Assessing Antineoplastic Drug Workplace Compliance

Jackie Gambrell, RN, BSN, OCN®
Oncology Nurse Navigator
Greenville Hospital Systems
Cancer Treatment Center
Oncology Multidisciplinary Center
Greenville, South Carolina

Oncology nurses, infusion pharmacists, physicians, operating room personnel and support services personnel who work in oncology settings are at risk of exposure to antineoplastic drugs in the workplace. According to the 1999 Bureau of Labor Statistics, the number of workers who may be exposed to hazardous drugs exceeds 5.5 million (Department of Health and Human Services, 2004.) Exposure to hazardous drugs most often occurs from aerosols, dust, spills, or touching contaminated surfaces during the preparation, administration or disposal of hazardous drugs. Exposure to hazardous drugs may occur through inhalation, skin contact, skin absorption, ingestion or injection. The purpose of this article is to enlighten healthcare workers about the serious nature of antineoplastic drug exposure, inform hospital administrators of safety compliance issues, and educate the healthcare industry regarding a simple, highly-effective, problem-solving process used in the manufacturing and industrial environment that can be used to make the medical workplace safer.

In a study of 7094 pregnancies involving pharmacy and nursing staff exposed to antineoplastic agents, there was a statistically higher risk of spontaneous abortion (Valanis, Vollmer & Steele, 1999.) Protection from hazardous drug exposure depends on safety programs established by employers and followed by workers. Factors that affect worker exposure to antineoplastic drugs include the following:
· Drug handling (preparation, administration or disposal)
· Frequency and duration of drug handling
· Potential for absorption through direct and airborne contact
· Availability of ventilated cabinets in the drug mixing environment
· Availability of personal protective equipment (PPE)
· Work practices that do not consider the long-term dangers of exposure

The likelihood that a worker will experience adverse effects from hazardous drugs increases with the frequency of exposure and risk of these adverse effects rises significantly with the lack of proper work practices.
Currently, neither the National Institute for Occupational Safety and Health (NIOSH), Occupational Safety and Health Administration (OSHA), nor the American Conference of Governmental Industrial Hygienists (ACGIH) has not established recommended exposure limits (REL's). or threshold limit values (TLVs) in regard to workplace safety for hazardous drugs in general. The referenced exposure limits refer to concentrations of chemical substances and represent conditions under which it is believed that nearly all workers may be repeatedly exposed over a working lifetime without adverse health effects. (NIOSH ALERT, 2004.) In the absence of such data, employers must implement and enforce more stringent guidelines governing work place safety. Moreover, employees must take personal ownership of these issues, and work with healthcare administrators to make the healthcare work place safer and hazard free.

A review of the literature shows issues of environmental contamination and personal exposure have been well-researched. Several studies have documented cytotoxic contamination of workers (Labuhn, Valanis, Schoeny, Loveday, & Vollmer, 1998; Pethran, Schierl, Hauff, Grimm, Boos & Nowak, 2003.) Studies have demonstrated surface contamination in the environment during drug preparation as well as contamination of administration areas (Connor, Anderson, Sessink, Broadfield, & Power, 1999; NIOSH, 2004; Polovich, 2003.) Guidelines have been proposed and implemented for oncology healthcare workers related to personal protection. There are no formal regulations in the United States regarding hazardous drugs, including cytotoxic agents. The literature reveals that there are global opportunities for improvement in handling hazardous drugs currently; Norway is the only country that has regulations regarding the handling of and workplace processing of chemotherapy (Kaijser, Underberg & Beijnen 1990.)

Evidence shows there are opportunities to improve the process of handling hazardous drugs. Adverse reproductive outcomes such as spontaneous abortions (Stucker, Caillard, Collin, Gout, Poyen, & Hermon, 1990) and infertility (Valanis, Vollmer, Labuhn, & Glass, 1997) have been reported in healthcare workers exposed to cytotoxic agents. Several studies have documented cytotoxic contamination of workers (Labuhn, et al,1998; Pethran, et al, 2003). Multiple studies have demonstrated contamination of the environment in drug preparation and administration areas (Connor, Anderson, Sessink, Broadfield & Power, 1999; NIOSH, 2004; Polovich, 2003). This article outlines practical steps to assess for antineoplastic drug safety and implementation measures to reduce the risk of exposure to all workers who prepare and administer hazardous drugs.

There are many published guidelines or recommendations on the handling of antineoplastic agents or hazardous drugs. The Occupational Safety and Health Administration (OSHA) guidelines are well known to the nursing profession (Occupational Safety and Health Administration.1996.). Other organizations that have produced guidelines are: Oncology Nursing Society (2005), the American Society of Hospital Pharmacists (ASHP), (1990). The American Society of Clinical Oncology (ASCO), (2002), and the International Society of Oncology Pharmacy Practitioners (ISOPP), (2005.) Conner (2002) has published an extensive list of more than fifty references featuring guidelines and recommendations for the handling of antineoplastic agents.

On March 25, 2004 .NIOSH released a comprehensive analysis and description of specific suggestions regarding prevention of occupational exposure to antineoplastic and other hazardous drugs in health care settings. With an abundance of information in the literature on the risks of personal exposure to cytotoxic drugs, it is paramount that oncology nurses assess compliance against published guidelines both as individual healthcare providers and healthcare organizations and outline measures to increase compliance when necessary.

Drugs that meet one or more of the following characteristics should be handled as hazardous: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity (ASHP, 1990.) A list of drugs that are defined as hazardous by NIOSH can be found in Appendix A of an electronic document available from the Centers for Disease Prevention and Control (NIOSH, 2004). The complete NIOSH alert is available on the NIOSH website at www.cdc.gov/niosh/docs/2004-165/#b.

The information presented by Page (2004) informs us that work practice environments do have an impact on patient outcomes. Friese (2005) states that the concerns expressed by the Institute of Medicine (IOM) build on twenty years of research that has found that poor work environments result in unfavorable nurse and patient outcomes. IOM identified areas of healthcare organizations that needed improvement: evidenced based staffing standards, work-hour regulations, the creation of interdisciplinary teams, and the establishment of visible and responsive nursing leadership (Page, 2004.) This evidence prompts the healthcare professional to consider the following questions for their safety as well as the safety of the patients, their fellow workers, as well as the safety of the healthcare worker's family:

§ As a healthcare provider, are you personally aware of any or all of the above guidelines?
§ How does your work environment influence your compliance or noncompliance regarding guidelines for handling hazardous drugs?
§ What could you do personally, professionally and corporately to improve compliance with established guidelines for handling hazardous drugs?
§ Are there incentives for policy compliance at every level of the organization?
§ Are supervisors and managers trained and qualified to understand and follow policies and procedures?
§ Do you have a work place reporting system for spills, accidents or non-compliance issues?
§ How is this reporting system managed and how does it interface with the entire organization?

In light of the consequences of potential legal action arising from non-compliance, it may be advantageous to assess your personal practice and work environment. If your assessment reveals that you are in compliance with the recommended guidelines, then schedule periodic assessments to verify continuing compliance, including updating policies according to your organizational procedures. If your practice is not compliant, an action plan to improve compliance is needed. A common theme observed in the literature was that policies and procedures for handling hazardous drugs are in place, but noncompliance persists at the implementation level with employees who are directly involved in the preparation and administration of hazardous drugs. Two recent studies have documented antineoplastic drugs in the urine of pharmacy and nursing personnel (Pethran et al, 2003; Wick, Slawson, Jorgenson, & Tyler, 2003). Pethran and colleagues (2003) collected urine samples in fourteen German hospitals over a three-year period. Cyclophosphamide, ifosfamide, doxorubicin, epirubicin, and platinum were identified in urine samples from many of the study participants. An investigation conducted in the United States demonstrated a reduction in both the percentage of urine samples with measurable levels of cyclophosphamide or ifosfamide present and the concentration of the drugs in the urine following use of a closed-system drug preparation device for six months (Wick et al. 2003)

Healthcare professionals may find it helpful to look to the manufacturing world to gain insight into methods to assess and implement change. Gilchrist and Mosher from Action Services LLC, a business consulting firm suggest that any organization can benefit from utilizing a root cause analysis method which is similar to the nursing process of assessment, nursing diagnosis, planning, implementation and evaluation. Gilchrist & Mosher (2005) have developed a five step problem solving process they call SOLVE©. Their method is:

(S) Situation Assessment: Promote continuous improvement by proactively seeking out chronic business issues that result in financial loss.

(O) Organize the investigation: Encourage and empower self directed formal and informal problem solving teams.

(L) Live evidence Collection: Uncover the problem (FACTS):
1. Find and interview people
2. Act quickly to begin the investigation
3. Collect physical evidence
4. Track time and position
5. Search for cause and effect relationships

(V) Verify the analysis: Precisely define the incident to be investigated. Develop hypothesis by asking how the incident could have occurred.. Use the scientific method to uncover the physical, human and organizational roots.

(E) Effective Corrective Action: Implement safeguards to prevent problem recurrence by eliminating root cause deficiencies.

SOLVE© is a root cause analysis based problem solving method used to find and eliminate problems by applying the scientific method to uncover the cause and effect steps that permitted the non conformance and take immediate corrective action. The SOLVE© methodology relies on personnel to openly and honestly expose organizational procedures, tools and training that empower personnel to act. The intent of exposing the human decision is to understand and correct organizational systems that allow the problem to occur, not to punish or blame the person who exposes the shortcomings. The SOLVE© method of problem resolution thrives in an organizational culture where the people are recognized as the company's most valuable resource and encourages an environment conducive to employee ownership and empowerment. (Mosher & Gilchrist, 2004.)
Any employee desiring to seek answers to a problem can use SOLVE©. Based on the problem's potential impact in terms of dollars or risk, a formal or informal team is assembled for problem analysis. The team defines the problem, and begins the investigation by examining known facts which stimulate investigators to generate plausible hypothesis explaining cause and effect relationships. The hypotheses are verified, become fact, and when further investigated by hypothesizing and verifying, lead to the problem roots. The problem roots are underlying causes that, when eliminated, prevent problem reoccurrence. Corrective action items resulting from the investigation must be followed to completion to insure problem elimination.

Investigation teams may or may not be responsible for all phases of the corrective action process. Team members who have control and influence over the area where the problem occurred can take immediate action and implement team decisions as soon as possible. If your team only has influence over the area where the problem occurred, appoint a team member to champion the corrective action phase with management who can take the plan for change to completion. Speak with the manager who owns the problem and is responsible for resolution and help this person complete problem corrective action. The problem will only be eliminated after the root cause of the problem has been identified and corrective actions fully implemented.

Using the SOLVE© method, the root cause of exposure issues associated with antineoplastic drugs can be identified and corrected. Healthcare administrators are aware that active or passive regulatory non-compliance can be uncomfortable from a public relations perspective as well as costly from a litigation standpoint.

Regulatory agencies provide government guidelines that must be followed to insure compliance. When utilizing the SOLVE© process in addressing compliance issues with antineoplastic drugs, the incident or undesirable event is defined as antineoplastic drug regulatory noncompliance. To complete the problem definition, the facts, or outstanding issues that further define the incident, must be listed for problem resolution. By being broad and all inclusive the facts can be grouped into either governmental regulations or organizational noncompliance. Healthcare administration can further examine governmental regulations to include all governing agencies and list all applicable regulations. Likewise, a review of the individual healthcare organization should uncover potential areas of noncompliance. Consider using a logic tree diagram to display problem definition as well as all phases of the investigation. Figure 1 contains a logic diagram that may be used as an investigation model.

Begin the investigation by researching governmental regulations and organizational non-compliance items that apply to your specific healthcare organization. Administration can start the process by informing employees of the reasons for conducting the investigation. Explain that this investigation is to ensure governmental compliance and improve safety, not to punish or blame employees. Addressing these issues proactively will help to secure employee acceptance of the initative more quickly. Ask for volunteers to lead the new initiative. Initially, start with one area such as preparation, listed under organizational noncompliance. Team members should plan to spend time observing work practices in this area and note situations that may require further follow up. Ask questions such as "How can a situation exist in the preparation area that might create an organizational noncompliance situation resulting in antineoplastic drug regulatory noncompliance?" Examples of potential problems include:
§ Counting out individual, uncoated oral doses and tablets from multi-dose bottles.
§ Crushing tablets to make oral liquid doses
§ Reconstituting powdered or lyophilized drugs
§ Diluting reconstituted powder or concentrated liquid forms of hazardous drugs
§ Compounding potent powders into custom dose capsules

Involve team members in developing hypotheses directed at the underlying problems that could be causing noncompliance. When all possible hypotheses have been uncovered, each individual hypothesis must be examined and verified to uncover the path to noncompliance. The verification process relies on factual evidence that can be found by employee interviews, and investigative type data gathering. The investigator continues to ask "How can…?" questions until problem roots - basic items that when corrected will prevent problem reoccurrence - appear. The essence of all investigations is to uncover and improve the organizational root, or company policies, procedures, manuals or training that empower the employee to conduct business. With practice, the SOLVE© method of problem analysis becomes a way of life and a basic continuous improvement tool.

There is evidence to support practice change in the area of handling hazardous drugs. A single person armed with relevant evidence and determination can make a positive difference in employee and organizational outcomes as they relate to the process of handling hazardous drugs Hold all members accountable to providing and maintaining a safe and pleasant work place. Do not become discouraged during the evaluation process - remember that old habits are hard to break. Consistently reinforce the expectations for the handling of hazardous drugs. All healthcare employees have the right to work in a safe environment and, when valued and empowered, will embrace the opportunity to improve their personal and professional safety within the workplace.

References:

Connor, T.H., Anderson, R,W., Sessink, P.J., Broadfield, L., & Power, L.A. (1999).
Surface contamination with antineoplastics in six cancer treatment centers in Canada and the United States.
American Journal of Health-System Pharmacists, 56, 1427-1432.

Conner, T H., Anderson, R.W., Sessink, P.J. & Spivey, S.M. (2002). Effectiveness of a closed system device in containing surface contamination with cyclosphamide and ifosfamide in an IV admixture area. American Journal of Health System Pharmacists, 59, 68-72.

Department of Health and Human Services (2004). NIOSH Alert: Preventing
Occupational Exposures to Antineoplastic and other Hazardous Drugs in Heathcare Settings. Washington, DC. Retrieved April 16, 2004, from http://www.cdc.gov/niosh.docs/2004-HazDrugAlert/

Eitel,A. Scherrer,M., Kummerer, K. (2005). Handling Cystotatic Drugs: A Practical
Guide. International Society of Oncology Pharmacy Practioners (ISOPP). Retrieved October 28, 2005, from http://www.iuk-freiburg.de/infomaterial/iuk_schriften/zytoengl.pdf

Friese, Christopher R., (2005). Nurse Practice Environments and Outcomes: Implications for Oncology Nursing. Oncology Nursing Forum, 32, 765-772

Gilchrist, W.P. & Mosher, D.L. (2004). Solve- A root cause analysis method
made simple for big business, small business- any business. Retrieved June 1, 2005, from www.SolveRootCause.com

Kaijser, G.P., Underberg, W.J. & Beijnen, J.H.. (1990) The risks of handling cytotoxic drugs II: Recommendations for working with cytotoxic drugs. Pharmacy World & Science (Historical Archive) 12: 228-35

Mosher, DL & Gilchrist, WP. Working to improve your organizational effectiveness (2004). Retrieved October 25, 2005, from www.SolveRootCause.com

National Institute for Occupational Safety and Health (NIOSH) (2004). Retrieved July 1, 2004, from www.cdc.gov/niosh

Occupational Safety and Health Administration (OSHA) (2004).United States
Department of Labor (2004), Technical Manual, Section VI, Chapter 2. Retrieved October 24, 2005, from http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html#3

Page, A. (Ed.). (2004). Keeping patients safe: Transforming the work environment of
nurses. Washington DC: National Academies Press.

Pethran, A., Schierl, R., Hauff,K., Grimm, C.H., Boos, K.S., & Nowak, D. (2003).
Uptake of antineoplastic agents in pharmacy and hospital personnel. Part I: monitoring of urinary concentrations. International Archives of Occupational and Environmental Health, 76, 5-10.

Polovich, M. (Ed). (2003). Safe handling of hazardous drugs. Pittsburgh, PA: Oncology Nursing Society.

Polovich, M., White, J., & Keller, L. (Eds) (2005). Chemotherapy and Biotherapy Guidelines and Recommendations for Practice. (2ed). Pittsburgh PA: Oncology Nursing Society.

Stucker, I., Caillard, J.F., Collin, R., Gout, M., Poyen, D.,& Hemon, D.(1990). Risks of spontaneous abortion among nurses handling antineoplastic drugs. Scandinavian Journal of Work and Environmental Health. 16, 102-107.

Valanis, B., Vollmer,W., Labuhn,L, & Steele, P.(1999). Occupational exposure to
antineoplastic agents: self-reported miscarriages and stillbirths among nurses and pharmacists. Journal of Occupational and Environmental Medicine, 41, 632-8.

Wick, C., Slawson, M.H., Jorgenson, J.A., Tyler,L.S. (2003). Using a closed-system
protective device to reduce personnel exposure to antineoplastic agents. American Journal of Health System Pharmacy, 60, 2314-2320.

Figure 1. Investigational model for assessing noncompliance in the healthcare organization