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79 Cards in this Set
- Front
- Back
What is the purpose of quality control and quality assurance testing? |
Both ensure medications contain: right drug right amount no contamination correct instructions will remain stable
Controlling quality through checks and balances. |
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What does WHMIS stand for? |
Workplace Hazardous Material Information System |
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What are the 3 components of WHMIS? |
1. Material Safety Data Sheets (MSDS) 2. Labelling 3. Training |
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What does a workplace label require? And when does one need to be used? |
The following needs to be included on the label: A. Product identifier information B. Precautionary measures C. Reference to the MSDS
It must be used when: I. Supplier label is lost or damaged II. When the product is transferred to a new container. Like transferring a small amount of drug from a bulk supply to a small vial. |
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What are the two types of WHMIS labels? |
1. Supplier labels 2. Workplace labels |
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Lists the types of water used in compounding from most sterile to least sterile, |
Sterile water for injection (INJ, EYE, EAR) Sterile water for irrigation (TOPICAL, ORAL) Distilled water (ORAL) |
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What information goes on a manufacturers label? |
indentity (generic/ brand, DIN, strength) usualy doage range directions for use stability/ storage requirements / expiry indications and contraindications reconstitution instructions |
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what temp should cold items be kept at? |
8.C (or 36-46. F) |
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what temp should fridge items be stored at? |
2-8.C or (36-46.F) |
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what temp should freezer items be stored at? |
minus 10-minus 25.C (14-10.F) |
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What temp should cool items be stored at? |
8-15.C (46-59.F) |
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what temp should warm items be stored at? |
30-40.C (86-104.F) |
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what temp should excessive heat items be stored at? |
above 40.C (104.F) |
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what temp should room temp items be stored at? |
15-30.C (59-86.F) |
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What is the thermostat room temperature? |
20-25.C |
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what goes on a label for compounded products? HINT: 7 points |
name of product strength dosage form LOT, Control, Batch Number Storage conditions Expiry date (Quantity) |
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what are the 5 types of drug stability? |
chemical stability physical stability microbiologic stability therapeutic stability toxicology stability |
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what type of drug becomes toxic when it decomposes? |
tetracyclines |
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what would be signs that a drug is beginning to chemically break down? |
change in colour change in texture odor precipitates |
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what are signs of physical breakdown in drugs? |
cracking and creaming of emulsions (separates into 2 phases like oil and water) chipped or crumbling tablets unpleasant or rancid smell |
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what is the definition of drug incompatibility? |
interaction between drugs component that may make the product undesirable, may lead to chemical reactions or destroy some form of the drug stability. this can be seen by formation of bubbles, precipitates, or odors. |
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what are preservatives used for in compounding? what are some examples of them? |
used to maintain chemical stability, prevent growth of bacteria, (commonly used in multidose containers)
Some examples are: methylparaben, propylparaben, sodium benzoate |
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true or false: repackaged drugs must have an updated beyond use date (BUD). the listed expiry on packaging no longer applies. |
True. |
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what is the process of hydrolysis in compounding practice? |
molecules interact with water and breakdown. Usually this reaction is initiated by an acid....
examples: pH buffers sometimes added coated tablets veg oil buffers glycerin |
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what is the process of oxidization in compounding practice? |
Loss of electrons/ hydrogen ions.
Results in change in colour, precipitates, odor. Commonly caused by light exposure, heat, moisture, oxygen exposure.
Antioxidants and chelating agents counteract this process. |
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what is an example of an antioxidant used in compounding? |
Ascorbic acid |
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what is an example of a chelating agent used in compounding? And what is a chelating agent? |
A chelating agent works with metals to prevent oxidization.
An example is citric acid. |
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what is the maximum amount of solute (like sucrose) that will dissolve in water? |
1g in 10 mL |
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what is special about an elixir? |
sweetener oral liquid high alcohol content not good at masking taste of drugs |
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what concentration is the simple syrup used in compounding? |
85% w/v |
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what flavour of meds do children like? |
fruity |
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what flavour of meds do adults like? |
minty |
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what flavour is good for masking the taste of bitter compounds? |
chocolate |
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what flavours are best for masking the taste of bitter compounds? |
citrus |
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what auxillary label goes on all suspensions and why? |
SHAKE WELL. drugs may settle or become unstable. |
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what is an emulsion? |
mixture of 2 unblendable substances.
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what are the 2 different types of emulsions?
(HINT: reversals of each other) |
w/o =water to oil
o/w = oil in water |
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what are the three rules of pediatric dosing? |
1. Clarks Rule
2. Young's Rule
3. Fried's Rule |
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what is the formula for clarks rule? |
{ weight of child (in lbs) x Adult dose } 150 lbs |
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what is the formula for Young's Rule? |
{ age of child (in years) x adult dose } -------------------------------------------------------- age of child + 12 years |
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what is the formula for Fried's Rule? |
{age of child (in months) x Adult dose } ------------------------------------------------------------ 150 months |
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what is another term for oral candidiasis? |
thrush |
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what is xerostomia more commonly known as? |
dry mouth |
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what are medicated lozenges commonly used for? |
anesthetics, antiseptics, antitussives, antibiotics, demulcent (soothing) |
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What is the full name for PEG? |
polyethylene glycol
(used as laxatives and as a base for lozenges) |
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what is the full name for PPG? |
polypropylene glycol |
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what is the full name for PG? |
polyglycol or Propylene glycol |
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what is the difference between compounding and manufacturing |
Compounding = preparing products not commercially available and not for resale
Manufacturing = bulk preparation of products that may be for sale commercially |
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what are 7 reasons for customer compounding medications for patients? |
1. Compliance 2. Exact strengths 3. Prevent allergies 4. Change the dosage form 5. Combine medications 6. Medication is unavailable 7. Cost effective |
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what does USP stand for? |
United States Pharmacopeia |
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what does BP stand for? |
Brittish Pharmacopeia |
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What section of USP deals with non sterile compounding? |
USP <795> |
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What section of USP deals with sterile compounding? |
USP <797> |
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what is the purpose of quality assurance and quality control testing? |
ensure the medication contains: the right drug right amount with no contamination
Controls quality though checks and balances. |
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what is the purpose of an alkalinizing agent?
Examples? |
provides an alkaline medium when required.
Ammonium carbonate, sodium hydroxide, sodium borate |
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what is the purpose of air displacement agents?
Examples? |
repleaces oxygen containing air with inert gas
nitrogen. |
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what is the purpose of anitfungal preservatives?
Examples? |
prevents fungal growth in liquid or semi-solid preparations.
sofium benzoate, methylparaben, propylparaben, benzoic acid, sodium propionate |
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what is the purpose of antibacterialpreservatives?
Examples? |
prevents bacterial growth.
benzalkonium chloride, benzyl alcohol, cetylpyridium chloride, chlorobutanol, phenol, thimerosal |
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what is the purpose of antioxidants?
examples? |
protects drugs and other ingredients from oxidization.
sodium bisulfate, butylated hydroxyanisole (BHA), monothioglycerol, propyl gallate, sodium sulfite, sodium metabisulfate |
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what is the purpose of buffering agents?
Examples? |
maintains required pH
di-sodium, di-potassium, lactic acid, boric acid, sodium acetate, sodium citrate. |
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what is the purpose of a chelating agent?
examples? |
removes metal ions from solutions by forming stable complexes with them.
di- tri- tetra- sodium salts of Edetic acid. |
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what is purpose of emulsifying agents?
examples? |
stabilizes emulsions of immiscible liquids.
sorbitan monoleate, polyoxyethylene 50, stearic acid, acacia, coconut oil, wax |
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what is the purpose of a humectant?
examples? |
prevents water loos from preparations because of affinity for moisture.
glycerin, sorbitol, propylene glycol |
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what is the purpose a levigating agent?
examples? |
liqiud used to break down particle size before incorporating into an ointment.
mineral oil, glycerin |
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what is the purpose of surfactants?
examples? |
stabilizes emulsions (lower surface tension)
sodium stearate, polysorbate 80, sodium lauryl sulfate |
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what is the purpose of suspending agents?
examples |
reduces sedimentation by increasing viscosity.
acacia, agar, bentonite, methylcellulose, tragacanth |
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what is the purpose of tonicity agents?
examples? |
makes solutions isotonic with body fluids (blood or tears)
sodium chloride, dextrose |
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what is the purpose of aerosol propellants
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causes expulsion of products by causing buildup of pressure.
"-fluromethanes" HFA-13A |
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what is the purpose of encapsulating agents?
examples? |
formed into gelatin capsules for encasing drug mixtures.
gelatin, cellulose acetate phthalate (CAP) |
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what is the purpose of solvents?
examples? |
liquid used to dissolve drugs and other substances to form solutions.
ethanol, water, peanut oil, isopropyl alcohol, PEG |
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what is the purpose of a stiffening agent?
examples? |
gives ointments body.
crtyl alcohol, parrafin wax |
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what is the purpose of disintegrants?
axamples? |
absorbs water and promotes rapid breakup of a tablet
constarch, sodium alginate, sodium starch glycolate |
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what is the purpose of anti-adherants?
examples? |
prevents sticking of tablet powder or finished tbalets to punches and dies
magnesium stearate |
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what is the purpose of binders
examples? |
causes powder particles to stick together during granulation procedure.
acacia, methylcellulose, gelatin, glucose solution |
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what is the purpose of diluents?
examples? |
provides bulk in formation of tablets
lactose, microstalline cellulose |
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what is the purpose of coating agents?
examples? |
enhances stability, masks odor and taste, changes drug release time and offers an attractive appearance.
sucrose, cellulose acetate phthalate (CAP), hydroxypropyl methyl cellulose |
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what is the purpose of glidants?
examples? |
improves the dispersion of powder
cornstarch, talc, collodial silica |
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what is the purpose of lubricants?
examples? |
reduces friction and adherance during compression stage.
stearic acid, magnesium stearate |
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what is the purpose of polishing agents?
examples |
makes tablets shiny (pharmaceutical elegance)
caranuba wax, beeswax |