Optimizing Outcomes: Best Practices in Documentation for Sterile and Nonsterile Compounding

Pharmacist CEU
notesMonograph
Contact Hours: 1.0

Course Summary

Documentation is vital to the compounding process. Proper documentation has implications for patient safety, legal compliance, and quality assurance, and meticulous record-keeping is crucial in promoting optimal outcomes. Pharmacists and pharmacy technicians involved in compounding should be well-versed in managing various types of records, including Master Formulation Records and Compounding Records. With a firm grounding in standards and best practices related to documentation and record-keeping, compounding personnel will be better equipped to ensure quality and consistency in compounded preparations. This monograph will describe various types of records, discuss best practices for documentation, and detail common errors that can occur in the documentation processes, with related strategies to prevent and mitigate such errors.


Course Objectives

Explain the role of documentation in the compounding process and its impact on patient safety, legal compliance, and quality assurance

Describe best practices in maintaining and managing various types of documentation involved in the compounding process, including Standard Operating Procedures, Master Formulation Records, and Compounding Records

Identify common errors that can occur in the documentation process of sterile and nonsterile compounding

Identify strategies to prevent and mitigate documentation errors


I. Introduction

II. Definitions of Compounding Records

III. Qualities of Good Record Keeping

1. How and When to Document
2. What to Do About Errors

IV. Types of Records

1. Logbooks
2. Standard Operating Procedures
3. Ingredient Records
4. Certificate of Analysis

V. Nonsterile Compounding Documentation

1. Master Formulation Record
2. Compounding Record

VI. Sterile Compounding Documentation

1. Master Formulation Record
2. Compounding Record

VII. Compounding Record Audits

VIII. Legal and Regulatory Considerations

IX. Summary

How to Earn Credit:
To earn credit for this course, participants must:
  1. Read the course objectives and faculty planner disclosure
  2. Read the course material
  3. Complete the post-test with a minimumĀ score of 70% and complete the course evaluation form.
  4. Results are automatically submitted to CPE Monitor

Faculty Planner Disclosure

The following individuals were involved in the development of this activity: Liz Fredrickson, PharmD, BCPS, and Pamela Sardo, PharmD, BS. Pamela Sardo was an employee of Rhythm Pharmaceuticals until March 2022 and has no conflicts of interest or relationships regarding the subject matter discussed. There are no financial relationships relevant to this activity to report or disclose by any of the individuals involved in the development of this activity.


Unlabeled Use Disclosures

The information provided in this course is general in nature and it is solely designed to provide participants with continuing education credit(s). This course and materials are not meant to substitute for the independent, professional judgment of any participant regarding that participant’s professional practice, including but not limited to patient assessment, diagnosis, treatment and/or health management. Medical and pharmacy practices, rules, and laws vary from state to state, and this course does not cover the laws of each state; therefore, participants must consult the laws of their state as they relate to their professional practice. Healthcare professionals, including pharmacists and pharmacy technicians, must consult with their employer, healthcare facility, hospital, or other organization, for guidelines, protocols, and procedures they are to follow. The information provided in this course does not replace those guidelines, protocols, and procedures but is for academic purposes only, and this course’s limited purpose is for the completion of continuing education credits. Participants are advised and acknowledge that information related to medications, their administration, dosing, contraindications, adverse reactions, interactions, warnings, precautions, or accepted uses are constantly changing, and any person taking this course understands that such person must make an independent review of medication information prior to any patient assessment, diagnosis, treatment and/or health management. Any discussion of off-label use of any medication, device, or procedure is informational only and such uses are not endorsed hereby. Nothing contained in this course represents the opinions, views, judgments, or conclusions of RxCe.com LLC. RxCe.com LLC is not liable or responsible to any person for any inaccuracy, error, or omission with respect to this course, or course material.

Computer Hardware/Software Requirements

Please ensure the device you plan to use meets these requirements and specifications:

  • Operating System: Windows 7,8,10, or 11 /Mac OS X 10.9 or later/iOS/Android
  • Supported Browsers: Microsoft Edge, Firefox, Google Chrome, Safari, Opera
  • A connection to the internet
  • For Live Webinars or Conferences: GoToWebinar application for iOS, Android, Mac, or PC. You cannot 'call into' a live conference.

  • Target Audience: Pharmacist
  • Contact Hours: 1.0
  • Activity Release Date: 8/19/2023
  • Activity Expiration Date: 9/19/2026
  • Activity Type: Knowledge
  • UAN: 0669-0000-23-130-H07-P
  • Topic: Compounding
  • CeBroker Number: 20-1099170

Author:

Liz Fredrickson, PharmD, BCPS

AUTHOR BIO

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