USP 800 versus 797: New Guide for Handling Hazardous Drugs Includes Shoe Covers

USP <800>, the U.S. Pharmacopeial Convention’s new standard for handling hazardous drugs (HDs) in healthcare settings, includes significant safety standards for all healthcare workers, as well as patients and the general public, who have access to facilities where HDs are prepared. This includes pharmacists, pharmacy technicians, physicians, nurses, physician assistants, home health care workers, veterinarians, and veterinary technicians.  Entities that store, transport, prepare, or administer HDs are also affected, including but not limited to pharmacies, hospitals, patient treatment clinics, physicians’ practice facilities, and veterinary clinics.

USP <800> provides facilities with direction on how to set policy and identify what needs to be done for employee safety while compounding and dispensing HDs. These new safety standards expand upon USP <797>, which focused primarily on minimizing the risk of contaminating medicines when compounding sterile IV preparations. USP <800>, on the other hand, is aimed primarily at addressing the entire life cycle of an HD so that all who might come in contact with it are protected.

USP <797> and <800> are related in that each refer to a chapter in the US Pharmacopoeia.  USP <800> is not just limited to chemotherapy but also many drugs that now fall under the National Institute for Occupational Safety and Health (NIOSH) list.  USP <800> has a minor component that currently falls under USP <797> this year but will become fully enforceable in December 2019 and will require full cleanroom and garbing precautions.  USP <797> is under revision; therefore the current version will hold until at least the next year.  This is the year the Joint Commission and Center for Medicare and Medicaid Services (CMS) is requiring compliance with USP <797>.  Since this is the first year that the CMS plans to enforce the IV compounding regulations, most facilities are scrambling to meet compliance.

Health Effects Resulting from Exposure to Hazardous Drugs

Green barrels with toxic substancesGrowing evidence, which has been accumulated over decades by the USP, Hematology/Oncology Pharmacy Association, Oncology Nursing Society, American Society of Clinical Oncology, and the Centers for Disease Control and Prevention indicates that occupational exposure to the more than 200 HDs commonly used in healthcare settings can cause acute and chronic health issues. In addition, over 100 studies have documented evidence of HD contamination in the workplace, including the presence of HDs in workers’ urine. With nearly 8,000,000 healthcare workers exposed to HDs each year, USP <800> aims to prevent associated acute and long-term health effects.

Required Upgrades Under USP <800> Include Shoe Covers

Personal protective equipment (PPE)(gowns; head, hair, and shoe covers; and two pairs of chemotherapy gloves) is required for compounding both sterile and non-sterile HDs, and two pairs of such gloves are required for administering antineoplastic HDs. Facilities also need to develop standard operating procedures regarding appropriate PPE for any workers who otherwise handle HDs.

Both USP <797> and <800> include several references to shoe covers as detailed below.

Compliant Shoe Covers + Automatic Shoe Cover Application and Removal

Shoe Inn’s shoe covers meet USP <797> and <800> guidelines.  If you want to take make Happy-doctors-smallputting shoe covers on faster, easier, safer and cleaner, go with an automatic shoe cover dispenser like the Shoe Inn Stay. You can even take it a step further by implementing an automatic shoe cover remover.  These products help eliminate workplace injuries, prevent contamination, and save precious time (see just how quick and easy in our application and removal videos).

USP <800> became effective on July 1, 2018.

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USP <797> references to shoe covers

Appropriate personnel protective equipment (PPE) shall be worn when compounding in a BSC or CACI and when using CSTD devices. PPE should include gowns, face masks, eye protection, hair covers, shoe covers or dedicated shoes, double gloving with sterile chemo-type gloves, and compliance with manufacturers’ recommendations when using a CACI.

After donning dedicated shoes or shoe covers, head and facial hair covers, and face masks…

When compounding personnel exit the compounding area during a work shift, the exterior gown may be removed and retained in the compounding area if not visibly soiled, to be re-donned during that same work shift only. However, shoe covers, hair and facial hair covers, face masks/eye shields, and gloves shall be replaced with new ones before re-entering the compounding area, and proper hand hygiene shall be performed.

Appendix I: Order of compounding garb and cleansing in ante-area: shoes or shoe covers, head and facial hair covers, face mask, fingernail cleansing, hand and forearm washing and drying; non-shedding gown.

Appendix III: Dons shoe covers or designated clean-area shoes one at a time, placing the covered or designated shoe on clean side of the line of demarcation, as appropriate.

Appendix III: Removes shoe covers or shoes one at a time, ensuring that uncovered foot is placed on the dirty side of the line of demarcation and performs hand hygiene again. (Removes and discards shoe covers every time the compounding area is exited).

USP <800> references to shoe covers

Gowns, head, hair, shoe covers, and two pairs of chemotherapy gloves are required for compounding sterile and non-sterile HDs.

Head and hair covers (including beard and moustache, if applicable), shoe covers, and sleeve covers provide protection from contact with HD residue. When compounding HDs, a second pair of shoe covers must be donned before entering the C-SEC and doffed when exiting the C-SEC. Shoe covers worn in HD handling areas must not be worn to other areas to avoid spreading HD contamination and exposing other healthcare workers.

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