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Pharm > Final > Flashcards

Final Flashcards

1
Q

What 2 categories are under ‘pharmaceuticals’?

A

Prescription drugs
Non-prescription drugs

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2
Q

who controls schedules 1, 2, 4 and unscheduled drugs – NAPRA or Health Canada?

A

NAPRA

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3
Q

prescription drugs are which schedule?

A

1

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4
Q

Non-prescription drugs are which schedule?

A

2, 4, and unscheduled

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5
Q

Controlled drugs fall under which schedules?

A

1-4

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6
Q

T/F: Pr drugs are federal

A

T

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7
Q

‘Prescription Drug List’ includes 2 categories…

A

Human Pr drugs
Veterinary Pr drugs

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8
Q

T/F: any drug used off-label is prescription

A

T

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9
Q

T/F: any Schedule 1 drug is prescription?

A

T

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10
Q

3 principles when Health Canada selects Pr drugs?

A
  1. supervision necessary
  2. uncertainty re: the drug justifies supervision
  3. drug can cause harm which supervision can mitigate
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11
Q

3 classes of Pr drugs

A

Narcotics (N)

Controlled <C></C>

Benzo + Targeted substances [T/C]

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12
Q

T/F: controlled drugs are dangerous because they have a high TI

A

F: low

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13
Q

T/F: NAPRA is federal

A

F: provincial

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14
Q

NAPRA stands for…

A

National Association of Pharmacy Regulatory Authorities

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15
Q

T/F: federal laws are stricter than provincial

A

F - provincial can be more strict!

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16
Q

T/F: NAPRA only deals with human drugs, so only human-labelled drugs in vet med fall under this domain

A

T

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17
Q

what is the ‘harmonized drug schedule model’?

A

created by NAPRA - lists classes recognized at a provincial level

schedule 1 - Pr required federally

sched 2 - non-Pr, but ‘behind the counter’ (ie. ephedrine)

sched 3 - non-Pr, but pharmacist supervises your selection (ie. extra strength formulas)

unscheduled - can be sold anywhere

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18
Q

to order ephederin, DVM must sign ‘end use declaration form’ how often?

A

annually

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19
Q

vet biologicals are regulated by ___ and enforced by ___

A

Health of Animals Act

CFIA

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20
Q

T/F: under no circumstances can rabies vaccines be sold to a non-vet

A

F

requests can be made in special circumstances:
- remote areas without veterinary services for temporary rabies vaccination clinics.
- trap-vaccinate-release programs run by provincial wildlife officials.

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21
Q
A
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22
Q

T/F: NAPRA regulates natural non-Pr health products?

A

F
NNDPD does (Natural + Non-Pr Health Products Directorate)

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23
Q

natural health products require ___ before they can be sold

A

product license - lets consumers know Health Canada has approved it

(8 numbers-NPN, or DIN-HM if homeopathic)

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24
Q

what is homeopathy?

A

treating disease with small doses of drugs that cause the same symptoms as the disease

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25
Q

T/F: only Pr drugs have a DIN

A

F - anything (Pr of OTC) with an active pharmaceutical ingredients does

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26
Q

what is a drug label?

A

monograph that comes with every drug
- must be included for every drug with a DIN!!

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27
Q

before being licensed, indications must have been…

A

tested

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28
Q

T/F: dosage, route are part of ‘indications’

A

T

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29
Q

what is the difference between precautions and warnings?

A

warnings are more serious or more frequent

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30
Q

veterinary drugs are regulated by….

A

VDD

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31
Q

WDT are determined by…

A

Health Canada

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32
Q

T/F: WDT is once drug reaches ‘0’ in tissues

A

F - when drug reaches max allowable level in tissue

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33
Q

T/F: WDT only applies to certain drugs

A

F - anything with a DIN!

although certain drugs do not have a labelled WDT

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34
Q

what drugs are banned from food animals?

A

(a) chloramphenicol or its salts or derivatives;
(b) a 5-nitrofuran compound;
(c) clenbuterol or its salts or derivatives;
(d) a 5-nitroimidazole
(e) diethylstilbestrol or other stilbene compounds
(f) oestrogenic activity

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35
Q

what does Canadian Global Food Animal Residue Avoidance Databank (CgFARAD) do?

A

non-profit that gives vets advice for drugs without labelled WDTs

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36
Q

T/F: If the prescription is for a drug that has no withdrawal period, this should be noted on the prescription.

A

T

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37
Q

T/F: WDTS must be on dispensing label, except not yet required for equine

A

T

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38
Q

T/F: vets can use drugs off-label as long as they have a DIN

A

T

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39
Q

ELDU cannot be used for which 2 categories?

A
  • those in Health of Animals Act (vaccines)
  • pesticides
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40
Q

T/F: RVTs can recommend compounding drugs

A

F - must be prescribed by vet

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41
Q

blanket prescriptions (herd health) are reviewed by a vet every….

A

year

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42
Q

prescriptions and refills expire when?

A

one year from the date the script was written

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43
Q

Prs can be given verbally if…

A

they are transcribed into medical record
- ie. DVM tells RVT what drug they want, RVT then records it and dispenses

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44
Q

info legally required on a dispensing label?

A
  • client
  • patient and spp.
  • drug (brand or generic)
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45
Q

T/F: narcotics can have refills

A

F

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46
Q

T/F: verbal Rx is ok for narcotics

A

F - written only

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47
Q

T/F: narcotics Rx can be transferred

A

F

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48
Q

how long must Rx’s be kept on file according to SVMA? federally?

A

5y, 2y

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49
Q

the dispensing record for narcotics must include a client’s….

A

name and address

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50
Q

T/F: verbal Rx is ok controlled drugs

A

T

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51
Q

T/F: verbal refills are ok for schedule 1 controlled drugs

A

F, must be written
- only 2 and 3 can be verbal

  • refill intervals must be stated!
52
Q

T/F: transferring Rx of controlled drugs is ok

A

F

53
Q

T/F: verbal Rx is ok for benzo + targeted?

A

T

54
Q

T/F: verbal refills are ok for benzo + targeted?

A

T

  • interval not required
55
Q

T/F: transfer of Rx for benzo + targeted is ok

A

T - but only once

56
Q

theft of N, C, or T/C drugs must be reported within…

A

10 days

57
Q

T/F: on-label Pr class drugs that have not had manufacturer’s label disturbed do not need a dispensing label

A

T

58
Q

R/OTC drugs can be sold without a Rx and a dispensing label as long as…

A
  • original package
  • labelled for vet use only
59
Q

T/F: human R/OTC drugs always require a Rx + label when used in an animal

A

T

60
Q

does dispensing require a VCPR?

A

no, RVT can do it

61
Q

how should large volumes of controlled drugs be discarded? small?

A

large = DVM destroys with witness

small = RVT can destroy with witness

62
Q

does non-controlled drug disposal require a witness?

A

no

63
Q

what 2 federal acts govern C/T drugs?

A
  • Controlled Drugs + Substances Act (CDSA)
    a) Narcotic Control Act
    b) Bzd + Targeted Regulations
  • FDA (G and J)
64
Q

define ‘controlled substance’

A

substance included in schedules 1-5

65
Q

what act combines Narcotic Control Act and Parst 3-4 of FDA into one piece of legislation?

A

CDSA

66
Q

What is the point of the CDSA?

A

control availability of psychotropic substances

67
Q

what is psychotropic?

A

can produce
a) dependence
b) CNS stimulation OR depression

68
Q

which schedule of CDSA is most tightly controlled? least?

A

1
4

69
Q

which schedules of CDSA are most vet drugs under?

A

1-4

70
Q

examples of sched 1 drugs

A

ephedrine
opioids
fentanyl

71
Q

examples of sched 4 drugs

A

barbituates
butorphanol
bzds

72
Q

which sched 1/2 drugs in CDSA are also covered in the Narcotics act?

A

heroin
cocaine
mathadone
PCP (ketamine)
morphine
codeine

73
Q

what is FDA part G?

A

restricts distribution of N/C/T drugs to practitioners and outlines records needed

74
Q

what is FDA part J?

A

control measures for ‘restricted’ drugs only available for research
- no therapeutic use
- hallucinogenic

75
Q

what are the rules for narcotic double doctoring?

A

can’t go to a new practitioner and get a subsequent prescription without disclosing all past prescriptions for 30 days

76
Q

what’s the SK rule to prevent narcotic double doctoring when transferring Rx?

A

must have hand-written script + signature

77
Q

what about federal Rx transferring?

A

verbal Rx is allowed

78
Q

prescribing which C drugs required special exemption?

A

methadone

79
Q

how much can we dispense at a time of sched 1 drugs? sched 4?

A

enough for 1 month
3 months

80
Q

inspection of narcotic records is usually done by ____, but can be done at any time by ____

A
  • provincial regulating body (SVMA)
  • minister of health
81
Q

federally, narcotics administered longer than ___ need to be recorded in a separate registry

A

3 days

(otherwise medical record is fine)

… however is is SVMA standards that every dispensing act is logged!

82
Q

2 record components SVMA requires?

A

master/acquisition log
- inventory

dispensing log
- use of inventory

83
Q

how often should logs be reconciled?

A

weekly

84
Q

T/F: you can keep logs with the actual drugs

A

F

85
Q

how much volume does a needle hub hold?

A

0.05ml

86
Q

SK security level 1 value? level 2?

A

1: <$500
2: $500-2500

87
Q

difference between level 1 and 2?

A

level 1 - device storing must have lock

level 2 - cabinet must have lock, alarm system required

88
Q

federal legislation states that safes must be….

A

immovable

89
Q

T/F: there are regulations re: method of discarding controlled drugs

A

F
- just SVMA recommendations

90
Q

all discard/spills/expired must be recorded and witnessed by ___, but if not available ___ is acceptable

A

DVM
RVT

91
Q

who do you report loss and theft to?

A

Office of Controlled Substances, Health Canada

92
Q

what is diversion?

A

using for a purpose other than intended

(AKA sneaky staff members)

93
Q

what is an Act?

A

legislation (law passed by gov’t)

94
Q

what is regulation?

A

imposed restrictions used to enforce an Act

95
Q

the drug schedules are an example of….

A

regulations

96
Q

what are bylaws?

A

regulations at provincial/lower level

97
Q

what are standards?

A

document consensus establishes that provides guidelines

98
Q

T/F: bylaws can be more permissive than federal laws/regulations?

A

F

99
Q

federal laws re: drugs are done through….

A

health canada

100
Q

health canada has 2 branches….

A

therapeutic drugs directorate (TPD)
- human use

veterinary drugs directorate (VDD)

101
Q

what is the difference between monitoring for TPD and VDD?

A

TPD:
- responsible for all pre/post market
- FDA requires scientific proof of safety before going to market

VDD:
- submissions for new drugs transfer to TPD for approval process
- all post-market done through CFIA

102
Q

7 steps of a drug going to market

A
  1. research
  2. patent protections
  3. pre-clinical testing
  4. clinical trial application
  5. clinical trial
  6. health canada review
  7. notice of compliance
103
Q

how long do patent protections last?

A

20 yrs

104
Q

what is pre-clinical testing?

A

done on tissue culture or lab spp.

105
Q

what is clinical trial? its 3 phases?

A

3 phases testing on target spp

1 (dose titration and pharmacokinetics)
- 20-100 volunteers
- 6-9mo
- 70% pass

2 (short term effects and ideal dose range)
- 100-300 patients with condition
- 6mo-3y

3 (confirm effectiveness, s/e)
- 1000-3000 patients
- 1-5y
- only 10% pass

106
Q

at what stage are drugs given a DIN?

A

notice of compliance

107
Q

what is vanessa’s law?

A

amendment to FDA that makes surveillance of therapeutic products necessary + makes practitioners report drug reactions

  • allows for recalls
  • jail time
  • label/packaging changes
108
Q

what is pharmacovigilance?

A

study of adverse effects

109
Q

chain of command for reporting adverse effects?

A

RVT -> DVM -> manufacturer or CFIA -> VDD

manufacturer -> CFIA -> VDD

110
Q

state the regulatory office (federal) for:
a) human drugs
b) vet drugs
c) herbal products
d) vaccine/biologicals

A

a) therapeutic products directorate (TPD)

b) veterinary drugs directorate (VDD)

c) natural health products directorate (NHPD)

d) biological and genetic therapies directorate

111
Q

T/F: emergency drug release lets vets access drugs not normally for sale in canada

A

T - vets request to VDD

112
Q

you know FDA part G (control) and J (restricted)… what are C and D?

A

C - drugs
D - vitamins + minerals

113
Q

the FDA deals with controlled and restricted, but not….

A

N or T/C
- CDSA deals with them

114
Q

‘keep out of reach of children’ must be on any drugs containing….

A

ASA
acetaminophen
>250mg iron
>120mg fluoride

115
Q

once a new drug is approved federally, who is in charge of conditions of sale?

A

provincial (Drug Schedules Regulations)

116
Q

according to Drug Schedules Regulations, which schedules require prescription?

A

1-3

117
Q

who determines how drugs are regulated with respect to Rx + point of purchase?

A

NAPRA (provincial)

118
Q

what is the SK pharmacy Act of 1979?

A

Veterinarian granted exemption from the Act which restricts dispensing/selling of Schedule I, II and III drugs to a registered pharmacist

119
Q

what is SK vet Act 1987?

A

Veterinarians have 2 roles related to drugs:
▫ Ability to prescribe
▫ Ability to dispense the prescribed drug

120
Q

who is the federal body?

A

Health Canada

121
Q

who is in charge of pharmacovigilance?

A

CFIA

122
Q

who outlines laws for the 7 federal drug classes?

(incl. minimum prescription requirements, manufacturing, labelling, common definitions, dispensing)?

A

Food and Drugs Act and Regulations

123
Q

who allows certain individuals to prescribe?

A

Drug Schedules Regulations

124
Q

what allows vets to prescribe and sell?

A

Pharmacy Act

125
Q

the conditions under which vets can prescribe/dispense are set by…

A

SVMA bylaws and practice standards

Pharm (5 decks)

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