Jurisprudence-UFT

Question 1

(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)

Answer 1

Aims assurance and improvement in medication safety program (AIMS)

Question 2

(def): practise policies (developed by OCP) expected for all ALL pharmacy professionals to practise within legislative framework (ie, policy about delegation of controlled act)

Answer 2

practise policies & procedure

Question 3

Any decisions by the college can be appealed by_______.

Answer 3

health professional appeal & review board (HPARB)

Question 4

Registration policies & procedures are reviewed by______.

Answer 4

office of the fairness commissioner (OFC)

Question 5

Any college decision related to discipline & fitness can be appealed by____.

Answer 5

court

Question 6

sets out the scope of practice of pharmacists

Answer 6

pharmacy Act

Question 7

An act that protects the patient’s right to have a copy of their prescription

Answer 7

DPRA

Question 8

A pharmacy cannot refuse the entry to the inspector during the course of their duty- if they do it is considered________.

Answer 8

proprietary misconduct

Question 9

The statuary committee required by the pharmacy act?

Answer 9

accreditation comittee

Question 10

college regulatory activities?

Answer 10

-restrictive
-reactive
-proactive
-transparent

Question 11

components of professional responsibilities?

Answer 11

-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)

Question 12

An organization that tests,certifies, & designs child-resistant containers

Answer 12

Canadian standard association (CSA)

Question 13

Name of the committee that decides drug scheduling according to risk factors.

Answer 13

National Scheduling Advisory Committee (NDSAC)

Question 14

_______ is established by Health Canada which allows persons to perform various activities related to manufacture/distribution of the drug

Answer 14

drug establishment licenses (DEL)
*manufacturers may have multiple DEL

Question 15

pharmacy structure requirement?

Answer 15

A total accredited area of 18.6 square meters or 200 square meters with a dispensary area NOT less than 9.3 square meters

Question 16

___________ must be supplied to protect personnel engaged in compounding

Answer 16

personal protective equipment or (PPE)

Question 17

The risk assessment followed by compounding pharmacies.

Answer 17

Level A
Level B
Level C (*highest level of risk and hence requires the most precautionary measures)

Question 18

who is responsible for designating products as interchangeable or removing the designation?

Answer 18

officer of the Ontario public drug programs

Question 19

The __________regulations make all owners or operators of a pharmacy accountable for its operations, whether they are members of OCP or not.

Answer 19

Proprietary Misconduct

Question 20

composition of the OCP?

Answer 20

i. College council (Board)
ii. Statutary committee (7 committees required by RHPA & pharmacy act
iii. Standing committee (created by college by laws)

Question 21

(def): failing to report a child in need of protection to local children’s aid society

Answer 21

allegation

Question 22

examples of mandatory reporting?

Answer 22

-sexual abuse
-facility operator
- self-reporting

Question 23

(def): permits persons to perform various activities related to the manufacture/distribution of drugs

Answer 23

drug establishment licenses (DEL)

Question 24

Which agency does the FDA fall under in the health portfolio?

Answer 24

Canadian inspection agency

Question 25

define the following: Schedule A Schedule B Schedule C Schedule D Schedule G

Answer 25

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)

Question 26

define the following: Part A Part B Part C Part D Part E

Answer 26

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

Question 27

_________ regulation outlines the exact info required by drug manufacturer if drug recall is initiated

Answer 27

food & drug (FDA)

Question 28

adverse drug reaction MUST be reported by the manufacturer to health Canada within_____.

Answer 28

15 days

Question 29

who represents the council of the Ontario college of pharmacists?

Answer 29

Appointed public members, elected pharmacist and pharmacy technician members, and the Deans of the Faculties of Pharmacy

Question 30

The name of Canada's post-surveillance program?

Answer 30

The Canada Vigilance program (*Med effect is the name of the reporting website)

Question 31

Advertising follows the requirements set forth by_____,

Answer 31

F&DA (*implemented by Health Canada)

Question 32

Who ensures reviews and implements FDA regulations in advertising?

Answer 32

Advertising preclearance agency

Question 33

approved advertising are authorized_____ .

Answer 33

APA logo(*indicating that it complies with FDA requirements)

Question 34

which branch of health canada deals with reviewing new drug submission forms prior to authorizing sale?

Answer 34

health products and food branch