Guidelines & Recommendations
The Centers for Disease Control, through the National Institute of Safety and Health (NIOSH), issued an alert entitled “Preventing Occupational Exposure to Antineoplastics and Other Hazardous Drugs in Healthcare Settings” in March 2004.2 The alert was published as an update to the United States Department of Labor’s Occupational Safety and Health Agency (OSHA) technical manual for employers, in order to minimize the risk to employees responsible for the handling of hazardous drugs.3 The NIOSH alert provides alarming evidence of the risk associated with handling hazardous drugs, and expands the risk beyond the individuals who compound and administer these products to all individuals (i.e., shipping/receiving, housekeeping, laundry staff, etc.) who may come into contact with these chemicals. In 2007, NIOSH published an update to the 2004 recommendations, emphasizing a formal medical surveillance program for personnel who handle HDs.4
Designating Drugs as Hazardous To date, the FDA has not mandated that drugs bear a symbol to designate them as hazardous. Each institution should individually assess new drugs based upon the hazardous drug criteria contained within the NIOSH document. Once they are identified, it is up to the institution to educate their personnel on the hazards involved with managing these agents. Based on the potential long-term risks associated with these agents, it is incumbent on the FDA to require a universal symbol on hazardous drugs to aid individuals in identifying them.
Nebraska Methodist Hospital (NMH) is a community-based, not-for-profit hospital located in Omaha, Nebraska. It is licensed for 440 beds with an average daily census of 300. The centers of excellence at NMH include oncology, obstetrics, orthopedics, and cardiovascular services. During the 2007 calendar year, the pharmacy department aseptically compounded 2,372 oncology-related hazardous drugs. Additionally, 33,779 doses of hazardous drugs, as defined by NMH with the assistance of Appendix A of the NIOSH alert, were dispensed for administration. In 2004, NMH’s hazardous materials committee formed a subcommittee, consisting of representation from pharmacy, nursing, human resources, safety, radiology, performance improvement, employee health, housekeeping, and administration, to formally address the safety of hazardous drugs and develop policies and procedures that could ensure the safety of NMH’s employees.
Identifying “At Risk” Employees
The NMH committee’s analysis identified an important gap: a knowledge deficit of hospital administration, pharmacy, and nursing personnel regarding the risk and severity of occupational exposure to HDs. Additionally, the spectrum of the problem was not fully understood. To better understand the magnitude of the risk, a “cradle to grave” concept for HD management was used when defining “at risk” employees. (See Figure 1 .)
Each person who handles an HD is at risk for an occupational exposure. Your safety program for managing these agents should take into account all aspects of HD management. A less-known point of exposure is the patient. NIOSH clearly states that body fluids (i.e., sweat, emesis, etc.) from patients receiving HDs may contaminate the linen associated with the care of the patient for up to seven days post-dosing. The hospital’s linen and waste management service providers should be notified that the end products they receive from the hospital may be contaminated with hazardous materials. Hospitals may have to assist their service providers with understanding the risks and provide guidance on how to formally address HD management.
During our assessment, NMH identified individuals who are at high risk and low risk of exposure. High-risk individuals are those whose position puts them at risk of coming into direct contact with concentrated forms of HDs. These employees include shipping/receiving personnel, compounding personnel (pharmacists, interns, and technicians), nurses, and physicians. Low-risk individuals, such as housekeeping personnel, linen handlers, and waste haulers, are those who have the potential of exposure due to a casual relationship to HDs. Actually, any person who crosses the path of the HD (visitors, chaplains, food-service personnel, contractors, etc.), as outlined in Figure 1, is at low risk of exposure. However, we limited the definition to those individuals whose job requires them to be involved with HDs or the ensuing waste. Using these criteria, NMH identified 48 high-risk individuals and 136 low-risk individuals on its staff.
Surveillance of Personnel
The NIOSH and OSHA documents emphasize the responsibility of employers to educate their employees on the risks associated with handling hazardous drugs and to implement steps to minimize exposure risk to employees. Both of these documents mention the inclusion of a medical surveillance program for at-risk employees. The concept of a medical surveillance program is only a recommendation and is not mandated. Building upon the NIOSH recommendations, NMH developed a four-tier surveillance program. (See Table 1.)
A comprehensive safety program should incorporate all four tiers. Currently, debate exists on the value of annualized laboratory tests. Hospital administration and employee health departments may be turned off by the additional expense of a tier-three surveillance program, which is due to the costs of obtaining lab results and the subsequent ramifications if an abnormal test result arises. That said, individuals who frequently work with HDs find value in knowing their employer has provided them with every possible recommendation to detect issues and assure their safety.
To implement NIOSH’s current recommendations for laboratory-based medical surveillance, you need to consider the time required to educate at-risk personnel and the cost associated with laboratory testing equipment and activities. The following guidelines, based on 2007 pricing, can be used to estimate the cost of laboratory tests for your facility:
•Complete blood count with differential (CPT4 #85025) = $3.00 to $6.00 per test
•Complete urinalysis with dipstick (CPT4 #81001) = $1.50 to $3.00 per test
At NMH, we estimated the cost of laboratory tests for a tier-three surveillance program for 48 high-risk staff to be $144 to $288 for the complete blood count and $72 to $144 for urinalysis, resulting in a total cost of $216 to $432 per year.
The implementation of a HD safety program involves incremental costs. It is important to note that the costs associated with protecting health care workers from exposure to hazardous chemicals is incalculable, in terms of the long-term mortality and morbidity of health care personnel. We do not fully understand the magnitude and long-term effects of hospital personnel’s continuous exposure to HDs, but because we are aware of the potential for risk, it is our obligation to prevent harm to our employees.
Firouzan ”Fred” Massoomi, PharmD, FASHP, has served as the pharmacy operations coordinator at the Nebraska Methodist Hospital for the past 11 years.
William Neff, RPh, is the infectious disease pharmacist for Nebraska Methodist Hospital. Neff received his BS in chemistry and biology from Wayne State College and a BS in pharmacy from Creighton University School of Pharmacy and Allied Health. He has worked for Nebraska Methodist Hospital for 15 years.
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