Hazardous Drugs and Reproductive Effects: Understanding the Risks

Martha Polovich, PhD, RN, AOCN

Martha Polovich, PhD, RN, AOCN

The new standards from the US Pharmacopeoal (USP) Convention address the importance of informing healthcare workers (HCWs) about the adverse reproductive outcomes from exposure hazardous drugs (HDs).¹ The standard appears in the USP Chapter <800> section on Hazard Communication and states that all personnel who are capable of reproduction must acknowledge in writing that they have received information and that they understand the risks associated with HD handling.

This is an important step forward in safety for HD handlers, which has implications for every organization where HDs are present, as implementation may require several changes in policy and practice.

Reproductive Toxins

Many drugs are hazardous to reproductive function in women, men, or both, affecting their ability to conceive and bear healthy children. Such effects may occur as a result of changes in ovarian function, sperm production, or hormonal changes. Some drugs have a direct effect on an embryo or fetus, such as antineoplastic agents that damage rapidly proliferating cells in the same way that they destroy cancer cells. Two criteria for drugs to be labeled as hazardous are teratogenicity (structural defects in a fetus) and reproductive toxicity.² (Table)

Table. Adverse Outcomes in Hazardous Drug-Exposed Versus Non-Exposed Workers

HDs are identified as reproductive toxins based on:

• Animal or human studies during drug development (eg, Black Box Warnings in prescribing information)
• Postmarketing reports of adverse outcomes (eg, thalidomide)
• Evidence of reproductive harm from epidemiologic studies (eg, increased miscarriages in Nurses' Health Study II)

Infertility has occurred in patients treated with antineoplastic drugs and has also been reported in nurses from occupational HD exposure. In one study, exposed nurses took longer to conceive than nonexposed nurses.³ In others, infertility occurred up to 1.5 times more frequently in exposed nurses.^4,5

Few studies have had sufficient numbers of participants to clearly document birth defects in HD-exposed healthcare workers. One recent study, in which “exposure” was defined as chemotherapy handling, reported an increase in miscarriages, with higher occurrence in exposed nurses during their first pregnancy^.6

The National Institute for Occupational Safety and Health (NIOSH) has compiled a list of drugs that should be handled as hazardous. The NIOSH list is divided into 3 separate tables: (1) Antineoplastic drugs; (2) Non-antineoplastic hazardous drugs; (3) Drugs with primarily reproductive effects. Drugs in table 3 need only be considered harmful “to males or females who are actively trying to conceive, women who are pregnant or may become pregnant, and women who are breastfeeding.”² Drugs in tables 1 and 2 may have adverse reproductive effects as well as being carcinogens, mutagens, and organ toxins.²

HD Precautions and Pregnancy

HD safe handling precautions are necessary for all personnel because healthcare settings should be safe for everyone. The recommendations from the American Society of Health System Pharmacists, NIOSH, the Occupational Safety and Health Administration, the Oncology Nursing Society (ONS), and USP agree that the use of engineering controls, administrative controls, and personal protective equipment (PPE) will reduce exposure. Evidence suggests, however, that current work practices cannot completely eliminate exposure.

Known spills and environmental contamination are sources of exposure that workers cannot necessarily avoid if they are involved in HD preparation, administration, or handling of contaminated excreta, illustrating the need for other practices that provide additional protection for workers who are vulnerable to reproductive harm because of their life situation.

One recommendation for nurses or other HCWs who are actively trying to conceive, pregnant, or breastfeeding is to refrain from HD handling activities. This is referred to as alternative duty or temporary reassignment and is a “recognized risk management strategy.”⁷

This involves identifying job tasks that do not include HD handling that the HCW can safely perform. In order for such a program to be implemented, all employees must be aware of the risks of exposure around pregnancy, the availability of alternative duty, and the process for requesting such duty.

Protecting Reproductive Rights

Information about the risks of HD exposure must be provided as a part of a hazard communication program. Employees may not be aware of the need to avoid HD exposure around pregnancy and should be provided with specific information during initial education and training.

The USP standard for acknowledging receipt of information in writing is a good way to document the initial education. HCWs should be retrained about the risks in annual updates, since their life situation may have changed.

Organizations must develop a policy that addresses alternative duty. Current recommendations from ONS and the American Nurses Association support alternative duty that does include HD handling when an employee requests it.^7,8 Policies should be written instead of implied, so that there is a formal mechanism to protect nurses when making patient care assignments.

The formal process should include who the employee should contact to request alternative duty and how that request is made. HCWs should notify their manager or supervisor when they want to refrain from handling HDs so that appropriate levels of staffing can be provided.

References

1. US Pharmacopeial Convention Chapter <800>: Hazardous Drugs—Handling in Healthcare Settings. http://www.usp.org/. Accessed June 14, 2017.

2. National Institute for Occupational Safety and Health. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016. https://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf. Accessed May 18, 2017.

3. Fransman W, Roeleveld N, Peelen S, et al., Nurses with dermal exposure to antineoplastic drugs: reproductive outcomes. Epidemiology. 2007;18(1):112-119.

4. Martin S. Chemotherapy handling and effects among nurses and their offspring (Abstract). Oncol Nurs Forum. 2005;32(2):425-426.

5. Valanis B, Vollmer W, Labuhn K, Glass A, et al. Occupational exposure to antineoplastic agents and self-reported infertility among nurses and pharmacists. J Occup Environ Med. 1997;39(6): 574-580.

6. Lawson CC, Rocheleau CM, Whelan EA, et al. Occupational exposures among nurses and risk of spontaneous abortion. Am J Obstet Gynecol. 2012;206(4):327.e1-e8.

7. American Nurses Association. Reproductive Rights of Registered Nurses Handling Hazardous Drugs. http://www.nursingworld.org/MainMenuCategories/WorkplaceSafety/Healthy-Work-Environment/reproductive-rights-of-rns-handling-hazardous-drugs.pdf. Accessed June 14, 2017.

8. Oncology Nursing Society. Ensuring healthcare worker safety when handling hazardous drugs. https://www.ons.org/advocacy-policy/positions/practice/hazardous-drugs. Accessed June 14, 2017.