Is Your Pharmacy USP 800 Compliant?

Published in MN Physician, June 2019

Health care facilities have until December 1, 2019, to comply with new, federally enforceable rules and regulations issued by the U.S. Pharmacopeial Convention under USP <800>

The primary objective of the rules and regulations is to promote patient safety, staff safety, and environmental protection from hazardous drugs.

USP <800> requires health care facilities to maintain a list of hazardous drugs used in the facility. The National Institute for Occupational Safety and Health (NIOSH) provides a list of hazardous drugs. The facility must address any agent listed as hazardous by NIOSH. However, facilities may add other items that are not on the NIOSH list. The three groups of hazardous drugs to be considered are antineoplastic drugs, non-antineoplastic drugs that meet one or more of the NIOSH criteria for hazardous drugs, and drugs that primarily pose a reproductive risk. Safe-handling precautions may vary based on activity and formulation of the drug. For some facilities, these precautions may require architectural redesigns and rebuilding.

Background

In 2004, NIOSH published an alert intended to increase awareness about the health risks posed by working with hazardous drugs. Exposure to hazardous drugs may occur from skin contact, inhalation, ingestion, or injection from a wide array of activities, and the results in health effects can include skin rashes, adverse reproductive outcomes, and possibly leukemia and other cancers. USP <800> clearly states that there is no acceptable level of personnel exposure to hazardous drugs, and it is intended to provide containment of hazardous drugs to as low a limit as reasonably achievable.

In addition to NIOSH, other organizations, such as the Occupational Safety and Health Administration (OSHA), the American Society of Health-System Pharmacists (ASHP), and the Oncology Nursing Society (ONS), have provided documents and/or best practices addressing hazardous drug handling. Where conflicts exist, the most stringent requirements prevail.

USP <800> provides safe practice requirements for receipt, storage, mixing, preparing, compounding, dispensing, administering, disposing, counting, crushing, and pouring hazardous drugs. The standard impacts sterile and non-sterile hazardous drugs. It applies to any health care setting, including pharmacies, hospitals, clinics, physician offices, veterinarian offices, and other locations and facilities where hazardous drugs are stored, transported, and administered. While a key component is focused on primary and secondary engineering controls, USP <800> covers everything from organizational planning to spill control and environmental monitoring.

Preparing for Compliance

Three action steps to consider in preparing for USP <800>

  1. Complete an assessment of risk and gap analysis for the facility.
  2. Upgrade the existing facility to meet standards.
  3. Educate and train personnel.

The first step is to have your pharmacist and technicians perform an assessment of risk of their facility. Review this thorough checklist for USP <800> in health care facilities: . Several organizations have provided gap analysis tools that can be extremely helpful in developing action plans for USP <800> compliance. Some examples of gap analysis tools include: www.HazMedSafety.com, www.800gaptool.com, and www.tinyurl.com/mp-compounding.

Some health care facilities may need to redesign and rebuild their physical space. Below is a list of common improvements necessary to meet the new standards.

Seeking Outside Help

After the assessment of risk has been completed, it is a good idea to hire a third-party organization that specializes in pharmacy LEAN design and understands the required changes, such as developing evidence-based standard operating procedures that are compliant with USP <800> but also meet the specific needs of their organization, workflows, HVAC (heating, ventilation, and air conditioning) improvements for proper air exchanges, adjustments to the facility’s footprint to comply with storage guidelines, temporary construction phasing if renovating in place, and cost of construction.

Once capital improvements are made, and new procedures are rolled out, personnel training and education is a key component of the compliance process. It’s not a one‐time event, but more a continuing cycle of training, assessment, and improvement, all of which keeps patients safe, themselves safe, and our environment safe.

Aside from primary and secondary engineering controls, adequate work practices with donning and doffing of personal protective equipment (PPE) are important to protect the worker and the work environment from contamination with hazardous drugs. Highly reliable cleaning procedures can prevent worker exposure and environmental contamination. Personnel performing cleaning activities need to be protected from inadvertent exposure to hazardous drugs. USP <800> provides comprehensive requirements and best practice recommendations for PPE and cleaning procedures.

USP <800> recommends environmental quality and control monitoring. To evaluate hazardous drug practices, wipe sampling is recommended at baseline and every six months. Wipe sampling can help to identify work practices or environmental controls that need to be altered to prevent worker and environmental contamination.

Knowing that USP <800> will become official on December 1, 2019, most facilities need to take USP <800> into account so that any newly built or renovated facility does not become obsolete in terms of conformance to standards after the deadline. To cover all bases, it is recommended that any facility contemplating this decision contact its State Board of Pharmacy to verify its position on this matter.

Redesigns and Upgrades

Hospitals and clinics are constantly changing, so rearranging existing space is usually necessary to integrate modern equipment and technology into these buildings. Facilities that are 30–60 years old can present many challenges. New medical equipment is often needed. For example, a new pharmacy chemo hood requires larger or reconfigured rooms in which to operate due to changing workflow, equipment layout, and clearances. As new medical equipment is added to support the new spaces, the existing mechanical and electrical infrastructure may need to be modified and/or upgraded to support the new spaces. When installing new handling units, for example, additional structural support may be required. The key to a successful retrofit project is to select a design and construction team that has worked together and is qualified and knowledgeable working in a health care environment. Bringing these professionals on early in the process of considering a retrofit can save the owner money caused by unforeseen delays.

Nicholas (Cole) Helbling, PharmD, is the Pharmacy Operations Senior Manager at Essentia Health St. Mary’s Regional Health Center in Detroit Lakes. He graduated with his Doctorate of Pharmacy from North Dakota State University and completed a PGY-1 pharmacy practice residency at Sanford Health in Fargo, ND. He is a Board-Certified Pharmacotherapy Specialist.

Stanley Schimke, CID, is Director | Health Practice at EAPC Architects Engineers Health Studio, which has implemented USP <795>, USP <797>, and USP <800> across the U.S. He is a recent co-speaker on USP <800> requirements and guidelines at the North Dakota Healthcare Engineering Society’s 2018 Annual Fall Education Conference.

James Anderson, AIA, NCARB, LEED AP, is an Architect/Sr. Project Manager at EAPC Architects Engineers. He received his Bachelor of Architecture degree from the University of Minnesota Institute of Technology.

Common redesign and rebuilding measures to ensure compliance with USP <800>

While individual needs will vary, some health care facilities have found it necessary to

  • Add a hazardous drug storage room with adequate negative air pressure and at least 12 hourly “air changes,” defined as how many times the air enters and exits a room from the HVAC.
  • Install a dedicated hazardous drug refrigerator.
  • Add adequate hoods for sterile and non-sterile compounding.
  • Upgrade rooms to support dedicated hazardous drug hoods and optimal air flows.
  • Place hand washing and eye wash stations for maximum efficiency.
  • Enact architectural finish requirements for sterile compounding under USP <795>. These include providing smooth, seamless, and impervious surfaces.
  • Install continuous-sheet vinyl flooring with integral cove base (no vinyl composite tile or carpet flooring).
  • Provide for external ventilation of all negative pressure hoods.
  • Install an air handler capable of providing adequate air exchanges and room pressures.
  • Build HVAC “chases”—ducts used to carry or return air from the air handler—and provide low air returns near the floor.
  • Build separate unpacking/receiving rooms for hazardous drugs. Room air pressure must be negative or natural to prevent contamination to areas outside of these rooms. This has been a risk factor at many facilities.
  • Replace acoustical ceiling tiles with “gypsum board clean room #5” tiles; include gasketed grid and hold-down clips.
  • Install recessed sprinkler heads.
  • Add more “data drops”—network cables and ports to share computer data.
  • Include HEPA filter test ports.
  • Replace existing pass-through cabinets and storage cabinets with interlocking, gasketed cabinets to comply with 797/800 requirements. Of note, some pass-through cabinets may need to be HEPA filtered.