Karteikarten
Regulation of Veterinary Medicinal Products
Karten in diesem Stapel (86)
- 1Which government agency is the Veterinary Medicines Directorate part of?DEFRA
- 2What is the legislative function of the VMD?Implementation of EU legislation regarding veterinary medicinal products
- 3What is the inspection function of the VMD?Inspection of veterinary medicinal product manufacturers
- 4What is the authorisation function of the VMD?Assess data in order to authorise veterinary medicial products
- 5What is the function of the VMD once a product has been authorised?Post-authorisation monitoring e.g. for adverse reactions or residues
- 6Which laws regulate veterinary medicinal products?Medicines Act (1965)
Various statutory instruments - 7How have the laws surrounding veterinary medicinal products been consolidated?EU Directive 2001 (amended 2004(
- 8What is the difference between an EU directive and a regulation?EU directive = does not have to be directly transposed, adapted by individual countries
EU regulation = must be specifically and exactly transposed - 9What is the UK specific interpretation of the EU directive for veterinary medicinal products?Veterinary Medicines Regulations
- 10What is the legal definition of a veterinary medicinal product?Substance presented as having properties for treating or preventing disease in animals
Substance administered to modify physiological functions by exerting a pharmacological, immunological or metabolic action (or to make a diagnosis) - 11Which steps occur before data on a product is submitted to the VMD?Therapeutic concept
Product development
Submission of data to VMD - 12Which 3 steps are carried out by the VMD once data has been submitted for a product?Inspection of manufacturers
Authorisation if favourable benefit-risk balance
Post-authorisation surveillance - 13What is the role of vets in post authorisation surveillance?Adverse event reporting
- 14Why is the process of developing a new veterinary medicinal product risky?Development cost is high
Failure rate is high - 15What is the term for the data submitted to the VMD on a veterinary medicinal product?Dossier
- 16Which 3 parts is the data submitted to the VMD divided into?Part 2 = quality of final form
Part 3 = safety for end user (e.g. vet, owner), consumer (for production animals) and the environment
Part 4 = efficacy and safety in target species - 17What damaging effect do many veterinary medicinal products have on the environment?Invertebrate toxicity
- 18What advice do the VMD provide regarding resistance to a product?Cross resistance
Emerging resistance - 19What is a product granted when it is approved by the VMD?Marketing authorisation
- 20How does the procedure for authorising a product vary depending on whether the manufacturer is national or international?Some procedures national only so Marketing Authorisation only valid in UK
Some procedures involve a number of EU Member States and so the Marketing Authorisation is valid in multiple countries - 21What does SPC stand for?Summary of Product Characteristics
- 22What is an SPC?Legal document with information about the veterinary medicinal product, based on assessment by the VMD
- 23What is an SPC specific to?Use of formulation in the named target species (may be one or more than one)
- 24How is an SPC presented?Standardised format
- 25Give 3 reasons why an SPC may be updatedNew indications agreed with VMD
New withdrawal periods agreed with VMD
Based on pharmacovigilance (adverse events) - 26What is the first choice of drug to use for an animal under the cascade?Veterinary drugs authorised in the UK
Specific to the species
Specific to the condition - 27What is the risk when using a drug not licensed for the species to which it is administered?Differences in metabolism and bioavailability
May reduce safety or efficacy of drug - 28What is the legislation for prescribing under the cascade?By way of exception, the vet may under direct personal responsibility, and in particular to avoid unacceptable suffering, treat with the following...
- 29What is 'off-label' use?Treating with a product licensed in the UK for another animal species
OR
Treating with a product licesnsed in the UK for a different condition in the same species - 30Which products may be chosen if there are no veterinary medicinal products available for 'off-label' use?1. Medicine authorised in UK for human use
2. Authorised veterinary medicine from another EU Member State - 31Are veterinarians able to make up medicines?Yes, on a one-off basis if none are available under the cascade
- 32Give the prioritised steps for choosing a medicine under the prescribing cascade1) Licensed in UK for species and condition
2) Off-label (licensed in UK but different species/condition)
3) Licensed in UK for humans or licensed in another EU country
4) Medicine made up by vet - 33What is the problem with using products licensed for human use?Veterinary generics have been compared with veterinary pioneer (leading) products
This is not the case for human generics - 34What is a POM-V medicine?Prescription Only Medicine
Prescription must be issued by a vet - 35What is a POM-VPS medicine?Prescription Only Medicine
Prescription can be issued by vet, pharmacist or suitably qualified person - 36Medicines for which species are often classified as POM-VPS?Large animal products
- 37What is a NFA-VPS medicine?Non-food animal
Prescribed by vet, pharmacist or suitably qualified person
No written prescription but advice must be given - 38Give an example of an NFA-VPS productFlea and tick products
- 39What is an AVM-GSL medicine?Authorised Veterinary Medicine - General Sales List
'Off the shelf' - 40What is a schedule 6 exemption product?Specifically for exotic species for which medicines would not normally be developed if they required the full authorisation process
Not fully assessed by VMD - 41In which species can schedule 6 exemption products not be used?Food animals
- 42How does a person become an SQP?Exams which may be species specific
- 43Which qualification must veterinary nurses take to become a suitably qualified person to give prescriptions?AMTRA qualification
- 44Which 2 classes of product can be sold by other products?AVM-GSL products
Schedule 6 exemption products - 45Are prescription diets regulated by the VMD?No
- 46Clients on holiday bring in an aggressive dog that has not been seen at the practice before, requiring phenobarbital which they have left at home. Can the vet dispense?Can phone normal vets to prescribe the phenobarbital
Can prescribe phenobarbital themselves if a clinical exam is given and the dog is considered under their care - 47Are vets allowed to split a packet of medication?Yes, but must give all information including a photocopy of the packaging and information leaflet
- 48Why is it important only to prescribe the amount of phenobarbital an animal requires?Controlled drug
- 49When does a premise require licensing for prescribing medicines?Any vet directly supplying medicines to a fee paying client must work from a registered premises
- 50Does a vet's car count as a premise that requires licensing?Yes
- 51Which body holds the register of licensed premises?RCVS
- 52To which body is the registration fee for licensing premises paid?RCVS
- 53Where is the inspection fee for licensed premises paid?RCVS for practices belonging to the Practice Standards Scheme
VMD for non-Practice Standard Scheme practices - 54Are SQPs allowed to split a pack of medication?No
Can only supply a product with the authorised label, except when supplying against a vet's prescription - 55Which 4 conditions must be satisfied in order for veterinary medicines to be sold online?Prescription available where necessary
Advice provided on safe administation
Supplier satisfied person is competent to use product safely and intends to use it for authorised purpose
Keep adequate records of supply - 56How has the VMD helped people buy veterinary medicines online safely?Accredited Internet Retailer Scheme
- 57Is the VMD online retailer scheme voluntary or compulsory?Voluntary
Receive VMD logo to place on website - 58When prescribing for backyard chickens, are they classed as food producing animals?Yes
- 59Which products should be selected for backyard chickens?Authorised for egg laying chickens
Withdrawal period provided for eggs - 60How is the prescribing cascade different for food producing animals?Only products authorised for food-producing species may be used
Must have an entry in Table 1 of allowed substances - 61Which veterinary medicinal products cannot be used in food producing animals?Table 2 listed substances
- 62What is the minimum withdrawal period for eggs and milk when prescribing under the cascade?7 days
- 63What is the minimum withdrawal period for meat from poultry and mammals when prescribing under the cascade?28 days
- 64What is the minimum withdrawal period for meat from fish when prescribing under the cascade?500 degree days
- 65What is the term for the minimum withdrawal periods provided by the EU for prescribing under the cascade?Statutory withdrawal periods
- 66What records should be kept when prescribing under the cascade?Record medicine use and retain the records for 5 years
- 67Who can prescribe under the cascade?Only veterinary surgeons registered with the RCVS
- 68Why is it important to see a horse's passport before prescribing phenylbutazone?Must have 'not for human consumption' declaration signed
- 69Are horses food producing species?Considered by EU law to be food producing species
- 70Is signing a horse out of the food chain reversible or irreversible?Irreversible
- 71How should a horse be treated if the passport is not available?Treat horse as if intended for human consumption
Issue document detailing medicines given which should be kept with the passport - 72Which drugs can be used to treat food producting horses under the cascade?Product authorised for food producing animal other than horses
Any product containing an active substance in the EU's List of Essential Substances - 73What minimum statutory withdrawal period needs to be observed in horses when prescribing under the cascade?6 months
- 74Where are medicines used in food producing horses recorded?Animal's passport
- 75What should the vet do if it is necessary in an emergency to prescribe a medicine not allowed for food producing horses?Legal requirement to sign animal's passport to exclude from food chain
- 76Where should adverse events be recorded?Record in animal's clinical notes
Report to VMD - 77If an adverse event is listed in possible side effects for a product, should the event be reported?Yes
- 78Does lack of efficacy count as an adverse event?Yes
- 79Which products are tested for residues by the VMD?UK products from food producing animals
Imported products from non EU countries - 80Should adverse events be reported when prescribing under the cascade?Yes
- 81Give 3 examples of adverse events in microchips that should be recordedChip migration
Failure to read
Implantation reaction - 82What are Animal Test Certificates?Issued to individuals, organisations and companies who intend to carry out clinical field trials of substances defined as veterinary medicinal products
- 83Which clinical field trials require an Animal Test Certificate?Assess safety or efficacy of a product
Usually conducted in client owned animals
Context does not fit with cascade - product used in a different species or condition - 84Are Animal Test Certificates required for nutraceuticals?No
- 85Are Animal Test Certificates required for non-medical therapies such as surgical interventions?No
- 86Are Animal Test Certificates required if the product is used in accordance with the SPC (summary of product characteristics) or cascade?No
Informationen
- Beschreibung
- Animal Disease 1 (Control of Disease) Karteikarten am Regulation of Veterinary Medicinal Products, erstellt von Florence Edwards am 11/03/2017.
- Erstellt von
- Florence Edwards
- Aufrufe
- 27
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