Chapter 15 - Parenterals part 3 Flashcards
name 4 USP official tests for parenterals
Sterility test
Pyrogen Test
Clarity Test
Leaker test
explain the USP Clarity Test
tests for the size and number of particles undissolved in solution
uses a “Coulter counter” to test
what is the leaker test done on?
ampuls
what USP General Chapter addresses compounding, preparation, and labeling of STERILE DRUG PREPARATIONS?
when was it published?
USP General Chapter <797>
published in fall 2003 and went into effect january 1, 2024
what does CSP stand for in Chapter <797>
compounded sterile preparations
chapter <797> applies to all organizations that…….
compound sterile preparations. this includes health care institutions, home infusion pharmacies, and other facilities
USP General Chapter <797> addresses _____, _____, and _______ of sterile drug preparations
compounding, preparation, and labeling
give the title of USP General Chapter <797>
“Pharmaceutical Compounding - Sterile Preparations”
name 5 requirements of compounding sterile preparations
-cleaner facilities
-personnel must be trained and tested in principles and practices of ASEPTIC manipulations
-air quality evaluation and maintenance (in the compounding area)
-sound knowledge of sterilization
-know and apply the principles and practices of solution stability
name 4 factors that affect compounding sterile preparations
-the status of the components used in the preparation
-the process used in preparing the preparation
-the performance of the personnel performing the preparation
-the environmental conditions in which the process was performed
there are ___ and ____ engineering controls
primary and secondary
primary engineering controls include…….
horizontal flow clean benches
vertical flow clean benches
biological safety cabinets
barrier isolaters (plexiglass)
secondary engineering controls are….
they provide a “buffer zone” or a buffer room as a core for the location of the workbenches or isolators
have the cleanest work surfaces
(horizontal/vertical workbenches, biological safety cabinets or isolators)
at least _______ quality of air must be provided to sterile ingredients and components
what does this mean?
ISO class 5
means the number of particles having a particle size 0.5 micrometers and larger in the environment DOES NOT EXCEED 3520 PARTICLES PER CUBIC METER
USP requires compounding personnel to be proficient in performing which 5 duties?
-performing antiseptic hand cleansing and disinfection of non-sterile compounding surfaces
-select and appropriately wear protective gloves, goggles, gowns, masks, and hair and shoe covers (PPE)
-use laminar flow clean-air hoods, barrier isolaters, and other contamination control devices
-identify, weigh, and measure ingredients
-manipulate sterile products aseptically and label and quality inpect compounded sterile preparations
name 5 sources of contamination
solid and liquid matter from the compounding personnel and objects (no jewelry, no earrings)
non-sterile components used and incorporated
inappropriate conditions within the compounding area
prolonged pre-sterilization procedures with aquepus preparations
non-sterile dosage forms used in compounding
name the rapid acting insulins
insulin lispro
insulin aspart
insulin glulisine
insulin glulisine brand name
APIDRA
regular insulin is ___ acting
short acting
name the intermediate acting insulins
Isophane (NPH) insulin
Insulin-zinc (Lente)
lente is insulin-_____ and it is ___ acting
insulin-zinc
intermediate acting
name the long-acting insulins
insulin-zinc extended (Ultralente)
insulin glargine
name the insulin mixtures
Isophane/regular insulin
NPL/lispro mix
which type of insulin has the shortest onset time?
what is the onset time
shortest onset - rapid-acting
0.25 hours (15 minutes)
which insulin has the shortest duration and what is the duration
rapid-acting
3 hour duration
insulin is a ____volume parenteral
SMALL VOLUME
name the insulin devices
insulin pens
insulin infusion pump
duration of the long-acting insulins
insulin-zinc extended (Ultralente) 24-28 hours
insulin glargine >24 hours
which insulin has no peak time?
insulin glargine
what is the onset time for short acting insulin
0.5 hours (30 mins)
what is the onset time for intermediate-acting insulin
1-2 hours
what is the onset time for the long-acting insulins
insulin-zinc extended (Ultralente) – 4-6 hours
Insuline Glargine – 2 hours
what is the onset time for NPL/lispro mix
what is the % of each
5 minutes
75% NPL 25% lispro
75/25
what is unique about NPH insulin
it is a suspension
name 4 uses for large volume parenterals
maintenance therapy (normalwater, dextrose, sodium, potassium, etc)
replacement therapy (when pt lost a heavy volume of water/electrolytes due to severe diarrhea and vomiting)
parenteral hyperalimentation (infusion of basic nutrients to achieve active tissue synthesis and growth)
enteral nutrition (like feeding tube(
replacement therapy via large volume infusion involves satisfying ____, ____, and ____ requirements
water, electrolyte, and caloric requirements
what is the daily water requirement for humans
25-40mL/kg
go into detail about the electrolyte requirements for humans
cations needed: sodium potassium, calcium, and magnesium
anions needed: chloride, phosphate, and acetate
TCPN
total central parenteral nutrition
PCTN
patient central parenteral nutrition
TPPN
total peripheral parenteral nutrition
PPPN
partial peripheral parenteral nutrition
what is the difference between total and partial parenteral nutriton
total – given when you can’t digest things at all
partial –supplement other kinds of feeding
what is the difference between central and peripheral parenteral nutrition
central – delivered through a central vein
peripheral – through a smaller peripheral vein
large volume parenterals are given via_____ infusion devices
intravenous
give 7 SPECIFIC examples of large volume parenterals
Amino Acid
Dextrose Injection, USP
Dextrose and Sodium Chloride Injection, USP
Mannitol Injection, USP
Ringer’s Injection, USP
Lactated Ringer’s Injection, USP
Sodium Chloride Injection, USP
what is the purpose of Amino Acid Injection
Fluid and nutrient replenisher
what is the purpose of Dextrose Injection, USP
fluid and nutrient replenisher
what is the purpose of Dextrose and Sodium Chloride Injection, USP
Fluid, nutrient, and electrolyte replenisher
What is the purpose of Mannitol Injection, USP
diagnostic aid in renal function
diuretic
fluid and nutrient replenisher
what is the purpose of Ringer’s Injection, USP
Fluid and electrolyte replenisher
what is the purpose of Sodium Chloride Injection, USP
fluid and electrolyte replenisher; isotonic vehicle
name 5 special considerations associated with parenteral therapy
-standardization of IV concentration – reduce error
-look-alike products
-adsorption of drug
-absorption (sorption) of drugs
-handling and disposal of chemotherapeutic agents for cancer
explain why “adsorption of drug” is a special consideration associated with parenteral therapy
studies have shown that some drugs are adsorbed to the inner lining of IV containers/tubing/administration sets. these most often include peptides and proteins
explain of “absorption (sorption) of drugs” is a special consideration with parenteral therapy
plastic material can absorb some drugs
___ and ___ are sterile products manufactured by the same standards used to process intravenous preparations
IRRIGATION AND DIALYSIS SOLUTIONS
True or false
irrigation and dialysis solutions are intended for infusion into the venous system
FALSE
Name the 2 ways in which irrigation solutions are administered and what they’re for
topical administration and infusion
topical administration – packaged in pour bottles to be poured directly on the area
used for irrigating wounds, moistening dressings, and cleansing surgical instruments
infusion – used for surgical patients
perfuse tissues (bring color/ fluidto them)
maintain integrity of the surgical field
remove blood
provide clear field of view
what is often put in irrigating solutions that are infused in order to decrease the risk of infection?
an antibiotic preparation (1 mL of Neosporin G.U. Irrigant)
dialysis solutions are used in patients with….
disorders like renal failure, poisoning, and electrolyte disturbances.
it removes waste materials, serum electrolytes, and toxic products from the body
name the types of dialysis
hemodialysis, peritoneal dialysis
in PERITONEAL DIALYSIS, a _______ dialysate is infused ________ via a _____
a HYPERTONIC dialysate is infused DIRECTLY INTO THE PERITONEAL CAVITY via a SURGICALLY IMPLANTED CATHETER
in peritoneal dialysis, what is infused?
dextrose and electrolytes
how does the dialysate remove harmful substances?
by OSMOSIS and DIFFUSION
what may be added to the dialysate in peritoneal dialysis?
antibiotics and heparin
explain hemodialysis
the patient’s blood is transfused through a dialyzing membrane unit that removes the harmful substances from the patient’s vascular system
after passing through this dialyzer, the blood reenters the body via a vein
low risk/medium risk/high risk compounding
didnt do
According to the practice problems, what is the onset time of NHP (Isophane)
1.5-4 hours
NPH/isophane is given through which route of administration
subcutaneous NOT IV
brand name NPH
humilin
steam sterilization sterilizes by mechanisms involving….
COAGULATION ONLY
Define sterilization
freeing an object from life of ANY kind
true or false
drugs given by intravenous route avoid first pass effects, are suitable when the oral route is not feasible, and has predictable drug release and absorption
FALSE — has predictable release but does not undergo absorption
name the 4 different types of parenteral hyperalimentation
TCPN (total central parenteral nutrition)
PCTN (partial central parenteral nutrition)
TPPN (total peripheral parenteral nutrition)
PPPN (partial peripheral parenteral nutrition)
explain what low risk compounding is
compounded with aseptic manipulation entirely within ISO class 5 or better quality environment
only the transfer, measuring, and mixing manipulations with CLOSED or SEALED packaging systems that are performed promptly and attentively
in low risk compounding, manipulations are limited to what?
aseptically opening ampuls, penetrating sterile stoppers on vials with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile administration devices and packages of other sterile products
explain medium risk compounding
multiple individual or small doses are pooled to prepare a COMPOUNDED sterile preparation that will be administered to either MULTIPLE PATIENTS or to one patient on MULTIPLE OCCASSIONS
NOT a single volume transfer (like low risk) — more complex. usually long duration (ie: achieve complete dissolution or homogenous mixing
in medium risk compounding, do the compounded sterile preparations contain a broad spectrum bacteriostatic substance?
how are the preparations administered? give specific examples
do NOT contain a broad spectrum antiseptic
administered over several days (example – internally worn or implanted infusion device)
explain high risk compounding
the sterile ingredients, components, and devices and mixtures are exposed to air quality inferior to ISO class 5 – includes storage in an environment inferior to ISO class 5 of opened or partially used of manufactured sterile products that lack preservatives
in high risk compounding, non-sterile preparations are exposed for at least _____ before being sterilized
6 hours
state whether it is low, medium, or high risk:
“filling of reservoirs of injection and infusion devices with multiple sterile drug products and evacuation of air from those reservoirs before the filled device is dispensed”
medium risk
state whether it is low, medium, or high risk compounding:
“manually mixing and measuring no more than 3 manufactured products to compound drug admixtures and nutritional solutions”
low risk
“single transfers” is a key word for which compounding
low risk
state whether it is low, medium, or high risk compounding:
“transfer of vials from mutliple ampuls or vials into a single, final sterile container or product”
medium risk
state whether it is low, medium, or high risk compounding:
“measuring and/or mixing sterile ingredients in non-sterile devices before sterilization is performed”
high risk
state whether it is low, medium, or high risk:
“assuming, without appropriate evidence or direct determination, that packages of bulk ingredients contain at least 95% of their active chemical moeity and have not been contaminated or adulterated between uses”
high risk
inferior to ISO class 5 air quality = ___ compounding
high risk
