United States Pharmacopeia <800>: Hazardous Drugs – Handling in Healthcare Settings

Section 6: Environmental Quality and Control

Sections 1 through 5 of United States Pharmacopeia (USP) Chapter <800>: Hazardous Drugs—Handling in Healthcare Settings is the blueprint and engineering structures for our road to compliance. What metric can we put into place to measure safety and a point in time assessment of progress?

Section 6 of USP <800> introduces the concept of environmental sampling (surface wipe sampling) for hazardous drug residues. Sitting on top of USP <797> requirements for viable (microbiological) and non-viable (non-microbiological) surface sampling, adding hazardous drug residue sampling adds to non-viable sampling program (non-microbiological). Surface wipe sampling is the method of choice to evaluate workplace contamination with hazardous drugs. Currently, there are a considerable number of studies published that have documented variations in the methodologies used for surface wipe sampling and reporting of results for hazardous drug residues. One consistency amongst all the published studies is the identification of residues of hazardous drugs in numerous locations throughout the compounding spaces, drug administration locations and throughout facilities.

USP <800>’s perspective for the use of wipe sampling is a recommendation that should be considered within a hazardous drug safety program. Sampling should be considered on a routine basis (i.e., every 6 months) or more often if spills or concerns over risky processes exist. Section 6 gives a highlight of sampling locations to consider based on published studies and include; primary engineering controls work surfaces (hoods); floor space below the hoods; counters where hazardous drugs are stored; door handles of the compounding areas; delivery locations for drug administration; arms of the chairs used for drug administration to name a few. Sites should perform a tracer (follow the drugs from receipt to disposal) to identify all touch points by personnel and equipment to set a map for sampling.

Environmental wipe sampling for hazardous drug residue does not define the overall efficacy of a program. It merely gives a point in time and the residue that is or is not measurable at that time. Sites should consider sampling for the most common drugs handled and may want to consider one or two representative hazardous drugs; i.e. cyclophosphamide (acidic) and fluorouracil (basic).

USP does not give any specific requirements for the number of samples and sites should choose the number of samples based on what they consider to be at risk, for example, one sample in each PEC and one on the drug administration area.

There are many vendors who provide kits with all the sampling materials needed. It is important to note that the process of sampling for hazardous drug residues is itself a hazardous process. Sites should have personnel don the appropriate personal protective equipment that would be donned for compounding. All materials not sent back to the sampling laboratory must be disposed of as hazardous waste. Personnel may be tempted to keep pens and stickers that are left over, however this should be highly discouraged due to their hazardous nature.

Results for the samples may take anywhere from two weeks up to one month. Once the report arrives, it should be reviewed and assessed by the designated person responsible for managing the hazardous drug program and the administrator in charge. Together, a decision on what to do with the results should be formulated. USP does not give ‘acceptable’ limits for measurable residue; best practice is to have no measurable residue. If the test(s) demonstrates an excursion (i.e., a positive sample for the presence of drug residue) a review of the processes surrounding the location of the positive sample should take place, education of personnel of the results and a thorough deactivation, decontamination, cleaning and disinfection of the area must take place followed by a repeat sampling. Sampling of the area should continue until results return to a baseline of no residue. If continuous positive samples continue, the site may warrant the use of an outside agency to assist with addressing the cleaning processes and operating procedures.

Although a recommendation, it is highly encouraged that sites consider using surface wipe samples as one metric in the measurement of a safe hazardous drug program in addition to the surface viable sampling program outlined within USP <797>.

As the official implementation date of July 1, 2018, for USP Chapter <800> Hazardous Drugs—Handling in Healthcare Settings compliance is rapidly approaching, the time for review of USP’s newest chapter is now rather than June 30, 2018.

Don’t know where to start with a hazardous drug safety program? Visante offers a full line of consulting activities to clients just starting down the road to compliance to practice sites on the journey and wanting to go beyond minimal practice standards.

References

[1] USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings

http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-healthcare-settings. Accessed May 10, 2017

[2] NIOSH [2004]. NIOSH alert: preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165. http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf Accessed May 10, 2017.

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