Albania Pharmacist State Exam (Provimi i Shtetit - Farmaci) cheat sheet

Eutomer/distomer: for chiral drugs the cutomer is the active enantiomer; e.g. S-(−)-propranolol is ~100× more potent at β-receptors than R-(+).

Prodrugs are inactive derivatives requiring biotransformation: enalapril → enalaprilat (hydrolysis), sulfasalazine → 5-aminosalicylic acid + sulfapyridine (azo reduction by colonic bacteria).

Henderson–Hasselbalch: pH = pKa + log([base]/[acid]); weak acids ionize more at high pH, weak bases at low pH - governs absorption and renal reabsorption.

Lipinski's rule of 5 for oral drugs: MW ≤ 500, logP ≤ 5, H-bond donors ≤ 5, H-bond acceptors ≤ 10.

Bioisosterism: replace a group with one of similar size/electronic properties (e.g. –OH with –NH2, –S– with –O–, COOH with tetrazole) to retain activity while altering metabolism.

β-lactam ring acylation of bacterial transpeptidases (PBPs) underlies penicillin action; β-lactamase inhibitors (clavulanic acid, tazobactam) restore activity.

SAR: for benzodiazepines, C7 electron-withdrawing substituent and C5 phenyl are required for anxiolytic activity; 3-hydroxylation shortens half-life.

Physicochemical stability: ester and amide hydrolysis is accelerated by heat and extremes of pH; amides are far more stable than esters, which is why amide prodrugs are common.

Bioavailability F = (AUC_oral × Dose_IV)/(AUC_IV × Dose_oral); absolute F compares to IV, relative F compares to a reference non-IV product.

Noyes–Whitney: dissolution rate ∝ (A × D/h) × (Cs − C); particle size reduction raises surface area A and increases dissolution of BCS class II drugs.

BCS: class I high solubility/high permeability, II low solubility/high permeability, III high solubility/low permeability, IV low/low; class I drugs are biowaiver candidates.

Particle-size descriptors: sieve number = mesh per inch; 100 mesh ≈ 150 µm opening; smaller mesh number means larger openings.

Sterile filtration uses 0.22 µm membranes for bacteria; 0.45 µm is not sterilizing. Autoclaving: 121 °C, 15 psi, 15–20 min.

Suspensions require a suspending agent (e.g. xanthan gum) and flocculating electrolyte; deflocculated systems settle slowly but form hard cakes.

Suppository bases: theobroma oil (cocoa butter) melts at 30–36 °C but is polymorphic; PEG bases are water-soluble and non-melting.

Ointment bases: hydrocarbon (petrolatum), absorption (wool fat), water-removable/emulsion (cetomacrogol), water-soluble (PEG).

First-order elimination: t1/2 = 0.693 × Vd/CL; steady state is reached in ~4–5 half-lives; loading dose = (Vd × target concentration)/F.

Receptor families: ligand-gated ion channels (nicotinic, GABA-A), G-protein coupled (β-adrenoceptors, M1–M5), kinase-linked (insulin), nuclear (steroids, thyroid hormone).

β1-selective blockers (bisoprolol, metoprolol) reduce mortality in heart failure; non-selective agents are avoided in asthma because of β2 blockade.

ACE inhibitors cause cough and hyperkalemia via bradykinin accumulation; ARBs avoid cough. Both are contraindicated in pregnancy.

Warfarin inhibits vitamin K epoxide reductase (factors II, VII, IX, X); effect is monitored by INR, target 2–3 for most indications.

Aminoglycosides are bactericidal, concentration-dependent, and nephro-/ototoxic; require therapeutic drug monitoring (trough levels).

NSAIDs inhibit COX and reduce renal prostaglandin synthesis; risk of GI bleeding, so add a PPI in high-risk patients.

Anticholinergic burden (e.g. amitriptyline, oxybutynin) causes confusion and urinary retention, especially in the elderly.

Alkaloids: basic nitrogen-containing natural products (morphine from Papaver somniferum, quinine from Cinchona, atropine from Atropa belladonna, caffeine from Coffea).

Cardiac glycosides (Digitalis purpurea, foxglove) contain a steroidal aglycone plus sugar; they inhibit Na+/K+-ATPase and have a narrow therapeutic index.

St John's wort (Hypericum perforatum) induces CYP3A4 and P-glycoprotein; it reduces efficacy of oral contraceptives, warfarin, and ciclosporin.

Ginkgo biloba extract is standardized to flavonol glycosides and terpene lactones; it inhibits platelet aggregation and increases bleeding risk with anticoagulants.

Valerian (Valeriana officinalis) and passionflower are used as mild sedatives; their effect is attributed to valerenic acid and flavonoids, respectively.

Senna (Cassia angustifolia) anthraquinones are hydrolyzed by colonic bacteria to active rhein anthrone, producing laxative action after 6–12 h.

Essential oils are volatile terpenes (menthol, eucalyptol); they are extracted by steam distillation and stored away from heat and light.

Beer–Lambert law: A = ε × b × c; absorbance is linear with concentration only at low concentrations and at a fixed wavelength.

UV-Vis: chromophores absorb 200–800 nm; quartz cuvettes are required below ~340 nm because glass absorbs UV.

HPLC: reversed-phase uses a C18 stationary phase with a polar mobile phase; retention increases with lower organic modifier and with higher pH for neutral acids.

Validation parameters per ICH Q2: accuracy, precision, specificity, linearity, range, detection limit, quantitation limit, robustness.

Titration: equivalence point detected by indicator or potentiometry; normality × volume = equivalents; primary standards are highly pure and stable (e.g. potassium hydrogen phthalate).

Karl Fischer titration measures water content; the endpoint is detected by dead-stop electrometric detection.

Pharmacopoeial identity tests: IR spectrum comparison to a reference standard is a definitive identity test; TLC Rf values are comparative.

Quality control limits: content uniformity requires each unit within 85–115% of label claim for most dosage forms.

Medication reconciliation must be performed at admission, transfer, and discharge to prevent unintended discrepancies.

Counseling on inhalers: shake, exhale, actuate during slow deep inhalation, hold breath 10 s, rinse mouth after ICS to prevent candidiasis.

Warfarin counseling: consistent vitamin K intake, INR monitoring schedule, and recognition of bleeding signs; avoid NSAIDs and interacting antibiotics.

Pharmacovigilance: ADRs are reported to the national center; serious ADRs include death, hospitalization, disability, congenital anomaly, or life-threatening events.

Naranjo scale scores the probability of an ADR: ≥9 definite, 5–8 probable, 1–4 possible, ≤0 doubtful.

Vancomycin AUC/MIC target 400–600 for serious MRSA infection; trough-only monitoring is less preferred than AUC-guided dosing.

Patient counseling on antibiotics: complete the full course, do not share, and report severe diarrhea (possible C. difficile).

High-alert medications (insulin, heparin, concentrated potassium, chemotherapy) require independent double-checks and standardized concentrations.

Prescription-only medicines require a valid prescription; narcotic and psychotropic drugs are subject to special record-keeping and secure storage requirements.

Pharmacists are personally accountable for dispensing errors; a prescription may be clarified with the prescriber but not altered independently.

Good Distribution Practice (GDP) requires temperature-controlled storage, traceability, and qualified personnel for wholesale distribution.

Confidentiality is a core ethical duty; patient information may be disclosed only with consent or where required by law.

Pharmacovigilance obligations: marketing authorization holders must maintain a pharmacovigilance system and submit periodic safety reports.

Advertising of prescription medicines to the public is prohibited; advertising to healthcare professionals must be accurate and non-misleading.

Expired or recalled medicines must be segregated and destroyed through authorized channels; returns cannot be resold.

Professional competence: continuing education is required to maintain registration; scope of practice is defined by national pharmacy law.

Paracetamol overdose: N-acetylcysteine is most effective within 8 h; the Rumack–Matthew nomogram guides treatment based on serum level and time post-ingestion.

Organophosphate poisoning: SLUDGE/muscarinic signs plus nicotinic effects; treat with atropine (titrated to dry secretions) and pralidoxime (oxime).

Opioid overdose: give naloxone; repeat dosing may be needed because naloxone half-life is shorter than many opioids.

Iron poisoning: deferoxamine chelation; activated charcoal does not bind iron, so it is not useful.

Salicylate toxicity: mixed respiratory alkalosis and metabolic acidosis; urinary alkalinization with sodium bicarbonate enhances elimination.

Methanol and ethylene glycol: give fomepizole or ethanol to block alcohol dehydrogenase; hemodialysis for severe cases.

Activated charcoal is contraindicated for corrosive ingestion and for patients with unprotected airway; it is most useful within 1 h of ingestion.

Digoxin toxicity: hyperkalemia and arrhythmias; treat with digoxin-specific antibody fragments (Fab).

Inventory control: EOQ = √(2DS/H), where D = annual demand, S = ordering cost, H = holding cost per unit per year.

Reorder point = (average daily demand × lead time) + safety stock.

ABC analysis classifies stock by value: A items are high-value/low-volume and require tight control; C items are low-value and can be bulk-ordered.

FIFO/FEFO: first-expiry-first-out minimizes wastage of short-dated stock.

Gross margin = (selling price − purchase price)/selling price; mark-up is expressed on cost, margin on price.

Pharmacoeconomics: cost-effectiveness ratio = cost/health outcome (e.g. cost per QALY); ICER = (ΔC1 − ΔC0)/(ΔE1 − ΔE0).

Pricing regulation: reimbursement and reference pricing systems set maximum reimbursed prices; generics are priced below originators.

Stock turnover ratio = cost of goods sold/average inventory; a low ratio signals overstocking and expiry risk.

Eutomer/distomer: for chiral drugs the cutomer is the active enantiomer; e.g. S-(−)-propranolol is ~100× more potent at β-receptors than R-(+).

Prodrugs are inactive derivatives requiring biotransformation: enalapril → enalaprilat (hydrolysis), sulfasalazine → 5-aminosalicylic acid + sulfapyridine (azo reduction by colonic bacteria).

Henderson–Hasselbalch: pH = pKa + log([base]/[acid]); weak acids ionize more at high pH, weak bases at low pH - governs absorption and renal reabsorption.

Lipinski's rule of 5 for oral drugs: MW ≤ 500, logP ≤ 5, H-bond donors ≤ 5, H-bond acceptors ≤ 10.

Bioisosterism: replace a group with one of similar size/electronic properties (e.g. –OH with –NH2, –S– with –O–, COOH with tetrazole) to retain activity while altering metabolism.

β-lactam ring acylation of bacterial transpeptidases (PBPs) underlies penicillin action; β-lactamase inhibitors (clavulanic acid, tazobactam) restore activity.

SAR: for benzodiazepines, C7 electron-withdrawing substituent and C5 phenyl are required for anxiolytic activity; 3-hydroxylation shortens half-life.

Physicochemical stability: ester and amide hydrolysis is accelerated by heat and extremes of pH; amides are far more stable than esters, which is why amide prodrugs are common.

Bioavailability F = (AUC_oral × Dose_IV)/(AUC_IV × Dose_oral); absolute F compares to IV, relative F compares to a reference non-IV product.

Noyes–Whitney: dissolution rate ∝ (A × D/h) × (Cs − C); particle size reduction raises surface area A and increases dissolution of BCS class II drugs.

BCS: class I high solubility/high permeability, II low solubility/high permeability, III high solubility/low permeability, IV low/low; class I drugs are biowaiver candidates.

Particle-size descriptors: sieve number = mesh per inch; 100 mesh ≈ 150 µm opening; smaller mesh number means larger openings.

Sterile filtration uses 0.22 µm membranes for bacteria; 0.45 µm is not sterilizing. Autoclaving: 121 °C, 15 psi, 15–20 min.

Suspensions require a suspending agent (e.g. xanthan gum) and flocculating electrolyte; deflocculated systems settle slowly but form hard cakes.

Suppository bases: theobroma oil (cocoa butter) melts at 30–36 °C but is polymorphic; PEG bases are water-soluble and non-melting.

Ointment bases: hydrocarbon (petrolatum), absorption (wool fat), water-removable/emulsion (cetomacrogol), water-soluble (PEG).

First-order elimination: t1/2 = 0.693 × Vd/CL; steady state is reached in ~4–5 half-lives; loading dose = (Vd × target concentration)/F.

Receptor families: ligand-gated ion channels (nicotinic, GABA-A), G-protein coupled (β-adrenoceptors, M1–M5), kinase-linked (insulin), nuclear (steroids, thyroid hormone).

β1-selective blockers (bisoprolol, metoprolol) reduce mortality in heart failure; non-selective agents are avoided in asthma because of β2 blockade.

ACE inhibitors cause cough and hyperkalemia via bradykinin accumulation; ARBs avoid cough. Both are contraindicated in pregnancy.

Warfarin inhibits vitamin K epoxide reductase (factors II, VII, IX, X); effect is monitored by INR, target 2–3 for most indications.

Aminoglycosides are bactericidal, concentration-dependent, and nephro-/ototoxic; require therapeutic drug monitoring (trough levels).

NSAIDs inhibit COX and reduce renal prostaglandin synthesis; risk of GI bleeding, so add a PPI in high-risk patients.

Anticholinergic burden (e.g. amitriptyline, oxybutynin) causes confusion and urinary retention, especially in the elderly.

Alkaloids: basic nitrogen-containing natural products (morphine from Papaver somniferum, quinine from Cinchona, atropine from Atropa belladonna, caffeine from Coffea).

Cardiac glycosides (Digitalis purpurea, foxglove) contain a steroidal aglycone plus sugar; they inhibit Na+/K+-ATPase and have a narrow therapeutic index.

St John's wort (Hypericum perforatum) induces CYP3A4 and P-glycoprotein; it reduces efficacy of oral contraceptives, warfarin, and ciclosporin.

Ginkgo biloba extract is standardized to flavonol glycosides and terpene lactones; it inhibits platelet aggregation and increases bleeding risk with anticoagulants.

Valerian (Valeriana officinalis) and passionflower are used as mild sedatives; their effect is attributed to valerenic acid and flavonoids, respectively.

Senna (Cassia angustifolia) anthraquinones are hydrolyzed by colonic bacteria to active rhein anthrone, producing laxative action after 6–12 h.

Essential oils are volatile terpenes (menthol, eucalyptol); they are extracted by steam distillation and stored away from heat and light.

Beer–Lambert law: A = ε × b × c; absorbance is linear with concentration only at low concentrations and at a fixed wavelength.

UV-Vis: chromophores absorb 200–800 nm; quartz cuvettes are required below ~340 nm because glass absorbs UV.

HPLC: reversed-phase uses a C18 stationary phase with a polar mobile phase; retention increases with lower organic modifier and with higher pH for neutral acids.

Validation parameters per ICH Q2: accuracy, precision, specificity, linearity, range, detection limit, quantitation limit, robustness.

Titration: equivalence point detected by indicator or potentiometry; normality × volume = equivalents; primary standards are highly pure and stable (e.g. potassium hydrogen phthalate).

Karl Fischer titration measures water content; the endpoint is detected by dead-stop electrometric detection.

Pharmacopoeial identity tests: IR spectrum comparison to a reference standard is a definitive identity test; TLC Rf values are comparative.

Quality control limits: content uniformity requires each unit within 85–115% of label claim for most dosage forms.

Medication reconciliation must be performed at admission, transfer, and discharge to prevent unintended discrepancies.

Counseling on inhalers: shake, exhale, actuate during slow deep inhalation, hold breath 10 s, rinse mouth after ICS to prevent candidiasis.

Warfarin counseling: consistent vitamin K intake, INR monitoring schedule, and recognition of bleeding signs; avoid NSAIDs and interacting antibiotics.

Pharmacovigilance: ADRs are reported to the national center; serious ADRs include death, hospitalization, disability, congenital anomaly, or life-threatening events.

Naranjo scale scores the probability of an ADR: ≥9 definite, 5–8 probable, 1–4 possible, ≤0 doubtful.

Vancomycin AUC/MIC target 400–600 for serious MRSA infection; trough-only monitoring is less preferred than AUC-guided dosing.

Patient counseling on antibiotics: complete the full course, do not share, and report severe diarrhea (possible C. difficile).

High-alert medications (insulin, heparin, concentrated potassium, chemotherapy) require independent double-checks and standardized concentrations.

Prescription-only medicines require a valid prescription; narcotic and psychotropic drugs are subject to special record-keeping and secure storage requirements.

Pharmacists are personally accountable for dispensing errors; a prescription may be clarified with the prescriber but not altered independently.

Good Distribution Practice (GDP) requires temperature-controlled storage, traceability, and qualified personnel for wholesale distribution.

Confidentiality is a core ethical duty; patient information may be disclosed only with consent or where required by law.

Pharmacovigilance obligations: marketing authorization holders must maintain a pharmacovigilance system and submit periodic safety reports.

Advertising of prescription medicines to the public is prohibited; advertising to healthcare professionals must be accurate and non-misleading.

Expired or recalled medicines must be segregated and destroyed through authorized channels; returns cannot be resold.

Professional competence: continuing education is required to maintain registration; scope of practice is defined by national pharmacy law.

Paracetamol overdose: N-acetylcysteine is most effective within 8 h; the Rumack–Matthew nomogram guides treatment based on serum level and time post-ingestion.

Organophosphate poisoning: SLUDGE/muscarinic signs plus nicotinic effects; treat with atropine (titrated to dry secretions) and pralidoxime (oxime).

Opioid overdose: give naloxone; repeat dosing may be needed because naloxone half-life is shorter than many opioids.

Iron poisoning: deferoxamine chelation; activated charcoal does not bind iron, so it is not useful.

Salicylate toxicity: mixed respiratory alkalosis and metabolic acidosis; urinary alkalinization with sodium bicarbonate enhances elimination.

Methanol and ethylene glycol: give fomepizole or ethanol to block alcohol dehydrogenase; hemodialysis for severe cases.

Activated charcoal is contraindicated for corrosive ingestion and for patients with unprotected airway; it is most useful within 1 h of ingestion.

Digoxin toxicity: hyperkalemia and arrhythmias; treat with digoxin-specific antibody fragments (Fab).

Inventory control: EOQ = √(2DS/H), where D = annual demand, S = ordering cost, H = holding cost per unit per year.

Reorder point = (average daily demand × lead time) + safety stock.

ABC analysis classifies stock by value: A items are high-value/low-volume and require tight control; C items are low-value and can be bulk-ordered.

FIFO/FEFO: first-expiry-first-out minimizes wastage of short-dated stock.

Gross margin = (selling price − purchase price)/selling price; mark-up is expressed on cost, margin on price.

Pharmacoeconomics: cost-effectiveness ratio = cost/health outcome (e.g. cost per QALY); ICER = (ΔC1 − ΔC0)/(ΔE1 − ΔE0).

Pricing regulation: reimbursement and reference pricing systems set maximum reimbursed prices; generics are priced below originators.

Stock turnover ratio = cost of goods sold/average inventory; a low ratio signals overstocking and expiry risk.

Eutomer/distomer: for chiral drugs the cutomer is the active enantiomer; e.g. S-(−)-propranolol is ~100× more potent at β-receptors than R-(+).

Prodrugs are inactive derivatives requiring biotransformation: enalapril → enalaprilat (hydrolysis), sulfasalazine → 5-aminosalicylic acid + sulfapyridine (azo reduction by colonic bacteria).

Henderson–Hasselbalch: pH = pKa + log([base]/[acid]); weak acids ionize more at high pH, weak bases at low pH - governs absorption and renal reabsorption.

Lipinski's rule of 5 for oral drugs: MW ≤ 500, logP ≤ 5, H-bond donors ≤ 5, H-bond acceptors ≤ 10.

Bioisosterism: replace a group with one of similar size/electronic properties (e.g. –OH with –NH2, –S– with –O–, COOH with tetrazole) to retain activity while altering metabolism.

β-lactam ring acylation of bacterial transpeptidases (PBPs) underlies penicillin action; β-lactamase inhibitors (clavulanic acid, tazobactam) restore activity.

SAR: for benzodiazepines, C7 electron-withdrawing substituent and C5 phenyl are required for anxiolytic activity; 3-hydroxylation shortens half-life.

Physicochemical stability: ester and amide hydrolysis is accelerated by heat and extremes of pH; amides are far more stable than esters, which is why amide prodrugs are common.

Bioavailability F = (AUC_oral × Dose_IV)/(AUC_IV × Dose_oral); absolute F compares to IV, relative F compares to a reference non-IV product.

Noyes–Whitney: dissolution rate ∝ (A × D/h) × (Cs − C); particle size reduction raises surface area A and increases dissolution of BCS class II drugs.

BCS: class I high solubility/high permeability, II low solubility/high permeability, III high solubility/low permeability, IV low/low; class I drugs are biowaiver candidates.

Particle-size descriptors: sieve number = mesh per inch; 100 mesh ≈ 150 µm opening; smaller mesh number means larger openings.

Sterile filtration uses 0.22 µm membranes for bacteria; 0.45 µm is not sterilizing. Autoclaving: 121 °C, 15 psi, 15–20 min.

Suspensions require a suspending agent (e.g. xanthan gum) and flocculating electrolyte; deflocculated systems settle slowly but form hard cakes.

Suppository bases: theobroma oil (cocoa butter) melts at 30–36 °C but is polymorphic; PEG bases are water-soluble and non-melting.

Ointment bases: hydrocarbon (petrolatum), absorption (wool fat), water-removable/emulsion (cetomacrogol), water-soluble (PEG).

First-order elimination: t1/2 = 0.693 × Vd/CL; steady state is reached in ~4–5 half-lives; loading dose = (Vd × target concentration)/F.

Receptor families: ligand-gated ion channels (nicotinic, GABA-A), G-protein coupled (β-adrenoceptors, M1–M5), kinase-linked (insulin), nuclear (steroids, thyroid hormone).

β1-selective blockers (bisoprolol, metoprolol) reduce mortality in heart failure; non-selective agents are avoided in asthma because of β2 blockade.

ACE inhibitors cause cough and hyperkalemia via bradykinin accumulation; ARBs avoid cough. Both are contraindicated in pregnancy.

Warfarin inhibits vitamin K epoxide reductase (factors II, VII, IX, X); effect is monitored by INR, target 2–3 for most indications.

Aminoglycosides are bactericidal, concentration-dependent, and nephro-/ototoxic; require therapeutic drug monitoring (trough levels).

NSAIDs inhibit COX and reduce renal prostaglandin synthesis; risk of GI bleeding, so add a PPI in high-risk patients.

Anticholinergic burden (e.g. amitriptyline, oxybutynin) causes confusion and urinary retention, especially in the elderly.

Alkaloids: basic nitrogen-containing natural products (morphine from Papaver somniferum, quinine from Cinchona, atropine from Atropa belladonna, caffeine from Coffea).

Cardiac glycosides (Digitalis purpurea, foxglove) contain a steroidal aglycone plus sugar; they inhibit Na+/K+-ATPase and have a narrow therapeutic index.

St John's wort (Hypericum perforatum) induces CYP3A4 and P-glycoprotein; it reduces efficacy of oral contraceptives, warfarin, and ciclosporin.

Ginkgo biloba extract is standardized to flavonol glycosides and terpene lactones; it inhibits platelet aggregation and increases bleeding risk with anticoagulants.

Valerian (Valeriana officinalis) and passionflower are used as mild sedatives; their effect is attributed to valerenic acid and flavonoids, respectively.

Senna (Cassia angustifolia) anthraquinones are hydrolyzed by colonic bacteria to active rhein anthrone, producing laxative action after 6–12 h.

Essential oils are volatile terpenes (menthol, eucalyptol); they are extracted by steam distillation and stored away from heat and light.

Beer–Lambert law: A = ε × b × c; absorbance is linear with concentration only at low concentrations and at a fixed wavelength.

UV-Vis: chromophores absorb 200–800 nm; quartz cuvettes are required below ~340 nm because glass absorbs UV.

HPLC: reversed-phase uses a C18 stationary phase with a polar mobile phase; retention increases with lower organic modifier and with higher pH for neutral acids.

Validation parameters per ICH Q2: accuracy, precision, specificity, linearity, range, detection limit, quantitation limit, robustness.

Titration: equivalence point detected by indicator or potentiometry; normality × volume = equivalents; primary standards are highly pure and stable (e.g. potassium hydrogen phthalate).

Karl Fischer titration measures water content; the endpoint is detected by dead-stop electrometric detection.

Pharmacopoeial identity tests: IR spectrum comparison to a reference standard is a definitive identity test; TLC Rf values are comparative.

Quality control limits: content uniformity requires each unit within 85–115% of label claim for most dosage forms.

Medication reconciliation must be performed at admission, transfer, and discharge to prevent unintended discrepancies.

Counseling on inhalers: shake, exhale, actuate during slow deep inhalation, hold breath 10 s, rinse mouth after ICS to prevent candidiasis.

Warfarin counseling: consistent vitamin K intake, INR monitoring schedule, and recognition of bleeding signs; avoid NSAIDs and interacting antibiotics.

Pharmacovigilance: ADRs are reported to the national center; serious ADRs include death, hospitalization, disability, congenital anomaly, or life-threatening events.

Naranjo scale scores the probability of an ADR: ≥9 definite, 5–8 probable, 1–4 possible, ≤0 doubtful.

Vancomycin AUC/MIC target 400–600 for serious MRSA infection; trough-only monitoring is less preferred than AUC-guided dosing.

Patient counseling on antibiotics: complete the full course, do not share, and report severe diarrhea (possible C. difficile).

High-alert medications (insulin, heparin, concentrated potassium, chemotherapy) require independent double-checks and standardized concentrations.

Prescription-only medicines require a valid prescription; narcotic and psychotropic drugs are subject to special record-keeping and secure storage requirements.

Pharmacists are personally accountable for dispensing errors; a prescription may be clarified with the prescriber but not altered independently.

Good Distribution Practice (GDP) requires temperature-controlled storage, traceability, and qualified personnel for wholesale distribution.

Confidentiality is a core ethical duty; patient information may be disclosed only with consent or where required by law.

Pharmacovigilance obligations: marketing authorization holders must maintain a pharmacovigilance system and submit periodic safety reports.

Advertising of prescription medicines to the public is prohibited; advertising to healthcare professionals must be accurate and non-misleading.

Expired or recalled medicines must be segregated and destroyed through authorized channels; returns cannot be resold.

Professional competence: continuing education is required to maintain registration; scope of practice is defined by national pharmacy law.

Paracetamol overdose: N-acetylcysteine is most effective within 8 h; the Rumack–Matthew nomogram guides treatment based on serum level and time post-ingestion.

Organophosphate poisoning: SLUDGE/muscarinic signs plus nicotinic effects; treat with atropine (titrated to dry secretions) and pralidoxime (oxime).

Opioid overdose: give naloxone; repeat dosing may be needed because naloxone half-life is shorter than many opioids.

Iron poisoning: deferoxamine chelation; activated charcoal does not bind iron, so it is not useful.

Salicylate toxicity: mixed respiratory alkalosis and metabolic acidosis; urinary alkalinization with sodium bicarbonate enhances elimination.

Methanol and ethylene glycol: give fomepizole or ethanol to block alcohol dehydrogenase; hemodialysis for severe cases.

Activated charcoal is contraindicated for corrosive ingestion and for patients with unprotected airway; it is most useful within 1 h of ingestion.

Digoxin toxicity: hyperkalemia and arrhythmias; treat with digoxin-specific antibody fragments (Fab).

Inventory control: EOQ = √(2DS/H), where D = annual demand, S = ordering cost, H = holding cost per unit per year.

Reorder point = (average daily demand × lead time) + safety stock.

ABC analysis classifies stock by value: A items are high-value/low-volume and require tight control; C items are low-value and can be bulk-ordered.

FIFO/FEFO: first-expiry-first-out minimizes wastage of short-dated stock.

Gross margin = (selling price − purchase price)/selling price; mark-up is expressed on cost, margin on price.

Pharmacoeconomics: cost-effectiveness ratio = cost/health outcome (e.g. cost per QALY); ICER = (ΔC1 − ΔC0)/(ΔE1 − ΔE0).

Pricing regulation: reimbursement and reference pricing systems set maximum reimbursed prices; generics are priced below originators.

Stock turnover ratio = cost of goods sold/average inventory; a low ratio signals overstocking and expiry risk.