Q&A with Seth Eisenberg, RN, OCN, BMTCN
Pharmacy Purchasing & Products: How should an organization approach staff training for safe handling of hazardous drugs (HDs)?
Seth Eisenberg: Prior to HD training, conduct a gap analysis to assess the current state of practice and compare that to the organization’s policies and procedures and to best practices. Ideally, this should be performed by both pharmacy and nursing representatives who are most familiar with workflow and existing practices. Identifying the organization’s current practice prior to training staff will help isolate key areas on which to focus. Because safety measures often require workflow changes, having an accurate understanding of the current state is vital before requiring staff to adopt different practices.
Defining why HDs are designated hazardous is a prerequisite to initiating all training activities for pharmacists, pharmacy technicians, and nurses. To assist in this endeavor, over the past three decades, a wealth of studies have been amassed that illustrate the health risks of improper HD handling, how environmental contamination may occur, and how that contamination can result in employee exposure. Introduce the most critical data from landmark HD studies to all staff who comes into contact with HDs (see SIDEBAR). Salient points to cover include:
After this information is presented, it is important to discuss what has been learned as a result of that research, with an emphasis on employing the necessary precautions and equipment (eg, the use of personal protective equipment [PPE] and closed system drug-transfer devices [CSTDs]) throughout the HD administration process.
When presented with the risks of HD exposure, this data may elicit various responses from staff. New oncology nurses may be shocked, which is not surprising given that little HD safety information is included in nursing school curricula. More seasoned oncology staff may bring up how chemotherapy was mixed and administered in the past and dismiss current HD exposure risks as exaggerated. Discussing the myriad studies that illustrate the real danger of HD exposure in the workplace can help reinforce the critical nature of HD precautions, including PPE and CSTD use, and help gain staff buy-in to adhere to safe practices.
Newly published data continue to demonstrate the prevalence of environmental contamination. For example, a 2014 study showed for the first time that hand contamination is problematic for a broader range of health care workers than previously believed, including those who do not directly handle or administer antineoplastic drugs (eg, unit clerks, aides, dieticians, and those working in shipping and receiving).1 Using a combination of historical and new data in the staff education process helps bring perspective to the problem, and reinforces the importance of safe practices.
In addition, it is vital for organizations to ensure that the PPE being utilized when handling HDs meets the guidelines set forth by NIOSH and the Oncology Nursing Society (ONS). (For more information, see PP&P’s January 2015 article, Are Gloves and Gowns Safe for Handling Chemotherapy?) Moreover, staff must understand that all safety equipment available must be employed every time an HD is compounded, administered, or handled. Using some, but not all, of the safety equipment available is insufficient for preventing exposure.
PP&P: How should pharmacy and nursing work together to reduce occupational exposure to HDs?
Eisenberg: Ideally, HD training should be interdisciplinary. It makes little sense, for example, if pharmacy employs strict HD safety procedures for compounding but nursing does not consistently wear gowns and gloves or use a CSTD during drug administration.
Working collaboratively, pharmacy and nursing can attack the challenge using a unified approach. Developing an HD work group comprising members that represent all areas of the facility affected by HDs (including housekeeping) allows input from all stakeholders and helps identify obstacles in all departments that may come into contact with HDs. Although pharmacy’s needs differ from nursing, the HD handling approach should consign an equal degree of importance to safety for both departments. In particular, when choosing and implementing a CSTD, both pharmacy and nursing must provide input and work together to identify a viable device.
PP&P: How can an organization ensure that safe HD practices continue over time?
Eisenberg: Monitoring is required to ensure compliance when changes have been implemented in an HD safety program. If the gap analysis shows that an improved HD safety program—one vastly different from current practice—is required, there will be resistance to change. Enlisting key clinical nursing leaders can help set an example and ensure all staff members are following HD safety procedures. These leaders should include nursing managers, as it has been shown that compliance is linked to an organization’s safety culture, as well as to practice at the patient’s bedside.2
ONS recommends that safe handling education and compliance auditing occur annually.3 After conducting appropriate staff education, perform audits to reduce the likelihood of practice drift over time. Practice drift can occur weeks to months after education, as staff becomes less diligent and the potential to revert back to pre-existing workflow habits grows. For this reason, periodic audits must continue well beyond the initiation of education. Another benefit of long-term, intermittent audits is that they keep the topic of safety consistently at the forefront. Conversely, a lack of follow-up after implementation may send the message that HD safety is no longer important within the organization.
PP&P: What do nurses need to know about USP <800>?
Eisenberg: Because USP is a pharmacy-centric organization, most nurses may not be familiar with the existence of USP Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. Moreover, the fact that USP is mandating how nurses administer HDs (such as the requirement that nurses, or any other personnel, use CSTDs when administering HDs) is likely to raise many questions. Pharmacy must provide comprehensive information detailing the changes that USP <800> will require. Requirements will include double gloving with chemotherapy-tested gloves, single-use chemotherapy-tested gowns, education for staff responsible for HD transport, and the use of CSTDs (ie, USP <800> will recommend CSTD use during drug preparation and require CSTD use during drug administration). While all of these have been recommended by NIOSH and ONS, USP <800> establishes specific required criteria (eg, chemotherapy-tested gloves and gowns). The use of a CSTD will likely be the most significant condition, as it will necessitate that institutions invest in safety components, which have, up until the present time, been recommended but not required.
In addition, because state boards of pharmacy will enforce USP <800>, pharmacy should ensure that nurses have a clear understanding of the impact of being subject to an enforcement body. Penalties for violations will vary depending on each state’s board of pharmacy, but citations for USP <800> violations can be issued, as can occur with USP <797>. While nurses usually are familiar with NIOSH and ONS guidelines, neither of these organizations have enforcement abilities. USP <800> ushers in a new era of accountability, heretofore belonging to each state’s department of health or to The Joint Commission.
Seth Eisenberg, RN, OCN, BMTCN, professional practice coordinator for infusion services at the Seattle Cancer Care Alliance Ambulatory Clinic, has worked in the field of oncology since 1983. His experience includes 30 years in hematopoietic stem cell transplantation associated with the Fred Hutchinson Cancer Research Center.
Seminal Hazardous Drug Studies (listed in chronological order)*
Falck K, Grohn P, Sorsa M, et al. Mutagenicity in urine of nurses handling cytostatic drugs. Lancet. 1979:1(8128);1250-1251.
Connor TH, Laidlaw JL, Theiss JC, et al. Permeability of latex and polyvinyl chloride gloves to carmustine. Am J Hosp Pharm. 1984;41(4):676-679.
Connor TH, Anderson RW. Demonstrating mutagenicity using the Ames test. Am J Hosp Pharm. 1985;42(4):783-784.
Sessink PJ, Anzion RB, Van den Broek PH, et al. Detection of contamination with antineoplastic agents in a hospital pharmacy department. Pharm Weekbl Sci. 1992;14(1):16-22.
Sessink PJ, Boer KA, Scheefhals AP, et al. Occupational exposure
to antineoplastic agents at several departments in a hospital. Environmental contamination and excretion of cyclophosphamide and ifosfamide in urine of exposed workers. Int Arch Occup Environ Health. 1992;64(2):105-112.
Sessink PJ, Scholtes MM, Anzion RB, et al. Determination of
cyclophosphamide in urine by gas chromatography-mass
spectrometry. J Chromatogr. 1993;616(2):333-337.
Valanis BG, Vollmer WM, Labuhn KT, et al. Association of antineoplastic drug handling with acute adverse effects in pharmacy personnel. Am J Hosp Pharm. 1993;50(3):455-462.
Sessink PJ, Friemel NS, Anzion RB, et al. Biological and environmental monitoring of occupational exposure of pharmaceutical plant workers to methotrexate. Int Arch Occup Environ Health. 1994;65(6):401-403.
Sessink PJ, Van de Kerkhof MC, Anzion RB, et al. Environmental
contamination and assessment of exposure to antineoplastic agents by determination of cyclophosphamide in urine of exposed pharmacy technicians: is skin absorption an important exposure route? Arch Environ Health. 1994;49(3):165-169.
Valanis B, Vollmer W, Labuhn K, et al. Occupational exposure to antineoplastic agents and self-reported infertility among nurses and pharmacists. J Occup Environ Med. 1997;39(6):574-580.
Connor TH, Anderson RW, Sessink PJ, et al. Surface contamination with antineoplastic agents in six cancer treatment centers in Canada and the United States. Am J Health-System Pharm. 1999:56(14): 1427-1432.
Valanis B, Vollmer WM, Steele P. Occupational exposure to antineoplastic agents: self-reported miscarriages and stillbirths among nurses and pharmacists. J Occup Environ Med. 1999;41(8):632-638.
Connor TH, Sessink PJ, Harrison BR, et al. Surface contamination of chemotherapy drug vials and evaluation of new vial-cleaning techniques: results of three studies. Am J Health-Syst Pharm. 2005;62(5):475-484.
*A more extensive listing of recent publications related to occupational exposure to antineoplastic agents and other hazardous drugs, including guidelines, recommendations, regulations, review articles, and surveys, is available at: www.cdc.gov/niosh/topics/antineoplastic/pubs.html#a.