Basic Biomedical Sciences
10%of exam
PhysiologyBiochemistry & EnzymologyMicrobiology & ImmunologyMolecular GeneticsPharmacogenomics Basics
Pharmaceutical Sciences
35%of exam
Pharmacology & ToxicologyPharmacokinetics & ADMEMedicinal ChemistryPharmaceutical CalculationsSterile & Nonsterile CompoundingPharmacognosy
Social/Behavioral/Admin Sciences
20%of exam
Saudi Pharmacy LawSFDA RegulationPharmacovigilancePharmacoeconomicsPharmacy ManagementBiostatistics & Ethics
Clinical Sciences
35%of exam
Cardiovascular TherapeuticsEndocrine TherapeuticsInfectious Disease TherapeuticsRespiratory TherapeuticsClinical PK & TDMSpecial Populations
Quick Facts
- Exam
- SPLE (Pharmacist)
- Owner
- SCFHS
- Delivery
- Prometric CBT
- Format
- 200 scored MCQs, two parts
- Time
- 4h30m, one 30-min break
- Passing score
- 536 on 200-800 scale
- Question types
- Recall plus scenario-based
- Eligibility
- SCFHS classification via Mumaris+
Competitive vs Noncompetitive Inhibition
Competitive
- Raises apparent Km
- Vmax unchanged
Noncompetitive
- Km unchanged
- Lowers Vmax
More substrate overcomes competitive inhibition only
Physiology & Biochem
- Frank-Starling law
- Preload raises stroke volume
- Km
- Substrate conc at half Vmax
- Vmax
- Max rate, saturated enzyme
- Competitive inhibitor
- Raises Km, same Vmax
- Noncompetitive inhibitor
- Lowers Vmax, same Km
- Beta-1 stimulation
- Raises heart rate, contractility
Gram-Positive vs Gram-Negative
Gram-Positive
- Thick peptidoglycan wall
- Stains purple
Gram-Negative
- Outer membrane with LPS
- Stains pink
LPS lipid A causes septic shock
Microbio, Immuno & Genetics
- Gram-positive wall
- Thick peptidoglycan, retains violet
- Gram-negative wall
- Outer membrane, LPS endotoxin
- Lipid A
- Endotoxin causing septic shock
- Type I reaction
- IgE-mediated, immediate anaphylaxis
- Type IV reaction
- T-cell mediated, delayed onset
- CYP2D6 poor metabolizer
- Low codeine to morphine conversion
Warfarin Blocks 1972
Warfarin blocks clotting factors two, seven, nine, ten
IIVIIIXX
Solution vs Suspension
Solution
- Fully dissolved
- Clear, no settling
Suspension
- Insoluble particles dispersed
- Shake before use
Suspensions always need shaking first
Calculation Method Picker
- Pediatric weight-based dosing→Clark's Rule(mg/kg often more accurate)
- Chemo or narrow-index dosing→Mosteller BSA formula(Height and weight based)
- Manual IV drip rate→gtt/min formula(Drop factor times volume)
- Dilute stock to lower strength→C1V1 equals C2V2(Solve for volume needed)
- Mix two different strengths→Alligation tic-tac-toe method(Differences give mixing ratio)
- Adjust dose for renal impairment→Cockcroft-Gault CrCl estimate(Weight, age, SCr, sex)
Pharmacology & Toxicology
- Naloxone
- Mu-receptor antagonist, opioid reversal
- NAPQI
- Toxic acetaminophen metabolite
- N-acetylcysteine
- Acetaminophen overdose antidote
- Warfarin target
- Inhibits VKORC1 enzyme
- COX-1 inhibition
- Raises GI bleeding risk
- COX-2 selective NSAID
- Raises cardiovascular thrombotic risk
Cockcroft-Gault Inputs
Age, weight, sex, and serum creatinine estimate clearance
AgeWeightSexSCr
Zero-Order vs First-Order Kinetics
Zero-Order
- Constant amount eliminated
- Rate independent of concentration
First-Order
- Constant fraction eliminated
- Rate proportional to concentration
Most drugs follow first-order elimination kinetics
Pharmacokinetics & ADME
- Vd formula
- Dose over initial concentration
- High Vd example
- Digoxin, about 500 L
- Low Vd example
- Warfarin, about 8-10 L
- Bioavailability F
- Fraction reaching systemic circulation
- IV bioavailability
- 100% by definition
- Steady state
- 94% reached after 4 half-lives
Pharmaceutical Calculations
- C1V1 = C2V2
- Dilution concentration-volume equation
- Alligation
- Mixing two strengths ratio
- Clark's Rule
- Weight over 150, times dose
- Mosteller BSA
- Height times weight, over 3600
- IV flow rate
- Volume times drop factor, over time
- Zero-order kinetics
- Constant amount eliminated per time
Pharmacy Practice & Compounding
- USP <797>
- Sterile compounding categories 1-3
- Category 3 CSP
- Up to 180-day beyond-use date
- Solution
- Fully dissolved, single phase
- Suspension
- Insoluble solids, shake before use
- Emulsion
- Two immiscible liquids, stabilized
- Bioequivalence
- Same rate and extent absorbed
Pharmacognosy & Natural Products
- St. John's Wort
- Induces CYP3A4 and P-gp
- Ginkgo biloba
- Antiplatelet, raises bleeding risk
- Digoxin source
- Foxglove (Digitalis) plant
- Herbal disclosure
- Ask before surgery, anticoagulants
- B12 malabsorption
- After gastrectomy or metformin use
SFDA vs SCFHS Roles
SFDA
- Regulates drugs and devices
- Runs pharmacovigilance (Tiyaqquz)
SCFHS
- Licenses healthcare practitioners
- Administers the SPLE exam
SFDA regulates products, SCFHS regulates people
Saudi Pharmacy Law
- SFDA
- Regulates drugs, devices, cosmetics
- SCFHS
- Licenses practitioners, runs SPLE
- Mumaris+
- SCFHS eligibility application platform
- Controlled schedules
- Saudi law, Schedules I-V
- Responsible manager
- Full-time licensed pharmacist required
- Wasfaty
- Free chronic medication e-prescribing
Pharmacovigilance & Pharmacoeconomics
- Pharmacovigilance
- Detects, assesses, prevents drug harm
- NPC
- SFDA's national ADR monitoring division
- Tiyaqquz
- SFDA's electronic ADR reporting system
- Cost-effectiveness analysis
- Cost per outcome, e.g. QALY
- QALY
- Quality-adjusted life year measure
- Formulary
- P&T committee's approved drug list
Management, Ethics & Biostats
- Informed consent
- Patient understands, agrees voluntarily
- Confidentiality
- Protect patient health information
- Cohort study
- Follows exposed group forward
- Case-control study
- Starts from outcome, looks back
- Relative risk
- Risk ratio between two groups
- CPOE
- Computerized order entry, reduces errors
RIPE for TB
Rifampin, Isoniazid, Pyrazinamide, Ethambutol treat active tuberculosis
RifampinIsoniazidPyrazinamideEthambutol
Trough-Only vs AUC-Guided Vancomycin
Trough-Only (older)
- Target 15-20 mg/L
- Higher nephrotoxicity risk
AUC24-Guided (current)
- Target AUC 400-600
- Preferred for serious MRSA
Use AUC24-guided dosing today
Empiric Therapy Picker
- Active drug-susceptible tuberculosis→RIPE regimen, 6 months(2mo intensive, 4mo continuation)
- Serious MRSA infection→Vancomycin, AUC24-guided dosing(Target AUC24 400-600)
- H. pylori peptic ulcer→Triple or quadruple therapy
- CAP with penicillin allergy→Macrolide or fluoroquinolone
- Azole plus CYP3A4 substrate→Adjust dose or avoid(Statin, warfarin risk rises)
- Cultures and susceptibility return→De-escalate to narrow agent
Cardiovascular & Endocrine Therapy
- First-line hypertension
- ACEI/ARB, CCB, or thiazide
- BP target
- Below 130/80 mmHg, most adults
- HFrEF four pillars
- ACEI/ARB/ARNI, beta-blocker, MRA, SGLT2i
- Target INR
- 2.0 to 3.0, most indications
- Metformin limit
- Avoid below eGFR 30
- Levothyroxine
- Empty stomach, recheck TSH later
Four Pillars of HFrEF
ACEI/ARB/ARNI, beta-blocker, MRA, and an SGLT2 inhibitor
ACEI/ARB/ARNIBeta-blockerMRASGLT2 inhibitor
Beta-1 Selective vs Nonselective
Beta-1 Selective
- Metoprolol, atenolol, bisoprolol
- Safer in asthma
Nonselective
- Propranolol, nadolol, timolol
- Avoid in asthma/COPD
Choose selective agents for reactive airways
Infectious Disease & Respiratory
- RIPE regimen
- Rifampin, isoniazid, pyrazinamide, ethambutol
- TB duration
- 2-month intensive, 4-month continuation
- Empiric antibiotics
- Guided by site, local resistance
- De-escalation
- Narrow therapy after culture results
- Azole interaction
- Inhibits CYP3A4, raises statin levels
- GINA asthma
- ICS-formoterol preferred reliever, all steps
Clinical PK & TDM
- Vancomycin target
- AUC24 400-600 mg*h/L
- Old vancomycin trough
- 15-20 mg/L, serious infection
- Digoxin range
- 0.5-2.0 ng/mL, narrow index
- Digoxin toxicity sign
- Yellow-green visual halos
- Cockcroft-Gault
- Estimates creatinine clearance, bedside
- Hypokalemia
- Increases digoxin toxicity risk
Special Populations
- Pregnancy contraindication
- ACEI/ARB, warfarin, isotretinoin, valproate
- Breastfeeding analgesic
- Short-term paracetamol usually preferred
- Pediatric amoxicillin
- Weight-based mg/kg/day dosing
- Geriatric polypharmacy
- Anticholinergics raise fall risk
- CKD stage 4
- Avoid standard adult NSAID dose
- CYP2C19 poor metabolizer
- Reduced clopidogrel activation
Common Traps
Digoxin Level Timing
Draw level pre-dose only ≠ Not right after dosing
ACE Inhibitors in Pregnancy
Contraindicated all trimesters ≠ Fetotoxic, especially later terms
SFDA vs SCFHS Confusion
SFDA regulates products ≠ SCFHS licenses practitioners
Outdated Vancomycin Trough Target
15-20 mg/L is old ≠ AUC24 400-600 now preferred
Km vs Vmax Inhibition
Competitive raises Km only ≠ Noncompetitive lowers Vmax only
Clark's Rule Limitations
Rough weight-based estimate only ≠ BSA more accurate, narrow-index
COX-2 Selective NSAID Risk
Spares GI, less bleeding ≠ Raises cardiovascular thrombotic risk
Last Minute
- 1.SPLE has 200 scored MCQs.
- 2.Exam splits into two 100-question parts.
- 3.Testing time totals 4h30m.
- 4.Passing score is 536 of 800.
- 5.Pharma & Clinical Sciences: 35% each.
- 6.Vancomycin targets AUC24 400-600 mg*h/L.
- 7.Target INR is 2.0 to 3.0.
- 8.TB regimen: RIPE for two months.
- 9.Cockcroft-Gault estimates creatinine clearance, bedside.
- 10.SFDA regulates drugs; SCFHS licenses pharmacists.
- 11.Wasfaty gives free chronic-disease medications.
- 12.USP <797> allows 180-day beyond-use dates.
- 13.ACE inhibitors are contraindicated in pregnancy.
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