Intro to Parenteral Nutrition Flashcards
Why are sterile products important for every pharmacist?
pharmacist is responsible for inspecting, approving or rejecting all formulas, calculations, a substances, containers, closures and in-process materials pertaining to compounded sterile preparations
Why are there concerns about PEN?
- Uncontrolled environments are still in use
2. Inadequate controls increase the incidence of medication errors
What is a tenfold medication error?
a decimal point error
Differentiate between USP chapters with numbers >1000 and those with numbers <1000
>1000 = chapter content is recommended. <1000 = chapter content is enforceable by law.
What two USP chapters are critical to parenteral products? What is their content?
USP <797> = pharmaceutical compounding for steriale preparations
USP <800> = handling hazardous drugs in HC settings.
Differentiate b/t the practical and etymological meaning of “parenteral.”
etymological = not oral practical = all injectable products
What are three things to take into consideration when administering parenteral products?
- Administration of therapeutic agent requires an injury to the body.
- Administration bypasses the body’s natural defense barriers
- Administration makes the body vulnerable
»> need stringent requirements
What are the requirements for compounding sterile preparations that are specific to parenterals
- Sterile
- Particle-free
- Pyrogen-free
What are the five topics that USP <797> covers?
- Microbial contamination
- Excessive bacterial endotoxins
- Variability in the intended strength of correct ingredients
- Unintended chemical and physical contaminants
- Ingredients of inappropriate quality.
What are methods of sterilization?
Steam (autoclave) filtration (bacteria retentive membrane) dry heat (oven) gas (ethylene oxide) irradiation (gamma rays)
What are pyrogens?
bacterial endotoxins that “produce fever” and can also produce septic shock.
Does sterilization eliminate pyrogens? Why or why not?
No; pyrogens are parts of bacteria, not actual bacterial. Sterilization may kill bacteria but it won’t get rid of the endotoxins still floating around.
Differentiate b/t septicemia and septic shock.
septicemia = infection of blood by live organisms
septic shock = acute reaction to bacterial endotoxins
Why do sterile preparations have to be particle-free?
Foreign particles can trigger immune response
Can damage lungs and kidneys
Can and have killed people
Differentiate between _____ injection/emulsion/suspension and _______ for injection/emulsion/suspension.
The former means that the ____ is ready to be used for injection/emulsion/suspension as is - no prep required.
Addition of “for” into the phrase means that the product must go through an additional step before being used as an injection/emulsion/suspension.
Differentiate between large volume parenteral (LVP) and small volume parenteral.
LVP = Single dose injections packaged in a acontainer containing more than 100mL.
small volume parenteral = 100mL or less
What is the most common vehicle used in parenteral products? The preferred?
water (for both)
Types of water used in parenteral products and the preferred type.
- Water for injection (WFI) - pyrogen free, non-sterile, single use sealed container.
- Sterile Water for Inejction USP (SWFI) = pyrogen free, sterile, packed in sealed containers not larger than 1000mL»_space; Preferred
- Bacteriostatic water for injection (BWFI) = pyrogen free, sterile with antimicrobial agent added.
Is it ok to inject SWFI directly into the blood stream?
No; it will cause hemolysis
What are some examples of aqueous isotonic vehicles?
NS, D5W, bacteriostatic sodium chloride injection (NS w/ microbial preservative), Ringer’s solution
What are some water miscible solvents used in parenterals?
alcohol, polyethylene glycol, propylene glycol
What are water miscible solvents used for in parenteral cases?
used to solubilize drugs
often used for intramuscular injection
Why is there a difference b/t the allowable concentrations of PEG and alcohol in IV?
alcohol - 10%
PEG - 40%
Their hemolytic potentials are different
What is the difference b/t oil and oil emulsions?
Oil = straight oil. Cannot be injected directly into the bloodstream b/c it is an embolus
Oil emulsion = little droplets of oil (smaller than RBCs) distributed in aqueous phase. No risk of embolism => can use for IV injection. Oil =/= oil emulsion.
Common antimicrobial preservatives used in parenterals.
Benzyl alcohol 0.9%
Parabens: methyl paraben 0.18% + propyl paraben 0.02% mix
Antimicrobials are not very effective in ____ solutions.
oil-based
Compatibility issues with antimicrobial preservatives
Some excipients sequester antimicrobial preservatives
E.g. polysorbate (through micelles) and PVP complex-like formation
Any sterile product intended for multiple dose use must contain __________.
antimicrobial preservative
Contraindications for antimicrobial preservatives in parenterals.
- Neonates - don’t use microbial preservatives, especially benzyl alcohol b/c it can cause gasping syndrome.
- Intra-spinal preparations cannot have antimicrobial preservatives
Examples of pH buffers in parenterals
citrates
acetates
phosphates
Citrate: appropriate routes
IV is ok
IM or subcutaneous is irritating
Phosphate: contraindications
Adding calcium (can precipitate)
Why do you want to make buffers as dilute as possible?
So the physiological pH takes over quickly
Antioxidants and the pHs they should be used at
Ascorbic acid
metabisulfate salts - low pH
bisulfite - intermediate pH
sulfite - high pH
Chelating agents - function and example
most common = EDTA
Enhance antioxidant’s effect and sequester trace metals
What glass type should e used for parenterals?
type 1
Are containers considered ingredients of the product?
Yes, because they are in direct contact with the product
Ampules are for how many uses?
one
Piggyback containers should be ____ than the large volume container.
Higher
What syringe is required for hazardous drugs?
Luer Lok
How is needle size described?
Two numbers, gauge and length
- gauge = diameter of the bore; higher gauge»_space; smaller bore diameter
- length = length of needle shaft. 3/8” to 3.5”
Are excipients for IV and non-IV formulations interchangeable?
No. Ok for IV»_space; generally ok for others. But ok for others =/= ok for IV.
IV route is characterized by rapid onstep because…?
no absorption phase