Jurisprudence-UFT Flashcards
(def): puts in place a mandatory consistent standard for medication safety for ALL pharmacies in Ontario
(*OCP adopted this to include in its standards of practise/code of ethics)
Aims assurance and improvement in medication safety program (AIMS)
(def): practise policies (developed by OCP) expected for all ALL pharmacy professionals to practise within legislative framework (ie, policy about delegation of controlled act)
practise policies & procedure
Any decisions by the college can be appealed by_______.
health professional appeal & review board (HPARB)
Registration policies & procedures are reviewed by______.
office of the fairness commissioner (OFC)
Any college decision related to discipline & fitness can be appealed by____.
court
sets out the scope of practice of pharmacists
pharmacy Act
An act that protects the patient’s right to have a copy of their prescription
DPRA
A pharmacy cannot refuse the entry to the inspector during the course of their duty- if they do it is considered________.
proprietary misconduct
The statuary committee required by the pharmacy act?
accreditation comittee
college regulatory activities?
-restrictive
-reactive
-proactive
-transparent
components of professional responsibilities?
-member responsibility to the college
-member responsibility to the patient
-fiduciary duty
-member responsibility to 3rd parties
-mandatory reporting (sexual abuse,facility operator, self-reporting)
An organization that tests,certifies, & designs child-resistant containers
Canadian standard association (CSA)
Name of the committee that decides drug scheduling according to risk factors.
National Scheduling Advisory Committee (NDSAC)
_______ is established by Health Canada which allows persons to perform various activities related to manufacture/distribution of the drug
drug establishment licenses (DEL)
*manufacturers may have multiple DEL
pharmacy structure requirement?
A total accredited area of 18.6 square meters or 200 square meters with a dispensary area NOT less than 9.3 square meters
___________ must be supplied to protect personnel engaged in compounding
personal protective equipment or (PPE)
The risk assessment followed by compounding pharmacies.
Level A
Level B
Level C (*highest level of risk and hence requires the most precautionary measures)
who is responsible for designating products as interchangeable or removing the designation?
officer of the Ontario public drug programs
The __________regulations make all owners or operators of a pharmacy accountable for its operations, whether they are members of OCP or not.
Proprietary Misconduct
composition of the OCP?
i. College council (Board)
ii. Statutary committee (7 committees required by RHPA & pharmacy act
iii. Standing committee (created by college by laws)
(def): failing to report a child in need of protection to local children’s aid society
allegation
examples of mandatory reporting?
-sexual abuse
-facility operator
- self-reporting
(def): permits persons to perform various activities related to the manufacture/distribution of drugs
drug establishment licenses (DEL)
Which agency does the FDA fall under in the health portfolio?
Canadian inspection agency
define the following:
Schedule A
Schedule B
Schedule C
Schedule D
Schedule G
A: disease states where tx may not be promoted to the public
B: publications describing official international standards
C: Radiopharmaceuticals
D: Allergenic substances, blood derivatives & immunizing agents
C+D= regulated to ensure that the premise meet federal requirements
G: Controlled substances + prescription drug lists (PDL)
define the following:
Part A
Part B
Part C
Part D
Part E
Part A: administration of food-related regulations
Part B: regulation on food product safety
Part C: rules & procedures for prescription drugs
Part D: vitamins,A.A.,minerals
Part E: cyclamate & saccharin sweeteners
Part G: controlled drugs
_________ regulation outlines the exact info required by drug manufacturer if drug recall is initiated
food & drug (FDA)
adverse drug reaction MUST be reported by the manufacturer to health Canada within_____.
15 days
who represents the council of the Ontario college of pharmacists?
Appointed public members, elected pharmacist and pharmacy technician members, and the Deans of the Faculties of Pharmacy
The name of Canada’s post-surveillance program?
The Canada Vigilance program
(*Med effect is the name of the reporting website)
Advertising follows the requirements set forth by_____,
F&DA (*implemented by Health Canada)
Who ensures reviews and implements FDA regulations in advertising?
Advertising preclearance agency
approved advertising are authorized_____ .
APA logo(*indicating that it complies with FDA requirements)
which branch of health canada deals with reviewing new drug submission forms prior to authorizing sale?
health products and food branch
