Archive Notice - OSHA Archive

NOTICE: This is an OSHA Archive Document, and no longer represents OSHA Policy. It is presented here as historical content, for research and review purposes only.



Hazardous Medications


Many important drugs used in medical care, such as anti-cancer agents and anesthetic gases, can cause serious unintended side effects not only in patients but in workers who may be exposed during their manufacture, preparation or administration. Hundreds of thousands of workers in hospitals, nursing homes, clinics, pharmacies and chemical plants are potentially exposed to these hazardous medications, which are capable of causing serious effects including cancer and adverse reproductive outcomes. OSHA has few specific standards designed to protect employees from these risks and there has been relatively little national attention devoted to these issues in the private sector. OSHA is developing an action plan to reduce worker exposures to these hazards but is not initiating rulemaking at this time.

Hazard Description

Scores of medications in common use today can have serious, unintended health effects including genetic damage, cancer, birth defects, fertility problems and organ toxicity (1). There are hundreds of thousands of workers, principally in health care facilities and the pharmaceutical industry, who are potentially exposed to these hazardous medications. although much remains unknown about actual exposures and effects in the workplace, there is a growing scientific literature that reveals an emerging problem worthy of national attention. Specifically:

  • Anti-neoplastic (anti-cancer) drugs can inhibit the growth of cells. A large number of these drugs not only fight cancer but are known or suspected of causing cancer in humans, according to the International Agency for Research on Cancer (IARC) (2,3). A large number of studies (although not all) document DNA damage in exposed workers (4-6). Several recent studies suggest an excess of leukemia and related cancers in those workers exposed (7-9).
  • Several recent studies among workers have documented an association between anti-neoplastic (anti-cancer) drug exposure and excesses in spontaneous abortions (10), births of malformed infants (11) and ectopic pregnancies (12).
  • Anesthetic agents used in operating rooms can cause nerve and brain damage. They can also cause reproductive damage in animals (13,14) and exposed workers (15-18).
  • Some anti-viral drugs cause reproductive damage to animals at doses which are relatively low compared to the doses absorbed by nurses administering the drug (19,20).
  • Health care workers may be exposed to various medications associated with a variety of potential health effects; these medications include aerosolized pentamadine used to prevent pneumocystis pneumonia in HIV patients (21, 22) and methyl methacrylate used as bone cement in orthopedic procedures (23, 24).
  • A variety of health effects have also been reported among pharmaceutical workers manufacturing estrogens (25) and opiates (26, 27).
Current Status

although there are NIOSH-recommended exposure limits (RELs) for some anesthetic gases such as halothane and nitrous oxide, there are no specific OSHA Permissible Exposure Limits (PELs) or standards governing safe handling of most hazardous medications.



In 1995 OSHA revised its guidelines and technical manual chapter for Hazardous Drugs. OSHA is developing a separate technical manual chapter for waste anesthetic gases.



The American Society of Hospital Pharmacists issued a Technical Assistance Bulletin on the Handling of Cytotoxic and Hazardous Drugs in 1990.

Rationale

Hazardous Medications meet several of the criteria for designation as an OSHA priority. In particular, a very large number of workers are potentially exposed in industry sectors that are growing rapidly; the potential health hazards are severe (cancer, reproductive abnormalities); there is a substantial body of scientific evidence and there are many known methods of feasibly reducing worker exposure. However, there are still gaps in our understanding about the pattern and levels of exposure and the degree of risk faced by workers under actual workplace conditions.

References
  1. American Society of Hospital Pharmacists: Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am. J. Hosp. Pharm. 47: 1033-1049, 1990.
  2. International Agency for Research on Cancer 1981. IARC monographs on the Evaluation of the Carcinogenic Risk of Chemicals to humans: some antineoplastic and immunosuppressive agents. Vol. 26 Lyon, France: IARC.
  3. International Agency for Research on Cancer 1990. IARC monographs on the Evaluation of the Carcinogenic Risk of Chemicals to humans: Pharmaceutical Drugs: Vol. 50 Lyon, France: IARC.
  4. Fuchs J, Hengstter J, Jhong D et al. 1995. DNA damage in nurses handling antineoplastic agents. Mut. Res. 342:17-23.
  5. Sessink PJM, Cerna M, Rossner P. 1994. Urinary cyclophosphamide excretion and chromosomal aberrations in peripheral blood lymphocytes after occupational exposure to antineoplastic agents. Mut Res. 309:193-199.
  6. Nikula E, Kivinitty K, Leisti J and Taskinese P. 1984. Chromosome aberrations in lymphocytes of nurses handling cytostatic agents. Scand J. Work Environ Health. 10:71-74.
  7. Hansen J, Olsen J. 1994. Cancer morbidity among Danish female pharmacy technicians. Scand J Work Environ Health 20: 22-26.
  8. Limit MS, McLaughlin JK, Malker HS. et al. 1994. Occupation and hematopoietic and lymphoproliferative malignancies among workmen: a linked registry study. J. Occup Med 36:1187-1198.
  9. Skov T, Maarup B, Olsen J et al. 1992. Leukemia and reproductive outcome among nurses handling antineoplastic drugs. Br. J. Ind. Med. 49: 855-861.
  10. Selevan SG, Lindbolm ML, Hornung RW and Hemminki K 1985. A study of occupational exposure to antineoplastic drugs and fetal loss in nurses. New England J. Med. 313:1173-1178.
  11. Hemminki K, Kyyronen P, Lindohm ML 1985. Spontaneous abortions and malformations in the offspring of nurses exposed to anesthetic gases, cytotoxic drugs and other potential hazards in hospitals, based on registered information of outcome J. Epidem. Comm Health 39:141-147.
  12. Saurel-Cubizolles MJ, Job-Spira N, Estryn-Behar M. 1993. Ectopic pregnancy and occupational exposure to antineoplastic drugs. Lancet 341: 1169-1171.
  13. Gofmeckler VA, Bekhman II, Golotin FG. The embryotropic action of nitrogen dioxide and a complex of atmospheric pollutants. Gigiena I Sanitariya 1977; 12:22-27.
  14. Corbett TH, Cornell RG, Endres JL, Millard RI. Effects of low concentrations of nitrous oxide on rat pregnancy. Anesthesiology 1973; 39:299-301.
  15. Cohen EN, Brown BW, Bruce DL, Cascorbi HF, Corbett TH, Jones TW, Whitcher CH. Occupational disease among operating personnel: A national study. Anesthesiology 1974; 41:321-340.
  16. Cohen EN, Brown BW, Williams ML, Whitcher CE, Brodsky JB, Gift HC, Greenfield W, Jones TW, Driscoll EJ. Occupational disease in dentistry and chronic exposure to trace anesthetic gases. J Am Dent Assoc 1980; 101:21-31.
  17. Corbett TH, Cornell RG, Endres JL, Lieding K. Birth defects among children of nurse-anesthetists. Anesthesiology 1974; 41:341-344.
  18. Guirguis SS, Pelmear PL, Roy ML, Wong L. Health effects associated with exposure to anaesthetic gases in Ontario hospital personnel. Br J Ind Med 1990; 47:490-497.
  19. Hillyard IW 1980. The preclinical toxicology and safety of ribavirin. In ribavirin: a broad spectrum antiviral agent, ed. Smith RA and Kirkpatrick W. New York: Academic Press.
  20. Harrison R, Bellows J. Rempel D. et al. 1988. Assessing exposures of health care personnel. Health Care Worker Exposure to Ribavarin Aerosol; Field Investigation FI-86-009; Occupational Health Surveillance and Evaluation Program, Epidemiologic Studies and Surveillance Section, California Department of Health Services.
  21. Kacmarek RM; Editorials - Ribavirin and Pentamidine Aerosols: Caregiver Beware! Respiratory Care; November 1990, Vol. 35, No. 11; pp. 1034-1035.
  22. McDiarmid MA; et al. 1993. Health effects and exposure assessment of aerosolized pentamidine handlers. Chest 104(2):382-385.
  23. Kassis V, Vedel P, Darre E 1984. Contact dermatitis to methyl methacrylate. Contact Dermatitis 11:26-28.
  24. Pickering CAC, et al. 1986. Occupational asthma due to methyl methacrylate in an orthopaedic theatre sister. British Medical Journal 292:1362-1363.
  25. Harrington JM, et al. 1978. The occupational hazards of formulating oral contraceptives--a survey of plant employees. Archives of Environmental Health 33(1):12-5.
  26. Biagini RE, et al. 1992. Evaluation of cutaneous responses and lung function from exposure to opiate compounda among ethical narcotics-manufacturing workers. Journal of Allergy and Clinical Immunology 89(1) Part 1:108-118.
  27. Klincewicz S, et al. 1990. Health Hazard Evaluation Report No. HETA-87-311-2087, Penick Corporation, Newark, New Jersey. Hazard Evaluations and Technical Assistance Branch, NIOSH, U.S. Department of Health and Human Services, Cincinnati, Ohio, Report No. HETA-87-311-2087, 59 pages, 28 references.

NOTICE: This is an OSHA Archive Document, and no longer represents OSHA Policy. It is presented here as historical content, for research and review purposes only.