8058158
Descripción
Fichas por Florence Edwards, actualizado hace más de 1 año
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Creado por Florence Edwards
hace más de 7 años
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| Pregunta | Respuesta |
| Which government agency is the Veterinary Medicines Directorate part of? | DEFRA |
| What is the legislative function of the VMD? | Implementation of EU legislation regarding veterinary medicinal products |
| What is the inspection function of the VMD? | Inspection of veterinary medicinal product manufacturers |
| What is the authorisation function of the VMD? | Assess data in order to authorise veterinary medicial products |
| What is the function of the VMD once a product has been authorised? | Post-authorisation monitoring e.g. for adverse reactions or residues |
| Which laws regulate veterinary medicinal products? | Medicines Act (1965) Various statutory instruments |
| How have the laws surrounding veterinary medicinal products been consolidated? | EU Directive 2001 (amended 2004( |
| What 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 |
| What is the UK specific interpretation of the EU directive for veterinary medicinal products? | Veterinary Medicines Regulations |
| What 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) |
| Which steps occur before data on a product is submitted to the VMD? | Therapeutic concept Product development Submission of data to VMD |
| Which 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 |
| What is the role of vets in post authorisation surveillance? | Adverse event reporting |
| Why is the process of developing a new veterinary medicinal product risky? | Development cost is high Failure rate is high |
| What is the term for the data submitted to the VMD on a veterinary medicinal product? | Dossier |
| Which 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 |
| What damaging effect do many veterinary medicinal products have on the environment? | Invertebrate toxicity |
| What advice do the VMD provide regarding resistance to a product? | Cross resistance Emerging resistance |
| What is a product granted when it is approved by the VMD? | Marketing authorisation |
| How 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 |
| What does SPC stand for? | Summary of Product Characteristics |
| What is an SPC? | Legal document with information about the veterinary medicinal product, based on assessment by the VMD |
| What is an SPC specific to? | Use of formulation in the named target species (may be one or more than one) |
| How is an SPC presented? | Standardised format |
| Give 3 reasons why an SPC may be updated | New indications agreed with VMD New withdrawal periods agreed with VMD Based on pharmacovigilance (adverse events) |
| What 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 |
| What 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 |
| What 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... |
| What 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 |
| Which 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 |
| Are veterinarians able to make up medicines? | Yes, on a one-off basis if none are available under the cascade |
| Give the prioritised steps for choosing a medicine under the prescribing cascade | 1) 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 |
| What 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 |
| What is a POM-V medicine? | Prescription Only Medicine Prescription must be issued by a vet |
| What is a POM-VPS medicine? | Prescription Only Medicine Prescription can be issued by vet, pharmacist or suitably qualified person |
| Medicines for which species are often classified as POM-VPS? | Large animal products |
| What is a NFA-VPS medicine? | Non-food animal Prescribed by vet, pharmacist or suitably qualified person No written prescription but advice must be given |
| Give an example of an NFA-VPS product | Flea and tick products |
| What is an AVM-GSL medicine? | Authorised Veterinary Medicine - General Sales List 'Off the shelf' |
| What 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 |
| In which species can schedule 6 exemption products not be used? | Food animals |
| How does a person become an SQP? | Exams which may be species specific |
| Which qualification must veterinary nurses take to become a suitably qualified person to give prescriptions? | AMTRA qualification |
| Which 2 classes of product can be sold by other products? | AVM-GSL products Schedule 6 exemption products |
| Are prescription diets regulated by the VMD? | No |
| Clients 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 |
| Are vets allowed to split a packet of medication? | Yes, but must give all information including a photocopy of the packaging and information leaflet |
| Why is it important only to prescribe the amount of phenobarbital an animal requires? | Controlled drug |
| When does a premise require licensing for prescribing medicines? | Any vet directly supplying medicines to a fee paying client must work from a registered premises |
| Does a vet's car count as a premise that requires licensing? | Yes |
| Which body holds the register of licensed premises? | RCVS |
| To which body is the registration fee for licensing premises paid? | RCVS |
| Where is the inspection fee for licensed premises paid? | RCVS for practices belonging to the Practice Standards Scheme VMD for non-Practice Standard Scheme practices |
| Are 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 |
| Which 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 |
| How has the VMD helped people buy veterinary medicines online safely? | Accredited Internet Retailer Scheme |
| Is the VMD online retailer scheme voluntary or compulsory? | Voluntary Receive VMD logo to place on website |
| When prescribing for backyard chickens, are they classed as food producing animals? | Yes |
| Which products should be selected for backyard chickens? | Authorised for egg laying chickens Withdrawal period provided for eggs |
| How 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 |
| Which veterinary medicinal products cannot be used in food producing animals? | Table 2 listed substances |
| What is the minimum withdrawal period for eggs and milk when prescribing under the cascade? | 7 days |
| What is the minimum withdrawal period for meat from poultry and mammals when prescribing under the cascade? | 28 days |
| What is the minimum withdrawal period for meat from fish when prescribing under the cascade? | 500 degree days |
| What is the term for the minimum withdrawal periods provided by the EU for prescribing under the cascade? | Statutory withdrawal periods |
| What records should be kept when prescribing under the cascade? | Record medicine use and retain the records for 5 years |
| Who can prescribe under the cascade? | Only veterinary surgeons registered with the RCVS |
| Why is it important to see a horse's passport before prescribing phenylbutazone? | Must have 'not for human consumption' declaration signed |
| Are horses food producing species? | Considered by EU law to be food producing species |
| Is signing a horse out of the food chain reversible or irreversible? | Irreversible |
| How 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 |
| Which 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 |
| What minimum statutory withdrawal period needs to be observed in horses when prescribing under the cascade? | 6 months |
| Where are medicines used in food producing horses recorded? | Animal's passport |
| What 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 |
| Where should adverse events be recorded? | Record in animal's clinical notes Report to VMD |
| If an adverse event is listed in possible side effects for a product, should the event be reported? | Yes |
| Does lack of efficacy count as an adverse event? | Yes |
| Which products are tested for residues by the VMD? | UK products from food producing animals Imported products from non EU countries |
| Should adverse events be reported when prescribing under the cascade? | Yes |
| Give 3 examples of adverse events in microchips that should be recorded | Chip migration Failure to read Implantation reaction |
| What 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 |
| Which 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 |
| Are Animal Test Certificates required for nutraceuticals? | No |
| Are Animal Test Certificates required for non-medical therapies such as surgical interventions? | No |
| Are Animal Test Certificates required if the product is used in accordance with the SPC (summary of product characteristics) or cascade? | No |
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