Not all medications are one-size-fits-all. Certain patient populations require customized formulations to support more effective clinical outcomes. The Food, Drug and Cosmetic Act defines this process as compounding, meaning the combination, mixing, or alteration of drug ingredients to create medications tailored to individual patient needs. The United States Pharmacopeia further defines it as "the preparation, mixing, assembling, altering, packaging, and labeling of a drug ... in accordance with a licensed practitioner's prescription."

Compounding has deep roots in pharmacy history, and quality standards have continued to evolve alongside advances in pharmaceutical science, technology, and regulatory oversight. In 2013, the Drug Quality and Security Act established a federal framework for outsourcing facilities that compound larger volumes of products for distribution. That regulatory shift raised the floor. Human factor design can raise it further.

Understanding the Problem

Even with strengthened regulatory standards, human factors continue to play a critical role in compounding quality and patient safety. Workflow design, environmental conditions, communication and system complexity can all influence the likelihood of errors. The World Health Organization defines medication errors as events that occur when weak medication systems and factors such as fatigue, poor environmental conditions or staff shortages affect prescribing, transcribing, dispensing, administration and monitoring practices. The result can be severe harm, disability and death.

Data from across healthcare illustrate the scale of the challenge. According to a 2024 World Health Organization systematic review, at least one in 20 patients worldwide is affected by preventable medication-related harm, and more than one-fourth of that harm is severe or life-threatening. The same review found that about 53% of all preventable medication-related harm occurs at the ordering and prescribing stage, and 36% occurs at the monitoring and reporting stage. The WHO's 2017 Medication Without Harm report estimated that medication errors cost $42 billion annually, almost 1% of global health spending. A 2010 HHS Office of Inspector General analysis of 2008 data estimated that adverse events contributed to roughly 180,000 deaths a year among hospitalized Medicare patients.

Common compounding errors include calculation mistakes that lead to incorrect dosages, contamination from improper techniques or facility design, and labeling errors from data entry. Compounded medication workflows rely heavily on technician duties, pharmacist double checks and multiple system interfaces. Any point in that chain can produce an error. At Revelation, engineering teams responsible for in-house software and integrations work together to help reduce the risk of error in manual transcription, calculation and labeling steps.

Understanding Human Factors Engineering

Human factors engineering, or HFE, is defined as "the application of human factors information to the design of tools, machines, systems, tasks, jobs, and environments for safe, comfortable, and effective human use." Its goals include reducing error and improving system performance while creating a work environment that supports workforce well-being.

Loading, whether physical, cognitive or emotional, directly impacts worker performance. Under-loading and over-loading both produce stress. Workplace stress also results from a mismatch between employee needs and environmental characteristics. Reorganizing inefficient work processes is critical to the health and modernization of any operation, and communicating the benefits of those staff changes is key to successful implementation.

Human error is often a symptom of technology and processes that lack effective controls. Accidents are rarely attributable to individual behavior alone. Leaders must examine how interactions between components fail, meaning how the system itself fails. In compounding, that failure directly impacts patient safety.

Environmental and Technological Controls

Environmental factors, including layout, lighting and noise, can be root causes of errors in compounding laboratories.

A well-designed layout guides technicians through correct, repeatable patterns and reinforces safe compounding practices from the start. At Revelation, a dedicated facility design leadership team applies HFE principles from the earliest planning stages, including workflow-directed layout, adjustable lighting, noise and traffic controls. Lighting demands equally careful consideration. During daytime hours, short wavelengths in the blue spectral range can sharpen alertness, boost concentration, accelerate reaction time and improve task accuracy. For optimal conditions, facilities should prioritize:

• A color rendering index score of 80 or above
• Technician-controlled lighting settings, which increase satisfaction and support stronger performance
• Engineering controls that restrict light exposure, safeguarding compounds sensitive to it

Technology plays a meaningful role, though its complexity can limit outcomes. Effective system controls include barcode-facilitated verification for components, lot numbers, expiration dates and labeling. Documentation of balance weight against system-calculated acceptance criteria also supports error reduction. Unclear instructions and look-alike or sound-alike drugs add complexity and increase risk. Standardized master formulation records, validated calculation workflows, defined checkpoints and verifications, and document control further reduce variability by supporting consistent preparation. At Revelation Pharma, our proprietary pharmacy management and compounding software is designed to connect with core operational systems, with the goal of reducing manual transcription and handoffs between systems.

Building a Culture of Safety

An organization must prioritize continuous quality improvement if it is committed to patient safety. That culture starts at the senior level, where leadership advocates and dedicates resources for improvement at the employee level. A compounding pharmacy requires dedicated leadership to report, track, trend and address every quality event. At Revelation, our quality team oversees the reporting, trending and corrective action of quality events within a non-punitive reporting culture. Each quarter, cross-functional leaders, led by quality, come together to review trend insights and the progress of continuous quality improvement (CQI) projects.

Non-punitive incident reporting is foundational. An efficient medication error reporting system is the backbone of reliable practice and a measure of progress toward safety. Direct observation and validated risk frameworks increase compliance in incident reporting. When pharmacists build lessons learned around errors and create discourse around those events, meaningful learning and error reduction follow.

Enhanced training programs and competency validations also reduce compounding errors. Dynamic training programs that evolve with the workforce and the systems they use are the most effective. Neither people nor systems will ever be perfect, which is exactly why HFE is a continuous discipline.

Standardizing processes through standard operating procedures and work instructions reduces ambiguity, defines expectations and lowers the likelihood of human error. When HFE design centers on the compounding process and the people who perform it, the result is more efficient operations and fewer errors, producing better outcomes for patients and the healthcare supply chain alike.

Takeaways and Recommendations

HFE is, above all else, a systems discipline that applies a holistic philosophy to the complex interactions between humans and their environments. Research increasingly supports human systems integration as an effective path to safety and quality improvement in compounding. Facilities should prioritize HFE adoption, as continued study and application can advance quality practices, reduce errors and strengthen patient safety outcomes for years to come. At Revelation Pharma, designing the facility, the software and the workflow together is how we work to reduce medication errors and support our teams.