Optimizing Outcomes: Best Practices in Documentation for Sterile and Nonsterile Compounding
Target Audience: Pharmacist
Course Overview
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.
Learning Objectives
Upon completion of this educational activity, participants should be able to:
- 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
Faculty
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
From August 19, 2023 through August 19, 2026, participants must:
- Read the "learning objectives" and "author and planning team disclosures"
- Study the section entitled "educational activity"
- Complete the Course Test and Evaluation form. The Course Test will be graded automatically. Following successful completion of the Course Test with a score of 70% or higher, a statement of participation will be made available immediately. (No partial credit will be given.)
Credit for this course will be automatically uploaded 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 Disclosure
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.
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Accreditation
In support of improving patient care, RxCE.com is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.