Pharmacy Regulations Flashcards

1
Q

PR vs. OTC

A
  1. Any human labelled product is extra label so will always require a prescription
    *does not matter whether it is an OTC drug or not
  2. Any vet labelled products with “PR” need a prescription
    **OTC vet labelled products do not need a prescription
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2
Q

Do compounded drug products need a vet prescription?

A

Yes, all compounded drug products need a vet rx, and NEED a proper dispensing label

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3
Q

Prescription refills

A

Refills are only good up to 1 year from date of prescription
**this is because need to renew vet client-patient relationship every year

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4
Q

Prescription transfers

A

Transfers can only occur between pharmacists

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5
Q

Can vets transfer prescriptions?

A

Sometimes vets can transfer from vet to vet

**In some areas vets are not allowed to transfer prescriptions from one vet to another because they have to have their own vet client-patient relationship

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6
Q

Veterinary Technicians role

A

-Can administer a drug, medicine, appliance, treatment as long as they are under the supervision of vet
*no prescriptions!!

-cannot make a diagnosis or determine course of treatment

-only a vet can give verbal order for client’s rx to a pharmacist
**phone in or fax

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7
Q

Dispensing of vet drugs by pharmacies

A

Vet drugs not typically available to human pharmacies due to marketing policies of vet drug companies
*therefore vet drugs available from their clinics BUT this might change

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8
Q

Human MDs and dispensing

A

Cannot dispense drugs to patients
-this is a pharmacists role

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9
Q

Legal requirements for a prescription

A

-prescribing vet and vet facility
-vet contact information
-date of prescription (tells you whether VCPR is still valid)
-patient owner and address
-ID of individual patient or group of animals/ species
-Drug: brand/generic name, strength/concentration, formulation type
-directions for use (route, dose, frequency, duration, withdrawal times)
-Mitte: total quantity of drug
-if generic substitution is available… not an issue in vet med usually
-number of refills (if not indicated=zero; include interval if controlled drug…no refills for narcotics)
-vet signature

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10
Q

Rx for in-feed drugs

A

-animal production type
-weight or age
-type of feed
-total amount of feed or feeding period
-amount of drug used per tonne (typically ppm)
-manufacturing instructions
-cautions
-CgFARAD # if applicable

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11
Q

Dispensing drug product

A

Either:
1. as is in the manufacturers packaging
2. Repacking and labelling a product for use by the client

**often dispensing by RVTs but must be under the direct vet supervision. Vets are legally responsible regardless of who does it

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12
Q

How to dispense medication?

A

Read to label 3x
-when take product from the shelf
-when removing product contents from the bottle/vial
-when replacing the product back on the shelf

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13
Q

Storage requirements of drugs

A

-Temperature
-Moisture
-Light
-Expiration
*entire course of treatment needs to be complete before expiry date

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14
Q

Dispensing label components for drugs being dispensed in manufacturer’s packaging

A

-name of client or owner
-name of prescribing vet and vet practice
-ID of patient or group of animals for which medication is dispensed
-total quantity of drug dispensed and refills
-directions for use

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15
Q

Dispensing label components for any package that is not in the manufacturer’s original package

A
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16
Q

Who regulates vet drug approvals in Canada?

A
  1. Health Canada
    (Health Products and Food Branch, Veterinary Drugs Directorate)

**identifies based on DIN number

17
Q

Who regulates vet drug residues and biologics in Canada?

A

CFIA- The centre for Veterinary Biologics

18
Q

Who regulates pesticide products in Canada?

A

Health Canada- Pest Management Regulatory Agency
**cannot be used extra label, and needs to be dispensed in original package
**has Pest Control Product Number (no DIN)

19
Q

Who regulates the use of veterinary drugs in Canada

A

-Provincial Veterinary Acts and regulations
*regulated by the vets themselves because self regulating body
-Provincial Pharmacy Acts
-VMA bylaws

**provincial laws can be more stringent than federal laws

20
Q

Prescribing medications

A

-Must have VCPR… not over phone. Lasts 12mths
-once medication removed from supervision, cannot sell, give or administer them to any other patient

21
Q

Drug regulation order of control

A
  1. Narcotics
  2. Controlled drugs
  3. Targeted/controlled drugs
  4. Prescription drugs

*none for non-prescription drugs and biologics and pest control products not considered drugs

22
Q

Prescription vs OTC

A

If on prescription drug list, need Rx and VCPR

23
Q

Narcotics

A

***Symbol with N

-Tramadol
-Buprenorphine
-Ketamine
-opioids

24
Q

Controlled Drugs

A

*will have a C symbol

-pentobarbital, phenobarbital, butorphanol

25
Q

Narcotic and controlled drug record keeping

A

-Vets must keep record of all narcotic prescriptions issued and dispensed/sold
*minister of health through governing bodies VMAs will request documentation

-must keep records for two years
-include client info for sales documentation

26
Q

What info is needed for narcotics and controlled substances?

A
  1. receiving the drugs
  2. dispensing the drugs
27
Q

How to tell if a drug is a prescription drug?

A

Will have Pr