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Final Exam Review Flashcards

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1
Q

What is compounding?

A

The process of creating customized medications by mixing, altering, or combining ingredients to meet the specific needs of a patient (based on a prescription or med order)

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2
Q

What is manufacturing?

A

Production and/or processing of a drug generally in bulk quantities without a prescription or medication order

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3
Q

What are the reasons for compounding?

A

strength, concentration, or dosage form not commercially available, drug has been discontinued by manufacturer, or a patient may have an allergy/ intolerance to excipients in manufactured product

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4
Q

What are requirements for labelling a compound?

A

Amounts of all APIs on label, APIs in order with highest strength 1st, same requirements as commercially available plus need BUD, auxiliary labels, info about excipients or vehicle when appropriate

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5
Q

What are the three compounding categories of the USP 795?

A

Simple, Moderate, and Complex

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6
Q

What is a simple USP 795 category?

A

Monograph contains specific quantities of all components, compounding procedure and equipment and stability data with appropriate BUDs eg. amlodipine oral solution

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7
Q

What is moderate USP 795 category?

A

Preparation requires special calculations or procedures to determine quantities or components or preparation does not have stability data eg. morphine sulfate suppositories

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8
Q

What is complex USP 795 category?

A

Special training, environment, facilities, equipment, and procedures are required to ensure appropriate therapeutic outcomes eg. transdermal dosage form

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9
Q

What are the NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations requirements?

A

Represents the MINIMUM requirements to compound. Outlines: 1. compounding personnel, 2. training and skills 3. policies and procedures, 4. facilities and equipment 5. product and preparation requirements 6. quality assurance program and documentation

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10
Q

What are the NAPRA risk assessment levels?

A

Level A, Level B, and Level C.

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11
Q

What is Level A of NAPRA risk assessment?

A

Simple and moderate compounds as defined in USP 795

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12
Q

What is Level B of NAPRA risk assessment levels?

A

Complex compounds as defined by USP 795, small quantities of ingredients or preparations that require ventilation and are compounded occasionally

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13
Q

What is Level C of NAPRA risk assessment levels?

A

Hazardous drugs classified by NIOSH as groups 1, 2, and 3, hazardous materials classifies by WHMIS as representing a health hazard

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14
Q

What are the NIOSH groups?

A

Group 1- antineoplastic drugs. Many also pose a reproductive risk for susceptible populations.
Group 2- Non-antineoplastic drugs that meet one or more of NIOSH criteria for a hazardous drug. Some may also pose reproductive risk.
Group 3- Drugs that primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breastfeeding (because some drugs may be present in breast milk)

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15
Q

What is an active ingredient?

A

The ingredient in the compound that is intended to treat, cure, diagnose, or prevent the condition being treated

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16
Q

What is beyond use date?

A

The date after which a compounded preparation should not be used; determined from date the preparation is compounded and does not exceed the expiry date of any one single ingredient

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17
Q

What are excipients?

A

The ingredients in the compound that has a non-medicinal purpose added to the compound to give form, consistency, flavouring, mask drug taste or to enhance stability

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18
Q

What is extemporaneous compounding?

A

preparation of a specific dosage form in response to a prescriber’s order. It involves mixing, assembling, packaging, and labelling a product that is NOT commercially available

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19
Q

What is geometric dilution?

A

The process of creating a homogenous mixture of even distribution of two or more substances. The smallest quantity of active ingredient is mixed thoroughly with a similar quantity of diluent or base. More diluent (base) is added in amounts proportionate to the volume of the mixture and repeated until all ingredients are incorporated in

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20
Q

What is a levigating agent?

A

a viscous liquid acting as a lubricating agent that wets the powder and aids the incorporation of a solid into a vehicle and creates a smoother preparation

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21
Q

What is levigation?

A

to rub, grind, or reduce a solid to a fine powder by mixing with a semisolid or liquid. This can be done in a mortar or ointment slab with spatula. when adding liquid, start with a levigating agent to wet the powder

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22
Q

What is a preservative?

A

A substance added to inhibit microbial growth or to prevent decomposition or undesirable chemical changes

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23
Q

What is spatulation?

A

The mixing of powders and semi-solids (ointments, creams, etc.) on an ointment pad or slab using a spatula. With this method there is no particle size reduction so the powders to be mixed must be fine and of uniform size

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24
Q

What is Trituration?

A

a method using a mortar and pestle to reduce particle size (comminution). Trituration is done by firmly holding the pestle and exerting a downward pressure with it while moving it in circles starting at the centre of the mortar, moving outward to the side of the mortar and back to the centre. AKA the process of grinding or crushing a substance into a fine powder

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25
What is drug stability?
The capability of a particular formulation in a specific container and under stated storage conditions to remain within acceptable physical, chemical, therapeutic and toxicological limits for a defined span of time
26
What factors affect drug stability?
the pH of a solution, the solvents used, the surface area or particle size of a drug, the concentration of reactants, environmental gases present, temperature, light, and the inherent reactivity of the compounds
27
What are the 2 common reactions leading to degradation of drugs?
1. Hydrolysis- molecules react with water molecules to break down products- so we use silica gel, humectants, dry formulas, or reconstitution when ready to dispense 2. Oxidation- reaction involves a loss of electrons by an atom or molecule in inorganic compounds (usually loss of hydrogen), accompanied by change in colour, the formation of precipitate, or a change in smell. - use opaque plastic or glass containers, antioxidants, chelating agents, nitrogen in ampoules
28
What is quality assurance? (QA)
MORE PROACTIVE INVOLVES STANDARD OPERATING PROCEDURES (SOPs)- documents procedures for every step of the compounding process and TRAINING AND COMPETENCY- ensuring staff are properly trained and competent and ENVIRONMENTAL MONITORING- regular checks of compound environment to prevent contamination and DOCUMENTATION- keeping records of all compounding activity
29
What is quality control (QC)?
MORE REACTIVE Focuses on testing and verification to ensure that the final compounded product meets quality standards. If something is wrong, need to reassess QA program
30
What are the three compounding references we talked about in class?
USP 795, NAPRA, and OCP
31
When should we use compounding references?
When receiving an RX (how will patient use, usual dosage), determining whether to compound (can it be compounded?, is there API available? If only in manufactured product, can it be manipulated and still be active?, what is more cost effective and better?), for product preparation (use of excipients, physical and chemical properties, patient considerations like allergies, labelling and storage and BUD), ancillary services like equipment maintenance
32
What are some specialty compounding organizations?
ACPC- Association of Compounding Pharmacists of Canada- advocating PCCA- Professional Compounding Centres of America- provides ongoing training, formulations, and research info to members IACP- International Academy of Compounding Pharmacists- represents members International Journal of Pharmaceutical Compounding- just FYI things
33
What type of documentation records should be kept according to USP 795?
Personnel training, competency assessments, and corrective actions for any failures * Equipment records (e.g., calibration, verification, and maintenance reports) * COA- certificates of analysis* Receipt of components * SOPs, Master Formulation Records, and Compounding Records * Release inspection and testing records * Information related to complaints and adverse events including corrective actions taken * Results of investigation and corrective actions
34
What are types of semi-solids?
Creams, ointments, lotions, gels, emulsions
35
Whats the expiry for water-containing topical/dermal products?
30 days or earliest expiry date of any API, whichever is less
36
What is expiry for non-water containing products?
6 months of earliest expiry date of any API, whichever is less
37
What is immiscible in water, not water washable, does not absorb water, and is occlusive and greasy?
Ointment
38
Describe features of ointment
immiscible in water, not water washable, does not absorb water, and is occlusive and greasy, helps "keep" ingredient in local area
39
What is opaque, thick liquid or soft solid, water removeable and disappears when rubbed into skin?
Creams
40
Describe features of creams
opaque, thick liquid or soft solid, water removeable and disappears when rubbed into skin
41
What are possible ways of incorporating a solid in a base?
1. Spatulation with geometric dilution 2. Levigation- to reduce particle size and disperse 3. Mortar and pestle 4. Ointment Mill 5. Use of heat (could change consistency of final product so needs to be described in formulation record if doing this)
42
What levigating agent is good for anhydrous bases (ointments)?
Agents like mineral oilW
43
What two levigating agent examples are good for aqueous bases like creams and lotions?
Propylene Glycol- for lotions because thinnger Glycerin good for creams
44
What are the two types of aqueous solutions?
Syrups and aromatic waters (for flavouring to mask taste)
45
What are some hydro-alcoholic solutions?
Elixirs, spirits, tinctures, extracts
46
What solutions have high alcohol content? Can they be used internally or externally or both?
Elixirs and spirits. Elixirs- only internal. Spirits- external and internal
47
What are the non-aqueous topical solutions?
Liniments and collodions eg. liniments are tiger balm and vaporub Collodion example is compound W
48
What is the USP solubility criteria for a solute to be freely soluble?
Less than 1 part of solvent required per part of solute. Eg. less than 1 gram in 100 grams is freely soluble
49
What is the USP solubility criteria for a solute to be practically insoluble?
10,000 or over
50
What is a saturated solution?
When solvent has dissolved the maximum amount of solute it can while still remaining in solution
51
What is a supersaturated solution?
Contains more dissolved solute than saturated, can be made by dissolving solute at elevated temperature and slowly cooling eg. rock candy
52
What is an unsaturated solution?
Less than saturated concentration
53
Ways to enhance solubility
Smaller particle size, heating, dispersing drugs in carriers like eutectic mixtures, using co-solvents
54
What is miscibility?
Defines how substances mix to form a homogenous solution. Miscible=mixable eg. water in alcohol Immiscible= substances do not mix eg. oil in water
55
What are suspending agents?
Substances used to keep solid particles equally dispersed in liquid medium and prevents settling to bottom and helps ensure patient is getting correct dose
56
Examples of suspending agents?
Methylcellulose, Acacia, Bentonite, Xanthan Gum
57
What is a suspending vehicle?
A liquid medium that contains a suspending agent
58
Examples of suspending vehicles?
Simple syrup, Ora-Plus, Ora-Sweet, Ora-Blend, Glycerin
59
Describe features of lotions
Thinner than creams, often used for larger areas of skin, lotions are pourable
60
Describe features of pastes
High % of insoluble solids (usually 50% or more), thick and stiff, should not be gritty, usually used for protective properties, can be prepared by trituration or fusion (heat), do NOT use levigating agent because don't want to dilute base
61
What has high % of insoluble solids (usually 50% or more), thick and stiff, should not be gritty, usually used for protective properties, can be prepared by trituration or fusion (heat), do NOT use levigating agent because don't want to dilute base
Paste
62
Describe properties of Gels
Semi-solid systems of either inorganic particles or large organic molecules in a liquid, used for topical applications because have cooling effect, usually greaseless, no residue on skin, good permeability eg. PLO-gel, Diffusimax
63
Describe properties of Emulsions
a system containing droplets of one liquid dispersed through body of a second liquid, when the two are immiscible. The liquid in droplets is the dispersed of internal phase and the liquid containing the droplets is the dispersing medium or external phase.
64
What are the 2 types of emulsions?
Oil in water (o/w) and water in oil (w/o)
65
What is creaming?
Where concentration of internal phase separates from emulsion. eg. in W/O, droplets sink or in o/w droplets rise. This can be reversed by shaking bottle to create uniform emulsion again
66
What is cracking/breaking?
Separation into 2 layers which cannot be returned to stable form by shaking. Freezing and thawing or extreme heat can cause this or microbial action or oxidation
67
What is a eutectic mixture?
mixture of substances having a melting point lower than that of any of its components, occurs because the components inhibit each others crystallization resulting in a homogenous mixture that melts and solidifies at a single sharp temp known as eutectic point. eg. mixtures of camphor, menthol, phenol
68
What is eutectic point?
The single sharp temperature point where a eutectic mixture melts when mixed because together they have a lower melting point than either substance on its own
69
What is the expiry for water containing topical/dermals?
30 days
70
Why is the expiry for water containing oral formulations?
14 days
71
What 4 things are compounding references used for?
Interpreting RX’s Labelling Development of formulation records Development of compounding records
72
What is the purpose of a risk assessment and who does it aim to protect?
To evaluate the safety of compounding activities. Aims to protect the preparation and the compounder
73
What do emulsions require the addition of to keep them stable?
An emulsifying agent
74
In the assessment of non sterile compounding skills and training, policies and procedures must be reviewed how often?
Every 3 years or more frequently is there is a change in practice/standards

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