Prescribing & Dispensing: The Prescribing Cascade Flashcards
what does authorized vet meds mean
scientific assessment of quality, safety, and efficacy
potential risks to the environment, animals, operators and consumers
SPC of dose, route of admin, etc
what are problems with unauthorized medicines
- may not be of consistent quality
- may not be safe and effective
- may pose a risk to consumers if administered to a food producing species
what are exemptions to the cascade (3)
- products for research (ASPA)
- exceptional circumstances (disease outbreak)
- immunological products for imported or exported animals
what is the cascade
a mechanism to allow us to prescribe unauthorized medicines to our patients
when is the cascade legal
- three steps of the decision tree are followed
- justified with regard to the animal’s welfare
- not using the drug as a cost-saving exercise
who can prescribe and dispense under the cascade
only a vet can prescribe
a pharmacist may dispense an authorized VMP for use under the cascade, human medicines or extemporaneously prepared medicines against a prescription from a vet
an SQP may dispense an authorized VMP for use under the cascade against a prescription from a vet, provided they have the relevent qualification for that species
what is good practice before you prescribe a medicine under the cascade
get informed consent from the owner RCVS recommends
what is required for food animals
extra regulations to protect the consumer
what are the regulations to prescribing under the cascade in food animals (5)
- treatment restricted to a single holding
- if using an imported product, it must be authorized in a FP species in the other member state
- active substances must be listed in Table 1: allowed substances
- vet must specify appropriate withdrawal period
- vet must keep specified records
what is maximum residue limit (MRL)
max safe concentration of residue resulting from use of a vet medicinal product
expressed in mg/kg
what is a withdrawal period
period of time, following treatment of an animal with a veterinary medicine, in which the meat, milk, eggs or honey from the treated animals must not enter the food chain due to possible presence of residues from pharmacologically active substances
how do you set a withdrawal period
the vet does this
check the SPC –> if the species is different or dose is higher then the minimum statutory withdrawal period should be set
what records must be kept (10)
- date of exam
- name and address of owner
- animal ID and number treated
- result of clinical assessment
- trade name of product
- batch number
- name and quantity of active substance
- dose administered and/or supplied
- duration of treatment
- withdrawal period
how long do records need to be kept
5 years
what is step 1 in the prescribing cascade
a product authorized in the UK for use in another animal species (must be another food-producing species)
or a product authorized for another condition in the same speices
what is step 2 in the prescribing cascade
a human medicinal product authorized in the UK
OR
a veterinary medicinal product authorized in another EU member state for use in an animal species (in the case of a food-producing animal it must be a food-producing species)
what is step 3 in the prescribing cascade
a medicinal product prescribed by the responsible VS and prepared extemporaneously by a pharmacist, a vet surgeon or a person holding a manufacturing authorization authorizing the manufacture of that type of product
OR
a medicine imported from third countries
what are the tables
Table 1: allowed substances
Table 2: prohibited substances
what is table 1
substances in which an MRL has been established, is being established or doesn’t need to be established
what are table 2 substances
MRL cannot be established
any residue at any level, constitutes a hazard to human health
administration of substances listed to food-producing animals is prohibited
what needs to be done before prescribing for a horse in the UK
check the passport
see if the horse is intended for human consumption
if not then treat as for any companion, non-food animal
follow normal cascade
if the horses is intended for human consumption what should you do
follow the food animal cascade
what is the essential substances list
additional substances that can be used in horses intended for consumption
BUT a minimum 6 month withdrawal period
which medicines are not permitted in horses intended for human consumption
anything listed in table 2
and anything not listed in either
table 1 or essential list
what if there is no horse passport
treat as intended for human consumption
can phenylbutazone be used in horses intended for human consumption
no