Pharmacology Legislation Flashcards
what is MAVIS?
Marketing authorisations veterinary information service - designed to provide information on the work of the VMD, plans and results.
What is The veterinary medicines directorate?
The VDM is the executive agency of DERA. they operate the licenseing system for animal medicines with the aim to safe gaurd public health, animal health and the environment. They ensure the safety, quality and efficacy of medicines within the uk.
what is SARSS?
The suspected adverse reaction surveillance scheme. Run by the VDM which aims to record and monitor reports of suspected adverse reactions to veterinary medicines in both humans and animals.
What are Prescription only medicines - by veterinarian (POM-V)
Can be prescribed by a Vet after clinical assessment of the animal or herd.
What is a Prescription only medicine - veterinarian, pharmacist, SQP? (POM-VPS)
Can be prescribed by a Vet or suitably qualified person (SQP). No clinical assessment is required but the prescribed must be sure the owner must be competent to administer the product. E.g medicines used to prevent disease in herds/flocks eg medicated feedstuffs.
What is a Non food animal - veterinarian, pharmacist, SQP medicine? (NFA-VPS)
Similar to POM-VPS but must be for non food animals.
What are authorised veterinary medicine - general sales list? (AVM - GSL)
No restrictions on its supply these have a wide safety margin and specialist advice is not required.
What are controlled drugs?
Must be stored in a home office approved cabinet attached to the fabric of the building. Schedule 1 - vets have no authority to possess or prescribe these e.g cannabis and LSD. Schedule 22 - special requirements for requisition, prescribing, record keeping storage and disposal e.g morphine, pethidine, fentanyl. Schedule 3 - same prescription and requisition requirements, e.g pentobarbital, buprenorphine, midazolam. schedule 4- Exempt from most of the restrictions - includes benzodiazepenes, ketamine and anabolic substances. Schedule 5 - Invoices need to be kept for two years. Certain preparations containing codeine, cocaine and morphine in less than specified amounts.
What records are needed for schedule 2 drugs?
Record on obtaining - date, name and address, amount obtained. Recorrd on supplying - date, name and address, amount supplied, vets name. If the drug is to be supplied for owner taking home - name of person collecting drug, proof of ID.
What is the cascade?
If there is no licensed product indicated for the condition and species to be treated there is a cascade of options which is recommended. 1) A product licensed for another condition in the same species or a product licensed for another animal species with the same condition. 2i) A human licensed product II) a human licensed product in any other country or a product licensed for veterinary use outwith the EU. iii) a product prepared extemporaneously by a veterinary surgeon, a pharmacist or person holding a manufacturers authorisation as prescribed by the VS.
What is the small animal exemption scheme?
Some veterinary products can be marketed for these species without a marketing authorisation and therefore are not required to prove safety, quality or efficacy but must be manufactured to certain standards. E.g aqaurium fish, cage birds, homing pigeons, terrarium animals, small rodents, ferrets and rabbits.
What are medicated feedstuffs?
These are classed as POM-V or POM-VPS. Feed additives can be defined as a substance used to maintain animals in good health or favourably affect their performance. Additives are classified into the following categories: Technological additives e.g preservatives, antioxidants. Sensory additives: flavours, colourants. Nutritional additives: vitamins, minerals, aminoacids. Zootechnical additives - gut flora stabilizers. Coccidiostats and histmonostats.
