Dr. Noriko Ishii,
Professor of Public Health and Basic Nursing Studies
Akita University Graduate School of Medicine and Faculty of Medicine
1) United States Guidelines
Guidelines are guiding principles indicating essential information for the prevention of exposure to anticancer drugs and are essential to provide a foundation for medical personnel handling anticancer drugs. Since it has been suggested that anticancer drugs affect normal cells 1) 2), nations 3) and employee groups 4) 5) have established guidelines and recommended compliance (see Chapter I by Ishii), since the 1970s in Northern European countries and in the United States since the 1980s.
The safe handling of anticancer drug cancers has also been proposed by the United States National Cancer Institute (NIOSH: National Institute for Occupational Safety and Health) alerts (warnings), the International Society of Oncology Pharmacy Practitioners (ISOPP) Standards, etc. (see Chapter II by Sasaki).
2) Guidelines of the Japanese Society of Hospital Pharmacists
In 1991, the Japanese Society of Hospital Pharmacists (Scientific Committee / 1st Subcommittee) created “In-hospital Antineoplastic Drug Handling Guidelines 6)
(not for sale)” as the first guidelines in Japan for the prevention of exposure to antineoplastic drugs. Its contents included guidelines and notes for the in-hospital handling of antineoplastic agents, a list of antineoplastic agents, a comparison of cautions and drug toxicity in the handling of antineoplastic agents, risk factors when handling antineoplastic agents, equipment, furniture, tools (injection apparatus and personal protective equipment), and a fact-finding survey regarding the handling of antineoplastic agents. These guidelines were created at a time when medical personnel were not sufficiently aware of the “occupational exposure due to anticancer drugs” in Japan, and because it was not for sale, it did not spread to nurses. In 2005, “Anticancer Drug Preparation Manual” was published as a revised edition 7)
, and in 2014, its 3rd Edition was published 8)
. It describes, in detail, anticancer drugs, injection apparatus, personal protective equipment, the basic preparation procedures of anticancer drugs for injection, and the standards for handling anticancer drugs. These guidelines are a considerable reference for knowledge about anticancer drugs and the safe method of mixing and preparing anticancer drugs for nurses as well.
3) Guidelines for Nurses
The number of facilities in which the mixing and preparation of anticancer drugs and the connection of IV drip lines are being performed in the pharmacy departments by pharmacists is growing. It also depends on the facility; however, although the opportunities for exposure by nurses up to the point of administering the anticancer drugs have been reduced, the care of patients from the start of administration, during administration, and after administration and processing of the used [equipment] are the work of nurses. Hence, guidelines that specifically indicate exposure prevention measures for all nursing work are required for nurses involved with anticancer drug therapies.
(1) United States Oncology Nursing Society Guidelines
The United States Oncology Nursing Society (ONS) appears to have been creating itemized guidelines from the 1990s, and in 2003, published them in book form as the “Safe Handling of Hazardous Drugs” 5)
. Its content consisted of the definition of hazardous drugs, risks of occupational exposure, a control hierarchy, administration preparation, safety tools, methods of administration, processing of bodily fluids of patients after administration, handling of linens soiled with excrement, etc. after administration, disposal of hazardous drugs, processing when hazardous drugs have been spilled, medical monitoring of employees handling hazardous drugs, employee education and training, and a check list for handling hazardous drugs. In 2011, the 2nd Edition was published 9)
. The 2nd Edition added to or revised all the content based on new literature regarding the handling of hazardous drugs.
(2) Manual for Handling Anticancer Drugs for Nurses
While the authors were surveying the awareness of Japanese nurses regarding exposure to anticancer drugs and safe behaviors and actions in addition to continuing to read relevant articles and guidelines from inside and outside of Japan, they thought that guidelines that could be used in the Japanese nursing workplace were necessary, and attempted to create “The Handling-Manual of Antineoplastic Drugs for Nurse (Draft)” in 2005. Its contents included I. Health issues of medical personnel handling anticancer agents, II. Methods of protecting against the anticancer drug exposure of medical personnel (11 items), and III. A check list for the safe handling of anticancer agents. To verify whether or not this manual was appropriate for the workplace, the authors sent it to the heads of nursing departments at hospitals throughout Japan for evaluation 10)
. They received responses from 78 heads of nursing departments indicating, “it is valid, and we would like to use it.” Requests to have it published were also received.
At this point, the authors organized the contents and, in 2007, published the “The Handling-Manual of Antineoplastic Drugs for Nurse” 11)
. Because there were no guidelines aimed at nurses in Japan up to that point, it became a reference for nurses and pharmacists in many facilities. In 2013, we created the “The Handling-Manual of Antineoplastic Drugs, 2nd Edition”12)
. In addition to introducing new survey results and measurement results regarding effects on health, we have made comprehensive additions and revisions in the 2nd Edition, including information on the use of various devices newly developed for the administration of anticancer drugs. It also includes guidelines providing guidance for the prevention of exposure of the patient and the patient’s family and an introduction to preventive measures and protective equipment observed by the authors at hospitals in the United States that are not seen in Japan.
We think the guidelines and manuals introduced here will provide references for when creating independent guidelines at each facility and in each department.
Together, the Japanese Society of Medical Oncology, the Japanese Society of Cancer Nursing, and the Japanese Society of Pharmaceutical Oncology are in the process of establishing guidelines for anticancer drug exposure countermeasures for cancer drug therapies. It is expected that exposure counter measures in the Japanese medical field will progress along with the establishment of these guidelines.
- Haddow A.: Influence of certain policyclic hydrocarbons on the growth of the jenson rat sarcoma. Nature 1935; 136: 868-869.
- Falck K, Grohn P, Sorsa M, et al.: Mutagenicity in urine of nurses handling cytostatic drugs. Lancet 1979; 313(8128): 1250-1251.
- Occupational Safety and Health Administration: Work practice guidelines for personnel dealing with cytotoxic (antineoplastic) drugs. Am J Hosp Pharm 1986; 43: 1193-1203.
- American Society of Hospital Pharmacists: ASHP Technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm 1990; 47: 1033-1049.
- Oncology Nursing Society. Safe handling hazardous drugs. Pittsburgh: ONS, 2003; 1-56.
- Japanese Society of Hospital Pharmacists Scientific Committee, In-hospital Antineoplastic Drug Handling Guidelines Tokyo: Japanese Society of Hospital Pharmacists, 1991.
- Japanese Society of Hospital Pharmacists, Editorial Supervision: In-hospital Antineoplastic Drug Handling Guidelines/Revised Edition: Anticancer Drug Preparation Manual. Tokyo: Jiho, 2005.
- Japanese Society of Hospital Pharmacists, Editors: In-hospital Antineoplastic Drug Handling Guidelines: Anticancer Drug Preparation Manual, 3rd Edition: Anticancer Drug Preparation Manual. Tokyo: Jiho, 2014.
- Oncology Nursing Society. Safe handling hazardous drugs. Second Edition. Pittsburgh: ONS, 2011.
- Ishii N, Nagaoka M et al.: Evaluation and intension to adopt of nursing administrators for “The Handling-Manual of Antineoplastic Drugs (Draft).” The 25th Annual Scientific Meeting of the Japan Academy of Nursing Science Lectures, p. 236, .
- Ishii N, Ed.: “The Handling-Manual of Antineoplastic Drugs for Nurses: Basic Skills to Prevent from Occupational Exposure.” Tokyo: Yuushobou, 2007.
- Ishii N, Ed.: “The Handling-Manual of Antineoplastic Drugs for Nurses: Basic Skills to Prevent from Occupational Exposure.” Tokyo: Yuushobou, 2013.