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Federal and provincial legilation Flashcards

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1
Q

Why drugs are regulated

A

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.

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2
Q

Why regulate medicinal drugs

A

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

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3
Q

Act is and what are the ones we follow

A

Legislation; law passed by government
Food and Drug Act (federal)
The Pharmacy and Pharmacy Disciplines Act, 2015 (provincial)
Veterinarians Act, 1987 (Provincial)

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4
Q

Regulations are and what ones do we follow

A

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.

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5
Q

bylaws are

A

Regulations at the provincial level or lower level of administration (i.e., regulatory body)
SVMA bylaws

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6
Q

Standards are

A

Document established by consensus and approved by a recognized body that provides guidelines aimed at achieving an optimal degree of order
Practice standards

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7
Q

Regulations with bylaws

A

**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.

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8
Q

Schedules are

A

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

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9
Q

Federal drug legislations are

A

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

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10
Q

Therapeutic products directorate (TPD) is

A

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

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11
Q

TPD mandate is

A

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

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12
Q

TPD is responsible for

A

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

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13
Q

Veterinary Drugs Directorate (VDD) is and regulates what

A

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

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14
Q

How do drugs get to market

A

Research and development
Patent protections
Preclinical testing
Clinical trial application
Clinical trial
Health Canadas drug review process
Notice of complience

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15
Q

Research and development for a drug going to market includes

A

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.

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16
Q

Patent protections when a drug going to market includes

A

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.

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17
Q

Preclinical testing for drugs includes

A

Tissue culture or laboratory species
Can take 3-5 years

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18
Q

Clinical test applications for drugs is

A

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

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19
Q

Clinical trial for drugs is

A

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.

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20
Q

Health Canada’s drug review process is

A

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

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21
Q

Notice of compliance for drugs wanting to go to marked is

A

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

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22
Q

Vanessas law is

A

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

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23
Q

Vanessas law gives the ability to

A

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

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24
Q

What falls under Vanessas law

A

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…..

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25
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
26
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
27
Where should you perform adverse drug reactions to
CFIA
28
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.
29
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
30
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
31
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)
31
What does part C of teh food and drug regulations cover
Drugs
32
What does part D of food and drug regulations include
Vitamins and minerals
33
What deos part G of the food and drug regulations cover
Controlled drugs
34
What does part J of the food and drug regulations cover
Restricted drugs
35
Part C of the food and drug regulations includes what definitions
Brand name Common name Expiration date Parenteral use Percent Practitioner Prescription Teaspon
36
Expiration date on a drug must include
Minimum year and month designating point at which drug loses its potency, purity, etc.
37
Percent of drug is catagorized by
By weight (expressed as gram/100 units, for solids g/100g, for liquids g/100ml)
38
Practicioner is
Person authorised by province to prescribe prescription list drug
39
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
40
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
41
How to tell its the brand name
Assigned by manufacturer, may have ® or ™ symbol following brand name
42
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
43
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)
44
N on medication indicates
“N” indicated in a contrasting color on the label and as defined in the CDSA and Narcotic Regulations
45
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
46
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
47
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
48
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
49
Lot number and expiration date are assigned by
the manufacturer
50
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.
51
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
52
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
53
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
54
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.
55
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.
56
Veterinarians have 2 roles related to drugs:
Ability to prescribe Ability to dispense the prescribed drug
57
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
58
The veterinarians act practice standards are
Outline practical pharmacy requirements Record keeping requirements, drug storage, label information
59
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
60
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
61

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