Objective 2 Flashcards
Predetermined criteria used to provide guidance as a standard for the preparation
& administration of a pharmaceutical substance
drug standard
Rules & regulations that govern acceptable practices of drug use, administration,
sales and promotion
legislation
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
food & drug act
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
food & drug act
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
controlled drugs and substances act
what are the factors that determine how drugs are placed into a particular schedule
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
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
cannabis act
Drugs listed have moderate potential for abuse, Mood modifying effects &
can be habit forming affect CNS
controlled drugs
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
greater control than schedule F
what are the categories of controlled drugs
pt 1
pt 2
pt 3
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
pt 1
controlled drugs with misuse potential prescribed for medical conditions.
Examples: sedatives such as barbiturates and derivatives (e.g., secobarbital),
thiobarbiturates (e.g., pentothal sodium
pt 2
controlled drugs with misuse potential. Examples: anabolic steroids (e.g.,
androstanolone), weight reduction drugs (anorexiants)
pt 3
Drugs available only by prescription
schedule 1
Restricted Access drugs available only from a pharmacist and
retained behind counter Ex. Insulin & acetaminophen with codeine 8mg
schedule 2
pharmacy only non prescription drugs ( consumer has open
access and pharmacist available to answer questions. Ex. Antihistamines
&ulcer medication
schedule 3
drugs that can be prescribed by a pharmacist according to
specific guidelines
schedule 4
non prescription drugs like ibuprofen, acetaminophen
and nicotine Gum that can be sold in any store by a nonpharmacist
unscheduled drugs
what must a label include?
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
what is the criteria for over the counter status?
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
