23 Chapter 23: Error Reduction Techniques

Patient safety and the integrity of compounded preparations rely on effective strategies to reduce errors throughout the compounding process. In Canada, pharmacies must follow applicable standards such as NAPRA’s Model Standards for Pharmacy Compounding, along with provincial regulatory requirements. The following error reduction techniques support quality, consistency, and safety in both sterile and non-sterile compounding environments.  Error reduction in pharmacy compounding is critical to ensure the safety, quality, and efficacy of preparations.

1. Standard Operating Procedures (SOPs)

• Develop and follow clear, written SOPs for all compounding processes.
• SOPs should include step-by-step instructions for preparation, labeling, documentation, and cleanup.
• Regularly review and update SOPs to reflect best practices and regulatory requirements.

2. Comprehensive Training and Competency Assessment

• Ensure all compounding personnel receive initial and ongoing training that includes:
  • Theory (eg calculations, ingredients, procedures)
  • Practical Skill development (eg. Weighing, various mixing techniques)
• Validate competency through written tests, observational assessments, and regular performance evaluations.
• Provide refresher training when new equipment, processes, or regulations are introduced.
• Training records must be maintained and updated as per regulatory requirements.
• There are great training courses through organizations like PCCA, Medisca etc.

3. Independent Double-Checks

• Implement independent double-checks at critical steps (e.g., ingredient selection, weighing, final product verification).
• Use a second qualified individual to verify calculations and measurements.
• Double checks help detect human errors before they affect the final product.

4. Environmental controls and clean workspace

• Organized, clean and clutter-free workspaces reduce distractions and improve accuracy.
• Designated compounding areas must be well-lit, properly ventilated, and compliant with NAPRA’s environmental requirements
• Use appropriate lighting, ventilation, and temperature control to support accuracy and safety.
• Minimize non-essential conversations and tasks during compounding.

5. Labeling and Documentation Accuracy

• Immediately label all ingredients, intermediate products, and final compounded preparations.
• Use standardized labels that include drug name, strength, quantity, BUD, storage conditions, and auxiliary warnings.
• Complete compounding records must include:
  • Formula and method
  • Ingredient lot numbers and expiry dates
  • Weights/volumes used
  • Final check sign-off

• Keep batch records, worksheets, and verification logs to enable traceability and audits.

6. Use of Technology and Automation

   🧪 Pearls of Wisdom for Preventing Errors in Pharmacy Compounding

    

   1. Apply a systematic approach
      • This helps to ensure nothing is missed.
   2. Slow down to Speed Up
      • Taking a few extra moments to double-check ingredients, calculations, or labels is faster than correcting a preventable mistake.
   3. Never Assume- Always Confirm
      • Even if you’ve compounded the same formula a hundred times, verify every step—every time.
   4. Label Everything Immediately.
      • Always label containers (including weigh boats and weigh papers), beakers, and syringes as soon as they are filled to avoid mix ups and dosing errors.
   5. Keep Your Workspace Clean and Focused
      • A tidy workspace reduces distractions and lowers the chance of cross- contamination or ingredient swaps.
   6. Use the rule of Two
      • Whenever possible, have a second qualified person independently verify key steps like calculations, ingredient selection and final product checks.
   7. Trust the Process, Not Your Memory
      • Always follow SOPs and use checklists—even when you’re confident. They protect you from memory lapses and overconfidence.
   8. When in doubt, Throw it out
      • If you suspect contamination, mislabeling, or an error—even slightly—discard the batch and start fresh.
   9. Don’t Compromise on Calculations
      • Double-check all math, and use a calculator or validated software. Watch out for unit conversions and dilutions.
   10. Stay Current and Curious
       • Stay up to date with compounding guidelines (e.g., NAPRA, USP), and continuously seek to improve your knowledge and skills.
   11. Speak Up, Even if You’re Unsure
       • If something doesn’t seem right, ask. Questions can prevent harm and save time—even if you’re new or in training.

• Utilize technology where possible to reduce human errors, such as:
  • o Electronic compounding systems for calculations
  • o Barcode scanning for ingredient verification
  • o Automated systems for weighing and mixing.
  • o Automated dispensing and labeling systems
• Validate and maintain equipment regularly.

7. Quality Assurance (QA) and Quality Control (QC)

• Regularly perform in-process checks, final inspections, and audits.
• Perform routine verification of equipment calibration and personnel technique.
• Maintain QA documentation to support compliance with regulatory standards and inspections.

8. Incident Reporting and Continuous Improvement

• Establish a non-punitive system for reporting near misses and actual errors and to encourage transparency.
• Conduct root cause analyses to identify trends and contributing factors.
• Share lessons learned with staff and incorporate changes into SOPs or training.