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Pharmacology > Drug directorate, laws & labels > Flashcards

Drug directorate, laws & labels Flashcards

1
Q

What does a “drug” include?

A

Any substance sold or manufactured, sold, or represented for the use in:
- diagnosis, tx, mitigation, or prevention of a disease, disorder, abnormal physical state, or its symptoms in humans or animals
- restoring, correcting or modifying organic functions in humans or animals
- disinfection in premises in which food is manufactured, prepared, or kept

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2
Q

What are the 5 classes of drugs by the National food and drugs act?

A
  • prescription & non prescription pharmaceuticals
  • biologically derived products (blood, biotechnology, vx)
  • tissues and organs
  • disinfectants
  • radiopharmaceuticals
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3
Q

How are natural health products classified?

A

> By the food and drugs act - considered drugs
Natural health products regulations - natural health products
Food and drug regulations - not drugs

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4
Q

What does health canada do?

A

responsible for protecting human and animal health and the safety of Canada’s food supply - evaluate and approve health products for sale, decide what medicinal ingredients require rx, cannot sell products without authorization of HC

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5
Q

What is the VDD?

A

Veterinary Drug Directorate - division of HC

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6
Q

What is the role of the VDD?

A
  • evaluate and monitor safety, quality, and effectiveness of vet drugs
  • set standards and promote prudent use of vet drugs administered to food producing and companion animals
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7
Q

What does the VDD actually do?

A
  • approve new vet drugs
  • ensure drugs are safe and effective
  • sets maximum residue limit (MRL), which then determines withdrawal period (WP or WT)
  • inspect pharmaceutical plants to ensure QC present
  • monitor adverse drug reactions (ADR)
  • authorize emergency drug releases (EDR)
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8
Q

What is pharmacovigilance?

A

collection and analysis of suspected adverse drug reactions

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9
Q

What is the purpose of pharmacovigilance?

A

monitor safety and efficacy of vet drugs & safety of humans handling the products and consuming food from treated animals

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10
Q

What is an emergency drug release?

A

authorization to allow the manufacturer of a new drug to sell a limited quantity of new drug to vet practitioner - not marketed in canada and requested by vet for purpose of diagnosing or treating a medical emergency in a patient under his/her care

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11
Q

What is considered off label use? (ELDU)

A

administered differently than what is on the label - species, dose, route

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12
Q

What is considered a compounded drug?

A

combining or mixing of 2 or more ingredients (one is a drug) to create a final product in an appropriate form for dosing

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13
Q

What are some reasons for compounding?

A
  • combine 2 or more drugs in one syringe
  • make a “sweat” ointment
  • drug is not available commercially
  • remove a component that patient has allergies to
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14
Q

What happens with the development of a new drug?

A
  1. discover or synthesize a new drug
  2. evaluate safety, efficacy, dosage, etc
  3. submit data to VDD who gives it a DIN if approved
  4. continued surveillance
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15
Q

What 15 things are required on a drug label/insert?

A
  1. Trade/Brand Name
  2. Generic Name
  3. Concentration
  4. VDD Classification
  5. DIN
  6. Veterinary Use Only
  7. Total Amount of drug
  8. Drug Company Name
  9. Indications
  10. Dosage and Administration
  11. Warning
  12. Contraindications and Cautions
  13. Storage Instructions
  14. Lot Number
  15. Expiration Date
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16
Q

What is the trade or brand name?

A

proprietary - legally owned by the company - indicated by a symbol (Baytril)

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17
Q

What is the generic name?

A

non-proprietary - active ingredients (may be actual chemical name but usually shorter) (enrofloxacin)

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18
Q

What is the VDD classification?

A

category of drugs that the VDD assigns - “broad spectrum antibiotic”

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19
Q

What should be included in dosage and administration?

A

species, amount, route, any restrictions

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20
Q

What is withdrawal time?

A

time between last administration of the drug until any food products can be used for human consumption - applies to specific bottle dosing only

21
Q

What is maximum residue limit?

A

level of drug residue that could safely remain in the tissue or food product derived from an animal that has been treated with a drug - ultimately determines the WT

22
Q

What are the 2 acts used by HC for definitions of categories of drugs?

A

food and drugs act
controlled drugs and substances act

23
Q

What are the 2 categories of veterinary drugs?

A

non-scheduled drugs
scheduled drugs

24
Q

What are considered non scheduled drugs?

A

= Over the counter (OTC)
safe to use with a very low potential for toxicities or addiction (not on prescription drug list, certain pesticides and parasiticides)

25
Q

Why would a drug be considered scheduled?

A
  • potential for human abuse of drug
  • serious side effects
  • therapeutic index is <10 (easy to OD)
  • new abx - to decrease potential for resistance through improper use
26
Q

What is AMR?

A

Antimicrobial drug resistance

27
Q

What are the 4 categories of scheduled drugs?

A

Prescription drug list - PR or RX
controlled drugs - C
narcotic drugs - N
targeted substances - T/C

28
Q

What do all scheduled drugs require before use?

A

an intervention - which can include PE, diagnostic workup, hospitalization, VCPR

29
Q

What do drugs that are dispensed require?

A

prescription & established/valid VCPR

30
Q

What are the 6 guidelines for vet prescribed drugs?

A
  1. labeled for use only by or on the order of a licensed vet
  2. to be used or prescribed within the context of a VCPR
  3. must be properly labeled before being dispensed
  4. appropriate dispensing and tx records must be maintained
  5. dispense only required amount
  6. any ELDU should be treated as a prescription drug
31
Q

What are the 3 conditions that must be met to have a valid VCPR?

A
  • vet assumes responsibility for making clinical judgements, and need for medical treatment, and client agrees to follow instructions
  • vet has sufficient knowledge of animal to give diagnosis, recently seen the animal and personally acquainted with keeping and care
  • vet is readily available for follow up, emergencies, etc
32
Q

What are the 7 parts of a prescription label?

A
  1. date
  2. vet name, address, ph # of clinic
  3. client name
  4. animal name and species
  5. drug name, strength, quantity
  6. directions for use - amount, route, frequency, duration
  7. refill information
33
Q

What are some products that aren’t pr but require a VCPR?

A
  • MLV vx
  • vet prescribed feed additives
  • not a pr drug but used off label
  • removed from original packaging
34
Q

What is considered a controlled substance?

A

higher-than-average potential for abuse or addiction – theft, fraud or resale on the street

35
Q

What are the 5 classes of controlled veterinary drugs?

A
  1. euthanasia solutions (pentobarbital)
  2. Phenobarbital (barbituarate)
  3. Thiopental (barbiturate)
  4. Torbugesic and Torbutrol (butorphanol)
  5. depo-testosterone
36
Q

Who makes the rules for narcotics?

A

Narcotic control regulation (NCR) which includes the controlled drugs and substances act

37
Q

What are the 3 divisions of narcotics?

A
  1. non-prescription - cough syrup with codeine
  2. oral narcotics - not many used in animals
  3. narcotics - parenteral use (fentanyl, hydro, etc)
38
Q

What are targeted substances?

A

human drugs used in vet clinics (not labeled for our rules), substances that can alter mental processes and may produce harm to health and society when diverted or misused

39
Q

What must be recorded for targeted substances?

A

date of transaction, specified name, quantity, when sold, exported, received, etc

40
Q

What drugs are classified as targeted substances?

A

all benzodiazepines (diazepam, midazolam)

41
Q

What does TPP stand for?

A

Tracked prescription program

42
Q

When must a TPP be written?

A

All controlled, narcotic, and targeted drugs prescribed for off clinic use for >96 hours

43
Q

What drugs require a TPP?

A

All narcotics, all barbituates, benzodiazepines, tramadol, anabolic steroids

44
Q

What drugs CANNOT be dispensed even with a TPP?

A

Ketamine, euthanasia solutions, general anesthetics, a-2 agonists (xylazine)

45
Q

How long is a TPP rx valid?

A

72 hours, day 1 is the date the rx is written, cannot be filled after midnight on the 3rd day

46
Q

What is recorded when a controlled substance arrives at the clinic?

A
  • supplier
  • arrival date
  • quantity
  • name of drug
  • concentration
  • invoice #
  • assigned # or letter to each bottle
47
Q

What must be included in a drug log?

A
  • name of drug
  • DIN
  • bottle #
  • strength & size
  • date
  • name of client and patient
  • quantity used - with running total
  • signed by vet
48
Q

What is required in a disposal record?

A
  • date
  • bottle #
  • amount discarded
49
Q

What is required for disposal of controlled drugs?

A

discarded so can’t be used again (cat litter)
must be destroyed in presence of 2 vet professionals (1 a vet), both must sign record

Pharmacology (9 decks)

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