Pharmacy OneSource Blog

Are You Ready for USP <800>?

Posted on 03/17/15

timeUSP <800> Hazardous Drugs – Handling in Healthcare Settings is in its second public comment period through May 31, 2015. This is your chance to influence public policy if there are issues in the proposal that you want to address.

The proposed chapter was originally published last March and many public comments were received. The comments were reviewed by the USP Compounding Expert Committee and by the Expert Panel of non-committee members. Many wording changes and a few substantial modifications were incorporated into the second proposed version.

Is your pharmacy compliant with the current hazardous drug aspects of USP <797> and what will be required by USP <800>? It’s time to review the following issues to be sure you are on track with safe practices.

Identifying the hazardous drugs you use: The NIOSH List of Antineoplastic and Other Hazardous Drugs is the “source of truth” for this evaluation. The NIOSH list was updated in September 2014. Review the list and identify the drugs and dosage forms that you handle. (This is also required for accreditation surveys, so you can complete two items on your to do list!) You will notice that the list is sorted into three tables: antineoplastic agent, non-antineoplastic agents, and reproductive hazards only. Be sure to read the information in proposed <800> that outlines decisions your organization needs to make on how each dosage form may be handled.

Use of proper Personal Protective Equipment (PPE): Gloves and gowns used for compounding hazardous drugs are different from those used for preparing non-hazardous agents. The gloves – which need to be sterile when compounding sterile agents – must meet the testing requirements of the ASTM standard for chemo gloves: D6978. Be sure that specific number is on the box of gloves which you use for compounding hazardous drugs; it deals with the levels of permeation of chemo agents through the material used for the gloves. Though there is no specific standard for chemo gowns, those gowns must be impervious, have a closed front (no snaps or zippers) and have long cuffs which are secure.

Receiving hazardous drugs: Often, the individuals who receive hazardous drugs are not the ones who compound them. Do these folks know what to expect? Would they be able to identify a box or tote that contains hazardous drugs? If it was leaking or sounded like items were broken, would they know the required policies to follow? Is there a spill kit in your receiving area?

Storing hazardous drugs: USP <797> requires separate storage of hazardous drugs, so this shouldn’t be a surprise. However, proposed <800> requires specific storage criteria for hazardous drugs, though there may be differences between how you store antineoplastics versus the other hazardous agents.

Compounding hazardous drugs: If your chemo hood is in an area that isn’t negative pressure, you need to take steps now to change that; details are in proposed <800>. A key element for protecting healthcare employees from exposure to hazardous drugs is the containment of any hazardous drug residue. All manipulation of hazardous drugs needs to be done in an area that safe for patients, healthcare workers, and the environment.

Administering hazardous drugs: Proposed <800> introduces a third tier of engineering control, in addition to the primary (hoods) and secondary (rooms) controls used for years. The third tier is defined as a supplemental engineering control. This includes the closed system drug-transfer devices (CSTDs) that are used as a containment device for compounding and administering oncology agents. Proposed <800> recommends their use for compounding and requires their use for administering these agents. Without use of a supplemental control, nursing has no engineering controls to protect them. Use of a CSTD for administration, where the dosage form allows, provides at least one level of engineering control in addition to use of proper technique and use of PPE.

Be sure to review the proposed chapter.

Topics: Sterile Compounding

About the Author

Patricia Kienle is the Director of Accreditation and Medication Safety for Cardinal Health Innovative Delivery Solutions. She received her pharmacy degree from the Philadelphia College of Pharmacy and Science, and a Masters in Public Administration from Marywood University in Scranton, Pennsylvania. She completed an Executive Fellowship in Patient Safety from Virginia Commonwealth University and is an Adjunct Associate Professor at Wilkes University in Wilkes-Barre, Pennsylvania. She has served on the Board of Directors of the American Society of Health-System Pharmacists and as President of the Pennsylvania Society of Hospital Pharmacists. She is a Fellow of the American Society of Health-System Pharmacists, named Pharmacist of the Year by the PSHP, and the recipient of the Distinguished Achievement Award in Hospital and Institutional Practice from the American Pharmaceutical Association Academy of Pharmacy Practice and Management, and the Distinguished Leadership Award from ASHP. She has served on the Pharmacotherapy Specialty Council of the Board of Pharmaceutical Specialties, as the pharmacist member of the Hospital Professional and Technical Advisory Committee of the Joint Commission, and on the Board of Governors of the National Patient Safety Foundation. She is a current member of the USP Expert Committee on Compounding, and chair of the Subcommittee and Expert Panel on Hazardous Drugs. Patti is the author of Compounding Sterile Preparations: ASHP’s Visual Guide to Chapter <797> video and Companion Guide and co-author of Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide, 8th edition. She edited Understanding JCAHO Requirements for Hospital Pharmacies. She is a frequent presenter to professional groups, with special interests in promoting medication safety, compounding sterile preparations, accreditation and regulatory issues.