Prescribing & Dispensing: Responsibilities & Controlled Drugs Flashcards

1
Q

what must a premise be registered with in order for a vet to supply medicines

A

RCVS

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2
Q

what does RCVS inspect the premise for

A

practice standard scheme (PSS)

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3
Q

what does the veterinary medicines directorate inspect

A

non-PSS premises

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4
Q

what aspects are considered during inspection of a premise

A
  1. security
  2. prescription and supply of medicines
  3. storage of medicines
  4. health & safety
  5. record keeping
  6. controlled drugs
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5
Q

what are health and safety precautions (4)

A
  1. control of substances hazardous to heath (COSHH)
  2. standard operating procedures (SOPs)
  3. personal protective equipment (PPE)
  4. manual handling
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6
Q

what are the VMD classifications for deficiencies

A

minor, major or critical

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7
Q

what is a critical deficiency as classified by the VMD

A

significant risk to human/animal health or the environment

significant deviation from VMR

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8
Q

what enforcement measures does the VMD do

A
  1. improvement notices
  2. seizure notices
  3. prosecution & removal from register of VPP
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9
Q

what are the problems associated with the mobile dispensary (4)

A
  1. temperature
  2. public access
  3. stock rotation
  4. drug waste
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10
Q

what do mobile dispensaries require

A

vehicle is a public place –> require a fixed lockable box or safe to meet safe custody requirements (bolted to the floor, etc)

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11
Q

what are the regulations when mailing medicines

A

can be mailed by royal mail

CDs cannot be sent in mail

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12
Q

what should you do if there is an adverse reaction to a medicine

A

report to the VMD in the UK

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13
Q

what types of adverse reactions should you report (4)

A
  1. suspected adverse reactions
  2. lack of efficacy
  3. reactions to authorized vet meds and human meds
  4. reactions in animals & people handling drugs
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14
Q

what are the 3 legislations of controlled drugs (3)

A
  1. misuse of drugs act 1971
  2. misuse of drugs (safe custody) regs 1973
  3. misuse of drugs regulations 2001
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15
Q

what does the misuse of drugs act legislate (3)

A
  1. controls availability of drugs considered to be “dangerous or otherwise harmful”
  2. defines unlawful activities with respect to CD
  3. vets can prescribe, administer or supply CD in the course of their work
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16
Q

what does the misuse of drugs (safe custody) regs legislate

A

describes requirements for storage

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17
Q

what does the misuse of drugs regulations 2001 legislate

A

governs use of CDs in veterinary medicine

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18
Q

what are the classifications of controlled drugs

A

Class A

Class B

Class C

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19
Q

what are class A controlled drugs

A

crack cocaine, cocaine, ectasy, etc.

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20
Q

what are class B drugs

A

amphetamines, barbituates, cannabis, codeine, ketamine, methyphenidate, synthetic cannabinoids, synthetic cathinones

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21
Q

what is the penalty for possession and supply of class B drugs

A

possession: 5 years in prison/and or fine
supply: 14 years in prison/and or fine

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22
Q

what are class C drugs

A

anabolic steroids, benzodiazepines, gamma hydroxybutyrate (GHB), gamma butyrolactone (GBL), piperazines (BZP), khat

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23
Q

what is the penalty for class C possession and supply

A

possession: 2 years in prison and/or fine
supply: 14 years and/or fine

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24
Q

what are controlled drugs under the misuse of drugs act divided into

A

schedules 1-5

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25
Q

what is the basis for dividing CDs

A

therapeutic benefit vs harm

schedule 1 risk of harm >> benefit

schedule 5 risk of harm << benefit

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26
Q

what are schedule 1 CDs

A

greatest potential harm

no significant therapeutic value

most strictly controlled

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27
Q

what does rescheduling of cannabinoids derived from cannabis allow

A

some products to be prescribed if they are pure

ex. tetrahydrocannabinol (THC) or cannabidiol (CBD)

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28
Q

what are the indications to prescribe cannabinoids

A

chronic pain, resistant forms of epilepsy, chemotherapy-related nausea and vommiting

29
Q

how must schedule 2 CDs be stored

A

must be stored in a fixed locked receptable

30
Q

what are schedule 2 CDs subject to

A

subject to special prescription requirements

31
Q

what must be done after a schedule 2 CD is used

A

use must be recorded in a register which must be signed by vet

32
Q

how must schedule 2 CDs be destroyed

A

authorized & witnessed

33
Q

how long must invoices be retained

A

minimum of two years

34
Q

what are examples of schedule 2 CDs

A

pethidine

morphine

methadone

fentanyl

quinalbarbitone

ketamine

35
Q

which schedule 2 CD is exempt from safe custody requirements

A

quinalbarbitone (somulose)

36
Q

what are schedule 3 CDs exempt from

A

safe custody requirements

37
Q

what are the prescription requirements of schedule 3 CDs

A

same as schedule 2 CDs

38
Q

is there a legal requirement to record transactions in a CD register when using schedule 3 drugs

A

no

39
Q

what are the destruction requirements of schedule 3 CDs

A

there isnt any requirements relating to destruction

40
Q

how long must invoices of schedule 3 CDs be retained

A

minimum of 2 years

41
Q

what are examples of schedule 3 CDs

A

pentobarbitone

phenobarbitone

midazolam

buprenorphine

tramadol

42
Q

what schedule is buprenorphine

A

schedule 3

43
Q

is buprenorphine subject to safe custody requirements

A

yes even though its a schedule 3 CD it must be stored in a fixed locked receptacle

44
Q

what are recent additions to schedule 3 and what are the rules

A

tramadol, gabapentin (& pregablin)

exempt from safe custody requirements but must be requisioned & prescribed as a CD

45
Q

are schedule 4 CDs exempt from safe custody requirements

A

yes

46
Q

what prescription writing requirements apply to schedule 4 CDs

A

some requirements

47
Q

how long must schedule 4 CD invoices be kept

A

minimum of 2 years

48
Q

what destruction requirements are there for schedule 4 CDs

A

none

49
Q

do schedule 4 CDs need to be kept

A

no

50
Q

what are examples of schedule 4 CDs

A

benzodiazepines (except midazolam which is a schedule 3)

anaobolic and androgenic steroids

51
Q

what are schedule 5 CDs and what are the rules

A

includes preparations of certain controlled drugs (codeine, morphine) which are exempt from full control when present at low concentrations

exempt from virtually all CD requirements (but invoices kept for 2 years)

52
Q

complete this chart

A
53
Q

how are CDs managed

A

using standard operating procedures (SOPs)

54
Q

what should SOPs cover (6)

A
  1. who has access to CDs
  2. where CDs are stored
  3. how to dispense CDs
  4. how to distroy & dispose of CDs
  5. what records need to be kept
  6. who to alert if complications arise
55
Q

what are the benefits of SOPs (5)

A
  1. improve governance of CDs
  2. ensure practice is in line with regulatory frameworks
  3. provide clarity & consistency for all staff
  4. training tool for new & existing staff
  5. accountability & responsibility including clarification of where responsibility can be delegated
56
Q

what are the requirements of the CD cabinet (6)

A
  1. must be bolted to wall or floor
  2. double locked preferably
  3. locked when not in use
  4. lock must be different to any other lock on ward
  5. keys must only be availble to authorized members of staff
  6. cupboard should be reserved soley for storage of CDs
57
Q

what are the keyholders

A

any responsible person within the practice

VS or VN

can be multiple people

not acceptable to allow unknown persons access to the CD cabinet

58
Q

what are the requirements of CD prescriptions (5)

A
  1. can be hand written; typed or computerized BUT must be signed IN INK by the prescriber
  2. it is an offence to supply against a faxed or emailed prescription (but can be prepared for issue)
  3. only valid for 28 days
  4. repeats on same prescription not allowed for 2 & 3
  5. only 28 days worth of medicated should be prescribed (unless long term meds)
59
Q

why are computer generated prescriptions considered good practice

A

easy to follow audit trail

60
Q

what must schedule 2 & 3 prescriptions state (7)

A
  1. CD is prescribed for an animal or herd under vet’s care
  2. full name & address of owner, plus name of animal to whom the CD is to be administered
  3. name & form of drug
  4. amount of product prescribed in both words & numbers
  5. strength of preparation
  6. dose to be administered and the route (take as directed or take as required is not acceptable)
  7. the prescribing vet’s MRCVS registration number
61
Q

what must the CD register contain

A
  1. record receipt: date, name & address of supplies & amount, running balance, signed by VS or VN
  2. record supply: date, name, address of patient (or case number) & amount, running balance, prescribers MRCVS number, signed by VS
62
Q

how long must CDs register be kept

A

min 2 years

63
Q

what does checking the balance of CDs entail

A

check and sign at regular intervals to identify discrepancies ASAP as easier to deal with

64
Q

how should mistakes on the register be corrected

A

don’t use white out

incorrect entries must be readable

bracket error & asterix

use footnote to record reason for error

on a new line write correct entry with new balance

if possible countersign error

65
Q

how should a register discrepancies

A

consult SOP

once resolved include footnote in register correcting discrepancy balance

keep records of action taken

if source cannot be identified a formal internal investigation must be undertaken

66
Q

how must out-of-date schedule 2 CDs be disposed of (4)

A

keep segregated & clearly marked in CD cabinet

  1. must be denatured (rendered irretrievable) –> denaturing kit or cat litter/sawdust
  2. disposed of as pharmaceutical waste
  3. must be recorded in register & balance adjusted (don’t sign out until destroyed)
  4. witnessed by: vet indpendent of practice, police (controlled drug liaison officer), VMD inspector or practice standards scheme assessor
67
Q

what should you do with a smashed schedule 2 ampoule

A

spill kit (SOP)

waste in appropriate containers

record in register that ampoule has been broken

counter sign

68
Q

how are residual CDs disposed of (4)

A
  1. denatured first
  2. dispose of as pharmaceutical waste
  3. recorded: residual in vial signed out in CD register, residual in syringe has already been signed out
  4. no legal requirement to witness destruction
69
Q

how must returned CDs be disposed of

A
  1. denatured
  2. disposed of as pharmaceutical waste
  3. no need to record