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Flashcards in Drugs and law 1 Deck (19)
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1

What is the role of the VMR?

The veterinary medicines regulations came into force 2013.
- Controls risks to human health, animal health and the environment by safe use of vet drugs. (professional advice/ controlled supply/ controlled manufacture/ surveillance)
- Provide assurance on efficacy
- Provide reliable information to users

2

What processes are used to achieve regulation for a veterinary licensed medicinal product?

- Data assessment/ authorisation
- Certification / qualification
-Prescribing, dispensing and supply
- Testing, inspection and investigation
-Post authorisation

3

What are the different drug distribution categories?

-POM-V (vet only)
-POM VPS (Vet, pharmacist, SQP)
-NFA-VPS (Non food animal- Vet, Pharmacist, SQP)
-AVM-GSL (general sales)
-Schedule 6 exemption products

4

Describe POM-V classification

- ONLY prescribed by a vet surgeon AFTER a clinical assessment
-The vet may then either dispense the drug or in accordance with written prescription another vet or pharmacist may do it
-Must be supplied by a registered premises
-Drug requires strict limitation on use due to safety reasons
-Requires specialist knowledge for use/ application and has a narrow safety margin

5

Describe POM-VPS classification

- Must be prescribed by a vet, pharmacist or SQP
-Supplied by a registered premises
-Client can have written prescription
-Clinical assessment NOT required
-Prescriber MUST be happy the client knows how to apply it safely and it will be used for intended purpose
- must ADVISE on safe administration
- These drugs are used to reduce/ prevent effects of endemic disease in herds, flocks or individuals
-Use implies risk for user, animal, consumer safety or environment

6

Describe NFA-VPS classification

-ONLY for companion animals (excl horses)
- Supplied from registered premises
-Vet, pharmacist, SQP only
- Clinical assessment NOT needed
- Advise of safe administration and ensure the client is competent
-Supply no more than minimum needed for treatment
-These drugs used to prevent endemic disease in NFA

7

What is the small animal exemption scheme? (SAES)

-Covers medicines used in certain species:
aquarium fish, cage birds, ferrets, homing pigeons, rabbits, small rodents
- These drugs are exempt from requirement for a marketing authorisation: not required to prove safety, quality, efficacy.
-Must be manufactured to same standards as authorised drugs
-Considered equivalent to AVM-GSL

8

Describe the rules of medicine distribution by a vet

- Vet can dispense against another vet's prescription
- Vet may supply to animals not under his/ her care (not POM-V drugs)
- Internet/ postal supply allowed so long as supplier applies controls

9

What is specified feed additive?

They are authorised under Reg EU 1831/ 2003 belonging to funcitonal groups; coccidiostats, histomonostats and other zootechnical additives)

10

What should be taken into account when prescribing?

-Circumstances of animals being treated
-Available authorised vet medicinal products
-Need for responsible use (of meds and minimum amount needed for treatment)
- Competence of client

11

What is meant be a registered premises?

-All premises where vet medicinal products (VMPs) are stored/ supplied are required to be listed on a register as a veterinary practice premises (VPP)
-Must be in a permanent/ secure building. That doesn't allow entrance of birds/ vermin
-Medicine storage area designed so drugs stored at correct temp,a way from excessive light/ and or moisture
-Toilets and hand washing facilities away from drug storage areas.

12

Who inspects VPPs?

Maintained by the RCVS on behalf of the VMD
- VMD can inspect wholesalers whos supply VPPs
-VPPs themselves inspected by RCVS practice standards scheme

13

Describe supply of POM-V and POM-VPS without a vet present

-Must be authoriseed by a vet
- Vet could write on clients notes tht repeat prescriptions can be supplied to the client, phone call can be used to get authority from vet if client suddenly appears in practice.
- Vet must be satisfied client is competent and drug will be used as intended
-Minimum amount needed only

14

What is a SOP?

Standard Operating Procedure

15

What does SIC and STC stand for?

Special import certificate
Special treatment certificate

16

Describe the procedure for records, storage and disposal

- Must be checked and kept for 5 years
- Reciept/ supply of prescription medicine
- Dates, name, batch, quantity, address
-Copies of written prescriptions
-Records of recent audit

17

What is an SQP?

They can prescribe/ supply POM-VPS and supply NFA-VPA and AVM-GSL.
- Can only supply from an authorised premises and for the species they are trained for (have passed relevant modules for)
-SQP work by a code of practice determined by the VMD

18

What is post authorisation monitoring?

-2 main processes: residues testing and pharmacovigilance
-Residues testing= home produce (meat/ game products etc). Imported products from non EU countried. Point of sale foodstuffs
-Pharmacovigilance= EU wide database, trend analysis

19

What is pharmacovigilance?

Range of activities to detect/ assess/ understand and ultimately prevent an adverse reaction or other sort of problems with a medicine (e.g. lack of efficacy)
-covers all species treated with vet medicines
-Anyone an report an adverse event
-Reports added to SARSS and followed up by VMD

(I.e. it ensures ongoing health. welfare of animals. Esnures safe use of VMps for consumers, users, animals and environemnt)