Prescribing & Dispensing: Responsibilities & Controlled Drugs Flashcards
what must a premise be registered with in order for a vet to supply medicines
RCVS
what does RCVS inspect the premise for
practice standard scheme (PSS)
what does the veterinary medicines directorate inspect
non-PSS premises
what aspects are considered during inspection of a premise
- security
- prescription and supply of medicines
- storage of medicines
- health & safety
- record keeping
- controlled drugs
what are health and safety precautions (4)
- control of substances hazardous to heath (COSHH)
- standard operating procedures (SOPs)
- personal protective equipment (PPE)
- manual handling
what are the VMD classifications for deficiencies
minor, major or critical
what is a critical deficiency as classified by the VMD
significant risk to human/animal health or the environment
significant deviation from VMR
what enforcement measures does the VMD do
- improvement notices
- seizure notices
- prosecution & removal from register of VPP
what are the problems associated with the mobile dispensary (4)
- temperature
- public access
- stock rotation
- drug waste
what do mobile dispensaries require
vehicle is a public place –> require a fixed lockable box or safe to meet safe custody requirements (bolted to the floor, etc)
what are the regulations when mailing medicines
can be mailed by royal mail
CDs cannot be sent in mail
what should you do if there is an adverse reaction to a medicine
report to the VMD in the UK
what types of adverse reactions should you report (4)
- suspected adverse reactions
- lack of efficacy
- reactions to authorized vet meds and human meds
- reactions in animals & people handling drugs
what are the 3 legislations of controlled drugs (3)
- misuse of drugs act 1971
- misuse of drugs (safe custody) regs 1973
- misuse of drugs regulations 2001
what does the misuse of drugs act legislate (3)
- controls availability of drugs considered to be “dangerous or otherwise harmful”
- defines unlawful activities with respect to CD
- vets can prescribe, administer or supply CD in the course of their work
what does the misuse of drugs (safe custody) regs legislate
describes requirements for storage
what does the misuse of drugs regulations 2001 legislate
governs use of CDs in veterinary medicine
what are the classifications of controlled drugs
Class A
Class B
Class C
what are class A controlled drugs
crack cocaine, cocaine, ectasy, etc.
what are class B drugs
amphetamines, barbituates, cannabis, codeine, ketamine, methyphenidate, synthetic cannabinoids, synthetic cathinones
what is the penalty for possession and supply of class B drugs
possession: 5 years in prison/and or fine
supply: 14 years in prison/and or fine
what are class C drugs
anabolic steroids, benzodiazepines, gamma hydroxybutyrate (GHB), gamma butyrolactone (GBL), piperazines (BZP), khat
what is the penalty for class C possession and supply
possession: 2 years in prison and/or fine
supply: 14 years and/or fine
what are controlled drugs under the misuse of drugs act divided into
schedules 1-5
what is the basis for dividing CDs
therapeutic benefit vs harm
schedule 1 risk of harm >> benefit
schedule 5 risk of harm << benefit
what are schedule 1 CDs
greatest potential harm
no significant therapeutic value
most strictly controlled
what does rescheduling of cannabinoids derived from cannabis allow
some products to be prescribed if they are pure
ex. tetrahydrocannabinol (THC) or cannabidiol (CBD)
what are the indications to prescribe cannabinoids
chronic pain, resistant forms of epilepsy, chemotherapy-related nausea and vommiting
how must schedule 2 CDs be stored
must be stored in a fixed locked receptable
what are schedule 2 CDs subject to
subject to special prescription requirements
what must be done after a schedule 2 CD is used
use must be recorded in a register which must be signed by vet
how must schedule 2 CDs be destroyed
authorized & witnessed
how long must invoices be retained
minimum of two years
what are examples of schedule 2 CDs
pethidine
morphine
methadone
fentanyl
quinalbarbitone
ketamine
which schedule 2 CD is exempt from safe custody requirements
quinalbarbitone (somulose)
what are schedule 3 CDs exempt from
safe custody requirements
what are the prescription requirements of schedule 3 CDs
same as schedule 2 CDs
is there a legal requirement to record transactions in a CD register when using schedule 3 drugs
no
what are the destruction requirements of schedule 3 CDs
there isnt any requirements relating to destruction
how long must invoices of schedule 3 CDs be retained
minimum of 2 years
what are examples of schedule 3 CDs
pentobarbitone
phenobarbitone
midazolam
buprenorphine
tramadol
what schedule is buprenorphine
schedule 3
is buprenorphine subject to safe custody requirements
yes even though its a schedule 3 CD it must be stored in a fixed locked receptacle
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
are schedule 4 CDs exempt from safe custody requirements
yes
what prescription writing requirements apply to schedule 4 CDs
some requirements
how long must schedule 4 CD invoices be kept
minimum of 2 years
what destruction requirements are there for schedule 4 CDs
none
do schedule 4 CDs need to be kept
no
what are examples of schedule 4 CDs
benzodiazepines (except midazolam which is a schedule 3)
anaobolic and androgenic steroids
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)
complete this chart
how are CDs managed
using standard operating procedures (SOPs)
what should SOPs cover (6)
- who has access to CDs
- where CDs are stored
- how to dispense CDs
- how to distroy & dispose of CDs
- what records need to be kept
- who to alert if complications arise
what are the benefits of SOPs (5)
- improve governance of CDs
- ensure practice is in line with regulatory frameworks
- provide clarity & consistency for all staff
- training tool for new & existing staff
- accountability & responsibility including clarification of where responsibility can be delegated
what are the requirements of the CD cabinet (6)
- must be bolted to wall or floor
- double locked preferably
- locked when not in use
- lock must be different to any other lock on ward
- keys must only be availble to authorized members of staff
- cupboard should be reserved soley for storage of CDs
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
what are the requirements of CD prescriptions (5)
- can be hand written; typed or computerized BUT must be signed IN INK by the prescriber
- it is an offence to supply against a faxed or emailed prescription (but can be prepared for issue)
- only valid for 28 days
- repeats on same prescription not allowed for 2 & 3
- only 28 days worth of medicated should be prescribed (unless long term meds)
why are computer generated prescriptions considered good practice
easy to follow audit trail
what must schedule 2 & 3 prescriptions state (7)
- CD is prescribed for an animal or herd under vet’s care
- full name & address of owner, plus name of animal to whom the CD is to be administered
- name & form of drug
- amount of product prescribed in both words & numbers
- strength of preparation
- dose to be administered and the route (take as directed or take as required is not acceptable)
- the prescribing vet’s MRCVS registration number
what must the CD register contain
- record receipt: date, name & address of supplies & amount, running balance, signed by VS or VN
- record supply: date, name, address of patient (or case number) & amount, running balance, prescribers MRCVS number, signed by VS
how long must CDs register be kept
min 2 years
what does checking the balance of CDs entail
check and sign at regular intervals to identify discrepancies ASAP as easier to deal with
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
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
how must out-of-date schedule 2 CDs be disposed of (4)
keep segregated & clearly marked in CD cabinet
- must be denatured (rendered irretrievable) –> denaturing kit or cat litter/sawdust
- disposed of as pharmaceutical waste
- must be recorded in register & balance adjusted (don’t sign out until destroyed)
- witnessed by: vet indpendent of practice, police (controlled drug liaison officer), VMD inspector or practice standards scheme assessor
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
how are residual CDs disposed of (4)
- denatured first
- dispose of as pharmaceutical waste
- recorded: residual in vial signed out in CD register, residual in syringe has already been signed out
- no legal requirement to witness destruction
how must returned CDs be disposed of
- denatured
- disposed of as pharmaceutical waste
- no need to record
