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Six Steps to Help Prepare for USP Chapter <800> — Handling Hazardous Drugs

Jeff Bariteauby Jeff Bariteau, Pharmacy Clinical Director, Intalere, based on information provided by Patricia Kienle, Director of Accreditation and Medication Safety, Cardinal Health

Oncology practices are most commonly identified as locations where hazardous drugs are routinely used. However, the use of hazardous drugs in non-oncology practices and the increased utilization of oral hazardous drugs is expanding rapidly.

In February 2016, the United States Pharmacopia (USP) published the nation’s first set of authoritative standards on the handling of hazardous drugs (USP General Chapter <800>) to help protect personnel and patients, and reduce the risk of residual exposure. USP Chapter <800> will be federally enforced on July 1, 2018.

All healthcare personnel and facility types where hazardous drugs are handled or manipulated must quickly adapt to the new requirements. The majority of facilities will be challenged by the potential financial ramifications and the changes that pharmacy practices will need to implement.

Following are six steps to help your facility prepare for USP Chapter <800> requirements: 

  • Develop Your Own Organization-Specific Hazardous Drug List – Identify the drugs and dosage forms that are handled in your organization. Your hazardous drug list must be based on the list of hazardous drugs available from the National Institute for Occupational Safety and Health (NIOSH).
  • Perform an Assessment of Risk – This assessment should be completed as outlined in USP Chapter <800> if you chose to identify alternative containment strategies and/or work practices for those drugs and dosage forms that are not antineoplastic agents requiring manipulation.Examples of alternative containment strategies include purchasing in unit dose packaging, purchasing premixed solutions, and use of dedicated equipment (such as counting trays and spatulas) for oral solid antineoplastics.
  • Perform a Gap Analysis of Your Facility – Perform a gap analysis of your hazardous drug compounding areas. Take steps now to prepare renovation plans and have them approved through the appropriate hospital committees and processes.
  • Evaluate Your Personal Protective Equipment (PPE) – Evaluate the PPE employees use for handling hazardous drugs. Especially for gloves, which must meet the testing standard of ASTM 6978, and gowns. Use the list of recommended PPE in the NIOSH hazardous drug list to develop your policies.
  • Review Your Decontamination and Cleaning Agents – Review the decontamination and cleaning agents you use to ensure they are adequate. A multi-step process for cleaning the hazardous drug preparation area must be used.
  • Ensure Antineoplastic Agents Are Handled in the Proper Engineering Controls – Check your stock records to see if you supply other departments with vials of antineoplastics. If you do, take steps to move preparation into the pharmacy’s proper facility.

Without a doubt, healthcare facilities will face many obstacles over the course of this two-year preparation period for USP Chapter <800>. To learn more, make sure to download our full article with more details on the six steps to help prepare for handling hazardous drugs.