Federal and provincial legilation Flashcards
Why drugs are regulated
A framework through which people in a society resolve their disputes and problems in a way that does not involve force and consistently yields results that are acceptable to most of society
Laws provide firm rules with some flexibility to accommodate the individual differences of each situation.
Why regulate medicinal drugs
To protect the public (patient and people)
Necessary and beneficial commodities that are subject to different types of Market Failure.
Orphan drugs and vaccines
Antibiotics
Patenting of new medications
Information asymmetry
The role of laws in pharmacy are to protect the patient and the society as a whole
Act is and what are the ones we follow
Legislation; law passed by government
Food and Drug Act (federal)
The Pharmacy and Pharmacy Disciplines Act, 2015 (provincial)
Veterinarians Act, 1987 (Provincial)
Regulations are and what ones do we follow
Imposed restrictions and procedures (rules) to be used to fulfill and enforce the written Act
Food & Drug Regulations (federal)
The Drug Schedules Regulations, 1997 (provincial)
Regulations can NOT exceed the scope of the Act, i.e. must comply with the Act.
bylaws are
Regulations at the provincial level or lower level of administration (i.e., regulatory body)
SVMA bylaws
Standards are
Document established by consensus and approved by a recognized body that provides guidelines aimed at achieving an optimal degree of order
Practice standards
Regulations with bylaws
**These cannot be more permissive than the Federal Laws/Regulations
**Bylaws are not passed by the government – they are created from lower jurisdictions (ex: SCP, a professional body, or perhaps a city – ex: city bylaw for speeding in school zones). Bylaws can NOT exceed the Act or Regulations.
Schedules are
Are Lists of drugs which the Acts, Regulations, Bylaws refer to.
E.g.
Food & Drug Act, Schedule A (federal)
Harmonized Drug Schedules 1,2,3,4
Federal drug legislations are
Federal regulations concerning drugs are through Health Canada and its branches:
Manufacturing and distribution (including import, export)
Licensing drugs
Drug lists
Prescribing and dispensing
Health Canada
Therapeutic Drugs Directorate (TPD)
Drugs licensed for human use
Veterinary Drugs Directorate (VDD)
Drugs licensed for veterinary use
Therapeutic products directorate (TPD) is
What is a therapeutic product??? Rx and OTC drugs, vaccines, gene therapies, cells, tissues and organs, and medical devices (wheelchair, syringes, etc.)
Division of Health Canada
Federal authority that regulates pharmaceutical drugs and medical devices for human use
TPD mandate is
Mandate (direction of action) is derived from several Acts of Parliament such as:
Food and Drug Act & the Drug and Medical Devices Regulations
Controlled Drugs & Substances Act & Narcotic Regulations
TPD is responsible for
Responsible for pre- and post-market drug development
Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product’s safety, efficacy and quality as required by the Food and Drugs Act and Regulations
Veterinary Drugs Directorate (VDD) is and regulates what
Division of Health Canada
Federal authority that regulates pharmaceutical drugs and medical devices for veterinary use
“For Veterinary Use Only”
Accepts submissions for new drug approval which are then transferred to the TPD for the approval process
All post-market monitoring is through the Canadian Food Inspection Agency (CFIA) e.g. adverse drug reaction reporting
How do drugs get to market
Research and development
Patent protections
Preclinical testing
Clinical trial application
Clinical trial
Health Canadas drug review process
Notice of complience
Research and development for a drug going to market includes
Scientists develop chemicals or biological molecules.
Guided by knowledge of disease processes, especially cause (genetic, infectious) and pathological process of disease.
Also includes research into formulation and other delivery substances.
Patent protections when a drug going to market includes
Up to 20 years as per international standards.
Protects developing company’s investment in the product and allows time to manufacture and market.
Note: Cost for a generic manufacturer to release a product already patented approx. $1-2 million. Generic companies can manufacture and market when original patent runs out.
Preclinical testing for drugs includes
Tissue culture or laboratory species
Can take 3-5 years
Clinical test applications for drugs is
Testing in the target species (human or veterinary)
Includes ingredients, dosage forms, duration, indications; must record all adverse effects, toxicity
Approx 1400 applications/year to Health Canada
Clinical trial for drugs is
3 successive phases in the target species
If any phase is failed, they must restart the process
Phase 1 – 20-100 volunteers; dose titration and pharmacokinetic studies; 6-9 months; 70% will pass Phase 1
Phase 2– 100-300 patients with targeted condition; to find short term effects and ideal dose range; 6 mo – 3 years
Phase 3– 1000-3000 patients to confirm effectiveness and determine side effects; 1-5 years; 10% of trials make it to Phase 3
Note: Many veterinary drugs are approved as an ancillary process of human drug development because they were tested on animals first.
Health Canada’s drug review process is
Drugs with successful clinical trials apply for authorization to sell in Canada.
Also applies to drugs developed in other countries that want to be marketed in Canada
Notice of compliance for drugs wanting to go to marked is
Final decision that drug is approved for marketing in Canada
Drug is given a DIN
All drugs with Notice of Compliance in Canada (aka approved for sale) can be found at Health Canada’s Product Database
Drugs can also be declined at this stage
Vanessas law is
An amendment to the Food and Drugs Act which strengthens the regulation of therapeutic products
Makes surveillance of therapeutic products mandatory, including mandatory adverse drug reaction reporting by healthcare professionals and drug manufacturers
Vanessas law gives the ability to
Recall unsafe therapeutic products
Impose tougher fines and penalties (including jail time)
Direct label changes/packaging changes
Compels drug companies to do further testing when issues identified
What falls under Vanessas law
Not for Natural products
Labels to be revised to clearly reflect health risk information
Note that a number of pharmaceuticals that are derived from natural sources would not be affected…..
Pharmacovigilance is
Aka drug safety
Pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
As per Vanessa’s Law, veterinary medicine is required to supply information about drug concerns to Health Canada for pharmacovigilance
Pharmacovigilance applies to
Manufacturers– Report to CFIA(who report to VDD)
Veterinarians– Report to manufacturer or CFIA
RVTs– Observe or from client; report to the veterinarian
Where should you perform adverse drug reactions to
CFIA
Emergency drug release is and allows the vet to
Allows veterinarians to request access to drugs for veterinary use that are NOT normally approved for sale in Canada
Veterinarian must make a special request to the VDD
Requires post-use report on results of use, type of emergency, efficacy and adverse reactions. Also requires detailed accounting of all drug used.
List of Federal Acts and Regulations
Food and Drugs Act
Non-Controlled Drugs Act
Prescription Drug List
Food and Drugs Regulations
Cannabis Act
Controlled Drugs and Substances Act
Narcotic Control Regulations
Benzodiazepines and Other Targeted Substances Regulations
Biologics and Genetic Therapies Act
Includes ALL vaccines and gene therapies
Pest Control Products Act (PCPA)
Anti-parasitics, insecticides
No ELDU
Health of Animals Act and Regulations
Federal legislation: food and drug regulations include
Prescription drug dispensing rules including record of written and verbal transcriptions
Schedule (list) of controlled drugs
Controlled drug storage conditions
Rules for dispensing antibiotics to a lactating food animal
Rules for stating withdrawal times
Federal legislation for food and drug relations do what
Describes the rules which comply to the Food and Drugs Act
Regulations are divided into Parts
Parts are further divided into Divisions
Also contains Schedules (lists)
What does part C of teh food and drug regulations cover
Drugs
What does part D of food and drug regulations include
Vitamins and minerals
What deos part G of the food and drug regulations cover
Controlled drugs
What does part J of the food and drug regulations cover
Restricted drugs
Part C of the food and drug regulations includes what definitions
Brand name
Common name
Expiration date
Parenteral use
Percent
Practitioner
Prescription
Teaspon
Expiration date on a drug must include
Minimum year and month designating point at which drug loses its potency, purity, etc.
Percent of drug is catagorized by
By weight (expressed as gram/100 units, for solids g/100g, for liquids g/100ml)
Practicioner is
Person authorised by province to prescribe prescription list drug
Part C of the drug regulations must include
Gives definitions
Medical label requirements- principle display panel
Product monograph/package insert
Brand name: on principle display
Common or proper name
Symbols
Generic name
Strength
DIN
Package quality
Active ingredients and strengths
Recommended dose
Storage requirements
Lot number
Expiration date
Manufacturer
Drug form
Product monograph/insert is
Outer packaging (principal display panel) often too small for all information. May instead refer reader to “package insert”
Or have a peel back label with more info on the reverse
How to tell its the brand name
Assigned by manufacturer, may have ® or ™ symbol following brand name
Pr symbol means
“Pr” enclosed in rectangle- indicates prescription required federally- is listed in prescription drug list to the FDA regulations or as required in part D
C enclosed in a diamond means
“C” enclosed in diamond– indicates controlled drug – is listed in Part G of the FDA Regulations and as defined in the Controlled Drug and Substances Act (CDSA)
N on medication indicates
“N” indicated in a contrasting color on the label and as defined in the CDSA and Narcotic Regulations
T/C symbol means
“T/C” enclosed in a rectangle and contrasting color – targeted substance as defined in the CDSA and Benzodiazepine and Other Targeted Substances Regulations
Generic name is
Proper or common name of the drug must immediately precede or follow the brand name and must be at least one-half the size of the Brand name -principal display panel
Active ingredients and strengths are
Quantitative list of name and strength of each active ingredient (by proper or common names i.e. generic names) per dosage unit, gram or mL - any panel
Storage requirements include
Including temperature and light sensitivity to maintain product stability and potency as required by standards (could include storage container or other information) – on any panel
Specific container material
Lot number and expiration date are assigned by
the manufacturer
Other Regulations in Part C
Section C.01.021 – Drug Dosage limits
Section C.01.028 – Required Cautionary Statements
Section C.01.029-031 - Serious Harm to a Child and Child-Resistant Packaging
Labelling requirements do not apply to a drug that is repacked by a pharmacist/practitioner at time of sale.
Drug dosage limits is
Sets out dosage limits for adults and children for certain drugs
Examples: Acetaminophen/ASA 650mg single and 4.0g daily
Ephedrine 11mg single, 32.5mg daily
Except when issued by prescription
Child warnings include
“Keep out of Reach of Children”
Any drugs containing ASA, Acetaminophen, more than 250mg elemental iron, more than 120mg fluoride ion
These drugs must be sold in child resistant packaging if recommended solely for children, or if not solely for children, have at least one package size available with child resistant packaging
Provincial Drug Regulations – Prescribing Privileges
Once a new drug has been approved, conditions of sale fall under provincial jurisdiction
Can be more strict than federal law; otherwise, must default to federal standards
The Drug Schedules Regulations, 1997
MDs, dentists, ophthalmologists, vets can prescribe; special conditions for pharmacists and LPNs
Schedule I, II and III drugs require prescriptions
National Association of Pharmacy Regulatory Authorities (NAPRA) is and regulates
Voluntary association of provincial and territorial pharmacy regulatory bodies. Only Quebec is exempt
Regulatory bodies created a Harmonized National Drug Schedule (NDS)
Determines how drugs are regulated with respect to requiring prescriptions, restricted access, unrestricted access at point of purchase.
Lists can be more restrictive (i.e., require more scrutiny) than federal lists.
The Pharmacy Act, 1979 (Saskatchewan) – Veterinary Privilege to Sell Drugs
Veterinarian granted exemption from the Act which restricts dispensing/selling of Schedule I, II and III drugs to a registered pharmacist
Non-application of Act to veterinary surgeons
107 Nothing in this Act prevents a veterinary surgeon from providing drugs or medicine for animals, fish or fowl. 1971,c.37, s.107; R.S.S. 1978, c.P-9, s.107.
Veterinarians have 2 roles related to drugs:
Ability to prescribe
Ability to dispense the prescribed drug
What must a vet have under the veterinarians act to prescribe medication
MUST have a valid VCPR (Veterinarian Client Patient Relationship) to carry out either role
The veterinarians act practice standards are
Outline practical pharmacy requirements
Record keeping requirements, drug storage, label information
SVMA Practice Standards has
A Consensus document
Standard 7 Relates to Pharmacy
Outlines physical/practical pharmacy requirements
Record keeping requirements, drug storage, label information , control drugs
What does all of the laws and regulations mean in the broad spectrum
Heath Canada is the federal body
VDD looks after veterinary labelled drugs – getting them to market and regulation
CFIA looks after pharmacovigilance of veterinary drugs
Vanessa’s Law requires that we report adverse drug reactions to VDD
Regulations are how Acts are carried out
Food and Drugs Act and Regulations outlines laws for the 7 federal drug classes, including minimum prescription requirements
Also: manufacturing, labelling, common definitions, dispensing
Provincial laws address majority of after-market use
The Drug Schedules Regulations allows certain individuals to prescribe
The Pharmacy Act allow veterinarians to dispense and sell
SVMA Bylaws and Practice Standards are documents that describe the conditions under which veterinarians can prescribe, dispense, sell
