Patient Safety, Compounding, & Medication Errors

Patient Safety, Compounding, and Medication Errors

Master patient safety protocols and medication error prevention with free flashcards and spaced repetition practice. This lesson covers medication error reporting systems, sterile and non-sterile compounding standards, high-alert medication management, and patient counseling requirements—essential concepts for NAPLEX success and pharmacy practice excellence.

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Welcome 🏥

Patient safety is the cornerstone of pharmaceutical care. As a pharmacist, you're the last line of defense against medication errors that could harm patients. This lesson equips you with the knowledge to prevent, identify, and respond to medication errors while mastering compounding standards that ensure product quality and patient safety.

What You'll Master:

• 🚨 Medication error classification and reporting systems
• 🧪 USP <795>, <797>, and <800> compounding standards
• ⚠️ High-alert medication protocols
• 📋 Patient counseling and safety communication
• 🔍 Root cause analysis and quality improvement

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Core Concepts

🚨 Medication Error Classification

Medication errors are preventable events that may cause or lead to inappropriate medication use or patient harm. Understanding error types helps implement targeted prevention strategies.

The Nine Rights of Medication Administration

Right	Verification Required	Common Error
Patient	Two patient identifiers (name + DOB/MRN)	Wrong patient selection
Drug	Generic + brand name verification	Look-alike/sound-alike (LASA) confusion
Dose	Calculate based on indication/weight	Decimal point errors, wrong strength
Route	Appropriate for drug formulation	IV vs PO, IM vs SubQ mix-ups
Time	Scheduled vs PRN, frequency check	Missed doses, wrong interval
Reason	Indication matches drug therapy	Therapeutic duplication
Documentation	Complete, legible records	Transcription errors
Form	Tablet, capsule, liquid appropriate	Crushing extended-release products
Response	Monitor for efficacy/adverse effects	Failure to assess outcomes

NCC MERP Error Categories

The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) classifies errors from A to I:

┌────────────────────────────────────────────────────┐
│         NCC MERP ERROR SEVERITY SCALE              │
└────────────────────────────────────────────────────┘

  NO ERROR
    │
    ├─ Category A: Capacity to cause error
    │
    ├─ Category B: Error occurred, no patient harm
    │
  ERROR, NO HARM
    │
    ├─ Category C: Reached patient, no harm
    │
    ├─ Category D: Monitoring/intervention required
    │
  ERROR, HARM
    │
    ├─ Category E: Temporary harm, intervention
    │
    ├─ Category F: Temporary harm, hospitalization
    │
    ├─ Category G: Permanent patient harm
    │
    ├─ Category H: Intervention to sustain life
    │
  ERROR, DEATH
    │
    └─ Category I: Patient death

💡 Tip: Most errors fall into categories A-D. The goal is to catch errors before they reach the patient (categories A-B).

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📊 Error Reporting Systems

MEDMARX & ISMP Reporting

MEDMARX (now part of RL Solutions) is a voluntary medication error reporting program used by hospitals to track and analyze errors internally.

ISMP (Institute for Safe Medication Practices) operates the national Medication Errors Reporting Program (MERP):

• 🔒 Confidential and voluntary
• 📈 Analyzes trends across institutions
• 📢 Issues safety alerts and recommendations
• 🌐 Report online at www.ismp.org

FDA MedWatch

MedWatch is the FDA's safety information and adverse event reporting program:

• Reports adverse drug reactions, product quality problems, and medication errors
• Can be submitted by healthcare professionals or consumers
• Form FDA 3500 for voluntary reporting
• Form FDA 3500A for mandatory reporting (manufacturers)

🔔 Did you know? ISMP maintains a list of "confused drug names" that has prevented countless errors. Examples include hydrALAZINE vs hydrOXYzine, and ceLEXA vs ceLEBREX.

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🎯 High-Alert Medications

High-alert medications bear a heightened risk of causing significant patient harm when used in error. ISMP identifies categories requiring special safeguards.

ISMP High-Alert Medication Categories

Category	Examples	Key Safety Measures
Anticoagulants	Heparin, warfarin, DOACs	Protocol-driven dosing, independent double-check
Insulin	All formulations	Never abbreviate "units," use insulin syringes only
Opioids	Morphine, fentanyl, hydromorphone	Standardized concentrations, PCA safeguards
Chemotherapy	IV and oral agents	BSA verification, dose capping, separate storage
Neuromuscular blockers	Rocuronium, vecuronium	Separate storage with warnings, restricted access
Concentrated electrolytes	KCl, NaCl >0.9%, MgSO₄	Remove from floor stock, dilute before use
Sedatives (IV)	Propofol, midazolam	Standardized dosing protocols, monitoring

Independent Double-Check Process

Independent double-check means TWO practitioners verify critical elements separately before administration:

┌─────────────────────────────────────────────┐
│     INDEPENDENT DOUBLE-CHECK WORKFLOW       │
└─────────────────────────────────────────────┘

  Practitioner 1                Practitioner 2
       │                              │
       ↓                              ↓
  📋 Check:                      📋 Check:
  • Right patient                • Right patient
  • Right drug                   • Right drug
  • Right dose                   • Right dose
  • Calculations                 • Calculations
  • Route/rate                   • Route/rate
       │                              │
       ↓                              ↓
  Document check ──────┐    ┌──── Document check
                       │    │
                       ↓    ↓
                  ✅ Both agree?
                       │
              ┌────────┴────────┐
              │                 │
            YES               NO
              │                 │
              ↓                 ↓
        Proceed with       Resolve
        administration     discrepancy

⚠️ Critical: "Independent" means the second checker performs calculations WITHOUT seeing the first checker's work. Simply asking "Is this right?" is NOT an independent double-check!

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🧪 USP Compounding Standards

USP <795>: Non-Sterile Compounding

USP Chapter <795> governs the preparation of non-sterile compounded preparations (creams, ointments, capsules, suspensions).

Key Requirements:

Element	Requirement
Personnel training	Documented competency assessment
Facility design	Designated compounding area, proper ventilation
Equipment	Calibrated balances (sensitivity ≤0.1% of target)
Ingredient sourcing	USP/NF grade preferred; Certificate of Analysis for bulk
Beyond-Use Dating (BUD)	See table below
Quality assurance	Master formulation records, compounding logs
Labeling	Drug name, strength, BUD, lot number, route

Beyond-Use Date (BUD) Guidelines for Non-Sterile Preparations:

Preparation Type	Storage Conditions	Maximum BUD
Non-aqueous formulations	Room temperature	6 months or earliest expiration of ingredient
Water-containing oral formulations	Room temperature	14 days
Water-containing topical/dermal/mucosal	Room temperature	30 days
All formulations	Refrigerated	Up to 6 months (unless otherwise justified)

💡 Mnemonic for BUD: "Water = Worry faster" (aqueous preparations have shorter BUDs due to microbial growth risk)

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USP <797>: Sterile Compounding

USP Chapter <797> establishes requirements for compounding sterile preparations (CSPs) to prevent harm from microbial contamination, excessive endotoxins, variability in strength, and incorrect ingredients.

Risk Categories:

Category	Definition	Examples	BUD (Room Temp)
Immediate Use	Simple transfer/mixing; starts immediately, completes within 1 hour	Emergency medication preparation	1 hour
Category 1 (Low Risk)	≤3 sterile ingredients; closed system; one manipulation	Single dose from vial to syringe	12 hours
Category 2 (Medium Risk)	Multiple doses, complex manipulation, or longer exposure	TPN compounding, multi-ingredient IV bags	4 hours
Category 3 (High Risk)	Non-sterile ingredients or devices, or exposed more than 6 hours before sterilization	Autoclaved preparations from powder	3 hours

Environmental Controls:

┌───────────────────────────────────────────────────┐
│        CLEANROOM CLASSIFICATION (ISO)             │
└───────────────────────────────────────────────────┘

    Cleanest ↑                         ↓ Dirtiest
             │                         │
    ┌────────┴──────────┬──────────────┴────────┐
    │                   │                       │
  ISO 5              ISO 7                   ISO 8
  (Class 100)        (Class 10,000)          (Class 100,000)
    │                   │                       │
    │                   │                       │
  Primary           Secondary              Ante room
  Engineering       Engineering            (if used)
  Control (PEC)     Control (SEC)
    │                   │
  Laminar Air       Buffer room
  Flow Hood         surrounding
  or Isolator       the PEC

  ↓ Work here        ↓ Gown here
  Compounding        Staging/prep
  happens in PEC     in SEC

Key Terms:

• PEC (Primary Engineering Control): ISO Class 5 environment where compounding occurs (laminar airflow workbench, biological safety cabinet, or compounding aseptic isolator)
• SEC (Secondary Engineering Control): ISO Class 7 buffer room containing the PEC
• Ante room: ISO Class 8 area for handwashing, garbing

🧠 Memory Device: "5-7-8 = Clean to Messy" – As you move outward from the compounding area, ISO classification numbers increase (cleanliness decreases)

Garbing Order (Critical!):

Step	Action	Rationale
1	Remove jewelry, cosmetics	Reduce contamination sources
2	Don shoe covers	Prevent floor contamination
3	Don head/hair cover	Cover all hair
4	Don face mask	Covers nose and mouth completely
5	Perform hand hygiene	Antiseptic soap and water, then alcohol-based hand sanitizer
6	Don non-shedding gown	Covers all skin, wrists to ankles
7	Don sterile gloves	Last step before entering SEC; sanitize frequently

💡 Mnemonic: "Shoes Head Mask Hands Gown Gloves" = SH-MH-GG

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USP <800>: Hazardous Drugs

USP Chapter <800> addresses handling of hazardous drugs (HDs) to protect healthcare personnel from occupational exposure.

HD Categories:

1. Antineoplastic drugs (chemotherapy)
2. Non-antineoplastic drugs meeting NIOSH criteria (teratogenic, carcinogenic, reproductive toxicity)
3. Drugs with manufacturer Safe Handling warning

Required Controls:

Requirement	Specification
Engineering controls	Containment-segregated compounding area (C-SCA) or containment-primary engineering control (C-PEC)
C-PEC type	Biological Safety Cabinet (BSC) Class II or Compounding Aseptic Containment Isolator (CACI)
Ventilation	Negative pressure (12-15 air changes/hour minimum)
PPE	Double gloving, protective gown, face/eye protection, respiratory protection if applicable
Decontamination	Regular cleaning of all HD areas with appropriate agents
Waste disposal	Yellow hazardous waste containers (RCRA or non-RCRA waste stream)
Spill kit	Readily accessible in all HD handling areas

Negative vs Positive Pressure:

  POSITIVE PRESSURE               NEGATIVE PRESSURE
  (Sterile compounding)           (Hazardous drugs)

  ┌─────────────┐                ┌─────────────┐
  │             │                │             │
  │   →→→→→→   │                │   ←←←←←←   │
  │   Room      │                │   Room      │
  │   →→→→→→   │                │   ←←←←←←   │
  │             │                │             │
  └─────────────┘                └─────────────┘
  Air flows OUT                  Air flows IN
  (protects product)             (protects worker)

⚠️ Critical Distinction: Sterile compounding uses POSITIVE pressure to prevent contamination entering the clean area. Hazardous drug compounding uses NEGATIVE pressure to prevent hazardous particles from escaping to other areas.

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💊 Look-Alike/Sound-Alike (LASA) Medications

LASA drugs are a leading cause of medication errors. The Joint Commission requires organizations to maintain a LASA list and implement safety strategies.

High-Risk LASA Pairs:

Drug 1	Drug 2	Safety Strategy
hydrALAZINE	hydrOXYzine	Tall Man lettering
vinBLAStine	vinCRIStine	Separate storage, indication on label
DOBUTamine	DOPamine	Different concentrations, separate bins
glipIZIDE	glyBURIDE	Tall Man lettering, indication required
ceLEBREX	ceLEXA	Tall Man lettering, brand and generic both displayed
clonIDine	cloNAZepam	Tall Man lettering, different storage locations

🧠 Study Tip: Create flashcards pairing LASA drugs with their DIFFERENT indications to reinforce the distinction (e.g., "hydrALAZINE = hypertension" vs "hydrOXYzine = anxiety/itch")

Prevention Strategies:

1. Tall Man lettering (emphasize differences: DOPamine vs DOBUTamine)
2. Separate storage locations
3. Auxiliary labels with indication
4. Barcode scanning at multiple checkpoints
5. Leading zeros prohibited (0.5 mg NOT .5 mg)
6. Trailing zeros prohibited (5 mg NOT 5.0 mg)

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🗣️ Patient Counseling & Medication Therapy Management (MTM)

OBRA '90 Counseling Requirements

The Omnibus Budget Reconciliation Act of 1990 (OBRA '90) requires pharmacists to offer counseling to Medicaid patients on:

1. Drug name (brand and generic)
2. Intended use and expected action
3. Route, dosage form, dosage, and administration schedule
4. Special directions and precautions
5. Common side effects and interactions
6. Therapeutic contraindications
7. Techniques for self-monitoring
8. Proper storage
9. Prescription refill information
10. Action to take if dose is missed

Show-and-Tell Technique: For devices (inhalers, insulin pens, etc.), use "teach-back" method:

1. Demonstrate proper technique
2. Have patient demonstrate back to you
3. Correct any mistakes
4. Document counseling

Medication Therapy Management (MTM)

MTM is a service provided to optimize therapeutic outcomes for patients with chronic diseases, multiple medications, or high drug costs.

Core Elements:

Element	Description
Medication Therapy Review (MTR)	Comprehensive review of all medications (prescription, OTC, supplements)
Personal Medication Record (PMR)	Comprehensive list provided to patient
Medication Action Plan (MAP)	Patient-friendly list of actions to improve medication use
Intervention/Referral	Address medication-related problems, coordinate with prescribers
Documentation & Follow-up	Track outcomes, schedule subsequent reviews

MTM Eligibility (Medicare Part D):

• Multiple chronic diseases (typically ≥3)
• Multiple Part D drugs (typically ≥8)
• High annual drug costs (threshold set annually)

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🔍 Root Cause Analysis (RCA)

Root Cause Analysis is a systematic process for identifying underlying factors that led to an error or adverse event.

The Five Whys Technique:

┌─────────────────────────────────────────────────┐
│         FIVE WHYS EXAMPLE                       │
└─────────────────────────────────────────────────┘

Problem: Patient received 10x overdose of insulin

Why #1: Why did patient get wrong dose?
  → Pharmacist entered wrong quantity

Why #2: Why did pharmacist enter wrong quantity?
  → Misread handwritten prescription "10 units" as "100 units"

Why #3: Why was prescription handwritten?
  → Prescriber doesn't use electronic prescribing

Why #4: Why doesn't prescriber use e-prescribing?
  → Clinic lacks integrated EHR system

Why #5: Why no verification caught the error?
  → No independent double-check for insulin

ROOT CAUSES IDENTIFIED:
• Handwritten prescriptions prone to misinterpretation
• Lack of e-prescribing technology
• No independent verification protocol for high-alert drugs

ACTIONS:
1. Implement mandatory double-check for all insulin
2. Contact clinic about e-prescribing implementation
3. Callback to prescriber for any insulin doses >50 units

Fishbone (Ishikawa) Diagram:

         MEDICATION ERROR
               |
    ───────────┼───────────
    ↙          ↓          ↘
  People    Process    Equipment
    ↓          ↓          ↓
  Staff      Workflow   Technology
  fatigue    complexity failures
    ↓          ↓          ↓
  Inadequate Standard   System
  training   procedures downtime
             unclear

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Detailed Examples

Example 1: Preventing a High-Alert Medication Error 💉

Scenario: A physician orders "morphine 10 mg IV push q4h PRN pain" for post-operative patient. The nurse prepares to administer from a vial labeled "morphine 15 mg/mL."

Error Prevention Steps:

Step	Action	Rationale
1	Identify as high-alert medication	Opioids require enhanced precautions
2	Calculate volume needed	10 mg ÷ 15 mg/mL = 0.67 mL
3	Independent double-check	Second nurse verifies: patient, drug, dose, calculation, route
4	Check patient allergies and current pain score	Ensure appropriateness of PRN dose
5	Verify no other opioids given recently	Prevent cumulative overdose
6	Document administration immediately	Prevent duplication
7	Monitor respiratory rate	Detect early signs of respiratory depression

What Could Go Wrong:

• ❌ Reading 15 mg/mL as "15 mL" and giving 150 mg
• ❌ Confusing with HYDROmorphone (5x more potent)
• ❌ Not checking recent administration, causing overdose
• ❌ Failing to monitor after administration

💡 Key Takeaway: High-alert medications require multiple verification checkpoints BEFORE, DURING, and AFTER administration.

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Example 2: Compounding a Sterile Preparation per USP <797> 🧪

Scenario: Compound a 50 mL IV bag of vancomycin 1000 mg in normal saline for a patient with MRSA bacteremia.

Risk Assessment: Category 1 (Low Risk)

• Single CSP from commercially available sterile products
• Closed system transfer
• Simple aseptic technique

Compounding Process:

Step	Action	Critical Point
1	Verify order and label match	Right patient, right drug, right dose
2	Perform hand hygiene and garb (per SH-MH-GG)	Follow garbing sequence exactly
3	Clean PEC per protocol (70% IPA, wait 30 seconds)	Allow alcohol to evaporate completely
4	Assemble materials in PEC (vancomycin 1g vial, NS 50 mL bag, transfer needle, alcohol swabs)	Place items in direct laminar airflow path
5	Swab vancomycin vial septum (70% IPA, allow to dry)	Never introduce needle through wet surface
6	Reconstitute vancomycin with 10 mL sterile water	Swirl gently, do not shake (prevents foaming)
7	Draw up reconstituted vancomycin using aseptic technique	Maintain ISO Class 5 environment, don't touch critical sites
8	Clean NS bag injection port, inject vancomycin	Use gentle pressure to prevent bag rupture
9	Mix by gentle inversion (5-10 times)	Ensure uniform distribution
10	Label with: patient info, drug, concentration, date/time, BUD, initials	Category 1 at room temp: 12 hours max
11	Perform final check (independent verification)	Second pharmacist verifies before dispensing

Beyond-Use Date Calculation:

• Category 1 (Low Risk)
• Room temperature storage: 12 hours from preparation
• Refrigerated: 24 hours (but vancomycin typically given at room temp)

🔍 Common Mistake: Confusing Category 1 BUD (12 hours) with Immediate Use (1 hour). Category 1 requires full cleanroom and garbing; Immediate Use is for emergencies only.

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Example 3: Conducting MTM for Polypharmacy Patient 📋

Scenario: 68-year-old male with diabetes, hypertension, hyperlipidemia, GERD, and osteoarthritis. Current medications:

1. Metformin 1000 mg PO BID
2. Glipizide 10 mg PO BID
3. Lisinopril 20 mg PO daily
4. Atorvastatin 40 mg PO daily
5. Omeprazole 20 mg PO daily
6. Ibuprofen 600 mg PO TID PRN
7. Aspirin 81 mg PO daily
8. Multivitamin daily
9. Fish oil 1000 mg BID (OTC)
10. Glucosamine 1500 mg daily (OTC)

MTM Process:

Step 1: Medication Therapy Review

Drug	Issue Identified	Severity
Ibuprofen + Aspirin + Lisinopril	NSAID reduces ACE inhibitor efficacy, increases bleeding risk with aspirin	⚠️ High
Glipizide BID	Increased hypoglycemia risk in elderly	⚠️ Medium
Fish oil + Aspirin	Additive antiplatelet effect, bleeding risk	⚠️ Medium
Glucosamine	May affect blood glucose control	⚠️ Low
Omeprazole long-term	Risk of fractures, B12 deficiency, drug interactions	⚠️ Low-Medium

Step 2: Personal Medication Record (PMR) Create comprehensive list with:

• Drug names (brand and generic)
• Indications
• Dosing schedule
• Prescriber for each

Step 3: Medication Action Plan (MAP)

Step 4: Intervention/Referral

• Document recommendations in SOAP format
• Fax or e-prescribe consultation to physician
• Recommend acetaminophen 650 mg TID scheduled for osteoarthritis
• Suggest glucosamine discontinuation trial (limited evidence of efficacy)

Step 5: Follow-up

• Schedule appointment in 4 weeks
• Review blood glucose log
• Assess pain control with acetaminophen
• Monitor blood pressure

💡 Key Principle: MTM is patient-centered. The goal is not just to identify problems, but to create an actionable plan the patient understands and agrees to follow.

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Example 4: Responding to a Medication Error 🚨

Scenario: A pharmacist dispenses amoxicillin 500 mg capsules instead of amoxicillin-clavulanate 875/125 mg tablets for a patient with sinusitis. The patient took 3 doses before noticing the error.

Immediate Response (CARE Framework):

Step	Action	Rationale
Contact	Call patient immediately	Stop further doses of wrong medication
Assess	Determine if patient experienced adverse effects	Amoxicillin alone less effective for resistant organisms
Resolve	Provide correct medication at no charge, apologize	Correct the therapeutic error
Evaluate	Contact prescriber to determine if additional treatment needed	May need extended therapy due to suboptimal initial treatment

Error Classification:

• NCC MERP Category: E (temporary harm requiring intervention - patient may need longer treatment course)

Root Cause Analysis:

┌──────────────────────────────────────────────┐
│         WHY DID THIS ERROR OCCUR?            │
└──────────────────────────────────────────────┘

Why #1: Wrong drug dispensed?
  → Selected "amoxicillin 500" instead of "amoxicillin-clav 875/125"

Why #2: Why was wrong item selected?
  → Look-alike bottles stored next to each other

Why #3: Why weren't they separated?
  → No LASA separation policy for stock bottles

Why #4: Why didn't final check catch it?
  → Tech and pharmacist both misread label

Why #5: Why no patient catch at pickup?
  → Patient counseling not offered (established patient)

ROOT CAUSES:
• Lack of LASA separation in storage
• Confirmation bias during verification
• No mandatory counseling for established patients

Prevention Strategies Implemented:

1. ✅ Separate amoxicillin and amoxicillin-clavulanate storage by 2+ shelves
2. ✅ Add auxiliary labels: "CHECK: Plain amoxicillin or WITH clavulanate?"
3. ✅ Implement mandatory barcode scan before bagging
4. ✅ Counsel ALL patients on antibiotics (not just new patients)
5. ✅ Add to LASA list for staff training

Documentation:

• Complete internal incident report
• Submit to ISMP (voluntary, anonymous)
• Document in patient profile
• Notify prescriber in writing
• Follow state board reporting requirements (if applicable)

💡 Professional Responsibility: When an error occurs, focus on:

1. Patient safety first (immediately correct the situation)
2. Transparency (honest communication with patient and prescriber)
3. System improvement (identify and fix root causes)
4. Learning (share lessons to prevent future errors)

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Common Mistakes to Avoid ⚠️

1. Confusing USP Chapter Requirements

❌ Mistake: "All compounding requires ISO Class 5 environment" ✅ Correct: Only STERILE compounding (USP <797>) requires ISO Class 5. Non-sterile compounding (USP <795>) needs designated area but not cleanroom.

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2. Incorrect Beyond-Use Dating

❌ Mistake: "Water-containing topical can have 6-month BUD at room temperature" ✅ Correct: Water-containing topicals have 30-day maximum BUD at room temperature (14 days for oral formulations).

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3. Inadequate Independent Double-Check

❌ Mistake: Checker asks, "Does this look right?" while pointing to prepared medication ✅ Correct: Second checker independently verifies ALL elements (dose calculation, drug selection, patient identity) WITHOUT seeing first checker's work.

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4. Misunderstanding NCC MERP Categories

❌ Mistake: "Category A means no error occurred" ✅ Correct: Category A means circumstances/events occurred that had CAPACITY to cause error (error-prone situation), even though no actual error occurred.

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5. Incomplete MTM Documentation

❌ Mistake: Writing "Discussed medications with patient" in chart ✅ Correct: Document specific drug-related problems identified, recommendations made, interventions, and follow-up plan. Use SOAP format:

• Subjective: Patient reports, concerns
• Objective: Medication list, lab values, vitals
• Assessment: Drug therapy problems identified
• Plan: Recommendations, follow-up

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6. Trailing Zeros on Insulin Orders

❌ Mistake: Writing "10.0 units" of insulin ✅ Correct: Write "10 units" (the decimal could be missed, leading to 100-unit dose). NEVER use trailing zeros. ALWAYS use leading zeros (0.5 mg, not .5 mg).

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7. Confusing Positive and Negative Pressure

❌ Mistake: "Hazardous drug compounding uses positive pressure to prevent contamination" ✅ Correct: Hazardous drug areas use NEGATIVE pressure (air flows IN) to protect workers. Sterile compounding uses POSITIVE pressure (air flows OUT) to protect products.

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8. Failing to Report Near Misses

❌ Mistake: "The error was caught before reaching the patient, so no need to report it" ✅ Correct: Near misses (Category B) should be reported! They reveal system vulnerabilities. Analyzing near misses prevents future actual errors.

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Key Takeaways 🎯

1. Medication errors are preventable events that may cause inappropriate medication use or patient harm. Most are system-based, not individual failures.

2. The Nine Rights provide a framework for safe medication use: right patient, drug, dose, route, time, reason, documentation, form, and response.

3. NCC MERP categories classify errors from A (capacity to cause error) to I (patient death), helping prioritize interventions.

4. High-alert medications (anticoagulants, insulin, opioids, chemotherapy) require enhanced safeguards including independent double-checks and restricted access.

5. LASA drugs need Tall Man lettering, separate storage, and barcode verification to prevent selection errors.

6. USP <795> governs non-sterile compounding with BUD guidelines: 6 months for non-aqueous, 14 days for water-containing oral, 30 days for topical.

7. USP <797> establishes sterile compounding standards with risk categories (Immediate, Category 1/2/3) and corresponding BUDs (1 hour to 12 hours at room temp).

8. USP <800> protects healthcare workers from hazardous drug exposure through containment engineering controls, negative pressure, and PPE.

9. Garbing sequence for sterile compounding: Shoes → Head → Mask → Hands → Gown → Gloves (SH-MH-GG).

10. ISO classifications: ISO 5 (PEC/hood) → ISO 7 (SEC/buffer room) → ISO 8 (ante room). Cleanest to less clean.

11. OBRA '90 mandates pharmacist counseling for Medicaid patients on 10 key elements including drug name, use, dose, side effects, and storage.

12. MTM includes five core elements: Medication Therapy Review, Personal Medication Record, Medication Action Plan, Intervention/Referral, and Documentation.

13. Root Cause Analysis uses techniques like Five Whys and Fishbone diagrams to identify system-level factors contributing to errors.

14. Error reporting to ISMP and FDA MedWatch is voluntary, confidential, and crucial for identifying trends and preventing future harm.

15. When errors occur, prioritize patient safety, communicate transparently, and implement system improvements to prevent recurrence.

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📚 Further Study

1. ISMP Medication Safety Resources
   https://www.ismp.org/resources
   Comprehensive database of medication safety alerts, guidelines, and LASA drug lists.

2. USP Compounding Standards (Official Chapters)
   https://www.usp.org/compounding
   Full text of USP <795>, <797>, and <800> with implementation resources.

3. ASHP Medication Safety Toolkit
   https://www.ashp.org/pharmacy-practice/patient-safety
   Evidence-based strategies for preventing medication errors in various practice settings.

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🎓 You're now equipped with essential patient safety knowledge for NAPLEX success and safe pharmacy practice! Remember: most medication errors are system failures, not individual mistakes. Focus on creating robust systems with multiple safety checkpoints, and always prioritize patient welfare in every decision.