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«Current Intelligence Bulletin XX Reproductive Risks Associated with Hazardous Drug Exposures in Healthcare Workers and Recommendations for Reducing ...»

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Current Intelligence Bulletin XX

Reproductive Risks Associated with Hazardous Drug Exposures in Healthcare

Workers and Recommendations for Reducing Exposures

by

Thomas H. Connor, PhD

Christina C. Lawson, PhD

Martha Polovich, PhD, RN, AOCN

Melissa A. McDiarmid, MD, MPH, DABT

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

National Institute for Occupational Safety and Health

Disclaimer: The findings and conclusions in this report are those of the author and do not necessarily represent the views of the National Institute for Occupational Safety and Health (NIOSH). Mention of any company or product does not constitute endorsement by NIOSH. In addition, citations to Web sites external to NIOSH do not constitute NIOSH endorsement of the sponsoring organizations or their programs or products.

Furthermore, NIOSH is not responsible for the content of these Web sites. All Web addresses referenced in this document were accessible as of the publication date.

This document is in the public domain and may be freely copied or reprinted.

Disclaimer Ordering Information To receive documents or other information about occupational safety and health topics, contact NIOSH at DHHS (NIOSH) Publication No. 2012–XXX Foreword The purpose of this Current Intelligence Bulletin is to increase awareness among healthcare workers and their employers about the potential adverse reproductive health effects from working with antineoplastic and other hazardous drugs. In addition, it will provide measures for protecting the reproductive health of workers and the health of their offspring. Healthcare workers who prepare or administer hazardous drugs or who work in areas where these drugs are used can be exposed when these agents are in the air or on work surfaces, drug vials and containers, contaminated clothing, medical equipment, and patient excreta. Workplace exposures to hazardous drugs have been associated with health effects such as skin disorders, adverse reproductive outcomes (including infertility, miscarriage, and congenital malformations), and possibly leukemia and other cancers. Of these, reproductive health is one of the most vulnerable endpoints, because many hazardous drugs used for cancer treatment target rapidly dividing cells in the same way teratogens target rapidly dividing embryonic cells. The risk can be influenced by the timing of the exposure and the potency and toxicity of the hazardous drug.

The production, distribution, clinical preparation, administration, and disposal of pharmaceutical products are widespread and essential to the healthcare industry. New areas of pharmaceutical development are continually bringing new drugs and fundamental changes to methods for treating and preventing or minimizing diseases. At the same time, a large number of medications or mixed exposures can be hazardous to healthcare workers who handle them and to their fetuses or nursing offspring. This NIOSH Current Intelligence Bulletin will help make workers and employers more aware of these hazards and provide recommendations for preventing exposures.

This Current Intelligence Bulletin applies to all healthcare workers who might handle hazardous drugs, such as pharmacists and pharmacy technicians, registered nurses, advanced practice registered nurses, licensed practical/vocational nurses, nurses’ aides, physicians, physicians’ assistants, operating room personnel, shipping and receiving personnel, waste handlers, maintenance workers, laundry workers, laboratory personnel, and workers in veterinary practices. The current number of healthcare workers in the United States potentially exposed to hazardous drugs exceeds 8 million. However, not all of these workers will be exposed to hazardous drugs, and only a fraction of those who are exposed will be at reproductive risk. Workers in the drug manufacturing sector may also be exposed to hazardous drugs. However, the primary focus of this Current Intelligence Bulletin is workers in healthcare settings because of their unique potential to be in an environment of multiple exposures.

–  –  –

Abstract Healthcare workers who handle, compound (prepare), administer, or dispose of hazardous drugs can incur risks to their health, including reproductive harm. This document describes the vulnerability of workers, fetuses, and nursing infants of exposed workers to reproductive and health hazards and reviews human and animal studies of exposure to hazardous drugs. On the basis of a review of published data, the National Institute for Occupational Safety and Health (NIOSH) recommends steps to reduce employee exposure to hazardous drugs for all healthcare workers and especially those at reproductive risk. Special consideration may be needed for those workers with underlying medical conditions that may put a worker at exceptional risk of harm.

These steps involve adhering to established industrial hygiene procedures, education and training for employees and employers on the safe handling of hazardous drugs, and including the implementation of an alternative duty program when exposure cannot be eliminated. Employers and all workers in healthcare settings (including employees and nonemployees such as contractors and credentialed providers) can work together to establish a program to provide a safe working environment for all healthcare workers, especially those who are at reproductive risk if exposed to hazardous drugs.





Contents Foreword Abstract Acknowledgments Abbreviations Glossary Reproductive Risks Associated with Hazardous Drug Exposures in Healthcare Workers and Recommendations for Reducing Exposures Background Description of Exposure When is a Worker Particularly Vulnerable to Reproductive Hazards?

Vulnerability of the Developing Fetus and Newborns Experimental Studies Animal Studies Human Studies Patients Treated with Antineoplastic Drugs Patients Treated with Drugs Other Than Antineoplastic Drugs Healthcare Workers Exposed to Hazardous Drugs Exposure to Antineoplastic Drugs Recommendations Use of Industrial Hygiene Practices to Reduce Exposure to Hazardous Drugs Implementation of an Alternative Duty or Temporary Reassignment Program Medical, Legal and Ethical Implications Summary References Tables Table 1. Review of Reproductive Epidemiology Studies of Occupational Exposure to Antineoplastic Drugs Figures Figure 1. Initial Health and Safety Assessment for Couples Trying to Conceive and Women who are Pregnant or Breast Feeding Appendices Appendix 1. Hazardous Drug Handling Activities in Healthcare Settings that can Result in Exposure Appendix 2. FDA Pregnancy Categories of Drugs that should be Handled as Hazardous Appendix 3. FDA-Assigned Pregnancy Categories Appendix 4. Databases Reviewed Appendix 5. Reproductive Health Recommendations for Alternative Duty Practices Acknowledgments The authors thank the following individuals for their assistance in reviewing this document: Kathleen Connick Editorial review and production assistance were provided by Susan Afanuh and Vanessa B. Williams.

Abbreviations AHFS American Hospital Formulary Service

–  –  –

USP United States Pharmacopeial Convention Glossary Alternative duty: Temporary reassignment of duties, often within the same job, to avoid hazardous situations or agents (in this case, exposure to hazardous drugs).

Antineoplastic drug: A chemotherapeutic agent that controls or kills cancer cells. Drugs used in the treatment of cancer are cytotoxic but are generally more damaging to dividing cells than to resting cells.

Carcinogenicity: The ability or tendency to produce cancer.

Chemotherapy drug: A chemical agent used to treat diseases. The term usually refers to a drug used to treat cancer. Similar drugs are also known as antineoplastic and cytotoxic.

Closed system drug-transfer devices (CDTDs): A drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system.

Cytotoxic: A pharmacologic compound that is detrimental or destructive to cells within the body.

Engineering controls: Devices designed to eliminate or reduce worker exposures to chemical, biological, radiological, ergonomic, or physical hazards. Examples of those used in healthcare include laboratory fume hoods, glove bags, needleless systems, closed system transfer devices, biological safety cabinets, containment isolators, and robotic systems.

Genotoxicity: The ability to damage or mutate DNA. Genotoxic substances are not necessarily carcinogenic.

Hazardous drug: Any drug identified by at least one of the following criteria: carcinogenicity; teratogenicity or developmental toxicity; reproductive toxicity in humans; organ toxicity at low doses in humans or animals; genotoxicity; or new drugs that mimic existing hazardous drugs in structure or toxicity.

Healthcare workers: All workers who are involved directly or indirectly in the care of patients. Examples of those at risk for exposure to hazardous drugs include pharmacists; pharmacy technicians; registered nurses, advanced practice registered nurses; licensed practical/vocational nurses; nurses’ aides;

physicians; physicians’ assistants; home healthcare workers; and workers in environmental services (housekeeping, laundry, and waste disposal).

Mutagenicity: The ability of increasing the spontaneous mutation rate by causing changes in the DNA.

Personal protective equipment (PPE): Items such as gloves, gowns, respirators, goggles, face shields, and others that protect individual workers from hazardous physical or chemical exposures.

Reproductive hazard: An agent that interferes with the ability of a couple to achieve a successful birth.

Reproductive hazards affect fertility, conception, pregnancy, and/or delivery.

Reproductive risk: Reproductive risk refers to risks to the reproductive systems of adult men and women, and outcomes of pregnancies, including: measurements of fertility in men and women, menstrual function, miscarriage (spontaneous abortion), preterm birth, abnormal birth weight, and developmental and reproductive outcomes in offspring.

Reproductive toxicity: The ability to cause adverse effects on the male and/or female reproductive system.

Risk assessment: Characterization of potentially adverse health effects from human exposure to environmental or occupational hazards. Risk assessment can be divided into five major steps: hazard identification, dose–response assessment, exposure assessment, risk characterization, and risk communication.

Susceptible populations: Those individuals with medical history or personal fertility history (e.g., repeated miscarriages) or any other underlying medical conditions that may put them at exceptional risk of harm.

Temporary reassignment: An assignment to another position, at the same pay scale, for a specified period. At the end of the temporary reassignment, the employee returns to the original position or to a position of comparable status, tenure, and pay.

Teratogenicity: The capability of producing fetal malformations.



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