Jurisprudence 3 Flashcards
Health Canada
-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
Food and Drugs Act
-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
Schedule A
List of disease states or conditions where treatments are not promoted to the public
Asthma, cancer, depression
Products are not advertised
Schedule B
Publications describing official or international standards
All drugs in Canada must follow these standards
Schedule C
Radiopharmaceuticals
Schedule D
Allergenic substances, blood derivatives and immunizing agents
Schedule G
Controlled Drugs and the prescription drug list
Food and Drug Regulations
- 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
Part A
Covers administrations
Part B
Food production and safety
Baby food, alcohol, flavourings, and dairy products
Food safety and inspection
Part C
Provides rules to dispensing
Part D
Vitamins, minerals, and supplements
Part E
Sweeteners
Part G
Controlled drugs
Part J
restricted drugs
Part C definitions: Practitioners
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
Part C definitions: child resistant packages
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
Part C symbols: Pr
N
C
TC
Pr - product requiring prescription for sale
N - narcotic
C - controlled drugs
TC - benzodiazepines and other targeted substances
Manufacturing and the process
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
GMP
Good Manufacturing Practices
- The FDA describes the regulatory requirements for manufacturers of drug products
What does a DIN identify?
strength
dosage form
name
use
DEL
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
Other manufacturing rules:
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
Compounding definition
The act of compounding drugs is regulated provincially to help ensure the quality and safety of compounded drugs by members of the pharmacy profession
compounded drug products in pharmacy
- 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
Type 1 Health Canada recall
- 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
Type 2 Health Canada recall
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
Type 3 health canada recall
Situation of which the use of, or exposure to, a product is not likely to cause any adverse health consequences
Suspected adverse drug reactions
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
MedEffect Canada
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
Canada vigilance program
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
Post-market surveillance
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
Prescription Drug List
- 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
Criteria for the PDL:
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
NAPRA
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
Conditions for sale NAPRA
- 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
Pr Symbol Conditions for sale (NAPRA)
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
Scheduling notes NAPRA
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
Footnotes
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
