Jurisprudence 3

Question 1

Health Canada

Answer 1

-Ensuring safety of food and drugs people consume
-Encouraging healthy lifestyles
-Involved in consumer product safety, supporting healthcare to first nations and Inuit, keep Canadians informed on safety matters
-Provincial legislation – derived from FDA
-Health Canada Health products and food branch deals with the therapeutic products directorate
o Medical devices bureau
o Special access bureau

Question 2

Food and Drugs Act

Answer 2

-Give federal minister of health the authority to regulate, inspect, seize, and impose penalties
Cosmetics
Medical devices

Safety quality and distribution of food, drugs, cosmetics
All drugs must first be approved by health Canada before being made public
FDA has 4 active schedules

Question 3

Schedule A

Answer 3

List of disease states or conditions where treatments are not promoted to the public
Asthma, cancer, depression
Products are not advertised

Question 4

Schedule B

Answer 4

Publications describing official or international standards

All drugs in Canada must follow these standards

Question 5

Schedule C

Answer 5

Radiopharmaceuticals

Question 6

Schedule D

Answer 6

Allergenic substances, blood derivatives and immunizing agents

Question 7

Schedule G

Answer 7

Controlled Drugs and the prescription drug list

Question 8

Food and Drug Regulations

Answer 8

• The regulations to the FDA set out that must be followed for respective products
• The most important regulations for pharmacy are the Food and Drug Regulations, the Natural Health Products Regulations, and the Medical Devices Regulations

Question 9

Part A

Answer 9

Covers administrations

Question 10

Part B

Answer 10

Food production and safety
Baby food, alcohol, flavourings, and dairy products
Food safety and inspection

Question 11

Part C

Answer 11

Provides rules to dispensing

Question 12

Part D

Answer 12

Vitamins, minerals, and supplements

Question 13

Part E

Answer 13

Sweeteners

Question 14

Part G

Answer 14

Controlled drugs

Question 15

Part J

Answer 15

restricted drugs

Question 16

Part C definitions: Practitioners

Answer 16

Refers to a person who is entitled under the laws of a province, to treat patients with a prescription drug and is practicing their profession in that province

Question 17

Part C definitions: child resistant packages

Answer 17

Referred to in other legislations (DPRA)
Is a package that meets the child test protocol requirements of the Canadian Standards Association (CSA) or other standards as specified in the Food and Drug Regulations
The CSA is an organization that tests, certifies, and designates containers as child-resistant

Question 18

Part C symbols: Pr
N
C
TC

Answer 18

Pr - product requiring prescription for sale
N - narcotic
C - controlled drugs
TC - benzodiazepines and other targeted substances

Question 19

Manufacturing and the process

Answer 19

Reviewing quality and safety of manufactured drug products
Process:
- Providing clinical evidence for efficacy and safety of drug
-The raw materials used to manufacture the drug
- The final drug product

Once a manufactured drug product is approved, it is given a DIN and market authorization

Question 20

GMP

Answer 20

Good Manufacturing Practices

- The FDA describes the regulatory requirements for manufacturers of drug products

Question 21

What does a DIN identify?

Answer 21

strength
dosage form
name
use

Question 22

DEL

Answer 22

Health Canada regulates the distribution of drugs through the issuance of drug establishment licences (DEL)

fabricate or manufacture drugs
package or label products
test drugs
distribute various classes of drugs

Question 23

Other manufacturing rules:

Answer 23

A manufacturer may have 1 or multiple drug establishment licences depending on the activities they wish to perform
The licenses may also have TLC placed on them
Failure to maintain good manufacturing processes may result in fines, suspension, or removal of license
The authority to regulate these manufacturing practices is found in the regulations
Policies and procedures are found in the Health Canada division that oversees and administers these practices
Only drugs that have received health Canada authorization are approved for sale in Canada

Question 24

Compounding definition

Answer 24

The act of compounding drugs is regulated provincially to help ensure the quality and safety of compounded drugs by members of the pharmacy profession

Question 25

compounded drug products in pharmacy

Answer 25

- Are prepared pursuant to a prescription within an established pharmacist-patient relationship - Require a consultation between the pharmacist and their patient in which the pharmacist uses their knowledge and expertise - Provide a customized therapeutic solution to improve patient care

Question 26

Type 1 Health Canada recall

Answer 26

- Most serious - Situation where there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences, or death

Question 27

Type 2 Health Canada recall

Answer 27

Situation where the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote

Question 28

Type 3 health canada recall

Answer 28

Situation of which the use of, or exposure to, a product is not likely to cause any adverse health consequences

Question 29

Suspected adverse drug reactions

Answer 29

Mandatory reporting requirement for manufacturers Any adverse reaction reports received by the manufacturer must be reported within 15 days to Health Canada Reporting by the public or health professionals is voluntary although health professionals are encouraged to report adverse drug reactions to MedEffect Canada through the Canada vigilance program

Question 30

MedEffect Canada

Answer 30

Provides consumers, patients, and health professionals with access to report an adverse reaction or side effect and find new safety information on drugs or products

Question 31

Canada vigilance program

Answer 31

Is health Canada’s post market surveillance program that collects and assesses reports of suspected adverse reactions to health products marketed in Canada MedEffect also posts warnings, advisories and recalls Health Canada may order a review of a product and act where there is potential risk to the public

Question 32

Post-market surveillance

Answer 32

Enables Health Canada to monitor the safety profile of health products once they are marketed to ensure that the benefits of the products continue to outweigh the risks

Question 33

Prescription Drug List

Answer 33

- FDA gives the Minister of Health the authority to establish a list of prescription drugs - The Prescription Drug List (PDL) is a list of prescription drugs in Canada PDL lists medicinal ingredients that when found in a drug, requires a prescription It does not include medicinal ingredients listed in Controlled Drugs and Substances Act Schedules The list includes: - Ingredients, their salts, and derivatives - Some examples of these ingredients - Any applicable qualifiers - Date the listing came into effect Divided into 2 sections: Products for human use Products for veterinary use

Question 34

Criteria for the PDL:

Answer 34

A drug that requires the supervision of a practitioner for the diagnosis, treatment or prevention of a disease or disorder of which the drug is recommend and for monitoring the drug’s use Consideration to the level of uncertainty with the drug’s use or its effects Potential harm that a drug could cause that would require supervision by a practitioner

Question 35

NAPRA

Answer 35

National Association of Pharmacy Regulatory Authorities (NAPRA) manages and maintains the National Drug Schedules Scheduling amendments made to the National Drug Scheduling System are immediately effective in Ontario National Drug Scheduling Advisory Committee adopted a cascading principal model whereby drugs are assessed, based on several risk factors, to determine whether they are considered schedule 1, 2 or 3 If a product does not meet any of the factors to be scheduled, it is considered unscheduled

Question 36

Conditions for sale NAPRA

Answer 36

- All drugs in schedule 1, 2, 3 must be sold only in a pharmacy but the conditions for sale range from most strict in schedule 1 which require a prescription, to the least strict in schedule 3 where they can be sold in the self-selection area of a pharmacy - Products that are unscheduled may be sold from any retail outlet

Question 37

Pr Symbol Conditions for sale (NAPRA)

Answer 37

appear on drug packaging to show that it is a part of the PDL but may not necessarily be the only indication that a drug requires a prescription Conditions for Sale: oNational Drug Schedules identify the conditions for the sale of a product based on risk to the patient oA product considered non-prescription by Health Canada could require a prescription under the National Drug Schedules oEx. Bactroban (mupirocin) is a schedule 1 drug, but does not include a Pr symbol on packaging stating that it is only for prescription use

Question 38

Scheduling notes NAPRA

Answer 38

The “Notes” that appear after the name of the drug provide useful information The NAPRA schedule assigned may be based on: - Strength or dosage of the drug listed - Package size - Route of administration - Indication Several drugs have multiple listings, it is important to read the notes to understand the rationale

Question 39

Footnotes

Answer 39

Footnotes appear at the top of the national drug schedules which are useful to identify the federal or health Canada schedule of a drug The federal or health Canada legislation has several lists or schedules of drugs which require a prescription: - Drugs listed in the prescription drug list - Narcotics - Controlled drugs - Benzodiazepine and other targeted substances