Health12 August, 2020

Hazardous drugs: NIOSH update impact on pharmacy

The NIOSH list was created in 2004 with an intent to prevent occupational exposure to hazardous drugs in healthcare workers. Since its inception, it has been revised to keep up to date with drug development and evolution, and it is undergoing its most recent update. If your pharmacy or facility is involved with hazardous drugs, here are the top three ways the NIOSH update will likely impact your practice.

New drug tables and classifications to understand and track

The basic definition of a hazardous drug has been updated. It is now classified as a drug that: 

  • Is approved for use in humans by the FDA-CDER, and
  • Is not otherwise regulated by the U.S. Nuclear Regulatory Commission, and
  • Either: 
    • Is accompanied by prescribing information in the package insert that includes a Manufacturer Special Handling Information (MSHI), or
    • Is identified as a carcinogenic, developmental, reproductive, genotoxic, or other health hazard

This means that the NIOSH list no longer includes drugs under investigationyou will need to perform an Assessment of Risk (AoR) on those drugs to ascertain appropriate precautions yourself. 

Based on this updated definition of hazardous drugs, there have been some major changes to the NIOSH tables. Historically, tables 1, 2 and 3 listed and classified the drugs based on whether they were antineoplastics (Table 1), non-antineoplastics (Table 2) or reproductive-only hazards (Table 3). In the update, NIOSH decided that antineoplastics is no longer the most clear-cut criteria for establishing a list of hazardous drugs; the updated tables use primarily the presence of MSHI and the classification of carcinogenic as their defining criteria. The NIOSH update includes two tables, which are outlined as follows: 

  • Table 1 includes drugs that: 
    • Meet the NIOSH definition of Hazardous Drug, and
    • Contain an MSHI, and/or
    • Are classified by the NTP as a known human carcinogen, and/or
    • Are classified by the IARC as carcinogenic or probably carcinogenic. 
  • Table 2 includes drugs that: 
    • Meet the NIOSH definition of Hazardous Drug, but
    • Do NOT contain an MSHI, or
    • Are NOT classified by the NTP as a known human carcinogen, orAre NOT classified by the IACP as carcinogenic or probably carcinogenic

So how were all the drugs on the existing NIOSH list doled out? Based on these criteria, 33 drugs moved from Table 1 to Table 2, 14 drugs moved from Table 2 to Table 1 and 48 drugs moved from Table 3 (which no longer exists) to Table 2. Those drugs that were originally Table 3, and are reproductive hazards only, are identified on Table 2 by blue designation in the supplemental information. 

Different Strategies for Assessment of Risk

Understanding the new NIOSH table structure will help you strategize how to move forward with risk assessment, containment strategies, and work practices. The purpose of an AoR is to keep employees safe, based on the NIOSH Hierarchy of Controls.

Because many hazardous drugs, especially those used in an oncological application, are necessary and lifesaving, elimination and substitution are not suitable controls. So, safe practice modifications must focus on the other three levels of control. USP Chapter 800 has a defined strategy of control for hazardous drugs, but an assess-and-stratify-risk approach may also be appropriate in certain situations. CriticalPoint uses a best practice strategy of: 

  • Everything on Table 1 should utilize USP 800 standards and strategies.
  • For those hazardous drugs not on Table 1, you should perform an AoR. Consider how the drug is received, who the recipient is, the structure of your facility (are you part of a centralized system, where drugs are packed and shipped, for example, or an independent entity?), and what your compounding procedures are. 

If you are a facility with few entity-exempted drugs, it may be safest to complete an AoR for each drug. However, if you are a facility with many entity-exempted drugs, you can implement a practice of breaking the alternate containment strategies and work practices into categories. One recommended method is the stoplight approach: 

  • Red category drugs are full USP <800> strategies and standards (full PPE, specialized work practices, etc.).
  • Yellow category drugs are a modified strategy based on their hazards. 
  • Green Category drugs require no PPE or special work practices. 

Once you've established your AoR strategies, you can carry that through into your Standard Operating Procedures. 

Adjustments to your SOPs

All of these classifications and standards will become official once the USP Chapter 800 update is finalized, so your SOPs will need to reflect this update to pass inspection. Hazardous drug handling can incite stress among your team; it can be helpful to overcommunicate when it comes to updating processes and procedures related to HDs. You'll need to establish clear messaging for your staff regarding what practices are changing and why. It can be helpful to build a crosswalk of hazardous drugs, based on the stoplight categories. Outline where drugs fall in the stoplight, and what practices will now apply to them based on that categorization. Your staff should be trained on the stoplight categoriesnot just those in the nursing units or pharmacy, but employees across the entire life cycle of the drug. 

With a clear understanding of hazardous drug classifications, a proactive strategy for Assessment of Risk, and informative and organized communications and training for your staff, the NIOSH Update will transition smoothly for your facility. And a turnkey pharmacy compliance software that's designed to meet and exceed USP <800> standards, such as Simplifi 797, can make this process as streamlined as possible for your facility. 

Simplifi 797®
Take the guesswork out of USP medication compounding compliance with a customizable, mobile, evidence-based solution.
Simplifi 797®

Take the guesswork out of USP medication compounding compliance with a customizable, mobile, evidence-based solution.

Simplifi 797 provides the latest evidence-based guidance and helps navigate the complex USP Chapters 795, 797 and 800 processes to ensure inspection confidence and keep patients and staff safe.
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