Hazardous Drug Sampling

EOC1 can provide hazardous drug sampling and testing for marker drugs in your facility to meet guidelines set forth by NIOSH, OSHA, and USP <800>. EOC1 was one of the first companies to provide antineoplastic environmental monitoring for our customers engaged in compounding chemotherapy drugs. According to the Centers for Disease Control and Prevention (CDC), environmental sampling is “a relatively new approach used to determine the level of workplace contamination by antineoplastic agents.”  

We played an important role in developing the original sampling process and analytics. To this day, the investigatory tools we helped develop, such as environmental wipe sampling, are used by many companies throughout the hazardous drug testing, monitoring, and compliance industries. Although specific analytical methods are not available for all hazardous drugs, we are capable of handling many chemotherapeutic and hormonal drugs through our hazardous drug sampling and non-antineoplastic drug testing services.

Hazardous Drug Sampling Graph

With the promulgation of USP <800>, compounding of hazardous drugs is coming under increased scrutiny by inspectors. Early work was performed in the 1990s by the American Society of Hospital Pharmacists (now known as the American Society of Health-System Pharmacists), to define potential threats posed by exposure to hazardous drugs. Although these standards are designed to protect both patients and healthcare workers, our work focuses primarily on keeping your employees safe.

Categories of concern include chemotherapy, hormones, and antiviral drugs, among others. While earlier USP standards, such as <797>, focused on the safety and purity of sterile products, the newer USP <800> standard focuses on the health and safety of employees involved in the formulation, handling, production, and administration of these potentially hazardous products.

As pioneers in the areas of hazardous drug sampling and hazardous drug testing, EOC1 excels at ensuring workplace safety and compliance. 

NIOSH categorizes these potentially problematic drugs in three groupings*:

Group 1:

Antineoplastic drugs (AHFS Classification 10:00) [ASHP/AHFS DI 2013]. Given that many antineoplastic drugs work by targeting rapidly dividing cells, exposure to these drugs can be especially dangerous for a developing fetus during the early stages of gestation. To ensure your employees’ safety, and your institution’s compliance with these important safety regulations, we offer hazardous drug sampling and testing.

Group 2:

Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a hazardous drug. Note that some of these drugs may also pose a reproductive risk among susceptible populations. To keep your employees safe, we offer non-antineoplastic drug testing services. As the pioneers of now-standard practices, such as environmental wipe sampling, EOC1 stands at the vanguard of hazardous drug sampling and workplace protection.

Group 3:

Drugs that primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breast feeding, because some of these drugs may be present in breast milk. Obviously, these drugs are particularly problematic for employees of reproductive age who may be actively engaged in trying to build a family. Given that breast feeding is recognized as important for the optimal health and development of infants, it’s crucial that breastfeeding employees be protected from exposure to these potent, and potentially dangerous, drugs.

USP <800> states:

“Environmental wipe sampling for HD surface residue should be performed routinely (e.g., initially as a benchmark and at least every 6 months, or more often as needed, to verify containment).”

“If any measurable contamination is found, the designated person must identify, document, and contain the cause of contamination. Such action may include reevaluating work practices, re-training personnel, performing thorough deactivation, decontamination, cleaning, and improving engineering controls. Repeat the wipe sampling to validate that the deactivation/decontamination and cleaning steps have been effective. “

*Citation:  NIOSH [2014]. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2014. By Connor TH, MacKenzie BA, DeBord DG, Trout DB, O’Callaghan JP.. 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. 2014-138 (Supersedes 2012-150). DHHS (NIOSH) Publication Number 2014-138 (Supersedes 2012-150).  September 2014

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