Health Canada, FDA, NAPRA

• Law


  All rules of conduct established and enforced by authority, legislation or custom of a given community, state or other group
• Bill


  A proposed Act that is before the Legislative Assembly for consideration
• Act


  A bill that is passed by the Legislative Assembly after its Third Reading becomes law
• What an Act Contains

  • Title
  • Definitions
  • Schedules
  • Regulations
  • Parts
  • Sections
  • Subsections
  • Clauses
  • Forms
• Definitions


  Acts explain certain definitions used under the act
• Schedules


  Detailed lists/principal document
• Parts


  The largest portion of a written law and serves to divide different content areas within the law
• Sections, Subsections, Clauses


  Small, distinct, numbered subdivision of an Act
• Regulations


  Deals with topics related to the Act, interpretation/description of procedures in an Act, supporting more detail "rules" to be followed
• Legislation


  Encompasses both Acts and Regulations
• Health Canada


  Most provincial legislation about pharmacy comes from FDA
• Pharmaceutical Drugs Directorate


  • Medical devices bureau
  • Special access program
• Food & Drugs Act (FDA)


  Gives federal minister of health the authority to: Regulate, Inspect, Seize, Impose penalties
• All drugs important or manufactured must be approved by Health Canada
• Schedules


  • A "advertising"
  • B "books"
  • C "radio"
  • D "immunoglobulin D"
  • E
  • F -> Prescription Drug List
  • G "controlled drugs"
• Prescription Drug List


  • Criteria: Drug that requires supervision of practitioner for diagnosis, treatment or prevention of a disease or disorder for which drug is recommended & for monitoring drug's use, Consideration to lvl of uncertainty with the drug's use or its effects, Potential harm that a drug could cause that would require supervision by a practitioner
• Prescription Drug List sections

  • Products for human use
  • Products for veterinary use
• Food & Drug Regulations

  • A -> administration
  • B -> food production & food safety and inspection
  • C -> drugs & defines rules for dispensing
  • D -> vitamins, minerals & amino acids
  • E -> cyclamate & saccharin sweeteners
  • G -> controlled drugs
  • J -> restricted drugs
• Practitioner


  Person who is entitled under laws of a province to treat patients with a prescription drug and is practicing their profession in that province
• Child resistant package


  Package that meets child test protocol requirements of Canadian Standards Associations (CSA) or other standards as specified in the Food & Drug Regulations
• Symbols


  • PR -> prescription
  • N -> narcotics
  • C -> controlled drugs
  • T/C -> benzos & other targeted substances
• Natural Health Products Regulations
• Medical Devices Regulations
• Manufacturing


  • Regulated by Federal government, Process for approving a drug is regulated from beginning to end: Providing clinical evidence for efficacy & safety of drug, Raw materials used to manufacture drug, Final drug product
• DIN


  Number given to a product once it is approved
• Distribution of drugs


  • Regulated through Drug Establishment License by Health Canada, permits: Manufacturing, Packaging, Wholesale
• Compounding


  • Regulated by provincial/territorial bodies, Compounded products: Are prepared pursuant to prescription w/in an established pharmist-pt relationship, Requires consultation btwn pharmacist & pt, Provide customized therapeutic solution to improve pt care
• Compounding is considered a controlled act & within scope of practice for pharmacy but also for physicians & nurses
• Health Canada's Policy on Manufacturing & Compounding Drug Products in Canada
• Recalls (lvl determined by Health Products & Foods Branch)

  • Type 1 (most serious): Reasonable probability that use or exposure to product will cause serious adverse health consequences or death
  • Type 2: Use or exposure to product may cause temp adverse consequences or where the probability of serious health consequences is remote
  • Type 3: Use or exposure to product is not likely to cause any adverse health consequences
• MedEffect


  • Provides consumers, pts & health professionals w/ access to report adverse reactions or side effects & find new safety info on drugs or products, Suspected adverse drug reactions are mandatory requirement for manufacturers -> must be reported w/in 15 days to Health Canada
• Canada Vigilance Program
• Health Canada Drug Product Database
• NAPRA - National Association of Pharmacy Regulatory Authorities

  • Schedule assigned may be based on: Strength or dosage, Package size, Route of admin, Indication
• A number of drugs have multiple listings (ex. 1, 2, 3…) so it is important to read the notes to understand rationale for scheduling
• Federal acts


  • CDSA
  • FDA
• Provincial acts


  • Regulated health professions act
  • Drug & pharmacy regulations act (dpra)
  • Ontario drug benefit act
• Regulatory bodies


  • Health Canada
  • FDA
  • NAPRA
• Law


  All rules of conduct established & enforced by authority, legislation or custom of a given community, state or other group
• Bill


  A proposed act that is before the legislative assembly for consideration