Chapter 15 - Parenterals part 3 Flashcards by amanda kastel

name 4 USP official tests for parenterals

Sterility test
Pyrogen Test
Clarity Test
Leaker test

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explain the USP Clarity Test

tests for the size and number of particles undissolved in solution

uses a “Coulter counter” to test

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what is the leaker test done on?

ampuls

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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

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what does CSP stand for in Chapter <797>

compounded sterile preparations

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chapter <797> applies to all organizations that…….

compound sterile preparations. this includes health care institutions, home infusion pharmacies, and other facilities

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USP General Chapter <797> addresses _____, _____, and _______ of sterile drug preparations

compounding, preparation, and labeling

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give the title of USP General Chapter <797>

“Pharmaceutical Compounding - Sterile Preparations”

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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

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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

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there are ___ and ____ engineering controls

primary and secondary

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primary engineering controls include…….

horizontal flow clean benches
vertical flow clean benches
biological safety cabinets
barrier isolaters (plexiglass)

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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)

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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

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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

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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

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name the rapid acting insulins

insulin lispro
insulin aspart
insulin glulisine

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insulin glulisine brand name

APIDRA

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regular insulin is ___ acting

short acting

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name the intermediate acting insulins

Isophane (NPH) insulin
Insulin-zinc (Lente)

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lente is insulin-_____ and it is ___ acting

insulin-zinc
intermediate acting

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name the long-acting insulins

insulin-zinc extended (Ultralente)
insulin glargine

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name the insulin mixtures

Isophane/regular insulin

NPL/lispro mix

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which type of insulin has the shortest onset time?
what is the onset time

shortest onset - rapid-acting
0.25 hours (15 minutes)

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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