Terminology, drug classes and drug labels Flashcards

Question

Natural and Non-Prescription Health Products Directorate is responsible for

Answer 1

Product licensing Clinical trials Ensuring Good Manufacturing Practices (Safety and quality control) Adverse reporting Product labelling (medicinal and non-medicinal ingredient, potency, dosage form, recommended use, risks and contraindications)

Answer 2

Information required on NHP’s includes: Product name, dosage form and potency Product license number Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) Quantity of product in bottle Complete list of medicinal and non-medicinal ingredients Recommended use (including purpose or health claim, route of administration and dose) Any cautionary statements, warnings, contra-indications, and possible adverse reactions Any special storage conditions

Answer 3

The World Health Organization probiotics definition is "live microorganisms which when administered in adequate amounts confer a health benefit on the host.“

Answer 4

A system of therapy based on the concept that disease can be treated with drugs (in minute doses) thought capable of producing the same symptoms in healthy people as the disease itself. These dilute amounts could then be used to treat the very symptoms they were known to produce. (from MedicineNet.com)

Answer 5

Similar to Drug Product Database, but: Provides information about NPN or DIN-HM products Lists medicinal and non-medicinal ingredients Gives dosage form(s) Recommended use(s) Risks and contraindications

Answer 6

Chemical name of a drug Gives the molecular formula of the drug; never changes Always listed on the “drug label”

Answer 7

Common name Refers to the active pharmaceutical ingredient Generic name never changes Human/veterinary, different countries Does not indicate the dose format or formulation USUALLy, starts with “small case” (not capitalized)

Answer 8

Capitalized; followed by a ® (registered) or (trademarked) Proprietary names that are licensed by a specific drug manufacturer Refers to a specific drug that has been formulated in a specific manner Names will change by country

Answer 9

Every prescription and OTC product (including Unscheduled products) containing an active pharmaceutical ingredient has a DIN The DIN is a specific number provided at the time of licensing that allows the product to be traced back and identified Every drug with a DIN has a “drug label”

Answer 10

Active pharmaceutical ingredient(s) Specific manufacturer Specific strength (weight or concentration) Specific dose form (tablet, oral liquid, capsule...) Specific formulation

Answer 11

Aka “generics” Contains the same active drug as the original licensed drug Manufacturers cannot produce until the original patent on the licensed trade name drug has expired (up to 20 years) Generics must contain comparable active ingredients and are usually less costly. But, not all generics have equal activity. Related to non-medicinal components that may affect drug absorption, and bioavailability in the body “ Studies have been carried out to prove that Meloxidyl is 'bioequivalent’ to the reference veterinary medicinal product: this means that Meloxidyl is equivalent to Metacam in the way it is absorbed and used by the body”

Answer 12

label/package insert Compendium Veterinary drug fomularies Drug label

Answer 13

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

Answer 14

DIN Trade name, generic, chemical name Manufacturer and contact info Labels to indicate class of drug (C, N, T, Pr, R...) Pharmacology - how the drug works (absorption rates, serum concentration, how the drug is eliminated,...) Storage and handling instructions Indications Precautions, s/e, warnings, contraindications

Answer 15

Always read this Look for Store away from light Temperature Room temperature (15-25 C) Fridge (4 C) Freeze Do not thaw Humidity Do not shake Shake before use

Answer 16

Why a drug is to be used What conditions it has been approved to treat Must have been part of the testing process for licensing

Answer 17

Conditions (disease or circumstances) Specific patient type (species, breed, age, food animal or not, lactating) Recommended dosage (mg/kg) – Can be given as a range or for specific indication Route of administration Frequency and duration of treatment

Answer 18

Fairly rare side-effects or mild side-effects Example - upset stomach from oral antibiotics; mild nausea and dry mouth with hydroxyzine

Answer 19

More serious or frequent side effects Example - blood thinner effect of aspirin; renal damage from NSAIDs Teratogenic effects

Answer 20

Must include all effects that were noted during licensing trials

Answer 21

Conditions in which drug should NOT be used as will cause severe harm “NEVER”

Answer 22

Specific health states (i.e., liver damage, heart disease, bleeding) Pregnancy, lactating animals If taking other medications that may cause undesirable drug interactions (e.g., counteract, increase adverse effects, increase intended effect)

Answer 23

Drugs which have been licensed for animal use have a Veterinary Drug Label Licensing, sale and use of these drugs is regulated by VDD Veterinary drug labels contains all of the above and,... “FOR VETERINARY USE ONLY” List of species for which drug is indicated Specific instructions for how drug is to be used in each of these species Withdrawal times (WDT), other regulations related to food residues

Answer 24

Original labels: Manufacturer’s website Drug packaging Compendium of Veterinary Products Summarized information based on label (good for general use such as storage and handling, precautions, side-effects): Drugs.com (be aware of country) Plumb’s Veterinary Drug Handbook

Answer 25

Duration of time from the last administration of a specific drug until the animal can be sent to slaughter or other products consumed i.e. milk, eggs It is the amount of time it takes to reach a maximum allowable drug level in the tissues of the animal. This level is determined by Health Canada – Not “0” drug Applies to ALL drugs (any product with a DIN number) that is administered to food animals Applies to all classes of drug (OTC and prescription)

Answer 26

Makes sure there are no significant drug residues in the human food chain Consequences of drug residues include: Adverse effects in humans consuming meat/milk/eggs Allergies (penicillin) Toxicity Known physiological effects (may be the intended physiological effect of the drug or an adverse effect) Antimicrobial resistance in humans

Answer 27

Determined by the following: Rate of drug metabolism and elimination What are safe levels of drug for incidental ingestion What tissues are consumed: meat, milk, eggs Also depends on any factor that affects the plasma drug curve for any drug: Specific dose given (mg/kg) Route of administration Frequency of administration Liver and kidney function (age, individual animal) Species Formulation of the drug Procaine Pen G - milk 3 d; meat 10 d Benzocaine Pen G – milk 28 d; meat 30 d Type of tissue being consumed (milk versus meat) Procaine Pen G: milk - 3 d; meat - 10 d Can drugs that are labeled for food animals be used in a manner not described on the Veterinary Drug label?

Answer 28

Certain drugs do NOT have a labeled WDT May state: “Not intended for use in food animal species” or not an issue Certain drugs are BANNED from use in food animals

Answer 29

C.01.610 No person shall sell any substance having oestrogenic activity for administration to poultry that may be consumed as food. C.01.610.1 No person shall sell a drug for administration to animals that produce food or that are intended for consumption as food if that drug contains (a) chloramphenicol or its salts or derivatives; (b) a 5-nitrofuran compound; (c) clenbuterol or its salts or derivatives; (d) a 5-nitroimidazole compound; or (e) diethylstilbestrol or other stilbene compounds

Answer 30

Non-profit organization made up of veterinary pharmacologists (Usask , U of Guelph) Support for veterinarians (and producers) for determining WDTs for drug/product use which does not have a labelled WDT (e.g., accidental route of delivery, etc) Recommendations based on research, unofficial reports, data from other countries or equivalent drugs, translating from known data in other species, etc Liability still falls on veterinarian/producer for not following label. WT monitored by CFIA via drug residues testing

Answer 31

Must be on dispensing label when dispensing products SVMA Practice Standards 7B-a Procedure (MA). Prescriptions contain a warning with the required withdrawal period for medications used in food producing animals. Rationale: The withdrawal period is essential information of which the client must be made aware. Guidelines: If the prescription is for a drug that has no withdrawal period, this should be noted on the prescription. WT not yet required for equine dispensing labels Don’t forget horses going to competition may be tested! Remind owners to check their competition doping rules.

Answer 32

Withdrawal time for meat is 21 days. Withdrawal time for milk is 10 days. (Do not slaughter for 21 days. Dump milk for 10 days.)

Answer 33

Using a drug according to the directions on the drug label without deviation On-label drug use is ALWAYS the preferred method of using a drug

Answer 34

Drug is more likely to be effective; known outcome Decreases risk of known and unknown side effects Known WDT for food animals Professional safety net in the event of adverse effects occurring. (In the event of adverse effects, the manufacturer will stand behind the product)

Answer 35

Aka “Off-label” drug use “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”

Answer 36

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

Answer 37

Different species (using a human drug in an animal, using in a dog versus a cat) Different age group Use of a drug for a treatment not listed on the drug label (ie.., different indication) Higher dose; lower dose than recommended Different route of administration Greater or lesser frequency Longer or shorter duration of use than recommended Splitting more than recommended (quartering a tablet) Crushing tablets and mixing in food Diluting drug and keeping it in that form for storage Turning tablets and capsules into liquids Turning drugs into “treat” forms so more palatable

Answer 38

Efficacy not established – May not treat patient Side effects not established – May harm patient No scientific (or industry) backing if something goes wrong; vet is responsible for any and all complications - Liability No known WDT – Monetary loss and harm to general public ELDU of antibiotics may cause resistance

Answer 39

Off-label use of any drug should be avoided whenever an approved product is available. Veterinarians have the privilege of using drugs with a DIN off- label Veterinarians who choose to make use of a drug in an off-label manner are responsible for the safety of the animals being treated... ...and for any illegal drug residues that are detected in animals and animal products sold for human consumption. Client should be made aware that the drug is being used off label as this can affect clinical efficacy and increase risk of adverse reactions – ideally written consent, note in medical record. If a drug product is left with a producer, and is then used off- label, the supervision lies with the veterinarian

Answer 40

ELDU is described in the Food and Drugs Act. Does NOT include products regulated under the Health of Animals Act (i.e., veterinary biologics) or those registered under the Pest Control Products Act (insecticides, pesticides). Thus, ELDU for those products is NOT a professional privilege. Veterinary biologicals (including vaccines) and pesticides can only be used on-label Absolute rule: ELDU ALWAYS requires a prescription. General rule: Avoid ELDU in all food-producing animals.

Answer 41

Always requires a prescription and valid VCPR Responsibility for all aspects, including safety, adverse reactions, withdrawal times lie with the prescribing vet Applies to all prescription drugs and OTC medications used off-label Not permitted for insecticides, pesticides, biologicals (including vaccines) Best to Avoid ELDU in ALL food producing animals due to questionable WT

Answer 42

Specific type of ELDU Drug is being altered so it is in a different format than how the manufacturer produced it at the time of sale and/or administration Requires advanced training to compound as a human pharmacist (e.g., “compounding pharmacies”) Always requires a prescription that specifically states a compounded format is required Aka - Always requires permission from the veterinarian Veterinarian is wholly responsible for any lack of treatment efficacy or side-effects Is considered ELDU “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” FDA May 1, 2023

Answer 43

Altering the concentration if a liquid and storing it Mixing different medications together in a secondary storage container Taking a capsule and converting to a suspension Pre-mixing with food and dispensing “medicated treats” or “medicated feed” Adding flavor drops

Answer 44

Can adjust dose size for variation in patient size Increase palatability Addresses limitation in veterinary drugs due to small market

Answer 45

Affects the stability of the drug; unknown expiry date May alter drug efficacy – Drug may not work May have unknown or increased side effect – Harm patient

Answer 46

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

Answer 47

Summit Veterinary Pharmacy (Aurora, ON) Wall Street Pharmacy (Saskatoon) Queen Street Pharmacy (Saskatoon) Medicine Shoppe It is not in the scope of RVT practice to recommend a drug in its compounded form for ease of administration – Must be prescribed in compounded form by the veterinarian Must communicate to client that the drug is a compounded drug

Answer 48

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

Terminology, drug classes and drug labels Flashcards

(74 cards)