Road to USP 800 Compliance
Section 14 Administering
Sections 1 through 13 of USP Chapter 800: Hazardous Drugs—Handling in Healthcare Settingsprovides the blueprint for safely getting a hazardous drug into our facilities and on to our shelves into a compounded product for patient administration. On our road to compliance, Section 14 provides us with a brief guidance on drug administration considerations for hazardous drugs.
This section is a new path for USP, traditionally limited to functions of products and compounding, this is the first time the administration of drug group is addressed by USP. The primary goal of this section is to provide guidance on safe administration guidelines while handling hazardous drugs. The guidance on administration provides a safety adjuvant to Centers for Disease Control (CDC) and Association for Professionals in Infection Control (APIC) intravenous drug administration practice standards.
The administration of hazardous drugs poses many challenges to nursing (drug administration) that the pharmacy (compounding) fully appreciates. Nurses are the extension of the pharmacy to the patient and in such must address many challenges associated with direct care. Unlike pharmacy (compounding) which has negative pressure rooms/negative pressure containment primary engineering controls (PEC) and personnel protective equipment, nursing (administration) must rely primarily on personnel protective equipment and pre-primed IV lines with non-HD solution to protect them and the patients. Due to this discrepancy between engineering controls, compounding and administration; USP <800> clearly states that closed-system transfer devices (CSTDs) should be used for compounding and must be used for drug administration. Using a CSTD in compounding provides nursing with protection by eliminating spiking or priming of IV lines at the bedside. Another technique that can be employed for priming lines with drug naïve fluid is the process of back-priming is the line, however, this must be accomplished using a CSTD.
Another risk point for nursing (administration) is with regards to oral solid dosage forms. Oftentimes, nurses are met with a patient who demonstrates a challenge to administer a drug according to the directions denoted on the eMAR. Nurses apply their vast knowledge to assuring the drug(s) are administered to the patient in a manner that meets the intent of the eMAR and the patient’s conditions (e.g., solid oral medications). If a patient is having trouble swallowing, oral solid forms are often crushed or split to allow for a carrier such as water or apple sauce to ease the swallowing process. There are a variety of pill crushers/pulverizers and splitters on the market. The use of these devices with a hazardous drug presents a unique challenge to minimize the aerosolization of powdered residue during the crushing and splitting processes. Sites should always default to commercially available liquid formulations or powders for reconstitution over crushing/splitting of solid dosage formulations. The Pennsylvania Patient Safety Authority just published in September 2018 a report which clearly demonstrates that inappropriately altering tablets and capsules can result in treatment failure and patient harm; specifically crushing and splitting tablets:http://patientsafety.pa.gov/ADVISORIES/Pages/201809_AlteringDosage.aspx
Released at the 2017 ASHP Midyear Clinical Meeting, Healthcare Logistics offered a nurse-designed closed process for crushing + mixing + aliquoting dosage + with ENFit tip for safe administration; Pictures:
Healthcare Logistics: http://shop.gohcl.com/default.aspx?page=item%20detail&itemcode=19847
The proper personal protective equipment must be donned during the drug administration process. It is important to note the 2016 NIOSH Hazardous Drug List; Table 5 gives a great summary of recommended PPE for various increments of risks associated with product type to product risk category; https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf.
For example, NIOSH recommended PPE for oral products:
Versus the NIOSH recommended PPE for injectable formulations:
It is important for sites to critically evaluate their practices surrounding hazardous drugs and work as an interdisciplinary team to define the required PPE for each tasks of handling and for everyone involved with the critical tasks of handling hazardous drugs. Sites must educate individuals that all PPE utilized during the handling of hazardous drugs, hazardous drug waste, and patients who receive hazardous drugs should be considered hazardous. In addition to the PPE, all equipment used for compounding and administering hazardous drugs, such as CSTDs, tubing, syringes, delivery bags, shipping bags, patient administration drapes, chemo-pads, and hazardous spill materials, must be considered as ‘Trace Hazardous Waste’ or if grossly contaminated as designated as ‘Hazardous Waste’ and must be disposed of accordingly.
Drugs can be administered through numerous routes to minimize toxicity and maximize effectiveness of the therapy. A gap often overlooked by facilities is the operating room suites. Pharmacy will often compound the hazardous drug and dispense the product in a package (syringe, IV bag) that does not suite the route of administration. For example, drugs instilled into the eye, bladder or intraperitoneal spaces may require ‘opening’ the package to allow the drug to enter the cavity. This process is high risk and in most cases healthcare providers involved with the administration with these special routes may not don the appropriate PPE for protection. This example highlights the importance of sites examining how each hazardous drug is administered to patients within their facilities. Manufacturers of CSTDs have worked through some of the open routes to provide adjuvant devices and processes to help minimize the risk.
As the official implementation date of December 1, 2019 for proposed USP <800> and subsequent revisions to USP <795> and USP <797> compliance allows time for sites to prepare for overall compounding compliance. The time for review of USP’s newest chapter in combination with keeping up with USP’s website for revisions to USP is now.
Don’t know where to start with a hazardous drug safety program? Visante offers a full line of consulting activities to clients just starting down the road to compliance to practice sites on the journey and wanting to go beyond minimal practice standards. Contact us today to get started.
 USP General Chapter 800 Hazardous Drugs—Handling in Healthcare Settings
 Pennsylvania Patient Safety Authority: The Breakup: Errors when Altering Oral Solid Dosage Forms; http://patientsafety.pa.gov/ADVISORIES/Pages/201809_AlteringDosage.aspx
 2016 NIOSH Hazardous Drug list: https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf