PEBC Pharmacy Evaluating & Qualifying Exam: Biomedical Sciences, Pharmacology, Pharmaceutical Calculations & Canadian Pharmacy Law (NAPRA)
High-yield Pharmacy Examining Board of Canada (PEBC) Evaluating and Qualifying (Part I MCQ & Part II OSCE) concepts covering pharmaceutical calculations, pharmacokinetics, pharmacology, OTC care, and NAPRA drug schedules.
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- intermediate
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- PEBC Pharmacy Evaluating & Qualifying Exam: Biomedical Sciences, Pharmacology, Pharmaceutical Calculations & Canadian Pharmacy Law (NAPRA) (.md)
Flashcards (32)
| # | Front (Term / Question) | Back (Definition / Answer) | Example | Multiple-Choice Options |
|---|---|---|---|---|
| 1 | Why does Phenytoin exhibit non-linear (Michaelis-Menten / capacity-limited) pharmacokinetics at therapeutic concentrations, and what is the clinical consequence? | Hepatic CYP2C9/2C19 metabolizing enzymes become saturated within the therapeutic range (10–20 mg/L or 40–80 µmol/L), switching kinetics from first-order to zero-order; small increases in daily dose produce disproportionately large, toxic increases in steady-state serum concentration. | ||
| 2 | In PEBC Cardiology, which Statins are classified as High-Intensity (lowering LDL-C by ≥50%), and what are their key drug interactions? | Rosuvastatin 20–40 mg daily and Atorvastatin 40–80 mg daily. Atorvastatin, Simvastatin, and Lovastatin are metabolized by CYP3A4 (avoid grapefruit juice, macrolides, azoles, protease inhibitors); Rosuvastatin and Pravastatin are minimally metabolized by CYP3A4 (safer with CYP3A4 inhibitors). Never combine Gemfibrozil with any statin due to rhabdomyolysis risk (OATP1B1 inhibition). | ||
| 3 | Under the National Association of Pharmacy Regulatory Authorities (NAPRA) National Drug Schedules (NDS) in Canada, define Schedule I, Schedule II, Schedule III, and Unscheduled drugs. | Schedule I: Requires a prescription for sale (dispensed by a pharmacist). Schedule II: Non-prescription ('Behind-the-Counter'—no public self-selection; requires pharmacist intervention/assessment at the counter, e.g., insulin, glucagon, emergency levonorgestrel in some jurisdictions, pseudoephedrine combinations). Schedule III: Available in the self-selection ('Lock-and-Leave') area of a pharmacy under direct pharmacist supervision (e.g., ibuprofen 400 mg, naproxen 220 mg). Unscheduled: Can be sold at any retail outlet. | ||
| 4 | What is the maximum recommended daily dose of Acetaminophen in healthy adults vs. patients with chronic liver disease or chronic alcohol use? | Healthy adults: 4,000 mg/day (4 g/day). Patients with chronic liver disease, cirrhosis, or chronic heavy alcohol intake: limit to ≤2,000 mg/day (2 g/day)—note that low-dose acetaminophen remains safer than NSAIDs in cirrhosis because NSAIDs precipitate hepatorenal syndrome and GI bleeding. | ||
| 5 | In PEBC Benign Prostatic Hyperplasia (BPH) management, compare Alpha-1 Blockers (tamsulosin, alfuzosin, terazosin) and 5-Alpha-Reductase Inhibitors (finasteride, dutasteride). | Alpha-1 blockers relax smooth muscle in the prostate neck and urethra for rapid symptom relief within days-weeks (tamsulosin/silodosin are uroselective alpha-1A blockers causing less orthostatic hypotension but cause Intraoperative Floppy Iris Syndrome during cataract surgery and retrograde ejaculation). 5-ARIs block conversion of testosterone to DHT, shrinking prostate volume by ~25% over 6 months and halving serum PSA (multiply PSA by 2 after 6 months on finasteride/dutasteride). | ||
| 6 | In PEBC Infectious Diseases, what is the first-line antibiotic treatment for Uncomplicated Acute Cystitis (UTI) in non-pregnant women in Canada? | 1) Nitrofurantoin monohydrate/macrocrystals (MacroBID) 100 mg PO BID for 5 days (contraindicated if CrCl <30 mL/min or at term pregnancy 38–42 weeks), 2) Fosfomycin tromethamine 3 g PO single dose, or 3) TMP-SMX (Septra) 1 DS tablet PO BID for 3 days (if local E. coli resistance <20%). Reserve fluoroquinolones for pyelonephritis. | ||
| 7 | Which antiepileptic and psychotropic medications carry a heightened risk of Stevens-Johnson Syndrome (SJS) / Toxic Epidermal Necrolysis (TEN), and which HLA allele must be screened in Asian patients before starting Carbamazepine? | Lamotrigine (risk markedly increased if co-prescribed with Valproic acid, which doubles lamotrigine's half-life—requires halved starting dose and slow titration), Carbamazepine, Phenytoin, Allopurinol, and Sulfonamides. Screen for HLA-B*15:02 in patients of Han Chinese or Southeast Asian descent before initiating Carbamazepine. | ||
| 8 | In PEBC Pharmaceutical Calculations, how many grams of hydrocortisone powder must be added to 120 g of a 1% w/w hydrocortisone cream to increase its concentration to 2.5% w/w? | Using Alligation Alternate (pure powder = 100%, cream = 1%, target = 2.5%): parts of 100% = (2.5 - 1) = 1.5 parts; parts of 1% cream = (100 - 2.5) = 97.5 parts. Mass of powder = (1.5 / 97.5) × 120 g = 1.85 g. | ||
| 9 | In PEBC Geriatrics (Beers Criteria), why are First-Generation Antihistamines (diphenhydramine, dimenhydrinate, hydroxyzine), Tricyclic Antidepressants (amitriptyline), and Oxybutynin avoided in older adults? | Strong central and peripheral anticholinergic activity ('Can't see, can't pee, can't spit, can't shit') causing delirium, cognitive decline, falls, urinary retention, constipation, and dry mouth. | ||
| 10 | In PEBC Inhaler Technique counselling, how does the inspiratory breath technique differ between a Metered-Dose Inhaler (MDI) and a Dry Powder Inhaler (DPI, e.g., Turbuhaler, Diskus, Ellipta)? | MDI (with or without spacer): shake well, breathe out, actuate and inhale SLOWLY and deeply over 3–5 seconds, hold breath 10 seconds. DPI: do NOT shake after loading, breathe out away from mouthpiece, inhale QUICKLY, forcefully, and deeply to de-aggregate the powder, hold breath 10 seconds; always rinse mouth and spit after any inhaled corticosteroid (ICS) to prevent oral candidiasis and dysphonia. | ||
| 11 | In PEBC Biopharmaceutics, what are the regulatory criteria for two oral drug products (Brand vs. Generic) to be declared Bioequivalent by Health Canada? | The 90% confidence interval of the geometric mean ratio (Test/Reference) for AUC (Area Under the Curve—extent of absorption) and the relative mean Cmax (rate of absorption) must fall within 80% to 125% (for Critical Dose Drugs like cyclosporine, digoxin, lithium, phenytoin, tacrolimus, theophylines, warfarin, AUC 90% CI must be 90%–112%). | ||
| 12 | In PEBC Smoking Cessation counselling, what are the dosing rules for Nicotine Replacement Therapy (NRT Patch + Gum/Lozenge), Varenicline (Champix), and Bupropion SR (Zyban)? | NRT: If smoking ≥10 cigarettes/day (or within 30 min of waking), start 21 mg patch + PRN 2–4 mg gum ('bite and park' technique, avoid acidic beverages 15 min prior). Varenicline (partial α4β2 nicotinic agonist): start 1–2 weeks before quit date (0.5 mg OD × 3d, 0.5 mg BID × 4d, then 1 mg BID × 11 weeks; renally cleared). Bupropion SR: start 1–2 weeks pre-quit, strictly CONTRAINDICATED in seizure disorders, eating disorders (bulimia/anorexia), or abrupt alcohol/benzodiazepine withdrawal. | ||
| 13 | In PEBC Diabetes Pharmacology, compare the mechanisms, weight effects, hypoglycaemia risks, and signature side effects of GLP-1 Receptor Agonists (semaglutide) vs. SGLT2 Inhibitors (empagliflozin) vs. DPP-4 Inhibitors (sitagliptin/linagliptin). | GLP-1 RAs: glucose-dependent insulin secretion + slowed gastric emptying + satiety → potent weight loss, low hypoglycaemia risk, GI nausea/pancreatitis/MEN2 medullary thyroid C-cell tumour box warning. SGLT2i: block proximal tubule glucose reabsorption → weight loss, BP lowering, CV/HF/CKD protection, genital mycotic infections & euglycaemic DKA. DPP-4i: weight-neutral, low hypoglycaemia, well tolerated (linagliptin requires no renal dose adjustment). | ||
| 14 | In PEBC Psychiatry, what dietary restriction is mandatory with non-selective irreversible MAO Inhibitors (Phenelzine, Tranylcypromine), and what washout period is required when switching between Fluoxetine and an MAOI? | Avoid high-tyramine foods (aged cheeses, cured/fermented meats, tap/unpasteurized beer, Marmite, soy sauce) to prevent a fatal Hypertensive Crisis. Washout: wait at least 2 weeks when switching from most SSRIs to an MAOI (or MAOI to SSRI), but wait a full 5 WEEKS when switching from Fluoxetine to an MAOI due to norfluoxetine's long half-life (7–15 days). | ||
| 15 | Under Canada's Controlled Drugs and Substances Act (CDSA) and Narcotic Control Regulations, distinguish Straight Narcotics, Verbal Prescription Narcotics (VPN), Targeted Substances (Benzodiazepines), and Controlled Drugs regarding refills and transfers. | Straight Narcotics (morphine, oxycodone, hydromorphone, fentanyl, methadone): Written/e-script ONLY (no verbal scripts), NO refills permitted (part-fills allowed with total quantity & interval specified), NO transfers (even under temporary CDSA exemptions, strict logging applies). VPNs (codeine preparations with ≥2 non-narcotic ingredients): verbal or written, NO refills, NO transfers. Benzodiazepines/Targeted Substances: verbal or written, refills allowed if within 1 year of prescribing date, 1 transfer allowed. Controlled Drugs (amphetamines, methylphenidate, anabolic steroids, barbiturates): refills allowed if written with interval specified; transfers generally prohibited under standard CDSA rules. | ||
| 16 | In PEBC Paediatrics, what is the standard weight-based OTC dosing of Acetaminophen vs. Ibuprofen in children, and when is Ibuprofen avoided? | Acetaminophen: 10–15 mg/kg/dose PO every 4–6 hours (max 75 mg/kg/day, not exceeding 5 doses/day or 4,000 mg/day). Ibuprofen: 5–10 mg/kg/dose PO every 6–8 hours (max 40 mg/kg/day)—avoid in infants <6 months, dehydration/gastroenteritis (AKI risk), or varicella (chickenpox—necrotizing fasciitis risk). Never give ASA to children/teens due to Reye syndrome. | ||
| 17 | In PEBC Sterile Compounding (NAPRA Model Standards), what ISO air quality class is required inside the Primary Engineering Control (Laminar Airflow Workbench / Biological Safety Cabinet), and what does BUD stand for? | ISO Class 5 environment inside the PEC (located within an ISO Class 7 buffer room and ISO Class 8 anteroom). BUD stands for Beyond-Use Date—the date or time after which a compounded sterile or non-sterile preparation must not be used. | ||
| 18 | How do you calculate the Corrected Phenytoin Concentration (Winter-Tozer equation) in a patient with hypoalbuminaemia (and normal renal function)? | Corrected Phenytoin = Measured Total Phenytoin / [(0.2 × Albumin in g/dL) + 0.1] (or using SI units g/L: Measured / [(0.02 × Albumin in g/L) + 0.1]); halve the 0.2 coefficient to 0.1 if CrCl <10 mL/min. | ||
| 19 | What is the mechanism of action of Allopurinol vs. Febuxostat vs. Probenecid vs. Rasburicase in Hyperuricaemia and Tumour Lysis Syndrome? | Allopurinol & Febuxostat inhibit Xanthine Oxidase (reducing uric acid synthesis; both drastically increase Azathioprine/6-MP toxicity). Probenecid is a uricosuric agent inhibiting URAT1 tubular reabsorption (ineffective if CrCl <50 mL/min, contraindicated in nephrolithiasis). Rasburicase is recombinant urate oxidase converting existing uric acid into soluble allantoin (contraindicated in G6PD deficiency due to haemolysis/methaemoglobinaemia). | ||
| 20 | In PEBC Pharmaceutical Calculations, calculate the Sodium Chloride Equivalent (E-value) and grams of NaCl needed to make 60 mL of a 2% w/v solution of Drug X (E-value = 0.20) isotonic with blood (0.9% NaCl). | Total NaCl needed for 60 mL isotonic solution = 60 mL × 0.009 g/mL = 0.54 g. Mass of Drug X = 60 mL × 0.02 g/mL = 1.20 g. NaCl equivalent represented by Drug X = 1.20 g × 0.20 = 0.24 g. Additional NaCl required = 0.54 g - 0.24 g = 0.30 g (300 mg). | ||
| 21 | What is the role of the Canadian Vigilance Program (MedEffect Canada), and what must hospitals mandatorily report under Vanessa's Law (Protecting Canadians from Unsafe Drugs Act)? | MedEffect Canada collects post-market adverse drug reaction reports; under Vanessa's Law, all Canadian hospitals are legally required to report all Serious Adverse Drug Reactions and Medical Device Incidents to Health Canada within 30 calendar days of documentation. | ||
| 22 | What does a DIN (Drug Identification Number) vs. NPN (Natural Product Number) on a Canadian health product signify? | An 8-digit DIN issued by Health Canada under the Food and Drug Regulations confirms a pharmaceutical drug has been evaluated for safety, efficacy, and quality. An 8-digit NPN (or DIN-HM for homeopathic products) under the Natural Health Products Regulations confirms licensing as a natural health product (vitamins, minerals, herbals, probiotics). | ||
| 23 | Which drugs classically cause Drug-Induced Lupus Erythematosus (DILE), and which autoantibody is positive in >95% of cases? | Hydralazine, Procainamide, Isoniazid, Minocycline, Methyldopa, Quinidine, and Anti-TNF biologics ('HIP MMQ'); characterized by anti-histone antibodies. | ||
| 24 | In PEBC Over-the-Counter (OTC) Counselling, what are the two main oral Emergency Contraception options in Canada, their time windows, and how BMI affects their efficacy? | 1) Levonorgestrel 1.5 mg (Plan B—Schedule III/Unscheduled): effective up to 72 hours (up to 120h with declining efficacy), reduced efficacy if BMI ≥25 kg/m² (or weight >75–80 kg). 2) Ulipristal acetate 30 mg (Ella—Prescription/Pharmacist-prescribed): constant high efficacy up to 120 hours (5 days), maintains better efficacy up to BMI 30–35 kg/m²; Copper IUD is the most effective (>99%) emergency contraception up to 7 days post-intercourse regardless of BMI. | ||
| 25 | In PEBC Pharmacology, compare the mechanisms and adverse effects of ACE Inhibitors (ramipril) vs. ARBs (candersartan) vs. ARNI (sacubitril/valsartan). | ACEi block conversion of Ang I to Ang II and inhibit bradykinin breakdown (causing dry cough in 10–15% and higher angioedema risk). ARBs selectively block AT1 receptors without raising bradykinin. ARNI combines an ARB with neprilysin inhibition (requiring a strict 36-hour washout when switching from/to an ACEi to prevent life-threatening angioedema). All three cause hyperkalaemia, hypotension, and are teratogenic. | ||
| 26 | What is the mechanism of the Disulfiram-like reaction (flushing, throbbing headache, severe nausea/vomiting, tachycardia), and which drugs require patients to avoid alcohol during and for 48–72 hours after therapy? | Inhibition of aldehyde dehydrogenase causing accumulation of toxic acetaldehyde; classically caused by Metronidazole (and Tinidazole, Cefotetan, or Disulfiram). | ||
| 27 | In PEBC Infectious Diseases, which oral medications require separation by at least 2 hours before or 4–6 hours after polyvalent cations (Calcium, Iron, Magnesium, Aluminum antacids, Dairy, Sucralfate, Zinc)? | Fluoroquinolones (ciprofloxacin, levofloxacin, moxifloxacin), Tetracyclines (tetracycline, doxycycline, minocycline), Integrase Inhibitors (bictegravir, dolutegravir, raltegravir), Levothyroxine (separate by 4 hours), and Oral Bisphosphonates. | ||
| 28 | What is the Cockcroft-Gault equation used in PEBC exams to estimate Creatinine Clearance (CrCl in mL/min) for drug dosing? | CrCl (mL/min) = [(140 - Age in yrs) × Weight in kg × 1.23 (for males) or × 1.04 (for females)] / Serum Creatinine (in µmol/L) [or [(140 - Age) × Weight] / (72 × SCr in mg/dL) × 0.85 for females]. | ||
| 29 | What is the Henderson-Hasselbalch equation for a Weak Acid vs. a Weak Base, and which form crosses lipid biological membranes? | Weak Acid: pH = pKa + log([Ionized A-] / [Unionized HA]). Weak Base: pH = pKa + log([Unionized B] / [Ionized BH+]). Only the UNIONIZED (non-polar, lipid-soluble) fraction readily diffuses across biological membranes; when pH = pKa, the drug is exactly 50% ionized and 50% unionized. | ||
| 30 | In PEBC Oncology & Supportive Care, what is the triple-therapy prophylactic antiemetic regimen for Highly Emetogenic Chemotherapy (HEC, e.g., Cisplatin)? | 5-HT3 receptor antagonist (Ondansetron or Palonosetron) + NK1 receptor antagonist (Aprepitant/Fosaprepitant) + Dexamethasone + Olanzapine. | ||
| 31 | In PEBC Pharmacokinetics, what are the formulas connecting Elimination Rate Constant (ke), Volume of Distribution (Vd), Clearance (CL), and Elimination Half-Life (t1/2) in a first-order one-compartment model? | CL = ke × Vd; t1/2 = 0.693 / ke = (0.693 × Vd) / CL. Time to reach steady state (Css) is ~4 to 5 half-lives regardless of dose or infusion rate (depends ONLY on t1/2). | ||
| 32 | How do you calculate an IV Loading Dose (LD) vs. Maintenance Dose Rate (MD) in clinical pharmacokinetics? | Loading Dose = (Target Css × Vd) / (F × S), which depends primarily on Volume of Distribution (Vd). Maintenance Dose Rate = (Target Css × CL) / (F × S), which depends primarily on Clearance (CL). |