. Other types of sterile products are also made in the IV room.
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Accurate and timely preparation of drugs for IV use often means life or death to a patient. Errors are unacceptable in the IV room. Once a drug is given by the IV route, it cant be taken back out. As a pharmacy technician working in the IV room, you must be a motivated, conscientious, and responsible individual. Youll help the pharmacist make many different kinds of IV preparations. Youll be diluting drugs in vials using syringes and needles. Youll be adding drugs to large volumes of solution. Youll use aseptic technique to prevent microbial contamination of the products you make. Youll be relied upon to perform accurate calculations. Youll label the final containers as to their final ingredients. All of this must be done in an accurate and timely manner. All IV products made must have double and triple checks at each stage of preparation.
Environmental Control
The IV room where admixtures are made must meet specific standards of cleanliness. The standards of cleanliness are established and enforced by organizations such as the Joint Commission on Accreditation of Health Care Organizations (JCAHO). These standards are set to ensure that bacterial and any other contamination of intravenous products will be avoided. These standards have evolved over time. As you read about some of the standards discussed, remember that these standards werent always in place and that some institutions dont strictly enforce them even now. As part of your responsibilities, youll be entrusted to see that the standards are being followed. As mentioned, all products prepared in the IV room must be sterile and free from bacteria. Many kinds of bacteria and viruses exist and are often referred to as microorganisms, or microbes. Some are more harmful to the human body than others. Some microbes cause many kinds of illnesses.
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Other types of bacteria live on the outside of our skin. If any microbe enters the body by coming into contact with blood or mucous membranes, it can cause an infection. Infections inside the body can be dangerous and life-threatening. Microbes multiply very quickly, and even one bacterium can divide into trillions within a couple of days. When a bacterium or virus enters an injectable solution, this condition is called microbial contamination. If an injectable product containing microbes is given to a patient, the microbes can multiply inside the patients body and cause a severe infection. Infection of the blood, called septicemia, can cause death. Obviously, contamination of injectable products must be completely avoided. This is done using special equipment and aseptic technique. (Aseptic technique will be described in detail a little later in this section.) Bacterial or viral contamination of sterile products can occur in many ways. Microbes can be carried into the area on clothing, skin, and hair and can then be transferred to the product. They may be growing on other surfaces in the IV room, like the counters, floors, and sinks. Dust and lint floating in the air may contain microbes. Microbes may exist on the surfaces of the ampules, vials, and other containers. Touching tips of needles or syringes to the skin or to any other surface contaminates the solution. If the container is cracked or leaking, microbes can easily enter the contents. Although its rare, contamination may even occur at the manufacturer level, prompting recalls of the product. Great care must be taken to ensure that microbial contamination isnt a problem. There are a number of considerations and procedures to follow to ensure that the standards of cleanliness in the IV room are maintained.
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Work Area
The work area (IV room) must be separate from the rest of the pharmacy. It should have a wall or partition that prevents airflow from other areas from reaching the IV room. Many hospitals dont allow non-IV room personnel to walk beyond a designated point in the room. Although the types of IV rooms vary from institution to institution, minimum standards must be met. Some institutions use a clean room, in which special HEPA (high-efficiency particulate air) filters are installed in the ceiling and air circulation grates in the floor. Entrance into these rooms is prohibited unless personnel have met all preparation requirements. Youll learn more about clean room specifications a little later in this study unit. All supplies kept in the IV room should be clean and free of lint and dust. Cardboard storage boxes shouldnt be allowed. All boxes in the room that contain supplies and drugs should be made of metal, plastic, or other material that doesnt produce dust.
Surfaces
All surfaces in the IV room must be cleaned frequently with an antimicrobial substance, such as alcohol or other disinfectant. Floors, counters, and other surfaces should be cleaned regularly. The surfaces of products (the rubber stoppers of vials and larger containers, and necks of ampules) must be swabbed or sprayed with alcohol before use. No surface that has been swabbed should be touched with fingers or contaminated in any way. If the surface of a product has been touched after swabbing or if youre uncertain whether its been touched, reswab it. If its a needle or a product that cant be swabbed, throw it away.
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FIGURE 8Technicians must wear the proper attire when working in the IV room.
Clothing/Apparel
All persons entering the IV room must wear clothing that hasnt been exposed to the outside or must wear a clean lab coat. Many personnel wear scrubs and sterile surgical attire (Figure 8). Lab coats and scrubs are made of relatively lint-free material that doesnt easily absorb or shed bacteriacontaining particles. Many hospitals require IV room personnel to wear latex gloves and coverings for their hair, face, and feet.
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FIGURE 9Technicians working in the IV room must follow the correct handwashing procedure.
Handwashing
Handwashing in the IV room is a strict requirement. This procedure is considered to be one of the first lines of defense against the spread of microorganisms. All personnel must thoroughly wash their hands with an antimicrobial cleanser such as chlorhexidine (Hibiclens) or povidone-iodine (Betadine) for at least 15 seconds upon entering the IV room (Figure 9). They also must wash their hands before beginning any preparation procedure and every time they return to the preparation area after leaving. IV room workers use a plastic brush to scrub under their fingernails, and they never touch the faucet or handles with their bare hands after washing. The water faucet should be turned off while holding a paper towel.
Behavior, Apparel, and Makeup

Food, drink, and chewing gum arent allowed into the IV room. While in the process of preparing admixtures, talking should be avoided. Talking not only distracts a person from the work being performed, but microscopic spittle can contaminate both
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the product and work surfaces. Jewelry must be kept to the bare minimum. Large rings or earrings, nose rings, necklaces, watches, and bracelets shouldnt be permitted in the IV room. Bacteria can grow in the crevices on jewelry, so it can be a source of contamination. Leave these items at home. In most institutions, IV personnel are permitted to wear small dot earrings and a wedding band. Makeup, especially mascara, can also be a problem in the IV room because it can flake off and contaminate the area.
Laminar Flow Hoods

Laminar flow hoods provide a clean work area by filtering microorganisms and other particles out of the normal room air. A laminar flow hood is the special area in the IV room where sterile admixtures are prepared. The principles previously discussed must be followed while working inside a laminar flow hood. Although available in different sizes and models, there are two basic types of flow hoods: the horizontal flow hood and the vertical flow hood. The hood, which resembles a cabinet, is a partially enclosed boxlike area with a counter. A pole, with hook rings, is located near the back and top of the hood. It reaches from one end of the hood to the other. This pole can hold the bags and bottles to which the drugs are added. An example of a vertical flow hood can be seen in Figure 10. Horizontal laminar flow hoods. The majority of admixtures in the IV room are prepared in horizontal flow hoods. A HEPA filter is located at the back of the hood. Air circulates from the top of the hood, behind the filter, and comes out in a horizontal direction toward the worker. Over 99.7 percent of the particles larger than 0.3 micron in size are caught in the filter, reducing the risk of airborne contaminants in the hood area. Vertical laminar flow hoods. A vertical flow hood is very similar to the horizontal hood, except that the air flows in a vertical direction. The HEPA filter is located at the top of the hood, and airflow is from top to bottom. Vertical flow hoods are used to prepare cytotoxic drugs, which are those that may be harmful to healthy human tissue. Cytotoxic drugs include cancer chemotherapy drugs that are used
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to treat cancer cells. The worker needs to be protected from any stray particles or droplets containing the cytotoxic drug. The vertical airflow prevents these particles from being blown toward the worker. The hoods also have a Plexiglas front, providing a clear window that further protects the worker from the drugs being prepared inside the hood. Technicians and pharmacists in this area must use even more specialized techniques when preparing products. If employed in this specialized area of pharmacy, youll receive training according to the policies and procedures in place in the institutions pharmacy department.
FIGURE 10Vertical Flow Hood
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Care of laminar flow hoods. Laminar flow hoods run continuously. If theyre turned off for some reason, they must be allowed to run for at least 30 minutes after being turned back on before being used again. The filters in the hoods need to be changed every month. The hoods themselves must be inspected and certified regularly to prove that theyre working properly. Records must be kept in the pharmacy to show that this is done. The laminar flow hoods must be cleaned regularly. A thorough cleaning with an antimicrobial cleaning solution should be performed every day. Before every work shift and after each preparation, the hood should be swabbed with isopropyl alcohol. Use cheesecloth that has been saturated with the alcohol to wipe the counter of the hood. A back-to-front and side-to-side (not circular) motion should be used. Isopropyl alcohol in a spray bottle may also be used to spray the counter, which is wiped in the same motion as described. All metal surfaces should also be washed. If there are sticky substances on the surface of the hood (from spills), the surface should first be washed with an antibacterial cleaning solution, rinsed, allowed to dry, and then swabbed again with isopropyl alcohol. The Plexiglas sides and front should not be cleaned with alcohol. These surfaces should be cleaned with another antibacterial cleanser. Also, dont spray alcohol at the filter or it will be damaged.
USP 797
New pharmacy regulations that govern the preparation of sterile products are being implemented as of this writing. USP 797 is a far-reaching regulation that governs a wide range of pharmacy policies and procedures. Its designed both to cut down on infections transmitted to patients through pharmaceutical products and to better protect staff working in pharmacies in the course of their exposure to pharmaceuticals. Issued by U.S. Pharmacopoeia (USP), the regulation governs any pharmacy that prepares compounded sterile preparations. Many pharmacies fit this description, and many large
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hospitals have several pharmaciesa main one and several satellite pharmaciesthat will be affected. The USP has the authority to set regulations on how drugs are mixed during the manufacturing and compounding process for both sterile and nonsterile products. The cleanliness of the air in the area in which the compounding is done is now classified and regulated by the International Standards Organization, better known as ISO. These standards now replace the old method of determining how many particles are in the air. Here are some more facts about USP 797: The Food and Drug administration gave the United States Pharmacopoeia the authority to regulate the way that sterile compounding areas are to be designed and built. The way the items are prepared and the purpose of their preparation are divided into low-, medium-, and highrisk categories. For example, mixing three ingredients or fewer in a conventional laminar flow area is considered low risk, while products that involve many ingredients and take a long time to mix fall into the medium-risk category. Personnel who prepare compounded sterile products must be provided with appropriate training from expert personnel, audio-video instructional sources, or professional sources before beginning to prepare products. Clean rooms must have an anteroom but dont need to be separated with a physical wall. Air classification or quality must meet ISO Class 8 standards. Walls, floors, fixtures, and ceilings should be smooth, impervious, free of cracks/crevices, and nonshedding. Surfaces should be resistant to damage from sanitizing agents.
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Aseptic Technique
The following procedures embody the practice of aseptic technique. We cant emphasize enough how important it is that everything possible be done to ensure a sterile product. Its essential to practice aseptic technique while working in the IV room.
Setting Up
Start with a clean hood and wash your hands and glove as weve described. Before beginning the admixture process, gather all materials that youll need: drugs, syringes, needles, bags, tubings, and alcohol swabs. All of the materials should be located on metal carts in the IV room (Figure 11). This prevents any contamination of clothing or hands after handwashing has taken place. Wash your hands again after youve gathered all your supplies because the packaging materials arent sterile. When working in a laminar flow hood, youll either stand or sit in front of it. Place all the products youll need at the center of the hood. Keep your hands and arms toward the center of the hood. Place all products (vials, ampules, bags, bottles, alcohol swabs, syringes, and needles) side by side, keeping them six inches from the front edge of the hood and away from the sides and back. None of the products should touch one another. Arrange all items so that the airflow isnt obstructed; that is, none of the items should be placed in front of any other drug or supply in the hood. Sometimes youll be working with many supplies (ampules, vials, bags, or bottles) in the hood at once. Other times you may only need one or two. The more supplies youre working with, the greater the chances of contamination.
FIGURE 11The materials you need should be located on metal carts in the IV room.
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You must now handle the drugs and supplies without touching any unnecessary surface. Remove all drugs and supplies from their protective coverings. Carefully remove the outer wrap from needles, syringes, and any IV bags. Discard these quickly without touching the surface of the refuse container with your hands. Once you remove a needle or syringe from the outer wrap, carefully replace it in its original position, side by side with the other supplies in the hood. Be very careful not to touch the tips of the needles or syringes to the surface of the hood. Attach the needles to the syringes. Once the needles and syringes are back in place, you may begin opening the ampules or vials that contain the drugs and diluents. (Remember, a diluent is the liquid, such as sterile water or normal saline, that may be needed to reconstitute a powdered drug.) The following steps demonstrate the withdrawal of solution from an ampule.
Using Ampules
As already mentioned, all work must be done six inches inside and away from the back and sides of the hood. When breaking open ampules, you must be careful not to allow anything to block the clean airflow to the surface of the container. This includes any bags or bottles hanging from the pole and your own hands or fingers. First, remove an alcohol swab from its package. Swab the neck of the ampule using the tips of your fingers to hold the swab. Make sure that you move the swab completely around the neck of the ampule. To avoid being cut and to avoid contaminating the product, you must use the proper technique to break open the ampule. Hold the ampule firmly in both hands away from your face and eyes. Your left and right thumbnails should meet each other at the neck of the ampule. Using a quick and firm snapping motion and, applying pressure from the thumbs, snap the ampule in an outward direction at the neck (Figure 12). Its usually very easy to break open an ampule, but a few practices with an inexpensive ampule will probably be necessary to perfect your technique.
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FIGURE 12Always wear gloves when you break open an ampule.
Before the medication from an ampule may be used or transferred to another container, you must withdraw it from the ampule into a syringe with an attached needle. Because microscopic glass fragments may enter the medication solution when the ampule is broken, a filter needle must be used to remove any glass particles that may have fallen into the medication. Using your thumb and forefinger, remove the cap from the filter needle. Carefully set the cap down on the hoods surface in its original place. Dont block airflow. Holding the ampule in one hand, use the thumb and forefinger of your other hand to insert the needle into the ampule until the bevel of the needle is below the surface of the solution. The needle will be upside down. At this point, use your thumb to depress the plunger of the syringe so its completely down. Now, use the thumb of the same hand to pull back on the plunger to withdraw the fluid from the ampule. Draw back on the plunger until the correct amount of fluid is in the syringe. Since the syringe will be upside down, its difficult to determine the exact volume of fluid in the syringe. You must set down the ampule and hold the syringe upright. A large bubble and smaller bubbles of air may rise to the surface of the liquid in the syringe. Tap the syringe gently to force any more air bubbles to the surface. Then push the plunger until the black mark at the end of the plunger is even with the volume you need.
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Once you have the correct volume, you must change the needle on the syringe before you transfer the drug into another container. To do this, carefully replace the cap on the filter needle without touching the surface of the needle. Do this slowly so that you dont poke yourself with the needle. Remove the capped needle from the syringe. You should still be holding the syringe in one hand, exposing the tip to clean airflow. With your free hand, pick up the needle youre replacing the filter needle with. Place it on the syringe with its cap still in place. To add the contents of the syringe to another container, such as a bag, hang the bag from the horizontal bar in the hood. Alternatively, you may place the bag sideways on the surface of the hood so that the clean air is flowing over the port. Swab the rubber port of the IV bag with an alcohol wipe. Uncap the needle on the syringe and hold the needle under the bag thats hanging from the pole (or lying on the hood surface). Carefully insert the needle into the tip of the rubber port, being careful not to pierce the sides of the port or the container. Slowly depress the plunger of the syringe, expelling its contents into the bag. If youre putting the additive into a glass vial rather than an IV bag, you must first remove the tamper-evident metal wrap from the top of the bottle. Remove the metal disk without blocking airflow to the top of the bottle. Underneath the metal disk is a thin rubber shield, or diaphragm. Insert the needle into the shield and inject the drug into the bottle. Figure 13 demonstrates the correct method for inserting a needle into a glass vial. Once youve injected the contents of the syringe into the larger volume (bag or bottle), you must shake the final solution gently to ensure complete mixing. When all additives have been injected and the solution is thoroughly mixed, youll place a small foil sticker on the port. The sticker discourages nursing staff from adding drugs to the prepared solution in the patient care area.
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FIGURE 13Carefully insert the needle into the rubber shield, being careful not to core the rubber.
Using Vials
Prepare a syringe as you did for withdrawing fluid from an ampule. When opening a vial you must work carefully so that you handle the vial without disturbing airflow to any other package in the hood. With your thumb, flip off the protective cap(s) of the vial in the hood to expose the rubber stopper. Remember to do this without disturbing airflow to any other supplies.
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Withdraw the liquid medication from the vial by inserting a needle through the rubber stopper and into the solution (Figure 14). Often the contents of a vial are in powder form that must be reconstituted. In this case, you must first withdraw sterile water or normal saline from another vial and inject the proper amount into the vial containing the powder. Recap the needle, and place it carefully back on the hood. When you recap a needle, you must ensure that the outer part of the cap doesnt touch the shaft of the needle.
FIGURE 14To withdraw the contents of a vial, insert the needle through the rubber stopper and into the solution.
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After youve added liquid to the powder in the vial, you may need to gently shake the vial until all the powder is dissolved. The resultant solution may be withdrawn using the same syringe, unless the syringe was contaminated while recapping. You must use strict sterile technique when doing this. Dont block airflow to the needles. Dont place your hands or any object in front of vials or ports under the hood that will receive the injection. To summarize what weve covered up to this point, aseptic technique in a sterile compounding area includes the following procedures: Start with clean products, areas, apparel, and hands. Work six inches inside the front of the hood and away from the back and sides. Swab all surfaces of ampules, vials, and rubber stoppers of larger volumes with isopropyl alcohol. Never block airflow to any surface. Never touch the needle insertion point on a rubber stopper with your hands. Never touch the needle or syringe tip to any surface other than the insertion point.
Final Inspection
Weve discussed that most drugs prepared by the pharmacy in the IV admixture area are in solution. Solutions are clear and free from particulate matter. This is a very important distinction. Particulate matter can be described as solids, or precipitates. A precipitate is what forms when two or more incompatible drugs are mixed in a solution, or when a drug is added to an incorrect base solution. The precipitate is a solid chemical that forms when the incompatible ingredients come into contact with each other. The appearance of a precipitate depends upon the ingredients. It may appear as a fine, snowlike substance, usually white or yellow in color. It may also appear as general cloudiness, causing the clear solution to have a foglike appearance.
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Cores (pieces of rubber stopper), undissolved drug, lint, dust, precipitates, or any solid are considered to be particulate matter. If a solution containing extra particulate matter is administered to a patient, he or she can become very ill. Any particle, if large enough, can block a blood vessel and cause brain or heart damage and even death. Its usually obvious when a precipitate forms, but each and every solution made in the IV admixture area must be visually inspected (looked at very closely) for any evidence of a precipitate or other solid particulate matter. If a core or piece of dust or lint is present in the solution, a final filtering device may be used to remove it. If a cloudy precipitate has formed, the solution should be discarded and the pharmacist must determine the cause of the precipitate. These occurrences should rarely take place if workers are careful to exercise aseptic techniques and good pharmacy practice. Occasionally, youll work with sterile parenteral suspensions. A suspension, by definition, contains undissolved solids. A suspension is cloudy, not clear. You must be aware of the injectable drugs that will have this cloudy appearance after preparation. There are only a few, and Primaxin, an antibiotic, is one of them.
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Self-Check 4
1. What does the acronym HEPA stand for?
__________________________________________________________
2. How often must HEPA filters be changed?
__________________________________________________________
3. What distinguishes a vertical laminar flow hood from a horizontal laminar flow hood?
__________________________________________________________
4. Describe good handwashing technique.
__________________________________________________________
5. Describe the proper attire in an IV room and explain its importance.
__________________________________________________________
6. Describe the ways in which bacterial contamination may occur in an IV room.
__________________________________________________________
7. What could happen to a patient if a contaminated IV product is administered?
__________________________________________________________
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TERMINOLOGY
The following words are commonly used in compounding sterile products. You may refer to these words as a good review. airborne Refers to anything thats carried in the air, such as airborne contaminants like dust or bacteria. alcohol, isopropyl A type of alcohol thats commonly used to clean and sterilize surfaces in the IV room. It may be sprayed, poured, or used as prepackaged individual wipes. All surfaces such as countertops, hood counters, and rubber stoppers should be swabbed with isopropyl alcohol before use. ampule A small glass package, usually from 1 ml to 20 ml, containing a drug in solution. It has an elongated shape that becomes very narrow at the neck, where it must be broken to withdraw the contents. antibacterial Refers to anything, such as a solution or cleanser, that kills bacteria or inhibits bacterial growth. aseptic technique A set of specific practices and procedures performed with the goal of minimizing contamination by pathogens. Aseptic technique is used to prepare sterile products to prevent contamination of the final product. Aseptic technique involves the observance of a no-touch policy. Sterile surfaces such as needles, the plunger and tip of syringes, and rubber stoppers shouldnt make any contact with fingers, hands, or any other surface other than to add or withdraw solution through an intended opening. Sterile airflow filtered through the laminar flow hood shouldnt be blocked by hands or supplies at any time. bacteria Living microscopic organisms that can cause infection and disease. bacteriostatic sodium chloride 0.9% A diluent used in IV product preparation that contains mostly sterile 0.9% NaCl for injection and a small amount of chemical, called a bacteriostat, that inhibits bacterial growth within the vial. This product is usually available in small vials (1030 ml).
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bacteriostatic water A diluent used in IV product preparation that contains mostly sterile water for injection and a small amount of chemical, called a bacteriostat, that inhibits bacterial growth within the vial. This product is usually available in small vials (1030 ml). chemotherapy The procedure of using drugs to treat cancer. The drugs used are called cytotoxic agents, antineoplastics, and cancer chemotherapy agents. chemotherapy flow hood See vertical laminar flow hood. chlorhexidine gluconate An antibacterial cleanser that can be used in the IV room for hand and surface cleansing. (A common trade name is Hibiclens.) clean room A separate room in an institution where a high level of cleanliness must be maintained with strict adherence to dress code limits placed on personnel who are admitted. Also a separate walled-off area within a larger room that maintains air quality by major reduction in airborne contaminants using HEPA filters in the ceiling. compounding The act of mixing two or more ingredients to prepare a final product. contamination The introduction of bacteria or particulate matter into a sterile product. controlled room temperature The normal temperature range of a room, between 59F and 86F or between 15C and 30C. The temperature shouldnt be permitted to fall below or rise above the range limits. core A piece of rubber stopper that may break off and enter a sterile solution. This breakage is caused by improper needle insertion or large-bore needles. diluent A substance thats mixed with a powder to dilute it into a liquid such as a solution or suspension. The most common diluents used in preparing IVs are sterile water for injection, bacteriostatic water for injection, sterile normal saline for injection, and sterile bacteriostatic normal saline for injection.
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electrolyte A salt, made up of positive and negative ions, that the body needs to perform certain electrical processes such as impulse transmission through the brain, nerves, and heart. evacuated container A glass container that has little or no air inside, creating a vacuum. Large volumes of IV solution may easily be transferred into an evacuated container. extemporaneous compounding See compounding. filtering device (final filtering device) Any deviceincluding filter needles, discs, and in-line filtersthat filters out bacteria or unwanted particulate matter from a solution. flow hood See laminar flow hood. HEPA filter A filter used in hoods and clean rooms that can filter out particles, including dust and bacteria, that are 0.3 microns or more in size. These filters help to maintain an area relatively free of airborne contaminants. hood See laminar flow hood. horizontal laminar flow hood A hood that uses a HEPA filter placed at the back of the cabinet, allowing the sterilized air to flow toward the worker in a horizontal direction. This is the type of hood that most admixtures are prepared in. hyperalimentation An IV solution thats made to give nutritional therapy to patients who are unable to eat enough food to keep them well. The solution contains many ingredients that increase the number of particles in solution, causing the solution to be hypertonic, hence the name hyperalimentation. Also referred to as hyperals. hypertonic The designation used for a solution thats more concentrated (i.e., contains more particles or solute) than normal blood or body fluids. hypotonic The designation used for a solution thats less concentrated (i.e., contains fewer particles or solute) than normal blood or body fluids. intermittent From time to time, or on a regular schedule such as every 6, 8, or 12 hours. Not continuous. intravenous (IV) Entering by way of the vein.
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isotonic The designation used for a solution thats the same concentration (i.e., contains the same number of particles or solute) as normal blood or body fluids. IV admixture Any preparation containing two or more ingredients thats intended to be given as IV therapy and is mixed in the pharmacy. IV infusion A method or product used to administer large-volume IV fluids (2503000 ml) at a relatively slow continuous rate. IV piggyback (IVPB) A method or product used to administer intermittently smaller volumes of IV fluids (50100 ml) containing drugs. IVPBs are usually given through a secondary tubing into the Y-site of a primary tubing thats attached to a large-volume continuous infusion. If theres no continuous infusion, IVPBs may sometimes be given as intermittent infusions directly into a needle attached to the patient. IV push (IVP) A method of IV administration that uses a syringe containing a drug in solution, without the further use of larger volumes. The plunger is depressed over a very short period of time (one second to five minutes) into the patients vein or tubing. IV therapy The use of drugs that are given through the IV route. IV therapy room The clean area in the pharmacy thats set apart as a place to make sterile products. laminar flow hood A cabinet used in an IV room to make sterile products. It permits clean air, which is sterilized by passing through a HEPA filter, to flow over, in, and around the inside of the cabinet, creating a work area thats relatively free from airborne contaminants. This is the area in which IV admixtures are prepared in the IV room. large-volume parenteral (LVP) A product made for IV infusion, usually between 250 ml and 3000 ml. microorganism Any microscopic bacteria, virus, or fungus. needle A cannula used in the preparation and administration of intravenous products. It consists of three parts: the shaft, the bore, and the hub.
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parenteral Refers to a method of or product for injection (e.g., a parenteral route, a parenteral admixture). povidone-iodine A cleanser or solution used in handwashing, cleaning, and sterilizing surfaces in the IV room. (A common trade name is Betadine.) precipitate Any unwanted solid matter in an IV solution thats formed by the reaction of two chemicals. prefilled syringe A syringe that contains medication in solution that has been added during production at the manufacturer. primary set See primary tubing. primary tubing Administration tubing thats used to give a continuous intravenous infusion to a patient. pyrogen Any item or chemical in an IV solution that may cause a fever in a patient. reconstitute To mix or dissolve a powder with a diluent. secondary set See secondary tubing. secondary tubing Administration tubing used to give an intermittent IVPB infusion to a patient. solution A liquid containing completely dissolved ingredients. An IV solution is completely sterile and contains ingredients that may be given by the intravenous route. solvent A diluent used to dissolve something and create a solution. sterile product Any sterile preparation made in the IV room, including IVs (LVPs, IVPBs, syringes), irrigations, and other products that should be free from microorganisms. sterile sodium chloride 0.9% A solution of 0.9% NaCl thats free of microorganisms. Also referred to as sterile normal saline (NS) or just sterile saline. Sterile saline for injection differs from sterile saline for irrigation in the strictness of packaging and use. Its also free from the preservative thats used in bacteriostatic saline for injection. It can be used as a diluent or as a base solution for drugs to be added for IV infusion.
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sterile water Water thats free from microorganisms and contaminants. Sterile water for injection differs from sterile water for irrigation in the strictness of packaging and use. Sterile water for irrigation doesnt contain the preservative thats used in bacteriostatic sterile water for injection. Sterile water for injection is normally used as a diluent, but not as a base solution for IV infusion. suspension A drug product that intentionally contains undissolved particles of drug. There are a few IV products and other sterile or injectable products that are available as a suspension. These should be shaken before use. syringe An instrument thats used to measure and prepare relatively small quantities of IV drugs that are to be added to larger volumes or to be administered directly to the patient by IV push with the use of an attached needle. A syringe is composed of three parts: the barrel, the plunger, and the tip. vertical laminar flow hood A hood that has the HEPA filter located at the top of the cabinet, allowing sterilized air to flow from top to bottom in a vertical direction, protecting the worker from cytotoxic drug particles. This is the type of hood in which cancer chemotherapy drugs for injection are prepared. Viaflex A type of flexible plastic (polyvinyl chloride, or PVC) thats used to make many sizes of IV bags. vial A small container made of glass or plastic that contains a sterile drug in solution or powder form, which is intended to be used for addition to larger volumes of fluid or direct IV push by withdrawing into a syringe. virus A type of microorganism that isnt considered to be a living thing but can cause disease.
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Self-Check 5
Match the terms on the left with their descriptions on the right. Indicate your choices in the spaces provided. ______ ______ ______ ______ ______ 1. antineoplastics 2. isopropyl alcohol 3. laminar flow hood 4. 0.3 micron 5. polyvinyl chloride a. Area where most IV admixtures are prepared b. Size of particle filtered out by a HEPA filter c. Prepared in a vertical laminar flow hood d. Material used to make flexible bags e. Used to swab surfaces in the IV room
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IV CALCULATIONS
Concentrations of Solutions
Because solutions are being made in the IV room, calculations mostly involve the use of ratio and proportion-type problems. The concentration of a solution is often expressed as a ratio and proportion. For practical purposes, the concentration of any solution is the total weight of the powder or drug divided by the total volume of the solution. For example, ampicillin oral suspension is available in the concentration of 500 mg/ 5 ml. An ampicillin IV solution, after reconstitution, can be 1 gram/10 ml. Almost every liquid product (solution or suspension) that you deal with will have its strength expressed as a concentration. When dealing with concentrations in solution, in means the same as per, which means the same as divided by, which means the same as over. These terms all mean the same thing (Figure 15).
10 mg per ml can also mean: 10 mg in 1 ml 10 mg 1 ml (10 mg divided by 1 ml) 10 mg/ml or 10 mg/1 ml (10 mg over 1 ml) 250 mg per 5 ml (which is also the same as 50 mg per 1 ml) can also mean: 250 mg in 5 ml 250 mg 5 ml (250 mg divided by 5 ml) 250 mg/5 ml (250 mg over 5 ml) 1 gram per 10 ml can also mean: 1 g in 10 ml 1 g 10 ml (1 g divided by 10 ml) 1 g/10 ml (1 g over 10 ml)
FIGURE 15Equivalent Expressions
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To help you to read and then set up the math for the example problems that well be doing together, its useful to say the following sentence to yourself, emphasizing the words that are in italic type: Concentration is usually expressed in weight per volume, weight in volume, weight divided by volume, and weight over volume. This way of looking at problems will help you to use the words and concepts in the following examples to mathematically set up your calculations. All ratio and proportion problems are set up in the same way. The numbers are arranged in fraction form. If you do these problems the same way each time, youll always obtain the right answer. Each problem should be done stepwise (step 1, step 2, etc.), as the following examples illustrate. Example 1: One gram of a drug is in a total of 10 ml of solution. How many grams of drug are in 2 ml of the solution? Solution: Step 1. Always put the weight (in this case, grams) over the volume (ml) in fraction form (remember that 1 g in 10 ml is the same as 1 g over 10 ml). Place an equal sign next to the fraction like this:
1g 10 ml
Step 2. On the other side of the equal sign, place the other fraction. One of the numbers in this fraction will be the unknown, which well represent by x. This is the answer youre looking for. Always place x directly across from the other number that has the same kind of units, such as grams or milliliters. In these examples well find x, or solve for x. Set up your equation like this:
1g xg = 10 ml 2 ml
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As you can see, the same units are directly across from each other. Grams are directly across from grams (both are numerators), and milliliters are directly across from milliliters (both are denominators). Step 3. Cross multiply to solve for x. To cross multiply, you must multiply the numerator from one side of the equation by the denominator of the other side, making the problem look like this:
1g xg = 10 ml 2 ml
1 2 = 10 x 2 = 10x Youll notice that we dropped the units for the time being. Well put the correct unit with the answer when weve finished our calculations. Step 4. To solve for x, we need to have x by itself on one side of the equation. Divide each side of the equation by 10 to get 2 = 10x 2 10 = 10x 10 0.2 = x 0.2 g = x Since x needs to be in gram units (see step 2), your answer is 0.2 grams. Therefore, the answer to the original question is that 2 ml of solution will contain 0.2 grams of drug. Always remember to use the same units in your calculation as are given in the problem. The question asked for grams, so you set up your calculations to find the answer in grams. If this problem had asked for the answer in milligrams, even though the concentration was given to you in grams per milliliter, you could convert (i.e., change) your final answer in grams to milligrams by taking what you just did one step further. You need only to convert 0.2 grams into milligrams by using what you know about conversions (Figure 16).
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Weights 1 kilogram (kg) 1 gram (g) 1 milligram (mg) 1 microgram (mcg) = 1000 grams (g) = 1000 milligrams (mg) = 1000 micrograms (mcg or mg) = 1000 nanograms (ng) Volumes 1 liter (L) = 1000 milliliters (ml)
FIGURE 16Conversions within the Metric System
(Note: A milliliter is equivalent to a cubic centimeter or cc or c3) 1 deciliter (dL) = 100 milliliters (ml)
Since there are 1000 milligrams per 1 gram, it can also be said that there are 1000 mg in 1 gram, 1000 mg over 1 gram, or 1000 mg divided by 1 gram. If the question had asked for the number of milligrams in 2 ml, you could still set up your problem in the same way, using fractions and ratio and proportion for an answer in grams as you did in steps 1 through 4. For step 5, set up the problem in fraction form again, instead putting the milligrams across from milligrams, and grams across from grams. This is the principle of ratio and proportion. Step 5. Convert 0.2 g to milligrams.
1000 mg x mg = 1g 0.2 g
Cross multiply: 1000 0.2 = 1 x Solve for x: 200 = x Your answer is 200 mg, which is the same as 0.2 grams, the answer in step 4.
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Reconstituted Vials
Not all drugs in the IV room are already in solution. Some are sterile powders that must be reconstituted, or mixed. You must keep in mind that the final volume of a reconstituted solution may not be the same as the volume of diluent that was added, because the powder takes up some space in the vial. For example, cefazolin comes in a powder for reconstitution. The 0.5 g vial size must be reconstituted using 2.0 ml of diluent. The final volume of the mixture is approximately 2.2 ml. The approximate concentration of the solution is 225 mg/ ml (0.5 g 2.2 ml = 227 mg/ml). This information is in the package insert. Remember, the concentration of any solution is the total weight of the powder or drug divided by the total volume of the solution. Example 2: You need to reconstitute an antibiotic. The concentration in the vial will be 2 g in 5 ml once its mixed with 4.7 ml of diluent. You want to withdraw from the vial a certain amount of solution that contains only 0.5 g of antibiotic. How many milliliters will contain 0.5 g? Solution: Step 1. Set up the problem in fraction form (2 g in 5 ml is the same as 2 g over 5 ml). Then place grams across from grams and milliliters across from milliliters:
2g 0.5 g (total volume) = 5 ml x ml
Step 2. Cross multiply: 2x = 0.5 5 2x = 2.5 Step 3. Solve for x: x = 1.25 ml Your answer is that 1.25 ml of solution will contain 0.5 g of drug. This is the amount of solution youll need.
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Example 3: What is the final concentration of a solution that has 3 g of powder and a total solution of 9 ml? Solution: Step 1. Set up the problem:
3g =x 9 ml
Step 2. Solve for x: 0.33 g per ml = x This is the concentration, expressed in grams per milliliter.
Concentrations as Percentages
Not all concentrations are expressed as weight over volume. Many times large-volume solutions are expressed as a percentage. For example, weve discussed isotonic sodium chloride, which is 0.9% sodium chloride. When a concentration is expressed in this way, its assumed that the sodium chloride (or whatever the substance) is in water, unless otherwise stated on the container. Therefore we can safely assume that a 0.9% solution of sodium chloride contains only two ingredients: salt (sodium chloride, NaCl) and water. This is also true for dextrose solutions. A 5% dextrose solution contains two ingredients: glucose (dextrose) and water. The percentage actually refers to the solute (in these cases, sodium chloride or dextrose). Remember that the solute is the substance (powder or drug) thats dissolved, the solvent is what the solute is dissolved in, and the solution is the entire product. Percentages can be turned easily into a weight over volume expression. Just remember that percentage can be expressed as follows: x percent solute is x g in 100 ml of solvent. In other words, 0.9% sodium chloride is 0.9 g in 100 ml of water.
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5% dextrose is 5 g in 100 ml of water. Now, you may be asking yourself, But what if I have 1000 ml of these solutions? The answer is, no matter how much you have, the concentration will be the same throughout the solution. The total amount of dissolved substance may be more in a 100 ml bag than in a 1000 ml size, but in each and every 100 ml of the solutions in our examples, theres 0.9 g of NaCl or 5 g of dextrose. You can easily calculate the total amount of solute when a percentage is given if you (1) remember that percentage of a weight in volume solution is grams per 100 ml and (2) set up the problem in ratio and proportion, as weve described. Example 4: How many total grams of sodium chloride are there in a 1000 ml bag of 0.33% solution? Solution: Step 1. Set up the problem. Remember, always put your grams over milliliters first, then grams across from grams. (Hint: 0.33% is the same as 0.33 g per 100 ml.)
0.33 g xg = 100 ml 1000 ml
Step 2. Cross multiply and solve for x: (0.33)(1000) = 100x 3.3 g = x Your answer is that there are 3.3 g of sodium chloride in a 1000 ml bag of 0.33% solution. Example 5: How many total grams of dextrose are there in a 50% syringe thats 10 ml in size? Solution: Step 1. Set up the problem. (Hint: 50% is the same as 50 g in 100 ml.)
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50 g x = 100 ml 10 ml
Step 2. Cross multiply and solve for x: (50)(10) = 100x 500 100 = x 5=x Your answer is that a 10 ml syringe of 50% dextrose contains a total amount of 5 g of dextrose. You can use this same process when answering the opposite type of question. Example 6: What is the percentage of a solution if youve dissolved 8 g in 20 ml of solute? (Hints: Remember that 8 g in 20 ml is the same as 8 g over 20 ml. If you set up the problem so that x is over 100 ml and is expressed in grams, then x will be the percentage.) Solution: Step 1. Set up the problem:
8g xg = 20 ml 100 ml
Step 2. Cross multiply and solve for x: (8)(100) = 20x 800 20 = x 40 = x Your answer is that you have a 40% solution.
Rate Problems
There are several types of situations where you may need to use an infusion rate (the rate at which an IV is being administered to a patient, usually expressed in ml/hr). Sometimes youll be called upon to figure out about how long it will take for an IV bag to become empty. Other times you may need to decide how large of a bag to use. Still other times, you may
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need to figure out the rate itself if you know the size of the bag and amount of time that the infusion will take. The general formula for determining these values is Rate = Volume/Time The unknown, or answer, that youre looking for is always called x. Example 7: If you have a 1000 ml bag thats to be infused over 24 hours, how fast should the IV rate be set on the pump? Solution: Step 1. Set up the problem:
x= 1000 ml 24 hr
Step 2. Solve for x, which is rate: x = 1000 ml 24 hr = 41.7 ml/hr Notice the units will be in milliliters per hour, which is ml over hours, the same way as they appear in the problem. Also notice that the answer has a decimal point. Solving calculations will often give you an answer as a decimal. This is all right for most types of problems (such as determining strength or volume). Answers for rate problems need to be in whole numbers, however, because the IV pumps and tubings can only be set using whole numbers such as 1, 2, 3, or 40, 42, 45, and so on. In Example 7, you need to round up to the nearest whole number, which is 42. Therefore, your answer is that the rate should be set at 42 ml per hour. Example 8: An IV is running at the rate of 100 ml per hour. How long will it take for the IV to run out if its a 500 ml bag? Solution: Step 1. Set up the problem. In this problem, since you were given the rate, you can do it one of two ways. First, use the ratio and proportion method:
100 ml 500 ml = 1 hr x hr
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Step 2. Solve for the unknown, which is time: 100x = 500 x = 5 hr You can also solve this example by using the rate formula: Step 1. Set up the problem:
Rate (100 ml/hr) = Volume (500 ml) Time (x hr)
This formula can be rearranged to read:

Time (x hr) = Volume (500 ml) Time (1000 ml/hr)
Step 2. Solve for x: x = 500 100 x = 5 hr
Metric Conversions
Even though conversions were mentioned before, this topic deserves additional attention. Many times a problem requires the conversion from grams to milligrams or milligrams back to grams, micrograms to milligrams, and so on. You need to know your metric conversions. In the pharmacy, almost everything is measured using the metric system, with very few exceptions. The most common metric units of weight used in the pharmacy are grams, milligrams, and micrograms. The most common metric units of volume used in the pharmacy are liters and milliliters. Youll rarely see kilograms, decigrams, nanograms (weights), or kiloliters and deciliters (volumes) when working with any pharmacy product. If you need to convert milligrams to grams, you can easily do this by using the ratio and proportion method, as illustrated in Example 9.
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Example 9: Convert 190 mg to grams. Solution: Step 1. Set up the problem. (Hint: Make sure the milligram units are across from milligrams and grams are across from grams.)
1000 mg 190 mg = 1g xg
Step 2. Cross multiply and solve for x: 1000x = (1)(190) x = 190 1000 x = 0.190 Therefore, 190 mg is the same as 0.190 g. Example 10: Convert 1500 mcg to milligrams. Solution: Step 1. Set up the problem (mcg across from mcg, mg across from mg):
1000 mcg 1500 mcg = 1 mg x mg
Step 2. Cross multiply and solve for x: 1000x = (1500)(1) 1000x 1000 = 1500 1000 x = 1.5 mg Something that you should be aware of is that because the abbreviations for grams (g), milligrams (mg), and micrograms (mcg or mg) are so similar, theyre easily confused. This is especially true for handwritten orders, which are often hard to read. Physicians are notorious for having bad handwriting. Even the best handwritten abbreviations, however, can be mistaken for another. Read all labels and orders very carefully. You must also be knowledgeable about the available strengths and concentrations of the drugs that youre working with. If you have any doubt whatsoever, ask.
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Self-Check 6
Solve the following problems. Be careful to express your answers using the correct unit of weight or measurement. 1. 2 g of a drug are in a total of 10 ml of solution. How many grams of drug are in 8 ml of the solution?
__________________________________________________________
2. 3.7 g of a drug are in a total of 15 ml of solution. How many milligrams of drug are in 10 ml of the solution?
__________________________________________________________
3. 5 g of a drug are in a total of 10 ml of a solution. How many milliliters are needed to obtain 2.3 g of drug?
__________________________________________________________
4. When reconstituted, 3 g of a drug are in a total of 10 ml of solution. How many milliliters of solution are needed if an order asks for 170 mg of the drug?
__________________________________________________________
5. Youre to reconstitute an antibiotic. The concentration in the vial will be 1 g in 5 ml once its mixed with 4.7 ml of diluent. You want to withdraw only 0.5 g from the vial. How many ml will contain 0.5 g?
__________________________________________________________
6. What is the final concentration (in g per ml) of a solution that has 3 g of powder and a total solution of 9 ml?
__________________________________________________________
(Continued)
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Self-Check 6
7. How many grams total of sodium chloride are there in a 250 ml bag of 0.33% solution?
__________________________________________________________
8. How many total grams of dextrose are there in a 50% syringe thats 50 ml in size?
__________________________________________________________
9. If youve dissolved 10 g of drug in 200 ml of solution, what is the percentage of the solution?
__________________________________________________________
10. If you have a 1000 ml bag thats to be infused over 12 hours, how fast should the IV rate be set on the pump?
__________________________________________________________
11. An IV is running at the rate of 60 ml per hour. How long will it take for the IV to run out if its a 1000 ml bag?
__________________________________________________________
12. How many micrograms are there in a milligram? Express this as a fraction.
__________________________________________________________
13. How many milligrams are there in a gram? Express this as a fraction.
__________________________________________________________
14. Convert 200 mg to grams.
__________________________________________________________
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COMMON PARENTERAL ADMIXTURES

This section will introduce you to a variety of admixtures that youll probably come into contact with in the IV room. The categories of drugs that youll probably see are Antibiotics Electrolyte solutions Cardiac drugs Pain medications Pulmonary drugs (used to improve breathing) Nutritional solutions (TPNs) Chemotherapy drugs (used to treat cancer)
Antibiotic Solutions
The majority of antibiotics that you make will be in the IV piggyback (IVPB) size. The most common ones will be covered in this section. There are very few antibiotics mixed in large volumes (LVPs). Antibiotic drugs are available in different forms in the IV area. The two general categories of antibiotics are those that must be reconstituted and those that are ready-made. Antibiotics that must be reconstituted are available in several forms. Single-dose vials contain one dose and are added to a larger volume (50100 ml) piggyback. Single-dose vials are convenient when only one dose needs to be mixed for a new order. Multiple-dose vials, or bulk vials, contain more than one dose. Their contents are added to several larger-volume (50100 ml) piggybacks. Multiple-dose vials are convenient to use when several doses of the same drug must be prepared. The antibiotic vials usually contain powders for mixing, and the resulting solution has a short expiration date, usually 2448 hours. If it isnt used within that time, it should be discarded.
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Antibiotics are also available in glass bottles that contain an antibiotic to be reconstituted. The glass bottle may be used as the piggyback container. The drug is reconstituted but may stay in the original bottle, which is larger than a normal vial size. The last form that well mention is a system that must be reconstituted but can be transferred to the IVPB container by special means, such as with the Add-Vantage System. Antibiotics that are ready-made are available as either nonfrozen or frozen premixed drugs. The premixes contain drugs already in solution in a flexible plastic bag. Premixed piggybacks are available in standard strengths for antibiotics that are used frequently, but are more expensive to use. Some must be kept frozen until use to prolong the expiration date. Once a frozen premix is defrosted, the expiration date is shortened. The package insert for any premix may be checked for the exact expiration date information. Antibiotics can be classified in several groups. Under each classification are several specific drugs that have chemical and therapeutic properties similar to other drugs in that category. The generic names of each of the drugs in the same group may sound a little (or a lot) like the other names in that category. Penicillin-type antibiotics and cephalosporins are the most frequently used. There are also other types that well discuss. Common cephalosporin antibiotics that are made in the IV room are listed in Figure 17. Notice that all of the generic names of the cephalosporin antibiotics start with the letters cef, because many of these drugs are available from generic drug companies. Another similarity is that the usual strength of most of the cephalosporins is 1 g or 2 g. These similarities often lead to confusion and errors, however. Anyone working with these drugs must be very careful to select the appropriate drug from the shelf. Penicillin-type antibiotics are all derivatives of (i.e., are chemically related to) the drug penicillin. Almost all penicillin generic drug names end with the letters illin. See Figure 18 for common penicillin-type antibiotics that are used in the IV room. Again, care must be taken when selecting these drugs from the shelves.
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Generic Name cefazolin cefotaxime cefotetan ceftazidime
Brand Name Ancef, Kefzol Claforan Add-Vantage Cefotan Add-Vantage Fortaz, Tazicef, Tazidime
Available Vial Strengths 250, 500 mg 1, 5, 10, 20 g 1, 2, 10 g (bulk) 1, 2 g 1, 2, 10 g (bulk) 1, 2 g 500 mg 1, 2, 6 g (bulk) 10 g (bulk) Add-Vantage 1, 2 g
Premix 500 mg or 1 g/50 ml frozen, 1, 2 g frozen, 1, 2 g frozen, 1, 2 g
ceftriaxone
Rocephin
250, 500 mg, 1, 2 g 10 g (bulk) Add-Vantage 1, 2 g
frozen, 1, 2 g frozen, 750 mg, 1.5 g
cefuroxime
Zinacef, Kefurox
750 mg, 1.5 g, 7.5 g (bulk) Add-Vantage 750 mg, 1.5 g
FIGURE 17Common Cephalosporin Antibiotics Found in the IV Room
Generic Name
Brand Name
Available Vial Strengths
Premix
penicillin G potassium penicillin G sodium ampicillin ampicillin/sulbactam piperacillin piperacillin/tazobactam ticarcillin ticarcillin/potassium clavulanate
Pfizerpen
1,000,000 units
1, 2, 3 million units/50 ml
Polycillin, Omnipen Unasyn Piperacil Zosyn Ticar Timentin
125, 250, 500 mg 1, 2, 10 g (bulk) 1.5, 3 g Add-Vantage 1.5 g 2, 3, 4 g 40 g (bulk) 2, 3, 4 g 1, 3, 6 g 30 g (bulk) 3.1 g, 31 g (bulk)
frozen, 2, 3 g
FIGURE 18Penicillin-Type Antibiotics
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Erythromycin is a macrolide-type antibiotic that many people are familiar with. This drug is available in many salts in the oral form, but only one salt in the IV form, which is erythromycin lactobionate. Figure 19 shows the strengths available in the IV form of the drug. Two of its derivations, clarythromycin and azithromycin, are also listed.
Generic Name Brand Name Available Vial Strengths erythromycin lactobionate clarythromycin azithromycin
FIGURE 19Erythromycin
Premix
Erythrocin Biaxin, Klaricid Zithromax
500 mg, 1 g 1g
Except for erythromycin (a macrolide-type antibiotic), aminoglycoside antibiotics often end with the letters mycin. These include gentamycin, tobramycin, netilmicin, and amikacin. Although these may come in standard strengths (Figure 20), these types of antibiotics are frequently dosed on an individual, or per patient, basis. This is because a patients height, weight, and diseases can strongly affect how the body will deal with these drugs. The other antibiotics can be affected by a patients height, weight, and disease as well, but not to the same extent as aminoglycosides.
Generic Name Brand Name Available Vial Strengths gentamycin Garamycin 40 mg/ml in 2 and 20 ml vials 10 mg/ml in 2 and 20 ml 2 mg/ml in 2 ml amps tobramycin Nebcin 40 mg/ml in 2 and 30 ml vials 10 mg/ml in various sizes Premix
FIGURE 20Aminoglycoside Antibiotics
Antifungals treat infections caused by fungi rather than by bacterial infections. Antifungals include fluconazole (Diflucan), and micafungin (Mycamine) (Figure 21).
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Generic Name
Brand Name
Available Vial Strength
Premix
fluconazole micafungin
FIGURE 21Antifungals
Diflucan Mycamine
50 mg
2 mg/ml in 100 and 100 ml glass
Miscellaneous antibiotics that are commonly encountered are given in Figure 22.
Generic Name Brand Name Available Vial Strengths metronidazole Flagyl 500 mg 500 mg/100 ml flex plastic imepenem/cilastin Primaxin 250, 500 mg Add-Vantage 250, 500 mg aztreonam ciprofloxacin Azactam Cipro 1, 2 g 200, 400 mg frozen/1, 2 g 200 and 400 flex plastic doxycycline vancomycin Vibramycin Vancocin 100, 200 mg 500 mg, 1, 5, 10 g (bulk) Add-Vantage, 500 mg, 1 g moxifloxacin* ciprofloxacin* Avelox Cipro 400 mg 200, 400 mg frozen, 500 mg, 1g 400 mg/200 ml 200 mg/100 ml 400 mg/200 ml levofloxacin* Levaquin 250, 500 mg 250 mg/100 ml 500 mg/200 ml gatifloxacin* daptomycin ertapenem meropenem quinupristin/dalfopristin tygecycline linezolid
*quinolone antibiotic
Premix
Zymar Cubicin Invanz Merrem Syneroid Tygacil Zyvox
400 mg 500 mg 1g 1g 500 mg 50 mg 600 mg
400 mg/200 ml 600 mg
FIGURE 22Miscellaneous Antibiotics
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Nonantibiotic Admixtures
Now that youve seen examples of different antibiotics, lets examine some other types of additives. Electrolytes, cardiac drugs, pain medications, pulmonary drugs (to improve breathing), nutritional solutions, and chemotherapy drugs are common categories of drugs that may be added to some of the base solutions listed back in Figure 4. Most of these additives are added to large-volume parenterals, but sometimes are placed in piggybacks as well. Some are available as premixed solutions. As with any other drug, you must be extremely careful to select the proper salt when preparing electrolyte solutions. Names of these salts are easily confused, and mixing up electrolytes is a common source of error in the IV room. Examples of electrolytes are listed in Figure 23. Examples of cardiac drugs made in the IV room include dopamine, procainamide, and diltiazem. Examples of pain medications added to LVPs include hydromorphone (Dilaudid) and morphine. Aminophylline is a breathing medication added to LVPs. Examples of cancer chemotherapy drugs include methotrexate, cisplatin, vincristine, and vinblastine. Intravenous nutritional products will be discussed in the next study unit. Some of these are available in single or multiple doses as powder for reconstitution or solution. These are only a few examples of the most common drugs. Youll encounter many more in your experiences.
Sodium Salts Sodium chloride (NaCl, or table salt) Sodium acetate Sodium bicarbonate Sodium phosphate
Potassium Salts Potassium chloride
Calcium Salts Calcium chloride
Magnesium Salts Magnesium sulfate
Potassium phosphate Potassium acetate
Calcium gluconate Calcium gluceptate
FIGURE 23Common Electrolytes
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Self-Check 7
1. Explain the differences between single-dose vials, multiple-dose vials, and premixed IV fluids.
__________________________________________________________
2. What happens to the expiration date of an antibiotic that has been reconstituted or a frozen premix that has been defrosted?
__________________________________________________________
3. Antibiotics are usually placed in what kind of container?
__________________________________________________________
4. List two electrolytes that are potassium salts.
__________________________________________________________
5. List two electrolytes that are sodium salts.
__________________________________________________________
6. List three calcium salts.
__________________________________________________________
7. List three cephalosporins.
__________________________________________________________
8. List three penicillin-type antibiotics.
__________________________________________________________
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NOTES
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Self-Check 1
1. d 2. c 3. Vials may be plastic or glass and may contain powder for reconstitution or solution. Theyre entered through a rubber stopper with the use of a needle. Ampules are made only of glass and contain drugs in solution. Theyre elongated and must be broken at the neck area to remove the contents. Prefilled syringes come ready to use from the manufacturer, already containing the drug in solution. 4. A package insert, which comes with every medication product, describes the characteristics, uses, prescribing recommendations, precautions, mixing and dilution instructions, compatibilities, and available sizes and strengths of that drug. The technician is concerned with the mixing, dilution, and compatibilities of the drug. 5. The brand and generic names, strength and amount of drug, company name, lot number, expiration date, precautionary comments, storage instructions, federal caution label, and sometimes directions for mixing 6. Patient name and room number, name of drug(s) and strength, base solution used and final volumes, date and time preparation was made, expiration date, and rate of IV administration.
Answers
Self-Check 2
1. c 2. c 3. a 4. b 5. An electrolyte is a salt that the body needs to perform electrical functions. 6. The IVPB and IV push routes
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Self-Check 3
1. Barrel, plunger, and tip 2. In milliliters or fractions of a milliliter, designated by marks on the syringe 3. A catheter tip syringe has a pointed tip and the needle is held on by friction. 4. To measure very small volumes of drugs in solution 5. Shaft, bore, and hub 6. In gauge size and length 7. Filter needle, filter straw, filter disc, and in-line filter 8. 0.22 micron
Self-Check 4
1. High-efficiency particulate air (filter) 2. Once a month 3. The direction of air flow 4. Hands should be washed upon entering the IV room and before beginning any preparation procedure. An antimicrobial cleanser such as chlorhexidine or povidone-iodine should be used for at least 15 seconds to wash hands and scrub under the nails. The faucet should be turned off with a paper towel. 5. Sterile surgical attire should be worn instead of street attire. Hair, face, hands, and feet may need to be covered. No jewelry or excessive makeup should be worn. Bacteria can grow on clothing lint and in crevices of jewelry. 6. Bacteria can be carried in on clothing, skin, and hair. It can grow on surfaces and on dust. Bacteria can enter by touch contamination or through cracked or leaking containers. 7. The patient could become very ill and even die.
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Self-Check Answers
Self-Check 5
1. c 2. e 3. a 4. b 5. d
Self-Check 6
1. 1.6 g 2. 2466.7 mg (2467 is an acceptable answer.) 3. 4.6 ml 4. 0.57 ml 5. 2.5 ml 6. 0.33 g/ml 7. 0.825 g 8. 25 g 9. 5% 10. 83.3 ml per hour 11. About 16.7 hr 12. There are 1000 micrograms in a milligram. This can be expressed as 1000 mcg/mg. 13. There are 1000 mg in a gram. This can be expressed as 1000 mg/g. 14. 0.2 g
Self-Check Answers
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Self-Check 7
1. Single-dose vials are convenient for making one dose of a drug. They usually must be reconstituted and added to a larger volume. Multiple-dose vials are convenient for making several doses of the same medication and are usually reconstituted before adding to several larger volume containers. Premixed IV fluids are ready to use; some may be frozen and are defrosted before use. 2. The expiration date becomes shortened and the product must be discarded usually within 2448 hours. 3. IV piggyback, usually between 50 ml and 100 ml 4. Any two of the following: potassium chloride, potassium phosphate, or potassium acetate 5. Any two of the following: sodium chloride, sodium acetate, sodium bicarbonate, or sodium phosphate 6. Calcium chloride, calcium gluconate, or calcium glucepate 7. Any three cephalosporins from Figure 17 are acceptable answers. 8. Any three penicillin-type antibiotics from Figure 18 are acceptable answers.
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Self-Check Answers

Compounding Sterile Products

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Compounding Sterile Products

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Study Unit

Compounding of Sterile Products 1

About the Author

METHODS OF INTRAVENOUS ADMINISTRATION

COMMON PARENTERAL ADMIXTURES

Compounding of Sterile Products 1

Compounding of Sterile Products 1

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Compounding of Sterile Products 1

FIGURE 3A 500 ml Size Vial

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Larger Container Systems and Components

Large-Volume Parenterals (LVPs)

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Small-Volume Parenterals (Piggybacks)

0.9% sodium chloride

Normal saline 0.9% NaCl

Dextrose 5% & 0.9% sodium chloride

D5 & 0.9 D5/NS

D5 & D5 & LR D5LR

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Brand and Generic Name

Strength and Amount

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Lot Number and Expiration Date

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Directions for Proper Storage

Federal Caution Label

Directions for Mixing and Dilution

The Final Pharmacy Label

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Compounding of Sterile Products 1

3. Explain the differences between vials, ampules, and prefilled syringes.

Compounding of Sterile Products 1

METHODS OF INTRAVENOUS ADMINISTRATION

Infusions for Patients Needing Rehydration

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Infusions for Electrolyte Replacement

Infusions for Drug Dilution

Infusions for Nutrition

PHYSICIANS ORDER FORM Jones, Mary

10-24-96 11:00 A.M.

Begin D5W 1000 ml at 40 ml/hr

FIGURE 5Physicians Order Form

Dr. John Smith

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Compounding of Sterile Products 1

Size of Piggyback 50 or 100 ml 100 ml 50 ml 100 ml 50 or 100 ml 250 ml

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Insulin and Tuberculin Syringes

Compounding of Sterile Products 1

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Final Filtering Devices

Compounding of Sterile Products 1

Compounding of Sterile Products 1

Compounding of Sterile Products 1

Compounding of Sterile Products 1

Compounding of Sterile Products 1

Compounding of Sterile Products 1