McCain - parenteral

Enteron means

a. Intestine

b. joint

c. skull

d. covering

a

Parenteral means _______ the _______

In practice, parenteral is understood to mean “by ________”

outside, intestine, injection

The three I’s of Parenterals

Imperative, invasive, irrevocable

Parenteral Advantages

1. Parenteral route would be indicated If drug is poorly absorbed or degraded by _____

2. _____ and predictable drug response

3. useful when patient is _______ or _______

4. useful when patient can’t absorb these ______

5. _____ drug therapy

6. ______ acting drug delivery

7. ______ pumps

1. GI

2. rapid

3. uncooperative, unconscious

4. orally

5. localized

6. long

7. implantable

Parenteral Disadvantages

1. Necessity of ______

2. Difficult and _____ to produce

3. Many require a ______ person to prepare and/or administer them

4. Once administered, it is difficult to _______ if adverse or toxic rxn occurs

5. _____ or risk of tissue ______ with administration

1. sterility

2. costly

3. trained

4. remove

5. pain, damage

USP Injectable Material Types (5)

1. injection → solution

2. for injection → dry solid, liquid upon prep

3. injectable emul

4. injectable susp

5. for injectable susp

Injectable suspensions are difficult to formulate because they must possess ________ and _______

syringeability, injectability

NDC Numbers

XXXXX-XXXX-XX

What does each group represent

1. company

2. product

3. size

Emulsions – relatively stable homogeneous mixtures of two __________ liquids

immiscible

IMPORTANT PARENTERAL CHARACTERISTICS (6)

1. sterile

2. particulate and pyrogen free

3. stable

4. pH

5. osmotic P

6. proper labeling and packaging

Sterility

1. Absence of living or ________ _______ form (ie. spore) of an organism

2. Cannot be 100% confirmed, is described using statistical probability known as __________ _________ _______

3. ^ Each log reduction (10^-1) represents _____% reduction in microbial population

4. ^ 6 log reduction represents that ____ unit(s) bacteria survived every 1,000,0000 units

5. 5 methods used for pharmaceuticals

1. viable vegetative

2. sterility assurance level SAL

3. 90%

4. 1

5. steam, dry heat, filtration, gas, ionizing radiation

T or F:

Steam sterilization is useful for oils, fats, and other oleaginous preparations or powders that may be damaged by moisture

F (dry heat is)

Dry heat sterilization is the method of choice when _____ conditions are required or when not effectively sterilized by _____ heat

Good for ____ and ____

dry, moist, oils, fats

Filtration Sterilization

1. ______ micron filter sterilizes a drug product

2. Advantages (3)

3. Disadvantages (2)

4. ______ _____ testing is used to ensure filter integrity

1. 0.2

2. speed, lower cost, complete removal of living and dead organisms

3. slow for large Vs, potential to retain drug in filter

4. bubble point

_____ sterilization interfere with cellular ________ function and can kill ______ known viruses, bacteria, fungi, and spores

Gas, metabolic, all

1. Radiation Sterilization may be ________ or ________

2. Advantages (2)

1. beam - electrical, ionizing - radioactive

2. cheap, nondestructive

1. Sources of particulates (6)

2. particulates can cause …. (5)

1. product itself, environment, equipment, personnel, packaging, administration devices

2. tissue injury, emboli, allergic rxn, tissue infarction, death

1. Pyrogen is any substance that can cause a _________

2. Endotoxin is the natural complex of lipopolysaccharide found in outer layer of live/dead gram-________ bacterial cell walls

3. Clinically important as can cause … (8)

1. fever

2. negative

3. fever, chills, nausea, malaise, pain, septic shock, respiratory distress, death

Pyrogen Testing

1. _________ test, cannot be precisely _______

Endotoxin Testing

2. _______ test, can be repeated

3. Aqueous extract of blood cells from the _______ _____ that reacts with lipopolysaccharide (forms a ________ gel)

1. rabbit, repeated

2. LAL

3. horseshoe crab, coagulation

Non sterile (“filthy”) vs pyrogenic

1. filthy → slow onset of fever, 100-102 F

2. pyrogenic → sudden onset of fever <20min and >104 F

IV Parenterals

1. Human blood plasma has pH of ______

2. Infusate pH btwn ______ can be tolerated by peripheral veins

3. ________ of exposure is a contributing variable to tolerability

4. ________ of vascular access is also a contributing variable

5. Blood has tonicity of _______ mOsm/L

1. 7.4

2. 5-9

3. duration

4. location

5. 280-310

The 3 isotonic solutions

1. 0.9% NS

2. 5% dextrose → hypotonic in body after rapid oxidation to CO2 and free H2O

3. Lactated Ringers LR

D5W + anything else is always _________ (ex: D5W + LR or D5W + 0.45% NaCl)

hypertonic

1. For intravenous administration, osmolar concentration NOT LESS than _______ mOsm/L is essential to avoid _________ (cell rupture)

2. Osmolar concentration NOT MORE than _______ mOsm/L to avoid tissue injury/cell _______

1. 112, hemolysis (hypotonic = burst)

2. 600, shrinkage (hypertonic = shrink)

Result of HEPA + LAF (high efficiency particulate air filtration + laminar air flow)

1. Not “sterile”, BUT is _______ _____ and therefore a “_______” environment

2. The focus then becomes preserving the particle-free air flow at the ________ ____

3. 2 types of hoods, which one for hazardous drugs?

1. particle-free, clean

2. critical site

3. horizontal, vertical for hazardous

Tuberculin/TB vs Insulin syringes (3)

1. both are 1 mL

2. insulin typically have pre-attached needles

3. TB marked in 0.01 mL, insulin marked in 2 unit (100 U → 1 mL)

what 2 parts is NOT okay to touch while drawing a syringe? (contamination)

tip and rib/plunger

Difference btwn BD Luer-Lok and Luer Slip

1. Luer-Lok → locking fit

2. Luer Slip → push and twist

Syringes

1. Recommended V of solution drawn up typically to _____- _____ of syringe capacity

2. _______ ______ of plunger is used for measuring V

3. These syringes are accurate to ______of the smallest increment marking on the syringe

1. 1/2-2/3

2. final edge

3. 1/2

10 units is equivalent to _____ mL

0.1

Needles: ______ mL for priming

0.1 mL

T or F:

Needle gauges: The higher the number, the smaller the diameter

T

Insulin needles

1. micro fine =

2. ultra fine =

3. nano =

1. 27-28 G

2. 31 G

3. 32 G

Which parts of the insulin needle should you NOT touch? (contamination risk)

ALL

T or F:

You can pull AND administer using filter needles

F

(always pull with the filter needle then change tip to administer OR pull with normal tip then change to filter and administer. always change tip)

Routes of Parenteral Administration

1. Intradermal ID → injection area just below the surface of the ____

2. ^ used for …

3. Subcutaneous SC, SQ, SubQ → injection area of _____ tissue located beneath skin btwn dermis and muscle

4. ^ used for ….

5. Intramuscular IM → Injection area in _______ mass

6. Formulations must be ________, V limited by ______ of injected muscle and _____

7. Intravenous IV → injection area: _________

8. Administration of drug that needs immediate _________ circulation, is _____, and/or requiring controlled ______ levels

1. skin

2. skin tests, small Vs

3. fat

4. acute/continuous therapies, insulin, heparin, 2.5 mL V

5. muscle

6. nonirritating, mass, age

7. vein

8. systemic, irritating, blood

Parenteral suspensions in oil have pharmaceutically _______-acting effect

These are administered ONLY ________ (not miscible w blood, _______ risk)

long, intramuscularly, embolic

Venous Access Devices

1. -

2. -

1. Peripheral catheters → most common, short duration/days, limitations on content and rate

2. Central catheters → more complicated, longer duration/days to months, fewer limitations

midline vs PICC line vs Implanted port

1. Midline → ends around shoulder

2. PICC → longer

3. implanted port → under skin

2 types of IV administration

1. bolus

2. infusion → continuous or intermittent

Bolus IV Push

1. advantages (5)

2. disadvantages (3)

1. shortest duration, not prolonged, immediate blood lvls, no pump, less expensive

2. drug toxicity, stability, blood fluctuation

infiltration vs extravasation

the type of medicine/fluid that is LEAKED

1. infiltration → non vesicant

2. extravasation → vesicant (irritating to tissues)

Continuous IV → simultaneous fluid + drug therapy

1. advantages (2)

2. disadvantages (4)

1. constant blood lvls, minimize vein trauma

2. greater monitoring, may require central catheter, infiltration or extravasation leaks, potential of adverse drug event ADE

Intermittent IV

1. advantages (4)

2. disadvantages (4)

1. limited admin time, less monitoring, less potential for ADE, inc stability

2. V/conc limits, less constant blood lvls, inc prep time, inc infection risk

Complications of IV administration (5)

1. phlebitis - vein inflammation

2. thrombosis - vein clot

3. air emboli

4. particulate emboli

5. infiltration/extravasation

1. commonly utilized for analgesia and/or anesthesia → __________ (space in spinal column)

2. MUST BE __________ ______ and have __________

3. used for analgesia/anesthesia AND select chemotherapeutic, injects INTO the spine → ____________

4. also must be ________ _____ and have _______

1. epidural

2. preservative-free, labeling for epidural use

3. intrathecal

4. preservative-free, labeling for intrathecal use

Vincristine should NEVER be given ________

intrathecally

Parenteral solutions are packaged as ….

1. large volume parenteral LVP > 100 mL

2. small volume parenteral SVP 100 mL or less

3. pharmacy bulk package → NOT intended for direct infusion, contains many single doses

3 types of containers for LVP

1. glass bottles

2. glass bottles with air vent tube

3. plastic bags → graduation marks roughly estimate (should not be used to measure), collapse as they empty and do not require venting

Before withdrawing contents from a vial, an equal volume of _____ is FREQUENTLY injected into the vial to pressurize the vial and aid in withdrawing the contents

air

BLACK “flip off” cap and a BLACK FERRULE with _______ ____ _______ warning

must be diluted

T or F:

Vial entry → use slight lateral P at 45 angle and move to 90 to prevent coring

T

1. Ampoules are ______ dose glass containers with elongated neck that must be broken off

2. Ampoules require use of a _________ filter

1. single

2. 5 micron

1. Single dose containers may be ______ or ____

2. they contain NO ________

3. ________ MUST BE discarded immediately

4. Multiple dose containers are limited to _______ volume

5. Must be discarded within ______ days unless specified by manufacturer

1. ampoules, vials

2. preservatives

3. ampoules

4. 30 mL

5. 28

T or F:

For reconstitution, all drugs should be shaken

F (some should NOT be shaken)