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AM - Week 1&2
Legislation
| Question | Answer |
|---|---|
| What Two Criteria Define A Veterinary Medicine? | -Presentation -Function |
| What License Do Veterinary Medicines Need In Order To Be Sold? | Marketing Authorisation. |
| What Are Some Requirements Of A Marketing Authorisation License? | -Must ensure products safety, efficacy and quality -Product must undergo ongoing assessment |
| Who Grants The Marketing Authorisation License? | The VMD (executive branch of DEFRA). |
| What Responsibilities Does The VMD Hold? | -Ensure animal medicines are safe and effective -Ensure animals are treated correctly -Protect owners from mis-selling of drugs -Prevent over- use of some medicines -Prevent medicines from entering the food-chain via meat or milk |
| What Legislations Relate To Veterinary Medicine? | Veterinary Medicines Regulations 2013 Misuse of Drugs Regulations 2001 Hazardous Waste Regulations 2005 Controlled Waste Regulations 1992 Environmental Protection Act 1990 Enterprise Act 2002 |
| What Are The Requirements Of POM-V Medications? | -Must be prescribed by a vet -Clinical assessment must be performed and animal must be under vets care (this must be in person if a controlled drug or antibiotic is being prescribed) -Vet must be satisfied that drug will be administered correctly/safely |
| What Are The Requirements Of POM-VPS Medications? | -Must be prescribed by a vet -Can be dispensed by SQP/pharmacist -Applies to food animals |
| What Are The Requirements Of NFA-VPS Medications? | -Non food animals only -Can be dispensed by vet, SQP, pharmacist |
| What Are The Requirements Of AVM-GSL Medications? | -None, for general sale -Wide safety margin |
| What Are Withdrawal Periods And What Is The Maximum Residue Limit? | Withdrawal Period = Length of time until medicine residues in food have fallen to a safe level. Maximum Residue Limit = The amount of medicine an average person weighing 60kg could consume daily for a prolonged period without it impacting their health. |
| What Records Need To Be Kept When Medication Is Dispensed? | -Date -Product -Batch no. -Quantity -Name & address -Also name and address of prescriber if dispensing against written prescription |
| How Long Do Records Need To Be Kept For POM-V and POM-VPS Mediation? | 5 Years |
| What Sequence Must Vets Follow When There Is No Licensed Medication To Treat A Patient (Cascade System)? | -Meds licensed in N Ireland for species/condition? -Meds licensed in UK/N Ireland for another species/condition? -Meds licensed in UK/N Ireland for human use or licensed for same species/condition in another country? -Extemporaneous preparation |
| What Rules Must Vets Follow When Selecting Non-Licensed Medication For Food Producing Animals? | -Medication must be authorised for a food producing animal -Vets must advise 7 day withdrawal period for milk and 28 day withdrawal period for meat |
| What Does Legislation Say About Medication For Horses? | -Grey area = Considered food producing animal + companion animal -Must keep a passport stating whether they will be entering food chain |
| What Does The VMD Say About Imported Medications? | -Import certificate needed -Treatment certificate needed -Only for individual use |
| What Guidelines Surround Medication For Small Mammals? | -Does not require marketing authorisation (not including antibiotics or anaesthetics) -Restricted to topical or oral use -AVM-GSL category |
| What Guidelines Surround Homeopathic Remedies? | -Cannot make medicinal claims -Must be of a safe dilution -AVM-GSL category |
| What Are The Five Schedules Of Controlled Drugs And Some Examples? | Schedule 1 = Ecstasy, heroin Schedule 2 = Morphine, ketamine Schedule 3 = Barbiturates, buprenorphine Schedule 4 = Diazepam, anabolic steroids Schedule 5 = Codeine, paracetamol |
| How Should Adverse Reactions To Medication Be Reported (SARSS Scheme)? | To the VMD. |
Created by:
aimee_knows_nothing
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