NIOSH recently released its anticipated 2018 update to the 2016 NIOSH Hazardous Drug List and is asking for individuals to review the proposed list and also the new peer review plan policy outlining how drugs are designated as a NIOSH hazard or not.
USP Chapter 800: Hazardous Drugs—Handling in Healthcare Settings requires sites to “maintain a list of hazardous drugs, which must include any items on the current NIOSH list that the entity handles. The entity’s list must be reviewed at least every 12 months”. Section 2 of the chapter references the National Institute for Occupational Safety and Health (NIOSH) document “NIOSH list of antineoplastic and other hazardous drugs in healthcare settings”, as the resource and starting point for facilities.
In the 2016 list, NIOSH presented a process for sub-classifying hazardous drugs according to their risks:
- Group 1: Antineoplastic drugs, including those with the manufacturer’s safe-handling guidance;
- Group 2: Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a hazardous drug, including those with the manufacturer’s safe-handling guidance;
- Group 3: Non-antineoplastic drugs that primarily have adverse reproductive effects.
For the proposed 2018 list, NIOSH presents the policy for how drugs are assigned to the 3 hazardous drug classifications using a new peer reviewed 5 Category system based on evidence of the hazard:
- Category 1—Special Handling Information
- Category 2—Insufficient Toxicity Information Available to Meet NIOSH Definition of Hazardous Drug
- Category 3—Available Information Shows a Toxic Effect that Does Not Meet the NIOSH Definition of a Hazardous Drug
- Category 4—Available Toxicity Information Does Not Demonstrate or Support a Determination that the Drug Meets the NIOSH Definition of a Hazardous Drug
- Category 5—Available Toxicity Information Demonstrates or Supports a Determination that the Drug Meets the NIOSH Definition of a Hazardous Drug
Drugs listed in Category 1 list special handling information listed within the manufacturers package insert. Examples would include compounding in biological safety cabinets.
Drugs listed in Categories 2 through 4 classifies studies, alerts and lack of evidence to support inclusion to the NIOSH hazardous drug list.
Drugs listed in Category 5 list drugs with confirming evidence to support inclusion on the NIOSH hazardous drug list.
For practice sites under the requirements of USP <800>, they really must focus on Category 1 and Category 5 drugs. Those drugs listed in Categories 1 and 5 will then be differentiated into the 2016 Groups. If the 2018 NIOSH list and classification policy are approved, the question is ‘will we see another revision to USP <800> prior to December 1, 2019?’
NIOSH is taking a more on-going approach to reviewing drugs versus the every two-ish year review, where a multitude of databases (FDA, NTP, EPA, WHO, NTP, CERHR, OHAT, SDS, etc.) are assessed based on the proposed Categories. As new drugs enter the US market, or new safety information is made available on existing drugs, or case reports of adverse events are announced will drive the assessment. The 2018 document gives examples of drugs both on the 2016 drug list and ones not listed going through the categorization process; tables 1 through 3. This is great information from a justification standpoint and may clarify categorization based on the 2016 Hazardous Drug document.
Drugs that shook out as ‘newly’ recognized hazards are presented in Table 4. These drugs are proposed for addition to the 2018 hazardous drug list based on the Category 1 and Category 5 classification. Highlighted are ones of interest (not the complete list):
- Botulinum toxins, all forms: Rational; Organ toxicity at low doses & Teratogenicity
- Darbepoetin alpha: Rational; Carcinogenicity in patients with cancer & reduced body weight in offspring in animals
- Dihydroergotamine: Rational; Reproductive toxicity oxytocic properties
- Triazolam: Rational; Mimics existing hazardous drugs exhibiting teratogenicity or other developmental toxicity
Of note, USP <800> mentions the additional classification in addition to the list provided by NIOSH, any investigational or new drug with insufficient safety information should be considered hazardous until more information is available.
This change in classification of hazardous drugs and the newly added drugs really should be reviewed by sites. Visante highly encourages sites to comment on the recommendations.
Sites are encouraged to review and submit comments with regards to the proposed drug list for 2018 and new peer review policy process. Commenting is open until April 16, 2018. Listed on the Federal Register’s notification; “Comments may be submitted, identified by docket numbers CDC-2018-0004 and NIOSH-233-B, by either of the following two methods:
- Federal eRulemaking Portal: www.regulations.gov Follow the instructions for submitting comments to docket CDC-2018- 0004.
- Mail: NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 1090 Tusculum Avenue, Cincinnati, OH 45226-1998.
Instructions: All information received in response to this request for comment must include the agency name (National Institute for Occupational Safety and Health, CDC) and the docket numbers (CDC-2018-0004; NIOSH-233-B). All relevant comments received will be posted without change to www.regulations.gov, including any personal information provided.
For additional information, please refer to a previous article where we describe an eight-step process for developing a hazardous drug list for your facility.
Please remember that the official implementation date of December 1, 2019 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 November 30, 2019.
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.
 USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings
http://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare Accessed February 20, 2018.
 NIOSH . 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 February 20, 2018.
NIOSH . NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. 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 Number 2016-161 (Supersedes 2014-138). http://www.cdc.gov/niosh/docket/review/docket233a/pdfs/2016-161finalpublication.pdf Accessed February 20, 2018.