PSD 1

  • Created by: LBCW0502
  • Created on: 30-11-18 19:59
What is the purpose of the Veterinary Medicines Regulations (VMR)?
Set out the UK controls on veterinary medicines, including their manufacture, advertising, marketing, supply and administration
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What is the Veterinary Medicines Directorate (VMD) responsible for? (1)
Monitoring/taking action on reports of bad effects from veterinary medicines. Testing for residues of vet meds or illegal substances in animals/products. Assess applications for authorising companies to sell vet meds in UK/EU
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What is the Veterinary Medicines Directorate (VMD) responsible for? (2)
Control how vet meds are made/distributed. Advise government ministers on developing veterinary medicines policy/putting it into action. Making/updating/enforcing UK legislation on vet meds
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What is a VMP? (1)
Any substance/combination of substances presented as having properties for treating/preventing disease in animals, or any substance/combination of substances that may be used in administration/view to restore/correct/modify physiological functions.
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What is a VMP? (2)
Exerting a pharmacological, immunological or metabolic action or to making a medical diagnosis (veterinary medicines regulations 2013) - applies to all animals: birds/reptiles/fish/molluscs/crustacea/bees
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In 2015, how much was the UK animal medicines market worth?
Veterinary medicine market - £625 million (NOAH 2015 data)
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Describe features of animal medicine sales
In 1986 when NOAH was formed, around 70% of animal medicines were used in farm livestock. Now over half animal medicine sales, by value are for companion animal use
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What is the role of a community pharmacist?
In 2015, it was estimated that 12 million (46% of) households in the UK had pets. Potential sales for the treatment of common parasite problems: fleas and worms. Dispensing of POM(V) prescriptions
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What are the categories of VMPS? (1)
4 legal categories authorised sale of veterinary medicines in the UK under VMR: POM-V (POM-Veterinarian), POM-VPS (POM-Veterinarian, pharmacist, suitability qualified person), NFA-VPS (Non-food producing animals - VPS)
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What are the categories of VMPS? (2)
AVM-GSL (authorised veterinary medicines - GSL)
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What is POM-V?
A veterinary medicinal product which may only be supplied to the client once it has been prescribed by a veterinary surgeon following a clinical assessment of an animal, or group of animals, under the veterinary surgeon's care
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What is POM-VS? (1)
Medicine for food producing animals (including horses) to be prescribed by any registered qualified person. Clinical assessment of animal not required when prescribing this category of veterinary medicine
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What is POM-VS? (2)
Animal doesn't have to be seen by prescriber. Sufficient information about the animal and the way it is kept must be known to the prescriber in order to prescribe and supply appropriately
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What is NFA-VPS?
A medicine for companion animals must be supplied by any RQP provided the requirements for supply are met. These medicines do not require a prescription
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What is AVM - GSL?
There are no legal restrictions in the VMR for the retail supply of veterinary medicines as AVM-GSL, but a responsible approach to the supply of these medicines is still expected
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What are the Small Animal Exemption Schemes (SAES)? (1)
'Exemptions for Small Pet Animals'. Permits certain medicines to be placed on the market without a MA subject to certain conditions. Active ingredient declared by Secretary of State/not requiring veterinary control
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What are the Small Animal Exemption Schemes (SAES)? (2)
Must be manufactured to same standard as authorised medicines and are subject to pharmacovigilance reporting. Applies to: aquarium fish, caged birds, ferrets, homing pigeons, rabbits, small rodents, terrarium animals
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Who can prescribe, dispense and supply? (1)
Veterinary surgeons: Can prescribe and supply all categories of veterinary medicines. Can prescribe to be used under the cascade. Can dispense prescriptions written by another veterinary surgeon
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Who can prescribe, dispense and supply? (2)
Pharmacists: Prescribe POM-VPS and supply NFA-VPS, AVM-GSL and SAES. Dispense prescriptions written by a veterinary surgeon
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Who can prescribe, dispense and supply? (3)
SQPs (AMTRA): Prescribe POM-VPS and supply NFA-VPS, AVM-GSL and SAES. Any retailer: Supply AVM-GSL and SAES products
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What are the Rx requirements for a veterinary prescription? (1)
Name/address/telephone number/qualification/signature of prescriber (RCVS reg no. must be included for Sch 2/3 CD). Name/address of owner. Identification/species of animal (+address if different to owner). Date (valid for 6 months, 28 days for CD)
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What are the Rx requirements for a veterinary prescription? (2)
Name, quantity, dose/administration instructions ('as directed' is not acceptable). Any necessary warnings and if relevant withdrawal period (time between when animal receives medicine to being used for food)
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What are the Rx requirements for a veterinary prescription? (3)
When appropriate, a statement for 'prescribed under the Cascade'. If sch. 2/3, declaration that 'item has been prescribed for an animal or herd under the care of the veterinarian (usual CD requirements also apply). Number of times it can be repeated
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What is the Veterinary Cascade? (1)
Where available it is a legal requirement to: supply a licensed veterinary medicine. Only where above is not possible: an existing licensed veterinary medicine for another species or different condition can be considered
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What is the Veterinary Cascade? (2)
Only where the above is not possible: a licensed human medicine or an EU-licensed veterinary medicine can be considered. Only where the above is not possible: extemporaneous or specially manufactured medicines can be considered
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Can a human medicine by supplied to a pet?
A veterinary medicinal product with a UK MA must be supplied where one exists. It is unlawful to supply a human medicine against a veterinary prescription unless it specifically states that it is 'for use under the cascade'
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What details must be included in labelling (use under the Cascade)? (1)
Name of prescribing veterinary surgeon, name/address of animal owner, name/address of pharmacy, identification/species of animal, date of supply, expiry date of product, name/description of product or its active ingredients/content quantity
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What details must be included in labelling (use under the Cascade)? (2)
Dosage/administration instructions, special storage instructions. Warnings for use (e.g. administration, disposal, target species). Withdrawal period. 'For animal treatment only', 'Keep out of reach of children'
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Describe the details included in record keeping (1)
Records must be kept for receipts/supplies of POM-V and POM-VPS products and must show: name of medicine, date of receipt/supply, batch number, quantity, name/address of supplier/recipient, (written prescription) name/address of prescriber
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Describe the details included in record keeping (2)
Keep copy of prescription, pharmacists can either keep all documents that show the required information or can make appropriate records in their private prescription book. Records can be kept electronically
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Describe the details included in record keeping (3)
Records and documents must be kept for at least 5 years. Pharmacies that supply POM-V and POM-VPS medicines must undertake an annual audit
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Describe features of the sale of unauthorised veterinary medicines (1)
Unlawful to sell/supply unauthorised veterinary medicines (not licensed as veterinary medicines) including human medicines (GSL) and P medicines, for an animal unless this takes place under the veterinary cascade
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Describe features of the sale of unauthorised veterinary medicines (2)
Applies even if a veterinary surgeon asks animal owner verbally to purchase an OTC human product from a pharmacy
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Re-cap points of CDs from MPharm 1
Harold Shipman (killing patients with morphine overdose, resulted in changes in regulations - audit trail and record keeping). Misuse of Drugs Act 1971, controls the sale/supply/possession of CDs, CDs are substances that are 'liable to misuse'
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Outline the CD schedules (from the Misuse of Drugs Regulations 2001) (1)
Sch 1 (CD Lic - hallucinogens). Sch 2 (CD POM register - morphine, diamorphine). Sch 3 (CD no reg POM - buprenorphine, midazolam, temazepam). Sch 4 part 1 (CD Benz POM - diazepam). Sch 4 part 2 (CD Anab POM - nandrolone)
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Outline the CD schedules (from the Misuse of Drugs Regulations 2001) (1)
Sch 5 (CD inv POM - co-codamol 30/500, CD inv P - co-codamol 8/500 (32))
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What are the requirements of Schedule 2 CDs? (1)
Prescription requirements, valid for 28 days, need address of prescriber within the UK, EEA/Swiss prescribers cannot legally prescribe, prescription is not repeatable - (register)
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What are the requirements of Schedule 2 CDs? (2)
No emergency supply, requisition necessary, requisition to be marked by supplier, no invoices retained for two years, licence required to import/export
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What are the requirements of Schedule 3 CDs? (1)
Prescription requirements, valid for 28 days, need address of prescriber within the UK, EEA/Swiss prescribers cannot legally prescribe, prescription is not repeatable - (no register)
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What are the requirements of Schedule 3 CDs? (2)
No emergency supply (except phenobarbital for epilepsy), requisition necessary, requisition to be marked by supplier, invoices retained for two years, licence required to import/export
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What are the requirements of Schedule 4 Part 1 CDs? (1)
No prescription requirements, valid for 28 days, don't need address of prescriber within the UK, EEA/Swiss prescribers can legally prescribe, prescription is repeatable
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What are the requirements of Schedule 4 Part 1 CDs? (2)
Emergency supply, requisition not necessary, no requisition to be marked by supplier, no invoices retained for two years, licence required to import/export
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What are the requirements of Schedule 4 Part 2 CDs? (1)
No prescription requirements, valid for 28 days, don't need address of prescriber within the UK, EEA/Swiss prescribers can legally prescribe, prescription is repeatable
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What are the requirements of Schedule 4 Part 2 CDs? (2)
Emergency supply, requisition not necessary, no requisition to be marked by supplier, no invoices retained for two years, licence required to import/export (unless done by person for self-administration)
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What are the requirements of Schedule 5 CDs? (1)
No prescription requirements, valid for 6 months, don't need address of prescriber within the UK, EEA/Swiss prescribers can legally prescribe, prescription is repeatable
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What are the requirements of Schedule 5 CDs? (2)
Emergency supply, requisition not necessary, no requisition to be marked by supplier, invoices retained for two years, no licence required to import/export
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What are the CD Rx requirements? (1)
Signature of prescriber. Date (28 days). Address of prescriber. Dose. Formulation. Strength. Total quantity (words/figures. Quantity prescribed. Dental wording where appropriate. Instalment wording where appropriate. Patient name/address. No PRN.
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What are the CD Rx requirements? (2)
Prescriber address has to be in the UK for Sch 2 CDs only (can be in the EU for Sch 3,4,5 CDs)
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Describe features of private CDs (1)
Following recommendations of the Shipman Inquiry, private prescriptions for Sch 2/3 CDs must be written on designated standardised forms. Sent to NHS authority - track number of CD prescriptions per prescriber
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Describe features of private CDs (2)
CD prescriptions: FP10CD for England, PPCD(1) for Scotland and WP10PCD for Wales
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Describe features of methadone and instalment dispensing (1)
Specific form (FP10MDA). Blue form, should include all basic information required. Date on prescription may not be the date for the treatment to start. Prescriber may request supervised daily doses. Dispenser puts total instalments - any missed
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Describe features of methadone and instalment dispensing (2)
Where prescriber has specified supervised consumption, a fee can be claimed for both the supervised dose and remainder taken away in advance. Sugar free methadone not usually used (more likely to relapse) unless specified
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Describe features of instalment direction for Schedule 2 and 3 CDs (1)
An instalment direction combines: amount of medicine per instalment and interval between each time the medicine can be supplied. Home Office confirmed that instalment prescription must have dose/instalment amount specified separately on prescription
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Describe features of instalment direction for Schedule 2 and 3 CDs (2)
First instalment must be dispensed within 28 days of appropriate date. Remainder of instalments should be dispensed in accordance with instructions (even if it runs beyond 28 days after appropriate date)
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Describe features of FP10MDA (1)
Form used for purpose of ordering a supply by instalments for Schedule 2 CDs plus buprenorphine, buprenorphine/nalaxone (Suboxone) and diazepam. Period of treatment is not to exceed 14 days
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Describe features of FP10MDA (2)
Prescriber must specify the number of instalments to be dispensed and the interval between each instalment
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What is Home Office introduce in November 2015?
A new set of approved wording for instalment prescribing. This new set of wording is shorter in length and more flexible than the previous set of approved wording
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What are the guidelines for the new set of approved wording? (1)
Please dispense instalments due on pharmacy closed days on a prior suitable day. If an instalment's collection day has been missed, please still dispense the amount due for any remaining days of that instalment
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What are the guidelines for the new set of approved wording? (2)
Consult the prescriber if 3+ consecutive days of a prescription have been missed. Supervise consumption on collection days. Dispense daily doses in separate containers
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Other cards in this set

Card 2

Front

What is the Veterinary Medicines Directorate (VMD) responsible for? (1)

Back

Monitoring/taking action on reports of bad effects from veterinary medicines. Testing for residues of vet meds or illegal substances in animals/products. Assess applications for authorising companies to sell vet meds in UK/EU

Card 3

Front

What is the Veterinary Medicines Directorate (VMD) responsible for? (2)

Back

Preview of the front of card 3

Card 4

Front

What is a VMP? (1)

Back

Preview of the front of card 4

Card 5

Front

What is a VMP? (2)

Back

Preview of the front of card 5
View more cards

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