Occupational risks evaluation in a centralized antineoplastic agent preparation unit

Introduction

Because numerous antineoplastic drugs have been found to be carcinogenic or possibly carcinogenic character for humans by the International Agency for Research on Cancer (IARC), handling and preparation of these products expose the health care personnel to occupational contamination. Therefore, in order to avoid contact with these products by health care workers, government institutions have promoted the centralization of the antineoplastic agent preparations in the hospital pharmacy unit. They developed safety guidelines for employees who could be exposed to antineoplastic drugs and provided information on statutory requirements. ¹ In addition, hospital managers are required by law to identify hazards and conduct a comprehensive occupational risks assessment of the clinical activity. The processes of hazard identification and risk assessment will define the actions required to ensure the safety and protection of the physical and mental health of the workers. They involve in the first place actions for the prevention of occupational hazards, information and training for workers, and the implementation of the resources and organization necessary to achieve the objectives. The prevention measures in the risk management plan cover the intelligent deployment of techniques, working organization and conditions, social relations, and the impact of work-related issues. In our hospital, it emerged that data on occupational risks were not available for personnel working in the centralized antineoplastic agent preparation unit.

In this context, the objectives of this study were to evaluate potential occupational risks associated with the centralized antineoplastic agent preparation unit; to identify hazardous situations for each danger; to develop a work safety plan; to limit the costs of work-related accidents, occupational illnesses, and absenteeism; and to improve work safety, standards, and conditions.

Materials and methods

Selected method

The nature of the selected method is a global risk analysis (GRA) used in multiple fields covering industrial, military, financial, environmental, and health care activities. The GRA is a systemic, rigorous, and inductive approach performed in two steps: the GRA system and the GRA scenario. ² The GRA system determines the general and specific hazardous situations and constructs the risk map. The GRA scenario associates each hazardous situation with a scale of severity, frequency, effort, and acceptance of risk level. For each hazardous situation, the occurrence of an accident can be dreaded depending on the association of possible causes that may trigger it (Figure 1). The severity scale is built at five levels corresponding to consequences on the system performance and on the system safety. The frequency scale is associated to recurrence periods. The effort scale is classified in three levels attributed to each risk management action. Then a criticality matrix derived from these scales is built to score the hazardous situations in acceptable, under control, or unacceptable risk. The map highlights the initial and residual risks after establishing a plan to reduce these risks.

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Figure 1.

Accident scenario description.

The GRA was applied to draft the global risk document–related global process (Figure 2).

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Figure 2.

Steps to draft the global risk assessment.

Evaluate the risks

Once the working group was formed, the occupational risks were identified. Information on occupational risks faced by employees was gathered based on ad hoc meetings. Each risk was determined using assessment parameters approved by the working group in terms of severity and frequency. For each identified risk, a least two observations were made to incorporate this risk in the study. As defined in Table 1, a value range from 1 to 4 was attributed to each hazardous situation to quantify severity and frequency. The severity scale was built by taking into account discomfort, degree of physical harm, possibility of hospitalization, and psychological integrity (Table 1). All the scales were established by the working group according to the methodology described previously by Desroches. ² The occupational risk was then rated by combining severity and frequency to provide a criticality matrix and prioritized (Table 2). To visualize initial and residual risks for hazard categories, radar charts, also called Kiviat diagrams, were built from the data values as represented in Figure 3 and plotted from criticality scale. The radar charts were developed using the software StatCart (V2.0, MAD-Environnement, Nailloux, France).

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Table 1.

Severity and frequency scales.

Severity scale
S1	Minor consequences	Discomfort, minor damage
S2	Significant consequences	Accidents with damage without cessation of work (i.e. irritant dermatitis with antineoplastic agent)
S3	Serious consequences	Accident with sequelae (reversible damage with cessation of work) or hospitalization (i.e. burn marks on skin)
S4	Catastrophic consequences	Accident with irreversible damage (i.e. eye burns) or death
Frequency
F1	Exceptional	One or less time a year
F2	Occasional	Between 2 and 5 times a year
F3	Frequent	Once a month
F4	Very frequent	More than once per month

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Table 2.

Criticality matrix.

Severity	Frequency
	F1	F2	F3	F4
S4
S3
S2
S1

1 to 3: the risk was considered as acceptable.

4 to 7: the risk was considered as tolerable under control.

8 to 16: the risk was considered as unacceptable.

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Figure 3.

Part of global risk assessment.

Results

Global analysis

The working group was constituted of four hospital dispensers, three hospital pharmacists, one hospital agent, and one technician. All of them were regularly operated in the centralized antineoplastic agent preparation unit. The working group drew up the global document on occupational risks based on the identified occupational hazards and their assessment (Figure 3). Thus, 33 hazardous situations have been identified and considered unacceptable. The critical categories of professional risks were “Product, emissions, and waste risks” with 17 (55%) hazardous situations; “Psychosocial risk factors” with 8 (24%) hazardous situations; and “Risks related to work equipment” with 6 (18%) hazardous situations. To visualize initial and residual professional hazards, radar charts (i.e. Kiviat diagrams) were built (Figures 4 and 5). After the risk reduction plan was designed, all hazardous situations were under control.

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Figure 4.

Radar chart for initial occupational hazards.

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Figure 5.

Radar chart for residual occupational hazards.

Indicators of occupational health and safety

The management of occupational risks related to the centralized antineoplastic agent preparation unit involves the establishment of specific occupational health and safety indicators. The indicators will quantify specific issues related to working conditions. A dashboard was constructed with some relevant indicators (Table 3). In a recent study, safety of occupational exposure to residual contamination with antineoplastic drugs was investigated, and the main corrective action was to strengthen the training program. ³

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Table 3.

Relevant indicators of occupational health and safety.

Subject	Strategic target	Indicator
Work conditions	No occupational accident	Number of incident related to needles
	Decrease work stoppage	Number of days lost
	No exceedance of normal work hours	Number of overtime hours
Training	Each staff member should be trained	Number of hours of training by employee
	Each staff member should be trained	Percentage of topics related to occupational safety
	Each staff member should be evaluated	Number of staff evaluated for professional risks
	Each staff member should be evaluated	Percentage of employees trained
Human conditions	Each staff member should have a medical visit	Percentage of members having a medical visit per year
	No more than 2 consecutive hours for the production	Number of hours exceeded
	No area contamination by antineoplastic drugs	Variation in contamination rate
	Budget devoted to professional safety	Amounts spent annually

Discussion

The drafting of the global occupational risk document for the centralized antineoplastic agent preparation unit in our hospital made it possible to identify corrective actions in the field of personnel health and safety. This report highlighted the main gaps in our workplace health system. The psychological pressures identified by personnel can have a negative impact on the mental or physical health of the worker. Data showed that psychological stress at work was associated to depression, emotional distress, anxiety, burnout, and psychoactive drug use.^4–8 The psychosocial work environment is critical to mental health, especially for employees operating in stress areas such as centralized antineoplastic drug preparation units. ⁶ The study focused on implementing corrective measures for work stressors. A key approach to preventing work-related stress consists of professional training. ⁹ The time spent on the computer screen was reported as high by the working group. Because eye symptoms were noted (irritation, dryness, eye strain, headache, and pain), working time on screen should be reduced to a minimum, if possible.^10,11

To assess the risks of antineoplastic agents to workers, some publications report an investigation of potential occupational exposure survey by measuring concentrations of antineoplastic drugs on surfaces. In Sugiura et al.’s ¹² study, surface contamination by cyclophosphamide was measured at the nursing station and in the biological safety cabinet (BSC). The results showed contamination on surface telephone table (4.45 ng/cm²), floor in front preparation table (1.12 ng/cm²), and floor below IV stand (4.82 ng/cm²). Near BSC, lower levels of contamination were noted on floor in front of BSC (0.11 ng/cm²). In a recent study, skin contact monitoring of antineoplastic drugs was performed using wipe samples from exposed surfaces. ¹³ The analysis in the preparation room ranged from < limit of detection to 276 ng/cm² with contamination on computer and telephone (14%), door (5%), cupboard (35%), table (10%), and floor (18%). Further studies have shown that surfaces of commercial vials, pre-filled syringes, and infusion bags can be contaminated by cytotoxic drugs.^14–16 In the study of Turci et al., ¹⁶ the determination of antineoplastic drug contamination on the surfaces showed high levels of 5-fluorouracil (FU) on drug vials (156 mg) and IV tubing set (22.2 mg). Because no occupational exposure limits have been established for antineoplastic drug concentrations, safe exposure levels should be at zero contamination. The cleaning protocol must be effective depending on the cleaning solution used, volume, exposure time, and application mode. ¹⁷ In addition, the efficacy of the decontamination process would include both the surface materials and the physicochemical properties of antineoplastic drugs. ¹⁷ Standardization, evaluation, and validation of the cleaning procedures are required to guarantee an optimal washing process. While safety precautions were applied in the centralized preparation unit, potential hazards were identified by the working group such as skin or inhalation exposure, unsafe needle punctures, and accidental contamination due to a lack of occupational hazard knowledge. To remove as much as possible these occupational risks, the exposure time was reduced to a minimum and personal respiratory equipment was supplied. Cytotoxic contamination tests were performed on technical areas. To manage antineoplastic drug exposure in emergencies, safety protocols and protective kits accessible to staff have been established. Moreover, a health program was suggested by the working group for the individual monitoring of personnel health status based on their activities in the centralized preparation unit. The pharmacy manager in charge of this unit assessed for each employee the risks of occupational exposures that could affect them. To support this initiative, the risk manager has planned information and training workshops for staff. Since dermal or inhalation exposures are not excluded, women of childbearing age who wish to have a child were immediately exempted from the centralized preparation unit. Likewise, pregnant women or women who are breastfeeding were inevitably prohibited to work in any activity related to antineoplastic agents. To assess chemical contamination of surfaces when handling antineoplastic drug preparation, antineoplastic agent levels were determined by an external organism. The cartography of most contaminated areas could allow remedial action for cleanup. In the study by Kiffmeyer et al., ¹⁸ it was suggested that repeated monitoring of contaminated areas should be scheduled. Decontamination and cleaning procedures for all devices in contact with antineoplastic drugs have been set up, independently of the mandatory use of gloves. Moreover, potential toxicity in humans was assessed by determining concentrations of antineoplastic substances in the urine. Contact exposure to antineoplastic drugs and technical risk assessment tools should be considered by the director of risk management.

In the present work, the global occupational risk document identified hazardous situations in a centralized antineoplastic agent preparation unit and defined occupational risks for each worker depending on their activities and measures to control them. The fields of corrective action concerned information on occupational risks for workers in contact with antineoplastic agents, updating emergency procedures, setting up regular health monitoring and continuous training. For each antineoplastic substance, a safety data sheet containing instructions for its safe use should be readily available to staff. In addition, accurate information on the potential risks of exposure to antineoplastic substances was also vital for a risk management strategy. The work tasks that could expose workers to toxic agents were identified and allowed the risk to be reassessed for each worker. The limitations of the analysis were the subjective appreciation of the experts, the need for sustained analysis, and the sample size of participants.

Conclusion

The drafting of the global occupational risk document for the centralized cytotoxic preparation unit revealed failures in our system and enabled corrective actions for personnel safety.