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NAVLE Veterinary Pharmacy, Prescribing Law & Medicines Regulation: practice questions

NAVLE (North American Veterinary Licensing Examination) · USA / Canada · International Council for Veterinary Assessment (ICVA); scored by NBME, delivered by Prometric

Original practice questions written to the published syllabus · not past papers
10worked here, free
63written 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 NAVLE asks from it

NAVLE, BCSE, ECFVG and PAVE (USA/Canada)

The VCPR, AMDUCA conditions for extra-label use, the 21 CFR 530.41 prohibited list, the Veterinary Feed Directive, DEA schedules and controlled-substance records, withdrawal times and FARAD, adverse-event reporting to FDA, USDA and EPA, and dose and CRI calculations.

Where the 63 questions fall

How our questions for NAVLE spread across the units of Veterinary Pharmacy, Prescribing Law & Medicines Regulation. Difficulty: 23 easy, 31 medium, 9 hard.

Dispensing20
Pharmacovigilance and adverse-event reporting8
Prescription writing7
Controlled drugs6
Extra-label use: US AMDUCA and the UK cascade5
Withdrawal periods5
Drugs prohibited in food-producing animals4
Who may prescribe: IVC Act s.30, the US VCPR and UK POM-V3
Record keeping3
Maximum residue limits2

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

A label reads 'Apply 1 drop OD'. The owner of a dog with an ulcer in the right eye puts one drop in the left eye once a day, reading OD as 'once daily'. What is the best prescribing practice to prevent this?

  1. Keep the abbreviation and explain it verbally at collection
  2. Use OD only for once daily and OS for every other day
  3. Write OU so that both eyes are covered whichever is meant
  4. Write the eye and the frequency in plain words, such as right eye once a day
Answer and working

D. Write the eye and the frequency in plain words, such as right eye once a day

OD means right eye (oculus dexter) to one reader and once daily to another. Plain words on the label remove the ambiguity. Treating both eyes (OU) exposes a healthy eye to a drug it does not need, and verbal explanation is forgotten.

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 · medium

A multi-dose injectable vial was first broached 35 days ago. Its SPC gives an in-use shelf life of 28 days. Half the liquid remains and the printed expiry date is next year. What should be done?

  1. Refrigerate it to reset the in-use shelf life for another 28 days
  2. Use it, because the printed expiry date has not yet been reached
  3. Use it for non-urgent cases only, until the printed expiry date
  4. Discard it; the in-use shelf life has ended
Answer and working

D. Discard it; the in-use shelf life has ended

Once a vial is broached, the in-use shelf life in the SPC applies, because of the risk of contamination and degradation. The printed expiry applies only to unopened product. Mark the opening date on every vial.

4 · Dispensing · medium

A horse is euthanased with an overdose of pentobarbital on a farm. Why must the carcass be disposed of securely and not left for scavengers?

  1. Leaving it exposed lets pentobarbital leach out and reach a safe level
  2. Pentobarbital residues in the carcass can kill dogs and wild scavengers that eat it
  3. Pentobarbital residues make the meat safe to eat but illegal to sell
  4. The drug breaks down into a gas that harms people near the carcass
Answer and working

B. Pentobarbital residues in the carcass can kill dogs and wild scavengers that eat it

Pentobarbital persists in the tissues of euthanased animals and has killed dogs, eagles and other scavengers (relay toxicosis). Secure burial or rendering, as local rules allow, prevents this.

5 · 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.

6 · 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.

7 · Withdrawal periods · medium

A vet gives a calf double the labelled dose of an antibiotic. Why is the label withdrawal period no longer reliable?

  1. Withdrawal depends only on the route of administration, never on the dose
  2. A higher dose speeds up elimination, so the label withdrawal becomes too long
  3. More drug must be cleared, so residues could exceed the MRL at label time
  4. Labels always build in a margin for a doubled dose, so nothing changes at all
Answer and working

C. More drug must be cleared, so residues could exceed the MRL at label time

Withdrawal periods come from depletion studies at the labelled dose, route and duration. More drug, a longer course or a different route can leave residues above the MRL after the label time.

8 · Withdrawal periods · medium

In the United States, how does a vet set the withdrawal time after extra-label use in a food animal?

  1. By setting a substantially extended withdrawal based on scientific data
  2. By applying a fixed 28-day meat and 7-day milk minimum
  3. By multiplying the label withdrawal by 1.5, as fixed in federal law
  4. By using the label time for the nearest approved species
Answer and working

A. By setting a substantially extended withdrawal based on scientific data

US law has no fixed multiplier; the vet must establish a substantially extended withdrawal supported by scientific information, and FARAD supplies estimates. The 1.5 multiplier and 28/7-day minimums are EU (and GB) cascade rules.

Further reading: 21 CFR 530.20; FARAD

9 · Pharmacovigilance and adverse-event reporting · easy

A farmer reports that a wormer, given correctly, no longer reduces faecal egg counts in his sheep. Is this a reportable adverse event?

  1. No; poor efficacy is a commercial matter for the seller
  2. Only if a sheep dies after treatment with the wormer
  3. Yes; lack of expected efficacy is reportable
  4. No; only reactions in the treated animals are reported
Answer and working

C. Yes; lack of expected efficacy is reportable

Veterinary pharmacovigilance includes lack of expected efficacy, which may signal resistance. Reports help regulators and companies spot emerging anthelmintic or antimicrobial resistance.

10 · Record keeping · easy

For how long must US records of extra-label drug use in animals be kept under 21 CFR Part 530?

  1. 10 years
  2. 6 months
  3. 5 years
  4. 2 years
Answer and working

D. 2 years

Extra-label use records must be kept for two years and made available to the FDA. VFD orders are also kept for two years.

Further reading: 21 CFR 530.5

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Read the subject

Veterinary Pharmacy, Prescribing Law & Medicines RegulationThe full study manual, free NAVLEFormat, sections and how it has changed

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Veterinary Pharmacy, Prescribing Law & Medicines Regulation for other exams

RCVS Statutory Membership Examination · UKAustralasian Veterinary Examination, formerly the National Veterinary Examination · Australia / New ZealandSAVC Registration Examination · South AfricaVeterinary Council of Ireland registration exam · IrelandNational Licensure Examination for Veterinarians · NepalKenya Veterinary Board pre-registration exam · Kenya

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