Our Insights

by Bryan Connors, M.S., C.I.H., H.E.M.

The National Institute for Occupational Safety and Health (NIOSH) estimates that the number of healthcare workers potentially exposed to hazardous drugs exceeds 5.5 million.   Studies have associated workplace exposures to hazardous drugs with health effects such as skin rashes, adverse reproductive outcomes and possibly leukemia and other cancers.  Workers involved in the preparation and administration of hazardous drugs, or who work in areas where these drugs are used, are at risk.  This includes:

• pharmacy, nursing, and OR staff
• physicians
• environmental services workers
• research laboratory workers
• housekeeping
• shipping and receiving personnel

The types of healthcare organizations with at-risk workers include large cancer hospitals, large teaching hospitals with oncology units, ambulatory healthcare centers, facilities for cancer treatment, and community hospitals.  The number of ambulatory healthcare centers that provide cancer treatment on an outpatient basis has increased dramatically over the last several years.  The U.S. Center for Disease Control and Prevention (CDC) reports that more than 1 million cancer patients receive outpatient chemotherapy, radiation therapy or both.  Ambulatory healthcare centers may not have all of the NIOSH recommended engineering controls that are often typical in larger hospitals, and due to space constraints they often have multi-use areas (e.g., an area used for both administrative activities and drug preparation).

In 2004 NIOSH released an alert to increase awareness among healthcare workers and their employers about the health risks posed by working with hazardous drugs and to provide methods for protection.  The NIOSH recommendations provide a framework for the development of a hazardous drug protection program and provide the definition of a hazardous drug.  If a drug meets one or more of the following criteria, it is classified as a hazardous drug.

• Carcinogenicity
• Teratogenicity or other developmental toxicity
• Reproductive toxicity
• Organ toxicity at low doses
• Genotoxicity
• Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria

Plan, Asses Risks, and Incorporate Key Program Elements

Developing an effective, comprehensive hazardous drug protection program involves planning and analysis of the risks.  To begin, review the NIOSH recommendations and prioritize them based on your institution’s operations.  Conduct a gap analysis to determine how closely your existing processes are in-line with the NIOSH recommendations, with an understanding that some of the recommendations may not be feasible for your institution.

Next, trace the path of hazardous drugs from point of delivery, preparation, administration, to disposal.  Focus on each “handoff” of the hazardous drug (e.g., delivery from the pharmacy to the nursing staff).  Conduct a risk assessment of each handoff to identify potential contamination points, practice issues, handling inconsistencies, how personal protective equipment is used, and training gaps.  Observe staff and talk with them to identify their questions and misconceptions.

The pharmacy employs a limited number of personnel, making it easier to communicate and control the risk of exposure to hazardous drugs.  Once the hazardous drug is handed off from the pharmacy, the number of staff potentially exposed increases and the certain types of exposure can be more difficult to control.  If the proper controls are implemented in the pharmacy, then the risk of exposure “downstream” (e.g., nursing, housekeeping) is minimized by reducing inadvertent exposure, such as contamination on the outside of containers. (See Figure 1.)

In addition to the main pharmacy, the following areas are impacted and should be considered when developing your program:

• Satellite pharmacies
• Ambulatory care
• Intensive care unit
• Bone marrow transplant
• General inpatient units
• Patient housing
• Respiratory care services
• Linen services
• Hazardous waste operations
• Laboratory

Training and communication to all potentially exposed staff will be critical.  We’ve found that pharmacists and oncology nurses are generally more aware of the risks and precautions while nurses in other units and housekeeping staff, for example, are less informed.  We’ve seen that personal protective equipment (PPE) is another common vulnerability; often the proper selection of PPE, training, and availability are deficient.  Proper eye protection is lacking in most healthcare facilities.

At a minimum, your hazardous drug protection program should include the following core elements:

Engineering Controls

• Biosafety cabinets, fume hoods, and enclosures.
• Air exchange rates for drug preparation areas.
• Product evaluations (such as IV tubing and connections, closed loop systems etc.).

Personal Protective Equipment (PPE)

• Specify proper PPE (gloves, gowns, respirators, eye protection).
• Selection, use, limitations, training.

Training and Communication

• Communicate the list of identified hazardous drugs to all staff.
• Establish a clear labeling system for hazardous drug containers.
• Define the level of training and competency for staff.
• Validation of work practice methods.

Disposal Procedures

• Contaminated linens, containers, blood, body fluids.
• NIOSH recommends body fluids be handled as hazardous within 48 hours after a patient is treated with certain hazardous drugs.

Cleaning and Decontamination

• Establish procedures for decontaminating surfaces and for responding to spills.

Hazardous drug protection is an emerging issue for many healthcare facilities.  The number of personnel and range of areas impacted, in addition to the continuous release of new drugs, makes implementing a hazardous drug protection program challenging.  Investing the time and resources up-front to properly plan and to assess the risks at each handoff will help significantly in ensuring that your program will be effective in protecting the health and safety of workers, and will be well worth the effort.

Bryan Connors, M.S., C.I.H., H.E.M., is Practice Director, Healthcare at EH&E.  He has extensive program management experience in environmental health and safety programs in the healthcare and biotechnology sectors, including 10 years of direct program management responsibilities in several tertiary care hospitals.  For more information, contact Bryan at bconnors@eheinc.com.