Abstract

A Simplified Method for Compounding Lidocaine Topical Gel: A Demonstration of Quality Assurance to Prevent Errors in 503A Pharmacies

Author(s): Hall Essence, Levesque Dan, Rashid Mamoon, Mullins Randy, Hossain Mohammad Faisal

Issue: May/Jun 2021 - Volume 25, Number 3

Page(s): 197-204

Download in electronic PDF format for $75

Abstract

Quality assurance is a key element in the process of creating safe and effective preparations. Furthermore, the implementation of quality-assurance measures allows 503A pharmacies to ensure accurate, well-made preparations to their customers. When corrective and preventive measures are not implemented, the risk of errors is increased, like subtherapeutic or supratherapeutic compounded medications. The objective of this article was to demonstrate the importance of quality assurance through the development and validation of the compounding method, preparation characterization, training, implementation of a master formulation record, compounding protocol, and verification to prevent compounding errors. Two groups, comprising of 10 students, compounded lidocaine gel following the quality-assurance guidelines in accordance with United States Pharmacopeia Chapter <1163>. Following the trial, the preparations from both groups were tested to evaluate the content of lidocaine using high-performance liquid chromatography and an ultra-viscosity detector. The study results indicated that the newly developed, validated procedure produced a stable, uniform, highly reproducible (%Assay ± SD; 101.65% ± 1.04), and elegant (clear hydro-alcoholic gel) preparation with a high yield (~98.5%). There was no significant difference observed in the %Assay results obtained from the two groups (%Assay ±SD; P1: 98.76% ±1.01, and P2: 99.02% ±1.39, %Difference: 0.3). Overall, our findings suggest that the implementation of quality assurance could significantly reduce compounding errors and improve both preparation quality and patient safety.

Related Keywords

Related Categories

Printer-Friendly Version

Related Articles from IJPC

Issue/Page View/Buy	Title/Author (Click for Abstract / Details / Purchase)
May/Jun 2021 Pg. 197-204	A Simplified Method for Compounding Lidocaine Topical Gel: A Demonstration of Quality Assurance to Prevent Errors in 503A Pharmacies Author(s): Hall Essence, Levesque Dan, Rashid Mamoon, Mullins Randy, Hossain Mohammad Faisal
May/Jun 2023 Pg. 211-217	Quality Assurance: Compounding Record Audits for Error Prevention Author(s): Hawkins Jessica
May/Jun 2004 Pg. 206-209	Basics of Compounding for Cold Sores or Fever Blisters Author(s): Allen Loyd V Jr
Jul/Aug 2004 Pg. 269-274	Current Topical Treatments in Wound Healing - Part 1 Author(s): Helmke Christopher D
May/Jun 2004 Pg. 181-185	Compounding in the Pharmacy Curriculum: Beyond the Basics Author(s): Hinkle Amanda R, Newton Gail D
Jul/Aug 2020 Pg. 322-326	Incorporating Quality Assurance in Pharmaceutical Compounding-related Courses in the PharmD Curricula Author(s): Hossain Mohammad Faisal, Levesque Dan, Frye John, Rashid Mamoon
Mar/Apr 2003 Pg. 106-113	Veterinary Transdermal Medications: A to Z Author(s): Davidson Gigi S
Nov/Dec 2015 Pg. 453-463	Applying Quality of Design Concepts to Pharmacy Compounding Author(s): Timko Robert J
Jul/Aug 2005 Pg. 300-302	Quality-Control Analytical Methods: Glossary of Quality Control/Quality Assurance Terms in Pharmaceutical Compounding Author(s): Kupiec Thomas C, Okeke Claudia, Allen Loyd V Jr, Denison Clay
May/Jun 2015 Pg. 215-221	Quality Assurance and Quality Control, Part 2 Author(s): Akers Michael J
Jan/Feb 2018 Pg. 7-16	Certification, Accreditation, and Credentialing for 503A Compounding Pharmacies Author(s): Pritchett Jon, McCrory Gary, Kraemer Cheri, Jensen Brenda, Allen Loyd V Jr
Nov/Dec 2009 Pg. 532-536	Setting Up a National System of Compounding Pharmacies: Preventing Error, Assuring Quality, Building Trust Author(s): Guedes de Souza Hugo, Favaro Alvaro Jr, Andrade Alba Livia, Gomes Lenir Yago, de Souza Aguiar Simone, do Carmo Garcez Maria
May/Jun 2008 Pg. 247-251	A Process Verification Model for Quality Assurance in a Compounding Pharmacy Author(s): Zolner William J
Jan/Feb 2016 Pg. 29-36	Performance Improvement in 503A Compounding Pharmacies: A Plan for Assessment, Implementation, and Sustained Success Author(s): Pritchett Jon, Mixon William, O'Connell Kevin
Mar/Apr 2021 Pg. 131-139	Intravenous Admixture Preparation Considerations, Part 9-A: Error Prevention in Intravenous Admixture Preparation Author(s): Allen Loyd V Jr
May/Jun 2008 Pg. 234-236	Obtaining Accreditation by the Pharmacy Compounding Accreditation Board, Part 3: Developing a Program of Quality Assurance and Continuous Quality Improvement Author(s): Cabaleiro Joe
Mar/Apr 2008 Pg. 116-120	Establishing a Quality-Assurance Program for Hospital Compounding Author(s): McElhiney Linda F
Mar/Apr 2015 Pg. 121-124	Quality Assurance and Quality Control, Part 1 Author(s): Akers Michael J
Sep/Oct 2014 Pg. 379-380	Final Guidance for Pharmacy Compounding of Human Drug Products Under Section 503A Author(s): Blankenship Cynthia E
Jan/Feb 2014 Pg. 83-86	E-Prescribing Errors Identified in a Compounding Pharmacy: A Quality-improvement Project Author(s): Reed-Kane Dana, Kittell Katrina, Adkins Jacquelyn, Flocks Sarah, Nguyen Thu