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Handling of hazardous drugs – Effect of an innovative teaching session for nursing students
Nurse Education Today 49 (2017) 72–78
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Nurse Education Today journal homepage: www.elsevier.com/nedt
Handling of hazardous drugs – Effect of an innovative teaching session for nursing students Janine Zimmer a,b, Stefanie Hartl a,b, Katrin Standfuß a,b, Till Möhn c, Astrid Bertsche d, Roberto Frontini b, Martina P. Neininger a, Thilo Bertsche a,⁎ a
Department of Clinical Pharmacy and Drug Safety Center, University of Leipzig, Eilenburger Str. 15a, 04317 Leipzig, Germany Pharmacy Department and Drug Safety Center, University Hospital Leipzig, Liebigstr. 20, 04103 Leipzig, Germany Faculty of Physics and Earth Sciences, Institute of Experimental Physics I, Linnéstraße 5, 04103, Leipzig University, Leipzig, Germany d Department of Women and Child Health, Hospital for Children and Adolescents and Centre for Paediatric Research, University of Leipzig, Liebigstr. 20a, 04103 Leipzig, Germany b c
a r t i c l e
i n f o
Article history: Received 20 July 2016 Received in revised form 22 October 2016 Accepted 3 November 2016 Available online xxxx Keywords: Nursing education Nursing students Hazardous drugs Fluorescence imaging Occupational safety
a b s t r a c t Background: Imparting knowledge and practical skills in hazardous drug handling in nursing students' education is essential to prevent hazardous exposure and to preserve nurses' health. Objectives: This study aimed at comparing routine nursing education with an additional innovative teaching session. Design: A prospective controlled study in nursing students was conducted in two study periods: (i) a status-quo period (routine education on handling hazardous drugs) followed by (ii) an intervention period (additional innovative teaching session on handling hazardous drugs). Settings/Participants: Nursing students at a vocational school were invited to participate voluntarily. Methods: In both study periods (i) and (ii), the following factors were analysed: (a) knowledge of hazardous drug handling by questionnaire, (b) practical skills in hazardous drug handling (e.g. cleaning) by a simulated handling scenario, (c) contamination with drug residuals on the work surface by fluorescent imaging. Results: Fifty-three nursing students were enrolled. (a) Median knowledge improved from status-quo (39% right answers) to intervention (65%, p b 0.001), (b) practical skills improved from status-quo (53% of all participants cleaned the work surface) to intervention (92%, p b 0.001). (c) Median number of particles/m2 decreased from status-quo to intervention (932/97, p b 0.001). Conclusions: Compared with routine education, knowledge and practical skills in hazardous drug handling were significantly improved after an innovative teaching session. Additionally, the amount of residuals on the work surface decreased. This indicates a lower risk for hazardous drug exposure. © 2016 Elsevier Ltd. All rights reserved.
1. Introduction Substances that are organ toxic, carcinogenic, mutagenic, or toxic for reproduction were defined as hazardous drugs (HD) by the National Institute for Occupational Safety and Health (NIOSH, 2004). Therefore, handling these drugs is associated with risk for occupational exposure. Even low doses of these drugs pose a risk to the health of the person handling them if safety standards and handling recommendations are not accurately followed (Valanis et al., 1993). This applies particularly to the increasing number of oral antineoplastic drugs (Weingart et al., 2008).
⁎ Corresponding author at: Department of Clinical Pharmacy, Leipzig University, Eilenburger Str. 15a, 04317 Leipzig, Germany. E-mail addresses: [email protected] (T. Möhn), [email protected] (A. Bertsche), [email protected] (R. Frontini), [email protected], [email protected] (T. Bertsche).
http://dx.doi.org/10.1016/j.nedt.2016.11.002 0260-6917/© 2016 Elsevier Ltd. All rights reserved.
Nurses have to be aware of these hazards. Accordingly, they have to be taught about risk and safety measures to appropriately protect themselves and others. Knowledge of handling HD and practical skills (hereinafter referred to as HD handling competence) are crucial from the very beginning of their professional careers since the side effects may occur with a delay of years after exposure. Hence, it is necessary to address the topic “HD handling” during nursing students' education. Education on HD in the current curriculum, however, is sparse. This indicates that the current education does not sufficiently sensitise nursing students for exposure risk. Lacking awareness becomes obvious in practice, since many nurses do not consider oral antineoplastic drugs hazardous and do not adequately adhere to self-protection recommendations (Johnson et al., 2008; Labuhn et al., 1998). Therefore, current nursing education needs to be evaluated for its impact on HD handling competence. In cases in which students tend to ignore important factors, education should be intensified and targeted strategies should be implemented to improve knowledge and practical skills. Multimodal presentation of information has shown to be an effective teaching method
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(Smart et al., 2010). Multimodal strategies combine verbal, visual, and auditory stimuli to deliver theoretical and practical information. 1.1. Objective This study aimed at comparing the effect of routine nursing education with an additional innovative teaching session on obtaining HD handling competence. The impact of competence on occupational safety in both study periods is demonstrated by fluorescent imaging of work area contamination. 2. Methods 2.1. Setting and Educational Structure The study was conducted at one vocational school for nurses in Germany between January and March 2015. The school principal was informed and gave his consent to the realisation of the project. All students from all three training years were invited to take part in the
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study without exception. Participation was voluntary for all invited nursing students. Nursing education in Germany is divided into theoretical and practical education regulated by a framework curriculum. Theoretical education is provided by teachers at vocational schools. Working in hospitals or nursing homes is part of the practical education in all three years of training. The practical education is provided by senior nurses and practice educators. Handling oral medication is part of the practical education. 2.2. Study Design A prospective controlled study was performed in two study periods: (i) a status-quo period (routine education on handling HD) followed by (ii) an intervention period (additional innovative teaching session on handling HD, Fig. 1). In a preliminary period, the innovative teaching session and the questionnaire were developed and pretested. The handling process list, the method for contamination detection and the image analysis were validated. The data acquisition method was defined and study
Purpose
Setting selection
Contact to and consent from school principal
Offer for nursing students to participate voluntarily
Recruitment of participants
Pilot testing
Instrumentation development, determination of effect size
Preliminary period
Operation
Routine education
Simulated handling scenario
Determination of practical skills
Fluorescence imaging
Determination of contamination
Status-quo period
Determination of knowledge
survey instruments
Questionnaire
Innovative teaching session
Simulated handling scenario
Determination of practical skills
Fluorescence imaging
Determination of contamination
Fig. 1. Study design.
Intervention period
Determination of knowledge
survey instruments
Questionnaire
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conditions were standardised. The study design was pilot-tested with a group of 10 nursing students independent from the study cohort. The preliminary results were used for optimisation of the instruments and effect size determination (see data analysis). In the status-quo period (i), all nursing students received routine education on HD. Afterwards, knowledge and practical skills in HD handling were assessed separately and pseudonymously for each participant. Following each skills assessment, the work area was photodocumented and evaluated for contamination. A fluorescent tracer acted as a non-hazardous substitute for a HD. In the following intervention period (ii), all nursing students received an innovative teaching session. Afterwards, each participant's knowledge and practical skills were assessed again. Images of the work area were captured and evaluated for the intervention period. 2.3. Survey Instruments The competence in handling of HD and its impact on safety was evaluated by three survey instruments in both study periods (i) and (ii).
Hazardous drug handling competence Knowledge
Protection
Formation
Distribution
Removal
Use of personal protective equipment
Choice of manipulation devices
Hand contact to surfaces
Cleaning
Practical skills
Contamination
Risk for exposure
Personal safety at risk
Peers’ safety at risk
Fig. 2. Framework for handling assessment.
2.3.1. Questionnaire: determining knowledge A questionnaire was designed to assess the nurses' knowledge of hazard potential and safe handling of HD by dichotomous rating of 13 statements. These statements reflected risk awareness, knowledge of personal protective equipment (PPE), tablet manipulation, distribution, exposition, cleaning, disposal, and first aid. The knowledge is given as percentage of right answers, ranging from 0% to 100%. Additionally, the questionnaire collected data on demographics. 2.3.2. Simulated handling scenario: determining practical skills A professional situation was simulated to evaluate specific practical skills in the area of HD handling. Participants were asked to carry out all drug preparation steps in the same way as in daily practice. To perform the simulated handling scenario, a room was installed to mimic the ward setting as realistically as possible. These conditions were standardised. The working environment was set up with working table, cabinets with different manipulation devices, PPE, waste bins, opportunity for hand washing and disinfection, cleaning material, and a telephone. A pseudo-patient's drug prescription that requested a common ward situation for handling HD was designed. All drug preparation processes including prearrangement, drug transfer, manipulation, and follow-up work were carried out by the nursing student and documented by a member of the study team (handling process list). While observing these steps, particular attention was paid to the procedures that were considered important for safe drug handling (Fig. 2). • The use of PPE was documented as a measure for self-protection. • The use of manipulation devices was analysed. All uses that enabled nurses to work with a low risk for contamination were considered “adequate”. Low risk for contamination means low risk for exposure for the handling person and for others. • Contact to surfaces with contaminated gloves/hands was recorded. Contact to surroundings was analysed to determine the distribution of hazardous substances that may lead to exposure of peers or others. • It was recorded if and how a cleaning procedure was conducted. Remaining residuals may lead to exposure of peers or others.
2.3.3. Fluorescence imaging: determining contamination For the assessment of contamination, tablets containing a fluorescent tracer were used. Residues of the handled tablets were visualised by ultraviolet (UV) light. Prior to each simulated handling scenario, the study team cleaned the work area and scanned it with UV light to ensure that there were no contamination residuals. Following each
handling simulation, the study team examined the work surface and the floor with UV light for contamination. • Contamination of the work surface was documented photographically by taking ten pictures under standardised conditions. The images were saved in RAW format, developed with RawTherapee (V4.2.74, http://rawtherapee.com), and analysed with ImageJ interface Fiji software v1.50a (Schindelin et al., 2012). Each image was assigned to the corresponding participant's handling process list. The summarised findings from the ten images were used for analysis. For the description of work surface contamination, the median number of particles of the fluorescent tracer per square metre of the work surface is presented. • Further, the floor in front of the work area was examined for contamination. The result was described qualitatively (rated yes/no).
2.4. Educational Methods 2.4.1. Routine Teaching Session The school conducted routine education on HD as a chalk-and-talk teaching in a classroom setting in the status-quo period. According to the framework curriculum, theoretical education on handling of drugs was curricular content in the first year of training. Theoretical background information on hazard potential and exposure was given using a slide presentation. Simulation training on oral medication handling was not performed. 2.4.2. Innovative Teaching Session Based on current guidelines and recommendations (American Society of Health-System Pharmacists, 2006; Connor and McDiarmid, 2006; NIOSH, 2004), a 45-minute teaching session on safe handling of HD was developed in this study. Theoretical information on protection, formation, distribution, and removal of contamination were emphasised using the following multimodal teaching techniques. Practical relevance: challenges in handling HD were identified at each consecutive step of the preparation process. All participants performed this preparation process for practical skills assessment in the status-quo period. Thus, those experiences' concrete practical relevance was established. To intensify students' understanding of this practical relevance, group results of error rates seen in the status-quo period were presented to the students. Interactive discussion: interactive elements that promoted active participation and discussions were included. Haptic elements: this study's concept included haptic elements such as demonstration of different manipulation devices. Visual element: the nursing students
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were shown images of visible fluorescent residuals in the working environment and on the equipment, captured in the status-quo period.
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Table 1 Participants' demographics. Total n = 53 n (%)
2.5. Data Analysis Based on the distribution in the pilot study, the data's distribution was anticipated to be nonparametric. A sample size calculation was performed for related-samples nonparametric procedures by using G*-Power 3.1 (Faul et al., 2007). Effect size was determined based on the weakest result in the pilot study (effect on knowledge: increase by 20% absolute). To detect this difference with 80% power at a two-sided level of 2.5%, a Wilcoxon signed-rank test was conducted. To compensate the influence of about 30% drop-out, 51 participants in total should be included. Medians and percentages were calculated for descriptive analysis. Frequencies were reported as percentage and total numbers. For descriptive and inferential analysis, statistical analysis software was used (IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp.). All data were recorded pseudonymously. For status-quo/ intervention comparison of two related samples, Wilcoxon signedrank tests and McNemar tests were used, depending on the underlying data. For investigation of the influence of handling processes on the contamination level (median number of particles/m2), a Mann-Whitney U test was conducted. A p-value ≤ 0.05 was considered to indicate significance. 3. Results 3.1. Participants and Demographics All 53 invited nursing students participated in our study. Participants' characteristics are presented in Table 1.
Age (years) Median Minimum/Maximum
21 17/33
Sex Female
42 (79.2)
School leaving qualification Lower secondary school leaving certificate Intermediate secondary school leaving certificate Upper secondary school leaving certificate Missing answers
3 (5.7) 42 (79.2) 3 (5.7) 5 (9.4)
Year of training First Second Third
24 (45.3) 14 (26.4) 15 (28.3)
quo/intervention: 5/4, p b 0.001). Contact to three of those declined significantly in the intervention period (telephone, pill box organiser, working table; p b 0.001, respectively). 3.3.4. Cleaning Process The cleaning processes increased in quantity and quality in the intervention period. The proportion of participants that cleaned the devices used for manipulation at the end of the simulated handling scenario increased from status-quo 35/49 (71%) to the intervention period 44/49 (90%, p = 0.022). In the status-quo period, 26 of 49 participants (53%) cleaned the work surface. This proportion increased to 45/49 (92%, p b 0.001).
3.2. Questionnaire: determining knowledge
3.4. Fluorescence Imaging: Determining Contamination
Participant's knowledge of handling HD was assessed by a questionnaire in both study periods. Of all participants, 48 completed pre- and post-questionnaires were available for knowledge assessment. Median knowledge, i.e. the number of questions that were answered correctly, increased significantly from 5/13 (39%) in the status-quo period to 9/13 (65%) in the intervention period (p b 0.001). A graphic representation of the result is given in Fig. 3.
3.4.1. Work Surface Contamination The detected contamination of fluorescent tracer at the end of the simulated handling scenario is associated with the level of knowledge and practical skills. The median number of particles/m2 of the photodocumented work surface declined significantly from 950 in the status-quo period to 97 in the intervention period (p b 0.001, Fig. 4). In the status-quo period, a detailed analysis of contamination caused by participants who cleaned the work surface and those who did not clean the surface at the end of the simulated handling scenario showed no significant difference between the two groups. The median number of particles/m2 after cleaning in the status-quo period was 431, without
3.3.1. Use of PPE In the intervention period, a higher number of participants wore PPE throughout the whole process of working with tablets mimicking HD. The use of gloves increased from 24/45 (53%) in the statusquo period to 43/45 (96%, p b 0.001) in the intervention period; the use of masks increased from 3/45 (7%) to 14/45 (31%, p = 0.003); the use of disposable aprons increased from 2/45 (4%) to 10/45 (22%, p = 0.008). 3.3.2. Choice of Manipulation Devices Compared to the status-quo period, the number of participants that used recommended low-exposure systems for splitting or crushing tablets increased significantly from 20/47 (43%) in the status-quo period to 39/47 (83%, p b 0.001) in the intervention period. 3.3.3. Distribution of Contamination All contacts to surroundings with potentially contaminated gloves/ hands were examined. Nine surfaces that were frequently touched during drug preparation were identified (Table 2). In the intervention period, the participants touched a lower number of objects during the preparation process (median number of touched objects in status-
*
100 90 80
Knowledge [%]
3.3. Simulated handling scenario: determining practical skills
70 60 50 40 30 20 10 0
Status-quo period
Intervention period
Fig. 3. Determining knowledge: percentage of right answers in the status-quo period and the intervention period; Box layers describe the 25, 50, 75th percentile, outliers are not shown, * p b 0.05, Wilcoxon signed-rank test.
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Hence, improved HD handling competence will likely enhance the nurses' personal safety and that of others.
Table 2 Determining practical skills: distribution of contamination. Touched equipment
Status-quo period (%)
Intervention period (%)
p-valuea
Telephone Pen Bin cover Patient medicine box Working table Cabinet door Manipulation devices Pill box organiser Outer drug packaging All together
29.8 10.6 6.4 44.7 53.2 86.7 89.4 59.6 91.5 52.3
3.9 5.9 9.8 41.2 13.7 90.2 86.3 35.3 90.2 41.8
0.002 n.s. n.s. n.s. b0.001 n.s. n.s. 0.021 n.s. b0.001
Percentage of participants that touched surfaces with contaminated gloves or hands during the simulated handling scenario in the status-quo and intervention period. a McNemar Test for status-quo/intervention comparison of related groups, n.s. not significant.
cleaning 1771 (p = 0.097, not significant [n.s.]). The innovative teaching session led to a reduction and significant difference in the intervention period (median number of particles/m2 after cleaning 88, without cleaning 532; p = 0.005). 3.4.2. Floor Contamination The respective influences of routine education and the innovative teaching session on airborne spreading of contamination were determined by fluorescent imaging. In almost all cases in both periods, the floor in front of the work area was found to be contaminated: statusquo 43/43 (100%), intervention 41/43 (95%, p = 0.500, n.s.). 4. Discussion High competence in HD handling from the very beginning of nurses' professional careers is crucial for their health preservation. This study compared the effect of routine education for nursing students with an additional innovative teaching session on developing competence. For comparison, the nursing students' knowledge and their practical skills in HD handling were assessed. The impact of both educational methods imparting knowledge and skills on contamination was assessed by fluorescence imaging. Thus, it was possible to determine whether the respective educational method had an effect on risk for exposure and safety without putting participants at risk. This study showed that routine education alone did not adequately prepare students for handling HD. Their knowledge and practical skills were poor. Comparing results of the status-quo period with those of the intervention period, the innovative teaching session was found to significantly improve HD handling competence. This resulted in less contamination in the work area.
*
N u m b e r o f p a r ti c l e s /m ²
5000
4000
3000
2000
1000
0
status-quo period
intervention period
Fig. 4. Determining contamination: number of particles/m2 of fluorescent tracer on the work surface in the status-quo period and intervention period; Box layers describe the 25, 50, 75th percentile, outliers are not shown, * p b 0.05, Wilcoxon signed-rank test.
4.1. Didactical Features Addressing various senses enhances the effective delivery of information. The majority of nursing students has multimodal preferences for information submission, first and foremost the kinaesthetic preference (Alkhasawneh, 2013; Hallin, 2014). Thus, various teaching approaches are required to effectively impart information in a timeframe that enables immediate transition of information to knowledge. For this reason, different teaching elements were added to the theoretical background information (for auditory learners) in the innovative teaching session: practical relevance (for kinaesthetic learners), visualisation of contamination (for visual learners), haptic relationship to devices (for tactile learners), and interactive discussion (to keep interest over time). Each element has been shown to be effective (Costa et al., 2007; Harris et al., 2014; Kooloos et al., 2014; Wigger-Alberti et al., 1997). The combination of these elements was found to be a very striking educational tool. Chalk-and-talk teaching is the most widely used teaching method in nursing schools. Although alternative training methods have shown to be effective (Kang et al., 2015; Mathibe, 2007), these are not commonly in use (Markham et al., 1998). Reasons given in the study of Markham et al. (1998) were mainly time-related. The innovative teaching session for nursing students presented in this paper has been both easy to develop and fast to conduct. It is a method that is not more staffintensive than routine education. Vocational schools can easily implement the new training session in their curriculum. The simulation element is gaining attraction and is considered an innovative and effective teaching method for nursing students (Oh et al., 2015). The experience of real-life scenarios in a safe environment was a main reason for choosing this practical assessment instrument. We consider the simulation element, which was used for skills assessment in this study, a promising tool in school education, combining theory and practice. The implementation of simulated HD handling offers a considerable potential to schools teaching health preservation before students are exposed to HD in their daily work. To establish a connection to the prevailing practical situation, practice educators should be involved in teaching. 4.2. Effects of Routine Education and Innovative Teaching Session on Competence Knowledge is the key to sensitise nursing students to possible health risks and for them to take safety measures accordingly. As described before (Keat et al., 2013), this study also shows that participating students' knowledge gained from routine education was poor. Methods to prevent contamination and to protect themselves and others when handling HD were not adequately conveyed. The innovative teaching session significantly improved the nursing students' knowledge of safe drug handling compared to routine education. The effect on personal protection was measured by rating the use of PPE. Recent studies indicate that PPE is not sufficiently used (Boiano et al., 2014). Accordingly, we found that only one out of two participants wore gloves during drug preparation in the status-quo period. After the innovative teaching session, almost all participants adhered to selfprotection recommendations concerning gloves (96% compared to 53% after routine education). This is an important achievement for self-protection, particularly in combination with the following aspects that are related to exposure. Closed systems for drug manipulation and devices that are easy to clean prevent dust formation. Therefore, the use of closed systems and single use material is recommended (Clark and Sessink, 2013; NIOSH, 2004; Wakui et al., 2013). After routine education, b 50% of the participants used the recommended manipulation devices, whereas the majority of participants used them after the innovative teaching session.
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Dust generation is the first step in the exposure chain and, therefore, its prevention is crucial. Beside the generation of contamination, its spreading may particularly influence the safety of other professional groups (National Research Council, 2012). Nurses' peers might be exposed to this contamination by touching a (invisibly) contaminated telephone, bin cover, or cupboard door without gloves (Boiano et al., 2014; Schneider et al., 1999). By contact, the hazardous substances may be transferred to the skin and absorbed into the body. Compared to the status-quo period, participants of the intervention period were more aware of this aspect. Hence, they touched fewer surrounding surfaces with contaminated gloves or hands and thereby prevented the distribution of contamination. The last step in the exposure chain for nurses preparing HD is the removal of contamination at the end of the process. Only one in two participants in the status-quo period cleaned the work surface at the end of the preparation process. But even when students cleaned the surface, it was not significantly less contaminated than surface that was not cleaned at all. This finding corroborates that common cleaning techniques may not resolve contamination residuals or might even spread them (Chu et al., 2012; Hon et al., 2013; Sessink et al., 1992; Touzin et al., 2010; Trent et al., 1995). In the intervention period, almost all participants cleaned the work surface. Furthermore, the quality of cleaning improved. Consequently, after imparting the cleaning strategy in the innovative teaching session, the value of fluorescent residuals on the cleaned work surface was significantly lower. This is of major concern for the safety of nurses who work at that worktable later on (even when handling non-hazardous substances). 4.3. Effects of Routine Education and Innovative Teaching Session on Contamination This study shows a strong impact of competence (knowledge and practical skills) on the topic of contamination. The competence obtained from routine education was associated with a high work surface contamination. The improved competence after the innovative teaching session resulted in a lower amount of residuals on the work surface. Hence, the risk for exposure has been reduced. It can therefore be concluded that improved competence enhances nurses' personal safety and that of others. Floor contamination was detected in almost all cases of the status-quo and intervention period. The high number remained unaffected by the intervention. This is in accordance to Kiffmeyer et al. (2013). They found the floor to be most commonly contaminated and the percentage of contaminated spots unchanged despite monitoring feedback. It can be assumed that our innovative teaching session was able to prevent “active” dispersion of contamination (by hand), whereas the deposition of airborne particles was more strongly influenced by general dispersion parameters than by handling, and was therefore unaffected. The impact of this alarming finding on the safety of other staff, such as the floor cleaning personnel, needs to be considered in a working environment. 4.4. Limitations Although this study was pilot-tested and used a close-to-reality approach, some limitations have to be considered. The results were drawn from only one vocational school. Even if a framework curriculum defines the curricular content for nursing students, divergent results at other schools cannot be completely excluded. Nursing students from all years of training were enrolled in the study. The theoretical training on drug handling is given in the first year of training, the practical experience increases within each year. This could have influenced the results among the students of different years of training. For this reason, a pre-post design was chosen to measure the individual increase of competence.
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The effects of each single handling improvement on contamination cannot be determined since the resulting residues that were detected are a sum of all changes. Furthermore, data were collected only once in each study period. Further studies are needed to evaluate long-term effects. We explicitly decided for education during the earliest phase of working life – at nursing educational level. However, it may not always be possible for trained nurses to adhere to handling recommendations when working in institutions where equipment (masks, gloves, aprons) is not (yet) available. Improving safety in a given setting may be particularly challenging when financial resources are needed. Practical skills were assessed in a simulated environment. The environmental conditions at hospitals or nursing homes may differ. During the simulated handling scenario, we did not apply time pressure or background noises. Furthermore, the processes observed by a member of the study team may be subject to a Hawthorne effect (Roethlisberger and Dickson, 1939; Wickström and Bendix, 2000). Thus, the results drawn from the simulated handling scenario may not be unconditionally applicable to working practice.
5. Conclusions Compared to routine education, HD handling competence was significantly improved after an innovative teaching session on HD handling that used multimodal elements. This also resulted in a safer workplace associated with a reduction of residuals of a fluorescent tracer mimicking hazardous substances. Thus, this study provides an approach for an effective introduction of HD handling competence to nursing students' education. We strongly recommend taking into account these multimodal elements in nurses' education.
Ethics We confirm that all personal identifiers have been removed or disguised so the participants described are not identifiable and cannot be identified through the details of the story. Participation was entirely voluntary.
Contributorship Statement All authors declare that they have made substantial contributions to the article including the following criteria: 1) Contributed substantially to the conception or design of the work; or the acquisition, analysis or interpretation of data for the work; AND 2) Contributed substantially to drafting the article or revising it critically for important intellectual content; AND 3) Approved the final version to be submitted. All authors declare that the work described has not been published previously, that it is not under consideration for publication elsewhere, that its publication is approved by all authors and tacitly or explicitly by the responsible authorities where the work was carried out, and that, if accepted, it will not be published elsewhere in the same form, in English or in any other language, including electronically, without the written consent of the copyright-holder.
Conflict of Interest: None All authors declare that they have no conflicts of interest regarding any financial, personal or other relationships with other people or organizations that could inappropriately influence (bias), or be perceived to influence, their work.
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Funding This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Acknowledgements We would like to thank the Ruth-Pfau-Vocational School, i.e. Friedhelm Schlüter and Ms. Sabine Wendorff, for supporting the practical realisation, and the Medical Technical School, Leipzig University for the successful cooperation. Thanks to Doris Kroth and Lena Schrader for language editing of the manuscript. References Alkhasawneh, E., 2013. Using VARK to assess changes in learning preferences of nursing students at a public university in Jordan: implications for teaching. Nurse Educ. Today 33 (12), 1546–1549. American Society of Health-System Pharmacists, 2006. Guidelines on handling hazardous drugs: drug distribution and control: preparation and handling: guidelines. http:// www.ashp.org/DocLibrary/BestPractices/PrepGdlHazDrugs.aspx . Boiano, J.M., Steege, A.L., Sweeney, M.H., 2014. Adherence to safe handling guidelines by health care workers who administer antineoplastic drugs. J. Occup. Environ. Hyg. 11 (11), 728–740. Chu, W.C., Hon, C.-Y., Danyluk, Q., Chua, P.P., Astrakianakis, G., 2012. Pilot assessment of the antineoplastic drug contamination levels in British Columbian hospitals preand post-cleaning. J. Oncol. Pharm. Pract. 18 (1), 46–51. Clark, B.A., Sessink, P.J.M., 2013. Use of a closed system drug-transfer device eliminates surface contamination with antineoplastic agents. J. Oncol. Pharm. Pract. 19 (2), 99–104. Connor, T.H., McDiarmid, M.A., 2006. Preventing occupational exposures to antineoplastic drugs in health care settings. CA Cancer J. Clin. 56 (6), 354–365. Costa, M.L., van Rensburg, L., Rushton, N., 2007. Does teaching style matter? A randomised trial of group discussion versus lectures in orthopaedic undergraduate teaching. Med. Educ. 41 (2), 214–217. Faul, F., Erdfelder, E., Lang, A.-G., Buchner, A., 2007. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav. Res. Methods 39 (2), 175–191. Hallin, K., 2014. Nursing students at a university - a study about learning style preferences. Nurse Educ. Today 34 (12), 1443–1449 (10). Harris, M.A., Pittiglio, L., Newton, S.E., Moore, G., 2014. Using simulation to improve the medication administration skills of undergraduate nursing students. Nurs. Educ. Perspect. 35 (1), 26–29. Hon, C.-Y., Teschke, K., Chu, W., Demers, P., Venners, S., 2013. Antineoplastic drug contamination of surfaces throughout the hospital medication system in Canadian hospitals. J. Occup. Environ. Hyg. 10 (7), 374–383. Johnson, P.E., Chambers, C.R., Vaida, A.J., 2008. Oncology medication safety: a 3D status report 2008. J. Oncol. Pharm. Pract. 14 (4), 169–180. Kang, K.-A., Kim, S., Kim, S.-J., Oh, J., Lee, M., 2015. Comparison of knowledge, confidence in skill performance (CSP) and satisfaction in problem-based learning (PBL) and simulation with PBL educational modalities in caring for children with bronchiolitis. Nurse Educ. Today 35 (2), 315–321. Keat, C.H., Sooaid, N.S., Yun, C.Y., Sriraman, M., 2013. Improving safety-related knowledge, attitude and practices of nurses handling cytotoxic anticancer drug: pharmacists' experience in a general hospital. Asian Pac. J. Cancer Prev. 14 (1), 69–73. Kiffmeyer, T.K., Tuerk, J., Hahn, M., Stuetzer, H., Hadtstein, C., Heinemann, A., Eickmann, U., 2013. Application and assessment of a regular environmental monitoring of the
antineoplastic drug contamination level in pharmacies - the MEWIP project. Ann. Occup. Hyg. 57 (4), 444–455. Kooloos, J.G.M., Schepens-Franke, A.N., Bergman, E.M., Donders, R.A.R.T., Vorstenbosch, M.A.T.M., 2014. Anatomical knowledge gain through a clay-modeling exercise compared to live and video observations. Anat. Sci. Educ. 7 (6), 420–429. Labuhn, K., Valanis, B., Schoeny, R., Loveday, K., Vollmer, W.M., 1998. Nurses' and pharmacists' exposure to antineoplastic drugs: findings from industrial hygiene scans and urine mutagenicity tests. Cancer Nurs. 21 (2), 79–89. Markham, T., Jones, S.J., Hughes, I., Sutcliffe, M., 1998. Survey of methods of teaching and learning in undergraduate pharmacology within UK higher education. Trends Pharmacol. Sci. 19 (7), 257–262. Mathibe, L.J., 2007. Perceptions of student nurses regarding the use of a popular autobiography as a teaching tool. Nurse Educ. Today 27 (3), 247–255. National Institute for Occupational Safety and Health (NIOSH), 2004S. NIOSH alert: preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) publication no. 2004–165. http://www. cdc.gov/niosh/docs/2004-165/. National Research Council (U.S.), 2012. Exposure Science in the 21st Century: A Vision and a Strategy, Washington, D.C. (196 pp.). Oh, P.-J., Jeon, K.D., Koh, M.S., 2015. The effects of simulation-based learning using standardized patients in nursing students: a meta-analysis. Nurse Educ. Today 35 (5), e6–e15. Roethlisberger, F.J., Dickson, W.J., 1939. Management and the Worker. Harvard University Press, Cambridge, Mass . Schindelin, J., Arganda-Carreras, I., Frise, E., Kaynig, V., Longair, M., Pietzsch, T., Preibisch, S., Rueden, C., Saalfeld, S., Schmid, B., Tinevez, J.-Y., White, D.J., Hartenstein, V., Eliceiri, K., Tomancak, P., Cardona, A., 2012. Fiji: an open-source platform for biological-image analysis. Nat. Methods 9 (7), 676–682. Schneider, T., Vermeulen, R., Brouwer, D.H., Cherrie, J.W., Kromhout, H., Fogh, C.L., 1999. Conceptual model for assessment of dermal exposure. Occup. Environ. Med. 56 (11), 765–773. Sessink, P.J., Boer, K.A., Scheefhals, A.P., Anzion, R.B., Bos, R.P., 1992. Occupational exposure to antineoplastic agents at several departments in a hospital. Environmental contamination and excretion of cyclophosphamide and ifosfamide in urine of exposed workers. Int. Arch. Occup. Environ. Health 64 (2), 105–112. Smart, D.A., Castillo, M., Bruya, M., Dekker, L., 2010. Outcomes of teaching baccalaureate nursing students about mastitis utilizing a multimodal teaching tool. Int. J. Nurs. Educ. Scholarsh. 7, 19. Touzin, K., Bussieres, J.-F., Langlois, E., Lefebvre, M., Metra, A., 2010. Pilot study comparing the efficacy of two cleaning techniques in reducing environmental contamination with cyclophosphamide. Ann. Occup. Hyg. 54 (3), 351–359. Trent, K.C., Myers, L., Moreb, J., 1995. Multiorgan failure associated with lomustine overdose. Ann. Pharmacother. 29 (4), 384–386. Valanis, B.G., Vollmer, W.M., Labuhn, K.T., Glass, A.G., 1993. Acute symptoms associated with antineoplastic drug handling among nurses. Cancer Nurs. 16 (4), 288–295. Wakui, N., Ookubo, T., Iwasaki, Y., Ito, R., Saito, K., Nakazawa, H., 2013. Development of a closed drug preparation method for oral anticancer drugs. J. Oncol. Pharm. Pract. 19 (4), 315–320. Weingart, S.N., Brown, E., Bach, P.B., Eng, K., Johnson, S.A., Kuzel, T.M., Langbaum, T.S., Leedy, R.D., Muller, R.J., Newcomer, L.N., O'Brien, S., Reinke, D., Rubino, M., Saltz, L., Walters, R.S., 2008. NCCN Task Force Report: oral chemotherapy. J. Natl. Compr. Cancer Netw. 6 (Suppl. 3), S1–14. Wickström, G., Bendix, T., 2000. The “Hawthorne effect”–what did the original Hawthorne studies actually show? Scand. J. Work Environ. Health 26 (4), 363–367. Wigger-Alberti, W., Maraffio, B., Wernli, M., Elsner, P., 1997. Training workers at risk for occupational contact dermatitis in the application of protective creams: efficacy of a fluorescence technique. Dermatology 195 (2), 129–133.
Contents lists available at ScienceDirect
Nurse Education Today journal homepage: www.elsevier.com/nedt
Handling of hazardous drugs – Effect of an innovative teaching session for nursing students Janine Zimmer a,b, Stefanie Hartl a,b, Katrin Standfuß a,b, Till Möhn c, Astrid Bertsche d, Roberto Frontini b, Martina P. Neininger a, Thilo Bertsche a,⁎ a
Department of Clinical Pharmacy and Drug Safety Center, University of Leipzig, Eilenburger Str. 15a, 04317 Leipzig, Germany Pharmacy Department and Drug Safety Center, University Hospital Leipzig, Liebigstr. 20, 04103 Leipzig, Germany Faculty of Physics and Earth Sciences, Institute of Experimental Physics I, Linnéstraße 5, 04103, Leipzig University, Leipzig, Germany d Department of Women and Child Health, Hospital for Children and Adolescents and Centre for Paediatric Research, University of Leipzig, Liebigstr. 20a, 04103 Leipzig, Germany b c
a r t i c l e
i n f o
Article history: Received 20 July 2016 Received in revised form 22 October 2016 Accepted 3 November 2016 Available online xxxx Keywords: Nursing education Nursing students Hazardous drugs Fluorescence imaging Occupational safety
a b s t r a c t Background: Imparting knowledge and practical skills in hazardous drug handling in nursing students' education is essential to prevent hazardous exposure and to preserve nurses' health. Objectives: This study aimed at comparing routine nursing education with an additional innovative teaching session. Design: A prospective controlled study in nursing students was conducted in two study periods: (i) a status-quo period (routine education on handling hazardous drugs) followed by (ii) an intervention period (additional innovative teaching session on handling hazardous drugs). Settings/Participants: Nursing students at a vocational school were invited to participate voluntarily. Methods: In both study periods (i) and (ii), the following factors were analysed: (a) knowledge of hazardous drug handling by questionnaire, (b) practical skills in hazardous drug handling (e.g. cleaning) by a simulated handling scenario, (c) contamination with drug residuals on the work surface by fluorescent imaging. Results: Fifty-three nursing students were enrolled. (a) Median knowledge improved from status-quo (39% right answers) to intervention (65%, p b 0.001), (b) practical skills improved from status-quo (53% of all participants cleaned the work surface) to intervention (92%, p b 0.001). (c) Median number of particles/m2 decreased from status-quo to intervention (932/97, p b 0.001). Conclusions: Compared with routine education, knowledge and practical skills in hazardous drug handling were significantly improved after an innovative teaching session. Additionally, the amount of residuals on the work surface decreased. This indicates a lower risk for hazardous drug exposure. © 2016 Elsevier Ltd. All rights reserved.
1. Introduction Substances that are organ toxic, carcinogenic, mutagenic, or toxic for reproduction were defined as hazardous drugs (HD) by the National Institute for Occupational Safety and Health (NIOSH, 2004). Therefore, handling these drugs is associated with risk for occupational exposure. Even low doses of these drugs pose a risk to the health of the person handling them if safety standards and handling recommendations are not accurately followed (Valanis et al., 1993). This applies particularly to the increasing number of oral antineoplastic drugs (Weingart et al., 2008).
⁎ Corresponding author at: Department of Clinical Pharmacy, Leipzig University, Eilenburger Str. 15a, 04317 Leipzig, Germany. E-mail addresses: [email protected] (T. Möhn), [email protected] (A. Bertsche), [email protected] (R. Frontini), [email protected], [email protected] (T. Bertsche).
http://dx.doi.org/10.1016/j.nedt.2016.11.002 0260-6917/© 2016 Elsevier Ltd. All rights reserved.
Nurses have to be aware of these hazards. Accordingly, they have to be taught about risk and safety measures to appropriately protect themselves and others. Knowledge of handling HD and practical skills (hereinafter referred to as HD handling competence) are crucial from the very beginning of their professional careers since the side effects may occur with a delay of years after exposure. Hence, it is necessary to address the topic “HD handling” during nursing students' education. Education on HD in the current curriculum, however, is sparse. This indicates that the current education does not sufficiently sensitise nursing students for exposure risk. Lacking awareness becomes obvious in practice, since many nurses do not consider oral antineoplastic drugs hazardous and do not adequately adhere to self-protection recommendations (Johnson et al., 2008; Labuhn et al., 1998). Therefore, current nursing education needs to be evaluated for its impact on HD handling competence. In cases in which students tend to ignore important factors, education should be intensified and targeted strategies should be implemented to improve knowledge and practical skills. Multimodal presentation of information has shown to be an effective teaching method
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(Smart et al., 2010). Multimodal strategies combine verbal, visual, and auditory stimuli to deliver theoretical and practical information. 1.1. Objective This study aimed at comparing the effect of routine nursing education with an additional innovative teaching session on obtaining HD handling competence. The impact of competence on occupational safety in both study periods is demonstrated by fluorescent imaging of work area contamination. 2. Methods 2.1. Setting and Educational Structure The study was conducted at one vocational school for nurses in Germany between January and March 2015. The school principal was informed and gave his consent to the realisation of the project. All students from all three training years were invited to take part in the
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study without exception. Participation was voluntary for all invited nursing students. Nursing education in Germany is divided into theoretical and practical education regulated by a framework curriculum. Theoretical education is provided by teachers at vocational schools. Working in hospitals or nursing homes is part of the practical education in all three years of training. The practical education is provided by senior nurses and practice educators. Handling oral medication is part of the practical education. 2.2. Study Design A prospective controlled study was performed in two study periods: (i) a status-quo period (routine education on handling HD) followed by (ii) an intervention period (additional innovative teaching session on handling HD, Fig. 1). In a preliminary period, the innovative teaching session and the questionnaire were developed and pretested. The handling process list, the method for contamination detection and the image analysis were validated. The data acquisition method was defined and study
Purpose
Setting selection
Contact to and consent from school principal
Offer for nursing students to participate voluntarily
Recruitment of participants
Pilot testing
Instrumentation development, determination of effect size
Preliminary period
Operation
Routine education
Simulated handling scenario
Determination of practical skills
Fluorescence imaging
Determination of contamination
Status-quo period
Determination of knowledge
survey instruments
Questionnaire
Innovative teaching session
Simulated handling scenario
Determination of practical skills
Fluorescence imaging
Determination of contamination
Fig. 1. Study design.
Intervention period
Determination of knowledge
survey instruments
Questionnaire
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conditions were standardised. The study design was pilot-tested with a group of 10 nursing students independent from the study cohort. The preliminary results were used for optimisation of the instruments and effect size determination (see data analysis). In the status-quo period (i), all nursing students received routine education on HD. Afterwards, knowledge and practical skills in HD handling were assessed separately and pseudonymously for each participant. Following each skills assessment, the work area was photodocumented and evaluated for contamination. A fluorescent tracer acted as a non-hazardous substitute for a HD. In the following intervention period (ii), all nursing students received an innovative teaching session. Afterwards, each participant's knowledge and practical skills were assessed again. Images of the work area were captured and evaluated for the intervention period. 2.3. Survey Instruments The competence in handling of HD and its impact on safety was evaluated by three survey instruments in both study periods (i) and (ii).
Hazardous drug handling competence Knowledge
Protection
Formation
Distribution
Removal
Use of personal protective equipment
Choice of manipulation devices
Hand contact to surfaces
Cleaning
Practical skills
Contamination
Risk for exposure
Personal safety at risk
Peers’ safety at risk
Fig. 2. Framework for handling assessment.
2.3.1. Questionnaire: determining knowledge A questionnaire was designed to assess the nurses' knowledge of hazard potential and safe handling of HD by dichotomous rating of 13 statements. These statements reflected risk awareness, knowledge of personal protective equipment (PPE), tablet manipulation, distribution, exposition, cleaning, disposal, and first aid. The knowledge is given as percentage of right answers, ranging from 0% to 100%. Additionally, the questionnaire collected data on demographics. 2.3.2. Simulated handling scenario: determining practical skills A professional situation was simulated to evaluate specific practical skills in the area of HD handling. Participants were asked to carry out all drug preparation steps in the same way as in daily practice. To perform the simulated handling scenario, a room was installed to mimic the ward setting as realistically as possible. These conditions were standardised. The working environment was set up with working table, cabinets with different manipulation devices, PPE, waste bins, opportunity for hand washing and disinfection, cleaning material, and a telephone. A pseudo-patient's drug prescription that requested a common ward situation for handling HD was designed. All drug preparation processes including prearrangement, drug transfer, manipulation, and follow-up work were carried out by the nursing student and documented by a member of the study team (handling process list). While observing these steps, particular attention was paid to the procedures that were considered important for safe drug handling (Fig. 2). • The use of PPE was documented as a measure for self-protection. • The use of manipulation devices was analysed. All uses that enabled nurses to work with a low risk for contamination were considered “adequate”. Low risk for contamination means low risk for exposure for the handling person and for others. • Contact to surfaces with contaminated gloves/hands was recorded. Contact to surroundings was analysed to determine the distribution of hazardous substances that may lead to exposure of peers or others. • It was recorded if and how a cleaning procedure was conducted. Remaining residuals may lead to exposure of peers or others.
2.3.3. Fluorescence imaging: determining contamination For the assessment of contamination, tablets containing a fluorescent tracer were used. Residues of the handled tablets were visualised by ultraviolet (UV) light. Prior to each simulated handling scenario, the study team cleaned the work area and scanned it with UV light to ensure that there were no contamination residuals. Following each
handling simulation, the study team examined the work surface and the floor with UV light for contamination. • Contamination of the work surface was documented photographically by taking ten pictures under standardised conditions. The images were saved in RAW format, developed with RawTherapee (V4.2.74, http://rawtherapee.com), and analysed with ImageJ interface Fiji software v1.50a (Schindelin et al., 2012). Each image was assigned to the corresponding participant's handling process list. The summarised findings from the ten images were used for analysis. For the description of work surface contamination, the median number of particles of the fluorescent tracer per square metre of the work surface is presented. • Further, the floor in front of the work area was examined for contamination. The result was described qualitatively (rated yes/no).
2.4. Educational Methods 2.4.1. Routine Teaching Session The school conducted routine education on HD as a chalk-and-talk teaching in a classroom setting in the status-quo period. According to the framework curriculum, theoretical education on handling of drugs was curricular content in the first year of training. Theoretical background information on hazard potential and exposure was given using a slide presentation. Simulation training on oral medication handling was not performed. 2.4.2. Innovative Teaching Session Based on current guidelines and recommendations (American Society of Health-System Pharmacists, 2006; Connor and McDiarmid, 2006; NIOSH, 2004), a 45-minute teaching session on safe handling of HD was developed in this study. Theoretical information on protection, formation, distribution, and removal of contamination were emphasised using the following multimodal teaching techniques. Practical relevance: challenges in handling HD were identified at each consecutive step of the preparation process. All participants performed this preparation process for practical skills assessment in the status-quo period. Thus, those experiences' concrete practical relevance was established. To intensify students' understanding of this practical relevance, group results of error rates seen in the status-quo period were presented to the students. Interactive discussion: interactive elements that promoted active participation and discussions were included. Haptic elements: this study's concept included haptic elements such as demonstration of different manipulation devices. Visual element: the nursing students
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were shown images of visible fluorescent residuals in the working environment and on the equipment, captured in the status-quo period.
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Table 1 Participants' demographics. Total n = 53 n (%)
2.5. Data Analysis Based on the distribution in the pilot study, the data's distribution was anticipated to be nonparametric. A sample size calculation was performed for related-samples nonparametric procedures by using G*-Power 3.1 (Faul et al., 2007). Effect size was determined based on the weakest result in the pilot study (effect on knowledge: increase by 20% absolute). To detect this difference with 80% power at a two-sided level of 2.5%, a Wilcoxon signed-rank test was conducted. To compensate the influence of about 30% drop-out, 51 participants in total should be included. Medians and percentages were calculated for descriptive analysis. Frequencies were reported as percentage and total numbers. For descriptive and inferential analysis, statistical analysis software was used (IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp.). All data were recorded pseudonymously. For status-quo/ intervention comparison of two related samples, Wilcoxon signedrank tests and McNemar tests were used, depending on the underlying data. For investigation of the influence of handling processes on the contamination level (median number of particles/m2), a Mann-Whitney U test was conducted. A p-value ≤ 0.05 was considered to indicate significance. 3. Results 3.1. Participants and Demographics All 53 invited nursing students participated in our study. Participants' characteristics are presented in Table 1.
Age (years) Median Minimum/Maximum
21 17/33
Sex Female
42 (79.2)
School leaving qualification Lower secondary school leaving certificate Intermediate secondary school leaving certificate Upper secondary school leaving certificate Missing answers
3 (5.7) 42 (79.2) 3 (5.7) 5 (9.4)
Year of training First Second Third
24 (45.3) 14 (26.4) 15 (28.3)
quo/intervention: 5/4, p b 0.001). Contact to three of those declined significantly in the intervention period (telephone, pill box organiser, working table; p b 0.001, respectively). 3.3.4. Cleaning Process The cleaning processes increased in quantity and quality in the intervention period. The proportion of participants that cleaned the devices used for manipulation at the end of the simulated handling scenario increased from status-quo 35/49 (71%) to the intervention period 44/49 (90%, p = 0.022). In the status-quo period, 26 of 49 participants (53%) cleaned the work surface. This proportion increased to 45/49 (92%, p b 0.001).
3.2. Questionnaire: determining knowledge
3.4. Fluorescence Imaging: Determining Contamination
Participant's knowledge of handling HD was assessed by a questionnaire in both study periods. Of all participants, 48 completed pre- and post-questionnaires were available for knowledge assessment. Median knowledge, i.e. the number of questions that were answered correctly, increased significantly from 5/13 (39%) in the status-quo period to 9/13 (65%) in the intervention period (p b 0.001). A graphic representation of the result is given in Fig. 3.
3.4.1. Work Surface Contamination The detected contamination of fluorescent tracer at the end of the simulated handling scenario is associated with the level of knowledge and practical skills. The median number of particles/m2 of the photodocumented work surface declined significantly from 950 in the status-quo period to 97 in the intervention period (p b 0.001, Fig. 4). In the status-quo period, a detailed analysis of contamination caused by participants who cleaned the work surface and those who did not clean the surface at the end of the simulated handling scenario showed no significant difference between the two groups. The median number of particles/m2 after cleaning in the status-quo period was 431, without
3.3.1. Use of PPE In the intervention period, a higher number of participants wore PPE throughout the whole process of working with tablets mimicking HD. The use of gloves increased from 24/45 (53%) in the statusquo period to 43/45 (96%, p b 0.001) in the intervention period; the use of masks increased from 3/45 (7%) to 14/45 (31%, p = 0.003); the use of disposable aprons increased from 2/45 (4%) to 10/45 (22%, p = 0.008). 3.3.2. Choice of Manipulation Devices Compared to the status-quo period, the number of participants that used recommended low-exposure systems for splitting or crushing tablets increased significantly from 20/47 (43%) in the status-quo period to 39/47 (83%, p b 0.001) in the intervention period. 3.3.3. Distribution of Contamination All contacts to surroundings with potentially contaminated gloves/ hands were examined. Nine surfaces that were frequently touched during drug preparation were identified (Table 2). In the intervention period, the participants touched a lower number of objects during the preparation process (median number of touched objects in status-
*
100 90 80
Knowledge [%]
3.3. Simulated handling scenario: determining practical skills
70 60 50 40 30 20 10 0
Status-quo period
Intervention period
Fig. 3. Determining knowledge: percentage of right answers in the status-quo period and the intervention period; Box layers describe the 25, 50, 75th percentile, outliers are not shown, * p b 0.05, Wilcoxon signed-rank test.
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Hence, improved HD handling competence will likely enhance the nurses' personal safety and that of others.
Table 2 Determining practical skills: distribution of contamination. Touched equipment
Status-quo period (%)
Intervention period (%)
p-valuea
Telephone Pen Bin cover Patient medicine box Working table Cabinet door Manipulation devices Pill box organiser Outer drug packaging All together
29.8 10.6 6.4 44.7 53.2 86.7 89.4 59.6 91.5 52.3
3.9 5.9 9.8 41.2 13.7 90.2 86.3 35.3 90.2 41.8
0.002 n.s. n.s. n.s. b0.001 n.s. n.s. 0.021 n.s. b0.001
Percentage of participants that touched surfaces with contaminated gloves or hands during the simulated handling scenario in the status-quo and intervention period. a McNemar Test for status-quo/intervention comparison of related groups, n.s. not significant.
cleaning 1771 (p = 0.097, not significant [n.s.]). The innovative teaching session led to a reduction and significant difference in the intervention period (median number of particles/m2 after cleaning 88, without cleaning 532; p = 0.005). 3.4.2. Floor Contamination The respective influences of routine education and the innovative teaching session on airborne spreading of contamination were determined by fluorescent imaging. In almost all cases in both periods, the floor in front of the work area was found to be contaminated: statusquo 43/43 (100%), intervention 41/43 (95%, p = 0.500, n.s.). 4. Discussion High competence in HD handling from the very beginning of nurses' professional careers is crucial for their health preservation. This study compared the effect of routine education for nursing students with an additional innovative teaching session on developing competence. For comparison, the nursing students' knowledge and their practical skills in HD handling were assessed. The impact of both educational methods imparting knowledge and skills on contamination was assessed by fluorescence imaging. Thus, it was possible to determine whether the respective educational method had an effect on risk for exposure and safety without putting participants at risk. This study showed that routine education alone did not adequately prepare students for handling HD. Their knowledge and practical skills were poor. Comparing results of the status-quo period with those of the intervention period, the innovative teaching session was found to significantly improve HD handling competence. This resulted in less contamination in the work area.
*
N u m b e r o f p a r ti c l e s /m ²
5000
4000
3000
2000
1000
0
status-quo period
intervention period
Fig. 4. Determining contamination: number of particles/m2 of fluorescent tracer on the work surface in the status-quo period and intervention period; Box layers describe the 25, 50, 75th percentile, outliers are not shown, * p b 0.05, Wilcoxon signed-rank test.
4.1. Didactical Features Addressing various senses enhances the effective delivery of information. The majority of nursing students has multimodal preferences for information submission, first and foremost the kinaesthetic preference (Alkhasawneh, 2013; Hallin, 2014). Thus, various teaching approaches are required to effectively impart information in a timeframe that enables immediate transition of information to knowledge. For this reason, different teaching elements were added to the theoretical background information (for auditory learners) in the innovative teaching session: practical relevance (for kinaesthetic learners), visualisation of contamination (for visual learners), haptic relationship to devices (for tactile learners), and interactive discussion (to keep interest over time). Each element has been shown to be effective (Costa et al., 2007; Harris et al., 2014; Kooloos et al., 2014; Wigger-Alberti et al., 1997). The combination of these elements was found to be a very striking educational tool. Chalk-and-talk teaching is the most widely used teaching method in nursing schools. Although alternative training methods have shown to be effective (Kang et al., 2015; Mathibe, 2007), these are not commonly in use (Markham et al., 1998). Reasons given in the study of Markham et al. (1998) were mainly time-related. The innovative teaching session for nursing students presented in this paper has been both easy to develop and fast to conduct. It is a method that is not more staffintensive than routine education. Vocational schools can easily implement the new training session in their curriculum. The simulation element is gaining attraction and is considered an innovative and effective teaching method for nursing students (Oh et al., 2015). The experience of real-life scenarios in a safe environment was a main reason for choosing this practical assessment instrument. We consider the simulation element, which was used for skills assessment in this study, a promising tool in school education, combining theory and practice. The implementation of simulated HD handling offers a considerable potential to schools teaching health preservation before students are exposed to HD in their daily work. To establish a connection to the prevailing practical situation, practice educators should be involved in teaching. 4.2. Effects of Routine Education and Innovative Teaching Session on Competence Knowledge is the key to sensitise nursing students to possible health risks and for them to take safety measures accordingly. As described before (Keat et al., 2013), this study also shows that participating students' knowledge gained from routine education was poor. Methods to prevent contamination and to protect themselves and others when handling HD were not adequately conveyed. The innovative teaching session significantly improved the nursing students' knowledge of safe drug handling compared to routine education. The effect on personal protection was measured by rating the use of PPE. Recent studies indicate that PPE is not sufficiently used (Boiano et al., 2014). Accordingly, we found that only one out of two participants wore gloves during drug preparation in the status-quo period. After the innovative teaching session, almost all participants adhered to selfprotection recommendations concerning gloves (96% compared to 53% after routine education). This is an important achievement for self-protection, particularly in combination with the following aspects that are related to exposure. Closed systems for drug manipulation and devices that are easy to clean prevent dust formation. Therefore, the use of closed systems and single use material is recommended (Clark and Sessink, 2013; NIOSH, 2004; Wakui et al., 2013). After routine education, b 50% of the participants used the recommended manipulation devices, whereas the majority of participants used them after the innovative teaching session.
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Dust generation is the first step in the exposure chain and, therefore, its prevention is crucial. Beside the generation of contamination, its spreading may particularly influence the safety of other professional groups (National Research Council, 2012). Nurses' peers might be exposed to this contamination by touching a (invisibly) contaminated telephone, bin cover, or cupboard door without gloves (Boiano et al., 2014; Schneider et al., 1999). By contact, the hazardous substances may be transferred to the skin and absorbed into the body. Compared to the status-quo period, participants of the intervention period were more aware of this aspect. Hence, they touched fewer surrounding surfaces with contaminated gloves or hands and thereby prevented the distribution of contamination. The last step in the exposure chain for nurses preparing HD is the removal of contamination at the end of the process. Only one in two participants in the status-quo period cleaned the work surface at the end of the preparation process. But even when students cleaned the surface, it was not significantly less contaminated than surface that was not cleaned at all. This finding corroborates that common cleaning techniques may not resolve contamination residuals or might even spread them (Chu et al., 2012; Hon et al., 2013; Sessink et al., 1992; Touzin et al., 2010; Trent et al., 1995). In the intervention period, almost all participants cleaned the work surface. Furthermore, the quality of cleaning improved. Consequently, after imparting the cleaning strategy in the innovative teaching session, the value of fluorescent residuals on the cleaned work surface was significantly lower. This is of major concern for the safety of nurses who work at that worktable later on (even when handling non-hazardous substances). 4.3. Effects of Routine Education and Innovative Teaching Session on Contamination This study shows a strong impact of competence (knowledge and practical skills) on the topic of contamination. The competence obtained from routine education was associated with a high work surface contamination. The improved competence after the innovative teaching session resulted in a lower amount of residuals on the work surface. Hence, the risk for exposure has been reduced. It can therefore be concluded that improved competence enhances nurses' personal safety and that of others. Floor contamination was detected in almost all cases of the status-quo and intervention period. The high number remained unaffected by the intervention. This is in accordance to Kiffmeyer et al. (2013). They found the floor to be most commonly contaminated and the percentage of contaminated spots unchanged despite monitoring feedback. It can be assumed that our innovative teaching session was able to prevent “active” dispersion of contamination (by hand), whereas the deposition of airborne particles was more strongly influenced by general dispersion parameters than by handling, and was therefore unaffected. The impact of this alarming finding on the safety of other staff, such as the floor cleaning personnel, needs to be considered in a working environment. 4.4. Limitations Although this study was pilot-tested and used a close-to-reality approach, some limitations have to be considered. The results were drawn from only one vocational school. Even if a framework curriculum defines the curricular content for nursing students, divergent results at other schools cannot be completely excluded. Nursing students from all years of training were enrolled in the study. The theoretical training on drug handling is given in the first year of training, the practical experience increases within each year. This could have influenced the results among the students of different years of training. For this reason, a pre-post design was chosen to measure the individual increase of competence.
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The effects of each single handling improvement on contamination cannot be determined since the resulting residues that were detected are a sum of all changes. Furthermore, data were collected only once in each study period. Further studies are needed to evaluate long-term effects. We explicitly decided for education during the earliest phase of working life – at nursing educational level. However, it may not always be possible for trained nurses to adhere to handling recommendations when working in institutions where equipment (masks, gloves, aprons) is not (yet) available. Improving safety in a given setting may be particularly challenging when financial resources are needed. Practical skills were assessed in a simulated environment. The environmental conditions at hospitals or nursing homes may differ. During the simulated handling scenario, we did not apply time pressure or background noises. Furthermore, the processes observed by a member of the study team may be subject to a Hawthorne effect (Roethlisberger and Dickson, 1939; Wickström and Bendix, 2000). Thus, the results drawn from the simulated handling scenario may not be unconditionally applicable to working practice.
5. Conclusions Compared to routine education, HD handling competence was significantly improved after an innovative teaching session on HD handling that used multimodal elements. This also resulted in a safer workplace associated with a reduction of residuals of a fluorescent tracer mimicking hazardous substances. Thus, this study provides an approach for an effective introduction of HD handling competence to nursing students' education. We strongly recommend taking into account these multimodal elements in nurses' education.
Ethics We confirm that all personal identifiers have been removed or disguised so the participants described are not identifiable and cannot be identified through the details of the story. Participation was entirely voluntary.
Contributorship Statement All authors declare that they have made substantial contributions to the article including the following criteria: 1) Contributed substantially to the conception or design of the work; or the acquisition, analysis or interpretation of data for the work; AND 2) Contributed substantially to drafting the article or revising it critically for important intellectual content; AND 3) Approved the final version to be submitted. All authors declare that the work described has not been published previously, that it is not under consideration for publication elsewhere, that its publication is approved by all authors and tacitly or explicitly by the responsible authorities where the work was carried out, and that, if accepted, it will not be published elsewhere in the same form, in English or in any other language, including electronically, without the written consent of the copyright-holder.
Conflict of Interest: None All authors declare that they have no conflicts of interest regarding any financial, personal or other relationships with other people or organizations that could inappropriately influence (bias), or be perceived to influence, their work.
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Funding This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Acknowledgements We would like to thank the Ruth-Pfau-Vocational School, i.e. Friedhelm Schlüter and Ms. Sabine Wendorff, for supporting the practical realisation, and the Medical Technical School, Leipzig University for the successful cooperation. Thanks to Doris Kroth and Lena Schrader for language editing of the manuscript. References Alkhasawneh, E., 2013. Using VARK to assess changes in learning preferences of nursing students at a public university in Jordan: implications for teaching. Nurse Educ. Today 33 (12), 1546–1549. American Society of Health-System Pharmacists, 2006. Guidelines on handling hazardous drugs: drug distribution and control: preparation and handling: guidelines. http:// www.ashp.org/DocLibrary/BestPractices/PrepGdlHazDrugs.aspx . Boiano, J.M., Steege, A.L., Sweeney, M.H., 2014. Adherence to safe handling guidelines by health care workers who administer antineoplastic drugs. J. Occup. Environ. Hyg. 11 (11), 728–740. Chu, W.C., Hon, C.-Y., Danyluk, Q., Chua, P.P., Astrakianakis, G., 2012. Pilot assessment of the antineoplastic drug contamination levels in British Columbian hospitals preand post-cleaning. J. Oncol. Pharm. Pract. 18 (1), 46–51. Clark, B.A., Sessink, P.J.M., 2013. Use of a closed system drug-transfer device eliminates surface contamination with antineoplastic agents. J. Oncol. Pharm. Pract. 19 (2), 99–104. Connor, T.H., McDiarmid, M.A., 2006. Preventing occupational exposures to antineoplastic drugs in health care settings. CA Cancer J. Clin. 56 (6), 354–365. Costa, M.L., van Rensburg, L., Rushton, N., 2007. Does teaching style matter? A randomised trial of group discussion versus lectures in orthopaedic undergraduate teaching. Med. Educ. 41 (2), 214–217. Faul, F., Erdfelder, E., Lang, A.-G., Buchner, A., 2007. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav. Res. Methods 39 (2), 175–191. Hallin, K., 2014. Nursing students at a university - a study about learning style preferences. Nurse Educ. Today 34 (12), 1443–1449 (10). Harris, M.A., Pittiglio, L., Newton, S.E., Moore, G., 2014. Using simulation to improve the medication administration skills of undergraduate nursing students. Nurs. Educ. Perspect. 35 (1), 26–29. Hon, C.-Y., Teschke, K., Chu, W., Demers, P., Venners, S., 2013. Antineoplastic drug contamination of surfaces throughout the hospital medication system in Canadian hospitals. J. Occup. Environ. Hyg. 10 (7), 374–383. Johnson, P.E., Chambers, C.R., Vaida, A.J., 2008. Oncology medication safety: a 3D status report 2008. J. Oncol. Pharm. Pract. 14 (4), 169–180. Kang, K.-A., Kim, S., Kim, S.-J., Oh, J., Lee, M., 2015. Comparison of knowledge, confidence in skill performance (CSP) and satisfaction in problem-based learning (PBL) and simulation with PBL educational modalities in caring for children with bronchiolitis. Nurse Educ. Today 35 (2), 315–321. Keat, C.H., Sooaid, N.S., Yun, C.Y., Sriraman, M., 2013. Improving safety-related knowledge, attitude and practices of nurses handling cytotoxic anticancer drug: pharmacists' experience in a general hospital. Asian Pac. J. Cancer Prev. 14 (1), 69–73. Kiffmeyer, T.K., Tuerk, J., Hahn, M., Stuetzer, H., Hadtstein, C., Heinemann, A., Eickmann, U., 2013. Application and assessment of a regular environmental monitoring of the
antineoplastic drug contamination level in pharmacies - the MEWIP project. Ann. Occup. Hyg. 57 (4), 444–455. Kooloos, J.G.M., Schepens-Franke, A.N., Bergman, E.M., Donders, R.A.R.T., Vorstenbosch, M.A.T.M., 2014. Anatomical knowledge gain through a clay-modeling exercise compared to live and video observations. Anat. Sci. Educ. 7 (6), 420–429. Labuhn, K., Valanis, B., Schoeny, R., Loveday, K., Vollmer, W.M., 1998. Nurses' and pharmacists' exposure to antineoplastic drugs: findings from industrial hygiene scans and urine mutagenicity tests. Cancer Nurs. 21 (2), 79–89. Markham, T., Jones, S.J., Hughes, I., Sutcliffe, M., 1998. Survey of methods of teaching and learning in undergraduate pharmacology within UK higher education. Trends Pharmacol. Sci. 19 (7), 257–262. Mathibe, L.J., 2007. Perceptions of student nurses regarding the use of a popular autobiography as a teaching tool. Nurse Educ. Today 27 (3), 247–255. National Institute for Occupational Safety and Health (NIOSH), 2004S. NIOSH alert: preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) publication no. 2004–165. http://www. cdc.gov/niosh/docs/2004-165/. National Research Council (U.S.), 2012. Exposure Science in the 21st Century: A Vision and a Strategy, Washington, D.C. (196 pp.). Oh, P.-J., Jeon, K.D., Koh, M.S., 2015. The effects of simulation-based learning using standardized patients in nursing students: a meta-analysis. Nurse Educ. Today 35 (5), e6–e15. Roethlisberger, F.J., Dickson, W.J., 1939. Management and the Worker. Harvard University Press, Cambridge, Mass . Schindelin, J., Arganda-Carreras, I., Frise, E., Kaynig, V., Longair, M., Pietzsch, T., Preibisch, S., Rueden, C., Saalfeld, S., Schmid, B., Tinevez, J.-Y., White, D.J., Hartenstein, V., Eliceiri, K., Tomancak, P., Cardona, A., 2012. Fiji: an open-source platform for biological-image analysis. Nat. Methods 9 (7), 676–682. Schneider, T., Vermeulen, R., Brouwer, D.H., Cherrie, J.W., Kromhout, H., Fogh, C.L., 1999. Conceptual model for assessment of dermal exposure. Occup. Environ. Med. 56 (11), 765–773. Sessink, P.J., Boer, K.A., Scheefhals, A.P., Anzion, R.B., Bos, R.P., 1992. Occupational exposure to antineoplastic agents at several departments in a hospital. Environmental contamination and excretion of cyclophosphamide and ifosfamide in urine of exposed workers. Int. Arch. Occup. Environ. Health 64 (2), 105–112. Smart, D.A., Castillo, M., Bruya, M., Dekker, L., 2010. Outcomes of teaching baccalaureate nursing students about mastitis utilizing a multimodal teaching tool. Int. J. Nurs. Educ. Scholarsh. 7, 19. Touzin, K., Bussieres, J.-F., Langlois, E., Lefebvre, M., Metra, A., 2010. Pilot study comparing the efficacy of two cleaning techniques in reducing environmental contamination with cyclophosphamide. Ann. Occup. Hyg. 54 (3), 351–359. Trent, K.C., Myers, L., Moreb, J., 1995. Multiorgan failure associated with lomustine overdose. Ann. Pharmacother. 29 (4), 384–386. Valanis, B.G., Vollmer, W.M., Labuhn, K.T., Glass, A.G., 1993. Acute symptoms associated with antineoplastic drug handling among nurses. Cancer Nurs. 16 (4), 288–295. Wakui, N., Ookubo, T., Iwasaki, Y., Ito, R., Saito, K., Nakazawa, H., 2013. Development of a closed drug preparation method for oral anticancer drugs. J. Oncol. Pharm. Pract. 19 (4), 315–320. Weingart, S.N., Brown, E., Bach, P.B., Eng, K., Johnson, S.A., Kuzel, T.M., Langbaum, T.S., Leedy, R.D., Muller, R.J., Newcomer, L.N., O'Brien, S., Reinke, D., Rubino, M., Saltz, L., Walters, R.S., 2008. NCCN Task Force Report: oral chemotherapy. J. Natl. Compr. Cancer Netw. 6 (Suppl. 3), S1–14. Wickström, G., Bendix, T., 2000. The “Hawthorne effect”–what did the original Hawthorne studies actually show? Scand. J. Work Environ. Health 26 (4), 363–367. Wigger-Alberti, W., Maraffio, B., Wernli, M., Elsner, P., 1997. Training workers at risk for occupational contact dermatitis in the application of protective creams: efficacy of a fluorescence technique. Dermatology 195 (2), 129–133.