Term
|
Definition
Outside of or beside the alimentary tract
para=outside
enteron=intestine |
|
|
Term
| List some advantages of a parenteral dosage form |
|
Definition
-Good for drugs with poor oral bioavailability
-Rapid response, emergency
-High degree of control
-GI irritation avoided
-Good for nauseating oral medications
-Can be local
-Can be long-lasting |
|
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Term
| List two ways a parenteral can be long lasting |
|
Definition
1. If muscle depot
2. Implantation |
|
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Term
| List some disadvantages of parenteral dosage form |
|
Definition
-Expensive
-Difficult to prepare
-Require administration training
-Strict regulations
-Must be sterile
-Difficult to remove |
|
|
Term
| List six injection dependent routes |
|
Definition
Intravenous
Intramuscular
Intradermal
Subcutaneous
Epidural
Intrathecal |
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Term
| What formulations can be injected? |
|
Definition
| Solutions, suspensions, and emulsions |
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Term
| What will excessive injection volumes cause? |
|
Definition
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|
Term
| What are the most commonly administered intravenous formulations? |
|
Definition
Solutions
Usually aqueous, but may have glycols, alcohols, or other nonaqueous solvents |
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Term
|
Definition
| The ease at which a suspension can be withdrawn from a container into a syringe |
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|
Term
|
Definition
The properties of the suspension while being injected
-flow evenness
-free from clogging |
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|
Term
|
Definition
Total parenteral nutrition
Typically high-calorie fat emulsions |
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|
Term
| Where are common sites on the body to administer intravenously? |
|
Definition
1. antecubital area (in front of the elbow)
2. The back of the hand
3. Some of the larger veins in the foot
4. Central administration in subclavian and jugular veins |
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|
Term
|
Definition
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|
Term
|
Definition
| The accidental administration of IV infused nonvesicant medications or fluids into the surrounding tissues |
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Term
|
Definition
| The accidental administration of IV infused vesicant medications or fluids into the surrounding tissues, either by leakage or by direct exposure |
|
|
Term
| Define thrombosis. What causes it? |
|
Definition
Formation of a blood clot inside a vessel
-caused by extremes in solution pH, particulate material, irritant properties of the drug, needle or catheter trauma, and selection of too small of a vein for the volume of solution injected |
|
|
Term
| Define phlebitis. What causes it? |
|
Definition
Inflammation of the vein
-Caused by the same factors that cause thrombosis |
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|
Term
|
Definition
Occurs when air is introduced into the vein
(purge all air bubbles from the formulation and administration sets before use) |
|
|
Term
| Define particulate material |
|
Definition
| Small pieces of glass that chip from the formulation vial or rubber that comes from the rubber closure on injection vials |
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|
Term
| List the three types of IV administration |
|
Definition
Intravenous Bolus
Intermittent Infusion
Continuous Infusion |
|
|
Term
| Define and describe intravenous bolus |
|
Definition
1-2 ml solution administered directly in vein via needle/syringe or catheter
Administration is fast (second to few minutes) and can be repeated at given intervals if necessary
Often used in emergencies |
|
|
Term
| What is a problem associated with intravenous bolus? |
|
Definition
Irritation as solution is injected undiluted into vein in a short time.
Toxicity can occur and patient drug levels may need monitoring. |
|
|
Term
| Define and describe intermittent infusion |
|
Definition
Drug is diluted in 25 – 100 ml of parenteral fluid and administered directly in vein every 15 – 60 minutes at given dosing intervals
Method is safer than IV bolus as drug is diluted but is less convenient to administer
NOT used to deliver nutrients/electrolytes
Drug plasma levels have greater variability than continuous infusion administration |
|
|
Term
|
Definition
| A form of intermittent infusion where a second drug solution can be administered to patient without the need of another venipuncture.
(Must make sure that solvents in primary line and piggyback are compatible!) |
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|
Term
| Define and describe continuous infusion |
|
Definition
Drug is added to a large parenteral fluid (up to 1 Liter), and the solution administered slowly and continuously directly in vein
Fluid and drug therapy can be applied to patient simultaneously if necessary
It provides a large degree of control of infusion rates and desired drug blood levels. Constant drug blood levels with small variability are usually obtained. |
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|
Term
| What are drawbacks with continuous infusions? |
|
Definition
Need for more patient monitoring as it runs continuously
Cannot be used for drugs that are unstable or poorly soluble in used solvent
Cannot be used in fluid restricted patients as large volumes are usually infused |
|
|
Term
| What are advantages to intramuscle injections? |
|
Definition
-Less hazardous and easier to use than the intravenous route
-Shorter onset of action than subcutaneous route |
|
|
Term
| What are disadvantages to intramuscle injections? |
|
Definition
-Onset of action is typically longer than with intravenous administration
-Patients generally experience more pain with the intramuscular route compared to the intravenous route |
|
|
Term
| Describe intramuscular injection, the location and needle size |
|
Definition
Injected in the striated muscle fibers that are under the subcutaneous layer of the skin
Needles 1 inch to 1.5 inches long and are generally 19 to 22 gauge in size (often incorrectly used)
Principle sites of injection: Gluteal, Deltoid, Vastus lateralis (thigh) |
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|
Term
| Describe the locations of an intramuscular injection |
|
Definition
Gluteal, Deltoid, Vastus lateralis
Sites should be rotated and far from major nerves and blood vessels |
|
|
Term
| Describe the volume limits of an intramuscular injection |
|
Definition
2 ml in the deltoid and thigh muscles
Up to 5 ml in the gluteus maximus
For children < 3 years old, IM maximum injection volume is 1 ml |
|
|
Term
| List injuries that can occur with IM injections |
|
Definition
Abscesses
Cysts
Embolism
Hematoma
Skin sloughing
Scar formation |
|
|
Term
| What does absorption rate of IM injectiosn depend on? |
|
Definition
-Physiological factors such as muscle exercise, depth of injection, and local blood supply
-Formulation factors
-Aqueous vs oleaginous solution (aqueous is faster)
-Presence of salts |
|
|
Term
| What is the difference between aqueous and oleaginous solutions? |
|
Definition
Aqueous- suspensions or colloids
Oleaginous- o/w or w/o emulsions |
|
|
Term
| Where are intradermal solutions injected? |
|
Definition
Injected between the epidermis and dermis layers of the skin
Usually the anterior surface of the forearm |
|
|
Term
| How large are the needles for intradermal injections? |
|
Definition
| Needles are generally 3/8 inches long and 25 to 26 gauge. |
|
|
Term
| What drugs would be used in an intradermal injection? |
|
Definition
-Agents for diagnostic determinations
-Desensitization
-Immunization |
|
|
Term
| What is the maximum volume that can be administered intradermal? |
|
Definition
|
|
Term
| Where are subcutaneous injections administered? |
|
Definition
In fat tissue between skin dermis layer and muscle
-loose interstitial tissues of the upper arm
-anterior surface of the thigh
-lower portion of the abdomen
-upper back |
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|
Term
| Are subcutaneous injections short or long term? |
|
Definition
|
|
Term
| What is the maximum amount of medication given SQ? |
|
Definition
|
|
Term
| How large are the needles for SQ injections? |
|
Definition
| 3/8 to 1 inch in length and 24 to 27 gauge. |
|
|
Term
| Describe SQ injection absorption |
|
Definition
Faster and more predictable than oral, but slower than IM and IV
Blood flow is poor to the sites |
|
|
Term
| How can SQ injection absorption be modified? |
|
Definition
-Heat or massage
-Co-admnster vasodilators (to increase) or epinephrine (to slow)
-Slowly soluble salt forms
-Suspension slower than solution
-Viscosity
-Particle size |
|
|
Term
| Describe drugs administered subcutaneously |
|
Definition
Solutions and suspensions
Ex. heparin, insulin
-Must be soluble and potent in small concentrations
-Can't be irritating or very viscous |
|
|
Term
| Describe Subcutaneous Implantable devices |
|
Definition
Implantation often requires a surgical procedure or a specialized injection device.
The device must be biocompatible with the subcutaneous tissue
The device can be easily removed if necessary |
|
|
Term
| Give examples of Subcutaneous Implantable devices |
|
Definition
Norplant
Oreton
Percoten
Alzet (an osmotically driven mini-pump)
Degradable microspheres
Vapor pressure devices for morphine release
Osmotic pressure devices to deliver insulin |
|
|
Term
| What are advantages of epidurals? |
|
Definition
-The drug dosages are generally much lower than when given by other routes and produce fewer side effects.
-Produces longer lasting pain relief
-Increases patient alertness
-Earlier ambulation |
|
|
Term
|
Definition
A nerve block in the epidural space; the space in the central cavities between the dura mater (covering the spinal cord) and the vertebral column.
(Preservatives must prevent nerve damage) |
|
|
Term
| Define intrathecal injection |
|
Definition
Intrathecal injections place formulations in the subarachnoid space, e.g., underneath the arachnoid mater. This space is filled with cerebral spinal fluid that circulates around the spinal cord and the brain.
(Preservatives must prevent nerve damage) |
|
|
Term
| What are advantages to intrathecal injection? |
|
Definition
-Allows dosages that may be about one-tenth those given by epidural administration
-Given for single injections of narcotics for postoperative pain management |
|
|
Term
| What are disadvantages to intrathecal injection? |
|
Definition
-Carries a greater risk for bacterial contamination because the cerebral spinal fluid is a good medium for bacteria growth
-“spinal headaches” caused by leaking of cerebral spinal fluid into the epidural space. |
|
|
Term
| List three injection independent parenteral routes |
|
Definition
1. Intranasal
2. Inhalation
3. Ophthalmic |
|
|
Term
| What are advantages to intranasal injection? |
|
Definition
-The nasal cavity has a very large surface area for absorption and a very rich blood supply.
-Similar blood concentrations to IV |
|
|
Term
| Describe intranasal preparations |
|
Definition
Sterile, Isotonic, Weakly buffered, Preserved
Drugs typically intended for upper respiratory tract |
|
|
Term
| Give examples of inhalation drugs |
|
Definition
Typically affect pulmonary function or treat allergic symptoms
Adrenocorticoid steroids (beclomethasone)
Bronchodilators (isoproterenol, metaproterenol, albuterol)
Antiallergics (cromolyn) |
|
|
Term
| How are inhalation administrations formulated? |
|
Definition
-Inhalation formulations are generally solutions, suspensions, and powders.
-Commercial aerosols are typically metered dose inhalers (MDI)
-For compounded inhalation solutions, atomizers, nebulizers, and vaporizers are the aerosol devices. |
|
|
Term
| What are requirements for sterile formulations? |
|
Definition
Sterility
Particulate material
Pyrogen-free
Stability
pH
Isotonic
Preservatives
Antioxidants/ Chelators |
|
|
Term
| List five methods of sterilization |
|
Definition
Dry heat
Steam
Filtration
Gas
Radiation |
|
|
Term
| Describe dry heat sterilization |
|
Definition
-Simplest and least expensive
-150 – 170°C for >2 hours
-Dehydration of cells then oxidation
-Not as effective as moist heat for killing microorganisms |
|
|
Term
| What substances couldn't be autoclaved and must be sterilized using dry heat? |
|
Definition
| fixed oils, glycerin, heat-stable powders, fatty substances, oleaginous preparations |
|
|
Term
|
Definition
-Most effective
-Denatures and coagulates essential proteins
-Autoclave
-Pressure used so >100°C
-Usually 121°C for 15-30 minutes |
|
|
Term
|
Definition
-Removes microorganisms, doesn't kill them
-Useful for small volumes
-Also removes particulates
-Convenient, reliable, fast, cheap
-Most filters made from synthetic polymers |
|
|
Term
|
Definition
-Seldom used for sterilization
-Rigid enough to filter a solution being pulled into a syringe
-Can be used to filter a solution being pushed out of a syringe. The same filter cannot be used to draw up and then expel a solution. A new needle is required before pushing the solution out of the syringe. |
|
|
Term
| Describe a membrane filter |
|
Definition
-Thin microporous sheets made from a variety of plastics
-Intended to filter a solution only as it is expelled from a syringe
-Eliminate the risk of air embolism. Once a membrane filter is wet, air cannot pass through it.
-Often built into administration sets and needles |
|
|
Term
| How small do pores in a membrane filter must be if they are used for sterlization? |
|
Definition
|
|
Term
| Describe gas sterilization |
|
Definition
-Often ethylene oxide (mixed with CO2 to avoid fire hazards)
-6 hours+ at 55°C, then removed by vacuum
-Good for heat and moisture sensitive
-Can effect drug potency |
|
|
Term
| Describe radiation sterilization |
|
Definition
-exposure to high energy radiation (e.g., gamma rays, beta rays)
-Limited use due to specialized equipment needed and adverse effects |
|
|
Term
| List some particulate material |
|
Definition
Insect parts
Bacteria fragments
Dust
Cellulose fibers
Lint
Glass fragments
Rubber fragments
Plastic fragments
Metal particles |
|
|
Term
|
Definition
-metabolic by-products of living organisms
-Bacterial cell wall components
-May remain after sterilization |
|
|
Term
| What USP guidelines for sterilization exist? |
|
Definition
-Particulate material
-Endotoxins/pyrogens |
|
|
Term
|
Definition
-A USP test for pyrogens
-Horseshoe crab blood cell reagent coagulates in the presence of pyrogens
-Replaced the vivo Rabbit test in most cases (some formulations have drug interference)
-More sensitive than Rabbit test
-LAL=Limulus ambocyte lysate |
|
|
Term
| Describe the USP Rabbit test |
|
Definition
Pyrogen test:
Parenteral product is administered to rabbits, and the rectal temperature is monitored for increases in body temperature after administration |
|
|
Term
| What are symptoms of pyrogen exposure? |
|
Definition
-Usually occur within 45 to 180 minutes after the injection of an endotoxin
-Inflammatory, endothelial damage
-Chills, fever, headache, malaise, myalgia
-If high doses, septic shock |
|
|
Term
| What parenteral solutions do not need to be isotonic? |
|
Definition
-Hypotonic solutions used to dilute excess serum electrolytes (as in hyperglycemia)
-Hypertonic solutions used to correct electrolyte imbalance (as in severe diarrhea)
Both require patient monitoring |
|
|
Term
| List common parenteral buffers |
|
Definition
| Phosphate, acetate, and citrate buffers |
|
|
Term
| List the acceptable pH ranges for IM, SC, and IV |
|
Definition
IM, SC pH: 4 – 9
IV pH: 3-10.5
(pH > 9 can cause necrosis; pH < 3 induces severe pain) |
|
|
Term
| List common parenteral preservatives |
|
Definition
| phenol, thimerosal, parabens, benzyl alcohol |
|
|
Term
| Describe parenteral antioxidants |
|
Definition
| Antioxidants prevent or inhibit drug oxidation of formulation components, e.g., α-tocopherol, ascorbic acid, sodium bisulfite |
|
|
Term
| Describe parenteral chelators |
|
Definition
| Chelators are added to complex with metals that may participate in oxidation process, e.g., ethylenediamine tetra-acetic acid (EDTA) |
|
|
Term
| Describe water for injection, USP |
|
Definition
- Pyrogen free purified water with <0.001% solid residue
-purified by distillation or reverse osmosis
-Not required to be sterile, so must be sterilized after preparation |
|
|
Term
| Describe sterile water for injection, USP |
|
Definition
-Stored in containers no larger than 1L
-Can contain residue from glass-lined tanks
-Can't be injected as is due to tonicity |
|
|
Term
| Describe bacteriostatic sterile water for injection, USP |
|
Definition
-Sterile water with antimicrobial agent(s)
-Small packages (>30mL)
-NOT for neonatal, intraspinal, or epidural |
|
|
Term
| Describe sodium chloride water for injection, USP |
|
Definition
-Sterile isotonic NaCl solution
-No microbial agents
-Used as a solvent, catheter, or IV line flush |
|
|
Term
| Describe bacteriostatic sodium chloride water for injection, USP |
|
Definition
-Isotonic solution with antimicrobial agents
-Small containers (<30mL)
-NOT for neonates |
|
|
Term
| Describe Ringer's injection |
|
Definition
-Sterile solution of NaCl, KCl, and CaCl2 in Water for Injection
-The chloride salts are present in concentrations similar to those in physiological fluids
-Used as solvent for other drugs or alone as an electrolyte replenisher and plasma volume expander |
|
|
Term
| Describe Lactated Ringer’s Injection, USP |
|
Definition
Sterile solution of NaCl, KCl, CaCl2, and sodium lactate in Water for Injection
The concentrations of the chloride salts are different than those on Ringer’s solution
Used as fluid and electrolyte replenisher and also as systemic alkalinizer |
|
|
Term
| List some nonaqueous vehicles used in parenteral forumations |
|
Definition
Fixed vegetable oils
Glycerin
Polyethylene glycols
Propylene glycol
Alcohol
Etc |
|
|
Term
| How do you prevent oil in parenterals from being absorbed? |
|
Definition
| Oils in parenteral formulations must contain mineral oil or paraffin which cannot be absorbed by body tissues |
|
|
Term
| Can oleaginous solutions be injected? |
|
Definition
Yes, but usually IM
Can't be IV as they cause pulmonary occlusion |
|
|
Term
| Define single dose container |
|
Definition
“A hermetic container holding a quantity of sterile drug intended for parenteral administration as a single dose; when opened, it cannot be resealed with assurance that sterility has been maintained”
1mL to 1L |
|
|
Term
| Describe Multiple Dose Containers |
|
Definition
Allow withdrawal of successive portions of content with maintenance of sterility
Have rubber closures that permit various penetrations
The volume should not exceed 30 ml. Containers usually have 10 doses
Are required to have antimicrobial agents |
|
|
Term
| What is the difference between Small and Large Volume Parenterals? |
|
Definition
| Large is <100mL single dose injection, small is >100mL |
|
|
Term
| How are frozen premixed products thawed? |
|
Definition
| Microwave or water baths are not recommended for thawing; instead, hospitals use conditioned air around frozen products |
|
|
Term
| Do small volume parenterals need to be isotonic? |
|
Definition
| Not usually, they are rapidly diluted by body fluid |
|
|
Term
| What are the three sets of guidelines for aseptic compounding? |
|
Definition
|
|
Term
| What are the three USP tests for aseptic compounding? |
|
Definition
USP <797> - Finished Product Testing
USP Chapter <71> - Microbial testing
USP Chapter <85> Endotoxin (Pyrogen) testing |
|
|
Term
| How effective is a High Efficiency Patriculate Air (HEPA) filter? |
|
Definition
| Removes 99.97% of all particles 0.3 microns or larger |
|
|
Term
| Which are more common, vertical or horizontal air filters? Why? |
|
Definition
Horizontal are more common
Vertical are more costly, reserved for agents that may produce an environmental hazard (chemotherapy) |
|
|
Term
| What class must Laminal flow hoods be? |
|
Definition
Class 100 (less than 100 particles of 0.05 micron size per cubic foot)
High risk compounding can require up to Class 100,000 |
|
|
Term
| Define "downstream contamination" |
|
Definition
| when an object comes between the HEPA filter and the sterile product |
|
|
Term
| Define "cross-stream contamination" |
|
Definition
| Occur due to rapid movements of the operator in the hood |
|
|
Term
| Are laminal flow hoods sterile? |
|
Definition
|
|
Term
| How close to a laminal flow hood should you work? |
|
Definition
| At least 6 inches into the hood |
|
|
Term
| What are the basic parts of the syringe? |
|
Definition
| The cap, needle, barrel, and plunger |
|
|
Term
| What sizes do syringes come in? What size should one select? |
|
Definition
1mL to 60mL
Select the size that is one size larger than the volume to be measured (a syringe filled to capacity can dislodge the plunger) |
|
|
Term
| What are the basic parts of the needle? |
|
Definition
The hub, shaft, and bevel
Lumen inside the shaft |
|
|
Term
| What kind of needle should be used when preparing admixtures? |
|
Definition
|
|
Term
| What gauges do needles come in? |
|
Definition
| Ranges from 27 (the finest) to 13 (the largest) |
|
|
Term
| What are the two main considerations when selecting a needle size? |
|
Definition
1. Viscocity of the solution
2. The possibility of coring the rubber cover |
|
|
Term
| What kind of containers are large volume parenterals available in? |
|
Definition
a glass bottle with an air vent tube
A glass bottle without an air vent tube
Plastic bags |
|
|
Term
| Describe the administration set port |
|
Definition
Has a plastic cover to maintain sterility
A spike for the administration set punctures the diaphragm, and solution will flow out of the bag into the administration set |
|
|
Term
| Describe the medication port |
|
Definition
| Drugs are added to this port using a needle and syringe |
|
|
Term
| What packages do small volume parenterals come in? |
|
Definition
Minibags (50 ml to 100 ml) – used primarily to deliver medication
Ampules
Vials
Prefilled syringes |
|
|
Term
Define ampule
What kind of needle should be used? |
|
Definition
Sealed glass container with an elongated neck that must be broken off
A 5 micron filter needle should be used when drawing the contents of the ampule into a syringe
The filter needle is replaced with a regular needle before adding the contents to a solution |
|
|
Term
| When breaking an ampule, where should you face it? |
|
Definition
| Towards the side (avoid hitting the filter or yourself with glass shards) |
|
|
Term
Define and describe parenteral vials
What must be done before withdrawing contents from a vial? |
|
Definition
Contents may be liquids or powders
Made of glass or plastic and sealed with a rubber stopper
Before withdrawing contents from a vial, an equal amount of air is usually added to the vial to pressurize the system |
|
|
Term
| What are the two types of pre-filled syringes? |
|
Definition
Cartridge type – a single syringe and needle unit are placed in a special holder for use. The syringe and needle are disposed, but the holder is reused.
Prefilled tube – a glass tube closed at both ends with rubber stoppers. It is placed into a specially designed syringe, and all parts are disposed of when finished |
|
|
Term
| Define process validation |
|
Definition
| A mechanism that will establish a high degree of assurance that specific processes are achieving their objective |
|
|
Term
|
Definition
| Testing aseptic technique with multiple transfers on rich growth medium to see if growth results |
|
|
Term
|
Definition
| The sum total of methods and manipulations required to minimize the contamination of sterile compounded formulations. |
|
|
Term
| How is a flow hood cleaned? |
|
Definition
| 70% isopropyl alcohol, or other antibacterial scrub such as benzalkonium chloride solution, working from top to bottom, then from back to front. |
|
|
Term
| How can coring be prevented? |
|
Definition
-Make the bevel face upward and the needle at a 45 - 60 degree angle
-Put downward pressure on a needle while bringing the needle to an upright position |
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|
