Megan Reed, CPhT, HDDP

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.

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.

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Competency, sporadic checks, and training can cut down on mistakes that cause contamination.

Perform Sterile Compounding Tasks Carefully

The pharmacy community has been hearing more about the CDC’s National Institute for Occupational Safety and Health (NIOSH) list and the United States Pharmacopeia (USP) General Chapter <800>.

Although compendial, some state pharmacy boards have chosen to adopt all or parts of USP General Chapter <800>. Many pharmacy technicians are still unaware how hazardous drug (HD) handling affects their sector of pharmacy. When asked if other areas of pharmacy need to put policies and procedures into place to prevent HD contamination, the simple answer is yes. But doing so is not so simple and takes careful planning.

In the compounding space, techs are often an integral part of the pharmacy operation. In traditional compounding pharmacies, techs handle raw powders and ingredients to make the final preparation that goes to the patient. During this process, incidents of exposure are highly probable. Exposure of the eyes, mouth, nose, or skin to hazardous chemicals while compounding can lead to both acute and chronic health issues. This includes cancers, rashes, and reproductive issues. Individuals who work in other types of pharmacy practice, such as hospital, oncology, rare diseases, retail, and specialty, may think they are not at risk for this type of exposure. In some scenarios, this is true. However, aspects of the job being performed each day could cause HD exposure. The powder residue from certain hazardous tablets, oral liquids being poured into a container and splashing onto a counter, the residue of hazardous drugs in the will-call area of any pharmacy, or a vial of an antineoplastic being used without precautions are all examples of potential inhalation or skin exposures in these types of pharmacies.

So how do techs become aware of risks and learn how to work with their pharmacists and pharmacy owners to prevent exposure? Have an open conversation about a plan to make sure that all employees around HDs can be protected. USP General Chapter <800> requires the use of a designated person who is qualified and trained to make sure that all aspects of pharmacy activities in HD handling are being performed. This is a perfect opportunity for techs looking to take on more responsibility and show leadership in this space. Acquiring new skills increases a tech’s value and could also lead to an increase in income.

The steps below summarize how a designated person can lead a pharmacy to be HD-handling compliant.

Start by identifying each dosage form of the HD, potential risks, and how an employee should be protected. USP General Chapter <800> provides examples of potential opportunities for exposure based on activity. This includes receipt, dispensing, compounding and other manipulations, administration, patient care activities, spills, transport, and waste. Go through each activity with those who complete those tasks and find the gaps.

Then become familiar with the drugs that are being handled in everyday activities. Receipt of inventory is the beginning stage of identifying HDs. Develop a process to receive these items, and determine what personal protective equipment (PPE) might be need- ed. Go over the pharmacy formulary, or in the case of compounding operations, the list of chemicals within the inventory. Use the CDC NIOSH list to identify which items are considered hazardous (anti-neoplastic drugs, drugs with antineoplastic effects, and nonantineoplastic hazardous drugs). Take it a step further by identifying inventory that may not be on the list but can cause issues if exposed to eyes or skin or if ingested or inhaled. This information can be found in the pharmacy’s safety data sheets that should be easily accessible in a binder or on a computer desktop.

Next, look at the facility to identify what areas need segregated, such as handling, receiving, and storing HDs. The result could be a designated area for counting and pouring drugs in their final dosage form, a negative-pressure room to compound HDs, a negative-pressure area with a refrigerator and storage, a packaging and transport area, and a neutral area for receiving inventory or for the pickup counter. Make modifications to these spaces to be compliant with HD handling requirements.

Then find out what PPE may be required, including chemo gowns and gloves, face shields, goggles, and head, shoe, and sleeve covers. Techs should have input on what works and what does not. Take into consideration that this may require ordering from multiple vendors. Most will send free samples to try. Note that these items may be hard to find during a global pandemic, natural disaster, or supply chain disruption. Follow CDC and USP guidelines to reuse PPE.

Finally, know how to clean equipment, dispose of HDs and PPE, and handle spills. There are 3 steps for cleaning up a non- sterile spill: deactivation, decontamination, and cleaning. In sterile compounding, there is a fourth step: disinfection. Figure out the scenarios that would require this process in everyday operations. Apply these steps to all cleaning of equipment and spills related to compounding, dispensing, packaging, and counting HDs. This could be as simple as a dedicated counting spatula and tray or a more complex item such as a containment primary engineering control. Make sure any items used to clean spills are disposed of properly in dedicated disposal receptacles.

Address the above areas in policies and procedures, and create standard operating procedures to make sure that all employees are on the same page when it comes to possible exposure to HDs. Competency and training on these procedures will help ensure employee safety.

Techs play a vital role in how a pharmacy operates and should be able to work with their places of employment to get the protections they need to do their jobs. As a result of becoming aware of the dangers of HD exposure, techs can take charge of their future, health, and work environment.

Address the risks in policies and procedures to ensure that all employees are on the same page.