Podcast
Questions and Answers
What are the two very important records that each compounded product must have?
What are the two very important records that each compounded product must have?
- Calibration record and maintenance record
- Prescription record and evaluation record
- Temperature log and chemical record
- Master formula record and compounding record (correct)
What is the purpose of the compounding log?
What is the purpose of the compounding log?
- To monitor temperature and humidity levels in the pharmacy
- To record equipment calibration and maintenance
- To track patient information and prescription history
- To provide detailed documentation for replication, evaluation, and traceability (correct)
What initial steps are similar for most formulations when preparing to compound?
What initial steps are similar for most formulations when preparing to compound?
- Evaluating patient prescriptions and formulating a plan
- Cleaning equipment and maintaining records
- Packaging and performing quality control
- Calibrating equipment and weighing ingredients (correct)
What must the pharmacy keep records of related to the compounded product?
What must the pharmacy keep records of related to the compounded product?
What is the purpose of using a powder sieve?
What is the purpose of using a powder sieve?
What is the range of particle size after grinding the powder?
What is the range of particle size after grinding the powder?
What is levigation in the context of comminution?
What is levigation in the context of comminution?
What does trituration primarily involve?
What does trituration primarily involve?
What is the main goal when making a compound with dry ingredients?
What is the main goal when making a compound with dry ingredients?
What is the sieve number based on?
What is the sieve number based on?
What is the term used to describe reducing particle size by grinding, crushing, milling, or vibrating?
What is the term used to describe reducing particle size by grinding, crushing, milling, or vibrating?
What is the purpose of levigating agent in levigation and spatulation?
What is the purpose of levigating agent in levigation and spatulation?
What type of calculations are often required for compounding?
What type of calculations are often required for compounding?
What is the recommended personal protective equipment (PPE) for compounding non-sterile, non-hazardous preparations?
What is the recommended personal protective equipment (PPE) for compounding non-sterile, non-hazardous preparations?
Where should the preparation of non-sterile hazardous drugs (HDs) ideally be done?
Where should the preparation of non-sterile hazardous drugs (HDs) ideally be done?
What is the primary containment equipment recommended for reducing exposure to non-sterile hazardous drugs (HDs)?
What is the primary containment equipment recommended for reducing exposure to non-sterile hazardous drugs (HDs)?
What is the primary purpose of Safety Data Sheets (SDS) for compounding?
What is the primary purpose of Safety Data Sheets (SDS) for compounding?
What is the recommended practice for packaging final formulations of non-sterile hazardous drugs (HDs)?
What is the recommended practice for packaging final formulations of non-sterile hazardous drugs (HDs)?
What is the recommended primary engineering control for preparing non-sterile hazardous drugs (HDs)?
What is the recommended primary engineering control for preparing non-sterile hazardous drugs (HDs)?
What is the primary technique recommended for most formulations when preparing to compound?
What is the primary technique recommended for most formulations when preparing to compound?
What is the primary goal of completing compounding steps?
What is the primary goal of completing compounding steps?
What is the primary aspect of quality control for compounded products?
What is the primary aspect of quality control for compounded products?
What is the primary part of the compounding record related to patient care?
What is the primary part of the compounding record related to patient care?
What is the recommended practice for compounding non-sterile hazardous drugs (HDs) into final formulations?
What is the recommended practice for compounding non-sterile hazardous drugs (HDs) into final formulations?
True or false: The compounding log must be detailed enough that another trained person can replicate the steps involved in the preparation.
True or false: The compounding log must be detailed enough that another trained person can replicate the steps involved in the preparation.
True or false: The main goal when making a compound with dry ingredients is to reduce particle size by grinding, crushing, milling, or vibrating.
True or false: The main goal when making a compound with dry ingredients is to reduce particle size by grinding, crushing, milling, or vibrating.
True or false: The pharmacy must keep records of steps and processes that relate to the compounded product, such as equipment cleaning, calibration and maintenance.
True or false: The pharmacy must keep records of steps and processes that relate to the compounded product, such as equipment cleaning, calibration and maintenance.
True or false: The initial steps for most formulations when ready to compound, include calibrating equipment and weighing ingredients.
True or false: The initial steps for most formulations when ready to compound, include calibrating equipment and weighing ingredients.
Comminution involves reducing particle size by grinding, crushing, milling, vibrating, or other processes.
Comminution involves reducing particle size by grinding, crushing, milling, vibrating, or other processes.
The size of particles after grinding the powder ranges from 0.1 - 10 microns.
The size of particles after grinding the powder ranges from 0.1 - 10 microns.
A sieve with a high mesh size has many wires that make many holes, allowing only a fine powder to get through the mesh.
A sieve with a high mesh size has many wires that make many holes, allowing only a fine powder to get through the mesh.
Trituration is a general term used to mean 'mix thoroughly' and is commonly associated with grinding tablets with a mortar and pestle until a fine powder is achieved.
Trituration is a general term used to mean 'mix thoroughly' and is commonly associated with grinding tablets with a mortar and pestle until a fine powder is achieved.
Levigation involves triturating the powder with a mortar and pestle and incorporating a small amount of liquid, called a levigating agent, to help with the grinding process.
Levigation involves triturating the powder with a mortar and pestle and incorporating a small amount of liquid, called a levigating agent, to help with the grinding process.
Sieves, which are sifters, are used to ensure that the particle size is uniform by sifting the powder through the mesh.
Sieves, which are sifters, are used to ensure that the particle size is uniform by sifting the powder through the mesh.
The number of holes per inch determines the sieve number, e.g., a #100 sieve has 100 openings per inch.
The number of holes per inch determines the sieve number, e.g., a #100 sieve has 100 openings per inch.
The primary goal when making a compound with dry ingredients is to make an evenly-distributed mixture with fine powder.
The primary goal when making a compound with dry ingredients is to make an evenly-distributed mixture with fine powder.
Compounding of non-sterile, non-hazardous preparations does not require any personal protective equipment (PPE).
Compounding of non-sterile, non-hazardous preparations does not require any personal protective equipment (PPE).
Safety Data Sheets (SDS) provide information on recommended personal protective equipment (PPE) for specific compounds, such as benzalkonium chloride.
Safety Data Sheets (SDS) provide information on recommended personal protective equipment (PPE) for specific compounds, such as benzalkonium chloride.
Compounding Record includes the drug name, strength, quantity, ingredients, compounding directions, and procedures.
Compounding Record includes the drug name, strength, quantity, ingredients, compounding directions, and procedures.
Techniques to reduce exposure for non-sterile hazardous drugs (HDs) include using shared equipment and placing final formulations into bulk packaging.
Techniques to reduce exposure for non-sterile hazardous drugs (HDs) include using shared equipment and placing final formulations into bulk packaging.
Common techniques for most formulations include trituration, emulsification, and geometric dilution.
Common techniques for most formulations include trituration, emulsification, and geometric dilution.
Quality control for compounded products involves validating weight, checking for mixing adequacy, color, clarity, odor, consistency, and temperature.
Quality control for compounded products involves validating weight, checking for mixing adequacy, color, clarity, odor, consistency, and temperature.
Calculations for compounding often require unit conversions, percentage and ratio strengths, basic geometry, and changing concentrations.
Calculations for compounding often require unit conversions, percentage and ratio strengths, basic geometry, and changing concentrations.
Preparation of non-sterile hazardous drugs (HDs) should be done in a containment primary engineering control (C-PEC) whenever possible.
Preparation of non-sterile hazardous drugs (HDs) should be done in a containment primary engineering control (C-PEC) whenever possible.
Completion steps for compounding include packaging the product, performing quality control, and applying container labels.
Completion steps for compounding include packaging the product, performing quality control, and applying container labels.
Master Formula #3755 for Ibuprofen 200mg Suppositories includes ingredients, quantities, and preparation steps.
Master Formula #3755 for Ibuprofen 200mg Suppositories includes ingredients, quantities, and preparation steps.
Counseling the patient and documenting any subsequent adverse drug reactions (ADRs) are part of the compounding record.
Counseling the patient and documenting any subsequent adverse drug reactions (ADRs) are part of the compounding record.
Compounding of non-sterile, non-hazardous preparations requires a clean lab coat and gloves as minimal personal protective equipment (PPE).
Compounding of non-sterile, non-hazardous preparations requires a clean lab coat and gloves as minimal personal protective equipment (PPE).
What is the primary purpose of using a powder sieve in compounding?
What is the primary purpose of using a powder sieve in compounding?
What is the range of particle size after grinding the powder for most formulations in compounding?
What is the range of particle size after grinding the powder for most formulations in compounding?
What is the recommended osmolarity for sterile preparations, including intravenous (IV) solutions and ophthalmic products, to prevent fluid transfer across biological semipermeable membranes?
What is the recommended osmolarity for sterile preparations, including intravenous (IV) solutions and ophthalmic products, to prevent fluid transfer across biological semipermeable membranes?
What is the primary technique recommended for most formulations when preparing to compound?
What is the primary technique recommended for most formulations when preparing to compound?
Which type of bag should be used for IV medications with leaching or sorption issues?
Which type of bag should be used for IV medications with leaching or sorption issues?
What should be done to equalize pressure when drawing up liquid from vials?
What should be done to equalize pressure when drawing up liquid from vials?
What is the primary purpose of lyophilized or freeze-dried powder in vials?
What is the primary purpose of lyophilized or freeze-dried powder in vials?
What is the volume range for Small Volume Parenteral (SVP) bags?
What is the volume range for Small Volume Parenteral (SVP) bags?
What is the primary characteristic of Large Volume Parenteral (LVP) containers?
What is the primary characteristic of Large Volume Parenteral (LVP) containers?
What is the risk level of Ready-to-use medications in terms of Compounded Sterile Preparations (CSP)?
What is the risk level of Ready-to-use medications in terms of Compounded Sterile Preparations (CSP)?
What is involved in the workflow for CSP preparation?
What is involved in the workflow for CSP preparation?
What is the primary requirement for sterile compounding space?
What is the primary requirement for sterile compounding space?
What is the recommended practice for Ready-to-use vial/bag systems?
What is the recommended practice for Ready-to-use vial/bag systems?
What is the primary containment equipment recommended for reducing exposure to non-sterile hazardous drugs (HDs)?
What is the primary containment equipment recommended for reducing exposure to non-sterile hazardous drugs (HDs)?
What is the primary technique for reducing exposure to non-sterile hazardous drugs (HDs)?
What is the primary technique for reducing exposure to non-sterile hazardous drugs (HDs)?
What is the primary aspect of quality control for compounded products?
What is the primary aspect of quality control for compounded products?
What determines the Beyond-Use Date (BUD) for compounded sterile preparations (CSPs)?
What determines the Beyond-Use Date (BUD) for compounded sterile preparations (CSPs)?
Which CSPs require sterilization before use?
Which CSPs require sterilization before use?
What is the primary purpose of immediate-use compounded sterile preparations (CSPs)?
What is the primary purpose of immediate-use compounded sterile preparations (CSPs)?
What is the required sterility testing for certain high-risk CSPs and those beyond recommended BUD?
What is the required sterility testing for certain high-risk CSPs and those beyond recommended BUD?
Which CSPs have the shortest Beyond-Use Date (BUD)?
Which CSPs have the shortest Beyond-Use Date (BUD)?
What type of CSPs are commonly prepared by pharmacy staff and use 1 to 3 sterile components?
What type of CSPs are commonly prepared by pharmacy staff and use 1 to 3 sterile components?
What determines the BUDs for Single-Dose Containers and Multi-Dose Containers?
What determines the BUDs for Single-Dose Containers and Multi-Dose Containers?
What must every facility preparing CSPs have in place to evaluate and improve the quality processes?
What must every facility preparing CSPs have in place to evaluate and improve the quality processes?
What is the primary requirement for immediate-use CSPs?
What is the primary requirement for immediate-use CSPs?
What do BUDs for room temperature and refrigerated CSPs vary based on?
What do BUDs for room temperature and refrigerated CSPs vary based on?
What are medium-risk CSPs examples of?
What are medium-risk CSPs examples of?
What are high-risk CSPs characterized by?
What are high-risk CSPs characterized by?
What is the primary purpose of the carbonic acid-bicarbonate buffer system in the body?
What is the primary purpose of the carbonic acid-bicarbonate buffer system in the body?
What is the potential consequence of administering lower osmolarity saline solutions alone?
What is the potential consequence of administering lower osmolarity saline solutions alone?
Why should hypertonic saline concentrations be restricted to specific areas in the hospital?
Why should hypertonic saline concentrations be restricted to specific areas in the hospital?
What is the primary reason for administering solutions with high osmolarity via a central line?
What is the primary reason for administering solutions with high osmolarity via a central line?
What is the potential consequence of administering hypertonic saline into a peripheral vein?
What is the potential consequence of administering hypertonic saline into a peripheral vein?
What is the classification for a recall that is not likely to cause adverse health consequences?
What is the classification for a recall that is not likely to cause adverse health consequences?
What is the primary purpose of Root cause analysis for medication errors or safety issues?
What is the primary purpose of Root cause analysis for medication errors or safety issues?
What is the primary function of the Standard Operating Procedures (SOPs) in pharmaceutical quality assurance?
What is the primary function of the Standard Operating Procedures (SOPs) in pharmaceutical quality assurance?
What must High-risk level Compounded Sterile Preparations (CSPs) have in place for daily observation of test specimens?
What must High-risk level Compounded Sterile Preparations (CSPs) have in place for daily observation of test specimens?
What are the primary components that a QA plan must include?
What are the primary components that a QA plan must include?
What is the primary role of failure mode and effects analysis in pharmaceutical quality assurance?
What is the primary role of failure mode and effects analysis in pharmaceutical quality assurance?
What is the primary reason for developing, following, and periodically reviewing Standard Operating Procedures (SOPs)?
What is the primary reason for developing, following, and periodically reviewing Standard Operating Procedures (SOPs)?
What is the recommended technique for handling closed-system transfer devices (CSTDs) when compounding?
What is the recommended technique for handling closed-system transfer devices (CSTDs) when compounding?
What is the primary purpose of using a filter straw or needle when withdrawing fluid from glass ampules?
What is the primary purpose of using a filter straw or needle when withdrawing fluid from glass ampules?
What is the primary purpose of using a negative-pressure technique for hazardous drugs?
What is the primary purpose of using a negative-pressure technique for hazardous drugs?
What is the recommended method for sterilizing heat-sensitive drugs?
What is the recommended method for sterilizing heat-sensitive drugs?
What must labels for compounded sterile preparations (CSPs) include?
What must labels for compounded sterile preparations (CSPs) include?
What is the primary purpose of auxiliary labels for compounded sterile preparations (CSPs)?
What is the primary purpose of auxiliary labels for compounded sterile preparations (CSPs)?
What is the primary goal of terminal sterilization methods for compounded products?
What is the primary goal of terminal sterilization methods for compounded products?
What is the primary purpose of visual inspection for rubber coring when using multi-dose vials?
What is the primary purpose of visual inspection for rubber coring when using multi-dose vials?
What is the recommended practice for changing the needle before injecting into an IV bag?
What is the recommended practice for changing the needle before injecting into an IV bag?
What is the primary purpose of testing certain compounded sterile preparations (CSPs) for endotoxins?
What is the primary purpose of testing certain compounded sterile preparations (CSPs) for endotoxins?
What is the primary purpose of rinsing glassware and utensils with sterile water and depyrogenating them?
What is the primary purpose of rinsing glassware and utensils with sterile water and depyrogenating them?
What is the primary purpose of inverting multi-dose vials after withdrawal?
What is the primary purpose of inverting multi-dose vials after withdrawal?
What is the osmotic pressure of human blood and body tissues equivalent to?
What is the osmotic pressure of human blood and body tissues equivalent to?
All hazardous drugs (HDs) should be labeled appropriately.
All hazardous drugs (HDs) should be labeled appropriately.
Is the osmolarity of most sterile preparations, including intravenous (IV) solutions and ophthalmic products, approximately -285 mOsm/L?
Is the osmolarity of most sterile preparations, including intravenous (IV) solutions and ophthalmic products, approximately -285 mOsm/L?
The pharmacist is not required to counsel the patient or caregiver about the proper use of a compounded product.
The pharmacist is not required to counsel the patient or caregiver about the proper use of a compounded product.
Closed-system transfer devices (CSTDs) equalize vial pressure and eliminate the need to inject air.
Closed-system transfer devices (CSTDs) equalize vial pressure and eliminate the need to inject air.
Multi-dose vials should be visually inspected for rubber coring after withdrawal.
Multi-dose vials should be visually inspected for rubber coring after withdrawal.
Glass ampules should be opened towards the user to avoid contamination.
Glass ampules should be opened towards the user to avoid contamination.
The needle must be changed after injecting into an IV bag to prevent glass particles from entering the bag.
The needle must be changed after injecting into an IV bag to prevent glass particles from entering the bag.
Heat-sensitive drugs can be sterilized using filtration with a 0.22-micron filter without the need for a bubble-point test.
Heat-sensitive drugs can be sterilized using filtration with a 0.22-micron filter without the need for a bubble-point test.
Labels for CSPs must include the total weight, BUD, and potential adverse reactions.
Labels for CSPs must include the total weight, BUD, and potential adverse reactions.
Low-risk sterile drugs have the lowest contamination risk and the shortest BUD.
Low-risk sterile drugs have the lowest contamination risk and the shortest BUD.
Auxiliary labels should be used for CSPs requiring special handling, and high-alert medications do not need appropriate auxiliary labels.
Auxiliary labels should be used for CSPs requiring special handling, and high-alert medications do not need appropriate auxiliary labels.
Certain CSPs must be tested for endotoxins, and glassware and utensils should be rinsed with regular water to avoid contamination.
Certain CSPs must be tested for endotoxins, and glassware and utensils should be rinsed with regular water to avoid contamination.
Terminal sterilization methods include steam, dry-heat, gas sterilization, ionizing radiation, and bidirectional aseptic processing.
Terminal sterilization methods include steam, dry-heat, gas sterilization, ionizing radiation, and bidirectional aseptic processing.
The negative-pressure technique should be used for non-hazardous drugs to prevent spraying and contamination.
The negative-pressure technique should be used for non-hazardous drugs to prevent spraying and contamination.
Sterile compounding space must have a temperature of 25°C and humidity of 60%.
Sterile compounding space must have a temperature of 25°C and humidity of 60%.
Which technique should be used to prevent contamination when withdrawing fluid from glass ampules?
Which technique should be used to prevent contamination when withdrawing fluid from glass ampules?
What must be done before injecting into an IV bag to prevent contamination?
What must be done before injecting into an IV bag to prevent contamination?
Low-risk CSPs use 1 to 3 sterile components and are commonly prepared by pharmacy staff.
Low-risk CSPs use 1 to 3 sterile components and are commonly prepared by pharmacy staff.
High-risk CSPs are uncommon and use non-sterile ingredients and equipment, requiring sterilization before use.
High-risk CSPs are uncommon and use non-sterile ingredients and equipment, requiring sterilization before use.
What is the primary purpose of using a 0.22-micron filter in sterilizing heat-sensitive drugs?
What is the primary purpose of using a 0.22-micron filter in sterilizing heat-sensitive drugs?
What information must be included in labels for Compounded Sterile Preparations (CSPs)?
What information must be included in labels for Compounded Sterile Preparations (CSPs)?
Sterility testing using tryptic soy broth or fluid thioglycollate medium is required for certain high-risk CSPs and those beyond recommended BUD.
Sterility testing using tryptic soy broth or fluid thioglycollate medium is required for certain high-risk CSPs and those beyond recommended BUD.
What is the recommended containment equipment for reducing exposure to non-sterile hazardous drugs (HDs)?
What is the recommended containment equipment for reducing exposure to non-sterile hazardous drugs (HDs)?
BUDs for Single-Dose Containers and Multi-Dose Containers depend on the type of container and the environment in which they are opened.
BUDs for Single-Dose Containers and Multi-Dose Containers depend on the type of container and the environment in which they are opened.
Immediate-use CSPs are intended for emergency administration and have specific requirements for administration within 1 hour.
Immediate-use CSPs are intended for emergency administration and have specific requirements for administration within 1 hour.
What is the recommended method for terminal sterilization of Compounded Sterile Preparations (CSPs)?
What is the recommended method for terminal sterilization of Compounded Sterile Preparations (CSPs)?
What is the primary aspect of quality control for compounded products?
What is the primary aspect of quality control for compounded products?
BUD is determined by USP 797 standards and the stability of individual ingredients, with shorter BUD for higher risk levels.
BUD is determined by USP 797 standards and the stability of individual ingredients, with shorter BUD for higher risk levels.
Room temperature and refrigerated BUDs vary based on CSP risk level, with longer BUD for low-risk CSPs and immediate-use.
Room temperature and refrigerated BUDs vary based on CSP risk level, with longer BUD for low-risk CSPs and immediate-use.
What is the recommended personal protective equipment (PPE) for compounding non-sterile hazardous drugs (HDs)?
What is the recommended personal protective equipment (PPE) for compounding non-sterile hazardous drugs (HDs)?
Immediate-use CSPs, prepared in emergency situations, have the shortest Beyond-Use Date (BUD).
Immediate-use CSPs, prepared in emergency situations, have the shortest Beyond-Use Date (BUD).
What is the purpose of using a levigating agent in levigation and spatulation?
What is the purpose of using a levigating agent in levigation and spatulation?
Every facility preparing CSPs must have a quality assurance plan to evaluate and improve the quality processes.
Every facility preparing CSPs must have a quality assurance plan to evaluate and improve the quality processes.
What must the pharmacy keep records of related to the compounded product?
What must the pharmacy keep records of related to the compounded product?
What is the recommended practice for packaging final formulations of non-sterile hazardous drugs (HDs)?
What is the recommended practice for packaging final formulations of non-sterile hazardous drugs (HDs)?
Low-risk, medium-risk, and high-risk CSPs have specific area requirements based on the number of sterile ingredients and complexity of manipulations.
Low-risk, medium-risk, and high-risk CSPs have specific area requirements based on the number of sterile ingredients and complexity of manipulations.
Medium-risk CSPs include parenteral nutrition preparations and compounding a batch of drugs like IV bags for surgeries.
Medium-risk CSPs include parenteral nutrition preparations and compounding a batch of drugs like IV bags for surgeries.
What is the term used to describe reducing particle size by grinding, crushing, milling, or vibrating?
What is the term used to describe reducing particle size by grinding, crushing, milling, or vibrating?
Non-PVC bags should be used for IV medications with leaching or sorption issues
Non-PVC bags should be used for IV medications with leaching or sorption issues
Ampules are small, sealed glass containers with a long neck containing liquid medication; breaking the ampule can introduce glass particles into the drug solution
Ampules are small, sealed glass containers with a long neck containing liquid medication; breaking the ampule can introduce glass particles into the drug solution
Small volume parenteral (SVP) bags contain 100 ml or less of fluid and can be sent to the patient care area for floor stock
Small volume parenteral (SVP) bags contain 100 ml or less of fluid and can be sent to the patient care area for floor stock
Ready-to-use medications do not have a CSP risk level and have an expiration date provided by the manufacturer
Ready-to-use medications do not have a CSP risk level and have an expiration date provided by the manufacturer
Large volume parenteral (LVP) containers contain more than 100 ml of fluids, including NS, DSW, DSNS, and others
Large volume parenteral (LVP) containers contain more than 100 ml of fluids, including NS, DSW, DSNS, and others
Ready-to-use vial/bag systems involve attaching vials to bags at the bedside or in the pharmacy cleanroom
Ready-to-use vial/bag systems involve attaching vials to bags at the bedside or in the pharmacy cleanroom
Lyophilized or freeze-dried powder in vials needs reconstitution by adding sterile water for injection, bacteriostatic water for injection, or a diluent supplied by the manufacturer
Lyophilized or freeze-dried powder in vials needs reconstitution by adding sterile water for injection, bacteriostatic water for injection, or a diluent supplied by the manufacturer
Vials containing liquids require drawing up the drug in a syringe and injecting a volume of air equal to the volume of drug withdrawn to equalize pressure
Vials containing liquids require drawing up the drug in a syringe and injecting a volume of air equal to the volume of drug withdrawn to equalize pressure
SVPs can contain plain fluid, drugs with or without a diluent, and can be piggybacked onto a large volume parenteral (LVP)
SVPs can contain plain fluid, drugs with or without a diluent, and can be piggybacked onto a large volume parenteral (LVP)
pH of sterile preparations should be close to neutral (pH of 7); blood is slightly alkaline at a pH of 7.35 - 7.45
pH of sterile preparations should be close to neutral (pH of 7); blood is slightly alkaline at a pH of 7.35 - 7.45
Workflow for CSP preparation involves pharmacist review, gathering and inspecting materials, aseptic preparation, disposal of syringes and needles, and visual inspection of finished CSPs
Workflow for CSP preparation involves pharmacist review, gathering and inspecting materials, aseptic preparation, disposal of syringes and needles, and visual inspection of finished CSPs
Space requirements for sterile compounding are discussed in detail, including the placement of items in the sterile hood and the transfer of solutions into IV bags
Space requirements for sterile compounding are discussed in detail, including the placement of items in the sterile hood and the transfer of solutions into IV bags
Osmolarity and tonicity are unrelated terms used to express solute concentration in solutions.
Osmolarity and tonicity are unrelated terms used to express solute concentration in solutions.
Hypertonic saline concentrations can be administered into a peripheral vein without causing adverse effects.
Hypertonic saline concentrations can be administered into a peripheral vein without causing adverse effects.
Lower osmolarity saline solutions can cause RBCs to absorb fluid and burst if administered alone.
Lower osmolarity saline solutions can cause RBCs to absorb fluid and burst if administered alone.
The carbonic acid-bicarbonate buffer system is the only buffer system used by the body to resist changes in pH.
The carbonic acid-bicarbonate buffer system is the only buffer system used by the body to resist changes in pH.
Preparations administered in sensitive tissues must be formulated to keep the pH within a narrow range to avoid tissue damage.
Preparations administered in sensitive tissues must be formulated to keep the pH within a narrow range to avoid tissue damage.
QA plan for pharmaceuticals must include environmental monitoring, equipment calibration, and maintenance, with documented follow-up actions and assigned personnel.
QA plan for pharmaceuticals must include environmental monitoring, equipment calibration, and maintenance, with documented follow-up actions and assigned personnel.
Root cause analysis should not be initiated for medication errors or safety issues.
Root cause analysis should not be initiated for medication errors or safety issues.
Standard Operating Procedures (SOPs) should not be developed, followed, and periodically reviewed for necessary revisions.
Standard Operating Procedures (SOPs) should not be developed, followed, and periodically reviewed for necessary revisions.
Recalls are classified as Class I (temporary or reversible adverse health consequences), Class II (serious adverse health consequences or death), and Class III (not likely to cause adverse health consequences).
Recalls are classified as Class I (temporary or reversible adverse health consequences), Class II (serious adverse health consequences or death), and Class III (not likely to cause adverse health consequences).
High-risk level Compounded Sterile Preparations (CSPs) must have a written procedure for daily observation of incubating test specimens and immediate recall if evidence of microbial growth is found.
High-risk level Compounded Sterile Preparations (CSPs) must have a written procedure for daily observation of incubating test specimens and immediate recall if evidence of microbial growth is found.
Solutions with high osmolarity should be administered via a central line to avoid vein damage.
Solutions with high osmolarity should be administered via a central line to avoid vein damage.
pH changes in body tissues are not resisted by buffer systems to maintain a narrow pH range in sensitive tissues.
pH changes in body tissues are not resisted by buffer systems to maintain a narrow pH range in sensitive tissues.
Study Notes
Compounding Formulation and Safety Procedures
- Always review Safety Data Sheets (SDS) for each bulk ingredient to determine safety procedures for compounding and recommended personal protective equipment (PPE).
- Master Formula #3755 for Ibuprofen 200mg Suppositories includes ingredients, quantities, and preparation steps.
- Compounding Record includes drug name, strength, quantity, ingredients, compounding directions, and procedures.
- Preparation of non-sterile hazardous drugs (HDs) should be done in a containment primary engineering control (C-PEC) when possible.
- Techniques to reduce exposure for non-sterile HDs include using dedicated equipment and placing final formulations into unit-dose sealed packaging.
- Compounding of non-sterile, non-hazardous preparations requires a clean lab coat and gloves as minimal PPE.
- Safety Data Sheets provide information on additional PPE needed for specific compounds, such as benzalkonium chloride.
- Calculations for compounding often require unit conversions, percentage and ratio strengths, basic algebra, and changing concentrations.
- Completion steps for compounding include packaging the product, performing quality control, and applying container labels.
- Common techniques for most formulations include trituration, levigation, and geometric dilution.
- Quality control for compounded products involves validating weight, checking for mixing adequacy, color, clarity, odor, consistency, and pH.
- Counseling the patient and documenting any subsequent adverse drug reactions (ADRs) are part of the compounding record.
Compounding Formulation and Safety Procedures
- Always review Safety Data Sheets (SDS) for each bulk ingredient to determine safety procedures for compounding and recommended personal protective equipment (PPE).
- Master Formula #3755 for Ibuprofen 200mg Suppositories includes ingredients, quantities, and preparation steps.
- Compounding Record includes drug name, strength, quantity, ingredients, compounding directions, and procedures.
- Preparation of non-sterile hazardous drugs (HDs) should be done in a containment primary engineering control (C-PEC) when possible.
- Techniques to reduce exposure for non-sterile HDs include using dedicated equipment and placing final formulations into unit-dose sealed packaging.
- Compounding of non-sterile, non-hazardous preparations requires a clean lab coat and gloves as minimal PPE.
- Safety Data Sheets provide information on additional PPE needed for specific compounds, such as benzalkonium chloride.
- Calculations for compounding often require unit conversions, percentage and ratio strengths, basic algebra, and changing concentrations.
- Completion steps for compounding include packaging the product, performing quality control, and applying container labels.
- Common techniques for most formulations include trituration, levigation, and geometric dilution.
- Quality control for compounded products involves validating weight, checking for mixing adequacy, color, clarity, odor, consistency, and pH.
- Counseling the patient and documenting any subsequent adverse drug reactions (ADRs) are part of the compounding record.
Pharmaceutical Quality Assurance and Osmolarity in Intravenous Drugs
- QA plan must include personnel training, environmental monitoring, equipment calibration, and maintenance, with documented follow-up actions and assigned personnel.
- Root cause analysis should be initiated for medication errors or safety issues, and failure mode and effects analysis can help identify problems with new procedures.
- Standard Operating Procedures (SOPs) should be developed, followed, and periodically reviewed for necessary revisions.
- High-risk level Compounded Sterile Preparations (CSPs) must have a written procedure for daily observation of incubating test specimens and immediate recall if evidence of microbial growth is found.
- Recalls are classified as Class I (serious adverse health consequences or death), Class II (temporary or reversible adverse health consequences), and Class III (not likely to cause adverse health consequences).
- Osmolarity and tonicity are related terms used to express solute concentration in solutions, and hypertonic saline concentrations should be restricted to specific areas in the hospital to avoid adverse outcomes.
- Hypertonic saline administered into a peripheral vein can cause RBCs to become shriveled and dysfunctional, while solutions with high osmolarity should be administered via a central line to avoid vein damage.
- Lower osmolarity saline solutions can cause RBCs to absorb fluid and burst if administered alone, and pH changes in body tissues are resisted by buffer systems to maintain a narrow pH range in sensitive tissues.
- The carbonic acid-bicarbonate buffer system is used by the body to resist changes in pH, with two other buffer systems also playing a role in pH regulation.
- Preparations administered in sensitive tissues must be formulated to keep the pH within a narrow range to avoid tissue damage and provide stability for the drug in the solution.
Sterile Compounding Best Practices
- Closed-system transfer devices (CSTDs) or the negative-pressure technique should be used to prevent contamination.
- CSTDs equalize vial pressure, eliminating the need to inject air, and should be handled at a 45-degree angle.
- Multi-dose vials should be inverted after withdrawal, and visual inspection for rubber coring is crucial.
- Glass ampules should be opened away from the user, and a filter straw or needle should be used to withdraw fluid to avoid glass particles.
- The needle must be changed before injecting into an IV bag to prevent glass or particles from entering the bag.
- Negative-pressure technique should be used for hazardous drugs to prevent spraying and contamination.
- Terminal sterilization methods include steam, dry-heat, gas sterilization, ionizing radiation, and unidirectional aseptic processing.
- Heat-sensitive drugs can be sterilized using filtration with a 0.22-micron filter, with a bubble-point test to test filter integrity.
- Labels for CSPs must include ingredient names, concentrations, total volume, BUD, route of administration, storage requirements, and hazardous warnings.
- Low-risk sterile drugs have the lowest contamination risk and the longest BUD.
- Auxiliary labels should be used for CSPs requiring special handling, and high-alert medications need appropriate auxiliary labels.
- Certain CSPs must be tested for endotoxins, and glassware and utensils should be rinsed with sterile water and depyrogenated to avoid contamination.
Pharmaceutical Quality Assurance and Osmolarity in Intravenous Drugs
- QA plan must include personnel training, environmental monitoring, equipment calibration, and maintenance, with documented follow-up actions and assigned personnel.
- Root cause analysis should be initiated for medication errors or safety issues, and failure mode and effects analysis can help identify problems with new procedures.
- Standard Operating Procedures (SOPs) should be developed, followed, and periodically reviewed for necessary revisions.
- High-risk level Compounded Sterile Preparations (CSPs) must have a written procedure for daily observation of incubating test specimens and immediate recall if evidence of microbial growth is found.
- Recalls are classified as Class I (serious adverse health consequences or death), Class II (temporary or reversible adverse health consequences), and Class III (not likely to cause adverse health consequences).
- Osmolarity and tonicity are related terms used to express solute concentration in solutions, and hypertonic saline concentrations should be restricted to specific areas in the hospital to avoid adverse outcomes.
- Hypertonic saline administered into a peripheral vein can cause RBCs to become shriveled and dysfunctional, while solutions with high osmolarity should be administered via a central line to avoid vein damage.
- Lower osmolarity saline solutions can cause RBCs to absorb fluid and burst if administered alone, and pH changes in body tissues are resisted by buffer systems to maintain a narrow pH range in sensitive tissues.
- The carbonic acid-bicarbonate buffer system is used by the body to resist changes in pH, with two other buffer systems also playing a role in pH regulation.
- Preparations administered in sensitive tissues must be formulated to keep the pH within a narrow range to avoid tissue damage and provide stability for the drug in the solution.
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Test your knowledge of compounding formulation and safety procedures with this quiz. Covering topics such as Safety Data Sheets, master formulas, compounding records, PPE, hazardous drugs, calculations, quality control, and common techniques, this quiz will help reinforce essential concepts for pharmaceutical compounding.
