USP : Are You Protecting Yourself?

The newest US Pharmacopeia (USP) standard adds significant changes to the way we handle hazardous drugs (HDs). While USP <797> focused on protecting sterile products, the new USP <800> focuses on protecting people — specifically healthcare workers and patients.¹ Not only does it dictate millions of dollars of renovations, but also unveils the true risks of handling HDs.

CDC reports over 8 million health care workers are exposed to hazardous drugs every year.² Over 50 studies confirmed urine samples of health care workers that indicated actual exposure to HDs.³ CDC also reported that occupational exposure to hazardous drugs has been linked to miscarriages, infertility and cancer, just to name a few health issues.⁴

Pharmacists and interns who prepare HDs or work in areas where these drugs are located are potentially at risk for these adverse health effects. It is important for us to understand the risks and be proactive about protecting ourselves.

NIOSH Antineoplastic and Other Hazardous Drugs

As a refresher, The National Institute for Occupational Safety and Health (NIOSH) offers a list of “Antineoplastic and Other Hazardous Drugs in Healthcare Settings.” This publication was last updated in 2016, but more recent changes have been posted to the CDC website.

NIOSH defines HDs as the following: ⁵

• Carcinogenicity
• Teratogenicity or other developmental toxicity
• Reproductive toxicity
• Organ toxicity at low doses
• Genotoxicity
• Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria

NIOSH divides HDs into 3 major groups:

• Antineoplastic drugs, including anastrozole, bendamustine, and gemcitabine.
• Non-antineoplastic drugs that meet 1 or more NIOSH criteria for hazardous drug. These include abacavir, carbamazepine, divalproex, estradiol, and spironolactone.
• Drugs that primarily pose a reproductive risk to men and women who are actively trying to conceive, and women who are pregnant or breastfeeding, such as clomiphene, clonazepam, dutasteride, and finasteride.

USP <800> Majors Points^1,5

These are the major changes that pharmacists should be made aware.

Receiving/Unpacking

When receiving antineoplastic HDs and HD active pharmaceutical ingredients (APIs), they must be unpacked in a neutral/normal or negative pressure area.

It is crucial that personal protective equipment, including chemotherapy gloves, must be worn when unpacking HDs. According to NIOSH, receiving/unpacking/storage for all types of HDs do not require gloves, but are recommended.

If unpacking HDs that are not contained in plastic, it is recommended personnel wear a protective respirator. NIOSH states that respiratory protection is only required when spills or leaks occur.

Storage

Antineoplastic HDs and HD API must be stored separately from non-HDs, which can pose a problem for certain hospitals who already have limited space. Reorganization or construction will have to take place.

Compounding

Hospitals are currently undergoing major construction to adhere to the new compounding standards. HDs must be prepared in a negative-pressure area via primary engineering controls that are solely dedicated to HDs. Furthermore, Class I Biological Safety Cabinets (BSC) or Containment Ventilated Enclosures (CVE) are no longer allowed for compounding sterile HDs.

Dispensing

When dispensing medications, clean equipment must be dedicated for use with HDs only. It is important to decontaminate equipment after every use. Some hospitals have leaned toward the idea of using disposable trays and spatulas to avoid any issues with cross contamination.

Administration

Although pharmacists are not necessarily involved in the administration of drugs, they will be more involved from now on. USP <800> requires nurses to crush tablets in a special plastic pouch to reduce exposure.

However, if tablets need to be cut, pharmacy is now the man for the job. This may disrupt workflow processes and delay patient care.

Personal Protective Equipment (PPE)

PPE refers to gloves, gowns, shoe covers, and eye and face protection. Hospitals are currently determining an assessment of risk for all of their HDs in order to figure out what level of PPE needs to be worn, whether it be double gloving or wearing a respirator.

Conclusion

In anticipation of the December 1, 2019 implementation date, hospitals will be undergoing major changes and pharmacy will be modifying many workflow processes. Although USP <800> may seem burdensome, we must focus on the positive impact it will have on healthcare workers in the long run.

Nancy Tang is a 2019 PharmD Candidate at the University of Texas at Austin.

References

• USP Compounding Compendium 2017. Rockville, Maryland: United States Pharmacopeia Convention; 2017. USP <800> Hazardous Drugs—Handling in Healthcare Settings; pp. 83—101.
• Hazardous Drug Exposures in Health Care. Centers for Disease Control and Prevention. https://www.cdc.gov/niosh/topics/hazdrug/default.html Accessed April 2019.
• Beans BE. USP <800> Adds Significant Safety Standards. P&T. 2017 May;42(5):336-339.
• Tomkins J. Ensuring Health Care Worker Safety When Handling Hazardous Drugs: The Joint Position Statement From the Oncology Nursing Society, the American Society of Clinical Oncology, and the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2015 Jul; 11(4):278-9.
• NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. Centers for Disease Control and Prevention. https://www.cdc.gov/niosh/docs/2016-161/default.html Accessed April 2019.