Systems Affected by Hazardous Drug Exposure

System Affected by Hazardous Drug Exposure	Adverse Health Effect of the Exposure
Malignancies	Leukemia Non-Hodgkin lymphoma Bladder cancer Liver cancer
Reproductive	Infertility Prolonged time to conception Premature delivery Low birth weight Ectopic pregnancy Spontaneous abortions; miscarriages Stillbirths Learning disabilities in offspring
Integumentary and mucosal	Skin irritation/contact dermatitis Mouth and nasal sores Hair thinning, partial alopecia
Neurologic	Headaches Dizziness
Gastrointestinal	Nausea Vomiting Abdominal pain
Respiratory	Dyspnea
Allergic	Allergic asthma Eye irritation
Note. Based on information from Fransman, Roeleveld, et al., 2007; Martin, 2005b; Petralia et al., 1999; Saurel-Cubizolles et al., 1993; Skov et al., 1990, 1992; Valanis et al., 1993a, 1999; Walusiak et al., 2002.

Courtesy of : https://www.ons.org/sites/default/files/publication_pdfs/2_Safe%20Handling_pages_CHAPTER_1.pdf

History of Hazardous Drugs

Nitrogen mustard, which was first used as a chemical weapon in World War I, caused bone marrow and lymph tissue regression in exposed service men. For this reason, the potent chemical was suggested as a treatment for lymphoid malignancies. This is often considered the beginning of the modern age of cancer chemotherapy (Brown et al., 2001).
Surgery and radiation therapy were the primary treatments for cancer in the 1950s. The National Chemotherapy Program, a federal program funded in 1955, supported the development of new chemotherapy agents. Due to advances in science, chemotherapy is now commonly administered for the treatment of cancer in patients with both solid tumors and hematologic malignancies. The United States Food and Drug Administration (FDA) approved 85 drugs used in the treatment of cancer between the years of 1949 and 1992, 85 drugs in the next eight years (1993-2000), and 34 drugs during the three-year period from 2001 to 2004 (FDA, 2004).
In the 1970s, several chemotherapy agents were linked to secondary leukemia and other cancers in treated patients. This information was accompanied by the notion that health risks might extend to persons occupationally exposed to the drugs (Donner, 1978; Ng, 1970). Lancet published the first convincing evidence in a letter to the editor by Falck, et al in 1979. In a small, but controlled study, mutagenic activity (as measured by the Ames test) was found in the urine of patients who received chemotherapy as well as nurses who administered chemotherapy. The Ames test measures genetic mutations in bacteria after exposure to compounds. Ninety percent of known carcinogens test positive on this test. The test is reliable during drug excretion in the urine, which is usually within 48 hours of exposure. It has neither high sensitivity nor specificity (Polovich, 2003). Several other studies followed that demonstrated risks from occupational exposure to chemotherapy.

OSHA published guidelines for the safe handling of [chemotherapy]agents...[that] described the equipment, garments, and work practices aimed at protecting pharmacists and nurses...

The Occupational Safety and Health Administration (OSHA), whose mission is to protect the health and safety of workers, became interested in the occupational risk of handling chemotherapy agents in the early 1980s. During a visit to a northern California hospital, California OSHA became aware of the facility’s chemotherapy preparation practices. The subsequent investigation resulted in the facility being cited for failure to provide protection for the pharmacists (Power, 1983). The safe handling program that was implemented was described in the American Journal of Hospital Pharmacy (Stolar, Power, & Veile, 1983) and became the basis for the first American Society of Hospital Pharmacists (ASHP) Technical Assistance Bulletin on Handling Cytotoxic Drugs (ASHP, 1990).
After several years of published data suggesting harm from occupational exposure to chemotherapy drugs, OSHA published guidelines for the safe handling of those agents (1986). The guidelines described the equipment, garments, and work practices aimed at protecting pharmacists and nurses from exposure. While the guidelines are not considered as standards, enforceable by law, the guidelines are responsible for hospitals and other health care organizations’ implementation of safe handling precautions.
In the 1970s and 1980s it was common practice for nurses to perform drug preparation activities in medication rooms on nursing units (Stolar, 1988). The main route of exposure to hazardous drugs (Table 2) was thought to be inhalation of drug aerosols generated during preparation. To reduce this risk, OSHA guidelines state that cytotoxic drug preparation must be performed in a biological safety cabinet (BSC) in a designated area, usually a pharmacy. A BSC has vertical airflow that moves away from the worker, as opposed to horizontal airflow that moves away from the product toward the worker. Vertical airflow protects the worker, while horizontal airflow is designed to protect the sterile product from contamination. Air leaving a BSC is filtered through a HEPA (high efficiency particulate air) filter.


http://nursingworld.org/MainMenuCategories/ANAMarketplace/ANAPeriodicals/OJIN/TableofContents/Volume92004/No3Sept04/HazardousDrugs.aspx


Courtesy of

Safe Handling of Hazardous Drugs

From


Recommendations for the safe handling of hazardous drugs have been available for more than twenty years. Evidence for continued risk of occupational exposure is abundant; however, nurses' use of the recommended precautions is not universal. This may be related to a lack of information or to a lack of serious concern for the potential hazards. This article includes a discussion of current issues related to handling hazardous drugs in the workplace and a review of the history of safe handling guidelines, current recommendations, and barriers to implementing guidelines in health care settings.


Hazardous drugs are drugs that pose a potential health risk to health care workers who may be exposed during preparation or administration. Such drugs require special handling because of their inherent toxicities. While most drugs are hazardous because they are cytotoxic, drugs from other categories are potentially harmful (such as the antiviral agent gancyclovir). Currently, the term "hazardous" is preferred over "chemotherapy" or "antineoplastic" because is it is more inclusive of drugs that present a risk


Drugs that meet one or more of the following criteria should be handled as hazardous:

• Carcinogenicity
• Teratogenicity or developmental toxicity
• Reproductive toxicity
• Organ toxicity at low doses
• Genotoxicity
• Structure or toxicity similar to drugs classified as hazardous using the above criteria

From Preventing Occupational Exposures To Antineoplastic And Other Hazardous Drugs In Healthcare Settings. (NIOSH, 2004)


Author

Martha (Marty) Polovich, MN, RN, AOCN
E-mail: marty.polovich@southernregional.org

Martha Polovich is an Oncology Clinical Nurse Specialist at Southern Regional Health System in the South suburban Atlanta area. She has been caring for persons with cancer and administering chemotherapy since 1980. Ms. Polovich has been a trainer and instructor trainer for the Oncology Nursing Society’s Cancer Chemotherapy Course since 1998. She is co-editor of the ONS publication Chemotherapy and Biotherapy Guidelines and Recommendations for Practice (2001) and editor of Safe Handling of Hazardous Drugs (2003).
Ms. Polovich represents the Oncology Nursing Society on the National Institute for Occupational Safety and Health (NIOSH) Hazardous Drug Safe Handling Working Group. She participated in the preparation of the NIOSH Alert "Reducing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings" which was published online in March 2004 and is available at: www.cdc.gov/niosh/docs/2004-HazDrugAlert/pdfs/2004-HazDrugAlert.pdf.

Routes of Accidental Exposure

Routes of Exposure to Hazardous Drugs

Inhalation of aerosolized drug Dermal absorption Ingestion Injection http://www.lni.wa.gov/Safety/Topics/AtoZ/HazardousDrugs/images/HazDrugsDrugs.jpg

Conditions For Exposure

Courtesy of the CDC : See full article at :
http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf




CONDITIONS FOR EXPOSURE

Both clinical and nonclinical workers may be exposed to hazardous drugs when they create aerosols, generate dust, clean up spills, or touch contaminated surfaces during the preparation, administration, or disposal of hazardous drugs. The following list of activities may result in exposures through inhalation, skin contact, ingestion, or injection:

 Reconstituting powdered or lyophilized drugs and further diluting either the reconstituted powder or concentrated liquid forms of hazardous drugs [Fransman et al. 2004]

 Expelling air from syringes filled with hazardous drugs

 Administering hazardous drugs by intramuscular, subcutaneous, or intravenous

(IV) routes

 Counting out individual, uncoated oral doses and tablets from multidose bottles

 Unit-dosing uncoated tablets in a unit-dose machine

 Crushing tablets to make oral liquid doses [Dorr and Alberts 1992; Shahsavarani et al. 1993; Harrison and Schultz 2000]

 Compounding potent powders into custom-dosage capsules

 Contacting measurable concentrations of drugs present on drug vial exteriors, work surfaces, floors, and final drug products (bottles, bags, cassettes, and syringes) [McDevitt et al. 1993; Sessink et al. 1992a,b, 1994b; Minoia et al. 1998; Connor et al. 1999, 2002; Schmaus et al. 2002]

 Generating aerosols during the administration of drugs, either by direct IV push or by IV infusion

 Priming the IV set with a drug-containing solution at the patient bedside (this procedure should be done in the pharmacy)

 Handling body fluids or body-fluid-contaminated clothing, dressings, linens, and other materials [Cass and Musgrave 1992; Kromhout et al. 2000]

 Handling contaminated wastes generated at any step of the preparation or administration process

 Performing certain specialized procedures (such as intraoperative intraperitoneal chemotherapy) in the operating room [White et al. 1996; Stuart et al. 2002

                                                                                                                      

ASHP Guidelines on Handling Hazardous Drugs

To see full article:


http://www.ashp.org/s_ashp/docs/files/BP07/Prep_Gdl_HazDrugs.pdf

Purpose

The purpose of these guidelines is to (1) update the reader

on new and continuing concerns for health care workers handling hazardous drugs and (2) provide information on recommendations,

including those regarding equipment, that have been developed since the publication of the previous

TAB. Because studies have shown that contamination occurs in many settings, these guidelines should be implemented

wherever hazardous drugs are received, stored, prepared, administered,

or disposed.2–7

Comprehensive reviews of the literature covering anecdotal

and case reports of surface contamination, worker contamination, and risk assessment are available from

OSHA,2,3 NIOSH,4 and individual authors.5–7 The primary

goal of this document is to provide recommendations for the

safe handling of hazardous drugs. These guidelines represent the recommendations of many groups and individuals who have worked tirelessly over decades to reduce the potential harmful effects of hazardous drugs on health care workers. The research available to date, as well as the opinions of thought leaders in this area, is reflected in the guidelines. Where possible, recommendations

are evidence based. In the absence of published data, professional judgment, experience, and common sense have been used.

Introduction

This is a pharmacology class project concerning safe handling of hazardous drugs.