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
what is the basis for dividing CDs
therapeutic benefit vs harm schedule 1 risk of harm \>\> benefit schedule 5 risk of harm \<\< benefit
26
what are schedule 1 CDs
greatest potential harm no significant therapeutic value most strictly controlled
27
what does rescheduling of cannabinoids derived from cannabis allow
some products to be prescribed if they are pure ex. tetrahydrocannabinol (THC) or cannabidiol (CBD)
28
what are the indications to prescribe cannabinoids
chronic pain, resistant forms of epilepsy, chemotherapy-related nausea and vommiting
29
how must schedule 2 CDs be stored
must be stored in a fixed locked receptable
30
what are schedule 2 CDs subject to
subject to special prescription requirements
31
what must be done after a schedule 2 CD is used
use must be recorded in a register which must be signed by vet
32
how must schedule 2 CDs be destroyed
authorized & witnessed
33
how long must invoices be retained
minimum of two years
34
what are examples of schedule 2 CDs
pethidine morphine methadone fentanyl quinalbarbitone ketamine
35
which schedule 2 CD is exempt from safe custody requirements
quinalbarbitone (somulose)
36
what are schedule 3 CDs exempt from
safe custody requirements
37
what are the prescription requirements of schedule 3 CDs
same as schedule 2 CDs
38
is there a legal requirement to record transactions in a CD register when using schedule 3 drugs
no
39
what are the destruction requirements of schedule 3 CDs
there isnt any requirements relating to destruction
40
how long must invoices of schedule 3 CDs be retained
minimum of 2 years
41
what are examples of schedule 3 CDs
pentobarbitone phenobarbitone midazolam buprenorphine tramadol
42
what schedule is buprenorphine
schedule 3
43
is buprenorphine subject to safe custody requirements
yes even though its a schedule 3 CD it must be stored in a fixed locked receptacle
44
what are recent additions to schedule 3 and what are the rules
tramadol, gabapentin (& pregablin) exempt from safe custody requirements but must be requisioned & prescribed as a CD
45
are schedule 4 CDs exempt from safe custody requirements
yes
46
what prescription writing requirements apply to schedule 4 CDs
some requirements
47
how long must schedule 4 CD invoices be kept
minimum of 2 years
48
what destruction requirements are there for schedule 4 CDs
none
49
do schedule 4 CDs need to be kept
no
50
what are examples of schedule 4 CDs
benzodiazepines (except midazolam which is a schedule 3) anaobolic and androgenic steroids
51
what are schedule 5 CDs and what are the rules
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
complete this chart
53
how are CDs managed
using standard operating procedures (SOPs)
54
what should SOPs cover (6)
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
what are the benefits of SOPs (5)
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
what are the requirements of the CD cabinet (6)
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
what are the keyholders
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
what are the requirements of CD prescriptions (5)
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
why are computer generated prescriptions considered good practice
easy to follow audit trail
60
what must schedule 2 & 3 prescriptions state (7)
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
what must the CD register contain
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
how long must CDs register be kept
min 2 years
63
what does checking the balance of CDs entail
check and sign at regular intervals to identify discrepancies ASAP as easier to deal with
64
how should mistakes on the register be corrected
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
how should a register discrepancies
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
how must out-of-date schedule 2 CDs be disposed of (4)
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
what should you do with a smashed schedule 2 ampoule
spill kit (SOP) waste in appropriate containers record in register that ampoule has been broken counter sign
68
how are residual CDs disposed of (4)
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
how must returned CDs be disposed of
1. denatured 2. disposed of as pharmaceutical waste 3. no need to record