Considerations Regarding the National Institute for Occupational Safety and Health 2016 Hazardous Drug List

In 2016, the National Institute for Occupational Safety and Health (NIOSH) published an updated list of antineoplastic and other hazardous drugs (HDs). This list, which is updated periodically, is crucial to the implementation of USP <800>, as the regulation requires institutions to identify all HDs dispensed in their facility. USP <800> will eventually be implemented by all boards of pharmacy and nursing throughout the United States.^1-4

The NIOSH list groups HDs into 3 categories. Group 1 products encompass antineoplastic drugs, group 2 products encompass nonantineoplastic drugs that meet other criteria for potential hazards, and group 3 products include drugs that may harm human reproduction. Importantly, group 3 is not the only group that may pose reproductive risk. Criteria for qualification of nonantineoplastic drugs as HDs include the potential for carcinogenicity, genotoxicity, organ toxicity, or other product-specific properties.¹

It is important to recognize that not all HDs pose a major risk during occupational exposure. For instance, HDs that are supplied in solid, intact dosage forms—such as coated tablets or capsules&mdash;generally do not pose a risk to workers.

However, products such as uncoated tablets that shed dust may result in exposure, skin contact, or inhalation of hazardous materials. Due to these risks, uncoated tablets should never be placed in automated counting machines; they should be counted manually and poured carefully to minimize the risk of exposure. Avoid activities involved in compounding HDs, such as crushing tablets or opening capsules.¹

Certain products may be more likely to be crushed or compounded in a community or specialty pharmacy setting. These include progesterone, which may be compounded into suppositories; any compounded formulations or hormones, such as testosterone, estradiol, or progesterone combinations; and compounded oral syrup formulations of finasteride to provide low-dose daily treatment for prevention or mitigation of alopecia. Other dosage forms, such as uncoated forms of warfarin tablets, colchicine tablets, or cyclophosphamide tablets, may pose a risk of exposure.¹

When handling hazardous medications, several precautions should be taken in terms of using personal protective equipment and engineering controls; it is also important to realize when protective gear is not required. For instance, when cleaning up a spill or leak of hazardous medication, wearing 2 layers of chemotherapy gloves, donning a protective gown, and using respiratory protection are all recommended practices.¹

NIOSH also recommends wearing 1 layer of chemotherapy gloves during unpacking or storage activities. However, wearing 2 layers of gloves, protective gowns, eye or face protection, or respiratory protection are not required under most circumstances.

Although many products that are on the NIOSH HD list are hazards well known to all pharmacists, some included products may not be thought of as hazardous medications in most contexts. For instance, 39 products on the list are classified as pregnancy category C: of this list, 13 are category 3 medications that have no toxicity other than a reproductive hazard (Table1). In addition, many medications that are classified as category X in pregnancy are not included on the list, such as all statins.^1,5

Although the NIOSH list is an important guide for pharmacists and other health care professionals when developing an institution-specific list of HDs, per USP <800> requirements, it is important to analyze all potential hazards regarding medication exposure. In developing a list, it is important to consider the perspectives of all stakeholders, including those handling medications. Even if medications are not listed by NIOSH, the concerns of staff with regard to any specific medication or class of medication should be considered.^1&ensp;

Michael R. Page, PharmD, RPh, has worked as a community pharmacist at CVS Pharmacy and is clinical editor in clinical and scientific affairs at Pharmacy Times^®.