Final Flashcards
1
Q
What 2 categories are under ‘pharmaceuticals’?
A
Prescription drugs
Non-prescription drugs
2
Q
who controls schedules 1, 2, 4 and unscheduled drugs – NAPRA or Health Canada?
A
NAPRA
3
Q
prescription drugs are which schedule?
A
1
4
Q
Non-prescription drugs are which schedule?
A
2, 4, and unscheduled
5
Q
Controlled drugs fall under which schedules?
A
1-4
6
Q
T/F: Pr drugs are federal
A
T
7
Q
‘Prescription Drug List’ includes 2 categories…
A
Human Pr drugs
Veterinary Pr drugs
8
Q
T/F: any drug used off-label is prescription
A
T
9
Q
T/F: any Schedule 1 drug is prescription?
A
T
10
Q
3 principles when Health Canada selects Pr drugs?
A
- supervision necessary
- uncertainty re: the drug justifies supervision
- drug can cause harm which supervision can mitigate
11
Q
3 classes of Pr drugs
A
Narcotics (N)
Controlled <C></C>
Benzo + Targeted substances [T/C]
12
Q
T/F: controlled drugs are dangerous because they have a high TI
A
F: low
13
Q
T/F: NAPRA is federal
A
F: provincial
14
Q
NAPRA stands for…
A
National Association of Pharmacy Regulatory Authorities
15
Q
T/F: federal laws are stricter than provincial
A
F - provincial can be more strict!
16
Q
T/F: NAPRA only deals with human drugs, so only human-labelled drugs in vet med fall under this domain
A
T
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
18
Q
to order ephederin, DVM must sign ‘end use declaration form’ how often?
A
annually
19
Q
vet biologicals are regulated by ___ and enforced by ___
A
Health of Animals Act
CFIA
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.
21
Q
A
22
Q
T/F: NAPRA regulates natural non-Pr health products?
A
F
NNDPD does (Natural + Non-Pr Health Products Directorate)
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)
24
Q
what is homeopathy?
A
treating disease with small doses of drugs that cause the same symptoms as the disease
25
T/F: only Pr drugs have a DIN
F - anything (Pr of OTC) with an active pharmaceutical ingredients does
26
what is a drug label?
monograph that comes with every drug
- must be included for every drug with a DIN!!
27
before being licensed, indications must have been...
tested
28
T/F: dosage, route are part of 'indications'
T
29
what is the difference between precautions and warnings?
warnings are more serious or more frequent
30
veterinary drugs are regulated by....
VDD
31
WDT are determined by...
Health Canada
32
T/F: WDT is once drug reaches '0' in tissues
F - when drug reaches max allowable level in tissue
33
T/F: WDT only applies to certain drugs
F - anything with a DIN!
although certain drugs do not have a labelled WDT
34
what drugs are banned from food animals?
(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
35
what does Canadian Global Food Animal Residue Avoidance Databank (CgFARAD) do?
non-profit that gives vets advice for drugs without labelled WDTs
36
T/F: If the prescription is for a drug that has no withdrawal period, this should be noted on the prescription.
T
37
T/F: WDTS must be on dispensing label, except not yet required for equine
T
38
T/F: vets can use drugs off-label as long as they have a DIN
T
39
ELDU cannot be used for which 2 categories?
- those in Health of Animals Act (vaccines)
- pesticides
40
T/F: RVTs can recommend compounding drugs
F - must be prescribed by vet
41
blanket prescriptions (herd health) are reviewed by a vet every....
year
42
prescriptions and refills expire when?
one year from the date the script was written
43
Prs can be given verbally if...
they are transcribed into medical record
- ie. DVM tells RVT what drug they want, RVT then records it and dispenses
44
info legally required on a dispensing label?
- client
- patient and spp.
- drug (brand or generic)
45
T/F: narcotics can have refills
F
46
T/F: verbal Rx is ok for narcotics
F - written only
47
T/F: narcotics Rx can be transferred
F
48
how long must Rx's be kept on file according to SVMA? federally?
5y, 2y
49
the dispensing record for narcotics must include a client's....
name and address
50
T/F: verbal Rx is ok controlled drugs
T
51
T/F: verbal refills are ok for schedule 1 controlled drugs
F, must be written
- only 2 and 3 can be verbal
* refill intervals must be stated!
52
T/F: transferring Rx of controlled drugs is ok
F
53
T/F: verbal Rx is ok for benzo + targeted?
T
54
T/F: verbal refills are ok for benzo + targeted?
T
* interval not required
55
T/F: transfer of Rx for benzo + targeted is ok
T - but only once
56
theft of N, C, or T/C drugs must be reported within...
10 days
57
T/F: on-label Pr class drugs that have not had manufacturer's label disturbed do not need a dispensing label
T
58
R/OTC drugs can be sold without a Rx and a dispensing label as long as...
- original package
- labelled for vet use only
59
T/F: human R/OTC drugs always require a Rx + label when used in an animal
T
60
does dispensing require a VCPR?
no, RVT can do it
61
how should large volumes of controlled drugs be discarded? small?
large = DVM destroys with witness
small = RVT can destroy with witness
62
does non-controlled drug disposal require a witness?
no
63
what 2 federal acts govern C/T drugs?
- Controlled Drugs + Substances Act (CDSA)
a) Narcotic Control Act
b) Bzd + Targeted Regulations
- FDA (G and J)
64
define 'controlled substance'
substance included in schedules 1-5
65
what act combines Narcotic Control Act and Parst 3-4 of FDA into one piece of legislation?
CDSA
66
What is the point of the CDSA?
control availability of psychotropic substances
67
what is psychotropic?
can produce
a) dependence
b) CNS stimulation OR depression
68
which schedule of CDSA is most tightly controlled? least?
1
4
69
which schedules of CDSA are most vet drugs under?
1-4
70
examples of sched 1 drugs
ephedrine
opioids
fentanyl
71
examples of sched 4 drugs
barbituates
butorphanol
bzds
72
which sched 1/2 drugs in CDSA are also covered in the Narcotics act?
heroin
cocaine
mathadone
PCP (ketamine)
morphine
codeine
73
what is FDA part G?
restricts distribution of N/C/T drugs to practitioners and outlines records needed
74
what is FDA part J?
control measures for 'restricted' drugs only available for research
- no therapeutic use
- hallucinogenic
75
what are the rules for narcotic double doctoring?
can't go to a new practitioner and get a subsequent prescription without disclosing all past prescriptions for 30 days
76
what's the SK rule to prevent narcotic double doctoring when transferring Rx?
must have hand-written script + signature
77
what about federal Rx transferring?
verbal Rx is allowed
78
prescribing which C drugs required special exemption?
methadone
79
how much can we dispense at a time of sched 1 drugs? sched 4?
enough for 1 month
3 months
80
inspection of narcotic records is usually done by ____, but can be done at any time by ____
- provincial regulating body (SVMA)
- minister of health
81
federally, narcotics administered longer than ___ need to be recorded in a separate registry
3 days
(otherwise medical record is fine)
... however is is SVMA standards that every dispensing act is logged!
82
2 record components SVMA requires?
master/acquisition log
- inventory
dispensing log
- use of inventory
83
how often should logs be reconciled?
weekly
84
T/F: you can keep logs with the actual drugs
F
85
how much volume does a needle hub hold?
0.05ml
86
SK security level 1 value? level 2?
1: <$500
2: $500-2500
87
difference between level 1 and 2?
level 1 - device storing must have lock
level 2 - cabinet must have lock, alarm system required
88
federal legislation states that safes must be....
immovable
89
T/F: there are regulations re: method of discarding controlled drugs
F
- just SVMA recommendations
90
all discard/spills/expired must be recorded and witnessed by ___, but if not available ___ is acceptable
DVM
RVT
91
who do you report loss and theft to?
Office of Controlled Substances, Health Canada
92
what is diversion?
using for a purpose other than intended
(AKA sneaky staff members)
93
what is an Act?
legislation (law passed by gov't)
94
what is regulation?
imposed restrictions used to enforce an Act
95
the drug schedules are an example of....
regulations
96
what are bylaws?
regulations at provincial/lower level
97
what are standards?
document consensus establishes that provides guidelines
98
T/F: bylaws can be more permissive than federal laws/regulations?
F
99
federal laws re: drugs are done through....
health canada
100
health canada has 2 branches....
therapeutic drugs directorate (TPD)
- human use
veterinary drugs directorate (VDD)
101
what is the difference between monitoring for TPD and VDD?
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
7 steps of a drug going to market
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
how long do patent protections last?
20 yrs
104
what is pre-clinical testing?
done on tissue culture or lab spp.
105
what is clinical trial? its 3 phases?
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
at what stage are drugs given a DIN?
notice of compliance
107
what is vanessa's law?
amendment to FDA that makes surveillance of therapeutic products necessary + makes practitioners report drug reactions
- allows for recalls
- jail time
- label/packaging changes
108
what is pharmacovigilance?
study of adverse effects
109
chain of command for reporting adverse effects?
RVT -> DVM -> manufacturer or CFIA -> VDD
manufacturer -> CFIA -> VDD
110
state the regulatory office (federal) for:
a) human drugs
b) vet drugs
c) herbal products
d) vaccine/biologicals
a) therapeutic products directorate (TPD)
b) veterinary drugs directorate (VDD)
c) natural health products directorate (NHPD)
d) biological and genetic therapies directorate
111
T/F: emergency drug release lets vets access drugs not normally for sale in canada
T - vets request to VDD
112
you know FDA part G (control) and J (restricted)... what are C and D?
C - drugs
D - vitamins + minerals
113
the FDA deals with controlled and restricted, but not....
N or T/C
- CDSA deals with them
114
'keep out of reach of children' must be on any drugs containing....
ASA
acetaminophen
>250mg iron
>120mg fluoride
115
once a new drug is approved federally, who is in charge of conditions of sale?
provincial (Drug Schedules Regulations)
116
according to Drug Schedules Regulations, which schedules require prescription?
1-3
117
who determines how drugs are regulated with respect to Rx + point of purchase?
NAPRA (provincial)
118
what is the SK pharmacy Act of 1979?
Veterinarian granted exemption from the Act which restricts dispensing/selling of Schedule I, II and III drugs to a registered pharmacist
119
what is SK vet Act 1987?
Veterinarians have 2 roles related to drugs:
▫ Ability to prescribe
▫ Ability to dispense the prescribed drug
120
who is the federal body?
Health Canada
121
who is in charge of pharmacovigilance?
CFIA
122
who outlines laws for the 7 federal drug classes?
(incl. minimum prescription requirements, manufacturing, labelling, common definitions, dispensing)?
Food and Drugs Act and Regulations
123
who allows certain individuals to prescribe?
Drug Schedules Regulations
124
what allows vets to prescribe and sell?
Pharmacy Act
125
the conditions under which vets can prescribe/dispense are set by...
SVMA bylaws and practice standards
