Key Points to Consider From USP

Pharmacy Practice in Focus: Health SystemsJanuary 2018
Volume 7
Issue 1

Each year, more than 8 million U.S. health care personnel are potentially exposed to hazardous medications. Acute and chronic health effects have been reported, including headaches, ocular problems, rashes, hair loss, adverse reproductive health, and increased cancer risk.

Each year, more than 8 million U.S. health care personnel are potentially exposed to hazardous medications. Since the 1970s, the literature has indicated the possible harmful effects on health care workers from low-level work-related exposure to any of more than 200 medications that are considered hazardous drugs (HDs). Acute and chronic health effects have been reported, including headaches, ocular problems, rashes, hair loss, adverse reproductive health, and increased cancer risk.1,2

Prior to USP <800>, the main guidance related to the handling of HDs was USP <797>. This regulation described the proper guidelines for sterile compounding of both hazardous and nonhazardous drugs, with a main goal of preventing harm to patients that could result from microbial or other contamination of sterile products; however, USP <797> lacked standards for the handling of HDs.2

USP <800> outlines new quality-of-practice standards for handling HDs that promote the safety of patients and health care personnel who are exposed daily to HDs. The chapter, effective July 1, 2018, includes the entire drug handling process, from receipt to the proper disposal of both sterile and nonsterile products1-3:

1. Compounding supervisor: Section 4 contains a unique requirement for organizations to designate a “compounding supervisor” who is qualified and trained in every aspect of the HD handling process. The United States Pharmacopeial Convention (USP) does not go into detail about specific credentials or even if the position needs to be in the pharmacy department. As a result, there is flexibility when creating a position within the pharmacy department or assigning more responsibility to an existing position. USP stresses that the person designated with this responsibility must understand the reasoning for HD risk-prevention policies, the risk HDs pose to everyone, and the risk of noncompliance. The compounding supervisor is responsible for the “oversight of monitoring the facility and maintaining reports of testing/sampling performed in facilities.”2,3

2. Facility requirement: Section 5 is broken into 4 subsections, which are receipt, storage, compounding, and containment supplemental engineering controls. In general, section 5 states that HDs must be handled at each stage in a way that promotes patient safety, employee safety, and environmental protection. For example, every entrance to HD handling areas must display a noticeable sign regarding the hazard. One key requirement is the designation of HD-specific areas for receipt and unpacking, storage, nonsterile compounding, and sterile compounding. This requirement can present challenges to organizations because it requires multiple spaces designated to specific steps in the HD handling process, most of which must have negative pressure from surrounding areas.2,3

3. Receipt: USP <800> requires unpacking of HDs and HD active pharmaceutical ingredients (APIs) from the original container be done in a neutral pressure or negative pressure room, reducing the risk of airborne contamination outside the pharmacy area. It is imperative that unpacking is not done in sterile compounding areas or positive pressure areas.2

4. Storage: USP <797> placed HDs in a separate space to prevent contamination and personal exposure. However, USP <800> takes the 2014 National Institute for Occupational Safety and Health (NIOSH) HD stratification into consideration, stating that nonantineoplastic HDs, reproductive risk—only HDs, and final dosage forms of antineoplastic HDs can be stored with nonhazardous drugs in inventory. Antineoplastic drugs or HD APIs requiring manipulation other than counting the final dosage must be stored separately from nonhazardous drugs in a negative pressure room with at least 12 air changes per hour (ACPH). In addition, refrigerated antineoplastic HDs must be stored separately from non- hazardous drugs in a dedicated refrigerator in a negative pressure area with at least 12 ACPH.2

5. Compounding: USP <800> mandates engineering controls to be used in all stages of the compounding process to protect from cross-contamination and microbial contamination2,3 and classifies these controls as primary, secondary, and supplemental, as shown in online Table 1.3 Sterile and nonsterile compounding facilities should also be considered, as shown in online Table 2.3 One key point is the use of a containment segregated compounding area (C-SCA), an ISO unclassified containment secondary engineering control (C-SEC) with minimal requirements for airflow and room pressure. Still, C-SCAs are segregated, maintain negative pressure, and have appropriate air exchange. A C-SCA can replace a C-SEC during sterile compounding only for low- and medium-risk drugs with beyond-use dating limited to 12 hours. Overall, a C-SCA is a less-expensive option, providing a benefit to clinics that do not have the required infrastructure.2

6. Closed-system transfer devices (CSTDs): CSTDs are C-SECs. In 2004, NIOSH cited a US investigation that demonstrated that the use of CTSDs for 6 months helped reduce the concentrations of drugs previously detected in the urine of health care personnel. When dosage form allows, CSTDs should be used when compounding HDs; they are required when administering antineoplastic HDs. However, USP states that there is no certainty that all CSTDs will perform adequately. Entities should carefully assess the performance claims about available CSTDs based on “independent, peer-reviewed studies and demonstrated containment reduction.3,4

7. Environmental quality and control: Environmental wipe sampling for HD surface residue should be per- formed initially and every 6 months thereafter. The sampling should expand from the interior and equipment of containment primary engineering controls to the patient administration areas. USP acknowledges the lack of studies on the effectiveness of wipe sampling kits, addressing the ambiguity on the correct number and size of wipe samples. It states that wipe sampling kits should be verified before use.3

8. Personal protective equipment (PPE): Although USP <800> outlines guidelines for the use of PPE, it requires that entities address all activities not listed in section 7 by developing appropriate standard operating protocols (SOPs) for PPE use. Specifics include the use of gloves, gowns, and head, hair, and shoe covers when compounding sterile and nonsterile HDs. Additionally, gloves, which must meet the American Society for Testing and Materials standard D6978, should be worn for all HD handling (antineoplastic, nonantineoplastic, and reproductive risk only). USP requires all personnel administering chemotherapy to use 2 pairs of gloves and requires the use of HD permeability-resistant gowns when administering any injectable HD.2,3

9. Spill prevention: SOPs must be developed for spill prevention and containment, and all personnel required to clean up an HD spill must receive training in spill management, use of PPE, and NIOSH-certified CTSDs. The SOPs must address the size and the scope of the spill, who is responsible, and the type of PPE required.2,3

10. Medical surveillance program: In section 18, USP addresses the medical surveillance program as part of a “comprehensive exposure control program” that complements the engineering control systems described earlier. This secondary prevention tool is a proactive approach to minimize adverse health effects in those who were potentially exposed. It encompasses early detection of health problems as it progresses and compares trends in the health care personnel population. Key elements of the program are outlined in this section, including the development of an approach to recognize personnel who were potentially exposed to HDs, as well as a follow-up plan if changes are found related to drug toxicity. USP stresses the importance of consistency with the entity’s human resource policies and confidentiality when handling employee medical records.2,3

USP <800> is intended to provide a standardized guideline because tight control of each step in the HD life cycle is necessary. Overall, properly educating pharmacy workers and phy- sicians—as well as risk management, legal, and drug delivery personnel&mdash;is crucial in providing quality protection to patients and their health care team.2

Marina Reed is a PharmD candidate at the University of Wisconsin—Madison School of Pharmacy.

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