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OTC > misc 2-lame stuff > Flashcards

misc 2-lame stuff Flashcards

1
Q

what do all emulsions need

A

an antimicrobial agent because aqueous phase is favorable to growth

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2
Q

another name for pseudoplastic system, and what it refers to

A

shear thinning system- viscosity (part of non newtonian flow),-

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3
Q

2 types of flow and how they are different

A

newtonian=pure liquids and dilute solutions that viscocity is a single value and plot of their shear stress vs rate of shear is linear. Non means viscosity is not constant, and depends on shearing stress or force applied )ex/ suspension, emulsion, dispersions, ointments, creams)-further classified into 3 groups

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4
Q

what does “plastic system” refer to

A

substance that exhibits newtonian flow patterns after certain shearing stress, called yield value (becomes linear)

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5
Q

what does thixtropy refer to

A

principle that when shear or force is applied (ex/ shaking) a substance loses its consistency and it takes a finite time to recover. Ideal for dispersions

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6
Q

what are suractants

A

aka surface active agents- molecules or ions that adsorb at interfaces. Has a hydrophilic and hydrophobic part- reduce interfacial energy and lower surface tension. Can act as wetting agents, detergents, foaming agents, dispersing agents, solubilizers, emulsifying agents

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7
Q

process of particle size reduction

A

comminution

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8
Q

trituration

A

method of comminution where rubbing solid in mortar with pestle reduces size of particles. Can also e mixing two or more substances with mortar to intimately mix them

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9
Q

what is pulverization by intervention

A

uses recrystallization to obtain fine particles. First dissolve drug in suitable solvent (minimum amount of volatile solvent like alcohol), then incorporated into liquid or semisolid prep. IE particle reduction with the aid of a chemical that can later be removed (volatile substance)

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10
Q

what is levigation

A

reduce particle size by triturating in a mortor or spatulating on an ointment slab with a small amount of liquid or semi solid in which it is not soluble. Optimal liquid is viscous with low surface tension to improve ease of wetting solid.

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11
Q

common levigating agents

A

mineral oil and glycerin

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12
Q

geometric dilution

A

combining two or more powders of enequal quantities

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13
Q

how numbers relate to capsule size

A

biggest number (5) means smallest pill. 000 is largest (00 is largest capsule size for human use)

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14
Q

how should powder be packed in capsules

A

loosely or slightly packed- too packed makes it less easy to disperse

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15
Q

what is the max BUD for products containing water if stability is unknown

A

14 days

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16
Q

emulsion

A

2 phase system in which one liquid is dispersed in another in the form of small droplets

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17
Q

lotion

A

an emulsion liquid dosage form

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18
Q

what is the most common emulsion type

A

oil in water

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19
Q

ante area

A

area adjacent to clean room- may ahve lesser air cleanliness. Must be calss 8 or higher. Handwashing, gowning, etc is done here. Cardboard boxes and packing material should not be brought in

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20
Q

what level must a clean room be

A

6 or 7

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21
Q

what level must the critical area be

A

class 5 environment

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22
Q

another name for vertical flow hoods

A

biologic safety cabinets- can be used for any aseptic processing but are required for cytotoxic or hazardous drugs

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23
Q

volume limit for SQ injection

A

2.5ml

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24
Q

IM volume limits for adults and kids

A

adult- 2mL in deltoid, 5 mL in butt. Kids up to 3 years- 1mL in gluteus maximus (recommended spot) and only 0.5 if under 15yo in deltoid.

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25
Q

IV limit per day in adults

A

3L per day

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26
Q

age 6-15 yo- never inject more than this into msucle tissues

A

2mL (may be less depending on age and muscle)

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27
Q

calculating expiration date/shelf life

A

use 0.9 x C (90% of original concentration) and C1= original concentration, along with rate constant

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28
Q

BUD of non aqueous liquids and solids

A

25% remaining from expiry date OR 6 months (lesser)

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29
Q

formulations other than non aquous liquids and solids and liquids BUD

A

30 days or intended duration of therapy

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30
Q

pore size of filter to remove microorganisms (free of)

A

0.22

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31
Q

the larger the mesh# of a seive, the ___ (size) particles it makes

A

smaller- mesh # is a count of the # of openings across the seive per inch

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32
Q

what do deflocculating agents help with

A

preventing particle aggregation

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33
Q

kind of zeta potential (charge) when a system is flocculated (loose aggregates) and predominated by attractive forces

A

low

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34
Q

kind of zeta potential when a system is predominated by repulsive forces (deflocculated)

A

high

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35
Q

what is coacervation, and what is it AKA, and what is it used commonly for

A

adding electrolytes of non solvents to replace the drug in a dispersion medium and cause precipitation- aka salting out, used a lot in micoencapsulation (coating for slow release of drug)

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36
Q

what size are colloidal particles

A

1-500nm

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37
Q

what is an emulsion

A

dispersed system with at least 2 immiscible liquids (internal and external phase)

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38
Q

for IV admin, what type of emulsion MUST it be? what about IM?

A

O/w or serious embolization may occur. For IM it is usually w/o so that it can be sustained release

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39
Q

what kinds of surfactants are least irritating and have less incompatibilities

A

non ionic

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40
Q

what must preservatives be compatible with in emulsions

A

the external phase (ie if o/w, must be compatible with water phase)

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41
Q

what is a humectant and what is it good for

A

capable of absorbing water from air- reduce evaporation and prevent drying of a preparation

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42
Q

what is HLB a measure of

A

surfactants’ relative polarity (hydrophile-lipophile balance). Ranges from 1-50, most fall between 1-20. 10-20 means hydrophilic, 0-10 means lipophilic

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43
Q

when dispersed droplets move upward in an emusion it is called ___. downward?

A

up=creaming (o/w), down=sedimentation (w/o)

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44
Q

what it mottling

A

uneven colour distribution on a tablet

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45
Q

friability

A

ability of compressed tablet to withstand abrasion or crumbling

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46
Q

three major properties material must possess to compress into a tablet

A

fluidity, compressibility and minimal segregation. Usually granulation is required for this to occur

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47
Q

what are the 3 major methods of processing to produce compressed tablets

A

wet granulation, dry gran, direct compression

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48
Q

what is preferentially absorbed through passive diffusion across membranes- ionized or non?

A

non ionized. Weakly acidic drug is more unionized in low pH, vs basic in is more unionized in high pH

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49
Q

what is the kp value

A

partition coefficient- ability of drug to penetrate membranes. Kp=Coil/Cwater. If too low, drug wil stay in aq cavity, but if too high it may get stuck in lipid membrane when it gets in

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50
Q

what does extensive PPB do to a drug

A

prolongs T1/2

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51
Q

what is the rate limiting step in drug delivery for MR system

A

release from the dosage form, NOT the absorption

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52
Q

a drug is considered safe if its therapeutic index (LD 50/ED 50) is greater than or equal to

A

10

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53
Q

main advantage of capsules

A

number of drugs can be combined into one unit

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54
Q

what do wetting agents act as

A

a sufactant- decrease surface or interfacial tension

55
Q

if an existing chemical drug is modified for changes in previously approved formulation (safety and or efficacy, dosing ie once daily to once weekly, less SE) is it a new drug?

A

yes

56
Q

how long is the drug discovery process

A

10-15 years. 1-2 out of 10000 drugs in pre clinical testing make it to human testing

57
Q

what is the cost to introduce a new drug to market

A

typically over 1 billion (1.3-1.6(

58
Q

when does a patient expire after on a new drug

A

20 years- ie companies will have about 7-10 years to recoop costs

59
Q

who is studied in: phase 1, 2 and 3 in clinical trials

A

1=healthy individuals, 2=people with the disease and look at dosing, 3= test on a wide patient pop

60
Q

if there is a new drug designed to treat a life threatening illness, what can be done for approval?

A

FDA has a fast track/priority program

61
Q

patent protection strategies

A

superior formulations, new route of admin, new use for drug, chiral switches,

62
Q

what is the key to ensuring bioequivalence

A

dissolution testing. Remember, extent of absorption is important, but not rate. Rate has no effect on efficacy, so can be considered bioequiv even if rate of absorption differs

63
Q

explain the precontemplation stage in models of change and some strategies

A

no intention of action in next 6 months. Increase awareness, don’t pressure the,

64
Q

explain the contemplation stage in models of change and some strategies

A

intends to take action in next 6 months. Motivate, encourage, help make decisions

65
Q

explain the preparation stage in models of change and some strategies

A

intends to take action in next 30 days. Assist in developing and implementing concrete plans and setting goals

66
Q

explain the action stage in models of change and some strategies

A

changed behaviour for less than 6 months. Provide feedback, support, monitoring and follow up

67
Q

explain the maintenance stage in models of change and some strategies

A

changed behaviour for more than 6 months. Assist with coping, reminders. It has now become a good habit for them

68
Q

what is the threshold for non adherence

A

80%

69
Q

mean vs count adherence

A

mean= average of all values. Count means assessing the number who were 80% or more adherenent, and taking the averages of the yes and no answers

70
Q

what is primary non adherence

A

prescription is never filled

71
Q

what is non persistence non adherence

A

d/c after at least one fill

72
Q

what is poor execution non adherence

A

doesn’t comply with dosing instructions (doesn’t take enough)

73
Q

when is the rate of non adherence highest

A

first year

74
Q

what is PAS

A

our advocacy group. Voluntary organization

75
Q

what is SCPP

A

our provinical regulatory authority. the group that holds us accountable- self regulatory body with primary purpose being to protect the public. Statutory organizations. Part of NAPRA- our larger regulatory body

76
Q

what does NAPRA do

A

sets standards for all provincial and territorial pharmacy regulators

77
Q

4 domains in the model standards of practice set out by NAPRA

A

expertise in meds and medication use, collaboration, safety and quality, professionalism and ethics

78
Q

5 principles of medicare as defined by the canada health act

A

public administration, universality, portability (anywhere in canada), accessibility (reasonable access without barriers) and comprehensiveness (insure all medically necessary services from hospitals and Drs) (this is medicare in Canada as we know it)

79
Q

what is a verbal prescription narcotic

A

single narc with at least two additional medical ingredients

80
Q

direct to consumer advertising laws in canada

A

cannot mention a disease and site a specific brand name in an advertisement directed to the general public. Can be EITHER product specific (brief mention of brand name occurs), or informational (increase public awareness about disease and availability of treatment- ie ED)

81
Q

amount of requried malpractice insurance

A

at least 2 million

82
Q

how many managers must be practicing pharmacists

A

over 50%

83
Q

when can you release information to a police officer

A

only if there is a warrant or imminent harm will come to patient or public

84
Q

what is the only straight narcotic you don’t have to sales record

A

propxyphene

85
Q

hierarchy of study designs

A

systematic review/meta analysis, RCT, cohort, case control, cross over, case report, authority/opinion

86
Q

what is internal validity and what are the 3 major threats to it

A

are the results due to our intervention or something else? chance, confounding and bias

87
Q

what is external validity

A

are the results generalizable (related to inclusion and exclusion criteria)

88
Q

hard endpoints vs surrogate

A

hard=death, stroke, MI. Surrogate=BP (which can lead to an event)

89
Q

what minimizes confounding

A

randomization

90
Q

what minimizes chance

A

increasing sample size

91
Q

block vs complete vs stratified randomization

A

complete has no limitations and may have unequal numbers between groups, block forces balanced number of subjects in each. Stratified uses similar characteristics to group and then randomize (ie all over 65 are randomized, then under 65, etc)

92
Q

what does per protocol mean and what is the issue with it

A

only looks at subjects who completed study or followed protocol exactly- ITT looks at everyone and preserves value of randomization. Once randomized, should be analyzed

93
Q

what does per protocol mean and what is the issue with it

A

only looks at subjects who completed study or followed protocol exactly- ITT looks at everyone and preserves value of randomization. Once randomized, should be analyzed

94
Q

p value

A

less than 0.05 means there is a statistically significant different between groups(rejects null hypothesis)

95
Q

what is attrition bias

A

part of selection bias- happens when people are lost to follow up

96
Q

CI can show if there really is a ____. If it crosses the no difference threshold, then there is not difference. For means/proportions no difference is ___ vs relative risk or odds ration ____

A

statistical sig. 0, 1. ie if it crosses this line, it is not stat sig

97
Q

what is “r” and what does it indicate

A

correlation coefficient- always bewteen -1 and 1. If 0= no correlation, if less than zero ie negative as one variable increases the other decreases, if positive they either increase or decrease together. If greater than 0.7 strong, 0.4-0.69 moderate, less than 0.4 weak

98
Q

correlation implies causation- T/F

A

F

99
Q

2 examples of observational studies

A

WHI and FHS

100
Q

types of observational studies

A

case report, cross sectional, case control, cohort

101
Q

case reports

A

narrative usually, suggest areas for further research or alarm, can help see trends but can’t confirm or prove anything. Series is a collection of these that can be used to form a hypothesis

102
Q

do cross sectional studies (snapshot in time) look at proportion or incidence

A

only proportion/prevalence. Not incidence. Survey, chart review, etc how do these. Can look for associations

103
Q

what is a case control study

A

observational retrospective study that looks at people with and without an outcome and compares, good for rare diseases and can establish association for further research, but really susceptible to confounding/bias

104
Q

cohort study- what is it

A

groups (cohorts) compared according to exposure and followed over time to see if outcome occurs. Similar to RCT but don’t randomize subjects into group or assign exposure. Best type to find a valid association out of observational study types (highest level of evidence). Can be prospective or retrospective. Bias big concern with selecting groups differently

105
Q

QALY equation

A

utility x survival time expected

106
Q

SAP

A

Health Canada program, can request access to drugs unavailable in Canada, operates 24hrs/day 365, for patients with serious or life threatening conditions only for compassionate or emergency basis where conventional therapies don’t work or are unavailable. Will consider if drug shortage, negative review from health canada, medically necessary with no other reasonable alternatives

107
Q

SAP- role of Dr

A

initiate request, provide supporting literature, provide progress reports to SAP upon request, ensure patient well informed or risk/benefit

108
Q

who has the final word on whether or not a drug will be supplied with SAP

A

manufacturer.They can also impose restrictions. If give, must provide drug info

109
Q

where can SAP meds be shipped to

A

only Dr office or hospital pharmacy

110
Q

documentation at end of SAP

A

LOA (letter of authorization) must be kept for 25 years

111
Q

look at ethical principles or moral rules first?

A

moral rules. then ethical principles, then ethical theories (consequential vs non)

112
Q

pipeda and hipa- federal or provincial?

A

pip is fed, hipa is provincial

113
Q

3 consent options under hipa

A

expressed, implied, deemed aka no consent

114
Q

what are the 4 ps in marketing

A

product, price, place, promotion

115
Q

what is porters analysis

A

assess risk and opportunity on market (helps develop strategic advantage over competitors); 5 forces are threat of new entrants or substitutes, bargaining power of suppliers or buyers, and rivalry among existing firms

116
Q

what is SWOT

A

strengths weaknesses opportunities threats

117
Q

what is another name for contingent work

A

floater- no contract for long term employment and hours of work can vary in a non systemic way

118
Q

what is a primary stakeholder

A

participates in economic transactions with the organization

119
Q

secondary stakeholder

A

does not engage in direct economic exchange with organization but is affected by or can affect its actions (ex advocacy group. gov, communities, etc)

120
Q

4 main components of a business plan

A

operations, human resources, marketing, financial

121
Q

what is the number one indicator of career success

A

work life balance

122
Q

centralization vs decentralization

A

cent means formal decision making authority is held by a few people at the top, vs decent is it is dispersed through the organization

123
Q

a balance sheet lists

A

assets (what the business owns or controls), equity (what is leftover for the owners-ie what you have invested) and liabilities (what it owes to outsiders -ie debt). Assets= liabilities + equity (ie total value is equal to what is owing and what you’ve already paid)

124
Q

what is a long term asset vs current assets

A

won’t be turned into cash or be consumed within one year (property**, plant, building, equipment). Current assets are things like cash, accounts payable, etc- things that are cash or will turn into cash within one year

125
Q

what are assets

A

something of value owned by the pharmacy

126
Q

what are liabilities

A

debts incurred by the pharmacy

127
Q

what is shareholders equity

A

the total net worth of the pharmacy (amount invested in it) aka stockholders or owners equity depending on context

128
Q

income statement is aka

A

profit and loss statement

129
Q

what is on the pharmacy income statement

A

gross profit, net income or loss, sales, operating expenses

130
Q

what are the 3 additional ps when a product is a service

A

people, process, physical evidence

131
Q

what are dividends

A

earnings of a business that are paid out to the owners

132
Q

gross profit vs margin

A

same but profit is expressed as a number vs margin as a percent. measures profitability

133
Q

naloxone schedule

A

1 (PDL) or if for emergency use is 2

OTC (21 decks)

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