Sterile Product Compounding Quiz
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Questions and Answers

What is the primary reason for generic prescription substitution?

  • To improve the quality of drugs
  • To increase the profit margin of pharmaceutical companies
  • To reduce the side effects of drugs
  • Cheaper price, cost savings (correct)

    • What is the FDA's bioequivalence range?

  • 90-110%
  • 80-125% (correct)
  • 70-130%
  • 50-150%

    • What is the term for drugs that have a narrow margin between therapeutic and toxic doses?

  • Narrow Therapeutic Ratio (NTR) (correct)
  • Pharmaceutical Equivalence (PE)
  • Critical Dose (CD)
  • Therapeutic Equivalence (TE)

    • What is the purpose of the FDA's Orange Book?

    <p>To determine the therapeutic equivalence of drug products</p> Signup and view all the answers

    What is the term for generic drugs that are therapeutically equivalent to brand-name drugs?

    <p>Therapeutically Equivalent (TE)</p> Signup and view all the answers

    What is the code assigned to drugs that are bioequivalent to reference listed drugs?

    <p>AB</p> Signup and view all the answers

    What is the purpose of a rubber stopper of vials in sterile product compounding?

    <p>To provide a barrier between the sterile interior of the vial and the non-sterile environment.</p> Signup and view all the answers

    What is the correct dosage and rate of compounded sterile products?

    <p>It is determined by the formula and calculations.</p> Signup and view all the answers

    What is UPS Chapter?

    <p>A chapter in the USP that governs sterile compounding.</p> Signup and view all the answers

    What is the scope of UPS Chapter?

    <p>Sterile compounding.</p> Signup and view all the answers

    What is the highest level of environmental control?

    <p>Category 3.</p> Signup and view all the answers

    What is the primary difference between a single-dose vial and a multi-dose vial?

    <p>The number of times the vial can be entered.</p> Signup and view all the answers

    What is the purpose of a sporicidal agent?

    <p>To destroy bacterial and fungal spores.</p> Signup and view all the answers

    What is the recommended needle gauge for an IM injection?

    <p>22-25 gauge.</p> Signup and view all the answers

    What is the purpose of a primary IV administration set?

    <p>To connect IV fluid to a peripheral IV access.</p> Signup and view all the answers

    What is the purpose of a heparin lock?

    <p>To prevent blood clots from forming in the IV line.</p> Signup and view all the answers

    What is the primary goal of generic substitution?

    <p>To reduce cost and increase drug use</p> Signup and view all the answers

    What is the purpose of USP General Chapter <800>?

    <p>To describe the scope of hazardous drug handling</p> Signup and view all the answers

    What is the purpose of a risk assessment?

    <p>To outline steps taken to reduce the risk of exposure to hazardous drugs</p> Signup and view all the answers

    What is the primary engineering control required for sterile compounding of hazardous drugs?

    <p>C-PEC</p> Signup and view all the answers

    What is the purpose of deactivation in the handling of hazardous drugs?

    <p>To render the compound inert or inactive</p> Signup and view all the answers

    What is the main reason to compound a medication?

    <p>To remove allergens or excipients</p> Signup and view all the answers

    What is the primary regulator of non-sterile compounding?

    <p>State Board of Pharmacy</p> Signup and view all the answers

    What is the purpose of USP Chapter <795>?

    <p>To regulate non-sterile compounding</p> Signup and view all the answers

    What is the purpose of a containment strategy?

    <p>To minimize worker and environmental HD exposure</p> Signup and view all the answers

    What is the purpose of supplemental engineering controls?

    <p>To provide supplemental containment</p> Signup and view all the answers

    What is the primary goal of the DQSA?

    <p>To give FDA more authority to regulate and monitor compounding</p> Signup and view all the answers

    What is the purpose of a wetting agent in a compounded ointment or cream formulation?

    <p>To facilitate uniform mixing of a powder into a liquid or semisolid</p> Signup and view all the answers

    What is the difference between an o/w and a w/o emulsion?

    <p>O/w emulsions are washable with water, while w/o emulsions are not</p> Signup and view all the answers

    What is the purpose of a stiffening agent in a compounded ointment or cream formulation?

    <p>To make the preparation more viscous</p> Signup and view all the answers

    What is the difference between a suspension and a solution?

    <p>A suspension is a mixture of a solid and a liquid, while a solution is a mixture of two or more liquids</p> Signup and view all the answers

    What is the purpose of a penetration enhancer in a compounded ointment or cream formulation?

    <p>To increase the rate of penetration through the skin</p> Signup and view all the answers

    What is the purpose of trituration in compounding?

    <p>To reduce the particle size of powder ingredients</p> Signup and view all the answers

    What is the purpose of geometric dilution in compounding?

    <p>To mix ingredients together in a specific order</p> Signup and view all the answers

    What is the purpose of a humectant in a compounded ointment or cream formulation?

    <p>To decrease the evaporation rate of water from the preparation</p> Signup and view all the answers

    What is the minimum frequency of refresher training required by USP Standards?

    <p>Every 12 months</p> Signup and view all the answers

    What is the primary location of a peripheral IV catheter tip?

    <p>Peripheral vein</p> Signup and view all the answers

    What type of IV tubing is most common and collapses as fluid exits?

    <p>Soft plastic</p> Signup and view all the answers

    What is the recommended needle gauge for IV administration?

    <p>22-25 gauge</p> Signup and view all the answers

    What is the purpose of a Broviac catheter?

    <p>Central IV access</p> Signup and view all the answers

    What type of IV infusion container does not collapse as fluid exits?

    <p>Glass</p> Signup and view all the answers

    What is the primary difference between peripheral and central IV access?

    <p>Location of the catheter tip</p> Signup and view all the answers

    What is the purpose of a midline peripheral catheter?

    <p>Temporary medication administration</p> Signup and view all the answers

    What is the recommended frequency of replacement for peripheral IV catheters?

    <p>Every 72-96 hours</p> Signup and view all the answers

    What is the primary regulator of non-sterile compounding?

    <p>State Board of Pharmacy</p> Signup and view all the answers

    What standard must nonsterile compounding follow?

    <p>Current revision of USP chapter 795</p> Signup and view all the answers

    What is the purpose of the DQSA?

    <p>To give FDA more authority to regulate and monitor compounding</p> Signup and view all the answers

    What is an active ingredient in a non-sterile compounded formulation?

    <p>Manufactured tablets, capsules, or liquids</p> Signup and view all the answers

    What is the minimum frequency of refresher training required by USP Standards?

    <p>Every 12 months</p> Signup and view all the answers

    What is the purpose of USP chapter 795?

    <p>To set standards for nonsterile compounding</p> Signup and view all the answers

    What is a suspending vehicle in a non-sterile compounded formulation?

    <p>Both A and B</p> Signup and view all the answers

    What type of pharmacy is defined by the DQSA?

    <p>Both A and B</p> Signup and view all the answers

    What is the primary difference between an o/w and a w/o emulsion?

    <p>One has oil as the external phase and the other has water as the external phase</p> Signup and view all the answers

    What is the purpose of a humectant in a compounded ointment or cream formulation?

    <p>To decrease the evaporation rate of water from the preparation</p> Signup and view all the answers

    What is the characteristic of an ointment that makes it useful for dry, scaly skin or lesions?

    <p>It is semisolid and softens or melts at body temperature</p> Signup and view all the answers

    What is the function of a wetting agent in a compounded ointment or cream formulation?

    <p>To facilitate uniform mixing of a powder into a liquid or semisolid</p> Signup and view all the answers

    What is the characteristic of a cream that makes it useful for moist, weeping lesions?

    <p>It is opaque and tends to vanish with rubbing</p> Signup and view all the answers

    What is the purpose of a base in a compounded ointment or cream formulation?

    <p>To hold the active ingredient together</p> Signup and view all the answers

    What is the unit of measurement equivalent to 30 milliliters?

    <p>1 oz</p> Signup and view all the answers

    What is the characteristic of a w/o emulsion that makes it greasy?

    <p>It has oil as the external phase</p> Signup and view all the answers

    What is the primary reason for a generic prescription substitution?

    <p>Cheaper price</p> Signup and view all the answers

    What is the purpose of USP General Chapter <800>?

    <p>To ensure safety of patients, workers, and the environment when handling hazardous drugs</p> Signup and view all the answers

    What is pharmaceutical equivalence?

    <p>Same drug, dosage form, route of administration, and strength</p> Signup and view all the answers

    Which of the following drugs must follow the containment requirements of USP General Chapter <800>?

    <p>All of the above</p> Signup and view all the answers

    What is the FDA's bioequivalence range?

    <p>80-125%</p> Signup and view all the answers

    What is the purpose of a risk assessment in USP General Chapter <800>?

    <p>To outline the steps taken to reduce the risk of exposure to hazardous drugs</p> Signup and view all the answers

    What is the purpose of the Orange Book?

    <p>To list approved drug products with therapeutic equivalence evaluations</p> Signup and view all the answers

    What is the primary engineering control required for sterile compounding of hazardous drugs?

    <p>A C-PEC device</p> Signup and view all the answers

    What type of personal protective equipment (PPE) is required for sterile compounding of hazardous drugs?

    <p>Two pairs of chemotherapy gloves, eye face protection, and a mask</p> Signup and view all the answers

    What is therapeutic equivalence?

    <p>Same drug, dosage form, route of administration, and strength, and has the same therapeutic effect</p> Signup and view all the answers

    What is the difference between deactivation and decontamination in the handling of hazardous drugs?

    <p>Deactivation renders the compound inert or inactive, while decontamination removes HD residue</p> Signup and view all the answers

    What does the code 'AB' represent in the Orange Book?

    <p>Products that are bioequivalent to reference listed drugs</p> Signup and view all the answers

    What is the primary difference between pharmaceutical equivalence and therapeutic equivalence?

    <p>Pharmaceutical equivalence is based on dosage form, route of administration, and strength, while therapeutic equivalence is based on clinical effect</p> Signup and view all the answers

    What is the purpose of a containment strategy in USP General Chapter <800>?

    <p>To minimize the risk of exposure to hazardous drugs</p> Signup and view all the answers

    Why is it important to perform a risk assessment when handling hazardous drugs?

    <p>To outline the steps taken to reduce the risk of exposure to hazardous drugs</p> Signup and view all the answers

    What determines the therapeutic equivalence of a generic drug product?

    <p>Pharmaceutical equivalence and bioequivalence</p> Signup and view all the answers

    What is the main advantage of using a topical preparation?

    <p>It allows for targeted delivery of the medication with minimal systemic absorption</p> Signup and view all the answers

    What should a pharmacist consider when counseling patients about compounded topical preparations?

    <p>The patient's medical history, including allergies and sensitivities</p> Signup and view all the answers

    What is the primary mechanism of transdermal delivery of medications?

    <p>Passive diffusion through the skin</p> Signup and view all the answers

    What is the primary function of emollients in topical preparations?

    <p>To moisturize and soften the skin</p> Signup and view all the answers

    What is the purpose of pharmacy calculations in compounding?

    <p>To determine the accurate amount of ingredients to use in the preparation</p> Signup and view all the answers

    What is the weight of Triamcinolone in 100 grams of 0.1% ointment?

    <p>0.06g</p> Signup and view all the answers

    What is the process of incorporating powder with liquid to make a paste called?

    <p>Levigation</p> Signup and view all the answers

    What is the purpose of propylene glycol in the preparation of Triamcinolone 0.1% in Aquaphilic Ointment?

    <p>To create a paste</p> Signup and view all the answers

    What is the ratio of Triamcinolone powder to Aquaphilic Ointment in the preparation?

    <p>0.06g : 60g</p> Signup and view all the answers

    What is the name of the equipment used to mix the Triamcinolone powder with the Aquaphilic Ointment?

    <p>Spatula</p> Signup and view all the answers

    What is an advantage of topical preparations?

    <p>They avoid the GI tract.</p> Signup and view all the answers

    What is an important counseling point to discuss with patients using compounded topical formulations?

    <p>The potential for contact dermatitis.</p> Signup and view all the answers

    What is a primary purpose of transdermal delivery of a drug?

    <p>To provide extended therapy with a single application.</p> Signup and view all the answers

    What is a function of emollients in topical preparations?

    <p>To provide hydration to the skin surface.</p> Signup and view all the answers

    Why is understanding percentage preparations important in pharmacy calculations?

    <p>To accurately calculate the amount of active ingredients.</p> Signup and view all the answers

    What percentage of Triamcinolone powder is required in a 60-gram ointment preparation?

    <p>0.1%</p> Signup and view all the answers

    How many grams of Triamcinolone powder are needed to make a 60-gram ointment preparation with a concentration of 0.1%?

    <p>0.06 grams</p> Signup and view all the answers

    What is the purpose of propylene glycol in the ointment formula?

    <p>As a wetting agent</p> Signup and view all the answers

    What is the ratio of Triamcinolone powder to the total weight of the ointment preparation?

    <p>1:1000</p> Signup and view all the answers

    What is the weight of the base (delivery system) in the ointment formula?

    <p>QS (quantity sufficient)</p> Signup and view all the answers

    What is the primary advantage of using topical preparations?

    <p>Minimizing systemic side effects</p> Signup and view all the answers

    What is the role of emollients in topical preparations?

    <p>Moisturizing and softening the skin</p> Signup and view all the answers

    What is the primary mechanism of transdermal delivery?

    <p>Passive diffusion through the skin</p> Signup and view all the answers

    When counseling patients on topical preparations, what should the pharmacist emphasize?

    <p>The correct application technique</p> Signup and view all the answers

    What is the purpose of a base in a compounded ointment or cream formulation?

    <p>To hold the active ingredient together and facilitate delivery</p> Signup and view all the answers

    What is the function of a penetration enhancer in a topical preparation?

    <p>To increase the rate of penetration of the drug through the skin</p> Signup and view all the answers

    What is the purpose of a humectant in a topical preparation?

    <p>To decrease the evaporation rate of water from the preparation</p> Signup and view all the answers

    What is the process of reducing the particle size of powder ingredients in a mortar and pestle?

    <p>Trituration</p> Signup and view all the answers

    What is the purpose of an emollient in a topical preparation?

    <p>To moisturize and soften the skin</p> Signup and view all the answers

    What is the process of reducing the particle size of a powder by mixing it with a small amount of liquid?

    <p>Levigation</p> Signup and view all the answers

    What is the primary consideration when determining the Beyond-Use Date (BUD) of a non-sterile compounded formulation?

    <p>The expiration date of the shortest-lived ingredient</p> Signup and view all the answers

    What is the purpose of identifying the components of a non-sterile compounded ointment or cream formulation?

    <p>To recognize common examples of each component</p> Signup and view all the answers

    What is the primary advantage of using creams in topical preparations?

    <p>They are useful for moist, weeping lesions</p> Signup and view all the answers

    What is the primary role of a pharmacist when counseling patients about compounded topical preparations?

    <p>To educate patients on the potential risks and benefits of the formulation</p> Signup and view all the answers

    What is the primary mechanism of transdermal delivery of medications?

    <p>Diffusion through the skin</p> Signup and view all the answers

    What is the primary function of emollients in topical preparations?

    <p>To moisturize and soften the skin</p> Signup and view all the answers

    What is the primary consideration when performing pharmacy calculations in compounding?

    <p>The accuracy of the measurement</p> Signup and view all the answers

    What is the primary difference between o/w and w/o emulsions?

    <p>The direction of the emulsion</p> Signup and view all the answers

    What is the primary purpose of identifying the components of a non-sterile compounded ointment or cream formulation?

    <p>To recognize common examples of each component</p> Signup and view all the answers

    What is the primary consideration when determining the storage conditions of a non-sterile compounded formulation?

    <p>The method of storage</p> Signup and view all the answers

    Study Notes

    Formulation of Triamcinolone 0.1% in Aquaphilic Ointment

    • Active ingredient: Triamcinolone USP micronized powder
    • Wetting agent: Propylene glycol
    • Base (delivery system): Aquaphilic ointment
    • Quantity: 60 grams
    • Calculations:
      • Percentage preparations:
        • % w/v: number of grams of an ingredient per 100 mL of product
        • % w/w: number of grams of an ingredient per 100 grams of product
        • % v/v: number of mL of an ingredient in 100 mL of product

    Triamcinolone 0.1% Ointment Calculations

    • 0.1% ointment means there are 0.1 grams of Triamcinolone powder for every 100 grams of preparation
    • Making 200 g of a 0.1% preparation requires 0.2 grams of Triamcinolone powder

    Clinical Use of Compounded Ointments and Creams

    • Applications:
      • Hormone replacement therapy
      • Topical pain management
      • Veterinary medications
      • Dermatologic preparations (acne, psoriasis, eczema, etc.)
      • Pediatric formulations
      • Allergen-free medications

    Components of a Formulation

    • Active ingredient: Ingredients that have a therapeutic effect (drug)
    • Base: Vehicle that holds the active ingredient(s) together and the driver that gets the active ingredient where we want them to be in the body
    • Wetting agent: Liquid chemicals used to wet a powder and facilitate uniform mixing into a liquid or semisolid
    • Examples:
      • Aquaphilic
      • Aquaphor
      • Eucerin
      • White petrolatum
      • Propylene glycol
      • Glycerin
      • Mineral oil

    Other Components of a Formulation

    • Stiffening agent: Ingredient intended to make a preparation more viscous and/or solid
    • Examples:
      • White wax
    • Humectants: Decrease evaporation rate of water from the preparation
    • Examples:
      • Glycerine
      • Polyethylene glycol
    • Penetration enhancers: Increase rate of penetration of drug through the skin
    • Examples:
      • Water
      • Many others

    Compounding Terms

    • Levigation: Process of reducing particle size of a powder by mixing it with a small amount of liquid (just enough to wet the powder) to make a smooth paste
    • Geometric dilution: Mixing process in which one starts with the ingredient in the smallest quantity, then adds additional ingredients in order of quantity required by approximately "doubling" the portion being mixed with each addition

    Compounding Ointments and Creams

    • Introduction to compounding solutions and suspensions
    • Beyond use date (BUD) for non-sterile compounded formulations
    • Non-preserved aqueous dosage forms: 14 days (refrigerator)
    • Preserved aqueous dosage forms: 35 days (controlled room temperature or refrigerator)
    • Oral liquids (non-aqueous): 90 days (controlled room temperature or refrigerator)
    • Other non-aqueous dosage forms: 180 days (controlled room temperature or refrigerator)

    Pharmaceutical Compounding

    • Definition: Creation of a unique drug product to meet a specific patient need
    • Critical sites in sterile product compounding:
      • Hub of needle
      • Shaft of needle
      • Hub of syringe
      • Exposed syringe plunger
      • Rubber stopper of vials
      • Ports of IV bags
    • Aseptic technique:
      • Airflow direction
      • Reconstitution of vials
      • Appropriate distance within the hood
    • Scope and components of UPS Chapter:
      • Sterile compounding
      • Category 1: Least controlled environmental conditions
      • Category 2: More environmental controls than Category 1
      • Category 3: Highest level of environmental controls
      • Immediate use CSPs
      • Single and multi-dose CSPs### USP Standards
    • USP sets standards for compounding, which states may choose to enforce, with minimum requirements:
      • Everyone must undergo training, demonstrate competency, and have refreshers every 12 months
      • Core competencies: hand hygiene, garbing, cleaning and sanitizing, handling and transporting components and CNSPs, measuring and mixing, proper use of equipment, documentation

    Compounding Regulations

    • Compounded drugs are not FDA-approved; DQSA was created in 2013 to give FDA more authority to regulate and monitor compounding
    • Helps regulate raw materials used in compounding
    • Category 503A and 503B pharmacies

    Compounding Non-Sterile Products

    • Solutions: liquid preparations that contain active ingredients dissolved in a solvent
    • Suspensions: liquid preparations that contain active ingredients suspended in a solvent
    • Identify the components of a non-sterile compounded formulation:
      • Active ingredient: manufactured tablets, capsules, or liquids, bulk powder/liquid
      • Solvent: water, alcohol, glycerin, saline
      • Suspending Vehicle: Ora-plus, methylcellulose, PCCA-plus, fixed oil
      • Sweeter: aspartame, sucrose, sorbitol
      • Flavoring
      • Base vehicle: Ora-sweet, PCCA suspendit, Cheery syrup
      • Preservatives: benzalkonium chloride, benzyl alcohol, sodium benzoate

    Ointments and Creams

    • Compare and contrast o/w versus w/o emulsions:
      • O/w: oil in water
      • W/o: water in oil
    • Compare and contrast ointments and creams:
      • Cream: topical dosage form for external use, liquid or semisolid, opaque, tends to vanish with rubbing, has more fluid-like consistency, useful for moist, weeping lesions
      • Ointment: topical dosage form for external use, semisolid, soften or melt at body temperature, spreads easily, not gritty, useful for dry, scaly skin or lesions

    Sterile Compounding

    • Identify critical sites in sterile product compounding:
      • Hub of needle
      • Shaft of needle
      • Hub of syringe
      • Exposed syringe plunger
      • Rubber stopper of vials
      • Ports of IV bags
    • Establish appropriate aseptic technique, taking into consideration airflow direction, reconstitution of vials, and appropriate distance within the hood
    • Determine the correct dosage and rate of compounded sterile products and prepare a label accordingly

    UPS Chapter <797>

    • Sterile compounding scope:
      • Category 1: least controlled environmental conditions
      • Category 2: more environmental controls than Category 1
      • Category 3: highest level of environmental controls
    • Immediate use CSPs:
      • Not subject to the requirements for Category 1, 2, or 3 CSPs when all the following are met:
        • Processes are in place to minimize contact with nonsterile surfaces, conventionally manufactured products or CSPs
        • Prepared according to drug labeling
        • Preparation involves not more than 3 different sterile products
        • Any unused starting component is discarded after preparation
        • Administration begins within 4 hours from start of preparation
        • Must be labeled with names, amount of ingredients unless administration is performed by person who compounded

    Parenteral Drug Administration

    • Recommend appropriate needle gauge for various administration routes:
      • Smaller the number, larger the gauge (inside diameter)
      • Ranges from 27 (finest) to 13 (largest)
    • Length is measured in inches from hub/shaft juncture to the tip of needle point
    • Ranges from 3/8 to 3 ½ inches
    • Route: muscle, IM; subcu tissue, SubQ (45); IV (25); ID (10)

    Compounding Regulations

    • State laws: in Iowa, pharmacy may request substitution of a lower-priced generic and TE drug for a higher-priced prescribed drug
    • Pharmacy shall obtain the approval of the provider prior to requesting subs
    • Pharmacy shall not subs an equivalent drug contrary to a prescription drug order that prohibits a subs### Calculations for Compounding
    • To make 60 grams of 0.1% Triamcinolone in Aquaphilic Ointment, 0.06 grams of Triamcinolone powder is required
    • The formula to calculate the amount of ingredient needed is: (concentration % x total weight) / 100
    • In this case, (0.1% x 60g) / 100 = 0.06g

    Definitions and Concepts

    • Percent weight in volume: number of grams of ingredient per 100 mL of product
    • Examples: 0.1% Triamcinolone = 0.1g/100mL, 8.4% Sodium bicarbonate = 8.4g/100mL

    Compounding Ointments and Creams

    • Advantages:
      • Helpful when oral or other routes are not available
      • Non-invasive route of administration
      • Avoids GI tract and first-pass effect
      • May provide extended therapy with a single application, improving compliance
    • Disadvantages:
      • Limited amounts of active ingredients may restrict use to more potent drugs
      • Some patients may develop contact dermatitis

    Topical Preparations

    • Primary purposes:
      • Protective preparations: protect skin from external factors and allow skin to heal
      • Emollients: provide skin with hydration and soften skin surface
      • Drug delivery: release an active drug to the application site for local or systemic effect

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    Test your knowledge on critical sites in sterile product compounding, aseptic technique, and best practices for handling vials and IV bags. Learn how to ensure a safe and contamination-free environment. Get ready to assess your skills!

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