Primary Literature
- original reports of clinical trials, research, and case studies; use for the most up to date information
Secondary Literature
- general reference works based upon primary literature sources; use to find primary literature
Tertiary Literature
- condensed works based on primary literature (e.g. textbooks); use to find background information or a summary of information
Abstracting Services
- services that summarize information from various primary sources for quick reference
Health Insurance Portability and Accountability Act (HIPAA)
- a federal law created to protect the privacy of patient health records
Off label indication
- a use of a medication for an indication not approved by the FDA
Orange Book
- the common name for the FDA's Approved Drug Products with Therapeutic Equivalence
Common References
1) AHFS Drug Information (www.ahfsdruginformation.com)
----- use AHFS when investigating off label medication indications (ie. an indication not approved by the FDA)
2) Martindale, The Complete Drug Reference
----- use Martindale to research foreign drugs
3) The Merck Index (www.merckmanuals.com)
----- use The Merck Index when information on chemical attributes of drug is needed
4) Physicians' Desk Reference (PDR) (www.pdr.net)
----- the information is similar to pharmaceutical manufacturers' drug package inserts since manufacturers prepare the essential drug information found in the PDR
5) Drug Facts and Comparison (DFC) (www.factsandcomparisons.com)
----- it is used to compare medications in the same therapeutic class
6) American Drug Index
----- use this reference to find trade and generic names
7) Handbook on Injectable Drugs (www.ashp.org)
----- it includes information on preparation, storage, administration, compatibility and stability of injectable drugs
8) King's Guide to Parenteral Admixtures (www.kingguide.com)
----- this reference provides information on injectable drug compatibility and stability, updated quarterly
9) Red Book: Pharmacy's Fundamental Reference (www.redbook.com)
----- it provides the latest pricing information, including nationally recognized AWP's and suggested retail prices for OTC products
10) Orange Book (www.accessdata.fda.gov/scripts/cder/ob/default.cfm)
----- Orange Book is the common name for the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations. Use the Orange Book to determine the therapeutic equivalence of a brand and generic drug
11) Purple Book
----- biosimilar products of Biotech products
Thursday, March 26, 2020
PTCB - Chapter 11 - Factors Affecting Drug Activitiy - Key Concepts
Human Variability
- Differences in age, weight, genetics, and genders are among the significant factors that influence the differences in medication responses among people.
- Drug distribution, metabolism, and excretion are quite different in the neonate and infant than in adults because their organ systems are not fully developed
- Children metabolize certain drugs more rapidly than adults
- The elderly typically consume more drugs and have a higher incidence of drug interactions than other age groups. They also experience more physiological changes that significantly affect drug action.
- Genetics can cause differences in the types and amounts of proteins produced in the body, which can result in different responses to the same drug at the same dose.
Disease States
- The disposition and effect of some drugs may be altered in one patient but not another by the presence of disease. Such changes are well documented in cardiovascular, hepatic, renal, and thyroid disease.
Adverse Drug Reactions
- Almost any drug, in almost any dose, can produce an allergic or hypersensitive reaction in a patient. Anaphylactic shock is a potentially fatal hypersensitivity reaction.
- Anorexia, nausea, vomiting, constipation, and diarrhea are among the most common adverse reactions to drugs in the GI tract.
Drug-Drug Interactions
- Many drug-drug interactions affect the disposition of one drug and result in either an increased or decreased effect.
- Decreased intestinal absorption of oral drugs occurs when drugs complex to produce nonabsorbable compounds.
- Displacement of one drug from protein binding sites by a second drug increases the effects of the displaced drug.
- Drugs that induce liver metabolism may also increase metabolism of other drugs that use the same metabolizing enzymes.
- Some drugs increase excretion by altering urinary pH and lessening renal reabsorption.
- Some drug-drug interactions do not alter a drug's disposition but interact at the site of action.
- Additive effect occur when two drugs with similar pharmacological actions result in an effect equal to the sum of the individual effects.
- Synergism occurs when two drugs with similar pharmacological actions produce greater effects than the sum of the individual effects.
- Potentiation occurs when one drug with no inherent activity of its own increases the activity of another drug that produces an effect.
Drug-Diet Interactions
- Dietary intake can influence drug action by altering one or all of the ADME processes.
- Some foods contain substances that react with certain drugs, e.g., foods containing tyramine can react with monoamine oxidase (MAO) inhibitors.
- Differences in age, weight, genetics, and genders are among the significant factors that influence the differences in medication responses among people.
- Drug distribution, metabolism, and excretion are quite different in the neonate and infant than in adults because their organ systems are not fully developed
- Children metabolize certain drugs more rapidly than adults
- The elderly typically consume more drugs and have a higher incidence of drug interactions than other age groups. They also experience more physiological changes that significantly affect drug action.
- Genetics can cause differences in the types and amounts of proteins produced in the body, which can result in different responses to the same drug at the same dose.
Disease States
- The disposition and effect of some drugs may be altered in one patient but not another by the presence of disease. Such changes are well documented in cardiovascular, hepatic, renal, and thyroid disease.
Adverse Drug Reactions
- Almost any drug, in almost any dose, can produce an allergic or hypersensitive reaction in a patient. Anaphylactic shock is a potentially fatal hypersensitivity reaction.
- Anorexia, nausea, vomiting, constipation, and diarrhea are among the most common adverse reactions to drugs in the GI tract.
Drug-Drug Interactions
- Many drug-drug interactions affect the disposition of one drug and result in either an increased or decreased effect.
- Decreased intestinal absorption of oral drugs occurs when drugs complex to produce nonabsorbable compounds.
- Displacement of one drug from protein binding sites by a second drug increases the effects of the displaced drug.
- Drugs that induce liver metabolism may also increase metabolism of other drugs that use the same metabolizing enzymes.
- Some drugs increase excretion by altering urinary pH and lessening renal reabsorption.
- Some drug-drug interactions do not alter a drug's disposition but interact at the site of action.
- Additive effect occur when two drugs with similar pharmacological actions result in an effect equal to the sum of the individual effects.
- Synergism occurs when two drugs with similar pharmacological actions produce greater effects than the sum of the individual effects.
- Potentiation occurs when one drug with no inherent activity of its own increases the activity of another drug that produces an effect.
Drug-Diet Interactions
- Dietary intake can influence drug action by altering one or all of the ADME processes.
- Some foods contain substances that react with certain drugs, e.g., foods containing tyramine can react with monoamine oxidase (MAO) inhibitors.
PTCB - Chapter 11 - Factors Affecting Drug Activity - Definitions
Pharmacogenomics
- a field of study that defines the hereditary basis of individual differences in absorption, distribution, metabolism, and excretion (the ADME processes)
Cirrhosis
- a chronic liver disease causing loss of function
Obstructive jaundice
- an obstruction of the bile duct that causes hepatic waste products and bile to accumulate in the liver
Acute Viral Hepatitis
- an inflammatory condition of the liver caused by viruses
Hypothyroidism
- a condition in which thyroid hormone secretions are below normal, often referred to as an underactive thyroid
Hyperthyroidism
- a condition in which thyroid hormone secretions are above normal, often referred to as an overactive thyroid
Adverse Drug Reaction
- an unintended side effect of a medication that is negative or in some way injurious to a patient's health
Carcinogenicity
- the ability of a substance to cause cancer
Idiosyncrasy
- an unexpected reaction the first time a drug is taken, generally due to genetic causes
Hypersensitivity
- an abnormal sensitivity generally resulting in an allergic reaction
Anaphylactic shock
- a potentially fatal hypersensitivity reaction producing severe respiratory distress and cardiovascular collapse
Complexation
- when two different molecules associate or attach to each other
Displacement
- a drug that is bound to a plasma protein is removed when another drug of greater binding potential binds to the same protein
Enzyme Induction
- the increase in hepatic enzyme activity that results in greater metabolism of drugs
Enzyme Inhibition
- the decrease in hepatic enzyme activity that results in reduced metabolism of drugs
Additive Effects
- the summation in effect when two drugs with similar pharmacological actions are taken
Synergism
- when two drugs with similar pharmacological actions produce greater effects than the sum of individual effects
Potentiation
- when one drug with no inherent activity of its own increases the activity of another drug that produced an effect
Antidote
- a drug that antagonizes the toxic effect of another
Drug-Drug Interactions examples
- Additive effects
trimethoprim + sulfamethoxazole for antibiotic effect
amiodarone + dofetilide for prolongation of hearts QT interval
- Synergism
aspirin + warfarin = increased anticoagulation (bleeding)
vancomycin + gentamicin = increased antibacterial effects of gentamicin
- Potentiation
amoxicillin + clavulanic acid = increased duration of amoxicillin's antibiotic effect
penicillin + probenecid = increased duration of penicillin's antibiotic effect
- Antidote
naloxone + morphine = relief of morphine induced respiratory depression
vitamin K + warfarin = opposition of the anticoagulant effect of warfarin and a return to normal blood clotting time
Drug-diet Interactions
- when elements of ingested nutrients interact with a drug and this affects the disposition of the drug
- a field of study that defines the hereditary basis of individual differences in absorption, distribution, metabolism, and excretion (the ADME processes)
Cirrhosis
- a chronic liver disease causing loss of function
Obstructive jaundice
- an obstruction of the bile duct that causes hepatic waste products and bile to accumulate in the liver
Acute Viral Hepatitis
- an inflammatory condition of the liver caused by viruses
Hypothyroidism
- a condition in which thyroid hormone secretions are below normal, often referred to as an underactive thyroid
Hyperthyroidism
- a condition in which thyroid hormone secretions are above normal, often referred to as an overactive thyroid
Adverse Drug Reaction
- an unintended side effect of a medication that is negative or in some way injurious to a patient's health
Carcinogenicity
- the ability of a substance to cause cancer
Idiosyncrasy
- an unexpected reaction the first time a drug is taken, generally due to genetic causes
Hypersensitivity
- an abnormal sensitivity generally resulting in an allergic reaction
Anaphylactic shock
- a potentially fatal hypersensitivity reaction producing severe respiratory distress and cardiovascular collapse
Complexation
- when two different molecules associate or attach to each other
Displacement
- a drug that is bound to a plasma protein is removed when another drug of greater binding potential binds to the same protein
Enzyme Induction
- the increase in hepatic enzyme activity that results in greater metabolism of drugs
Enzyme Inhibition
- the decrease in hepatic enzyme activity that results in reduced metabolism of drugs
Additive Effects
- the summation in effect when two drugs with similar pharmacological actions are taken
Synergism
- when two drugs with similar pharmacological actions produce greater effects than the sum of individual effects
Potentiation
- when one drug with no inherent activity of its own increases the activity of another drug that produced an effect
Antidote
- a drug that antagonizes the toxic effect of another
Drug-Drug Interactions examples
- Additive effects
trimethoprim + sulfamethoxazole for antibiotic effect
amiodarone + dofetilide for prolongation of hearts QT interval
- Synergism
aspirin + warfarin = increased anticoagulation (bleeding)
vancomycin + gentamicin = increased antibacterial effects of gentamicin
- Potentiation
amoxicillin + clavulanic acid = increased duration of amoxicillin's antibiotic effect
penicillin + probenecid = increased duration of penicillin's antibiotic effect
- Antidote
naloxone + morphine = relief of morphine induced respiratory depression
vitamin K + warfarin = opposition of the anticoagulant effect of warfarin and a return to normal blood clotting time
Drug-diet Interactions
- when elements of ingested nutrients interact with a drug and this affects the disposition of the drug
Saturday, March 14, 2020
PTCB - Chapter 10 - Basic Bio Pharmaceuticals - Key Concepts
How Drugs Work
- The objective of drug therapy is to deliver the right drug, in the right concentration, to the right site of action, and at the right time to produce the desired effect
- Only those drugs able to interact with the receptors in a particular site of action can produce effects in that site. This is why specific cells respond only to certain drugs
Concentration and Effect
- To produce an effect, a drug must achieve a minimum effective concentration (MEC). This is when there is enough drug at the site of action to produce a response
- The range between the minimum effective concentration and the minimum toxic concentration is called the therapeutic window. When concentrations are in this range, most patients receive the maximum benefit from their drug therapy with a minimum of risk
- Therapeutic drug monitoring can be useful when the blood concentration of the drug reflects the concentration at the site of action
ADME Processes and Diffusion
- Blood concentrations are the result of four simultaneously occurring processes: absorption, distribution, metabolism, and excretion (the ADME processes)
- Besides the four ADME processes, a critical factor in drug concentration and effect is how drugs move through biological membranes. Most drugs penetrate biological membranes by passive diffusion
Absorption
- One of the primary factors affecting oral drug absorption is the gastric emptying time
Distribution
- Many drugs bind to proteins in blood plasma to form a complex that is too large to penetrate biological membranes, essentially making the drug inactive
Metabolism
- Enzymes catalyze the transformation of drugs to metabolites. Most metabolites are inactive molecules that are excreted
Excretion
- The kidneys filter blood and remove wastes, drugs, and metabolites from the body
- Urinary excretion = glomerular filtration + renal secretion - urinary reabsorption
Bioavailability
- The amount of a drug that is delivered to the site of action and the rate of which it becomes available is called the bioavailability of the drug
Bioequivalence
- Bioequivalent drug products are pharmaceutical equivalents or alternatives that have essentially the same bioavailabilities (ie. rate and extent of absorption) when administered in the same dose of the active ingredient under similar conditions
- Pharmaceutical equivalents are drug products that contain identical amounts of the same active ingredient in the same dosage form, but may contain different inactive ingredients
- Pharmaceutical alternatives are drug products that contain the identical active ingredient, but not necessarily in the same salt form, same amount, or dosage form
- The objective of drug therapy is to deliver the right drug, in the right concentration, to the right site of action, and at the right time to produce the desired effect
- Only those drugs able to interact with the receptors in a particular site of action can produce effects in that site. This is why specific cells respond only to certain drugs
Concentration and Effect
- To produce an effect, a drug must achieve a minimum effective concentration (MEC). This is when there is enough drug at the site of action to produce a response
- The range between the minimum effective concentration and the minimum toxic concentration is called the therapeutic window. When concentrations are in this range, most patients receive the maximum benefit from their drug therapy with a minimum of risk
- Therapeutic drug monitoring can be useful when the blood concentration of the drug reflects the concentration at the site of action
ADME Processes and Diffusion
- Blood concentrations are the result of four simultaneously occurring processes: absorption, distribution, metabolism, and excretion (the ADME processes)
- Besides the four ADME processes, a critical factor in drug concentration and effect is how drugs move through biological membranes. Most drugs penetrate biological membranes by passive diffusion
Absorption
- One of the primary factors affecting oral drug absorption is the gastric emptying time
Distribution
- Many drugs bind to proteins in blood plasma to form a complex that is too large to penetrate biological membranes, essentially making the drug inactive
Metabolism
- Enzymes catalyze the transformation of drugs to metabolites. Most metabolites are inactive molecules that are excreted
Excretion
- The kidneys filter blood and remove wastes, drugs, and metabolites from the body
- Urinary excretion = glomerular filtration + renal secretion - urinary reabsorption
Bioavailability
- The amount of a drug that is delivered to the site of action and the rate of which it becomes available is called the bioavailability of the drug
Bioequivalence
- Bioequivalent drug products are pharmaceutical equivalents or alternatives that have essentially the same bioavailabilities (ie. rate and extent of absorption) when administered in the same dose of the active ingredient under similar conditions
- Pharmaceutical equivalents are drug products that contain identical amounts of the same active ingredient in the same dosage form, but may contain different inactive ingredients
- Pharmaceutical alternatives are drug products that contain the identical active ingredient, but not necessarily in the same salt form, same amount, or dosage form
PTCB - Chapter 10 - Basic Bio Pharmaceuticals - Definitions
Agonist
- drugs that activate receptors to accelerate or slow normal cellular function
Antagonist
- drugs that bind with receptors but do not activate them
- they block receptor action by preventing other drugs or substances from activating them
Receptor
- the cellular material located at the site of action that interacts with the drug
Selective (action)
- the characteristic of a drug that makes its action specific to certain receptors and tissues
Site of action
- the location where an administered drug produces an effort
Duration of action
- the time drug concentration is above the MEC
Minimum Effective Concentration (MEC)
- the blood concentration needed for a drug to produce a response
Minimum Toxic Concentration (MTC)
- the upper limit of the therapeutic windows
- drug concentrations above the MTC increase the risk of undesired effects
Onset of action
- the time MEC is reached and the response occurs
Therapeutic window
- a drug's blood concentration range between its MEC and MTC
Active transport
- the movement of drugs from an area of lower concentration to an area of higher concentration; cellular energy is required
Disposition
- a term sometimes used to refer to all of the ADME processes together
Elimination
- the processes of metabolism and excretion
Hydrophilic
- capable of associating with or absorbing water
Hydrophobic
- water repelling; cannot associate with water
Lipoidal
- fat like substance
Passive diffusion
- the movement of drugs from an area of higher concentration to lower concentration
ADME
- blood concentrations are the result of four simultaneously occurring processes
- absorption, distribution, metabolism, excretion
Absorption
- the movement of a drug from the dosage formulation to the blood
Gastric emptying time
- the time a drug will stay in the stomach before it is emptied into the small intestine
Complexation
- when different molecules associate or attach to each other
Protein binding
- the attachment of a drug molecule to a plasma or tissue protein, effectively making the drug inactive, but also keeping it within the body
Enterohepatic cycling
- the transfer of drugs and their metabolites from the liver to the bile in the gallbladder, then into the intestine, and then back into circulation
Enzyme
- a complex protein that catalyzes chemical reactions
Enzyme induction
- the increase in hepatic enzyme activity that results in reduced metabolism of drugs
First pass metabolism
- the substantial degradation of an orally administered drug caused by enzyme metabolism in the liver before the drug reaches the systemic circulation
Metabolite
- the substance resulting from the body's transformation of an administered drugs
Glomerular filtration
- the blood filtering process of the nephron
Nephron
- the functional unit of the kidney
Absolute bioavailability
- the bioavailability of a drug product compared to the same drug in a rapidly administered IV solution
Bioavailability
- the amount of an administered dose that reaches the general circulation and the rate at which this occurs
Relative bioavailability
- the bioavailability of a drug product compared to the same drug in any other dosage form than a rapidly administered IV solution
Bioequivalency
- the comparison of bioavailability between two dosage forms
Pharmaceutical alternative
- drug products that contain the same active ingredient, but not necessarily in the same salt form, amount, or dosage form
Pharmaceutical equivalent
- drug products that contain identical amounts of the same active ingredient in the same dosage form
Therapeutic equivalent
- pharmaceutical equivalents that produce the same effects in patients
- drugs that activate receptors to accelerate or slow normal cellular function
Antagonist
- drugs that bind with receptors but do not activate them
- they block receptor action by preventing other drugs or substances from activating them
Receptor
- the cellular material located at the site of action that interacts with the drug
Selective (action)
- the characteristic of a drug that makes its action specific to certain receptors and tissues
Site of action
- the location where an administered drug produces an effort
Duration of action
- the time drug concentration is above the MEC
Minimum Effective Concentration (MEC)
- the blood concentration needed for a drug to produce a response
Minimum Toxic Concentration (MTC)
- the upper limit of the therapeutic windows
- drug concentrations above the MTC increase the risk of undesired effects
Onset of action
- the time MEC is reached and the response occurs
Therapeutic window
- a drug's blood concentration range between its MEC and MTC
Active transport
- the movement of drugs from an area of lower concentration to an area of higher concentration; cellular energy is required
Disposition
- a term sometimes used to refer to all of the ADME processes together
Elimination
- the processes of metabolism and excretion
Hydrophilic
- capable of associating with or absorbing water
Hydrophobic
- water repelling; cannot associate with water
Lipoidal
- fat like substance
Passive diffusion
- the movement of drugs from an area of higher concentration to lower concentration
ADME
- blood concentrations are the result of four simultaneously occurring processes
- absorption, distribution, metabolism, excretion
Absorption
- the movement of a drug from the dosage formulation to the blood
Gastric emptying time
- the time a drug will stay in the stomach before it is emptied into the small intestine
Complexation
- when different molecules associate or attach to each other
Protein binding
- the attachment of a drug molecule to a plasma or tissue protein, effectively making the drug inactive, but also keeping it within the body
Enterohepatic cycling
- the transfer of drugs and their metabolites from the liver to the bile in the gallbladder, then into the intestine, and then back into circulation
Enzyme
- a complex protein that catalyzes chemical reactions
Enzyme induction
- the increase in hepatic enzyme activity that results in reduced metabolism of drugs
First pass metabolism
- the substantial degradation of an orally administered drug caused by enzyme metabolism in the liver before the drug reaches the systemic circulation
Metabolite
- the substance resulting from the body's transformation of an administered drugs
Glomerular filtration
- the blood filtering process of the nephron
Nephron
- the functional unit of the kidney
Absolute bioavailability
- the bioavailability of a drug product compared to the same drug in a rapidly administered IV solution
Bioavailability
- the amount of an administered dose that reaches the general circulation and the rate at which this occurs
Relative bioavailability
- the bioavailability of a drug product compared to the same drug in any other dosage form than a rapidly administered IV solution
Bioequivalency
- the comparison of bioavailability between two dosage forms
Pharmaceutical alternative
- drug products that contain the same active ingredient, but not necessarily in the same salt form, amount, or dosage form
Pharmaceutical equivalent
- drug products that contain identical amounts of the same active ingredient in the same dosage form
Therapeutic equivalent
- pharmaceutical equivalents that produce the same effects in patients
Thursday, March 12, 2020
PTCB - Chapter 9 - Parenterals: Compounding Sterile Formulations - Key Concepts
Compounding Sterile Formulations
- Parenteral solutions must be sterile, free of all visible particulate material, pyrogen free, stable for their intended time of use, be isotonic, and in most cases (but not all) have a pH around 7.4
LVP Solutions
- Large volume parenteral (LVP) are 100mL or more and come in plastic bags or glass bottles
SVP Solutions
- when a drug is added to a parenteral solution, the drug is referred to as the additive, and the final mixture is referred to as the admixture
Special Solutions
- Parenteral nutrition solutions are complex admixtures composed of dextrose, fat, protein, electrolytes, vitamins, and trace elements used to meet a patient's nutritional needs
Administration Devices
- LVP solutions are usually administered with an administration set. In addition to the basic components (tubing, spikes, clamps, needle adapters), administration sets may have drip chambers, volume control chambers, and Flashballs
- Parenteral administration devices use either gravity or a pump to push the solution into the patient
Laminar Flow Hoods
- A laminar flow hood establishes and maintains an ultraclean work area for preparing parenteral solutions
Biological Safety Cabinets and Clean Rooms
- Chemotherapy agents are to be made in a biological safety cabinet, not a laminar flow hood
- Clean rooms are isolated rooms that house laminar flow hoods and biological safety cabinet; however, clean rooms that meet ISO Class 5 standards do not need a hood or cabinet
Aseptic Techniques for Hoods and Cabinets
- Aseptic techniques maintain the sterility of all sterile items and are used in preparing admixtures
Working with Vials
- There is the potential of coring the rubber stopper of a vial when inserting a needle
Working with Ampules
- Ampules may be pre-scored by the manufacturer or need to be scored with a file
Syringes and Needles
- Syringes come in sizes ranging from 1 to 60 mL
- Needle sizes are indicated by length and gauge. Large needle lumens may be needed for highly viscous solutions but are more likely to cause coring
Filters
- Syringe filters are used to remove particular materials or microorganisms from parenteral solutions
Quality Assurance and Infection Control
- A significant part of preparing parenteral solutions is to have and follow environmental quality and infection control plan
- Drugs and supplies used in making parenteral solutions should be disposed of properly. This may involve using a sharps container, or following procedures prescribed by the EPA and local landfill requirements
Parenteral Incompatibilities
- An incompatibility can exist between the drugs in an admixture or between a drug and the base IV solution
Units of Measurement
- Equivalent (Eq/L) or milliequivalent (mEq/L) concentrations are commonly used to describe concentrations of electrolytes in parenteral solutions
- Percentage concentrations refer to the drug's weight per 100 mL if the drug is a solid, or the drug's volume per 100 mL if the drug is a liquid
- Parenteral solutions must be sterile, free of all visible particulate material, pyrogen free, stable for their intended time of use, be isotonic, and in most cases (but not all) have a pH around 7.4
LVP Solutions
- Large volume parenteral (LVP) are 100mL or more and come in plastic bags or glass bottles
SVP Solutions
- when a drug is added to a parenteral solution, the drug is referred to as the additive, and the final mixture is referred to as the admixture
Special Solutions
- Parenteral nutrition solutions are complex admixtures composed of dextrose, fat, protein, electrolytes, vitamins, and trace elements used to meet a patient's nutritional needs
Administration Devices
- LVP solutions are usually administered with an administration set. In addition to the basic components (tubing, spikes, clamps, needle adapters), administration sets may have drip chambers, volume control chambers, and Flashballs
- Parenteral administration devices use either gravity or a pump to push the solution into the patient
Laminar Flow Hoods
- A laminar flow hood establishes and maintains an ultraclean work area for preparing parenteral solutions
Biological Safety Cabinets and Clean Rooms
- Chemotherapy agents are to be made in a biological safety cabinet, not a laminar flow hood
- Clean rooms are isolated rooms that house laminar flow hoods and biological safety cabinet; however, clean rooms that meet ISO Class 5 standards do not need a hood or cabinet
Aseptic Techniques for Hoods and Cabinets
- Aseptic techniques maintain the sterility of all sterile items and are used in preparing admixtures
Working with Vials
- There is the potential of coring the rubber stopper of a vial when inserting a needle
Working with Ampules
- Ampules may be pre-scored by the manufacturer or need to be scored with a file
Syringes and Needles
- Syringes come in sizes ranging from 1 to 60 mL
- Needle sizes are indicated by length and gauge. Large needle lumens may be needed for highly viscous solutions but are more likely to cause coring
Filters
- Syringe filters are used to remove particular materials or microorganisms from parenteral solutions
Quality Assurance and Infection Control
- A significant part of preparing parenteral solutions is to have and follow environmental quality and infection control plan
- Drugs and supplies used in making parenteral solutions should be disposed of properly. This may involve using a sharps container, or following procedures prescribed by the EPA and local landfill requirements
Parenteral Incompatibilities
- An incompatibility can exist between the drugs in an admixture or between a drug and the base IV solution
Units of Measurement
- Equivalent (Eq/L) or milliequivalent (mEq/L) concentrations are commonly used to describe concentrations of electrolytes in parenteral solutions
- Percentage concentrations refer to the drug's weight per 100 mL if the drug is a solid, or the drug's volume per 100 mL if the drug is a liquid
PTCB - Chapter 9 - Parenterals: Compounding Sterile Formulation - Definitions
Aseptic techniques
- technique or methods that maintain the sterile condition of products
Hypertonic
- when a solution has a greater osmolarity than that of blood
Hypotonic
- when a solution has a lesser osmolarity than that of blood
Isotonic
- when a solution has an osmolarity equivalent to that of blood
Osmotic Pressure
- a characteristic of a solution determined by the number of dissolved particles in it
Pyrogens
- chemicals produced by microorganisms that can cause pyretic reactions (fever) in patients
Special requirements for Parenteral Dosage Form
1. solutions must be sterile - i.e. free from bacteria and other microorganism
2. solutions must be free of all visible particulate material
3. solutions must be pyrogen free
4. the solution must be stable for its intended use
5. the pH of an IV solution should not vary significantly from physiological pH, about 7.4
6. IV solutions should be formulated to have an osmotic pressure similar to that of blood
Compounded Sterile Preparation (CSP)
- a compounded sterile parenteral dosage form that will be parenterally administered
Additive
- a drug that is added to a parenteral solution
Admixture
- the resulting solution when a drug is added to a parenteral solution
Diluent
- a solvent that dissolves a lyophilized powder or dilutes a solution
Lyophilized
- freeze dried
Ready to mix
- a specially designed minibag by which a drug is put into the SVP just prior to administration
Total Parenteral Nutrition (TPN) solution
- complex solutions with two base solutions (amino acids and dextrose) and additional micronutrients
- they are hypertonic solutions
Total Nutrient Admixture (TNA) solution
- a TPN solution that contains IV fat emulsion.
- when IV fat emulsion is admixed with a TPN solution, the resulting solution is referred to as a TNA
- hypertonic solutions
Dialysis
- movement of particles in a solution through permeable membranes
Osmosis
- the action in which a drug in a higher concentration solution passes through a permeable membrane to a lower concentration solution
Peritoneal Dialysis Solution
- a solution placed in and emptied from the peritoneal cavity to remove toxic substances
Irrigation solution
- large volume splash solutions used during surgical or urologic procedures to bathe and moisten tissues
- washing out wounds
Flow rate
- the rate (in mL/hour or mL/minute) at which solution is administered to the patient
Flashball
- flexible rubber bulb near the needle adapter on an administration set; used to determine if the needle is properly placed in the vein
Piggybacks
- small volume solutions connected to an LVP
Heparin Lock
- an administration device used when a primary LVP solution is not available
- heparin lock is a short piece of tubing attached to a needle or IV catheter
when the tubing is not being used for the minibag, heparin is used to fill the tubing
- heparin prevents blood from clotting in the tubing
HEPA filter
- a high efficiency particulate air filter
Laminar flow
- continuous movement at a uniform rate in one direction
Horizontal flow head
- a laminar flow hood with horizontal air flow across the work area
Zone of turbulence
- an area of blocked air flow in a laminar flow hood
Vertical flow hood
- a laminar flow hood with vertical air flow across the work area
Coring
- when a needle damages the rubber closure of a parenteral container, causing fragments of the closure to fall into the container and contaminate its contents
Ampules
- sealed glass containers with an elongated neck that must be snapped off
Bevel
- an angled surface at the tip of a needle
Gauge
- a measurement with needles; the higher the gauge, the smaller the lumen
Hub
- the part of the needle that attaches to the syringe
Lumen
- the hollow center of a needle
Shaft
- the stem of the needle that provides the overall length of the needle
Slip-Tip, Luer-Lok, eccentric, oral
- different types of syringe tips
Depth filter
- a filter that can filter solutions being drawn into or expelled from a syringe, but not both ways in the same procedure
Membrane filter
- a filter that filters solution as the solution is expelled from the syringe
Final filter
- a filter placed immediately before a solution enters a patient's vein
Sharps
- needles, jagged glass or metal objects, or any items that might puncture or cut the skin
Anhydrous
- without water molecules
Equivalent weight
- a drug's molecular weight divided by its valence, a common measure of electrolyte concentration
Ions
- molecular particles that carry electric charges
Molecular weight
- the sum of the atomic weights of a molecular
Valence
- the number of positive or negative charges on an ion
Waters of hydration
- water molecules that attach to drug molecules
- technique or methods that maintain the sterile condition of products
Hypertonic
- when a solution has a greater osmolarity than that of blood
Hypotonic
- when a solution has a lesser osmolarity than that of blood
Isotonic
- when a solution has an osmolarity equivalent to that of blood
Osmotic Pressure
- a characteristic of a solution determined by the number of dissolved particles in it
Pyrogens
- chemicals produced by microorganisms that can cause pyretic reactions (fever) in patients
Special requirements for Parenteral Dosage Form
1. solutions must be sterile - i.e. free from bacteria and other microorganism
2. solutions must be free of all visible particulate material
3. solutions must be pyrogen free
4. the solution must be stable for its intended use
5. the pH of an IV solution should not vary significantly from physiological pH, about 7.4
6. IV solutions should be formulated to have an osmotic pressure similar to that of blood
Compounded Sterile Preparation (CSP)
- a compounded sterile parenteral dosage form that will be parenterally administered
Additive
- a drug that is added to a parenteral solution
Admixture
- the resulting solution when a drug is added to a parenteral solution
Diluent
- a solvent that dissolves a lyophilized powder or dilutes a solution
Lyophilized
- freeze dried
Ready to mix
- a specially designed minibag by which a drug is put into the SVP just prior to administration
Total Parenteral Nutrition (TPN) solution
- complex solutions with two base solutions (amino acids and dextrose) and additional micronutrients
- they are hypertonic solutions
Total Nutrient Admixture (TNA) solution
- a TPN solution that contains IV fat emulsion.
- when IV fat emulsion is admixed with a TPN solution, the resulting solution is referred to as a TNA
- hypertonic solutions
Dialysis
- movement of particles in a solution through permeable membranes
Osmosis
- the action in which a drug in a higher concentration solution passes through a permeable membrane to a lower concentration solution
Peritoneal Dialysis Solution
- a solution placed in and emptied from the peritoneal cavity to remove toxic substances
Irrigation solution
- large volume splash solutions used during surgical or urologic procedures to bathe and moisten tissues
- washing out wounds
Flow rate
- the rate (in mL/hour or mL/minute) at which solution is administered to the patient
Flashball
- flexible rubber bulb near the needle adapter on an administration set; used to determine if the needle is properly placed in the vein
Piggybacks
- small volume solutions connected to an LVP
Heparin Lock
- an administration device used when a primary LVP solution is not available
- heparin lock is a short piece of tubing attached to a needle or IV catheter
when the tubing is not being used for the minibag, heparin is used to fill the tubing
- heparin prevents blood from clotting in the tubing
HEPA filter
- a high efficiency particulate air filter
Laminar flow
- continuous movement at a uniform rate in one direction
Horizontal flow head
- a laminar flow hood with horizontal air flow across the work area
Zone of turbulence
- an area of blocked air flow in a laminar flow hood
Vertical flow hood
- a laminar flow hood with vertical air flow across the work area
Coring
- when a needle damages the rubber closure of a parenteral container, causing fragments of the closure to fall into the container and contaminate its contents
Ampules
- sealed glass containers with an elongated neck that must be snapped off
Bevel
- an angled surface at the tip of a needle
Gauge
- a measurement with needles; the higher the gauge, the smaller the lumen
Hub
- the part of the needle that attaches to the syringe
Lumen
- the hollow center of a needle
Shaft
- the stem of the needle that provides the overall length of the needle
Slip-Tip, Luer-Lok, eccentric, oral
- different types of syringe tips
Depth filter
- a filter that can filter solutions being drawn into or expelled from a syringe, but not both ways in the same procedure
Membrane filter
- a filter that filters solution as the solution is expelled from the syringe
Final filter
- a filter placed immediately before a solution enters a patient's vein
Sharps
- needles, jagged glass or metal objects, or any items that might puncture or cut the skin
Anhydrous
- without water molecules
Equivalent weight
- a drug's molecular weight divided by its valence, a common measure of electrolyte concentration
Ions
- molecular particles that carry electric charges
Molecular weight
- the sum of the atomic weights of a molecular
Valence
- the number of positive or negative charges on an ion
Waters of hydration
- water molecules that attach to drug molecules
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