Objective 2

Question 1

Predetermined criteria used to provide guidance as a standard for the preparation
& administration of a pharmaceutical substance

Answer 1

drug standard

Question 2

Rules & regulations that govern acceptable practices of drug use, administration,
sales and promotion

Answer 2

legislation

Question 3

Primary piece of legislation governing drugs, food, cosmetics
and medical devices in Canada.
* Started in 1953, has been amended several times since.
* Together with other federal legislation (the Proprietary or
Patent Medicine Act, and the Controlled Drugs and Substances
Act), provincial acts and regulations that cover the sale of
drugs they help protect Canadians from health hazards

Answer 3

food & drug act

Question 4

Determines safety of drugs before marketing
* Determines labelling specifications
* Manufacturers are req’d to submit drug applications for safety review
prior to sale of product
* Ensure that advertising claims are met (Prohibits advertising any food,
drug, cosmetic or device as a cure for certain diseases)
* Government may withdraw from market drugs found to be toxic
* New drug must be proven safe and effect in human clinical studies

Answer 4

food & drug act

Question 5

passed in 1997
* Replaced the Canadian Narcotic Control Act
* provides requirements for control, sale, manufacture,
production & distribution of Narcotics in Canada
* Allows authorized personnel to prescribe & dispense
narcotics with strict records

Answer 5

controlled drugs and substances act

Question 6

what are the factors that determine how drugs are placed into a particular schedule

Answer 6

international requirements,
the dependence potential and the likelihood of abuse of the substance,
the extent of its abuse in Canada,
the danger it represents to public safety
the usefulness of the substance as a therapeutic agent

Question 7

Designed to better protect the health and safety of
Canadians
* Prevent youth access to cannabis
* Displace the illegal market
* Keep profit out of hands of illegal market
Adult possession allows for:
Possess up to 30 grams
Share up to 30 grams
Grow up to 4 plants

Answer 7

cannabis act

Question 8

Drugs listed have moderate potential for abuse, Mood modifying effects &
can be habit forming affect CNS

Answer 8

controlled drugs

Question 9

Consist of schedules aka classes
* Obtained by written/verbal Rx., but refills allowed only with written Rx.
(Must have a C in upper quarter of the label)
* Have short refills; kept in locked cupboard
* Require strict and very specific instructions re: dispensing
* 2 nurses required to count at beginning and end of each shift 13

Answer 9

greater control than schedule F

Question 10

what are the categories of controlled drugs

Answer 10

pt 1
pt 2
pt 3

Question 11

designated controlled drugs with misuse potential that may be used for
designated medical conditions outlined in Food and Drug Regulations. Examples:
amphetamines, methylphenidate, pentobarbital, preparations containing one
controlled drug and one or more active noncontrolled drug

Answer 11

pt 1

Question 12

controlled drugs with misuse potential prescribed for medical conditions.
Examples: sedatives such as barbiturates and derivatives (e.g., secobarbital),
thiobarbiturates (e.g., pentothal sodium

Answer 12

pt 2

Question 13

controlled drugs with misuse potential. Examples: anabolic steroids (e.g.,
androstanolone), weight reduction drugs (anorexiants)

Answer 13

pt 3

Question 14

Drugs available only by prescription

Answer 14

schedule 1

Question 15

Restricted Access drugs available only from a pharmacist and
retained behind counter Ex. Insulin & acetaminophen with codeine 8mg

Answer 15

schedule 2

Question 16

pharmacy only non prescription drugs ( consumer has open
access and pharmacist available to answer questions. Ex. Antihistamines
&ulcer medication

Answer 16

schedule 3

Question 17

drugs that can be prescribed by a pharmacist according to
specific guidelines

Answer 17

schedule 4

Question 18

non prescription drugs like ibuprofen, acetaminophen
and nicotine Gum that can be sold in any store by a nonpharmacist

Answer 18

unscheduled drugs

Question 19

what must a label include?

Answer 19

Purpose and use of product
* Storage information
* Dosage instructions
* Inactive ingredients
* Specific warnings and adverse effects that may occur
* When the product should not be used under any circumstances
* When it is appropriate to consult a doctor or pharmacist
* Information to facilitate adverse event reporting and quality reporting

Question 20

what is the criteria for over the counter status?

Answer 20

I: Indications for Use
Consumer must be able to easily:
* Diagnose condition
* Monitor effectiveness
Benefits of correct usage must outweigh
risks.
II: Safety Profile
Drugs must have:
* Favourable adverse event profile
* Limited interaction with other drugs
* Low potential for misuse
* High therapeutic index*
III: Practicality for Over-the-
Counter Use
Drugs must be:
* Easy to use
* Easy to monitor