Legal text on: - authorization - distribution - manufacture - marketing - post-authorisation surveillance of vet. meds

Week 1 Pharma legislations Flashcards by Emma Dedman

Year of Veterinary Surgeons Act?

1966

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Year of Misuse of Drugs Act

1971

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Year of Health & Safety at Work Act?

1974

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Year of Misuse of drugs regulations?

2001

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Year of COSHH Regulations?

2002

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Year of Veterinary Medicines Regulations?

2013

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What are the legislations and acts related to pharma regulations?

Vet surgeons act 1966
Misuse of drugs act 1971
Health & Safety at work 1974
Misuse of drugs regulations 2001
COSHH Regulations 2002
Veterinary Medicines Regulations 2013
RCVS CoPC

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Who are the VMD?

Veterinary Medicines Directorate

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Who does VMD oversee?

VMR

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What is the VMR?

Veterinary Medcines Regulations

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What is the goal of the VMD?

Protect:
- Animal health
- Public health
- Environment

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What do VMR set out?

Legal text on:

authorization
distribution
manufacture
marketing
post-authorisation surveillance

of vet. meds

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First definition of veterinary medicinal product?

Substance
Presenting
Properties for treating or preventing disease

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Second definition of veterinary medicinal product?

Substances used to
Restore
Correct
or modify

Physiological functions by
exerting
Pharmaco
Immuno, or
Metabolic action

Or diagnosing

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What are the 4 categories of drug prescriptions?

POM-V
POM-VPS
NFA-VPS
AVM-GSL

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POM-V restrictions

Only by VS
VS must carry out clinical exam of animal U their care

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What is ESPA

Exemptions for small pets animals

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What is the previous name of ESPA?

SAES Small Animal Exemption Scheme

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What is the ESPA for?

Allows certain meds to be placed on the market with no marketing authorisation
Subject to certain conditions

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What are controlled drugs?

Group of specialised drugs that have certain controls under the misuse of drugs act 2002

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Who regulates the law about controlled drugs?

Home office
VMD
RCVS

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What recording of CDs needs to be done?

All movement of CDs shld be in the Controlled Drugs Register CDR
(Deliveries, usage and remaining stock)

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Which schedule of drugs legally have to be locked away?

Schedule 2 + buprenorphone (S3)
RCVS recommends all S3 also locked

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Who can access locked CD cabinet?

Only authorised personnel
Listed on SOP

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Can the CD cabinet be loose?

No, it needs to be bolted to wall/ floor

What does the outside of the CD cabinet look like?

Blank with no indication of what is inside

Can the CD cabinet be visible to public?

Can the CD store other things?

No it must only contain CDs

Schedule 1 drugs general facts

Not in use in vet medicine LSD, cannabis

Examples of schedule2 drugs

Methadone Ketamine Fentanyl Morphine

Examples of schedule 3 drugs

Buprenorphine Pentoparbitone Phenobarbitone Midazolam Tramadol

Example of schedule 4 drug

Diazepam

Example of schedule 5 drug

Codeine Morphine (low dose prep)

What do you need to do when a schedule 2 drug expires?

Denature it with a witness present

Who can witness denaturing a schedule 2 drug?

Vet from different practice CDLO Controlled Drug Liaison Officer VMD inspector

Method for denaturing schedule 2 drug?

1. Draw up drugs 2. Record amount 3. Place in denaturing kit (Kit turns liquid to solid - unusable)

What must be recorded when denaturing schedule 2 drug? (6)

Name of drug Date Quantity Strength Name of professional Name of witness

Definition of prescribing

Act of assessing patient & making a decision on most appropriate meds to treat a condition or disease

Definition of prescription

Verbal/written communication of instruction for a med

Definition of supplying

Act of providing the product

Can SQPs prescribe or supply POM-V?

They can supply them if prescribed by a VS but not prescribe them

Definition of dispensing meds

Physically hand over the product

When do you need to use the prescribing cascade?

When we need med that has - no authorised GB/UK wide product - for condition that needs treating - for that specific animal

What is step 1 of prescribing cascade?

Meds are available for specific specie for that condition and is licensed in the UK

What is step 2 of the prescribing cascade?

Is there a licensed medication in NI?

What is step 3 of the prescribing cascade?

Is there a licensed medication for same specie but for a different condition?

What is step 4 of the prescribing cascade?

Is there a licensed med for human for same condition?

What is step 5 of the prescribing cascade?

Med prepared by VS specifically for this occasion

How long are controlled drugs prescription valid for?

28 days

How long are POM-V prescriptions valid for?

6 months

What areas of the dispensary need risk assessments? (5)

Waste disposal General medicines handling Spillage of medicine Handling cytotoxic medicines Manual handling - access to high shelves

What legislation is controlled waste regulated by?

Controlled Waste (England and Wales) Regulations 2012

What are these for?

Sharps for incineartion/ altern tx Not contaminated with POM-V

What are these for?

Denatured CDs Out of date meds Materials cont. with pharma agents

What are these for?

Sharps inc. Infectious For incineration only

What are these for?

Offensive waste Faeces Non-Infectious blood Urine stained swabs

What are these for?

Infectious clinical waste May be treated e.g. autoclaving

What are these for?

Infectious waste Needs disposal by incineration e.g. Blood contaminated swab from infectious animal

What needs to go in a spillage kit?

Absorbent towel Absorben material (cat litter) PPE Plastic disposable bags Forcepts for broken glass Water and disinfectants

3 ways to remove a needle safely

Forceps Sharps bin Foam wedge

Examples of low and medium risk substances?

Injectable anaesthetics Inhalation anaesthetics Pour-on anthelmintics Steroidal compounds Vaccines Antibiotics Disinfectants

Examples of high risk substances

Cytotoxic meds Micotil Hormones Oil-based vacccines

What is considered an offense of the misuse of drugs act 1971? (4)

Unlawful possession Possession with intent to supply Supply or offer to supply Allow premises you occupy to be used unlawfully

Penalties of misuse of drugs act 1971 Class A Posession

6 mo-7y £5000 - unltd fine

Penalties of misuse of drugs act 1971 Class B Possession

3mo -5 y £2500 - unltd fine

Penalties of misuse of drugs act 1971 Class C Possession

3mo - 2 y £500 - unltd

Penalties of misuse of drugs act 1971 Class A Intent to supply

6 mo - Life £ 5000 - unltd

Penalties of misuse of drugs act 1971 Class B Intent to supply

6 mo - 14 y £ 5000/ unltd fine

Penalties of misuse of drugs act 1971 Class C Intent to supply

3 mo - 14 y £2000 - unltd

What year did nurses and pharmacists start to be able to prescribe some meds?

2012

Week 1 Pharma legislations Flashcards

(70 cards)