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PHARMA SKILLS > 1. Terminology, Drug Classes, Drug Labels > Flashcards

1. Terminology, Drug Classes, Drug Labels Flashcards

1
Q

What is the difference btw Prescription, Drug Label and Dispensing label

A

Prescription: A written prescription requesting a med for a patient
Drug Label: Package inset, product monograph, where term “off label” comes off
Dispensing Label: Label WE apply to the outside of the dispense med

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2
Q

What are prescription drugs?

A

Pr
Drugs that are included in the food and drugs act, prescription drug list
In Canada, all manufacturers’ labels and packaging have the Pr label

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3
Q

How do you know if a drug is a prescription drug?

A

Aka Legend drug
Look for the Pr symbol on original packaging
check the prescription drug list
Any drug used “off-label” is prescription
Any shedule l drug from NAPRA’s harmonized drug schedules

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4
Q

How are Pr drugs selected?

A
  1. Supervision by a practitioner is necessary
  2. The lvl of uncertainty respecting the drug, its use or its effects justifies supervision by a practitioner
  3. Use of drug can cause harm to human or animal health or risk to a public health and the harm or the risk can be mitigated by a practioner’s supervision
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5
Q

What is the 1st principle of how Pr drugs are selected?

A

Supervision by a practitioner is necessary; for the dx and tx of a dz or disorder or its symptoms, OR, to monitor a dz, disorder or abnormal physical state, or its symptoms, in respect of which drug is recommended for use, or to monitor the use of the drug
Used in tx of serious dz or dz easily misdiagnosed by public - 1. individualized patient instructions, 2. their use may mask other ailments

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6
Q

What is the 2nd principle of how Pr drugs are selected?

A

The lvl of uncertainty respecting the drug, its use or its effects justifies supervision by a practitioner
Ex. Drugs that are new so there may be unknown adverse effects including potential for addiction, drugs with unknown or severe side effects
routine animal or lab monitoring req.

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7
Q

What is the 3rd principle of how a Pr drug is selected. WHat are some examples of it?

A

Use of drug can cause harm to human/human health or risk to public health and the harm or risk can be mitigated by practitioner’s supervision
Ex. Known adverse reactions @ therapeutic dose
2. lower TI, 3. adjunctive therapy req(drug interactions), 4. They have contributed to, or are likely to contribute to, the development of resistant strains of microorganisms. Ex antibiotics
5. Potential to cause adverse reactions in people
6. Possess dependence or abuse potential likely to lead to harmful non-medical use

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8
Q

What are the 3 subclasses of Pr drugs?

A

Narcotics, controlled and benzodiazepines/targeted/controlled drugs

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9
Q

Who regulates the use of narcotics, controlled and benzodiazepines & targeted/controlled drugs

A

Use, handling and sale of thse drugs are strictly regulated by federal govt via the Controlled Drugs and Substances act “under lock and key”
Defined in the Food and Drug act

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10
Q

Why might Pr drugs be controlled?

A

They are dangerous - drugs with very low TI, potential for human abuse and addiction, street value
Range from illegal street drugs to Pr meds
Opiod analgesics, sedatives, anes’s, euth drugs
Ex. Narcotics - ketamine, opioids
Controlled - Pentobarbital
BZD and targeted substances -diazepam

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11
Q

What is the abbreviation of NAPRA?

A

National association of Pharmacy Regulatory Authorities - Provincial and Territory regulatory bodies

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12
Q

What does NAPRA do?

A

Set consistent conditions across Canada for sale of (human) drugs
most of regulations for every-day transactions in human med are regulated @ provincial lvl or thru NAPRA regulations
Provincial laws/regs are more strict than federal laws

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13
Q

Does vet med fall under NAPRA? WHat about drugs used in vet med that are human-labelled or handled by a pharmacy/pharmacist?

A

Vet med does NOT fall under NAPRA, but they do provide best practice for pharmacy and dispensing
Drugs used in vetmed that are human labelled do fall under NAPRA

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14
Q

What is the harmonized drug schedule model?

A

Created by NAPRA, list of drug classes recognized @ provincial lvl across Canada

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15
Q

What are the 4 drug schedules with the harmonized drug schedule model?

A

Schedule 1 - Prescription req
Schedule 2 - no prescription required; restricted access, “behind the counter” ex. Cough/cold meds with ephedrine
Schedule 3 - Avilable for self-selection under supervision of pharmacist (pharma only drugs. ex extra strength formulations or greater than 50/pkg)
Unscheduled - can be sold anywhere (not just a pharmacy) ex. travel size pkg of reg strength tylenol

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16
Q

What is ephedrine?

A

To order ephredrine products from WDDC and end use declaration form must be signed annually by DVM

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17
Q

What is included with veterinary biologicals? What is their mode of action and how are they regulated?

A

Includes: vx’s (live, killed, bacterin, toxoid), colostrum, Ab products and in bitro diagnostics test kits used for prevention of/tx/dx of infectious dx, interferon
Mode of action is related to an immunological response
Products contain a Canadian Veterinary Biologics Establishment License #
Regulated under the health of animals act, enforced by the CIFA

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18
Q

Can you sell Rabies? Why or why not?

A

The federal Health of Animals Regulations [section 134.2] prohibits the sale of rabies vx’s to non-vets in CAD
Upon request/application exceptions can be made for 1. remote areas w/o vet services for temp rabies vx clinics, 2. trap-vx-release programs run by provincial wildlife officials
Since rabies vx of pets is important to protect people from rabies as well as to protect their pets, many provinces have legislation that req pets be certified vx by vets

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19
Q

what should we remember about biologicals and non-prescription drugs?

A

Altho no prescription, vets are not obligated to sell these products to the public and are still responsible for advice and recommendations

Ex. acepromazine

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20
Q

What are natural health products?

A

vita’s/minerals w/ human label
Herbal remedies, homeopathic meds, traditional meds (traditional Chinese meds), probiotics (lactobacillus), other products like AA’s (lysine) and essential fatty acids (omega-3 fatty acid)
some personal care products such as antiperspirants, med shampoos and mouth washes
MUST be safe for consideration as OTC products and not require a pr to be sold

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21
Q

What do natural health products require before they can be sold in Canada?

A

A product license
Req submitting detailed info to health Canada incl. med ingredients, source, potency, non-medicinal ingredients, recommended use(s)

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22
Q

How do we identify natural health products?

A

Authorized product labels have an 8 digit product license # preceded by distinct letters NPN(natural product #)
Homeopathid meds have letters DIN-HM (homeopathic medicine #)
ID # on the label says its been reviewed/approved for health Canada for safety, efficacy and quality

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23
Q

What scope do natural halth products fall under?

A

Natural and non-prescription health products directorate (NNDPD)
Natural health products: market authorization requirements differ from those required for traditional pharmaceuticals, so monitoring and enforcement of conditions of sale are beyond the scope of pharmacy regulatory authorities
NAPRA policy: some NHP are listed under NDS and still remain in schedules, even if they have a NPN

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24
Q

What is the natural and non-prescription health products directorate?

A

est. 2004, regulating authority for the sale and distribution of natural health products in CAD
NNHPD role - “ ensure CAD’s have ready access to NHP that are safe, effective and are high quality while respecting freedom of choice and philosophical and cultural diversity”
Responsible for; product licensing, clinical trials, adverse reporting, product labelling (medicinal/non ingredient, potency, dosage form) ensuring good manufacturing practices

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25
Q

How are Natural health products labeled?

A

info req on NHP’s includes
Product name/dosage form + potency
License # - NPN or DIN-HM
Quantity of product in bottle, complete list of medicinal/non ingredients, recommended use, any cautionary statements, warnings, contra-indications, and possible adverse reactions, any special storage conditions

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26
Q

What is the WHO’s definition of probiotics?

A

live microorganisms which when administered in adequate amounts confer a health benefit on the host

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27
Q

What is homeopathy?

A

system of therapy based on the concept that dz can be treated w/ drugs (in minute doses) thought capable of prod the same symptoms in healthy people as the dz itself
these dilute amounts could then be used to treat the very symptoms known to produce

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28
Q

What is the licensed natural health product database?

A

sim to drug product database but;
provides info about NPN or DIN-HM
lists medicinal/non ingredients, gives dosage forms, recommended uses, risk and contraindications

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29
Q

What is the IUPAC name?

A

internaltional union of pure and applied chemistry
chem name of drug, gives molecular formula of drug; never changes, always listed on drug label

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30
Q

What is the generic name?

A

common name
refers to active pharmaceutical ingredient
name never changes btw human/vet, country
does not indicate dose format or formulation
usually stars with lowercase so not capitalized

31
Q

What is a tradename?

A

capitalized followed by a tm or R
proprietary names licensed by a drug manufacturer
Refers to specific drug has been formulated in a specific matter
Names will change by country
ex. Aspirin (bayer)

32
Q

What is a drug identification number?

A

every Pr and OTC (including unscheduled products) containing an active pharmaceutical ingredient has a DIN
DIN is specific # provided @ time of licensing that allows product to be traced back and identified
Every drug with DIN has a drug label

33
Q

What can be traced back and identified if a drug has a DIN?

A

active pharmaceutical ingredients, specific manufacturer, specific strength (weight or concentration), specific dose form (tablet, oral liquid, capsule), specific formulation

34
Q

What are generic equivalents

A

“generics”
contains same active drug as the original licensed drug
manufacturers cannot prod until original patent on the licensed trade name drug has expired (<20yrs)
generics must contain comparable active ingredients and are usually less costly
not all generics have equal activity. related to non-medicinal components that may affect drug absorption, and bioavailability in the body

35
Q

Where can you go as sources for drug information?

A
  1. label/package insert
  2. Compendium
  3. Vet drug formulatins
36
Q

What is a drug label?

A

monograph (insert) that comes with every drug
every drug w/ a DIN must have a drug label
You should read this the first time you handle a drug!

37
Q

What does a drug label contain?

A

DIN, trade name, generic and chemical name
Manufacturer and contact info
Labels to indicate class (C, N, T, Pr, R)
Pharmacology - how drug works (absorption rates, serum conc, how the drug is elimed)
storage and handling instructions, indications, precations, S/E, warnings, contraindications

38
Q

How do we know how to handle and store drugs?

A

always read the insert
look for - store aware from light, temp (room temp (15-25), fridge (4C), freeze, do not thaw
Humidty, do not shake, shake b4 use

39
Q

What are indications of a drug? What might they include

A

why a drug is to be ued - what conditions approved to treat
must ave been part of the testing process for licensing
Includes: conditions (dz or circumstances), specific patient type (signalment, food anim or not, lactating), recommended dosage (mg/kg) can be given as a range or specific indication, route of admin, frequency and duration or tx

40
Q

What are precautions, warnings and side-effects

A

Precautions: fairly rare side-effects or mild s/e, ex. upset tummy from oral antib
Warnings: more serious or frequent side effects. EX - blood thiner effect of aspirin
Must include all effects that were noted during licensing trials

41
Q

What are contraindications?

A

conditions in which drug should NOT be used as it will cause harm. “NERVER”
may include: specific health states (liver damage, heart dz, bleeding), preg/lactating anims, if taking other meds that may cause undesirable drug interactions

42
Q

What does veterinary drug label mean

A

drugs licensed for use in animals must have this label.
licensing, sale and use of drugs is regulated by VDD
must contain “for vet use only” list of species drug indicated for, specific use instructions, WDT, other regulations related to food residues, contra/indications, S/e

43
Q

Where are some sources of (veterinary) drug labels that you can find

A

original labels: manufacturer’s website, drug packaging, compendium of vet products
summarized info based on label (good for general use such as storage/handling, precautions, s/e)

44
Q

What are withdrawal times?

A

duration of time from the LAST admin of a specific drug until the animal can be sent to slaughter or other products consumed (eggs)
Amount of time it takes to reach a max allowable drug lvl in tissue of animal. This level determined by health Canada - not “0” drug
Applies to ALL drugs (any with DIN #)
Dairy - time of milking/slaughter
Beef + other meats, poultry - time of slaughter, eggs - time of collection
applies to all classes

45
Q

Why are following WDT’s important?

A

make sure there are no significant drug residues in human food chain. Consequences of this are 1. adverse effects in humans consuming meat/milk/eggs (allergies to penicillin, toxicity, known physiological effects), 2. Antimicrobial resistance in humans

46
Q

What factors affect WDT?

A

determined by rate of drug metab and elim
what are safe lvls of drug for incidental ingestion. what tissues are consumed?
also depends on specific dose given, route of admin, frequency of admin and liver/kidney function. Species. Formulation of drug (procain pengG milk 3d, meat 10d///Benzocain penG milk 28d, meat 30d) type of tissue consumed (procain peng milk 3d, meat 10d)

47
Q

Do drugs need a wdt?

A

no, some do not have one but may state “not intended for use in food animal species” or not an issue

48
Q

What is the canadian global food animal residue avoidance databank?

A

non-profit organization made up of vet pharmacologists
support for vets for determining WDTs for drug/product for use which does not have one
recommendations based on research, unofficial reports
liability still falls on vet/producer if label not followed
WT monitored by CFIA via drug residue testing

49
Q

What happens if an animal is given 3 drugs with different WDT? Which one do you go with?

A

The longest one.
Ex. Drug A is 8d, B is 21d and C is 3d. B is longest so WDT is 21d

50
Q

What is on-label drug use

A

using a drug according to directions on th drug label without deviation
advantages: drug more likely to be effect bc of known outcome, dec risk of known/unknown s/e. known WDT for food anims, professional safety net in event of adverse effects occuring

51
Q

What is extra-label drug use

A

the “The use of a drug product in a manner that is not consistent with what is indicated on the label, package insert, or product monograph of any drug product
approved by Health Canada”
* Benefits -Veterinary market is small, so allows for increased access to drugs that might not be available (i.e., human drugs)
* Allows dose adjustment for size of animal
72

52
Q

What are some examples of ELDU?

A

diff species (human drug for animal use)
Diff age group, use of drug for tx not on label
Higher/lower dose than recommended
diff route of admin
greater/lesser frequency
longer/shorter duration of use than needed
splitting more than recommended
crushing tablets and mixing in food
diuting drug and keeping it in that form for storage
turning tablets/capsules into liquids
turning drugs into treat forms to be more palatable

53
Q

What are the disadvantages of eldu?

A

1 efficacy not established - may not treat patient
2. s/e not established - may harm patient
3. no scientific (or industry) backing if something goes wrong; vet responsible for any and all complications - liability
4. no known wdt - monetary loss and harm to general public
5. eldu of antib may cause resistance

54
Q

What is the veterinary drug directorate policy on eldu?

A

ELDU use of any drug avoid whenever approved product is available
vets have privilege of using drugs w/ DIN eldu
vets who choose to ELDU are responsible for safety of anims being treated and for any illegal drug residues detected in anims and byproducts
clients made away drug is being ELDU, in written consent

55
Q

What are the rules with ELDU?

A

ALWAYS req a prescription, avoid in all food prod anims

56
Q

What are the responsibilities of ELDU?

A

always require a prescription and valid VCPR
responsible for all aspects, including safety, adverse reactions, WDT lie with prescribing vet
applies to all prescription drug and OTC meds used off label
not permitted for insecticides, pesticides, bioligcals

57
Q

An owner calls and would like the dose
of Gravol for their dog that suffers from
car-sickness
Is this ELDU?

A

Yes, gravol is a human med

58
Q

What is compounding?

A

specific type of ELDU
drug altered so its in diff format than how its prod @ time of sale and/or admin
Req advanced training to compound as human pharmacist
alwas req a prescription that states a compounded format is req
AKA - always requires permission from vet
vet is wholly responsible for any lack of tx efficacy or s/e

59
Q

What is the FDA definition of compounding?

A

Animal drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual animal or a small group of animals, and these drugs can play a critical role in
veterinary medicine”

60
Q

What is an example of compounding a drug?

A

Having a pharmacist compound a drug into a dosage form to ease administration e.g. methimazole topical gel for cats.
* Mixing penicillin with dexamethasone into ointment in your clinic to make “scratches ointment” for a horse.

61
Q

What are some examples of compounding drugs in vet med?

A

altering conc of liquid and storing it
mixing diff meds together in 2nd storage container
taking pasul and converting to suspension
pre-mixing w/ food and dispensing as “medicated treats” or “medicated feed”
adding flavor drops

62
Q

What are the advantages of compounding drugs?

A

can adjust dose size for variation in patient size
increase palatability
addresses limitation in vet drugs due to small market

63
Q

What are the disadvantages of compounding drugs?

A

affects the stability of drug; unknown expiry date
may alter drug efficacy - drug may not work
may have unknown/inc s/e - harm patient

64
Q

When should a compounded drug be used?

A

no other options exist
scientific literature to back up how the drug is compounded

65
Q

What is the hierarcy of vet prescriptons?

A
  1. Approved Veterinary Drug (On-label)
  2. Approved Veterinary Drug (ELDU)
  3. Approved Human drug (ELDU)
  4. Compounded Drug
  5. From approved vet drug - ELDU
  6. From approved human drugs – ELDU
  7. From raw active ingredient
66
Q

How many lbs are in a kg? how many grams in a kg?

A

2.2lb/ki
1000g/kg

67
Q

Ex. 10kg dog needs drug X that comes in 250mg tablets. The Rx is 10mg/kg PO EOD x4. How much do they need?

A
  1. “Give a 100mg dose by mouth every other day for 4 doses”
  2. Check if 125mg is okay instead of 100, if yes, on label split tablet. If no, may need to consider diff drug, manufacturer, compounding etc. Since can NOT split tablet to get 100mg dose
    Assuming good to split, give 1/2 tablet by mouth every other day until finished or 4 times/tx. Send home 2 pills
68
Q

You have a lidocaine 2% solution. How much drug (in mg) is in each 100ml of drug? What volume is req for 5mg of drug? How much would you draw up if asked to give 4mg/kg to a 20kg dog to treat an arrhythmia

A

x% = x number of g/100ml of solution
1. 2g of lidocaine per 100ml of solution
2. 2g/100ml = 2000mg/100ml = 20mg/ml = 5mg in 0.25ml
3. 4ml/kg x 20kn = 80/20mg/ml = 4ml

69
Q

How much drug is there per ml of 0.5% of metacam? What volume do you need for a 20kg dog if dosing at 0.1 mg/kg

A

0.5% = 0.5g/100ml
500mg/100ml = 5mg/ml
20kgx0.1mg/kg = 2mg
2mg/5mg/ml = 0.4ml

70
Q

You are asked to prepare 15ml of a 5mg/ml
enrofloxacin solution. You have 22.7mg/ml
enrofloxacin on hand and sterile water for injection.
How much of each do you need?

A

c1v1=c2v2
(22.7mg/ml)V1=5mg/ml(15ml) = 3.3ml and dilute up to 15ml w/ sterile water for injection (11.7ml) remember v2 is TOTAL VOLUME

71
Q

What does dilute up mean?

A

referred to as adding a quantity of sufficient to arrive at the desired volume. OR qs in pharmacy shorthand
3.3 qs 15ml

72
Q

We still want to make a 5mg/ml enrofloxacin solution from 2ml of 22.7mg/ml enrofloxacin you have on hand and sterile water for injection. How much of each do you need?

A

22.7mg/ml (2ml) = 5mg/ml (V2) =9.08ml
add 7.08ml sterile water to original 2ml to make 9.08 of 5mg/ml concentration

73
Q

Horse: 2.5-5 mL (0.5 - 1 g) per 250 kg body
weight daily. Total daily dose should not exceed 20 mL, regardless of weight. Do not treat intravenously for more than 5 consecutive days.
You are asked to give a single high-end dose to
a 1200lb horse. How much do you draw up?

A

1200lb/2.2lb/kg = 545.5kg
Xml/545.5 = 5ml/250kg = 10.91ml
Can we draw it up with accuracy? No, could draw up 10.9 and estimate the lines between 10.8 and 11.0
Cannot give this same dose again in 12hrs because total daily dose is 20ml/day

PHARMA SKILLS (5 decks)

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