Quality refers to a set of systems that minimizes errors, maximizes performance and efficiency, and which provides the user with an optimal experience to receive the greatest health benefits.
Quality is sometimes regarded as a nebulous term. It has been described in some circles as a measure of excellence, while others see quality as far more subjective in nature. The Institute of Medicine (IOM) refers to quality of care as that which will increase the likelihood of desired outcomes. In any event, even with variations on the principal concept, we understand the basic premise of quality.
In the case of operations management for pharmacy, quality refers to a set of systems that minimizes errors, maximizes performance and efficiency, and which provides the user with an optimal experience to receive the greatest health benefits. This premise can be applied to any pharmacy practice environment.
Researcher Loyd V. Allen expounded upon the concept of quality control in a compounding pharmacy.1 Allen explains that every compounding pharmacy must have a quality control (QC) program covering all aspects of compounding performed in the facility. Even in the absence of fully equipped quality control laboratories, it is still possible to establish an adequate quality control program. All personnel must be properly trained on standard operating procedures (SOPs), and those procedures should include monitoring room temperature, air quality, and other environmental factors. Written procedures for the compounding of drugs must be available to ensure integrity of the final product and ingredients must be properly weighed using equipment carefully monitored for their functional accuracy. Pharmacists must also review all compounding records for accuracy and conduct in process.1
Allen then distinguishes quality control from quality assurance (QA). Unlike QC, Allen defines QA as a system of steps and actions taken to ensure the maintenance of proper standards, including thorough and accurate documentation. He suggests that failures tend to occur when employees do not know their responsibilities, are not well versed in SOPs, have not been provided with resources needed to do their jobs, and do not take their responsibilities seriously.1
Allen then distinguishes the concept of continuous quality improvement (CQI) from QC and QA. According to Allen, CQI evaluates the latter 2 in a systematic manner, making it a routine that is part of a culture of quality. In this way, a comprehensive check of final preparations becomes habitual and includes evaluation of product yield, physical tests when appropriate, package labeling, and dissemination of information to the patient.1
In another article, Lisa D. Ashworth, RPh, goes into detail on what comprises a good set of SOPs.2 She states that SOPs are very similar to policies and procedures; they describe how to perform tasks, identify individuals with certain operational responsibilities, and are the bridge between the employee and the equipment used to perform the task. Types of SOPs include those involving administrative duties, dispensing, emergency procedures, equipment handling, personnel issues, purchasing, testing, and maintenance. Well-written SOPs include the who, what, when, where, why, and how for each aspect. Ashworth also clarifies what an SOP is not, saying that an SOP is not a description from a monograph, a certificate of analysis, a license or permit, a finished preparation, or an award for a job well done. She ends the article with a helpful appendix providing a sample SOP template.2
Although these articles consider the concept of quality for those in the compounding pharmacy environment, pharmacists and technicians in any setting can learn a lot about quality. Total quality management must be the cultural ethos within every pharmacy organization. SOPs are necessary to minimize errors and, to the extent possible, to compel good habits and reliable products and services. Importantly, following such quality controls does not detract from professional autonomy or diminish the opportunity to tailor a service to a particular patient’s needs.
Additional information about Ensuring Quality in Pharmacy Operations can be found in Pharmacy Management: Essentials for All Practice Settings, 5e.
About the Author
Shane P. Desselle, RPh, PhD, FAPhA, is a professor of social and behavioral pharmacy at the Touro University California College of Pharmacy.
1. Allen LV. Introduction of quality control in a compounding pharmacy. Intl J Pharmaceut Compound. 2016;20(6):481-484.
2. Ashworth LD. Quality-control: Standard operation procedures—an essential tool for developing quality preparations. Intl J Pharmaceut Compound. 2016;20(6):226-229.