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Pharmacology > Pharmacy and Compounding > Flashcards

Pharmacy and Compounding Flashcards

1
Q

4 categories of veterinary medications

A

-Drugs; veterinary drugs directorate
-Pesticides
-Biologics
-VHP (veterinary health products…. not a drug)

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2
Q

What is required for a vet to dispense/prescribe medication

A

Valid vet client patient relationship

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3
Q

What are drugs categorized based on?

A

-Safety concerns
-Abuse potential
-Ability of a lay person to understand and execute directions for their use

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4
Q

What does scheduling of drugs/products dictate?

A

-How drug is ordered for dispensing from a clinic
-How drug it to be stored
-How drug is obtained by the client

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5
Q

What are the requirements for NAPRA I drug schedules? What are included in this category?

A

-Prescription needed for sale by pharmacist
-May be stocked and dispensed by rDVM at clinic
-Things like narcotics, controlled drugs, and targeted substances

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6
Q

What is NAPRA II?

A

A classification where a prescription is not required, but the medication must be dispensed by a pharmacist (behind the counter).

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7
Q

What is NAPRA III?

A

A classification that allows clients to obtain medications at a pharmacy without needing a pharmacist’s intervention.

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8
Q

What does “unscheduled” mean in the context of NAPRA III?

A

It refers to medications that can be obtained at retail stores without any specific scheduling or prescription requirements

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9
Q

What is required for all prescription medications (NAPRA I) in terms of labeling?

A

-They must include the name, strength, and quantity of the drug
-Date drug is dispensed
-Expiration date
-Name of the owner
-Drug identification number (DIN)
-Name and address of the dispensing veterinarian
-Identity of the animal(s)
-Directions for use
-Storage precautions and other warnings

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10
Q

What is an exception to labeling requirements for non-PDL medications?

A

Non-PDL medications that are veterinary-approved, in their original packaging, and state “veterinary use only” do not require a veterinary label.

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11
Q

What must be done if a drug is dispensed and used in an extra-label manner

A

It must be labeled with new directions for use.

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12
Q

What is required of veterinarians who dispense drugs?

A

They must create a written record (patient record) of the dispensed medications.

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13
Q

What is the veterinarian’s responsibility regarding medication use?

A

To communicate effectively with the client about medication use.

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14
Q

What factors can lead to client noncompliance with medications? (4)

A

-Health beliefs/disbeliefs
-Communication problems
-Skills and experience
-Dosage regimen
-Challenging patient behavior

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15
Q

What communication strategies are most effective for client compliance?

A

Combination of written and verbal

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16
Q

What types of materials can help with client communication?

A

Manufacturers’ materials and client handouts.

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17
Q

What is compounding in veterinary practice?

A

It is the combining or mixing of two or more ingredients (at least one being a drug) to create a final drug in an appropriate dosage form that does not comply with the approved label directions.

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18
Q

What can compounding involve?

A

-Alteration of the form or strength of commercially available formulations
-Use of raw bulk chemicals (active pharmaceutical ingredients, API)

19
Q

What are some examples of compounding? (5)

A
  • Combining/mixing 2 or more drugs to create a new drug
  • Diluting a drug other than according to label
  • Mixing to administer by a different route than on the label
  • Converting an approved medication into a differing form eg.
    tablet to liquid, splitting one capsule into two capsules
  • Adding an unapproved non-drug substance eg flavouring
    agent
20
Q

What does the client need to know to ensure informed consent expectations are met?

A

-Drug has not been approved by the VDD of Health Canada
-Efficacy of the drug may not be known; drug not rigorously tested
-Any potential ADRs that may be incurred with the compounded product
-Not required for routinely utilized compounded drugs analgesic and anesthetic
drugs (eg ketamine /valium in same syringe, dilution of narcotics)

21
Q

When is a compounded product considered a controlled substance?

A

If any of its ingredients contain a controlled substance.

22
Q

Can veterinarians re-dispense compounded products?

A

Yes, veterinarians can compound or obtain a compounded product from a pharmacist for use in their accredited veterinary facility, labeling it for “in clinic use.”

23
Q

Under what conditions can compounded products be re-dispensed to animals?

A

They can be re-dispensed to individual animals or groups where a valid veterinarian-client-patient relationship (VCPR) exists, provided records show the original pharmacy that made the product.

24
Q

Should veterinarians report adverse drug reactions (ADRs) when using compounded products?

A

Yes, while reporting ADRs associated with compounded products to the VDD of Health Canada is voluntary, it is encouraged.

25
Q

When should compounding for vet patients be considered rational and legitimate drug therapy? (8)

A

-Valid V-C-P-R exists including owner consent and risks noted
-Veterinarian (not pharmacist) driven; evidence-based
-Within confines of a legitimate practice and provincial/federal
rules governing compounding are observed
-No approved animal drug, or similar, exists for the intended use (Potassium bromide, cisapride)

-Approved drug is not ……
->Appropriate dosage form (Methimazole transdermal gel)
->Appropriate concentration (Metronidazole oral suspension-kittens)
->Effective when used according to label

-Response to therapy can be monitored; clinical parameters
-Safety and efficacy been demonstrated
-Withdrawal times need to be modified when using comp’ded drugs in food animals

26
Q

When is compounding not considered a legitimate activities?

A

-Compounding of drugs where the health of the animal was not threatened or
suffering/death was not likely if there was failure to treat
-Comp’ding drugs for 3rd parties for resale
-Comp’ding on a commercial scale
-Failing to operate in accordance with Provincial laws
-Comp’ding in anticipation of receiving prescriptions, with some exceptions
-Comp’ding drugs from unapproved substances
-Comp’ded product mimics an approved drug
-Comp’ding drugs banned for use in food animals
-Cost driven
-Advertised to general public

27
Q

What are the 6 components of the vet compounding decision tree?

A
  1. Approved vet product according to label directions
  2. Approved vet product in an extra label manner (ELDU)
  3. Approved human product
  4. Compounded product that are reformulated from vet approved products
  5. Compounded products that are reformulated from human approved products
  6. Compounded products prepared from unapproved or approved bulk drug
28
Q

Are brand name and generics equivalent to each other?

A

Yes, Health Canada deemed generics are bioequivalent. Efficacy and safety data available

29
Q

What are compounded products?

A

Medications prepared by pharmacies that are tailored to meet specific patient needs.

30
Q

What are the things to be aware of about compounded products? (4)

A

-Not Health Canada approved
-No evidence-based efficacy or safety data for support
-Not subject to GMP; stability may/may not be known
-Pharmacy subject to inspection by province (Ont College of Pharm)

31
Q

What are some causes of drug instability? (4)

A

-pH, temperature, light exposure, reactions (oxidation, hydrolysis)

32
Q

What is evidence of drug instability in liquid compounded products?

A

Colour change, cloudiness/film formation, precipitation, gas, odor

33
Q

What is evidence of drug instability in solid compounded products?

A

excessive crumbling, breaks/cracks in tablets, capsules/tablets sticking together

34
Q

Is transdermal delivery an effective and convenient means of drug delivery?

A

It can be

35
Q

What are some examples of drug that are transdermal?

A

-Antiparasiticides (pour ons)
-Opioid patches (fentanyl and buprenorphine pathces)

36
Q

What is the dose needed for transdermal delivery of drugs?

A

Compounded TD drugs need to be soluble/potent to provide a dose in 0.1-0.2 mL volume !!

37
Q

What are some general concerns about transdermal drug delivery? (5)

A

-Absorption is incomplete, or nonexistent
-Inter-patient variability is high
-Chronic safety is unknown
-Lack of potency and stability
-Risk to human caregiver

38
Q

What are commonly compounded products for vets by pharmacists?

A

-Potassium bromide
-Metronidazole oral suspension
-Methimazole oral liquid
-Prednisolone oral liquid
-Cisapride
-Transdermal
-Tramadol and buprenorphine
-Doxycycline

39
Q

What is often used to enhance palatability of compounded products?

A

flavouring agents

40
Q

What are some products that are difficult for vets to compound? (4)

A

Sterile products, extended release products, transdermal products, ophthalmic products

41
Q

What features do ideal drugs for compounding have? (3)

A

-Wide therapeutic index
-TDM available or quantitative end-points
-Clinical data exists with the compounded product

42
Q

What sources should vets seek if they want to create/prescribe compounded products?

A
  • International Academy of Comp’ding Pharmacists

-Professional Compounding Center of America

-American College of Veterinary Pharmacists

43
Q

What information must vets supply in emergency drug release situations?

A

-Nature of emergency (species, production type, age, disease, #)
-Efficiency, safety data in target species
-Human drug safety (withdrawal times)
-Amt of drug needed and dosing regimen

44
Q

Who permits vets access to drugs that arent available in Canada and in what scenarios is this done?

A

Veterinary Drug Directorate (Health Canada)

This happens when there is need to treat diseases on an emergency basis

Pharmacology (22 decks)

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