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RCVS Statutory Membership Examination Veterinary Pharmacy, Prescribing Law & Medicines Regulation: practice questions

RCVS Statutory Membership Examination (SME) · UK · Royal College of Veterinary Surgeons

Original practice questions written to the published syllabus · not past papers
10worked here, free
66written to this exam in this subject
10syllabus units

What this subject covers

Writing a lawful prescription and dispensing safely: who may prescribe, extra-label use and the cascade, withdrawal periods and MRLs, drugs prohibited in food animals, pharmacovigilance, controlled drugs and records.

In the exams: EAEVE Day One competences on prescribing, dispensing and reporting adverse reactions; WOAH Day 1 veterinary products; RCVS Day One competences (the cascade)

What RCVS Statutory Membership Examination asks from it

RCVS Statutory Membership Examination (UK) and Veterinary Council of Ireland registration exam

Legal categories (POM-V, POM-VPS, NFA-VPS, AVM-GSL), animals under care, the cascade steps and conditions, minimum withdrawal periods for off-label use in food animals, horse passports and the food chain, controlled-drug schedules, registers and prescriptions, and reporting suspected adverse events to the VMD.

Where the 66 questions fall

How our questions for RCVS Statutory Membership Examination spread across the units of Veterinary Pharmacy, Prescribing Law & Medicines Regulation. Difficulty: 26 easy, 27 medium, 13 hard.

Dispensing16
Prescription writing10
Withdrawal periods10
Pharmacovigilance and adverse-event reporting8
Record keeping6
Who may prescribe: IVC Act s.30, the US VCPR and UK POM-V4
Extra-label use: US AMDUCA and the UK cascade4
Controlled drugs4
Maximum residue limits2
Drugs prohibited in food-producing animals2

10 practice questions, worked

Choose an answer, then open the working. Each explanation says why the right answer is right and why the others are not.

1 · Prescription writing · hard

In the UK, a vet writes a prescription for a Schedule 2 opioid for a dog under her care. Which feature is a legal requirement for this prescription but not for an ordinary POM-V prescription?

  1. The animal's microchip number written in the margin
  2. A countersignature from a second veterinary surgeon
  3. The total quantity in words and figures
  4. The pharmacist's name entered in advance by the vet
Answer and working

C. The total quantity in words and figures

Schedule 2 and 3 controlled-drug prescriptions must state the total quantity in words and figures so it cannot be altered, along with the prescriber's registration number and a declaration that the drug is for an animal under the vet's care. No countersignature or pre-named pharmacist is required.

Further reading: Misuse of Drugs Regulations 2001; RCVS supporting guidance

2 · Dispensing · easy

An owner asks whether she can crush an enteric-coated tablet to hide it in food for her dog. What is the correct advice?

  1. Yes, provided the powder is mixed into a fatty food
  2. No, but it may be split into quarters without any loss of effect
  3. Yes; all tablets work the same once they have been crushed
  4. No; crushing defeats the protective enteric coating
Answer and working

D. No; crushing defeats the protective enteric coating

An enteric coating stops the tablet dissolving in the stomach, either to protect the drug from acid or to protect the stomach from the drug. Crushing or splitting defeats it. Ask for a different formulation instead.

3 · Dispensing · easy

How many milligrams of drug are there in 1 mL of a 2% w/v solution?

  1. 2 mg
  2. 0.2 mg
  3. 200 mg
  4. 20 mg
Answer and working

D. 20 mg

2% w/v = 2 g per 100 mL = 2000 mg per 100 mL = 20 mg/mL. Rule of thumb: % w/v × 10 = mg/mL. 2 mg and 200 mg are tenfold slips in either direction; 0.2 mg divides by 10 instead of multiplying.

4 · Dispensing · easy

5 g of a drug is dissolved and made up to 250 mL. What is the strength as % w/v?

  1. 0.2%
  2. 2%
  3. 20%
  4. 5%
Answer and working

B. 2%

% w/v = g per 100 mL. 5 g in 250 mL = 2 g in 100 mL = 2%. 20% and 0.2% are tenfold slips; 5% ignores the volume.

5 · Withdrawal periods · medium

Under Article 115 of Regulation (EU) 2019/6, a product authorised for cattle with a zero meat withdrawal is used under the cascade in turkeys. What is the minimum meat withdrawal?

  1. 1 day
  2. 7 days
  3. Zero days
  4. 28 days
Answer and working

A. 1 day

When a product with a zero withdrawal period is used in a different taxonomic family, the EU minimum is 1 day for meat. Zero is the label figure for the authorised species only; 28 days is for products not authorised in food animals.

Further reading: Regulation (EU) 2019/6, Article 115

6 · Withdrawal periods · hard

A UK horse's passport has not been signed out of the food chain. The vet wants to treat chronic lameness with phenylbutazone. What is the legal position?

  1. Not allowed: phenylbutazone has no MRL and the horse is in the food chain
  2. It may be given because horses are never classed as food-producing animals
  3. It may be given with a 6-month withdrawal as an essential substance
  4. It may be given with a standard 28-day meat withdrawal under the cascade
Answer and working

A. Not allowed: phenylbutazone has no MRL and the horse is in the food chain

In the UK and EU every horse is a food animal unless its passport declaration excludes it. Phenylbutazone has no MRL and is not on the essential substances list, so it may not be used in a food-chain horse. The 6-month withdrawal applies only to listed essential substances.

Further reading: Commission Regulation (EU) 122/2013; VMD guidance on horse medicines

7 · Pharmacovigilance and adverse-event reporting · hard

Milk from a cow tests positive for residues above the MRL even though the farmer observed the label withdrawal period exactly. How should this be treated?

  1. As the farmer's fault, so no report to the regulator is needed
  2. As an adverse event suggesting the label withdrawal is too short
  3. As normal biological variation that needs no further action
  4. As a laboratory error, so the positive result can safely be ignored
Answer and working

B. As an adverse event suggesting the label withdrawal is too short

A residue violation after the correct withdrawal is part of the scope of pharmacovigilance in the EU and GB. Reports can lead to a review of the withdrawal period.

8 · Pharmacovigilance and adverse-event reporting · hard

Who has a legal obligation to collect, record and report adverse events for a veterinary medicine in the EU and GB?

  1. The wholesaler that supplied the practice
  2. Only the animal's owner or keeper
  3. Only the prescribing veterinary surgeon
  4. The marketing authorisation holder
Answer and working

D. The marketing authorisation holder

Marketing authorisation holders must run a pharmacovigilance system and report adverse events. For vets, reporting is a professional duty set by codes of conduct rather than the core legal obligation.

9 · Controlled drugs · medium

Under the UK Misuse of Drugs (Safe Custody) Regulations 1973, which of these veterinary drugs must be kept in a locked controlled-drug cabinet?

  1. Buprenorphine
  2. Furosemide
  3. Meloxicam
  4. Amoxicillin
Answer and working

A. Buprenorphine

Schedule 2 drugs and certain Schedule 3 drugs, including buprenorphine, are subject to safe custody. Meloxicam, amoxicillin and furosemide are not controlled drugs.

Further reading: Misuse of Drugs (Safe Custody) Regulations 1973

10 · Record keeping · easy

Under EU rules, keepers of food-producing animals must keep records of medicines bought and given. For how long at minimum?

  1. 6 months
  2. 2 years
  3. Until the animal is slaughtered
  4. 5 years
Answer and working

D. 5 years

Regulation 2019/6 requires keepers of food-producing animals to keep medicine records for at least five years, so residue investigations can trace treatments after the animal has gone.

Further reading: Regulation (EU) 2019/6, Article 108

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Read the subject

Veterinary Pharmacy, Prescribing Law & Medicines RegulationThe full study manual, free RCVS Statutory Membership ExaminationFormat, sections and how it has changed

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