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4703 > Introduction to Veterinary medicines > Flashcards

Introduction to Veterinary medicines Flashcards

1
Q

What is the purpose of Veterinary Medicines Regulations (VMRs) 2013?

A
  • Set out the legal controls of veterinary medicines.
  • The VMRs are updated about once a year (or thereabouts).
  • Enforced by the Veterinary Medicines Directorate (VMD).
  • Veterinary medicines supplied in UK must have a GB or UK marketing authorisation.
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2
Q

What is a Veterinary Medicinal Product (VMP)?

A

Any substance or combination of substances presented as having properties for treating or preventing disease in animals;

or

Any substance or combination of substances that may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical
diagnosis.

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3
Q

What is the role of the Veterinary Medicines Directorate?

A

Are an executive agency of DEFRA (Department of the Environment, Food and Rural Affairs).

Main statutory functions include:

  • Assessing veterinary medicines for safety, quality and efficacy.
  • Granting marketing authorisations for veterinary medicines.
  • Regulating the manufacture and distribution of veterinary medicinal products and animal feeding stuffs containing veterinary medicines and specified feed additives.
  • Surveillance of adverse events.
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4
Q

What is considered by the VMD in terms of the safety of veterinary medicines?

A
  • The animal being treated.
  • The person administering the medicine.
  • The consumer of milk, meat, eggs or honey (if administered to a food producing animal).
  • The potential impact on the environment.
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5
Q

Can the same veterinary medicines be used in
different animals?

A
  • No
  • Different products are authorised in different species.
  • This is not only to do with the size of the animal but also to do with drug handling and metabolism.
  • Paracetamol for example, is extremely toxic to cats, since they lack the necessary glucuronyl transferase enzymes to safely metabolise it.
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6
Q

What are the classes of authorised VMPs?

A
  • POM-V
  • POM-VPS
  • NFA-VPS
  • AVM-GSL
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7
Q

What is a POM-V?

A
  • Prescription-only Medicine – Veterinarian.
  • Subject to highest level of control.
  • Includes VMPs containing controlled drugs and those intended for administration only following a diagnosis and clinical assessment by a veterinary surgeon.
  • Available only on the written prescription of a vet.
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8
Q

What is a POM-VPS?

A
  • Prescription-only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person (SQP).
  • Medicines in the POM-VPS category must also be prescribed, but this can be by a pharmacist, Suitably Qualified Person (SQP) or a veterinary surgeon.
  • Prescriptions may be oral or written.
  • A written prescription is only required if the supplier is not the prescriber.
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9
Q

What is a NFA-VPS?

A
  • Non-Food Producing Animal – Veterinarian, Pharmacist, SQP.
  • Do not require a written prescription.
  • Product must be provided with appropriate advice at point of sale in order to ensure that the products will be properly administered.
  • Medicines intended for use in food-producing animals would normally be classified as POM-VPS.
  • The NFA-VPS category contains many of the dog and cat worm and flea control products.
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10
Q

What is a AVM-GSL?

A

Authorised Veterinary Medicine, General Sales List.

Medicines in this category may be supplied by any retailer without any restrictions, or provision of advice.

Exemptions for small pet animals:

  • These products are exempt, under Schedule 6 of the VMRs.
  • Intended solely for use in small, non-food producing animals.
  • Not authorised, so they have not been assessed for quality, safety or efficacy, but may be legally marketed and administered according to the instructions on their labelling.

Unauthorised products:

  • An unlicensed medicine that does not have a marketing authorisation and is not eligible for exemption through the Small Pet Animals scheme.
  • Can only be prescribed by a veterinary surgeon under the cascade.
  • This includes any human medicine used for animals.
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11
Q

What can pharmacists not do?

A
  • Only veterinary surgeons can diagnose clinical conditions in animals.
  • Pharmacists cannot sell human medicines for use in animals, unless they are prescribed under the cascade.
  • Prescriptions for animals are not allowed on the NHS.
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12
Q

What can pharmacists do?

A
  • Dispense POM-V and POM-VPS medicines in accordance with prescriptions written by a UK registered veterinary surgeon.
  • Dispense veterinary medicines prepared extemporaneously, but only in accordance with a prescription from a veterinary surgeon.
  • Dispense human medicines for use under the cascade in accordance with prescriptions written by a veterinary surgeon.
  • Prescribe and supply POM-VPS veterinary medicines.
  • Supply NFA-VPS, AVM-GSL veterinary medicines and Small Pet Animal Exempt products.
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13
Q

What are the prescription requirements for POM-V, POM-VPS and medicines supplied under the veterinary cascade?

A
  • Name, address, telephone number, qualification and signature of the prescriber.
  • Name and address of the owner.
  • Identification and species of the animal and its address.
  • Date; prescriptions are valid for six months or shorter if indicated by the prescriber.
  • Prescriptions for schedule 2, 3 and 4 controlled drugs are valid for 28 days.
  • Name, quantity, dose and administration instructions of the required medicine.
  • As with prescriptions for human medicines, ‘as directed’ is not an acceptable administration instruction.
  • There is no standardised prescription form, but the British Veterinary Association provide a useful template (see example).
  • Any necessary warnings and if relevant the withdrawal period (for food producing animals).
  • Where appropriate, a statement highlighting that the medicine is prescribed under the veterinary cascade.
  • If the prescription is repeatable, the number of times it can be repeated.
  • Where Schedule 2 or 3 CDs have been prescribed, the Royal College of Veterinary Surgeons (RCVS) registration number of the prescriber must also be included.
  • For S2 / S3 CDs, also: a declaration that “the item has been prescribed for an animal or herd under the care of the veterinarian”.
  • Usual CD prescription requirements also apply and the RCVS (Royal College of Veterinary Surgeons) registration number of the prescriber must also be included.
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14
Q

What is the veterinary cascade?

A
  • VMR state that only authorised veterinary medicines may be prescribed or administered to animals.
  • However, If there is not an authorised veterinary medicines available in GB or the UK, then Schedule 4 to the VMR allows a veterinary surgeon to prescribe an alternative to treat an animal.
  • This process is known as the cascade.
  • It is unlawful to supply a human medicine or veterinary medicine without a GB/UK licence unless the prescription clearly includes a statement that the medicine is prescribed under the veterinary cascade (e.g. “prescribed under the cascade” or other wording to the same effect).
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15
Q

Define the withdrawal period:

A

A veterinary surgeon prescribing for, or administering a medicine to, food-producing animals under the cascade is required to specify an appropriate withdrawal period for the animal produce.

When setting the withdrawal period, a veterinary surgeon must take into account known information about the use of the product on the authorised species when prescribing to another species under the cascade.

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16
Q

How are food producing animals treated?

A
  • Food producing animals may only be treated under the cascade with medicines which contain pharmacologically active substances listed in the EU ‘table of allowed substances’.
  • This is in the interest of food safety.
  • The period of time regulatory authorities have set between giving the animal its last dose of veterinary medicine, and it, or its food products, being allowed into the food chain.

If the medicine does not indicate a withdrawal period for the species concerned, this should not be less than:

  • 7 days for eggs and milk.
  • 28 days for meat from poultry and mammals.
  • 500 degree days for meat from fish.
  • A degree day - calculated by multiplying the average temperature by the number of days. For example 300 degree days may be 30 days at 10oC, 100 days at 3oC or any other multiple that results in 300.
17
Q

What are the regulations for veterinary controlled drugs?

A

All veterinary medicines must meet the requirements of the VMRs.

For CD veterinary medicines, the Misuse of Drugs Act / Regulations apply as they
do for human medicines, except:

  • Standardised forms are not required for veterinary prescriptions (these prescriptions are always private).
  • Veterinary prescriptions should be retained for five years and not submitted to the relevant NHS agency.
  • For all CDs, it is considered good practice for only 28 days’ supply of treatment to be prescribed on veterinary prescriptions unless in situations of long term therapy.
18
Q

Is a label always required for veterinary medicines?

A

When a medicine is supplied under the cascade, certain details must appear on
the dispensing label unless they already appear on the packaging and are not
obscured by the dispensing label.

If the medicine is not prescribed under the cascade, the VMRs do not specify that a
dispensing label is required.

However, the RPS advises that it would be appropriate to generate a dispensing label for all veterinary medicines, particularly for
individual companion animals.

19
Q

What records must be kept for POM-V and POM-VPS products?

A
  • Name of the medicine.
  • Date of the receipt or supply.
  • Batch number.
  • Quantity.
  • Name and address of the supplier or recipient.
  • If there is a written prescription, record the name and address of the prescriber and keep a copy of the prescription.

Records and documents must be kept for at least five years.

Pharmacies that supply POM-V and POM-VPS medicines must undertake an annual audit.

20
Q

What are the aims of pharmacovigilance?

A

The aims are to ensure:

  • The safe and effective use of veterinary medicines in animals.
  • The safety of people who come into contact with veterinary medicines.
  • The safety of veterinary medicines for the environment.
21
Q

How does the suspected adverse reaction surveillance scheme (SARSS) work?

A
  • Reports are on a ‘yellow form’.
  • Reporting is voluntary but the Royal College of Veterinary Surgeons (RCVS)
    considers it to be part of a veterinary surgeon’s professional responsibility to the
    general public.
  • Pharmacists and SQPs should also record and report adverse events.
  • Animal owners are encouraged to report.
  • Suspected adverse events can be reported to the marketing authorisation holder of a veterinary medicine, or to the VMD.
  • The marketing authorisation holder has a legal obligation to report serious adverse events involving death or prolonged severe clinical signs to the VMD within 15 days following receipt of the information.
22
Q

What are the responsibilities of a pharmacist when supplying veterinary medicines?

A
  • The pharmacist must be present when it is handed over, unless the pharmacist authorises each transaction individually beforehand and is satisfied that the person
    handing it over is competent to do so.
  • It is illegal to supply a product after the expiry date shown on the pack.
  • Any out of date products should be disposed of in accordance with the wording on the product literature.
23
Q

Which of the following statements is incorrect with respect to the GPhC(10 Points)

It is the regulator for pharmacy technicians in Great Britain

Regulation by the GPhC is to be seen purely as a means of discipline

The Council has representatives from England, Wales and Scotland

The Council (i.e. the governing board for the organisation) has equal numbers of lay and registrant members

The over-riding purpose of the GPhC is the protection of the public and patients.

A

Regulation by the GPhC is to be seen purely as a means of discipline

24
Q

Which of the following statements is incorrect in relation to a pharmacy professional’s use of social media.
A pharmacy professional:(10 Points)

can avoid any problems by including a statement that the content reflects solely their own views

must maintain confidentiality and privacy at all times

must maintain proper professional boundaries

must not get drawn into negative, unconstructive discussions

must not intimidate others

A

can avoid any problems by including a statement that the content reflects solely their own views

25
Q

Which of the following statements about Fitness to Practise is incorrect?(10 Points)

A pharmacy professional is fit to practice when they: act professionally and meet the principles of good practice set out in our various standards, guidance and advice.

A pharmacy professional is fit to practice when they: have the skills, knowledge, character and health necessary to do their job safely and effectively;

Fitness to Practise concerns only apply to errors which have occurred in the workplace

Fitness to practise processes are there to protect patient safety

One sanction that a Fitness to Practise Committee (FtPC) can impose on a pharmacy professional is a suspension of up to 12 months.

A

Fitness to Practise concerns only apply to errors which have occurred in the workplace

26
Q

Which of the following statements about the destruction of controlled drugs (CDs) is incorrect?

Pharmacies in England and Wales cannot accept CDs returned from care homes.

Schedule 2 CD stock which goes out of date in a pharmacy, must be destroyed in the presence of an authorised witness.

There is no legal requirement for patient returned CDs should be denatured in the presence of another member of staff, preferably a pharmacist or pharmacy technician if available.

A

Pharmacies in England and Wales cannot accept CDs returned from care homes.

Feedback: Pharmacies can accept CDs returned from care homes that provide patients with personal care. Pharmacies in England and Wales are not able to accept waste medicines, including CDs, from care homes which provide nursing care for disposal under the NHS funded unwanted medicines service. Read more here. https://psnc.org.uk/quality-and-regulations/pharmacy-regulation/controlled-drug-regulations/

27
Q

Which of the following statements is incorrect in relation to an NHS prescription for MST 30mg Tablets?(10 Points)

The address of the prescriber must be within the UK

The dose on the prescription must be written in words and figures

It is good practice that the amount prescribed should not exceed 30 days

The prescription is only be legally valid for 28 days from the appropriate date

It is a legal requirement that the form of the medicine must be included

A

The dose on the prescription must be written in words and figures

28
Q

Which one of the following is correct, with regards to a requisition to purchase a CD?(10 Points)

A requisition is always required before a S2 CD can be supplied by way of wholesale

A standardised form must be used for the requisition, as a legal requirement

It is a legal requirement to retain a copy of the requisition in the pharmacy for two year from the date of supply.

Following supply, the original requisition must be retained in the pharmacy for 2 years

Supplies of S2 CDs may be made against a faxed or photocopied requisition

A

A standardised form must be used for the requisition, as a legal requirement

29
Q

From which of the following places is it not possible to lawfully purchase a packet of ibuprofen 200 mg tablets (12 pack)?(10 Points)

A flight flying from London Gatwick airport to Glasgow airport (both UK)

A vending machine situated in the toilets of a hotel

A supermarket which does not have an in-store pharmacy

A petrol station

A market stall

A

A market stall

Feedback: Sales of GSL medicines are only permitted under Regulation 221 of the HMR from premise, other than registered pharmacies, where the place at which the medicinal product is sold, supplied, or offered for sale or supply, consists of premises of which that person is the occupier and which they are able to close so as to exclude the public. This cannot happen with a market stall and so is not permitted. For further reading go to Dale and Appelbe, Edition 12. Chapter 7

29
Q

The following question relates to lawfully conducting a Retail Pharmacy Business. Which of the following statements is incorrect.(10 Points)

A retail pharmacy business may not be lawfully conducted by a body corperate

The titles Chemist and Pharmacist are restricted titles

A retail pharmacy business is required to have a Responsible Pharmacist in charge of the premised for the sale of GSL medicines to take place

A notice must be conspicuously displayed at a retail pharmacy premises which provides the GPhC registration number of the Responsible Pharmacist

A

A retail pharmacy business may not be lawfully conducted by a body corperate

30
Q

Which of the following medicines are not to be sold as a GSL medicines(10 Points)

A nasal spray

A suppository

An ear drop

An eye drop

An eye ointment

A

An eye ointment

Feedback: The Human Medicines Regulations 2012 (Sch.1) specify certain classes of medicinal product which are to be available only from a pharmacy: that is, which are not to be on general sale and this includes eye drops. Refer to Dale and Appelbe 12 Edition. Chapter 7. Products not to be on general sale

31
Q

The following question relates to the sale of Aspirin containing products. Which of the following is correct?(10 Points)

Aspirin 300mg tablets may be sold OTC to children over 12 years of age

Aspirin 300mg in a pack size of 32 has the legal classification of P

Aspirin 75mg effervescent tablets in a pack size of 100 has the legal classification of POM

It would be illgeal to sell 2 x 100 boxes of Aspirin 300mg effervescent tablets to one person

A

Aspirin 300mg in a pack size of 32 has the legal classification of P

32
Q

Which of the following would NOT equate to the supply of a medicinal product not of the nature or quality demanded? Dispensing …..(10 Points)

a contra-indicated drug, in accordance with a prescription?

a different form (from that ordered) of a drug, in response to a prescription?

the wrong drug, in response to a prescription?

an out of date item, in response to a prescription?

a cold storage item that had inadvertently been left out on the dispensary shelves?

A

a contra-indicated drug, in accordance with a prescription?

32
Q

Which of the following statements relating to advertising directed to the public is incorrect?(10 Points)

The advert must have the note ‘read the label’ on it

The advert must not promote the use of a POM medicine

Vaccinations cannot be promoted in the lay press

The advert may be endorsed by a celebrity, as long as there is a proven evidence base for its use.

A

Vaccinations cannot be promoted in the lay press

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