Perform Sterile Compounding Tasks Carefully

Pharmacy technicians have one of the toughest jobs in the industry, especially when it comes to sterile-compounding tasks, many of which they are expected to perform daily.

Most techs are just trying to get through cleaning, compounding, packaging, scheduling orders, and shipping. Amid the chaos, techs should look at the processes they perform and verify they are doing them correctly per the policies, regulations, and rules, not just doing the tasks on autopilot.

Picture a tech’s first day performing sterile-compounding activities. The training may have started with reading a policy and procedure manual. Or perhaps the tech received didactic training on a computer module or via an onsite workshop. Most techs learn the basics of compounding on the job. For advanced techs, who have been performing their duties for years, it remains important to self evaluate every task that is performed and ensure nothing is overlooked. The level of comfort should not hinder being vigilant in performing sterile processes.

Over time, due to workload or just repetition, the steps taken in compounding processes can be changed or skipped to speed up the process. But these actions, whether done consciously or not, can cause life-threatening results. The integrity and quality of the compounded preparation may be called into question. To ensure safety, there needs to be time to evaluate how techs are trained and how competently they are doing their jobs. Techs must be aware of how they are performing their tasks and not be afraid to critique how others perform the same task, including pharmacists. Pharmacists cannot supervise techs without also being competent and trained. This is a matter of patient safety.

Per United States Pharmacopeia (USP) Chapter <797>, high risk—level compounded sterile preparations pose the greatest threat to patients because compounding personnel are tasked with processing nonsterile components and devices to achieve sterility. Low- and medium-risk compounding can also threaten patient safety if all aseptic processes are not followed. If a tech does not follow specific protocols, contamination is possible.

The FDA frequently finds deficiencies, noted on Form 483, that involve pharmacies that do various forms of compounding. The agency cites mistakes, including air and surface sampling, aseptic technique, cleaning and disinfection, garbing and gloving, and testing. For example, a deficiency that has occurred at multiple sites is insanitary conditions. Many cleanrooms do not have a consistent cleaning schedule, including maintenance of International Organization for Standardization (ISO) class 5 areas. Rusted carts, hoods, and wheels are found consistently. This happens when techs are not involved in the education of which cleaners, disinfectants, and sporicidal are compatible with surfaces they use daily. They also may not know that they must become internal detectives, looking for wear and tear in their own cleanrooms and on equipment.

Another deficiency is proper garbing and gloving. Over time, this has become an automated procedure. Instead of washing from the fingertips to elbows, techs may be washing from elbows down or have stopped using a nail pick. The last and most important is using the ISO class 5 hood correctly. If a tech has 60 items to compound, the focus is how to get things done quickly and in a short amount of time. Items brought in might not be cleaned or gloves might not be sprayed with sterile isopropyl alcohol when reintroduced into the hood. Another observation is the importance of first air in the hood. Techs need to read the USP chapters and understand the “why” behind their activities. If they understand the reasoning behind the jobs they perform, they become invested in preventing mistakes.

Competency, sporadic checks on daily activities, and training can cut down on mistakes. Not everyone is able to learn by reading and comprehension; many people are visual learners. Taking a risk-based approach enables techs to self-assess and correct daily, instead of waiting for media fill tests (annually for low and medium risk; biannual for high risk) or annual trainings. There also must be the ability to critique one another without offense being taken. A team-based approach is beneficial to a pharmacy and makes a difference in recognizing mistakes and producing ways to solve issues as they occur. Communication is key to preventing life-threatening problems for employees and patients, especially if a tech goes to a manager about a serious issue. All reporting of adverse events should be investigated and remediated.

For all techs, no matter what their experience level, asking for what is needed to perform the required duties is the key to a successful pharmacy. Continuously asking questions about the processes, improving knowledge, and being aware of what goes on each day will lead to awareness of potential process gaps and improvements.

Megan Reed, CPhT, HDDP, is a pharmacy technician at the Pharmacy Compounding Accreditation Board and is a member of the pharmacy clinical team at the Accreditation Commission for Health Care in Cary, North Carolina.