Medical Surveillance for Healthcare Workers Exposed to Hazardous Drugs

Summary Description of Exposure Healthcare workers who prepare, administer, or transport hazardous Drugs are considered hazardous if stud- drugs or dispose of hazardous drug ies in animals or humans show that they waste may face risks to their own have the potential to cause cancer, repro- health such as skin disorders, re- ductive toxicity, birth defects, or damage productive disorders, and possibly to organs at low doses [NIOSH 2004]. In cancer. NIOSH recommends that the United States, an estimated 8 million employers establish a medical sur- healthcare workers are potentially ex- veillance program as part of a com- posed to hazardous drugs or drug waste prehensive prevention program at their worksites [BLS 2011]. Healthcare that also minimizes worker expo- Figure 1. Multi-channel infusion pump workers who should be included in the for delivery of chemotherapy. sure through engineering controls, medical surveillance program are work- good work practices, and person- ers who may be exposed to hazardous al protective equipment (PPE) and drugs directly such as nurses, pharma- Table 1. Job titles that may provides education about working cists, and pharmacy technicians; or oth- involve exposure to hazardous with hazardous drugs. Medical sur- er workers (e.g., nurses’ aides, laundry drugs: veillance involves collecting and in- workers) who may come into contact 1. Pharmacists and pharmacy terpreting data to detect changes in with hazardous or patient waste [OSHA technicians the health status of working popu- 1999; NIOSH 2004; ASHP 2006; ONS 2. Nurses (RNs, ARNPs, LPNs) lations potentially exposed to haz- 2011]. Table 1 lists job titles that may in- 3. Physicians and physician assistants ardous substances. The elements of volve handling hazardous drugs. Work- a medical surveillance program are ers may be exposed to hazardous drugs 4. Operating room personnel used to establish an initial baseline when they create aerosols, generate dust, 5. Home healthcare workers of workers’ health and then moni- clean up spills, or touch contaminated tor their future health as it relates to 6. Veterinarians and veterinary surfaces when compounding, adminis- their potential exposure to hazard- technicians tering, or disposing of hazardous drugs ous agents. This information can be or patient waste [NIOSH 2004]. 7. Environmental service workers used to identify and correct preven- (housekeeping, laundry, mainte- tion failures leading to disease. Ear- Exposure to hazardous drugs may oc- nance workers) ly identification of health problems cur through skin contact, inhalation, 8. Workers who ship, transport, or can also benefit individual workers. ingestion, or injection. Skin contact receive hazardous drugs and inhalation are the most likely ways

DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health a worker may be exposed to hazardous drugs. However, in- Elements of a Medical gestion (from hand to mouth) or injection through a needle stick or sharps injury is also possible. Surveillance Program Several important issues should be considered in designing Many hazardous drugs are used to treat illnesses such as a medical surveillance program for workers responsible for cancer or HIV infection (see Figure 1). For the patients, handling hazardous drugs. The first is to develop an organized the potential benefits of hazardous drug treatment out- approach to identifying workers who are potentially exposed weigh the possible negative side effects. However, ex- to hazardous drugs on the basis of their job duties. The second posed healthcare workers risk the same side effects with is to provide medical surveillance that is appropriate to the ex- no benefit. Workers exposed to hazardous drugs have de- posure because the various classes of hazardous drugs differ veloped skin disorders, adverse reproductive effects, and in their modes of action and may affect specific target organs. possibly leukemia and other cancers. For example, nurses Because healthcare workers are typically exposed to numer- and pharmacists who were exposed to hazardous drugs at ous hazardous drugs [NIOSH 2004; 2012], no single biolog- their worksite reported an increase in adverse reproduc- ical monitor is suitable for all of these drugs. Organizations tive events including spontaneous abortions, stillbirths, should use the information obtained through medical surveil- and congenital malformations compared with unexposed lance to help affected workers and to identify and correct sys- healthcare workers [NIOSH 2004]. A recent epidemiolog- tem failures that may have resulted in harmful exposures. ical evaluation of nurses found a statistically significant, nearly 2-fold increase in risk for spontaneous abortion Elements of a medical surveillance program for workers ex- among those exposed to antineoplastic agents for more posed to hazardous drugs should include the following: than 1 hour per day during the first trimester [Lawson et. „„ Reproductive and general health questionnaires com- al. 2012]. pleted at the time of hire and periodically thereafter (see ONS 2011 for a sample questionnaire). Unless informa- tion about relevant symptoms and medical events such Medical Surveillance as spontaneous abortions is deliberately sought, their occurrence is likely to go unreported. Opportunities to NIOSH recommends medical surveillance of workers identify patterns of occurrence implying defects in en- who handle hazardous materials and are therefore at risk gineering controls, technique, or other preventive mea- of adverse health effects from exposure. The goal of med- sures may be similarly missed. ical surveillance is to minimize adverse health effects in „ workers exposed to hazardous substances. By identify- „ History of drug handling as an estimate of prior and cur- ing and correcting failures in exposure prevention (iden- rent exposure, including dates of duty assignment relat- ed to hazardous drugs and similar types of information. tified through medical surveillance), employers can lim- it exposure and prevent adverse health outcomes in other „„ A plan to provide initial baseline clinical evaluation, including workers (primary prevention). In addition, by identify- appropriately targeted medical history, physical examination, ing the earliest reversible biologic effects, exposure can and laboratory testing for workers identified as being poten- be reduced or eliminated, and further adverse health ef- tially exposed to hazardous drugs that anticipates their poten- fects can be limited in individual workers (secondary pre- tial toxicities. vention). Medical surveillance is a second line of defense, „„ A follow-up plan as needed for workers who have shown augmenting the protection afforded by engineering con- health changes suggesting toxicity or who have experi- trols, other administrative controls, work practice con- enced an acute exposure (substantial skin contact or in- trols, PPE, and worker education about the hazards of the halation exposure, cleaning a large spill [a broken IV bag, materials they work with or they may come into contact leaking IV line], etc.). with in the course of their duties [NIOSH 2004; 2009]. An If clinical laboratory studies and/or biological monitoring is effective surveillance program begins with a hazard iden- contemplated, a rational approach to selecting clinical stud- tification program that is integrated with surveillance for ies would consider the toxicity patterns of the drugs to which disease or illness. The following types of data are often workers are exposed. obtained and evaluated by medical surveillance programs: Medical surveillance program results should be examined 1. Medical (including reproductive) and occupational history in aggregate for trends that may be a sign of health chang- 2. Physical examination es because of exposure to hazardous drugs. If health changes 3. Laboratory studies are found during follow-up evaluations, the employer should 4. Biological monitoring take the following actions: „„ Evaluate current protective measures that are already under a contract with the Division of Federal Occupational in place: Health, served as the lead writer/editor. —— Engineering controls (Class II biological safety cab- inets/compounding aseptic containment isolators, robotic systems, ventilation, closed system transfer References devices, and closed IV systems). ASHP (American Society of Health-System Pharmacists) ƒƒ Compare performance of controls with rec- [2006]. ASHP guidelines on handling hazardous drugs. ommended standards. Am J Health-Syst Pharm 63:1172–1193. ƒƒ Conduct environmental sampling when ana- ASTM [2005]. Standard practice assessment of resistance lytical methods are available. of medical gloves to permeation by chemotherapy drugs. —— Policies for the use of PPE and worker compli- West Conshohocken, PA: American Society for Testing ance with PPE use and policies. and Materials. ASTM D 6978–05. BLS [2011]. Occupational employment statistics homep- —— Availability of appropriate PPE such as double age. May 2011 employment and wage estimates. Wash- gloves tested for use with hazardous drugs [ASTM ington, DC: Bureau of Labor Statistics, [http://www.bls. 2005], nonpermeable gowns, and respiratory pro- gov/oes/home.htm] tection [NIOSH 2009]. Lawson CC, Rocheleau CM, Whelan EA, Lividoti Hibert „„ Verify that all controls are in proper operating condition EN, Grajewski B, Spiegelman D, Rich-Edwards JW [2012] and monitor worker compliance with existing policies or Occupational exposures among nurses and risk of spon- when new policies go into effect. taneous abortions. Am J Obstet Gynecol 206:327.e1−8. „„ Develop a plan of action that will prevent further work- NIOSH [2004]. NIOSH Alert: preventing occupational ex- er exposure. posures to antineoplastic and other hazardous drugs in „„ Ensure confidential two-way communication between a health care settings. Cincinnati, OH: U.S. Department of worker and the employee health unit regarding notification: Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safe- —— By any worker wishing to discuss a change in health condition such as pregnancy or chronic illness with ty and Health, DHHS (NIOSH) Publication No. 2004– the employee health unit, or 165, [http://www.cdc.gov/niosh/docs/2004-165/]. NIOSH [2009]. NIOSH: Workplace Solutions: Person- —— By the health unit, when communicating the find- al Protective Equipment for Health Care Workers Who ing of an adverse health effect and instructions for Work with Hazardous Drugs. Cincinnati, OH: U.S. De- follow-up back to the workers. partment of Health and Human Services, Centers for „„ If an employee health unit is not available for a facility, Disease Control and Prevention, National Institute for workers should be encouraged to address exposure issues Occupational Safety and Health, DHHS (NIOSH) Pub- with their primary medical provider. lication No. 2009–106, [http://www.cdc.gov/niosh/docs/ „„ Provide ongoing medical surveillance for all workers at wp-solutions/2009-106/]. risk to determine whether the new plan is effective. NIOSH [2012]. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings (2012). Cincinna- ti, OH: U.S. Department of Health and Human Services, Acknowledgments Public Health Service, Centers for Disease Control and The principal authors of this document were Melissa McDi- Prevention, National Institute for Occupational Safety armid, University of Maryland; Martha Polovich, Oncology and Health, DHHS (NIOSH) Publication No. 2012–150, Nursing Society; Luci Power, Power Enterprises; and Thom- [http://www.cdc.gov/niosh/docs/2012-150/]. as H. Connor and David Weissman of NIOSH. ONS (Oncology Nursing Society) [2011]. Safe handling of hazardous drugs. Polovich M, ed. 2nd ed. Pittsburgh, PA: The current document supersedes DHHS (NIOSH) Publica- Oncology Nursing Society. tion No. 2007–117, written by Melissa Leone, Apria Health- care; Melissa McDiarmid, University of Maryland; Martha OSHA [1999]. Controlling occupational exposure to hazard- Polovich, Oncology Nursing Society; Barbara Coyle, Wis- ous drugs. In: OSHA technical manual (TED 01–00–015: consin State Laboratory of Hygiene; Luci Power, University TED 1–0.15A), Section VI, Chapter 2. Washington, DC: of California Medical Center in San Francisco, and Thomas Occupational Safety and Health Administration, [http:// H. Connor and Laurence D. Reed of NIOSH. John J. Whalen, www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html] DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health 4676 Columbia Parkway Cincinnati, OH 45226–1998

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NIOSH has published an Alert describing measures to This document is in the public domain and may be control worker exposure to hazardous drugs: www.cdc.gov/ freely copied or reprinted. NIOSH encourages all niosh/ docs/2004-165/ readers of the Workplace Solutions to make them Additional information about hazardous drugs is available available to all interested employers and workers. on the NIOSH Web site at www.cdc.gov/niosh/topics/haz- drug/default.html. To receive copies of NIOSH publica- tions, contact NIOSH: As part of the Centers for Disease Control and Preven- Telephone: 1–800–CDC–INFO (1–800–232–4636) tion, NIOSH is the Federal agency responsible for con- TTY: 1–888–232–6348 ■ E-mail: [email protected] ducting research and making recommendations to prevent work-related illness and injuries. All Workplace Solutions or visit the NIOSH Web site at www.cdc.gov/niosh are based on research studies that show how worker expo- For a monthly update on news at NIOSH, subscribe to sures to hazardous agents or activities can be significant- NIOSH eNews by visiting www.cdc.gov/niosh/eNews. ly reduced.

Medical Surveillance for Health Care Workers DHHS (NIOSH) Publication No. 2013–103 Exposed to Hazardous Drugs (Supersedes 2007–117)

Safer • Healthier • PeopleTM November 2012