Hospital and Clinical Pharmacy: Distribution, TDM and Pharmacovigilance
What the domain tests
Hospital and clinical pharmacy asks how drugs move safely through a hospital and how therapy is individualised. Items cover the pharmacy and therapeutics committee, formulary, drug distribution systems, sterile compounding, therapeutic drug monitoring, adverse drug reaction reporting and clinical trial phases.
Core rules to hold
- PTC and formulary: the committee evaluates drugs for the hospital formulary; the formulary is a continually revised list of selected medicines with dosage and cost information.
- Distribution systems: unit dose (individually packaged, patient-specific, pharmacist-controlled) versus floor stock and ward stock; unit dose reduces medication errors and drug wastage.
- Inventory control: ABC analysis (annual consumption value), VED (vital, essential, desirable), EOQ to balance ordering and holding costs.
- TDM indications: narrow therapeutic index, poor correlation of dose with effect, toxicity risk - digoxin, lithium, phenytoin, vancomycin, aminoglycosides, theophylline.
- Pharmacovigilance: ADR reporting to the national programme coordinated by IPC Ghaziabad under CDSCO; causality assessed by WHO-UMC or Naranjo scales.
- Clinical trial phases: I safety in healthy volunteers, II efficacy and dose finding, III confirmatory comparative trials, IV post-marketing surveillance.
- Biomedical waste: yellow for incineration, red for recycled plastics, white for sharps, blue for glassware.
Worked example
Cockcroft–Gault for a 60-year-old man weighing 60 kg with serum creatinine 1.2 mg/dL: CrCl = (140 − 60) × 60 / (72 × 1.2) = 4800/86.4 ≈ 55.6 mL/min. For a woman multiply by 0.85. This guides dose adjustment for renally cleared drugs such as gentamicin before any TDM result is available.
Traps that cost marks
Forgetting the 0.85 female factor; equating floor stock with unit dose; reporting an ADR without a causality assessment; confusing phase I tolerability with phase III comparative efficacy.