Handling Hazardous Drugs Presents Opportunities

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Pharmacy Times, November 2022, Volume 88, Issue 11

A compliance officer role represents an exciting new challenge to ensure safe handling in compliance with United States Pharmacopeia.

The latest revision to the United States Pharmacopeia (USP) General Chapter <800> “Hazardous Drugs—Handling in Healthcare Settings,” published in December 2019,1 makes clear that pharmacy technicians can play an important role in adhering to USP <800> and ensuring the safety of patients and pharmacy personnel.

Of note, every pharmacy will require a designated individual to assume responsibility for the handling of hazardous drugs (HDs). Given the rapidly advancing role of pharmacy technicians andavailability of training and credentialing in this area, they may be ideally suited to serve in this critical new role.

Background on HDS

Concerns over exposure to hazardous chemicals began in the 1970s. Pharmaceutical drugs were 1 group among many groups of chemicals investigated as potentially hazardous. In December 1970, the Occupational Safety and Health Act was signed, establishing the National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA). NIOSH and OSHA are federal organizations that protect employees from exposures to work-related hazards.2

Although the organizations are closely related, they are separate entities. OSHA is an office within the US Department of Labor that creates and enforces regulations using fines and lawsuits. NIOSH does not create or enforce regulations but instead advances the research and education related to workplace safety. In 1971, NIOSH published its first list of toxic substances, which has been updated over the years and is the gold-standard list for hazardous substances for governmental and health care organizations.

A key publication from NIOSH used in pharmacy and other health care settings is the “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016.”3 This publication specifically lists HD chemicals most likely found in the health care setting (Table 1).3 The HDs are divided into 3 groups: antineoplastics, nonantineoplastics, and reproductive-only hazards.

Pharmacy Profession's Handling of HDS

Although NIOSH is the authority on classification and identification of HDs in the United States, the USP serves as the primary resource for the pharmacy profession on handling the drugs to minimize risks to patients andpharmacy personnel.1 The United States Pharmacopeia Convention is anot-for-profit, private organization that is responsible for appointing members of the USP Compounding Expert Committee, which is a group of independent experts in health care quality standards. This group develops these standards that are ultimately published in the United States Pharmacopeia–National Formulary (USP-NF), which is the primary resource used by boards of pharmacy, community pharmacies, health systems, and hospitals to develop or enforce pharmacy policies and procedures. For example, USP-NF chapter <795> guidance instructs pharmacists to assign a 14-day expirationwhen reconstituting amoxicillin prescriptions for children at community pharmacies.

Of the 40 general chapters in USP-NF, <800> specifically relates to HDs. The chapter “describes requirements, including responsibilities of personnel handling [HDs]; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation. These standards apply to all health care personnel who receive, prepare, administer, transport, or otherwise come in contact with [HDs] and all the environments in which they are handled.”4

This chapter supplements but does not replace chapters <795> on nonsterile compounding or <797> on sterile com-pounding. Also important is the fact that <800> is the first enforceable standard that protects health care personnel from the risk of HDs, not by USP itself but by boards of pharmacy, health care accreditation bodies, and organizations themselves. Note that <800> is only for health care settings and, practically speaking, simply emphasizes existing prac tices required by OSHA, bringing health care settings, such as pharmacies, up to that level of compliance.

USP <800> is organized into 18 main sections, but let’s focus on 2 key areas: personal protective equipment (PPE) and storage. PPE is a general term that encompasses a wide variety of protective gear that is designed to protect health care workers from workplace hazards, including exposure to HDs. Examples include face masks, gloves, goggles, gowns, and shoe covers.

Ensuring quality of PPE purchased for pharmacies is critical, and there are several organizations that can certify the quality of this equipment. However, the gold standard is the American Society for Testing and Materials. This is particularly important to note, as not all PPE protects against HD exposure. When purchasing or using PPE, it is a best practice to review the certification for the particular item to ensure it is HD protective. For instance, a glove appropriate for handling an HD may state something to the effect of “this glove has been tested for resistance to permeation of chemotherapy drugs by the ‘Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.’” This statement may then be followed by a list of chemotherapy drugs and their minimum breakthrough times in minutes.

When handling HDs, a single pair of nitrile, polyvinyl chloride, or rubber gloves may be sufficient. However, if compounding, an individual must use a double-glove procedure, which involves a first pair of gloves worn under a gown cuff and a subsequent pair worn over a gown cuff. Additionally, gloves should be changed every 30 minutes, as the longer the exposure to the HD, the more likely the drug is to fully permeate and break through the glove.

Goggles, gowns, hair covers, respiratory protectors, and shoe covers are essential PPE for HD compounding but are not often seen in community pharmacy settings. However, in community pharmacies that also have a compounding laboratory or in hospitals, this PPE is critical and must be used in the preparation of compounded products, including HDs. In particular, respiratory protectors are often overlooked. These include full-face, N95, R95, and surgical masks (Table 2).4

How and where HDs are stored is important for preventing unintended exposures or spills. Every pharmacy organization is unique, so the policies and procedures will vary across organizations. However, there are some general HD storage recommendations made in <800>. When receiving and unpacking HDs, it is recommended that these activities be performed in an area separated from others, ideally in a room with neutral or negative pressure, where there is no airflow being pushed out from the room. NIOSH group 1 (antineoplastic HDs) should also be separated from NIOSH group 2 (nonneoplastic HDs) and group 3 (reproductive-only HDs). Finally, HDs in all 3 groups that require refriger-ation must be placed in a separate refrigerator and kept at a negative pressure of 12 air changes per hour. If an HD spill occurs, PPE must be used.

Key Role

Based on guidance from <800>, NIOSH, OSHA, USP, and USP-NF, pharmacies can create pharmacy-specific policies and procedures to ensure compliance with national regulations and standards. However, ensuring an organization stays compliant with its own policies and procedures is a challenge.

For this reason, <800> requires that each pharmacy organization have a designated person who is “qualified and trained to be responsible for developing and implementing appropriate procedures; overseeing entity compliance with this chapter and other applicable laws, regulations, and standards; ensuring competency of personnel; and ensuring environmental control of the storage and compounding areas.”

This individual is also responsible for the oversight of monitoring the facility, maintaining reports of internal testing, and acting on results. Importantly, <800> does not specify who this designated person should be, so this opens the door for a well-qualified technician who is experienced and/or trained in drug preparation, dispensing, compounding, and handling HDs to serve in this role. Although the technical job title for the designated person varies, this individual is typically referred to as a compliance officer.

Compliance officers have several critical responsibilities within an organization, including developing standard operating procedures (SOPs), which follow national standards and regulations but are specific to the organization. These SOPs are typically developed in collaboration with several employees and leaders at pharmacies, but their development and maintenance are facilitated primarily by compliance officers.

A compliance officer is also typically tasked with personnel competency, or training and assessing staff members for their ability to adhere with the organization’s SOPs. For instance, if a community pharmacy states in its SOPs that all NIOSH group 1 HDs must be stored in a refrigerator in the back of the pharmacy, that meansall newly hired technicians must be trained on propergroup 1 HD storage. Compliance officers may ask a new technician to receive and store a new medication delivery and observe where each medication is placed to assess whether the individual adheres to the SOP and if not, performs retraining and a reassessment.

Compliance officers are also in charge of facility monitoring, which may include daily or monthly cleaning, work area compliance with SOPs, and any routine testing that is required. Typically, an annual evaluation of the pharmacy’s SOPs and the facility’s compliance with those SOPs is done. Finally, compliance officers are the <800> content experts at pharmacies. This means pursuing continuing education on <800>, keeping up to date with changes, and being the individual to whom pharmacy personnel can direct questions about HDs.

Conclusion

HDs represent a serious health risk for patients and pharmacy personnel. However, with over 50 years of research and policy development, there are established national regulations standards to help mitigate these risks. Each pharmacy organization must ensure compliance with these regulaltions and standards, and for this reason a pharmacy compliance officer is required per <800>. Although many pharmacy staff members could serve in this role, well-trained technicians are well suited to be compliance officers, given their typical job tasks and the availability of training and credentialing in this area. The role of the compliance officer represents an exciting new role for technicians, whose critical role ensures safe handling of HDs.

References

1. USP general chapter <800>. United States Pharmacopeia. February 1, 2016. Accessed September 30, 2022. https://www.usp.org/compounding/gener-al-chapter-hazardous-drugs-handling-healthcare

2. Notable milestones in NIOSH history. CDC. Updated March 28, 2018. Accessed September 30, 2022. https://www.cdc.gov/niosh/timeline.html

3. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. CDC. Updated March 31, 2017. Accessed October 25, 2022. https://www.cdc.gov/niosh/docs/2016-161/default.html

4. USP general chapter <800> hazardous drugs—handling in healthcare settings. United States Pharmacopeia. November 26, 2019. Accessed October 25, 2022. https://www.usp.org/sites/default/files/usp/document/our-work/compounding/usp-800-context-for-implementation-fs.pdf

About the Authors

Kenneth Hohmeier, PharmD, is an associate professor of clinical pharmacy and translational science and director of community affairs at The University of Tennessee Health Science Center in Nashville.

Scarlett M. Hohmeier, PharmD, is a consulting pharmacist in Nashville, Tennessee.