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High-risk medicines

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Quick Overview

High-risk medicines require enhanced prescribing vigilance due to significant patient harm potential from incorrect use, dose, or monitoring. NICE NG5 emphasizes structured safety checks, mandatory documentation, and recognition of NPSA-identified drug categories. Mastery prevents Never Events and reduces medication-related morbidity/mortality.

Core Facts & Concepts

NPSA High-Risk Drug Categories:

CategoryExamplesKey Risk
AnticoagulantsWarfarin, DOACs, heparinBleeding/thrombosis
InsulinAll formulationsHypoglycaemia
OpioidsMorphine, fentanylRespiratory depression
ChemotherapyMethotrexate, vincristineToxicity/wrong route
SedativesMidazolam, propofolOver-sedation

Critical Prescribing Requirements:

  • Anticoagulants: Document indication, duration, target INR (warfarin 2-3 for AF/VTE, 2.5-3.5 for mechanical valves)
  • Insulin: State formulation type (rapid/short/intermediate/long-acting), device, timing relative to meals
  • Methotrexate: Weekly dosing only for rheumatology/dermatology (NOT daily), prescribe with folic acid 5mg once weekly (different day)
  • Potassium: Maximum 20mmol/hour via peripheral line, 40mmol/hour via central line

Figure 1: Chest X-ray showing bilateral pulmonary infiltrates from methotrexate pneumonitis

Never Events Related to Prescribing:

  • Mis-selection of strong potassium solutions
  • Overdose of insulin due to abbreviations or device errors
  • Overdose of methotrexate for non-cancer treatment
  • Intrathecal route administration of vincristine (always IV)

Problem-Solving Approach

Systematic High-Risk Prescription Check:

  1. Verify indication - Is this drug appropriate for diagnosis?
  2. Calculate dose - Use ideal/actual body weight appropriately; check renal/hepatic function
  3. Check interactions - Review current medications (especially for warfarin, digoxin)
  4. Confirm monitoring - Pre-prescription bloods required? (e.g., U&Es before ACEi, FBC before methotrexate)
  5. Document clearly - Avoid abbreviations (write "units" not "U", "micrograms" not "μg")
  6. Patient education - Explain monitoring requirements and warning symptoms

Figure 2: Blood film showing thrombocytopenia with reduced platelet count

Red Flags 🚩:

  • Abbreviations: "U" (units), "IU", "μg" → write in full
  • Decimal points without leading zeros: ".5mg" → write "0.5mg"
  • Trailing zeros: "5.0mg" → write "5mg"
  • Verbal orders for high-risk drugs → always obtain written prescription

Analysis Framework

Warfarin vs DOAC Decision:

FactorWarfarinDOACs
MonitoringRegular INRNone required
Renal impairmentSafer in CKD 4-5Avoid if eGFR <15-30
Mechanical valve✓ Indicated✗ Contraindicated
ReversibilityVitamin K, PCCIdarucizumab (dabigatran), andexanet alfa (Xa inhibitors)
Drug interactionsExtensiveFewer

Insulin Error Prevention:

  • Use brand names (Lantus, Novorapid) not generic "insulin"
  • State dose in units (never "U")
  • Specify device: pen, vial, pump
  • Prescribe basal and bolus separately

Visual Aid

Monitoring Requirements Table:

DrugBaselineOngoing Monitoring
WarfarinINR, FBC, LFTsINR (target-dependent frequency)
MethotrexateFBC, U&Es, LFTs, CXRFBC, LFTs every 2-4 weeks initially
LithiumU&Es, TFTs, ECGLithium level 12h post-dose, U&Es, TFTs 6-monthly
DigoxinU&Es, ECGDigoxin level if toxicity suspected, annual U&Es
AmiodaroneTFTs, LFTs, CXRTFTs, LFTs 6-monthly

Key Points Summary

NPSA categories: Anticoagulants, insulin, opioids, chemotherapy, sedatives require enhanced vigilance

Never abbreviate: Write "units" not "U", "micrograms" not "μg", avoid decimal errors (leading/trailing zeros)

Methotrexate: Weekly dosing only for non-cancer indications; daily prescription = Never Event

Warfarin targets: 2-3 for AF/VTE, 2.5-3.5 for mechanical valves; DOACs contraindicated in mechanical valves

Potassium infusion limits: 20mmol/hour peripheral, 40mmol/hour central maximum rates

Vincristine route: IV only - intrathecal administration is fatal Never Event

Documentation mandatory: Indication, duration, monitoring plan, patient counselling for all high-risk medicines

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