Course 630 - Hospital Hazards and Solutions: Pharmacy

Safety guides and audits to make your job as a safety professional easier

Hazardous Drugs

health concerns

Introduction

OSHA says worker exposure to hazardous drugs is a major health concern for workers in healthcare facilities and the pharmaceutical industry. The preparation, administration, manufacturing, and disposal of hazardous medications are the primary activities that may expose hundreds of thousands of workers to potentially significant workplace levels of these chemicals.

Health Effects

Hazardous drugs can cause serious acute and chronic health effects such as skin rashes, fertility problems, genetic damage, birth defects, organ toxicity, and possibly leukemia and other cancers.

Potentially harmful exposure can occur when you handle or work around hazardous drugs. These drugs include antineoplastic cytotoxic medications, anesthetics, anti-viral drugs, hormones, and others.

Antineoplastic Drugs

The numbers and types of work environments, including pharmacies that contain antineoplastic drugs are expanding as these agents are used increasingly for nonmalignant rheumatologic and immunologic diseases and for chemotherapy in veterinary medicine. The likelihood that a worker will experience adverse effects from antineoplastic and other hazardous drugs increases with the amount and frequency of exposure and the lack of proper work practices. The following case illustrates one example of the health effects reported after exposure to antineoplastic drugs:

CASE: ALLERGIC REACTION TO AEROSOLS

A 41-year-old patient-care assistant working on an oncology floor developed an itchy rash approximately 30 minutes after emptying a commode of urine into a toilet. She denied any direct contact with the urine, wore a protective gown and nitrile gloves, and followed hospital policy for the disposal of materials contaminated with antineoplastic drugs. The rash subsided after 1 to 2 days. Three weeks later, she had a similar reaction approximately 1 hour after performing the same procedure for another patient.

Upon investigation, it was found both hospital patients had recently been treated with vincristine and doxorubicin. The patient-care assistant had no other signs or symptoms and reported no changes in lifestyle and no history of allergies or recent infections. After treatment with diphenhydramine (intramuscular) and oral corticosteroids, her symptoms disappeared.

Although the cause could not be definitely confirmed, both vincristine and doxorubicin have been associated with allergic reactions when given to patients. The aerosolization of the drug present in the urine may have provided enough exposure for symptoms to develop.

For more information on antineoplastic drugs see 2016 NIOSH List of Antineoplastic and Other Hazardous Drugs

Hazardous Drug Exposure

exposure

Exposure occurs during manufacturing and packaging, receiving, preparation and administration, and cleaning and disposal activities. Clinical and non-clinical workers with potential exposure include:

  • pharmacists and pharmacy technicians
  • nurses
  • physician assistants
  • physicians
  • nursing home, home health care, and assistive care staff
  • housekeeping and environmental services staff (custodial, laundry, and waste handling workers)
  • shipping and receiving personnel
  • veterinarians and veterinary technicians and assistants

Exposure Routes

Exposures to hazardous drugs may occur through inhalation, skin contact, skin absorption, ingestion, or injection. Inhalation and skin contact/absorption are the most likely routes of exposure, but unintentional ingestion from hand-to-mouth contact and unintentional injection through a needlestick or sharps injury are also possible.

Hazard Communication Program (HCP)

exposure
The HCS Process.

Employers should implement a written program which meets the requirements of the Hazard Communication Standard (HCS) for employees who are handling or exposed to the chemicals, including drugs that represent a health hazard to employees. Manufacturers are responsible for evaluating their chemical products, and creating the Safety Data Sheet (SDS), which is the most comprehensive written information about that chemical.

The written program must provide for worker training, warning labels, and access to Safety Data Sheets (SDSs). HCS Labeling and SDS best practices include the following actions:

  • Always check container labels before starting any task involving a chemical.
  • Labels placed on containers are basic and typically do not include pertinent, detailed information so in some instances refer to the Safety Data Sheet or SDS.
  • Any chemical transferred from its original container to a secondary container must be labeled with at least the basic information from the original container.

Hazardous Drug Safety and Health Plan

exposure
Pharmacies should develop an effective Hazardous Drug Safety and Health Plan.

As part of the HCS, a written Hazardous Drug Safety and Health Plan should also be developed. It should be readily available and accessible to all employees, including temporary employees, contractors, and trainees.

OSHA says the plan should include each of the following elements and indicate specific measures that the employer is taking to ensure employee protection:

  • Standard operating procedures relevant to safety and health considerations to be followed when health care workers are exposed to hazardous drugs.
  • Criteria the employer uses to determine and implement control measures to reduce employee exposure to hazardous drugs, including engineering controls, the use of personal protective equipment, and hygiene practices.
  • A requirement that ventilation systems and other protective equipment function properly, and specific measures to ensure proper and adequate performance of such equipment.
  • The plan should have a provision for information and training and medical examinations of potentially exposed personnel.
  • The circumstances under which the use of specific hazardous drugs require prior approval from the employer before implementation.
  • Employers should designate a responsible person to implement the Hazardous Drug Safety and Health Plan. This includes assigning a Hazardous Drug Officer (who is an industrial hygienist, nurse, or pharmacist health and safety representative) and, if appropriate, establishment of a Hazardous Drug Committee or a joint Hazardous Drug Committee/Chemical Committee.
Download this excellent sample Hazardous Drug Program developed by the Washington State Department of Labor & Industries.

HCS Information and Training

employee

HCS information and training are a critical part of the hazard communication program. It is through effective information and training that employees will learn to read and understand labels and SDSs, determine how to acquire and use them in the pharmacy, and understand the risks of exposure to the chemical as well as the ways to protect themselves. HCS procedures, for example, purchasing, storage, and handling of these chemicals will improve, and thereby reduce the risks posed to employees exposed to the chemical hazards involved.

Each pharmacy employee who may be "exposed" to hazardous chemicals when working must be provided information and be trained prior to initial assignment to work with a hazardous chemical, and whenever the hazard changes. "Exposure" or "exposed" means that an employee is subjected to a hazardous chemical in the course of employment through any route of entry (inhalation, ingestion, skin contact, or absorption) and includes potential (e.g., accidental or possible) exposure.

Employees must also be informed of the requirements of the Hazard Communication Standard, including:

  • any operation/procedure in their work area where hazardous drugs are present
  • the location and availability of the written hazard communication program

Employer Responsibilities

employer

Departments with employees who handle hazardous drugs on a regular basis must:

  • Ensure employees follow the procedures in the hazardous drug safety and health plan.
  • Develop additional written procedures as appropriate.
  • Ensure all hazardous drugs are labeled properly and safety data sheets are available for all drugs in liquid, powdered, and gaseous form.
  • Develop a plan for cleaning up hazardous drug spills and provide spill kits to all areas where hazardous drugs are administered.
  • Whenever possible, spills of liquid hazardous drugs will be handled by employees in the area of the spill.

Employee Responsibilities

Employees who handle hazardous drugs should:

  • Comply with the procedures outlined in the plan and with department- or site-specific procedures related to handling hazardous drugs.
  • Report any exposures (skin or eye contact or inhalation of an aerosol or dust) to their supervisors.

Hazard Assessment

responsibility

The hazard assessment is conducted to help you identify what tasks have the potential for exposure, which employees may be exposed, and how to control exposure. It will form the foundation of your Hazardous Drug Control Program.

Written Hazard Assessment

Here are some steps to help you conduct your hazard assessment:

  1. Develop an inventory of hazardous drugs stored, transported, or otherwise handled in your facility.
  2. Identify the tasks performed where an employee may be reasonably anticipated to have exposure to a hazardous drug.
  3. Characterize the potential exposure for each task, including exposure by contact, injection, or inhalation.
  4. Determine the preventive methods that will be used for each of the identified tasks and exposures for your work operations and worksites.
  5. Complete a diagram of the physical layout of your work areas where hazardous drugs may be located or used; however, a diagram will not be needed for temporary worksites.

HCS Exemptions

responsibility

OSHA requires SDSs only for materials that meet OSHA's definition of "hazardous," and are "known to be present in the workplace in such a manner that employees may be exposed under normal conditions of use or in a foreseeable emergency".

Drugs regulated by the U.S. Food and Drug Administration (FDA) are covered by the HCS. However, section (b)(6)(vii) of the HCS exempts FDA drugs when they are:

  • in solid, final form for direct administration to the patient (e.g., tablets or pills)
  • drugs which are packaged by the chemical manufacturer for sale to consumers in a retail establishment (e.g., over-the-counter drugs)
  • drugs intended for personal consumption by employees while in the workplace (e.g., first aid supplies)

Examples of those needing SDS's for drugs would include pill manufacturing facilities and pharmacies (if the drug is compounded, crushed etc.).

There are other exceptions to the standard, such as:

  • Drugs dispensed by a pharmacy to a health care provider for direct administration to a patient (e.g., tablets or pills).
  • OSHA considers most office products (such as pens, pencils, adhesive tape) to be exempt under the provisions of the rule, either as articles or as consumer products.
  • "Articles" such as paper clips, pencils, office equipment, and furniture, etc.
  • Food and food products which are sold, used, or prepared in commercial establishments, and foods intended for personal consumption.
  • Cosmetics packaged for sale to consumers, or intended for personal consumption by employees.
  • Tobacco and tobacco products.
  • Wood or wood products, including lumber when the only hazard they pose is the potential for flammability or combustibility.
  • Biological hazards are exempt under the HCS if the only hazard they pose is biological. Examples include microbes, vaccines, and cell cultures.

Instructions

Before beginning this quiz, we highly recommend you review the module material. This quiz is designed to allow you to self-check your comprehension of the module content, but only focuses on key concepts and ideas.

Read each question carefully. Select the best answer, even if more than one answer seems possible. When done, click on the "Get Quiz Answers" button. If you do not answer all the questions, you will receive an error message.

Good luck!

1. A written hazardous drug safety and health plan must include which of the following components?

2. When a hazardous drug safety and health plan is developed, it should be _____ to all employees.

3. Employers should designate a responsible person to _____ the Hazardous Drug Safety and Health Plan.

4. Employees must be informed of which of the following requirements of the Hazard Communication Standard?

5. Employees who handle hazardous drugs should do which of the following?


Have a great day!

Important! You will receive an "error" message unless all questions are answered.