Sterile and non sterile compounding Pharmacy tech

Sterile compounding equipment

70% isopropyl alcohol: Used to clean laminar air hood surfaces • Administration sets: Disposable sterile tubing that connects the IV solution to the injection site • Alcohol pads: Used to clean the ports on an IV bag, the rubber stopper of a vial, or an area of the skin before an injection • Ambulatory pumps: A small, lightweight, portable pump worn by a patient that may be either therapy specific or used for multiple therapies • Ampule breaker: A device used to break the neck of an ampule • Ampules: Elongated glass container in which the neck is broken off • Catheters: Devices that are inserted into veins for direct access to the vascular system that may be either peripheral venous or central venous catheters • Clamps: Adjusts the rate and shutting down of the flow of the IV; they include slide clamps, screw clamps, and roller clamps • Depth filter: A filter that works by trapping particles as a solution moves through the channels • Drip chamber: A hollow chamber where drops of an IV solution accumulate that prevent air bubbles from entering the tubing • Filters: Used to remove particulate material and microorganisms from solution; they can be attached to the end of a syringe, the end of the administration kit, or the end of the needle • Filter needles: Needles that include a filter that prevents glass from entering the final solution when one draws from an ampule • Filter straws: Used for pulling medication from ampules • Final filters: Filter used before a solution enters a patient's body • Flexible bag: Plastic container that may hold volumes ranging from 50 to 3000 mL • Heparin lock: A short piece of tubing attached to a needle or catheter when the tubing is filled with heparin to prevent potential clotting • Infusion pumps: Regulate the flow of medication into a patient • Large-volume parenterals (LVPs): Parenterals with a volume greater than 100 mL • Male and female adapters: Fit a syringe on each end and are used in the mixing of the two contents • Membrane filters: Consist of small pores that retain particles that are larger than the pores. Membrane filters may be placed between syringe and needle before a medication is introduced into an LVP or a small-volume parenteral (SVP). • Minibags: Contain volumes between 50 and 100 mL • Multidose vial: A vial or container that can be used for more than one admixture that normally contains preservatives and contains a maximum dating of 28 days unless otherwise specified by manufacturer • Needles: Composed of a hub and a shaft and are designated by two numbers (gauge and length). The gauge measures the diameter of the needle bore; the larger the gauge, the smaller the bore. The length of the needle is measured in inches. • Needle adapter: A needle or catheter may be attached to it. • Piggyback: A small-volume solution added to an LVP • Roll clamp: Allows for variable flow rates • Single-dose vial: A vial or container that can only be used once and does not contain a preservative • Small-volume parenterals (SVPs): Packaged products, containing a volume of 100 mL or less, that are either directly administered to the patient or added to another parenteral • Spike: A rigid, sharpened plastic piece that is inserted into the IV bag • Syringe: Components include a plunger, plunger flange, barrel, and tip Syringe caps: A sterile cap used to prevent contamination of syringes during the transportation out of the pharmacy • Syringes needles: Components include a hub, shaft, bevel, lumen, and point Transfer needles: Specially designed needles that look like two needles attached together at the hub that are used to transfer sterile solutions from one vial directly into another without the use of a syringe • Vials: Glass or plastic containers with rubber stoppers. Single-dose vials do not contain a preservative, but multidose vials do. Laminar flow hoods • Type A hoods: Recirculate a portion of the air (after it first passes through a HEPA filter) within the hood and exhaust a portion of this air back into the parenteral room • Type B1 hoods: Expel most of the contaminated air through a duct to the outside atmosphere and passes through a HEPA filter • Type B2 hoods: Remove all of the contaminated air to the outside atmosphere after it passes through a HEPA filter. This air is not recirculated within the hood or returned to the parenteral room atmosphere. • Type B3 hoods: Use recycled air within the hood. All exhaust air is discharged to the outside atmosphere. A type A hood may be converted to a type B3 hood. Intravenous solutions used • ¼ NS: One fourth normal saline (0.225% sodium chloride) • ½ NS: One half normal saline (0.45% sodium chloride) • D10W: 10% dextrose in water • D5NS: 5% dextrose in normal saline (0.9% solution) • D5W: 5% dextrose in water • LRS: Lactated Ringer solution • NS: Normal saline solution (0.9%) • SW: Sterile water Types of injectable water • Purified water USP: Not intended for parenteral administration; used in the reconstitution of oral products • Water for injection USP: Is not sterile and cannot be used in aseptic compounding of sterile products • Sterile water for injection USP: Has been sterilized but has no antimicrobial agents; can be used in parenteral solutions • Bacteriostatic water for injection USP: Sterile water with antimicrobial agents that can be used for injection • Sterile water for irrigation USP: Has been sterilized but contains no antimicrobial agents; used as an irrigating solution Aseptic Technique: Techniques used in the preparation of both hazardous and nonhazardous materials • Used to prevent the introduction of microbes or unwanted debris that may cause a serious infection to occur • Includes hand hygiene and wearing personal protective equipment (PPE)

non sterile equipment and supplies

Beakers: May be either glass or plastic and are used to estimate and mix solutions • Class A (III) balance: Required in all pharmacies and is used to weigh small quantities of ingredients; has a sensitivity requirement of 6 mg • Counter balance (bulk balance): Two-pan balance used to weigh quantities up to 5 kg with a sensitivity of 100 mg • Digital balances: Sensitive to a tenth of a milligram and are used to replace class A balances • Compounding slab (ointment slab): Used for mixing compounds • Filter paper: Paper used to filter a solution • Forceps: Used to pick up prescription weights and are used to ensure that oil is not deposited on the weight, which would affect it • Funnels: Used to filter or pour liquids • Glass stirring rods: Used to stir solutions and suspensions • Glycine paper: Placed under substances to be weighed • Graduates: Used to measure liquids. There are two types of graduates, conical and cylindrical (most accurate method to measure a volume). Graduates will either be TD or TC. TD means the volume delivered is the exact amount desired, and the residual remaining solution is in addition to the volume measured. TC will hold the desired volume but, when transferred, a residual remains, making the amount measured inaccurate. • Master formula sheet (pharmacy compounding log): Lists the ingredients and their quantities and the procedures to follow in the preparation Mortar and pestle: Used to mix ingredients • Glass: Used for mixing liquids and semisolid dosage forms • Wedgwood: Used in the trituration of crystals, granules, and powders • Porcelain is similar to Wedgwood and is more commonly used in the blending of powders Pharmaceutical weights: Brass weights are available in both metric and apothecary systems. The weights should never be touched by the hand; they should be stored in a clean state and should be calibrated once per year. • Pipettes: Used to measure volumes less than 1.5 mL • Sink with hot and cold running water: Used to wash equipment and hands • Spatula: May be rubber (used for corrosive ingredients), plastic, or steel • Hard rubber spatula: Used in the compounding of ingredients that react with metal • Stainless steel spatula: Most commonly used because of its flexibility and ability to remove materials from a mortar

Non sterile compounding processes

Blending: An act of combining two substances • Comminution: An act of reducing a substance to small, fine particles • Geometric dilution: A technique used in mixing two ingredients of unequal quantities, where one begins with the smallest quantity and adds an equal quantity of the ingredient having the larger amount; the process continues until all of the ingredients are used • Levigation: Trituration of a powder drug with a solvent in which the drug is insoluble with the solvent • Pulverization by intervention: Reducing the size of a particle in a solid with the aid of an additional material • Sifting: A technique to either blend or combine powders • Spatulation: Mixing powders using a spatula in a mortar, an ointment slab, or a plastic bag; it is a process used when ingredients may liquefy on mixing; there is no reduction in particle size • Trituration: A process of rubbing, grinding, or pulverizing a powder to create fine particles • Tumbling: Combining powders in a bag and shaking it Equipment calibration • Calibration is a comparison between measurements, one of known magnitude or correctness made or set with one device and another measurement made in as similar a way as possible with a second device. • Weighing: Scales must be tared before being used for each weighing and be inspected once a year by the state department of taxation. Torsion balance procedures • Leave the balance in a draft-free area If the balance has a level bubble, make sure the bubble is inside the bull's eye and make adjustments using the leveling feet. • Place a weighing boat or a single piece of paper on the pan. • When the balance has determined the final weight, press the tare bar to compensate for the weighing boat. • As ingredients are added or removed, the digital display will show the weight. Measuring liquids procedures • Choose properly sized graduates such that quantity to be measured is not less than 20% of the total volume of graduate Pour liquid down the center of the graduate slowly and watch the level of liquid rise to desired volume. • Allow time for all liquid to fall in graduate before taking measurement. • Measure level of liquid at eye level and make observation at the bottom of the meniscus. • Pour liquid into the container and allow for liquid to be completely drained from the graduate. Powders • Powders are prepared through the use of trituration and geometric dilution. • Particle size is determined through the use of a sieve. Punch method procedure for capsules • Triturate ingredients to the same particle size. • Mix using geometric dilution. • Calculate enough ingredients for several extra capsules. • Place powder on the ointment slab, where the depth of powder is approximately half the length of the capsule body. • Hold the capsule vertically and punch the open end into the powder until capsule is filled. • Place the cap on the capsule and weigh it using an empty capsule as a counterweight. Add or remove ingredient as needed. • Hints: Remove the exact number of capsules from the box, wear finger cots to protect the fingers, and roll capsules on a clean towel to remove traces of the drug on the outside. • Place completed capsules in either a glass or plastic vial and store in a dry place to prevent them from absorbing moisture or becoming dryProcedure for preparing an emulsion using the wet gum method • Primary emulsion is formed by triturating one part gum and two parts water to form a mucilage. • Add four parts oil and triturate slowly. • Add additional ingredients. Continental method (dry gum) method • The primary emulsion is formed from four parts oil, two parts water, and one part gum (an emulsifier, acacia). • Using a Wedgwood or porcelain mortar, the gum and oil are levigated. • Water is added and the trituration continues. • After the primary emulsion is formed, additional ingredients may be added and are added up to the initial volume with the external phase. Procedure for preparing emulsions using the beaker method • Water-soluble and oil-solute ingredients are mixed in separate containers. • Heat both phases to 70° C and remove from heat. • Add the internal phase to the external phase. • The final product is cooled to room temperature but is continually stirred. Procedure for preparing a liquid drug in a liquid vehicle • Measure quantities of each liquid in a graduated cylinder. • Add drug to vehicle slowly; then shake and stir. Procedure for dissolving a solid drug in a liquid vehicle • Weigh the solid and measure the solvent. • Triturate drug if needed and dissolve in solvent. • If needed, heat gently, stir, or shake gently. Procedure for preparing nonaqueous solution • Prepare by dissolving alcohol-soluble ingredients in alcohol and water-soluble ingredients in water. • Add the alcohol portion to the aqueous portion and stir. Procedures for preparing syrups • Heat method: Heat must be controlled; works fastest, but not all ingredients can be used with heat • Without heat method: Must use a container that is twice the size of the final volume. The syrup needs to be shaken or stirred. Procedure for preparing suspensions • The solid drug to be suspended is weighed and levigated in mortar and pestle with either alcohol or glycerin. • A portion of the vehicle is added to mortar and is mixed with the levigated drug until a uniform consistency occurs. • This portion of the drug is placed in the final container. • The mortar and pestle are rinsed with the balance of the vehicle, and the suspension is added up to the final volume with the vehicle being used. • A "SHAKE WELL" label should be affixed to the container. • Note: A flocculating and thickening agent may be used in the preparation of a suspension. Fusion mold procedure for preparing suppositories • Active ingredients are dispersed or dissolved in a melted base. • Weigh quantities of base and active ingredient. • Melt the suppository base at a low temperature and dissolve the drug in it. • The base is poured and overfilled into a special suppository mold (metal, plastic, or rubber) and is left to harden. • Excess material is removed from the top of the mold.Compression mold procedure for preparing suppositories • Weigh quantities of base and active ingredient. • Mix the suppository base and drug ingredients. • Force the mixture into a special compression mold. Procedures for preparing ointments and creams Note: Ointment bases are chosen based on their characteristics to deliver a drug• Weigh quantities of each ingredient and place them either on an ointment slab or parchment paper. • Prepare by using geometric dilution and two spatulas to mix the ingredients. • Transfer the final product into an ointment jar using a spatula. • Remove air pockets from the ointment by using a spatula. • Spread evenly in the container. Factors to be considered in preparing ophthalmic products • Sterilization: Can be accomplished by autoclave, filtration, gas, or radiation • Clarity: Free from foreign particles, which can be accomplished through filtration • Stability: Affected by chemical nature of the drug substance, pH, method of preparation, solution additives, and packaging • Buffer and pH: Should be formulated at a pH of 7.4, but this rarely occurs. The pH chosen should be optimum for stability. • Tonicity: Refers to the osmotic pressure exerted by the salts. An isotonic solution should have tonicity equal to that of sodium chloride 0.9%. • Viscosity: Agents are used to prolong contact time in the eye and enhance drug absorption and activity.

Pharmacology

Dosage forms A dosage form is a system or device for delivering a drug to a biologic system. Solid dosage forms A dosage form that can be contained in various packages and when administered enterally can be given orally, rectally, or sublingually. Advantages of solid dosage forms • Easy to package, transport, store, and dispense • Convenient for self-dosing • Lack smell or taste • Extremely stable for products that are not stable in liquid form • Predivided dosage form • Suited for sustained- or delayed-release medications Types of solid dosage forms • Tablets: Prepared either by compressing or by molding. The dosage form is accurate, compact, portable, and easy to administer. May come in various shapes and be scored (able to be broken in halves or quarters). The most common types of marketable tablets include standard compressed, enteric-coated, sugar-coated, film-coated, sublingual or buccal, multiple compressed, chewable, sustained-action, and delayed-action tablets. • Capsules: A drug is contained in a shell of gelatin (either soft or hard) that dissolves in 10 to 20 minutes. The drug may be in either a solid or a liquid form with the shape being either spherical or ovoid. The capacity of capsule may vary up to 1 g and can be produced manually by using the punch method. • Effervescent salts: Granules or powders; when dissolved in water, they effervesce and release carbon dioxide • Implants or pellets: Dosage forms that are placed under the skin through injection and are effective for a long period of time • Lozenges, troches, or pastilles: Solid dosage forms with flavoring that dissolve in the mouth • Pellets: Small cylinders that are implanted subcutaneously for continuous absorption • Plasters: Medicated or nonmedicated preparations that adhere to the skin by a backing material • Powders: Finely ground substances that can be administered internally or externally. Their chief disadvantages are their taste and that they are not stable when exposed to the air. Powders may be dispensed in a bulk form, a multidose form, or as a divided dose such as a powder paper. • Suppositories: Solid dosage forms to be inserted in body orifices, such as the rectum, vagina, or urethra. They may produce either a local or systemic effect. Their mechanism of action is either through melting or dissolving, and the medication is released over a period of time. The major disadvantages of a suppository are that it may be easily expelled from the body, and the medication's absorption into the body can be erratic. Oral extended-release dosage forms Examples • Controlled diffusion (CD) • Continuous- or controlled-release (CR) tablet • Controlled-release tablet (CRT) • Long acting (LA) • Sustained action (SA) • Sustained or slow release (SR) • Time delay (TD) • Time release (TR) • Extra long (XL) • Extended release (XR) Liquid dosage forms A dosage form composed of various solutions whose term relates to the type of liquid with which the medication is mixed Advantages of liquids • Effective more quickly than a solid dosage form because the drug is already dissolved • Easier to swallow than a solid dosage form for many patients • Drugs may be available only in liquid form owing to convenience of administration. • Uniformity and flexibility of dosage form in dosing • Certain medications may cause gastrointestinal distress if administered in a solid dosage form. Disadvantages of liquids • Deterioration and loss of potency occur more quickly than in a solid dosage form. • May require special sweetening or flavoring to be palatable • Incompatibilities of dissolved substances • May require preservatives to prevent bacteria or mold from developing • Inaccurate measuring of a dose for a patient may occur • Bulkier to carry than solid dosage forms • Interactions may develop from changes in solubility. Types of solutions Solutions: Contain a solute that is dissolved in a solvent, which may be aqueous, alcoholic, or hydroalcoholic • Aromatic waters: Solutions of water-containing oils that have a smell and are volatile • Collodion: Topical dosage form that contains pyroxylin and is dissolved in alcohol and ether • Elixir: Clear, sweetened, flavored hydroalcoholic solution containing water and alcohol that may or may not be medicated • Enema: Solution administered rectally for either cleansing or drug administration • Extract: Process by which active ingredients are removed from their source through the application of solvents • Douche: An irrigating or bathing solution • Isotonic (iso-osmotic): A liquid having the same tone or osmolarity of another substance, where there is no loss or gain of water by the cell. The dilution of an isotonic solution may affect the composition of solution. Ophthalmic solutions are considered isotonic. • Liniments: An emulsion or alcoholic or oleaginous solutions applied through rubbing • Spirits: Alcoholic or hydroalcoholic solutions containing volatile aromatic ingredients • Syrups: Aqueous solutions containing sucrose or sucrose substitutes • Tinctures: Alcoholic or hydroalcoholic solutions of pure chemicals or extracts Types of dispersions Dispersions: A solute dispersed through a dispersing vehicle • Suspension: A two-phase system in which solid particles are dispersed in a liquid vehicle, which may be oral, topical, or injectable. The suspended material should not settle rapidly and should pour freely. A topical suspension should be fluid enough to spread over the affected area but should not run off the surface of application and dry quickly. Topical suspensions provide a protective film and have an acceptable color and odor. • Emulsion: One liquid is dispersed in another liquid; may be water in oil (w/o) or oil in water (o/w). Emulsions are stabilized through the use of an emulsifying agent. Oral emulsions are o/w preparations; topical emulsions may be either o/w (washable and nonstaining) or w/o. An o/w emulsion will become diluted with water, but a w/o emulsion will not. • Lotion: A liquid for topical application that contains insoluble solids or liquids • Gel: A two-phase system containing an extremely fine solid particle that when mixed is difficult to distinguish between the two phases and is considered a semisolid form • Ointment: A homogeneous, viscous, semisolid preparation, most commonly a greasy, thick oil (oil 80%, water 20%) with a high viscosity that is intended for external application to the skin or mucous membranes. They are used as emollients or for the application of active ingredients to the skin for protective, therapeutic, or prophylactic purposes and when a degree of occlusion is desired. • Anhydrous ointments: Absorb water but are insoluble in water and are not water washable • Oleaginous ointments: Insoluble in water, do not contain or absorb water, and are not water washable • Pastes: Contain more solid materials than ointments • Creams: An emulsion of oil and water in approximately equal proportions. Cream is thicker than a lotion and maintains its shape when removed from its container. It tends to be moderate in moisturizing tendency. Types of inhalants Inhalants: Gases, vapors, solutions, or suspensions intended to be inhaled either orally or intranasally • Aerosol: A spray in a pressurized container that contains a propellant, an inert liquid, or gas under pressure meant to carry the active ingredient to its location of application. Particles may be either a fine solid or a liquid. Aerosols are used for administration into body cavities. Aerosols are convenient and easy to apply. • Spray: A dosage form that consists of a container with a valve assembly that, when activated, will emit a dispersion of liquid, solid, or gaseous material. Nebulizer: A device used to administer medication in the form of a mist inhaled into the lungs. Nebulizers use oxygen, compressed air, or ultrasonic power to break up medical solutions and suspensions into small aerosol droplets that can be directly inhaled from the mouthpiece of the device. Transdermal products • Provide systemic therapy for acute or chronic conditions that do not involve the skin • Deliver a controlled dose of medication through the skin and is absorbed directly into the bloodstream • A convenient system that results in improved patient compliance, accurate drug dosage, and regulation of drug concentration

Infection control

Infection control includes PPE, hand washing, and so on. • Addresses the issues involving the transmission of germs that may cause infections within a health care setting • Involves the education of health care providers dealing with the prevention, monitoring, management and investigation of suspected spread of an infection • Infection transmission includes airborne, droplet, and contact. • Each health care institution must establish policies and procedures addressing infection control. Examples of infection control processes • Universal precautions (standard precautions) apply to all individuals in an institution who may come in contact with blood, other body fluids, or body substances. • Gloves must be worn when there is a possibility the individual may come in contact with these substances. • Hands must be washed after removing the latex gloves. • Specially trained individuals must be notified for cleanup or removal of contaminated waste. • Contaminated materials such as syringes, needles, swabs, and catheters must be placed in red plastic containers labeled for disposal of biohazardous materials. • A first-aid kit must be maintained and adequately stocked for use if an individual does come in contact with contaminated waste or body fluids. Items to be contained in the first-aid kit include adhesive bandages, alcohol, antiseptic or disinfectant, bleach, disposable latex gloves, disposable towels, medical tape, sterile gauze, and plastic bags for contaminated waste disposal. • Employees should not use patient restrooms; they should only use employee restrooms. • Medication refrigerators and freezers may only hold medications; they should not be used in the storage of food or drinks. • Eating is prohibited in any drug preparation or patient care areas. Specific pharmacy infection control processes • All injectable drugs and other sterile products must be compounded under laminar flow hoods. • Laminar flow hoods must be recertified every 6 months by an independent contractor. • Routine maintenance of the laminar flow hoods includes cleaning all work surfaces and prefilters. • Inspection records must be kept on file within the pharmacy department.

Sterile Compounding procedures

Procedures to prepare intravenous admixtures • The flow hood should be on for at least 30 minutes. • Wear PPE. • Clean the laminar flow hood with 70% isopropyl alcohol or another suitable disinfectant. Then clean the pole to hang IV bags, the sides of the hood by moving from the back to the front, and finally the bottom of the hood by moving side to side from the back to the front. • Collect supplies; check expiration dates and bags for leaks. Remove dust coverings before placing supplies in the hood. Use presterilized needles, syringes, and filters. • Position supplies in the hood. • Sterilize puncture surfaces with an alcohol wipe. • Prevent coring by placing the vial on a flat surface and insert the needle into the rubber closure at a 45- to 60-degree angle. Use downward pressure on the needle and move the needle to a 90-degree angle. • Using vials with solutions: Draw into syringe a volume of air equal to amount of volume being replaced (Figure 3-9). Penetrate the vial without coring. Invert the vial upside down and pull back on the plunger to fill the syringe. Tap to bring air bubbles to the top of the syringe. Transfer the solution to the final container.Vials with lyophilized powder: Determine the correct volume of diluent and withdraw it. Transfer the diluent into a vial containing the powder. Remove more air from vial than amount of diluent injected. Whirl the vial until the powder is dissolved. Use a new syringe and needle and proceed as if using a vial with solution. • Using ampules: Hold the ampule upright and tap it to ensure all liquid is in the bottom of the ampule. Wipe the neck of the ampule with an alcohol swab. Wrap gauze around the neck and gently snap the neck away from the individual. Inspect and use a filter needle or filter straw to withdraw. Hold the ampule downward at a 20-degree angle and withdraw the solution with a filter syringe. Considerations in preparing chemotherapy medications Uses the same aseptic techniques used in preparing IV solutions except for the following: • Chemotherapy requires a vertical laminar airflow hood, which is smaller than a horizontal laminar flow hood. • Special chemotherapy clothing is worn. • The hands in a vertical flow hood should not be over the top of any needle, vial, or IV bag. Considerations in preparing parenteral antineoplastics • The safety cabinet work surface should be covered with a plastic-backed absorbent paper, which is disposed of in a hazardous container after use. • Personnel should wear approved gloves for chemotherapy products that are double gloved and a closed-front surgical gown with knit cuffs that is specially designed for handling chemotherapeutic agents. Contaminated gloves or outer gloves should be removed and replaced. If the skin comes in contact with antineoplastics, the area should be washed with soap and water. • Reconstituted vials should be vented to reduce the possibility of spraying and spillage. • A sterile alcohol pledget should be wrapped around the needle and vial top during withdrawal of solution. • External surfaces of syringes and IV bags (bottles) should be wiped clean of contamination. • When using ampules, wrap the neck of the ampule with a sterile alcohol pledget to protect one's fingers from being cut by the glass. • Syringes and IV bottles should be properly identified and dated. Cautionary labels should be affixed to the outer bag of the containers. • The safety cabinet should be wiped down with 70% alcohol on completion of compounding. • Contaminated needles, syringes, and hazardous waste should be placed in the sharps container. Disposable gowns, gloves, masks, and head and shoe covers should be placed in red hazardous bags. • Wash hands. • Dispose of remaining antineoplastic agents according to federal and state regulations. Considerations in preparing total parenteral nutrition • TPN normally contains 50% dextrose, 10% amino acids, and 20% fat. • Aseptic technique is required because TPN is infused into the right atrium of the heart. • TPN compounders have been developed that include a multichannel pump for the amino acids, dextrose, fats, and other additives that is connected to a personal computer. The computer assists in the calculations and drives the pump. Micro compounding pumps are used for the electrolytes and other additivesTPN and peripheral parenteral nutrition (PPN) are premixed from the manufacturer, but electrolytes, vitamins, and medications may be added to the nutrients at the pharmacy. Compounding techniques for total parenteral nutrition solution (requires aseptic technique) • Method 1: Amino acids and dextrose are mixed first. Fat emulsion is added next followed by the additives. • Method 2: Amino acids are added to the fat emulsion. Dextrose is added next followed by the additives. • Method 3: Dextrose, amino acids, and fat emulsion are added simultaneously while swirling and mixing. Additives are incorporated last. Examples of TPN additives: • Potassium chloride (KCl) • Potassium phosphate (KPO3) • Calcium gluconate (Ca gluconate) • Magnesium sulfate (MgSO4) • Sodium phosphate (NaPO4) • Sodium chloride (NaCl) • Multivitamin (MVI) • Multiple trace elements (MTE) • Zinc (Zn) Considerations in preparing radiopharmaceuticals • Radiopharmaceuticals may be diagnostic or therapeutic; they may be oral, IV, or inhaled. • The individual must wear a meter indicating the radioactive levels to which the individual is exposed. • Quality-control tests are performed to ensure the radiopharmaceutical is sterile, pyrogen free, and pure. • Proper handling of isotopes during preparation and disposal must be ensured. • Radiopharmaceuticals are to be prepared in a vertical flow hood. • Radiopharmaceuticals have strict packaging requirements, including the use of special shipping containers. • Safety principles of time, distance, and shielding are observed. • Special training must be completed if one is to work in a nuclear pharmacy. Considerations in preparing reconstituted injectable and noninjectable medications • Reconstitution is the process of mixing a liquid and powder to form a suspension or solution. • Solvent is the larger part of the solution. • Solute is the agent or ingredient used with solvent. • Solution is the solvent plus the solute. • Measure the solute and solvent (distilled water) to be used. • Add the solute to the solvent in small portions; mix thoroughly. • Check precipitation for solutions or changes in color. • Add a new expiration date and time of day to product bottle and affix a "SHAKE WELL" auxiliary label. Components of a label for intravenous medication • Name of pharmacy • Patient's name • Date the medication was filled • Ingredients with quantity of each in IV • Total quantity of IV • Directions for usage • Infusion rate • Any special notes • Expiration date • Must be initialed by the technician who prepared it • Licensed pharmacist's initials • Expiration date of repackaged drugs: Federal law mandates that the expiration date cannot exceed 6 months and cannot exceed 25% of the remaining time on the manufacturer's original expiration date on the bulk container (Figure 3-11).

Handling and disposal requirements

Storage of hazardous drugs and materials • Only authorized personnel should have access. • Warnings should be applied to all hazardous drug containers to include the shelves and bins where they are stored. • Hazardous drugs requiring refrigeration should be stored in a separate refrigerator from nonhazardous drugs. Handling of hazardous drugs and materials • PPE that includes laboratory coats, masks, and gloves should be worn at all times. • Hands should be washed before and after removal of gloves. • Powder-free gloves should be doubled when handling hazardous drugs; hypoallergenic gloves should be available for those employees allergic to latex. • The inner glove should be under the cuff and the outer glove should be above the cuff of a disposable lab jacket with a solid front. • Gloves should be changed hourly or after contamination. • Glove removal should be such that there is no skin contact with the outside of the gloves. • Facial masks should be worn to prevent the splashing or spraying of hazardous drugs into the eyes, nose, or mouth. Preparing hazardous drugs • Should only be prepared in areas designated for preparation. • Use syringes with Leur-Lok for preparing hazardous drugs. • Drug-contaminated syringes and needles should be placed in a chemotherapy sharps container. • Hazardous waste and contaminated materials should be placed in separate trash receptacles from nonhazardous trash. • The work area should be cleaned and decontaminated before and after each compounding and at the end of each shift. Disposal of hazardous drugs • Hazardous waste bags should be labeled as "Hazardous Drug Waste"; they should be thick, leakproof, and a different color than other trash bags. • Hazardous waste bags should be placed in trash receptacles labeled "Hazardous Drug Waste." • One receptacle should in each area where hazardous drugs are prepared. • Bags should be sealed when they are full. • Sharps containers should be used for the disposal of needles and other breakable items; sharps containers should be labeled "Hazardous Drug Waste Only." • Hazardous waste should be stored in a secure area while waiting for transfer. Controlled substances • Controlled substances are classified under P-waste. • A request for the destruction of controlled substance must be done using a Drug Enforcement Agency (DEA) Form 41 and must be submitted to the DEA 2 weeks before the scheduled destruction. • Retail pharmacies are permitted one destruction per year; hospital pharmacies may be awarded a "blanket destruction" for controlled substances. Radioactive materials • The U.S. Department of Transportation (DOT) regulates the shipment of hazardous materials under the Hazardous Materials Transportation Act of 1994. Radioactive materials are considered hazardous materials. The DOT has set regulations regarding packaging, labeling, and transporting of radioactive materials. • The shipping container (metal) for transporting radioactive material must be able to maintain the integrity of the product during shipping. The container must be specifically labeled based on the activity of the radioactive material: Radioactive White I, Radioactive Yellow II, and Radioactive Yellow III (which contains the highest concentration of radiation). • The container must have a "Caution: Radioactive" label with the name of the nucleotide, the quantity, the date, and the time. • Shipping papers must be inside the shipping container and include the following information: name of nucleotide, quantity, form, label category, emergency response telephone number, information regarding emergency personnel, and pharmacy name. The driver carries a copy of the shipping papers. • A placard must be on the vehicle if it is carrying Radioactive Yellow III material. Shipped material must be braced inside the transportation vehicle.

Determine product stability

The following factors affect a drug's stability: • Dosage form • Humidity • Ingredients used in a compound • Light • Material of the container • Order and method of preparation • Temperature Product incompatibilities and signs of product instability • Physical incompatibilities: Occur from changes in solubility, which may result in changes in color or the formation of a precipitate. A change in the pH of a solution, the use of buffers, and the type of solvent used may create problems. • Chemical incompatibilities: Chemical reaction occurs between one or more of the ingredients. Incompatibilities may not be noticeable. Changes in pH or chemical decomposition may occur. The presence of light may cause deterioration of the ingredients. • Therapeutic incompatibilities: The mixing together of two or more ingredients, resulting in a change in the therapeutic response of the drugs Storage temperatures The United States Pharmacopeia (USP) has defined terminology associated with temperature for the storage of medications: • Freezer: A place in which the temperature is maintained thermostatically between -25° and -10° C (-13° and 14° F) • Cold: Any temperature not exceeding 8° C (46° F). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2° and 8° C (36° and 46° F). • Cool: Any temperature between 8° and 15° C (46° and 59° F) • Controlled cold temperature: This temperature is defined as the temperature maintained thermostatically between 2° and 8° C (36° and 46° F) that allows for excursions in temperature between 0° and 15° C (32° and 59° F) that may be experienced during storage, shipping, and distribution • Room temperature: The temperature prevailing in a working area • Controlled room temperature: A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25° C (68° to 77 °F) • Warm: Any temperature between 30° and 40° C (86o and 104° F) • Excessive heat: Any temperature above 40° C (104° F) • Protection from freezing: Where, in addition to the risk of breakage of the container, freezing medications can lose strength or potency, or to destructive alteration of its characteristics. The container label bears an appropriate instruction to protect the article from freezing. • Dry place: The term "dry place" denotes a place that does not exceed 40% average relative humidity at controlled room temperature or the equivalent water vapor pressure at other temperatures. Beyond-use dating Whereas expiration dates are determined by a drug manufacturer, beyond-use dating (BUD) is established by the repackager or the compounder. It is used when a pharmacy either repackages a medication or compounds a product. There are two possible methods, the 6-month and 1-year versions. • 6-month version: The date assigned will be a maximum of 6 months or one fourth of the time to the manufacturer's expiration date. • 1-year version: Maximum of 1 year of the drug life as long as it does not exceed the expiration date assigned by the drug manufacturer State boards of pharmacy determine which method will be used.

Sterile compounding

sterile compounding techniques are used to create customized medications that will either be directly injected into the patient or will be inserted into their eye. These medications carry a high risk of infection or other medical problems, so they are compounded according to sterile rules and regulations. This is due to the fact any bacteria or fungi that are allowed to get into the medication could seriously endanger the patient's life. Sterile compounding practices ensure that all injectable medications and any applications that will be made directly to the eye will be fully sterile and free from even tiny amounts of bacteria or fungi. Sterile compounding usually takes place in a completely clean environment, such as a cleanroom. The pharmacists who are responsible for compounding the Sterile Medication will also wear appropriate safety gear including clothing, face and hair coverings.

non sterile compounding

t refers to the practice of preparing a specific medication for a patient to swallow in pill form, apply as a topical treatment to their skin or insert the medication under their skin. Although this practice is considered to be non-sterile, it is still performed in a closely monitored environment and under the applications of very strict rules and professional guidelines. The medications are customized according to legal standards that ensure that every pharmaceutical that is used in the medication maintains the proper ingredient potency and purity standards. In addition to creating customized medications that adhere to the industry's and the law's strict standards, non-sterile Compounding pharmacists are also responsible for making sure their mixtures are pure and accurate, that they provide proper labels and medication packages and that they maintain a clean working environment.