ksb-d06-k0015

name: "KSB-D06-K0015" description: "Product Factors: Look-alike/sound-alike drugs, packaging design, labeling clarity, strength availability..." version: "1.0.0" domain: "D06" domain_name: "Medication Errors & Quality" type: "Knowledge" proficiency_level: "L4" bloom_level: "create" triggers: - "explain product factors" - "what is product factors" - "create product factors" epa_mapping: "EPA-01, EPA-07, EPA-09" cpa_mapping: "CPA-01, CPA-03" regulatory_refs: "FDA-CFR-001, FDA-CFR-003, ICH-E2A, ICH-E2B(R3), ICH-E2D, EMA-GVP-003"

KSB-D06-K0015: Product Factors

Overview

Domain: D06 - Medication Errors & Quality Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Create

Description

Look-alike/sound-alike drugs, packaging design, labeling clarity, strength availability

Context

• Major Section: Comprehensive Medication Error Taxonomy and Classification
• Section: Contributing Factor Analysis

EPA Mapping

• EPA-01:3001-3003
• EPA-07:3016-3017
• EPA-09:3020-3022

CPA Pathway

• CPA-01, CPA-03

Regulatory References

• FDA-CFR-001
• FDA-CFR-003
• ICH-E2A
• ICH-E2B(R3)
• ICH-E2D
• EMA-GVP-003

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in product factors
2. Apply create level cognitive skills to create the topic
3. Reference relevant regulatory guidance (FDA-CFR-001, FDA-CFR-003, ICH-E2A, ICH-E2B(R3), ICH-E2D, EMA-GVP-003)
4. Connect to related EPAs: EPA-01, EPA-07, EPA-09

Key Competencies

• Look-alike/sound-alike drugs, packaging design, labeling clarity, strength availability

Assessment Criteria

• Can create core concepts independently
• Demonstrates understanding of regulatory context
• Applies knowledge appropriately to PV scenarios

Related Skills

• Other D06 skills in Contributing Factor Analysis
• Cross-domain integrations per DAG architecture

Generated from PV KSB Framework v1.0 | 2025-12-31