Luci A Power
University of California Medical Center
San Francisco, CA
In December 2005, the American Society of Health Systems Pharmacists (ASHP) issued its latest guidelines for the safe handling of hazardous drugs.(2) These come 25 years after the first English-language safe-handling guidelines were published by the Australian Society of Hospital Pharmacists.(3) In comparing the two documents, they are actually quite similar, which could lead practitioners to believe that not a great deal of innovation has occurred in this area in the quarter century.
US and European studies
A 1979 study by Falck et al(4) reported mutagenic responses in nurses who were involved in both preparing and administering antineoplastic drugs. Anecdotal reports appeared in the literature describing adverse reactions, such as hair loss, mucosal sores, nasal and nail problems, in nurses and pharmacists who handled these drugs in an uncontrolled environment using no special techniques.(5–8) These early reports led to concerns about the safety of occupational exposure to antineoplastic and hazardous drugs. In 1982, MD Anderson Cancer Center published an intervention study showing that the Class II biological safety cabinet (BSC) was an effective method of reducing occupational exposure during preparation of injectable antineoplastic drugs as measured by a reduction in urinary mutagens in pharmacists preparing these doses.(9) Occupational safety concerns coupled with a potential safe-handling solution led, in the USA, to a series of guidelines developed by professional groups and governmental agencies.(10–13) All of these guidelines shared the core premise that the use of the Class II BSC, in lieu of the traditional horizontal-flow clean air workbench, would provide a safe environment when preparing injectable doses of antineoplastic and other hazardous drugs. This environmental control was accompanied by personal protective equipment, special aseptic technique, spill control and waste management. These safety programmes, adopted throughout the USA, were very similar to the European programmes. By 1990, pharmacy and nursing practitioners in the USA were complacent with their safety programmes. Updated safety guidelines were produced that sought to clarify and strengthen earlier recommendations, but little research was conducted in the USA into the efficacy of the safety programmes.
Fortunately, European researchers were not complacent and many studies were undertaken. Utilising newly developed, more sensitive assays, European researchers documented environmental and worker contamination with the hazardous drugs despite implementation of safety programmes.(14–21) In an effort to determine if this was uniquely a European failure, researchers from MD Anderson conducted a multicentre study at three sites in the USA and three in Canada utilising methods developed in Europe.(22)
Though limited to surface contamination of marker drugs, this study, published in 1999, documented contamination in all preparation and infusion sites similar to the European studies. It was not only time to re-evaluate the safety programmes in the USA, but also the attitudes that produced this complacency.
In 2000, the US National Institute for Occupational Safety and Health (NIOSH) partnered with the National Occupational Research Agenda (NORA) to assemble a group of interested parties to assess the extent and impact of occupational exposure to hazardous drugs and to help NIOSH and others make recommendations for protecting workers from exposure to these drugs. This Hazardous Drug Working Group consisted of members representing government, labour, pharmacy, nursing, academia, research, pharmaceutical manufacturing and trade associations. The Working Group developed the NIOSH Alert,(1) Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings (NIOSH 2004-165), published in 2004. The Working Group will continue assisting NIOSH in the development and implementation of a process for updating the definition and list of hazardous drugs that are described in the NIOSH Alert. It is also helping NIOSH to work with the FDA in modifying its drug package inserts to reflect the new health effects information from the NIOSH Alert. The Working Group plans to develop additional work products, as NIOSH Workplace Solutions, to expand on recommendations made in the Alert.
As the Working Group included members of the Oncology Nursing Society (ONS) and ASHP, it is not surprising that the 2005 ONS Chemotherapy and Biotherapy Guidelines and Recommendations for Practice(13) and the 2005 ASHP Guidelines on Handling Hazardous Drugs(2) are remarkably similar to the NIOSH Alert. While each group has attempted to individualise its recommendations to the needs of its members, the overall safety programme is the same: meticulous work practices within a framework of ventilation controls and personal protective equipment to reduce the amount of hazardous drug released into the environment during manipulation.
The NIOSH Alert Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings (NIOSH 2004-165) is a public domain document and may be downloaded (see Resources). The prepublication ASHP Guidelines on Handling Hazardous Drugs are currently available on the ASHP website (see Resources).
After 25 years of scrutiny, the risk of occupational exposure to hazardous drugs is still a mystery. Drug therapy has become more prevalent and diverse, and many drugs used in a variety of disease states are potent and toxic. The discovery and validation that drug vials arrive in the workplace contaminated with drug residue on the outside,(23,24) and the speculation that some hazardous drugs may vaporise,(26,27) increase concern that truly controlling exposure to hazardous drugs is beyond the scope of a workplace safety programme. Continued diligence on the part of practitioners and concern from governmental agencies are necessary steps for protection. Newer technologies for preparation and administration of hazardous drugs may present a breakthrough in safe handling. Manufacturers must recognise their role in protecting workers who manipulate these drugs. Worker and patient safety are both important, and neither should be compromised.
- NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. US Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No 2004-165.
- ASHP guidelines on handling hazardous drugs. http://www.ashp.org/bestpractices/drugdistribution/Gdl_HazDrugs.pdf
- Aust J Hosp Pharm 1980;10:127-30.
- Lancet 1979;1:1250-1.
- Am J Hosp Pharm 1980;37:1184, 86.
- NITA 1980;3:77-8.
- NITA 1982;5:264-6.
- Reynolds RD, Ignoffo R, Lawrence J, et al. Adverse reactions to AMSA in medical personnel. Cancer Treat Rep 1982;66:1885.
- Am J Hosp Pharm 1982;39:1881-7.
- Am J Hosp Pharm 1990;47:1033-49.
- Controlling occupational exposure to hazardous drugs. In: OSHA Technical Manual (OSHA Instruction CPL 2-2.20B CH-4). Washington, DC: Directorate of Technical Support, Occupational Safety and Health Administration; 1995:Chap 21.
- National Institutes of Health. Recommendations for the safe handling of cytotoxic drugs. Available from: http://www.nih.gov/od/ors/ds/pubs/cyto/index.htm
- Polovich M, White JM, Kelleher LO, editors. Chemotherapy and biotherapy guidelines and recommendations for practice. 2nd ed. Pittsburgh, PA: Oncology Nursing Society; 2005.
- Int Arch Occup Environ Health 1992;64:105-12.
- Arch Environ Health 1994;49:165-9.
- Arch Environ Health 1997;52:240-4.
- Occup Environ Med 1994;51:229-33.
- Int Arch Occup Environ Health 1994;65:339-42.
- Int Arch Occup Environ Health 1997;70:205-8.
- Rapid Commun Mass Spectrom 1998;12:1485-93.
- Int Arch Occup Environ Health 1997;70:209-14.
- Am J Health-Syst Pharm 1999;56:1427-32.
- J Oncol Pharm Practice 2000;6:13.
- Am J Health-Syst Pharm 2005;62:475-84.
- J Oncol Pharm Practice 2000;6:15.
- Pharmaceut J 2002;268:331-7.
- Mutat Res 2000;470:85-92.
CDC: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings
ASHP Guidelines on Handling Hazardous Drugs