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Monitoring for Hazardous Drugs in the Operating Room

National Institute for Occupational Safety and Health, Cincinnati, Ohio
Netherlands Cancer Institute, Amsterdam, The Netherlands
Exposure Control, Al Wijchen, The Netherlands

To the Editor:

We have some concerns about the methodologies employed in the evaluation of potential exposure of operating room personnel to heated mitomycin C. We feel that unproven and insensitive techniques were used in this study that resulted in a possible underestimation of exposure to this antineoplastic agent.

Our comments about the methodology include the following:

The air sampling technique of bubbling the air through methanol is not documented. Because 40% of the methanol was lost during the sampling, it could be assumed that some of the mitomycin was lost also. It is not possible to determine the effectiveness of this technique nor is a reference given for it. A similar study¹ used a cryotrap at -80° for collection of cyclophosphamide. This technique could increase the recovery of the mitomycin from the air samples. There is one article in the literature that deals with the possible vaporization of several antineoplastic agents, including mitomycin, and this was not cited.²

The smoke evacuation system utilized a charcoal filter to collect the mitomycin. No citation or data were given for the effectiveness of charcoal filters for collection of mitomycin or for the elution of the drug off of the charcoal. Stanetzek et al.³ have shown that polar compounds are difficult to desorb from activated charcoal. Additionally, Larson et al.⁴ and we (T.H.C., unpublished data, 2001) have shown that other antineoplastic agents are very difficult to elute from charcoal. While some of this information was not available to the authors, a recovery study would have confirmed what fraction of the mitomycin was recoverable from the charcoal. Without this, the efficiency of this procedure is unknown.

The authors state that mitomycin is a good candidate for a study of this nature because it is excreted in the urine unchanged. Apparently this may be true of patients receiving the drug by intraperitoneal lavage.⁵ In patients given intravenous mitomycin, urine recovery is between 1% and 20% and the plasma elimination half-life is 25–90 minutes.⁶ At typical doses of mitomycin, approximately 10% of the drug is excreted unchanged in the urine.⁷ Therefore, to detect the drug in the urine of operating room personnel, their exposure would have to have been considerable.

We found it somewhat disconcerting that the authors did not cite any of the numerous references in the literature concerning occupational exposure to antineoplastic agents, sampling for antineoplastic agents in the health care setting, vaporization of antineoplastic agents, and glove permeation. Several pertinent articles should certainly have been included in the discussion.^8,9 This indicates that the authors may not be aware of recent, similar studies in this area that might have been helpful to them in designing their studies.¹⁰

In summary, the authors appear to have used some apparently undocumented, and possibly, insensitive techniques and found little evidence of exposure. Based on these findings, they concluded that the work practice was safe for the operating room personnel. Their argument would have been much stronger if they could attest to the efficiency of their techniques in actually detecting environmental and worker contamination with mitomycin in the operating room. The procedures in the operating room appear to pose the potential for exposure of personnel to a toxic drug and should therefore be evaluated using well-documented, proven industrial hygiene techniques.

It is commendable that the authors undertook such a study to determine possible worker exposure in a potentially hazardous procedure. However, if the techniques used were not efficient in collecting the drug, the actual exposure and potential risk could have been considerably underestimated. Therefore, their conclusions that the procedure poses little to no risk to the operating room personnel may not be accurate.

REFERENCES

1. Kiffmeyer TK, Kube C, Opiolka S, Schmidt KG, Schöppe G, Sessink PJM. Vapour pressures, evaporation behaviour and airborne concentrations of hazardous drugs: implications for occupational safety. Pharmaceut J 2002; 268: 331–7.
2. Connor TH, Shults M, Fraser MP. Determination of the vaporization of mutagenic antineoplastic agents at 23 and 37°C using a desiccator technique. Mutat Res 2000; 470: 85–92.[Medline]
3. Stanetzek I, Giese U, Schuster RH, Wünsch G. Chromatographic characterization of adsorbents for selective sampling of organic air pollutants. Am Ind Hyg Assoc J 1996; 57: 128–33.
4. Larson RR, Dillon HK, Khazaeli MB. A new monitoring method using solid sorbent media for evaluation of airborne cyclophosphamide and other antineoplastic agents. Appl Occup Environ Hyg 2003; 18: 120–31.[CrossRef][Medline]
5. Jacquet P, Averbach A, Stephens AD, Stuart OA, Chang D, Sugarbaker PH. Heated intraoperative intraperitoneal mitomycin C and early postoperative intraperitoneal 5-fluorouracil: pharmacokinetic studies. Oncology 1998; 55: 130–8.[CrossRef][Medline]
6. Verweij J, Schellens JHM, Loo TL, Pinedo HM. Antitumor antibiotics. In: Chabner BA, Longo DL, eds. Cancer Chemotherapy and Biotherpy: Principles and Practice. 2nd ed. Philadelphia: Lippincott-Raven, 1996: 395–434.
7. Physicians’ Desk Reference, 1999. Montvale, NJ: Medical Economics Co, Inc., 1999.
8. Connor TH, Anderson RW, Sessink PJM, Broadfield L, Power LA. Surface contamination with antineoplastic agents in six cancer treatment centers in Canada and the United States. Am J Health-Syst Pharm 1999; 56: 1427–32.[Abstract/Free Full Text]
9. Sessink PJM, Boer KA, Scheefhals APH, Anzion RBM, Bos RP. Occupational exposure to antineoplastic agents at several departments in a hospital: environmental contamination and excretion of cyclophosphamide and ifosfamide in urine of exposed workers. Int Arch Occup Environ Health 1992; 94: 105–12.
10. Pethran A, Schierl R, Hauff K, Grimm C-H, Boos K-S, Nowak D. Uptake of antineoplastic agents in pharmacy and hospital personnel. Part I: monitoring of urinary concentrations. Int Arch Occup Environ Health 2003; 76: 5–10.[Medline]

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