Dosage Forms Ii Exam 2: Parenetrals Part2

Front 1

what are the disadvantages or hazards of parenteral therapy?

Back 1

1) discomfort or pain, 2) phlebitis, 3) extravasation & infiltration, 4) infection, 5) pyrogenic response, & 6) cost

Front 2

what are some contributing factors to discomfort from parenteral therapy? (4)

Back 2

1)the needle or catheter 2)the administration site, 3) technique, 4) drug product

Front 3

give an example of why administration site could cause discomfort or pain?

Back 3

IM injections could cause tissue distension, needle may hit a nn, & different mm have different nn issues

Front 4

what are 2 ways the technique of parenteral therapy can cause discomfort or pain?

Back 4

needle penetration where it's more painful if nonlinear & mm contraction (if mm site is relaxed, it will be less painful)

Front 5

How can a drug product cause pain or discomfort via parenteral route?

Back 5

ingredients in the formulation, including the drug itself, can stimulate pain nn or nocieceptors & or physically or chemically irritate

Front 6

This results from injury to the endothelial cells lining a vein?

Back 6

phlebitis

Front 7

What is the possible sequelae of phlebitis?

Back 7

thrombus formation w/c is hastened by damaged endothelial surface. this can become dislodged & become an embolus w/c leads to embolism

Front 8

Obstruction of a blood vessel by foreign substances or blood clot?

Back 8

embolism

Front 9

T/F: an embolus is any unsolved matter in the blood or lymphatic vessel?

Back 9

True

Front 10

What are the 4 contributing factors that could lead to phlebitis?

Back 10

1) needle or catheter, 2) administration site, 3) technique used to inject & manipulation of the catheter during or after insertion, 4) the drug product

Front 11

How can a needle or catheter lead to phlebitis?

Back 11

they can injure the vein directly or a small vein can be blocked & reduce blood flow leading to injury

Front 12

How can the administration site lead to phlebitis?

Back 12

small peripheral veins are less able to dilute a product & leg vein have a relatively stagnant blood flow w/c may slow down product dilution

Front 13

How can drug product cause phlebitis?

Back 13

thru endothelial damage from chemical irritation or from irritation from particles

Front 14

How can particles cause irritation to cause phlebitis?

Back 14

physical abrasion of the vascular endothelium or drug crystals can embed in the vascular endothelium & lead to high local drug [ ]

Front 15

give 4 examples of how chemical irritation from the drug product formulation can alter cellular function?

Back 15

(1) Non-isotonic formulations can affect cellular water content (2) Non-physiological pH can affect ionizable biomolecules (3) Cosolvents/surfactants can alter membrane properties (4) The drug itself may be irritating
This results from injury to the endothelial cells lining a vein? phlebitis

Front 16

This defines the escape of fluid into the surrounding tissue so it flows outside the vein?

Back 16

extravasation or infiltration

Front 17

What is the possible sequelae of extravasation & infiltration?

Back 17

1)swelling/pain, 2) cell death from chemical irritation, 3) tissue death & possible infection of the necrotic wound, 4) nn damage & loss of use of a limb, 5) loss of limb

Front 18

what are the contributing factors to extravasation?

Back 18

1) administration technique, 2) trauma to the venous endothelium, & 3) drug product

Front 19

How can the administration technique lead to extravasation?

Back 19

puncture of a vein so drug comes out from the other side or slippage of a catheter out of the vein could also cause extravasation.

Front 20

How can trauma to the venous endothelium lead to extravasation?

Back 20

can lead to reflex vasoconstriction w/c may cause back pressure

Front 21

This defines any material that causes blisters?

Back 21

vesicants

Front 22

when can vesicants be a significant problem?

Back 22

they are a significant problem in general but especially w/ regard to extravasation injury.

Front 23

What are some IV agent classes that have been know to cause tissue necrosis?

Back 23

1) certain solutions & lytes, 2) antibiotics, 3) chemotherapeutic agents, 4) vasopressors

Front 24

Give 2 examples of solutions that cause tissue necrosis & state why they do?

Back 24

Dextrose 10% or greater & TPN solutions; these are both hypertonic so can cause cell damage

Front 25

Since chemo agents cause tissue necrosis, what would be the better route of administration?

Back 25

Central IV

Front 26

How do vasopressors cause tissue necrosis?

Back 26

they constrict blood vessels so w/ constricted blood vessels, it decreases the chance for the body to flush out the agents

Front 27

what are 2 ways that infection can cause discomfort & pain?

Back 27

location of infection & source of microbes

Front 28

Talk about location of infection in terms of parenteral administration & outcome?

Back 28

it can be localized or it can spread under the skin leading to cellulitis or it can be systemic leading to septicemia.

Front 29

what are some some sources of microbes that could lead to infection during a parenteral administration?

Back 29

1)the air, 2)the skin, 3the IV fluid itself can be contaminated

Front 30

What is a typical scenario of how the skin can cause infection associated w/ an IV catheter?

Back 30

during venipuncture, after venipuncture where organisms begin to recolonize the skin & may lead to infection around the catheter therefore catheter should be changed periodically. The last one is during infusion where the IV fluid itself is contaminated.

Front 31

What are the 2 types of pyrogens?

Back 31

endogenous & exogenous

Front 32

Give an example of an exogenous pyrogen?

Back 32

bacterial endotoxin

Front 33

Give an example of a bacterial endotoxin?

Back 33

LPS associated w/ gm- bacteria

Front 34

w/c part of the LPS is the critical portion that concerns us?

Back 34

Lipid A w/c is a water soluble cell wall fragment

Front 35

What is the effect of lipid A?

Back 35

shock at high [ ] & fever at minute [ ]

Front 36

what are the 2 biological effects of lipid A that we need to know?

Back 36

pyrogenicity & limulus lysate gelation

Front 37

what are the practical implications for pyrogens in parenterals?

Back 37

they can complicate the illness of the ver sick & they are a sign of poor quality control

Front 38

what is the source of pyrogens in parenterals?

Back 38

they are as ubiquitous as the gm- microbes that produce them

Front 39

what are the 2 points to consider when talking about costs of parenteral therapy?

Back 39

costs of administration & cost of manufacture or compounding

Front 40

what are the 3 fundamental requirements for the parenteral product?

Back 40

1) freedom from pathogens, 2) "freedom" from pyrogens, & 3) "freedom" from particulates

Front 41

w/c 2 site administration must be sterile?

Back 41

parenteral & ophthalmics & any devices used in conjunction

Front 42

What is usually the cause of infection in the parenteral route?

Back 42

usually related to microbial contamination of devices or injected fluids & usually results from poor aseptic technique or contamination during manufacturing storage & use

Front 43

infection in parenteral route usually results from what?

Back 43

poor aseptic technique or contamination during manufacturing, storage & use

Front 44

The parenteral product must leave the manufacturer _________ & must be handled w/ _________ __________ thereafter?

Back 44

sterile, aseptic technique

Front 45

this defines the complete destruction or removal of living organisms & their spores?

Back 45

sterilization

Front 46

What are the 4 methods of sterilization?

Back 46

1)thermal, 2) filtration, 3) radiation, 4) gas

Front 47

What are the 2 types of thermal heat?

Back 47

moist & dry heat

Front 48

this type of heat is conducted at a high pressure in an autoclave?

Back 48

moist thermal heat

Front 49

dry thermal heat is used for what reason?

Back 49

for substance not effectively sterilized by moist heat

Front 50

Retention of particles larger than the rated pore size?

Back 50

Filtration

Front 51

what numbers do we need to be concerned w/ for filteration?

Back 51

0.22mcg filters out all fungi & bacteria & 1-5 mcg is for removing particulates

Front 52

this is used for sterilization of heat sensitive solutions?

Back 52

filtration

Front 53

w/ this sterilization method, there is possible drug adsorption?

Back 53

filtration

Front 54

What are the 2 types of rays used in radiation sterilization?

Back 54

gamma rayes & UV light

Front 55

UV light rays is used mainly to sterilize what?

Back 55

the air & surfaces

Front 56

This type of sterilization can sterilize contents in sealed package w/o heat?

Back 56

radiation

Front 57

This type of sterilization has great penetration therefore it's used for surgical supplies & disposable syringes?

Back 57

gas

Front 58

When sterility tests are performed on parenteral products, what is the focus?

Back 58

bacteria

Front 59

what are the 2 USP sterility tests?

Back 59

1) direct transfer & 2) membrane filtration

Front 60

This type of sterility test puts a sample on sterile culture media?

Back 60

direct transfer

Front 61

In this sterility test, the filter is used to concentrate the microbes?

Back 61

membrane filtration

Front 62

Three characteristics of pyrogens? what does this say about their elimination

Back 62

small, stable, & inanimate therefore they are difficult to eliminate

Front 63

what are the 2 pyrogen tests?

Back 63

rabbit test & limulus amebocyte lysate or LAL test

Front 64

what is the original USP pyrogen test?

Back 64

rabbit test

Front 65

How does the rabbit test work?

Back 65

the product is administered to rabbits then single & collective rectal temp rises are monitored

Front 66

How does the LAL test work?

Back 66

the product is mixed w/ the test reagent then the mixture is monitored for gel formation

Front 67

"Freedom" from particulates means what?

Back 67

unwanted mobile insoluble matter

Front 68

what is the principle danger from particulates? what is the size of those particles?

Back 68

vascular occlusions; particle size of about 8mcg may be lodged

Front 69

Vascular occlusions can lead to what 2 things?

Back 69

blood vessel collapse & possibly a granuloma

Front 70

Two possible places that these particles may end up?

Back 70

either occlude the arteries of the lung or bypass the lung & enter the systemic circulation

Front 71

Besides vascular occlusions, what are other possible dangers of particulates in parenterals?

Back 71

interaction w/ RES cells leading to host response or they can also lead to tissue irritation

Front 72

what are some sources of particulates?

Back 72

product, container, closure, manufacturing processes, administration system

Front 73

T/F: it's virtually impossible to remove every vestige of unwanted particulate matter.

Back 73

True

Front 74

What are the 2 USP limits for particulates? what is the volume that constitutes these 2?

Back 74

Large volume parenterals LVP w/ 100mL or larger & small volume parenterals SVP w/ less than 100ml

Front 75

How small can a naked eye see?

Back 75

50 mcg

Front 76

What is used to remove particulates? name the 2?

Back 76

particulate filters & air eliminating or air venting filters

Front 77

what do particulate filters filter?

Back 77

1-5mcg & they are required during the preparation of IV meds using glass ampules

Front 78

W/c filter is used when glass ampules are used?

Back 78

particulate filters

Front 79

what size does air venting filters catch?

Back 79

0.2mcg