by Celeste Zizzamia, PharmD, BCSCP, PCCA Clinical Compounding Pharmacist

USP 800 discusses Environmental Quality and Control (Section 6) related to environmental wipe sampling for hazardous drug (HD) surface residue. This is not a requirement in USP 800; instead, it is stated that this should be performed routinely. What does this mean for those who handle HDs and why should compounders consider performing routine HD wipe sampling?

When handling HDs, the goal is to minimize exposure through different containment control strategies, from receiving through administration. Containment controls used in practice can be looked at as a hierarchy, with personal protective equipment (PPE) as the least effective and elimination of the HD as most effective. Elimination of HD handling is not an option in most cases, so one must utilize proper engineering controls such as negative pressure rooms, biological safety cabinets, containment ventilated enclosures and closed system transfer devices.

Other forms of containment controls include proper donning and doffing of PPE and removal of HDs through deactivation, decontamination, cleaning and disinfecting (DDCD). Containment can also be achieved through proper administrative controls such as HD communication, training and assessment of risk. Still, even if you follow all containment strategies, how do you know if they are working and that your staff and patients are not exposed?

HD wipe sampling can determine if your containment control strategies are working properly to reduce the risk of HD exposure to your team in any step of the handling processes.

What and where should I test?

USP 800 recommends HD wipe sampling be performed as a baseline at least every six months. Once you identify the areas to test, wipe sampling is a fairly simple process. It is recommended to test at various locations in your facility, starting from the time the HD enters the facility until the time it leaves. There are several companies that offer a wipe sampling kit. The contents may include a set of instructions, tubes for collection, a template to measure the area for collection and a swab used for sampling in each location. It is important to follow the instructions carefully and properly document the HDs to be tested and the corresponding areas within the facility that were swabbed.

USP 800 states the following areas should be tested when performing wipe sampling; however, it would be best to identify high-touch areas throughout the facility — again, from receiving to dispensing/administration — when possible:

• Interior of the C-PEC and equipment contained in it
• Pass-through chambers
• Surfaces in staging or work areas near the C-PEC
• Areas adjacent to C-PECs (e.g., floors directly under C-PEC, staging and dispensing area)
• Areas immediately outside the HD buffer room or the C-SCA
• Patient administration areas

A good place to start is to look at where HDs are handled throughout your facility. In a community pharmacy, this includes areas where patients pick up HD medications. In a health system, consider including medication rooms and patient rooms. Identify locations that have the highest touch rates to determine which areas to sample.

You also need to determine which drugs to test. Depending on the testing company you choose, you can test for a variety of drugs — from antineoplastics to hormones and even drugs such as spironolactone or finasteride. Consider testing for the HD drugs used most frequently in your facility.

What do I do with the sampling results?

Sampling results appear as a quantity if a drug is detected or listed if the drug(s) tested was not detected or present in the area sampled. Some companies color the results if a detected HD is higher than average.

If detectable contamination is found, the designated person is required to identify, document and contain the source of contamination. This can be done by creating an “environmental action plan,” a detailed document that outlines strategies and processes, including actions, timelines, responsible parties and measurable goals. Tracking and trending the wipe sampling results can drive change in your facility to contain the identified HD.

Again, there is not an established action limit for HD contamination levels, so any detectable amount will need to be addressed. Wipe sample results should be used to drive change and improve processes. Changes may include revising the DDCD process, seeking alternatives to HD storage or the use of a closed system transfer device.

Sampling data can be shared with staff to show where HD contamination is working and where it isn’t. Once you start collecting data, you will be able to keep track of sampled locations and start to trend results. The results may never reach zero, but using HD wipe sampling data should lead to a reduction in HD contamination levels.

PCCA members with clinical service access may contact our Clinical Services team for additional information on HD wipe sampling and other compounding concerns. Members without clinical services access can learn how to connect with the experts on our Clinical Services team HERE.

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Reference

1. United States Pharmacopeia. Online Subscription Required.

These statements are provided for educational purposes only. They have not been evaluated by the Food and Drug Administration, and are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care or encourage its abandonment.