Prescribing and Dispensing Flashcards
Name the 3 aims of the Veterinary Medicines Regulations 2013
- To control risks to human health, animal health, and the environment through safe use of veterinary medicines.
- To provide assurance on efficacy
- To provide reliable information to users
How is the regulation of drugs achieved (governing bodies)
Data assessment and authorisation by VMD
Centralised application of European Medicine Agency
Name the processes by which the regulation of medicines is achieved (x4)
- Certification and qualification
- Prescribing, dispensing and supply of veterinary medicines
- Testing, inspection and investigation
- Post-marketing authorisation
What is an SQP and what can they do
Suitably Qualified Person
Can supply some medicines, work in accordance with the VMD code of practice
Must have training and have passed exams
What is a POM-V medicine
Prescription-only medicine from a Vet
Must be prescribed by a veterinary surgeon following a clinical exam of the animal, which must be under their care
When can POM-V medicines be prescribed
Must be prescribed by a veterinary surgeon following a clinical exam of the animal, which must be under their care
When is a medicine classed as POM-V (x4)
- It requires a strict limitation on its use for specific safety reasons
- It requires the specialised knowledge of a veterinary surgeon for its use/application
- It has a narrow safety margin requiring above-average care in its use
- It is government policy to demand professional control at a high level
What is a POM-VPS medicine
Prescription-only medicine from a vet, pharmacist or SQP
Can a POM-VPS medicine be prescribed without a clinical assessment of an animal
Yes
What must the prescriber do before prescribing a POM-VPS
- Be satisfied the person who administers the medicine is competent to do so
- Advise on warnings/contraindications and safe administration
When is a medicine classified as a POM-VPS
When used to reduce or prevent the effects of endemic disease in herds, flocks or in individual animals e.g. antiparasitic drugs
What is a NFA-VPS drug
Non-Food Animal medicines which can be prescribed by a vet, pharmacist or SQP
When is a medicine classed as a NFA-VPS
It is indicated for use only in non-food animals with no requirement for a prescription-only status
It is used routinely to prevent or limit the effects of endemic disease in non-food animals
What is the Small Animal Exemption Scheme (SAES)
Medicines for use in certain pet species the active ingredient of which has been declared by the Secretary of State as not requiring veterinary control
they are exempt from the requirement for a marketing authorisation
Pet species - fish, cage birds, ferrets, rabbits, small rodents
What is an AVM-GSL medication and what does it mean
Authorised Veterinary Medicine – General Sales List
No legal restrictions
How many schedules of controlled drugs are there
5
What 4 things should be taken into account when prescribing a medication
- The circumstances of the animal being treated
- The available authorised vet medicines
- The need for responsible use of medicines
- The competence of the person who is administering the product
How many years must records of drugs be kept for
5 years
What are the requirements for the premises where medicines are stored/supplied
Listed on a register as a Veterinary Practice Premises (VPP)
Premises must be in a permanent and secure building
The building must not allow the entrance of birds or vermin
List the drug distribution categories
POM-V
POM-VPS
NFA-VPS
AVM-GSL
What 3 laws regulate prescriptions
Vet surgeons act
Veterinary medicines regulation
Misuse of drugs act
What are the 5 schedules of controlled drugs and what controls are they subject to
Schedule 1 - possession requires a home office licence
Schedule 2 - drugs obtained and supplied must be recorded in a register
Schedule 2 and 3 - prescriptions are subject to additional requirements
Schedule 4 and 5 - have fewer controls
Define “under your care” when talking about POM-V prescriptions
The veterinary surgeon must have been given the responsibility for the health of the animal or herd by the owner or the owner’s agent
Veterinary surgeon must maintain clinical records of the animal
What things must someone who is prescribing medicines do before prescribing
- the person using the product is competent
- advise safe administration
- advise on any warnings or contraindications
- Do not prescribe more than the minimum quantity required for the treatment
Who do you report a prescription misuse to
Veterinary Medicines Directorate (VMD)
Define an Adverse Event
Any observation in animals, whether or not considered to be product-related, that is unfavourable and unintended and that occurs after any use of a veterinary medicine
Includes lack of efficacy
Name the 4 types of adverse events
- Lack of expected efficacy
- Unexpected AE
- Serious AE
- Non-serious AE
What is an unexpected adverse event
If the nature, severity or outcome of an observed AE is not described in the SPC = unexpected
What is a serious adverse event
Results in death, or increased rates of death in a species for which there is an expected death rate
Life-threatening clinical signs
Significant disability or incapacity
Congenital anomalies or birth defects
Permanent or prolonged signs.
Define an Adverse Reaction to a drug
A reaction to veterinary medicine which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or to restore, correct or modify a physiological function.
What are the characteristics of the drugs in each of the 5 controlled drug schedules
1 - no current therapeutic use
2 - have therapeutic use but are highly addictive
3 - misuse may lead to low or moderate physical dependence or high psychological dependence
4 - misuse may lead to limited physical dependence or psychological dependence
5 - potential for abuse is extremely low
Give examples of schedule 2 drugs used in veterinary medicine (x6)
Methadone
Morphine
Fentanyl
Ketamine
Pethidine
Quinalbbarbitone
Give examples of schedule 3 drugs used in veterinary medicine (x5)
Buprenorphine
Tramdol
Gabapentin
Midazolam
Pentobarbitone
Give examples of schedule 4 drugs used in veterinary medicine
Part 1 - diazepam, alprazolam
Part 2 - Nandrolone, clenbuterol, somatotropin
Give an example of a schedule 5 drugs used in veterinary medicine
Paracetamol with codeine (Pardale)
What does procurement of schedule 2 and 3 drugs require
A requisition form
How are schedule 2 drugs stored
Kept in a locked cabinet
Recorded in Register
Which schedule 3 drugs must be kept in a locked cabinet (x4)
Buprenorphine, Diethylpropion, flunitrazepam and temazepam
If being kept in a vehicle, how are schedule 2 and 3 drugs stored
In a locked box which must be secured to the vehicle itself
Who can prescribe a controlled drug
An MRCVS
How are controlled drugs disposed of
Must be made irretrievable before disposal
- denaturing kits
- soap for tablets
- cat litter
What are the requirements when destructing a schedule 2 drug
Witnessed by
- Veterinary Medicines Regulations (VMR) inspector
- Controlled Drug Liaison Officer (CDLO)
- Independent MRCVS
Must be recorded in CDR (controlled drugs register)
