Are we protecting ourselves adequately when handling hazardous drugs? What is considered a hazardous drug? The definition of hazardous drug has changed over the years. As recent as last year in 2016,  NIOSH – The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention has released a new list of antineoplastic and other hazardous drugs in health care settings.

Drugs considered hazardous include those that exhibit one or more of the following six characteristics in humans or animals:

Definition
Table Adapted from White Paper – Safe Handling of Hazardous Drugs in Health Care

NIOSH has categorized hazardous drugs into three main groups.

  • Group 1: Antineoplastic drugs (AHFS classification 10:00).
    • The drugs in Table 1 meet one or more of the NIOSH criteria for a hazardous drug. In addition to many of these drugs being cytotoxic, the majority are hazardous to males or females who are actively trying to conceive, women who are pregnant or may become pregnant, and women who are breast feeding, because they may be present in breast milk. These drugs represent an occupational hazard to healthcare workers and should always be handled with use of recommended engineering controls and personal protective equipment (PPE), regardless of their formulation (IV [intravenous], SC [subcutaneous], topical, tablet, or capsule). Unopened, intact tablets and capsules may not pose the same degree of occupational exposure risk as injectable drugs, which usually require extensive preparation. Cutting, crushing, or otherwise manipulating tablets and capsules will increase the risk of exposure to workers. The manufacturer’s safe-handling guidance (MSHG) is typically in Section 16 of the DPI. See Table 5 for safe-handling recommendations.

    • Examples include: cisplatin, cyclophosphamide, daunorubicin, methotrexate, hydroyxurea, letrozole, leuprolide, megestrol, tamoxifen, mitomycin, pertuzumab.
  • Group 2: Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a hazardous drug.
    • The drugs in Table 2 meet one or more of the NIOSH criteria for a hazardous drug. Some of these drugs may represent an occupational hazard to males or females who are actively trying to conceive, women who are pregnant or may become pregnant, and women who are breast feeding, because they may be present in breast milk.

    • Unopened, intact tablets and capsules may not pose the same degree of occupational exposure risk as injectable drugs, which usually require extensive preparation. Cutting, crushing, or otherwise manipulating tablets and capsules will increase the risk of exposure to workers. The manufacturer’s safe-handling guidance (MSHG) is typically in Section 16 of the DPI. See Table 5 for safe-handling recommendations.

    • Examples include cidofovir, azathoprine, cyclosporine, carbamazepine, divalproex, estradiol, ganciclovir, leflunomide, liraglutide, mycophenolate, paliperidone, phenytoin, risperidone, raloxifen, siroliumus, spirolactone, valgancyclovir.
  • Group 3: Drugs that primarily post a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breastfeeding.
    • The drugs in Table 3 primarily meet the NIOSH criteria for reproductive hazards. They represent a potential occupational hazard to males or females who are actively trying to conceive, women who are pregnant or may become pregnant, and women who are breast feeding, as they may be present in breast milk. Unopened, intact tablets and capsules may not pose the same degree of occupational risk as injectable drugs that usually require extensive preparation. Cutting, crushing, or otherwise manipulating tablets and capsules will increase the risk of exposure to workers. The manufacturer’s safe-handling guidance (MSHG) is typically in Section 16 of the DPI. See Table 5 for safe handling recommendations.

    • Examples include acitretin, bosenten, clonazepam, colchicine, finasteride, fluconazole, paroxetine, temazepam, testosterone, topiramate, valproic acid, voriconazole, vigabatran, warfarin, ziprasidone.

In the document, Table 5 provides guidelines on how to handle different formulations of hazardous drugs; it specifically provides guidance on what personal protective equipment and engineering control would be required based on the formulation and the activity.

The document also indicates that each employer should develop a hazard communication program specific to the workplace environment, focusing on hazardous drugs that are handled as well as implementing training specific to activities that are relevant to the workplace environment.

After browsing the document, below are some of my thoughts:

  • According to this document, some many medications are considered hazardous! For example, double chemo-therapy gloves and protective gown should be worn when preparing or administration liquid formulation of risperidone or phenytoin.  Both of which aren’t medications that I typically consider “hazardous” but they do meet the definition of hazardous drugs based on their criteria.
  • If a nurse is administering Premarin vaginal cream, he or she should be wearing double chemo-therapy gloves and protective gown. I am not sure how many institutions are currently following this recommendation.
  • I do find that there are variations and inconsistencies among different institutions, pharmacies and other healthcare settings. This in turn, causes confusion for the front line health care workers. For example, one hospital will label azathioprine as hazardous but when the medication is dispensed in the community, it may not have the same labeling instructions.  One pharmacy may package finasteride as a separate unit dose when a different pharmacy may package it along with other medications.
  • It is costly to implement. While it is important to ensure all health care workers are handling hazardous drugs safely, it will be costly to roll out. Training resources need to be developed. A system must be maintained to keep track of new information or new drugs added to the list. Annual training is necessary to ensure everyone is always current in their knowledge in the day-to-day activities of handling hazardous drugs as well as understand what to do in case of a spill.
  • Occupational health is important. Hence there should be some concerted effort to implement a mandatory training program for handling hazardous drugs.  But we must first change the culture around hazardous drugs. It no longer only encompasses the “cytotoxic” cancer drugs but also include seizure medications, antipsychotics, antivirals, hormones and many others as long as they meet the criteria for hazardous drugs.
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