On May 1, 2020, the National Institute for Occupational Safety and Health (NIOSH) released the long-awaited proposed “NIOSH List of Hazardous Drugs in Healthcare Settings, 2020”, as well as “Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings” and “Managing Hazardous Drug Exposures: Information for Healthcare Settings” in the Federal Register. The comment period has ended, the review period has begun and the final publication timeline….unknown.
These documents provide the fundamentals referenced in USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings which direct the safe handling of hazardous drugs.
So, what is the impact for your organization?
First and foremost, each organization is responsible for updating their hazardous drug list at least annually, regardless of the publication frequency of NIOSH Lists, and the changes in hazardous drugs from 2016 to 2020 must be reflected in the list. At a minimum an organization must use the NIOSH List as their starting point and consider including other drugs as hazardous drugs based on the organization’s risk assessment of drugs on their formulary.
Next, the change in tables reflects a change in how hazardous drugs were and are categorized. This results in a potential change in your assessment of risk decisions based on the hazard profile of the drug.
And lastly, the PPE and engineering controls operationalized by your organization may also change based on the hazardous drugs in the lists, the categorizations and the change in management standards.
As proposed, 44% of drugs on the NIOSH List 2016 will be transitioned to a different table in the NIOSH List 2020 and there is a 5% change in the hazardous drugs listed.
The last published NIOSH List was in 2016, so what are the proposed changes?
The proposed NIOSH List 2020 reflects;
1.A change in format (5 tables in NIOSH List 2016 to 2 tables in NIOSH List 2020),
2. A change in placement of hazardous drugs on specific tables
3. A change in hazardous drug content (18 hazardous drugs have been added, and 5 hazardous drugs have been removed).
4. Additionally, some of the recommendations for managing the exposures have also changed.
It is from the NIOSH List that an entity must, at a minimum, identify their hazardous drug list based on the drugs that the entity handles; the procedures which define the criteria used to identify HDs (post publication of the list) that the organization purchases; and the personal protective equipment (PPE) and engineering controls that an organization will operationalize to minimize the risk of exposure to hazardous drugs by their employees.
Need help drilling into your hazardous drug details, please contact us at PharmEcology Services, Waste Management Sustainability Services.
PharmEcology provides a one-stop solution to help your organization identify, segregate, manage, and dispose of pharmaceutical waste in a compliant and cost-effective manner. We now offer a unique Assessment of Risk customized to your inventory as required by USP <800>.
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