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79 Cards in this Set

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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.

What does WHMIS stand for?

Workplace Hazardous Material Information System

What are the 3 components of WHMIS?

1. Material Safety Data Sheets (MSDS)


2. Labelling


3. Training

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.

What are the two types of WHMIS labels?

1. Supplier labels


2. Workplace labels

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)

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

what temp should cold items be kept at?

8.C (or 36-46. F)

what temp should fridge items be stored at?

2-8.C or (36-46.F)

what temp should freezer items be stored at?

minus 10-minus 25.C (14-10.F)

What temp should cool items be stored at?

8-15.C (46-59.F)

what temp should warm items be stored at?

30-40.C (86-104.F)

what temp should excessive heat items be stored at?

above 40.C (104.F)

what temp should room temp items be stored at?

15-30.C (59-86.F)

What is the thermostat room temperature?

20-25.C

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)

what are the 5 types of drug stability?

chemical stability


physical stability


microbiologic stability


therapeutic stability


toxicology stability

what type of drug becomes toxic when it decomposes?

tetracyclines

what would be signs that a drug is beginning to chemically break down?

change in colour


change in texture


odor


precipitates

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

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.

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

true or false:


repackaged drugs must have an updated beyond use date (BUD). the listed expiry on packaging no longer applies.

True.

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

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.

what is an example of an antioxidant used in compounding?

Ascorbic acid

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.

what is the maximum amount of solute (like sucrose) that will dissolve in water?

1g in 10 mL

what is special about an elixir?

sweetener oral liquid


high alcohol content


not good at masking taste of drugs

what concentration is the simple syrup used in compounding?

85% w/v

what flavour of meds do children like?

fruity

what flavour of meds do adults like?

minty

what flavour is good for masking the taste of bitter compounds?

chocolate

what flavours are best for masking the taste of bitter compounds?

citrus

what auxillary label goes on all suspensions and why?

SHAKE WELL.


drugs may settle or become unstable.

what is an emulsion?

mixture of 2 unblendable substances.


what are the 2 different types of emulsions?



(HINT: reversals of each other)

w/o =water to oil



o/w = oil in water

what are the three rules of pediatric dosing?

1. Clarks Rule



2. Young's Rule



3. Fried's Rule

what is the formula for clarks rule?

{ weight of child (in lbs) x Adult dose }
------------------------------------------------------


150 lbs

what is the formula for Young's Rule?

{ age of child (in years) x adult dose }


--------------------------------------------------------


age of child + 12 years

what is the formula for Fried's Rule?

{age of child (in months) x Adult dose }


------------------------------------------------------------


150 months

what is another term for oral candidiasis?

thrush

what is xerostomia more commonly known as?

dry mouth

what are medicated lozenges commonly used for?

anesthetics, antiseptics, antitussives, antibiotics, demulcent (soothing)

What is the full name for PEG?

polyethylene glycol



(used as laxatives and as a base for lozenges)

what is the full name for PPG?

polypropylene glycol

what is the full name for PG?

polyglycol


or


Propylene glycol

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

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

what does USP stand for?

United States Pharmacopeia

what does BP stand for?

Brittish Pharmacopeia

What section of USP deals with non sterile compounding?

USP <795>

What section of USP deals with sterile compounding?

USP <797>

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.

what is the purpose of an alkalinizing agent?

Examples?
provides an alkaline medium when required.

Ammonium carbonate, sodium hydroxide, sodium borate
what is the purpose of air displacement agents?

Examples?
repleaces oxygen containing air with inert gas

nitrogen.
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
what is the purpose of antibacterialpreservatives?

Examples?
prevents bacterial growth.

benzalkonium chloride, benzyl alcohol, cetylpyridium chloride, chlorobutanol, phenol, thimerosal
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
what is the purpose of buffering agents?

Examples?
maintains required pH

di-sodium, di-potassium, lactic acid, boric acid, sodium acetate, sodium citrate.
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.
what is purpose of emulsifying agents?

examples?
stabilizes emulsions of immiscible liquids.

sorbitan monoleate, polyoxyethylene 50, stearic acid, acacia, coconut oil, wax
what is the purpose of a humectant?

examples?
prevents water loos from preparations because of affinity for moisture.

glycerin, sorbitol, propylene glycol
what is the purpose a levigating agent?

examples?
liqiud used to break down particle size before incorporating into an ointment.

mineral oil, glycerin
what is the purpose of surfactants?

examples?
stabilizes emulsions (lower surface tension)

sodium stearate, polysorbate 80, sodium lauryl sulfate
what is the purpose of suspending agents?

examples
reduces sedimentation by increasing viscosity.

acacia, agar, bentonite, methylcellulose, tragacanth
what is the purpose of tonicity agents?

examples?
makes solutions isotonic with body fluids (blood or tears)

sodium chloride, dextrose
what is the purpose of aerosol propellants
causes expulsion of products by causing buildup of pressure.

"-fluromethanes" HFA-13A
what is the purpose of encapsulating agents?

examples?
formed into gelatin capsules for encasing drug mixtures.

gelatin, cellulose acetate phthalate (CAP)
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
what is the purpose of a stiffening agent?

examples?
gives ointments body.

crtyl alcohol, parrafin wax
what is the purpose of disintegrants?

axamples?
absorbs water and promotes rapid breakup of a tablet

constarch, sodium alginate, sodium starch glycolate
what is the purpose of anti-adherants?

examples?
prevents sticking of tablet powder or finished tbalets to punches and dies

magnesium stearate
what is the purpose of binders

examples?
causes powder particles to stick together during granulation procedure.

acacia, methylcellulose, gelatin, glucose solution
what is the purpose of diluents?

examples?
provides bulk in formation of tablets

lactose, microstalline cellulose
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
what is the purpose of glidants?

examples?
improves the dispersion of powder

cornstarch, talc, collodial silica
what is the purpose of lubricants?

examples?
reduces friction and adherance during compression stage.

stearic acid, magnesium stearate
what is the purpose of polishing agents?

examples
makes tablets shiny (pharmaceutical elegance)

caranuba wax, beeswax