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Law Semester 2 > Veterinary Medicines > Flashcards

Veterinary Medicines Flashcards

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1
Q

What are the Veterinary Medicines Regulations 2013?

A

ONE piece of legislation that pulls together

  • EU Directives (concern over food producing animals)
  • UK Statutory Instruments
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2
Q

Animal and Human Medicines sit under the same legislation - true or false?

A

False. All medicines except for CDs for animals sit under the Veterinary Medicines Regulations.

CDs are the SAME as they are for humans and sit under the Misuse of Drugs Act 1971.

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3
Q

Who are the Veterinary Medicines Directorate?

A

a GOVERNMENT agency that produce guidance notes

  • the same as the MRHA but for animals
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4
Q

Who are the National Office of Animal Health (NOAH)?

A

brings all the pharmaceutical industry together in one organisation
- where all of the SPCs are etc.

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5
Q

What is the definition of a Veterinary Medicinal Product?

A

‘any substance or combination of substances that are

  • presented as having properties for treating or preventing disease in animals OR
  • that may be used in/administered to, animals with a view to restore/correct/modify OR
  • to make a medical diagnosis’

THE SAME WORDING AS IT IS FOR HUMANS, BUT SPECIFIED AS FOR ANIMALS

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6
Q

Do Veterinary Medicinal Products need a Marketing Authorisation?

A

yes - works that same as for human medicines in terms of manufacturing/wholesaling/record keeping

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7
Q

Who are the Registered Qualified Persons that are able to prescribe Veterinary Medicinal Products

A
  • Veterinary Surgeons
  • Pharmacists
  • Suitably Qualified Persons

what they can prescribe depends on the distribution categories

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8
Q

What are the Distribution Categories of Veterinary Medicinal Products?

A
  1. POM - V = Vets ONLY
  2. POM - VPS = Vets/Pharmacists/Suitably Qualified Persons
  3. NFA -VPS = Non-Food Animal (similar to a P medicine)
  4. AVM - GSL = Authorise Veterinary Medicine

ALL medicines for food producing animals are prescription only medicines

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9
Q

Who are the governing body that register veterinary surgeons?

A

Royal College of Veterinary Surgeons

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10
Q

Vets may only SUPPLY medicines from premises registered with the RCVS as a Veterinary Practice Premises - true or false?

A

TRUE - they work similar to dispensing doctors. They supply from their own premises so that owners would not have to come to you in the pharmacy for a prescription.

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11
Q

What are the regulations of supplying a veterinary medicine from a Veterinary Practice Premises?

A

the vet supplying must be PRESENT unless

  • they authorise each transaction individually before the product is supplied
  • they are satisfied that the person that hands over the product is competent
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12
Q

Supply of Veterinary Medicinal Products cannot be supplied from a premise that is registered with the GPhC - true or false?

A

FALSE

- Pharmacists are able to supply VMPs from their own pharmacy that is registered

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13
Q

What are the regulations of supplying a veterinary medicine by a pharmacist?

A

the pharmacist must be PRESENT unless

  • they authorise each transaction individually before the product is supplied
  • they are satisfied that the person that hands over the product is competent
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14
Q

What premises can a pharmacist’s supply a veterinary medicinal product from?

A
  • a GPhC registered premise
  • Veterinary Practice Premises
  • Premises approved and Registered for the storage and supply of VMPs by a Suitably Qualified Person
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15
Q

Who is a ‘suitably qualified person’?

A

an animal medicine advisor who is qualified to prescribe/supply certain veterinary medicines
- they must pass examinations
- they undergo training with
Animal Medicines Training Regulatory Authority or
Vet Skills ltd

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16
Q

What Veterinary Medicinal Products are suitably qualified persons able to supply?

A

POM-VPS
- that they themselves have prescribed OR that another vet/pharmacist/SQP has prescribed

NFA-VPS from a registered premises

  • suitably qualified person retailer premises that is approved by the VMD
  • a pharmacy
  • veterinary practice premises
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17
Q

What types of medicines are classified as POM-V?

A
  • CDs Schedule 2 and 3
  • All new active substances
  • All narcotic/psychotropic substances
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18
Q

What are the regulations regarding prescribing a POM - V?

A
  • carry out a clinical assessment of the animal
  • animals must be under their care

clinical assessment could include a physical examination or looking at documents

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19
Q

It is not an offence to prescribe more than the minimum amount of Veterinary Medicinal Product required for treatment - true or false?

A

FALSE - it is an offence

20
Q

The sale of an NFA-VPS requires a prescription - true or false?

A

FALSE - treated like a P medicine, where there is some control over the sale but doesn’t actually require a prescription

21
Q

Medicines for Small Pet Animals can be put on the market without a marketing authorisation - true or false?

A

TRUE, although subject to certain conditions
- labelled for use in only specific small pet animals

they can be sold by ANY retailer

22
Q

What small pet animals can medicines without an MA be put on the market for/

A
  • Aquarium Animals
  • Cage Birds
  • Homing Pigeons
  • Terrarium Animals
  • Small Rodents
  • Ferrets
  • Rabbits
23
Q

What are the requirements for prescribing/supplying POM V, POM VPS or NFA-VPS?

A
  • ensure the recipient is competent to use product for prescribed/authorised purpose
  • advise on its safe administration
  • provide information about contraindications/warnings
  • limit the amount of product prescribed to a MINIMUM amount required for immediate treatment

MUCH MORE DETAILED THAN HUMAN MEDICINES - VET MEDICINES HAVE TO GIVE ADVICE

24
Q

AVM - GSL medicines have to be sold from a retail building - true or false?

A

FALSE - doesn’t have to be sold from a retail premises as many animals aren’t kept indoors

25
Q

What are the record requirements for RECEIPT/SUPPLY of a POM-V or POM-VPS veterinary medicines?

A
  • Name of Medicine
  • Date and Receipt of Supply
  • Batch Number
  • Quantity
  • Name and Address of the Supplier/Recipient
  • Name and Address of Prescriber AND keep a copy of the prescription - IF THERE IS A WRITTEN PRESCRIPTION
26
Q

How long do you keep a receipt/supply record of a POM-V or POM-VPS medicine for?

A

5 years

27
Q

What are the requirements for PRESCRIBING of POM - V or POM - VPS veterinary medicines?

A
  • the prescription can be ORAL or can be WRITTEN

but the prescription has to be written if the Veterinary Medicinal Product id not supplied by the SAME person that has prescribed

  • prescription is valid for 6 months
  • written prescription has to be indelible/transmitted in a secure electronic format
28
Q

What are the prescription requirements of a POM - V or POM - VPS? (9)

A
  1. Name/Address/Telephone Number/Qualification of the Prescriber (also the RCVS no. if its a CD)
  2. Name/Address of Animal Owner/Keeper
  3. Species of Animal/Identification/Address of animals if not the owners address
  4. Date of the Prescription
  5. Name/Amount of Required Medicine/Dosage/Administration Instructions - AS DIRECTED IS NOT ACCEPTABLE
  6. Any necessary warnings and any withdrawal period if relevant
  7. Where relevant, statement ‘prescribed under the cascade’
  8. CD Schedule 2/3 ‘the item has been prescribed for an animal or herd under the care of the veterinarian’
  9. If prescription is repeatable need to state how many times it can be repeated
29
Q

EEA & Swiss Veterinarians are NOT allowed to prescribe for animals in the UK - true or false?

A

FALSE - they can as long as

  • they are registered with the RCVS
  • animals are under THEIR care and
  • a clinical assessment has been carried out

but it can still be dispensed by UK pharmacists at their discretion

30
Q

Additional veterinary prescription requirements for CDs Schedule 2 and 3? (7)

A
  1. Declaration that CD is prescribed for an animal/herd under vet’s care
  2. Specify RCVS registration number of prescribing vet
  3. Name of the animal, full name of owner and address where prescribed CD is to be delivered
  4. Name and Form of Drug
  5. Amount of product prescribed in both words and figures
  6. Strength of preparation - if there is more than one strength available
  7. Dose to be administered - AS DIRECTED/PRN IS NOT ACCEPTABLE
31
Q

It is legal to dispense a CD against a faxed prescription - true or false?

A

FALSE - faxed prescription are not legally valid, and it is illegal to dispense against this

32
Q

What should the label and package inserts of Veterinary Medicinal be?

A
  • in English

- have ‘UK Authorised Veterinary Medicinal Product’

33
Q

What needs to be on the immediate container label of veterinary medicinal products?

A
  1. Name of the VMP/Strength/Form
  2. Name and Proportion of EACH active substance and any excipient that is specified in the MA
  3. Batch Number
  4. Expiry Date

and also the words ‘keep the container in the outer carton’’ and provide an insert with all additional information required

if all the information fits on the package then there will be no need for the insert

34
Q

the label CANNOT obscure any information that is on the packaging - true or false?

A

TRUE, detailed in the veterinary regulations but not in the human regs - ALL OF THE INFORMATION NEEDS TO BE PASSED ON

35
Q

What are the labelling requirements of veterinary medicines NOT INCLUDING POM - V?

A
  • labelled in accordance with the MA

- Name and Address of the supplying practice

36
Q

What are the labelling requirements of POM - V veterinary medicines?

A
  • Name and Address of the Animal Owner
  • Name and Address of the Veterinary Practice Supplying the Medicine
  • Date of Supply
  • Name/Strength/Quantity
  • Dosage and Directions
  • ‘for animal treatment only’
37
Q

In which circumstances would a vet administer medicines ‘under the cascade’?

A
  • if there is no suitable veterinary medicinal products available
38
Q

What additional requirements on a prescription would there need to be if a product was ‘under the cascade’?

A
  • ‘prescribed under the cascade’

- ‘for administration under the cascade’

39
Q

What is step 1 of the cascade?

A

Veterinary Medicinal Product for use in

  • another animal species
  • for a different condition in the same species

similar to ‘off label’ for human medicines

40
Q

What is step 2 of the cascade?

A
  • a UK medicinal product for HUMAN use

- a veterinary medicinal product NOT authorised in the UK but in another EU country for use with any animal species

41
Q

What is step 3 of the cascade?

A
  • a medicine that is prepared extemporaneously
42
Q

Any of the suitably qualified persons can prescribe under the cascade - true or false?

A

FALSE - only vets can prescribe under the cascade

43
Q

Suitably Qualified Persons can dispense any of the products under the cascade - true or false?

A

FALSE - they can only dispense AUTHORISED Veterinary Medicinal Product

only PHARMACISTS are able to dispense authorised Veterinary Medicinal Products, Human Medicines AND extemp products against a vet’s prescription

44
Q

What are the labelling requirements for products under the cascade?

A
  • Name and Address of the Pharmacy Supplying
  • Name of Prescribing Vet
  • Name and Address of the animal owner
  • Identification of animal or groups of animals
  • Date of Supply
  • Expiry Date
  • Name and Quantity of Active Ingredients
  • Dosage and Administration Instructions
  • Any special storage precautions
  • Any necessary warnings for users
  • Withdrawal period
  • ‘for animal treatment only’/’keep out of sight and reach of children’
45
Q

Human and Veterinary Medicinal Products are interchangeable and you can supply and sell GSL and P medicines for animals - true or false?

A

FALSE - humans and animals may react differently

it is UNLAWFUL to sell unauthorised veterinary medicines including GSL and P medicines - unless it is under the cascade with a prescription

THIS INCLUDES: even if a vet told an owner to purchase an OTC human product from a pharmacy - this would be illegal

Law Semester 2 (16 decks)

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