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PVS > Pharmacology: Law > Flashcards

Pharmacology: Law Flashcards

1
Q

When did the Veterinary Medicines Regulations 2013 (SI 2033) (VMR) come into force?

A

on 1 October 2013.

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2
Q

When can POM-V drugs be prescribed?

A

Medicines in this category must only be prescribed by a veterinary surgeon following a clinical assessment of the animal or group of animals, which must be under their care.

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3
Q

Who can hand out POM-V’s?

A

The medicine may then be supplied by that veterinary surgeon or in accordance with a written prescription by another veterinary surgeon or a pharmacist

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4
Q

All medicines classified as POM became what after 2005?

A

POM-V

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5
Q

Where must POM-V’s be kept?

A

The medicine must be supplied from registered premises

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6
Q

Can a vet write a prescription for a POM-V?

A

Yes

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7
Q

What makes a medicine classified as a POM-V?

A

It requires a strict limitation on its use for specific safety reasons
It requires the specialized knowledge of a veterinary surgeon for its use/application
It has a narrow safety margin requiring above average care in its use
It is government policy to demand professional control at a high level (for example, antimicrobials and Controlled Drugs

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8
Q

Who can prescribe and supply POM-VPS?

A

Medicines in the POM-VPS category must be both prescribed and supplied by a veterinary surgeon, pharmacist or SQP. This can be more than one person: any authorized supplier may supply in accordance with a written prescription from any authorized prescriber. The medicine must be supplied from registered premises

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9
Q

Is a clinical exam required for POM-V?

A

yes

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10
Q

Is a clinical exam required for POM-VPS?

A

No

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11
Q

Before supplying a POM-VPS the person must be satisfied that…

A

The person who will be administering the medicine is competent to do so safely, & intends to use it for a purpose for which it is authorized
Advise on the safe administration of the medicine & on warnings/ contraindications stated on the label or package

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12
Q

What classification are drugs used to reduce or prevent the effects of endemic disease in herds, flocks or in individual animals

A

POM-VPS

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13
Q

Who can supply NFA-VPS?

A

NFA non food animal
Medicines in the NFA-VPS category are for companion animals (excluding horses) & must be supplied by a vet, pharmacist or SQP from registered premises

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14
Q

What are AVM-GSL products?

A

AVM authorised veteriary medicine General Sales List- (buy at pet store)

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15
Q

What is the small animal exemption scheme?

A

If the active ingredient of a drug has been declared by the Secretary of State as not requiring veterinary control, may be marketed under the SAES
These medicines are exempt from the requirement for a marketing authorization & not required to prove safety, quality or efficacy, but must be manufactured to same standards as authorized medicines and are subject to pharmacovigilance reporting

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16
Q

Who can provide SAES?

A

These medicines may be considered for sale and supply purposes to be equivalent to AVM-GSL

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17
Q

What is the legislation surrounding controlled rugs?

A

All CDs are listed in one of five Schedules in the Misuse of Drugs Regulations 2001 (MDR) and the Misuse of Drugs Regulations (Northern Ireland)(MDR (NI)) 2002

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18
Q

What must premises that supply/store VMP’s be registered as?

A

Veterinary Practice Premises (VPPs)

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19
Q

What are the criteria for registering as a Veterinary Practice Premises (VPPs)?

A

These premises must be in a permanent and secure building, which does not allow the entrance of birds or vermin
The medicines storage areas are designed to allow drugs to be stored at the correct temperature monitored by maximum and minimum thermometers to check & medicines should be stored in areas away from excessive light and/or moisture
There are appropriate staff amenities, toilets and hand washing facilities, separate from the drug storage areas.

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20
Q

What checks up on the VPP?

A

The VPP is maintained by the Royal College of Veterinary Surgeons (RCVS) on behalf of the Veterinary Medicines Directorate (VMD).

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21
Q

Who must supply the vet surgeon?

A

VMPs can be supplied by a wholesaler to a veterinary surgeon at non- registered premises, but the veterinary surgeon can only supply the VMPs from a VPP.

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22
Q

Who inspects practices that are members of the RCVS Practice Standards Scheme (PSS)?

A

The VMD will be able to inspect these premises but practices that are members of the RCVS Practice Standards Scheme (PSS) will not currently be inspected by the VMD inspectors, as their pharmacies will be inspected as part of the PSS.

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23
Q

If a vet wants to prescribe a POM-V but cannot physically hand over the prescription, what can be done?

A

Must be authorized by a veterinary surgeon
A vet could meet the requirement to authorize each transaction by making a note on a clients’ record that repeat prescriptions can be supplied to that client, or by a member of staff taking a call from a client and putting a medicine aside for the veterinary surgeon to authorize before it is supplied, or in the case of a client unexpectedly coming into the practice by means of a phone call to the veterinary surgeon to authorize the supply

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24
Q

Records should be kept for 5 years in the case of POM-V, what should be recorded?

A

Receipt and supply of prescription medicines
Date of supply/receipt, name, batch, quantity, address
Copies of all written prescriptions
Records of recent audit
Imported drugs (SIC (special import certificate) & STCs (special treatment certificate)) maintained

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25
Q

What can SQP’s prescribe?

A

An SQP can prescribe and supply POM-VPS and supply NFA-VPS and AVM-GSL medicines, but only from authorized premises and only from within the animal group category they are trained for.

26
Q

What are R-SQP, E-SQP and C-SQP allows to prescribe to?

A

R- all animals
E - equine and companion
C- companion

27
Q

What is pharmacovigilance?

A

– Monitoring the use of medicines in everyday practice to identify previously unrecognised adverse effects or changes in the patterns of adverse effects
– Assessing the risks and benefits of medicines in order to determine what action, if any, is necessary to improve their safe use
– Providing information to healthcare professionals and patients to optimise safe and effective use of medicines

28
Q

What systems are there to allow early communication of safety concerns of drugs, and to who?

A

The rapid alert (RA) and non-urgent information (NUI) systems have been established to allow early communication of safety concerns and rapid exchange of pharmacovigilance information between national competent authorities and the Agency (EMA).

29
Q

What happens to a reported SAR?

A

It is inputted on SARSS (Suspected Adverse Reaction Surveillance Scheme), VMD follow this up.

30
Q

Marketing-authorisation holders have the legal obligation to periodically provide summary reports on the safety of their products. What do these reports contain?

A

These periodic safety update reports (PSURs) discuss and evaluate the overview of all adverse events (serious as well as non-serious) that were recorded during the period.

They provide information on the frequency of occurrence of adverse events: the total amount of product sold and estimated number of animals treated are put into relation to the number of animals affected by an adverse event.

They also include information on other aspects, such as lack of expected efficacy, environmental issues or residue violations

31
Q

What is the outcome from these PSUR’s?

A

Based on its assessment of these PSURs, the Committee for Medicinal Products for Veterinary Use (CVMP) draws conclusions concerning the current benefit-risk balance of a product.

32
Q

If there is no medicine authorized in the UK for a specific condition, the veterinary surgeon responsible for treating the animal may, in particular in order to avoid unacceptable suffering, treat the animal with…

A

A veterinary medicine authorized in the UK for use in another animal species or for a different condition in the same species.

33
Q

In accordance with the cascade if there is no veterinary medicine authorized in the UK for use in another animal species or for a different condition in the same species, a vet can use…

A

If there is no such medicine, use either: (a) A medicine authorized in the UK for human use (b) A veterinary medicine from another Member State or country outside the EU in accordance with an import certificate from the Veterinary Medicines Directorate (VMD).

34
Q

Using the cascade if there is no human/animal medicine licensed in any country, a vet can….

A

If there is no such medicine, a medicine prepared extemporaneously by a veterinary surgeon, pharmacist or a person holding an appropriate manufacturer’s authorization

35
Q

If using the cascade in food animals, the drug must….

A

– any medicine imported from another Member State must be authorized for use in a food-producing species in the other Member State
– the pharmacologically active substances contained in the medicine must have MRLs
– the prescribing vet must specify an appropriate withdrawal period – statutory minimums are in the Regulations.

36
Q

Why should we avoid using human medicines, and not just use them because they’re cheaper?

A

In addition, animal medicines containing the same active ingredient as human medicines may be formulated differently. For instance, the formulation needs to ensure that the medicine is properly absorbed through the gut (which is rather shorter in a cat than a human). Human medicine formulations may contain different excipients or have different bioavailability from veterinary medicines. Therefore, using a medicine which is not authorized for animals increases the risk of harm to the patient.

37
Q

What do you need to import a VMP from another country?

A

A VMP authorized in another EU Member State requires a special import certificate (SIC)
A veterinary medicine without a full marketing authorization, or an authorized veterinary medicine from outside the EU, or a human medicine from outside the UK all require a STC.

38
Q

What is the minimum withdrawal time for meat/milk/eggs and fish if it not stated on the product?

A

28 days Meat from poultry and mammals including fat and offal
7 days Milk
7 days Eggs
500 degree days for meat from fish

39
Q

What are degree days?

A

Calculated by multiplying the average temperature by the number of days.
For example 500 degree days may be 50 days at 10’C, 100 days at 5’C or any other multiple that results in 500

40
Q

What regulation classifies the CD’s?

A

Misuse of Drugs Regulations 2001

41
Q

Who can possess schedule one drugs?

A

Vets have NO authority to possess
A home office license is required to possess
Production, possession and supply of these drugs are limited to research or other special purposes.

42
Q

What type of drugs are schedule one?

A

Have no recognized medicinal use and include cannabis, coca leaf, lysergic acid diethylamide, LSD & Mescaline

43
Q

What type of drugs are schedule 2?

A

Schedule 2 includes morphine, pethidine, fentanyl (big problem), alfentanil, methadone, the amphetamines and secobarbital/quinalbarbitone (horse PTS so exempt from safe custody) and ketamine (as of 30/11/15)

44
Q

Where must schedule two drugs be stored, how must they be requested?

A

These drugs are subject to safe custody requirements and should be stored in a suitable locked cabinet secured to the fabric of the building at all times.

Receipt and supply of Schedule 2 Controlled Drugs must be recorded in a Controlled Drugs Register.
Written requisitions must be made to wholesalers.

45
Q

How long are prescriptions for schedule 2 drugs valid for?

A

28 d

46
Q

Who must be present to destroy schedule 2 drugs?

A

Schedule 2 Controlled Drugs must not be destroyed, except in the presence of a person authorized by the Secretary of State.

47
Q

Can you have a repeat prescription for schedule two and three drugs? How must the prescription be sent?

A

Repeat prescriptions are not permitted.

Prescriptions cannot be faxed or sent electronically.

48
Q

What type of drugs are schedule 3?

A

Schedule 3 includes buprenorphine, pentobarbital, phenobarbital, midazolam and some minor stimulants, including benzphetamine and tramadol (exempt from safe custody)

49
Q

Do schedule 3 drugs need to be recorded in the controlled drugs register?

A

These drugs are subject to safe custody requirements (with some exceptions) but do not have to be recorded in the Controlled Drugs Register

50
Q

How must schedule 3 drugs be requested from wholesalers?

A

In writing

51
Q

How long are schedule 3 prescriptions valid for?

A

28 d

52
Q

How is schedule four split?

A

Schedule 4 is split into two parts: part I includes benzodiazepines; part II contains anabolic and androgenic steroids.

53
Q

Are schedule four drugs subject to safe custody requirements?

A

No

54
Q

How long are schedule 4 prescriptions valid for?

A

28 d

55
Q

What drugs are schedule 5?

A

Low strength, e.g. Pardale V(codeine/paracetamol)

56
Q

How long do you need to keep records of schedule 5 drugs for?

A

2 years

57
Q

What must be recorded on the prescription for controlled drugs?

A

Date supplied
– Name and address of the person to whom the drug was supplied
– Name and signature of veterinary surgeon
– Amount supplied
– Form in which supplied
– Running total (recommended).

If a Schedule 2 Controlled Drug is dispensed to a client, the following should also be recorded:
• Name of the person collecting CD
• Was proof of identity of the person collecting the drug requested (yes/no)?

58
Q

If a client returns a controlled drug that they haven’t used, what should you do?

A

Record it in the returns book to await its destruction

59
Q

Who must witness the destruction of out of date CD’s?

A

Destruction of out-of-date Controlled Drugs must be witnessed by either a member of the Animal Medicines Inspectorate, an inspector of the RCVS Practice Standards Scheme, a veterinary surgeon who is independent of the practice, or a police officer (such as a Controlled Drugs Liaison Officer).

60
Q

Where should you record the destruction of a controlled drug?

A

An entry must be made in the Controlled Drugs Register detailing the items destroyed and the running total updated. This entry must be signed by the authorized witness.

61
Q

Controlled Drugs should be rendered irretrievable before destruction, how can this be done?

A

Crush solid dosage forms in a mortar and pestle and add to the denaturing kit
Pour in liquids
Add parenteral preparations, open ampoules and empty into denaturing kit, and remove products from vials
Fold any transdermal patches in on themselves and add
Fill denaturing kit with water and store in the Controlled Drugs cupboards for 24 hours until denaturing is complete

62
Q

When commercial denaturing kits aren’t available how can the drugs be destroyed?

A

Alternatively, tablets can crushed and mixed with soapy water and injectable products can be mixed with sawdust or cat litter
Incinerate with other pharmaceutical waste, labelling the waste to show it contains Controlled Drugs.

PVS (43 decks)

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