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LAW EXAM > s2 w4 > Flashcards

s2 w4 Flashcards

vet meds retail pharmacy business

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1
Q

which types of animals are under the vet med regulation 2013?

A

food producing animals
household pets
zoo animals
wild animals

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2
Q

what is a veterinary medicinal product (VMP)?

A

Any substance or combination of substances:-
• presented as having properties for treating or preventing disease in animals
OR
• that may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis

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3
Q

a veterniary medicinal product does not need a marketing authorisation

A

FALSE

this is an offence

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4
Q

who can prescribe VMPs?

A

veterinary surgeons
pharmacists
suitably qualifed person (SQP)

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5
Q

what is a POM-V

A

prescription only medicine - veterinarian

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6
Q

what is a POM-VPS

A

prescription only medicine - veterinarian, pharmacist, SQP

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7
Q

what is NFA-VPS

A

non food animal - veterinarian, pharmacist, SQP

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8
Q

what is AVM-GSL

A

authorised veterinary medicine - general sales

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9
Q

AVM-GSL requires a prescription?

A

FALSE

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10
Q

AVM-GSL can be sold on any premises

A

TRUE

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11
Q

A vet may only prescribe and supply vet meds if they are registered with the RCVS?

A

TRUE

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12
Q

Vets who are registered with RCVS can supply from any premises?

A

FALSE

the premises needs to be registered with RCVS as a veterinary practice premises (VPP)

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13
Q

vet supplying must be pesent when it is being handed over to patient?

A

TRUE

unless they have authorised transaction or are satisfied with compotency of person doing so

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14
Q

what is a SQP?

A

animal medicine advisor who is qualified to prescribe and or supply certain veterinary medicines under the VMR

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15
Q

SQP need to pass two exams?

A

TRUE

in order to be qualifed under two organisations (AMTRA and Vet skills ltd)

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16
Q

SQP can supply POM-VPS and NFA-VPS?

A

TRUE

they can prescribe or give out those which have been prescribed

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17
Q

SQP can give out a POM-V

A

FALSE

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18
Q

when is product included in POM-V catergory?

A

– requires a strict limitation on its use for specific safety reasons
– requires vet’s specialised knowledge for its use/application
– has narrow safety margin
– is Government policy to demand professional control at high level

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19
Q

who prescribes POM-V?

A

A veterinarian who must:
• Carry out a clinical assessment of the animal
• The animal(s) must be under his care (registered Dr or Vet, very clear responsibility for the animal, should have seen the animal recently)

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20
Q

a POM-V can be prescribed for whatever length of time

A

FALSE

needs to be minimum time required for the treatment

21
Q

when is a medicine a POM-VPS?

A

– used to reduce or prevent effects of endemic disease in herds, flocks or in individual animals (such as treatment for worms and other parasites)
– use implies risks for user, animal, consumer safety or environment, but users can be made aware of suitable countermeasures through simple advice
– professional user can be given adequate training in its regular use

22
Q

NFA-VPS is equivalent to P for human medicines

A

TRUE

there is some control over the supply

23
Q

AVM-GSL are equivalent of GSL

A

TRUE

there is a wide safety margin and the treatment for common ailments

24
Q

which small animals have exemptions?

A 
–	aquarium animals
–	cage birds
–	homing pigeons
–	terrarium animals
–	small rodents
–	ferrets 
–	rabbits
25
Q

the small animal exemptions mean they can be sold at any retailer?

A

TRUE

aslong as they are on the list they can be on market without MA

26
Q

when supplying VMP what must they make sure?

A
  • Ensure recipient is competent to use product for prescribed/authorised purpose
  • Advise on its safe administration
  • Provide information about contraindications/ warnings etc.
  • Limit the amount of product prescribed (supplied) to minimum amount required for immediate treatment
27
Q

AVM-GSL have restriction to supply?

A

FALSE

they can be sold from any retail with a responsible approach of supply

28
Q

what are the record requirements for POM-V and POM-VPS?

A

• Name of medicine
• Date of receipt or supply
• Batch number
• Quantity
• Name and address of supplier or recipient
• Name & address of Rx-er + keep copy of Rx
– if there is written Rx

29
Q

how long are POM-V and POM-VPS reocrds kept for?

A

5 YEARS

30
Q

a POM-V and POM-VPS prescription must be in writing?

A

FALSE

it can be oral (usually done in surgery)

31
Q

how long is POM-V or POM-VPS valid for?

A

6 months

unless CD 2,3 or 4 –> 28 days

32
Q

what is needed on Rx for POM-V and POM-VPS?

A
  1. Name, address, phone number and qualification of Rx-er
  2. Signature of Rx-er
  3. Name and address of owner
  4. Species of animal and its identity
  5. Date of Rx
  6. Name and amount of medicine
  7. Any warnings
  8. where relevant if rx-ed under cascade
  9. Where Schedule 2 or 3 CDs Rx-ed – statement: “the item has been prescribed for an animal or herd under the care of the veterinarian”
  10. if repetable how many times
33
Q

EEA and Swiss vets are allowed to prescribe for animals in UK?

A

TRUE

given that they are registered with RCVS, animal is under their care and a clinical assessment was carried out

34
Q

what is needed for Rx of CD 2-3 VMP?

A

1) Declaration that CD is prescribed for an animal/ herd under vet’s care
2) Specify RCVS registration number of Rx-ing vet
3) Name of 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 more than one strength available)
7) Dose to be administered

35
Q

VMP products do not need to have authorisation stamp

A

FALSE

must state’ UK authorised veterinary medicinal product’

36
Q

what is needed on the manufacturers label of a VMP?

A

a) Name of VMP, strength and form*
b) Name and proportion of each active substance*
c) Route of administration (if not apparent)*
d) Batch number*
e) Expiry date*
f) Words “For animal treatment only”*
– and for POM-V and POM-VPS products also the words “To be supplied only on veterinary prescription”*
g) Contents by weight, volume or number of dose units
h) Marketing authorisation number
i) Name and address of MA holder or distributor
k) Target species
l) Distribution category – in box
m) Words “Keep out of the reach of children” or “Keep out of reach and sight of children”
n) Storage instructions
o) In-use shelf life (if appropriate)
p) For food-producing species, withdrawal period for each species or animal product concerned (even if zero days)
q) Any warning specified in MA (target species or user or environment) considered essential for that product
r) Disposal advice
s) Full indications
t) Dosage instructions
u) Contraindications
v) Any further information required by MA

37
Q

what needs to be on label of a POM-V

A
  • Name and address of the animal owner
  • Name and address of the veterinary practice supplying the medicine
  • Date of supply
  • Name, strength and quantity of product
  • Dosage and directions for use
  • ‘For animal treatment only’
  • For topical preparations ‘For external use only’.
38
Q

what is the veterinary cascade?

A

used if there is no suitable authorised VMP in the UK for the treatment of an animal, a vet may treat the animal following ‘the Cascade’
 in sequence

39
Q

Anyone can prescribe under the cascade?

A

FALSE

only vets can prescribe under the cascade

40
Q

what must be on label of product under cascade?

A

a) Name and address of pharmacy supplying
b) Name of prescribing vet
c) Name and address of animal owner
d) Identification (incl. species) of animal or group of animals
e) Date of supply
f.) Expiry date (if applicable)
g) Name and quantity of active ingredients
h) Dosage and administration instructions
i) Any special storage precautions
j) Any necessary warnings for user re:
– target species, administration or disposal of product
k) Withdrawal period, if relevant
l) Words
– “For animal treatment only” and
– “Keep out of reach of children”

41
Q

you can supply human medicines to an animal for anything?

A

FALSE

this is unlawful unless it is done under the cascade, even if asked verbally.

42
Q

what is definition for retail sale?

A

Any sale which does not fall within the definition of “wholesale dealing” is a retail sale.

43
Q

what is a retail pharmacy business?

A

needs to be a registered premises
– a business (other than a professional practice carried on by a doctor or dentist) which consists of or includes the retail sale of medicinal products that are not subject to general sale
provided in all cases there is a responsible pharmacist in charge.

44
Q

who can lawfully conduct a retail pharmacy business?

A

a) Individual pharmacist or partnership of pharmacists
– (i.e. all the partners must be pharmacists)
b) Body corporate
– [see later slides]
c) Representative of a pharmacist
– in case of death or disability*

45
Q

in case of death a representative of a pharmacist can act for 5 years?

A

TRUE

if not due to death only for 3 years

46
Q

what is a body corporate?

A

Association of individuals constituted to acquire collective legal personality
• Retail pharmacy business
– so far as concerns the keeping, preparing and dispensing of medicinal products other than a GSl
• Must be
– Under management of a superintendent

47
Q

what are the requirement for superintendents?

A

a) Superintendent is a pharmacist
b) Statement in writing signed by him/her, and signed on behalf of body corporate
– specify his/her name and
– stating whether s/he is a member of the board of that body or not
must be sent to the registar
c) S/he does not act in a similar capacity for any other body corporate

48
Q

what is the role of a superintendent?

A

overall responsibilty
manage the pharmaceutical aspects of the business
legal obligations under the medicines act 1968

LAW EXAM (8 decks)

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