Occupational exposure to hazardous drugs—recommendations for oral dosage forms
The risks of occupational exposure to hazardous drugs and chemicals have long been recognized. Hazardous drugs are generally defined as those that may cause toxicity following contact, such as genotoxicity, carcinogenicity, teratogenicity, or have adverse effects on fertility (including miscarriages). Although occupational exposure to hazardous drugs is a concern for all healthcare workers, exposure to these drugs by female healthcare workers who are pregnant or attempting a pregnancy is of special concern, due to risks to the fetus. The American Society of Health-System Pharmacists recommends that alternative duty or work areas be offered to female healthcare workers who are pregnant or who are breastfeeding, or to any individual attempting to conceive or father a child. Most information and guidelines on risks associated with occupational exposure to hazardous drugs relates to injectable drugs—primarily chemotherapies used for treatment of various cancers. Since exposure usually occurs during compounding and/or administration of the intravenous dosage forms, precautions such as the use of gowns and gloves and ventilated cabinets are recommended. However, a number of oral drugs that carry a pregnancy category rating of D or X, also have the potential to cause reproductive harm; specific information on the handling of these agents is limited.
Several publications have addressed this issue. Timpe and colleagues summarized information from manufacturers, published literature, and the Internet on the handling of category D and X drugs by pregnant healthcare workers. The Pharmacist’s Letter has published a similar document, and the Institute for Safe Medication Practices has included information on the risks to pregnant women in their “Oral dosage forms that should not be crushed” drug list. Information from these 3 sources is summarized in the table below.
Table. Summary of recommendations for handling of potentially hazardous drugs by pregnant healthcare workers.
|Drug (brand)||Pregnancy category||Recommendation|
|Acitretin (Soriatane)||X||Do not handle broken tablets or opened bottles|
|Atorvastatin (Lipitor)||X||Exercise caution regarding exposure|
|Azathioprine (Imuran)||D||Exposure should be reviewed by employer|
|Bicalutamide (Casodex)||X||Avoid inhalation|
|Bosentan (Tracleer)||X||Do not handle crushed or broken tablets|
|Carbamazepine (Tegretol)||D||Caution should be exercised|
|Cyclophosphamide (Cytoxan)||D||Use containment equipment and practices to avoid risk|
|Dasatinib (Sprycel)||D||Do not handle crushed or broken tablets (whole tablets surrounded by wax matrix)|
|Dihydroergotamine mesylate (D.H.E.45)||X||Caution should be exercised|
|Doxycycline (Vibramycin)||D||Avoid handling|
|Dutasteride (Avodart)||X||Do not handle capsules; men should not donate blood until at least 6 months after last dose|
|Ergotamine (Erogmar)||X||Caution should be exercised|
|Finasteride (Proscar, Propecia)||X||Do not handle broken or crushed tablets|
|Fluvastatin (Lescol)||X||Caution should be exercised|
|Ganciclovir (Cytovene)||C||Caution for everyone handling tablets, capsules, or intravenous solution; men should use a barrier contraceptive for at least 90 days after last dose|
|Isotretinon (Accutane)||X||Do not handle broken or crushed tablets|
|Lenalidomide (Revlimid)||X||Avoid contact with capsule contents and body fluids|
|Melphalan (Alkeran)||D||Chemical hazard|
|Minocycline (Minocin)||D||Wear gloves or avoid contact with open capsules or broken tablets|
|Mycophenylate (CellCept)||C||Avoid inhalation or direct contact of powder in capsules, oral suspension, or injection for reconstitution|
|Raloxifene (Evista)||X||Do not crush tablets|
|Ribavirin (Virazole, Copegus, Rebetol)||X||Avoid direct care of patients receiving aerosolized ribavirin; surgical masks to not provide adequate protection. No recommendations for handling oral dosage forms, but 2 forms of birth control are recommended for female partners of men taking ribavirin, during therapy and for 6 months after treatment.|
|Tamoxifen (Nolvadex)||D||Chemical hazard|
|Testosterone topical (AndroGel, Testoderm)||X||Avoid skin contact|
|Thalidomide (Thalomid)||X||Do not handle or come into direct contact with capsules|
|Tretinon (Vesanoid)||D||Avoid using but handling is considered acceptable|
|Valganciclovir (Valcyte)||C||Avoid direct contact of broken or crushed tablets with skin or mucous membranes|
Timpe et al also suggested general precautions while handling hazardous drugs by pregnant healthcare workers, such as:
Although the reproductive risks of occupational exposure to injectable drugs, such as chemotherapies for treatment of cancer, are well known, oral drugs may also be associated with adverse effects on reproduction. Female healthcare workers should be aware of what drugs should be handled cautiously, if at all, while pregnant or attempting a pregnancy. Use of specific precautions (wearing gloves and facemasks or frequent handwashing) to minimize exposure while handling these drugs should be considered.
Timpe E, Motl S, Hogan M. Environmental exposure of health care workers to category D and X medications. Am J Health-Sys Pharm. 2004;61(15):1556-7.
Reproductive hazards of handling medications. Pharmacist’s Letter/Prescriber’s Letter 2006;22:220339.
Mitchell J. Oral dosage forms that should not be crushed. Institute for Safe Medication Practices. Available at: http://www.ismp.org/Tools/DoNotCrush.pdf. Accessed March 1, 2008.
American Society of Health-System. ASHP Guidelines on Handling Hazardous Drugs. Available at: http://www.ashp.org/s_ashp/bin.asp?CID=6&DID=5420&DOC=FILE.PDF. Accessed March 1, 2008.