Questions & answers about the new Hazardous Drugs Rule

Background

The 2011 Legislature passed Engrossed Substitute Senate Bill (ESSB) 5594, requiring the Department of Labor & Industries (L&I) to set requirements to protect workers who handle chemotherapy and other hazardous drugs. The bill required L&I to adopt rules that are consistent with and do not  exceed provisions in the National Institute for Occupational Safety and Health's (NIOSH) 2004 Alert on preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings, as updated in 2010.   

L&I's hazardous drugs rule was adopted on January 3, 2012. Under this rule, if there is a reasonably anticipated occupational exposure to one or more hazardous drugs, then the employer must develop and implement  a written hazardous drug control program to protect  workers. 

• When does the new Hazardous Drugs Rule become effective? 

  The rule takes effect in stages. 

  • Jan. 1, 2015: Employers must have completed and implemented a written hazardous drugs control program. 
  • July 1, 2015: Employers must have implemented employee training.
  • Jan. 1, 2016: Installation of appropriate ventilated cabinets must be completed.  
• Which businesses are required to comply with this new rule?

  The rule applies to all employers in health care facilities that have employees with occupational exposure to hazardous drugs. For the purpose of this rule, health care facilities are defined as places where a health care provider provides health care to patients, including the following:

  • Hospitals.
  • Clinics.
  • Nursing homes.
  • Laboratories.
  • Offices.
  • Veterinary medicine clinics.
  • Retail pharmacies.
  • Home health care agencies.
  • Research laboratories where a health care provider offers health care to patients.

   

  Affected workers could include the following:

  • Pharmacists and pharmacy technicians.
  • Physicians and physician assistants.
  • Nurses.
  • Patient care assistants, such as health care assistants or nursing assistants.
  • Operating room personnel.
  • Home health care workers.
  • Veterinarians and veterinary technicians.
  • Environmental services employees in health care facilities, including workers involved with housekeeping, laundry, or waste disposal.
  • Employees in health care facilities who ship or receive hazardous drugs from the manufacturer or distributor.
• Under the rule, what is considered a hazardous drug?

   A hazardous drug is any drug identified as hazardous by NIOSH in the "NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012" (CDC.gov) and any other drugs identified by the employer that:

  • can cause cancer,
  • can cause birth defects or prevent reproduction,
  • causes reproductive toxicity in humans,
  • causes organ toxicity at low doses in humans or animals,
  • can damage the DNA structure, or
  • mimics existing hazardous drugs in structure and toxicity.

  
  PLEASE NOTE: The NIOSH list was further updated in June 2012 and includes 26 new drugs

• What must be in the written hazardous drugs control program?

  The written hazardous drugs control program must be created with input from workers and address the following elements as applicable to the facility:  

  • A written inventory of hazardous drugs in the workplace.
  • A current hazard assessment for the hazardous drugs.
  • Hazardous drugs policies and procedures that cover, but are not limited to:
  • Engineering controls (equipment use and maintenance).
  • Personal protective equipment (PPE).
  • Safe handling practices (receiving and storage, labeling, preparing, administering, and disposing of hazardous drugs).
  • Cleaning, housekeeping, and waste handling.
  • Spill control.
  • Personnel issues (such as exposure of pregnant workers).
  • Training.
• The NIOSH hazardous drug list includes chemotherapy drugs, but also drugs such as hormones, birth control pills, and commonly prescribed anti-depression medicine. Will the rule require employers to treat all these drugs the same as chemotherapy drugs?

  No. L&I agrees that some hazardous drugs pose less risk than others. The rule's requirements only apply to hazardous drugs for which there is a reasonably anticipated occupational exposure and then allows a tiered approach that effectively matches precautions to the nature of exposure.

• What about dispensing pre-packaged birth control pills?

  Handling pre-packed birth control pills would not result in occupational exposure and would therefore not trigger requirements under the rule. However, there may be occupational exposure if altered (for example, if they are crushed or dissolved, or if capsules are pierced or opened).

• Will ventilated cabinets be required for retail pharmacies where the only occupational exposures are from activities such as counting uncoated tablets or splitting of tablets?

  No. The rule allows alternative precautions where the hazard assessment determines a low occupational exposure risk while preparing hazardous drugs other than chemotherapy agents, for example, from crushing and splitting tablets or drawing medication into a syringe. These alternatives could include temporarily designating a space as the preparation area, using appropriate personal protective equipment, and instituting specific cleaning procedures.

• Since our health care facility already prepares all hazardous drugs in a ventilated cabinet, we do not believe this use will result in exposure. Would the rule still apply to us?

  Yes, for purposes of determining whether the rule applies to a specific facility occupational exposure is that exposure which would be reasonably anticipated in the absence of engineering controls or personal protective equipment.

• What will L&I do to help employers implement these new rule requirements?

  L&I, through its Division of Occupational Safety and Health (DOSH) has created a Hazardous Drugs Advisory Committee to discuss new NIOSH recommendations, scientific and technological developments and other issues related to implementing this rule. The committee includes both employer and employee representatives from the health care industry and representatives of affected state agencies.

  DOSH will also work with trade associations, labor unions, and others from the health care industry to develop model programs for implementation of these rules in a variety of health care settings. DOSH will provide education, training, and consultation services to ensure that these model programs are widely distributed and can be effectively utilized. 

  A meeting open to all interested stakeholders was held on Jan. 25, 2012 to discuss the formation of a Hazardous Drugs Advisory Committee and development of the model programs. The meeting was from 2 to 4 p.m. in the main auditorium of L&I's Tumwater building.

  L&I has established a Hazardous Drugs Web page for resources. As sample plans and forms and other materials are developed, they will be posted there. In addition, subscribing to the Hazardous Drugs email Listserv will ensure you stay up to date on this information.

• Does the rule require medical surveillance for workers?

  No. While medical surveillance was in the proposed rule it has been deleted from the final rule. This was done because NIOSH is currently updating medical surveillance guidelines. DOSH will review the updated guidelines and determine at that time what requirements, if any, should be added to the rule regarding medical surveillance.

• How can I stay aware of developments related to this rule?

  Check L&I's new topic page for information about the rule and related developments. Subscribe to our email list and select the Hazard Drugs Rule Implementation topic when you sign up.

• Who do I call if I have questions about compliance with the rule?

  DOSH technical services can be reached at 360-902-5436.

• Once the rule is in effect, and I am a worker and my boss isn't implementing these rules in our workplace, is there anything I can do?

  First, inform your employer of the rule. If your employer fails to take action, contact L&I. It is against the law for your employer to retaliate against you in any way for reporting a safety hazard. You can learn more at www.WorkplaceRights.Lni.wa.gov or call 1-800-423-7233.

  If you have questions before the rule is in effect, visit the Hazardous Drugs topic page or call DOSH Technical Services at 360-902-5436 for assistance.