Follow-Up Questions 2

Front 1

DILE

Back 1

drug-induced lupus erythematosus; in which the body’s immune system mistakenly attacks healthy tissue

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Hypertensive Urgency

Back 2

BP (≥ 180/110-120) without acute target organ damage; oral drug with quick onset (15-30 min); reduce BP gradually over 24-48 hrs

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Hypertensive Emergency

Back 3

BP (≥ 180/110-120) WITH acute target organ damage (e.g.; encephalopathy, MI, unstable angina, pulmonary edema, stroke, aortic dissection, renal impairment, etc.); reduce MAP or BP by no more than 10-25% (within the 1st hr), then if stable, to 160/100-110 mmHg within the next 2-6 hrs; use IV drugs (hydralazine, labetalol, sodium nitroprusside, nicardipine, etc.)

Front 4

MAP

Back 4

mean arterial pressure

Front 5

DSHEA

Back 5

Dietary Supplement Health and Education Act

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ADR

Back 6

Adverse drug reaction

Front 7

SDS

Back 7

safety data sheet

Front 8

API

Back 8

active pharmaceutical ingredient

Front 9

QC

Back 9

quality control

Front 10

BUD

Back 10

beyond-use date

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USP

Back 11

United States Pharmacopeia

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NF

Back 12

National Formulary

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FCC

Back 13

USP's Food Chemicals Codex; the materials compendium

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excipients

Back 14

= inactive ingredients

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vehicle

Back 15

= drug carrier (e.g. capsule shell, diluent)

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ruminant

Back 16

= "Wiederkäuer"

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levigation

Back 17

process of reducing the size of a particle

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wetting agent

Back 18

a small amount of liquid in which the solid is not soluble used for spatulating it on an ointment slab for levigation

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o/w

Back 19

oil in water dispersion - aqueous systems

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w/o

Back 20

water in oil dispersion - oleaginous systems

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levigating agents for o/w dispersions

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glycerin, propylene glycol, polyethylene glycol 80

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levigating agents for w/o dispersions

Back 22

mineral oil (light and heavy), castor oil, cottonseed oil, Tween 80

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trituration

Back 23

the process of reducing fracturable powder substances into fine particles by rubbing (or grinding) them with a mortar and pestle, or on an ointment slab

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eutectic mixture

Back 24

mixture of 2 or more components that melt at a temperature lower than the melting temperature for the individual components

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geometric dilution

Back 25

the process by which a homogenous mixture or even distribution of two or more substances is achieved. When using this method, the smallest quantity of active ingredient is mixed thoroughly with an equal volume of the diluent or base on the ointment slab. More diluent (base) is added in amounts equal to the volume of the mixture on the ointment slab. This process is repeated until all of the diluent (base) is incorporated in the mixture. This method, though time consuming, will create a homogenous mixture or smooth dispersion of the drug in the ointment/cream base

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"plasticizers"

Back 26

soften the capsule, e.g. glycerol, sorbitol

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punch method - capsules

Back 27

The powder is placed on a powder paper or ointment slab and smoothed with a spatula to a height approximately half the length of the capsule body. The base of the capsule is held vertically and the open end is repeatedly pushed or "punched" into the powder until the capsule is filled; the cap is then replaced to close the capsule. Each filled capsule is weighed using an empty capsule as a counterweight. Powder is added or removed until the correct weight has been placed in the capsule. The filled capsule is tapped so that no air spaces are visible within the contents.

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troche

Back 28

oral lozenge; deliver drug to the oral mucosa; dissolves in the mouth

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deflocculated

Back 29

the repulsive forces between particles predominate so that the particles in the suspension repel each other and remain as discrete, single particles

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vegetable hydrocolloid

Back 30

acacia, tragacanth, agar, pectin, carrageenan

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animal hydrocolloid

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gelatine. lanolin, cholesterol, lecithin

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semi-synthetic hydrocolloid

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methylcellulose, carboxymethylcellulose

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synthetic hydrocolloid

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(stongest) cabomers and polyvinyl alcohol clays, e.g. bentonite and veegum

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surfactant

Back 34

"wetting agent", which reduces the surface tension between the two liquids > the two different substances can move closer to each other

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HLB

Back 35

hyrophilic-lipophilic balance number; is used to choose which surfactant to select when preparing an emulsion to provide good "emulsification"; agents with low HLB number: more oil-soluble; agents with low HLB number: more water-soluble;HLB scale range: 0-20, 10 is the breakpoint between water and oil solubility

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Glyceryl monostearate ®

Back 36

Glyceryl monostearate; HLB 3.8

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PEG 400 Monooleate ®

Back 37

Polyoxyethylene monooleate; HLB 11.4

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Span 65 ®

Back 38

Sorbitan tristearate; HLB 2.1

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Tween 81 ®

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Polyoxyethylene sorbitan monooleate; HLB 10

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Tween 85 ®

Back 40

Polyoxyethylene sorbitan trioleate; HLB 11

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emollient

Back 41

a single agent that is used to soften and smooth the skin

Front 42

common gels used as thickeners

Back 42

the alginates: Na+, K+, Ca+ alginate, agar, carrageenan, gelatin, carbomer, tragacanth, bentonite

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Mesalamine

Back 43

Common brands: Pentasa, Lialda, Canasa; NSAID (anti-inflammatory); It can treat and prevent flare-ups of ulcerative colitis.

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BUD - non-sterile - nonaqueous formulations

Back 44

not later than the time remaining until the earliest expiration date of any API or 6 months, whichever is earlier

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BUD - non-sterile - water-containing oral formulations

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not later than 14 days when stored at controlled cold temperatures

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BUD - non-sterile - water-containing topical/dermal and mucosal liquid and semisolid formulations

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not later than 30 days

Front 47

NIOSH

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National Institute of Occupational Safety and Health

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CSPs

Back 48

compounded sterile preparations

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PEC

Back 49

primary engineering control; refers to the isolator device or the room that provides the ISO Class 5 area for compounding CSPs; PECs all rely on high-efficiency particulate air (HEPA) filter

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HEPA

Back 50

high-efficiency particulate air

Front 51

isotonic

Back 51

osmotic pressure matches the human blood by having the same number of particles in solution; [mOsm/L] > prevents fluid transfer across the (biological) semipermeable membranes

Front 52

osmolarity of human blood

Back 52

285 mOsm/L

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pH of blood

Back 53

pH of 7.35 - 7.45; slightly alkaline

Front 54

sterile low-risk level - ISO - BUD

Back 54

ISO class 5, ISO class 7 buffer area, ISO class 8 ante area; BUD RM TEMP 48 hours, BUD REFRIG 14 days, BUD FROZEN 45 days; e.g. small volume injections, IV fluids with max of 3 components, single dose vial reconstitution

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sterile low-risk level with < 12-hr BUD - ISO - BUD

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ISO class 5 segregated from other operations; BUD RM TEMP 12 hours, BUD REFRIG 12 days, BUD FROZEN N/A; e.g. small volume injections, IV fluids with max of 3 components, single dose vial reconstitution

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sterile medium-risk level - ISO - BUD

Back 56

ISO class 5, ISO class 7 buffer area, ISO class 8 ante area; BUD RM TEMP 30 hours, BUD REFRIG 9 days, BUD FROZEN 45 days; e.g. batched syringes, parenteral nutrition, ophthalmics made from sterile products

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sterile high-risk level - ISO - BUD

Back 57

ISO class 5 PEC, ISO class 7 buffer area, ISO class 7 ante area; BUD RM TEMP 24 hours, BUD REFRIG 3 days, BUD FROZEN 45 days; e.g. CSPs from bulk drug containers, preparations that require sterilization, products made with non-sterile components

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sterile imediate use - ISO - BUD

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"Clean, uncluttered, functionally separate area" per USP; BUD RM TEMP 1 hour, BUD REFRIG N/A, BUD FROZEN N/A; e.g. used in patient care & procedural units, medical offices, ambulances

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sterility testing - with:

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tryptic soy broth (TSB), or fluid thioglycollate medium (FTM) and should include: bacterial endotoxin (Pyrogen) testing prior to use

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sterilization methods:

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autoclave, filtration w. 0.22 micron filter (filter integrity first tested with bubble-point test), dry heat, gas sterilization w. ethylene oxide (toxic residues, flammable), ionizing radiation

Front 61

examples for heat-labile drugs

Back 61

hormones, other proteins

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IPA

Back 62

isopropyl alcohol

Front 63

cleaning - sterile comp - water

Back 63

dilute with sterile water, when cleaning surfaces with water use sterile water and followed by 70% IPA

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buffer area - cleaning schedule - sterile comp

Back 64

at the beginnning of each shift, before and after each batch, after spills, every 30 min of continuous use, anytime contamination is suspected

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counters, work surfaces - cleaning schedule - sterile comp

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daily

Front 66

walls, ceiling, stoarge shelves - cleaning schedule - sterile comp

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monthly

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class I recall

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reasonable probability that the use or exposure will cause serious adverse health consequences or death, e.g. morphine TAB with x10 the amount of API

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class II recall

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use or exposure can cause temporary or reversible adverse health consequences or where the probability of harm is remote, e.g. ketorolac inj. recalled due to the possibility of particles in the vials

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class III recall

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a situation in which use of or exposure is not likely to cause adverse health consequences, e.g. coloring on tablets may have been applied inconsistently

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CFUs

Back 70

colony forming units

Front 71

Intrathecal administration

Back 71

a route of administration for drugs via an injection into the spinal canal, or into the subarachnoid space so that it reaches the cerebrospinal fluid (CSF) and is useful in spinal anaesthesia, chemotherapy, or pain management applications. This route is also used to introduce drugs that fight certain infections, particularly post-neurosurgical. The drug needs to be given this way to avoid the blood brain barrier

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BET

Back 72

bacterial endotoxins test

Front 73

reagent for bacterial endotoxins test

Back 73

Limulus Amebocyte Lysate (LAL); based on clotting properties of the horsesgoe crabs's blood

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LAL

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Limulus Amebocyte Lysate

Front 75

temperature monitoring - sterile compounding

Back 75

daily (at a minimum)

Front 76

sterile compounding - Qualified certifier certifies area every:

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every 6 months (semi-annually)

Front 77

sterile compounding - air sampling by compounding personnel or certifier, every:

Back 77

at least every 6 months

Front 78

sterile compounding - gloved fingertip sampling

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Passing requirements: 3 samples (2 plates each) with zero CFUs; verifiy at initial training, low and medium risk (annually); high risk (semi-annually)

Front 79

sterile compounding - surface sampling

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periodically

Front 80

sterile compounding - HEPA filter pressure check

Back 80

each shift (preferably) or daily (minimally)