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PHARMA SKILLS > 2. Legislation and Regulation of Drugs > Flashcards

2. Legislation and Regulation of Drugs Flashcards

1
Q

Why are drugs 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 ituation

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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 diff types of Market Failure (ophan drugs and vx’s, 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

What is an act and what are some examples of it?

A

Legislation; law passed by government
food and drug act (federal)
the pharmacy and pharmacy disciplines act (provincial)
the veterinarians act (provincial)

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4
Q

What is a regulation and what is an example of it?

A

imposed restrictions and procedures (rules) to be used to fulfill and enforce the written act
ex. food and drug regulations (federal)
the drug schedules regulations (provincial)
regulations can NOT exceed the scope of the act and must comply with the act

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5
Q

What are bylaws and an example of it?

A

regulations at the provincial level or lower level of administration (regulatory body)
SVMA bylaws

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6
Q

What are standards and an example of it?

A

documents established by consensus and approved by a recognized body that provides guidelines aimed at achieving an optimal degree of order
ex. practice standards

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7
Q

How are bylaws created?

A

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

What are schedules? Give an example

A

are lists of drugs which the acts, regulations and bylaws refer to
ex. food and drug act, schedule A (federal)
harmonized drug schedules 1, 2, 3, 4

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9
Q

What is the federal drug legislation?

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

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10
Q

What are the two drug directorates and who do they have to go through?

A

Health canada
Therapeutic drugs directorate (drugs for human use)
veterinary drug directorate (licensed for vet use)

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11
Q

What is the therapeutic products directorate?

A

Division of health canada
federal authority that regulates pharmaceutical drugs and medical devices for human use
Mandate (direction of action) derived from several acts of parliament such as food and drug act and drug and medical devices regulations, also controlled drugs and substances act and narcotic regulations
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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12
Q

What is a therapeutic product?

A

Rx and OTC drugs, vaccines, gene therapies, cells, tissues and organs, and medical devices (wheelchair, syringes, etc.)

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13
Q

What is the veterinary drug directorate (VDD)

A

division of health canada
federal authority that regulates pharmaceutical drugs and medical devices for vet us
“for vet use only”
accepts submissions for new drug approval which are then transferred to the TPD for approval process
all post market monitoring thru CFIA ex. adverse drug reaction reporting

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14
Q

How does a drug get to market?

A
  1. researh and development
  2. patent protection
  3. precinical testing
  4. clinical trial application
  5. Clinical trial
  6. health cad drug review process
  7. notice of compliance
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15
Q

In getting drugs to market, why do we research and develop?

A

scientists develop chemicals or biological molecules
guided by knowledge of dz processes, especially cause (genetic, infectious) and pathological process of dz
also includes research into formulation and other delivery substances

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16
Q

In getting drugs to market, what are patent protections?

A

up to 20yr 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

In getting drugs to market, what are pre-clinical testing

A

tissue culture or lab species
can take 3-5yrs

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18
Q

In getting drugs to market, what are clinical trial application

A

testing in target species (human/vet)
includes ingredients, dosage forms, duration, indications; must record all adverse effects, toxicity

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19
Q

In getting drugs to market, what are clinical trials?

A

3 successive phases, any fails = repeats
phase 1: 20-100 volunteers: dose titration and pharmacokinetic studies; 6-9mo; 70% will pass
Phase 2: 100-300 patients w/ targeted condition; to find short term effects and ideal dose range; 6mo-3yrs
Phase 3: 1000-3000 patients to confirm effectiveness and determine s/e; 1-5yr; 10% of trials make it here
Note: many vet drugs approved as an ancillary process of human drug development bc first tested on anims

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20
Q

In getting drugs to market, what is the health CAd drug review process?

A

drugs w/ successful clin trials apply for authorization to sell in CAD
also applied to drugs developed in other countries that want to be marketed in CAD

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21
Q

Which regulatory office do I need to apply to when making human drugs/ vet drugs / vitamin/mineral supplements, herbal products/ vx, colostrum, anti-serum, radio-pharmaceutical drugs?

A

TPD - human drugs
VDD - vet drugs
NHPD - vitamin/mineral supplements, herbal
BGTD - vx, colostrum, antiserum, radio-pharmaceutical drugs
Cannabis directorate

22
Q

In getting drugs to market, what is the notice of compliance?

A

final decision that drug is approved for marketing in CAD
drug given a DIN
all drugs w/ notice of compliance in CAD can be found at health canada’s product database
Drugs can also be declined at this stage :(

23
Q

What is vanessas law?

A

protects CADs from unsafe drugs act
an amendment to the Food and drugs act which strengthens regulation of therapeutic products
makes surveillance of therapeutic products mandatory incl. mandatory adverse drug reaction reporting by healthcare professionals and drug manufacturers

24
Q

What does vanessa’s law gives the ability to do?

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
Not for natural products - labels to be revised to clearly reflect health risk info
note that a # of pharmaceuticals that are derived from natural sources would not be affected

25
Q

What is pharmacovigilance?

A

drug safety
pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects w/ pharmaceutical products
As per Vanessa’s Law, vet med is required to supply info about drug concerns to Health Canada for pharmacovigilance
Applies to: manufacturers, vets and RVTs

26
Q

What is the emergency drug release?a

A

allows vets to request access to drugs for vet use NOT normally approved for sale in CAD
vets must make a special request to the VDD
requires post-use report on results of use, type of energy, efficacy and adverse reactions. Also requires detailed accounting of alld rug used

27
Q

What is the list of federal acts and regulations?

A

food and drugs act - non-controlled drugs act, prescription drug list
Food and drug regulations
Cannabis act
controlled drugs and substances act - narcotic control regulations, benzodiazepines and other targeted substances regulations
biological and genetic therapies act - includes ALL vx’s and gene therapies
pest control products Act (PCPA) - antiparasites, insecticides - no ELDU
health of animals act and regulations

28
Q

What is the food and drug regulations and what does it include?

A

described rules which comply to the FDA, regulations divided into parts >divisions (also contains schedules (lists)
includes: Pr 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

29
Q

What is in Part C, D, G and J of the food and drug regulations?

A

C - drugs
D - vitamins and minerals
G - controlled drugs
J - restricted drugs

30
Q

What is included in part C of the FDR?

A

gives definitions
Brand name: assigned by manufacturer
Common name: name by which drug is commonly known
EXP date: min yr and month designating point at which drug loses its potency, purity,etc
Parenteral use: “…administration of a drug by hypodermic syringe, needle or other instrument thru or into the skin or mucous membrane”
* Percent: By weight (expressed as grams/100 units, for solids g/100g, for liquids g/100mL)
* Practitioner: Person authorized by province to prescribe Prescription List drug
* Prescription: “…order given by a practitioner directing that a stated amount of any drug or mixture of drugs specified therein be dispensed for the person named in the order”
* Teaspoon: = 5cc for calculation of dose

31
Q

What is the product monograph/package insert?

A

outer packaging (principle display panel) often too small for all info. May instead refer reader to package insert
or have a peel back label with more info on the reverse

32
Q

What is a brand name?

A

on the principle display panel
assigned by manufacturer, may have a r or tm symbol

33
Q

What is the common or proper name?

A

on principle display panel

34
Q

What does the Pr symbol look like and what does it indicate?

A

enclosed in a rectangle
indicates prescription required federally – is listed in Prescription Drug List to the FDA
Regulations or as required in Part D

35
Q

What does the C symbol look like and what does it indicate?

A

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)

36
Q

What does the N symbol look like and what does it indicate?

A

“N” indicated in a contrasting color on the label and as defined in the CDSA and Narcotic Regulations

37
Q

What does the T/C symbol look like and what does it indicate?

A

“T/C” enclosed in a rectangle and contrasting color – targeted substance as defined in the CDSA and Benzodiazepine and Other
Targeted Substances Regulations

38
Q

What is the generic name?

A

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

39
Q

Where is the strength of a drug located?

A

on principle display panel

40
Q

Where can you find the DIN assigned by health Canada?

A

principal display panel

41
Q

Where can you find the package quantity?

A

Number of units contained in the package (solid dosage forms,
grams or mL) – any panel

42
Q

Where can you find the active ingredients/strengths, recommended dose, storage requirements and lot #

A

On any panel
active ingredients/strengths: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
Recommended dose:Adequate directions for use of the drug
Storage requirements; Including temperature and light sensitivity to maintain product
stability and potency as required by standards (could include storage container or other information) Specific container materiall
Lot Number: assigned by manufacturer

43
Q

Where can you find the EXP date, manufacturer and drug form

A

exP: assigned by manufacturer, min moth/yr
Manufact: name and address
Drug form: must be evident - if not, special characteristics of form must be noted
All on any panel

44
Q

What other regulations might be in part C?

A

drug dosage limits
sets out dose limits for adults and children for certain drugs
Ex. acetaminophen/asa 650mg single and 4.0g daily
ephedrine 11mg sing, 32.5 mg daily
except when issues by prescription
Keep out of reach from children

45
Q

Do labeling requirements need to be applied to a drug that is repacked by a pharmacist/practitioner at time of sale?

A

no

46
Q

What is the national association of pharmacy regulatory authorities?

A

NAPRA
voluntary association of provincial and territorial pharmacy regulatory bodies. only QC is exempt
regulatory created a harmonized national drug schedule (NDS)
determines how drugs are regulated w/ respect to requiring prescription, restricted access, unrestricted access at point of purchase
lists can be more restrictive than federal lists

47
Q

What is the pharmacy act, 1979?

A

Allows vets privilege to sell drugs

48
Q

What is the veterinarian act, 1987 (SK)

A

vets have 2 roles related to drugs - can prescribe and dispense said drug
MUST have valid VCPR
Practice standards - outline practical pharmacy requirements
record keeping requirements, drug storage, label info

49
Q

What is the SVMA practice standards?

A

A consensus document
standard 7 relates to pharmacy
outlines physical/practical pharmacy requirements
record keeping requirements, drug storage, label info and control drugs

50
Q
A

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