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research-article2014

JPOXXX10.1177/1043454213517749Journal of Pediatric Oncology NursingHariss et al.

Article

Caregivers’ Perception of Drug Administration Safety for Pediatric Oncology Patients

Journal of Pediatric Oncology Nursing 2014, Vol. 31(2) 95­–103 © 2014 by Association of Pediatric Hematology/Oncology Nurses Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1043454213517749 jpo.sagepub.com

Nariman Harris, RN1, Lina Kurdahi Badr, PhD, RN CPNP, FAAN2, Raya Saab, MD1, and Aziza Khalidi, PhD3

Abstract Medication errors (MEs) are reported to be between 1.5% and 90% depending on many factors, such as type of the institution where data were collected and the method to identify the errors. More significantly, the risk for errors with potential for harm is 3 times higher for children, especially those receiving chemotherapy. Few studies have been published on averting such errors with children and none on how caregivers perceive their role in preventing such errors. The purpose of this study was to evaluate pediatric oncology patient’s caregivers’ perception of drug administration safety and their willingness to be involved in averting such errors. A cross-sectional design was used to study a nonrandomized sample of 100 caregivers of pediatric oncology patients. Ninety-six of the caregivers surveyed were well informed about the medications their children receive and were ready to participate in error prevention strategies. However, an underestimation of potential errors uncovered a high level of “trust” for the staff. Caregivers echoed their apprehension for being responsible for potential errors. Caregivers are a valuable resource to intercept medication errors. However, caregivers may be hesitant to actively communicate their fears with health professionals. Interventions that aim at encouraging caregivers to engage in the safety of their children are recommended. Keywords medication safety, pediatric oncology, caregivers

Introduction Studies on caregivers’ involvement in preventing medication errors (MEs) in the pediatric population are nonexistent. However, adult patients’ involvement in error prevention has been recommended recently as an important measure to reduce adverse drug events (ADEs; Darzi, 2008; Davis, Sevdalis, Jacklin, & Vincent, 2012; Schwappach & Wernli, 2010a; Weingart et al., 2005). These recommendations arise from the documented reality of MEs or ADEs, which result in increased hospital stay, increased mortalities and morbidities, and increased health care costs (Barker, Flynn, Pepper, Bates, & Mikeal, 2002; Schwappach & Wernli, 2010a). MEs are the most preventable cause of adverse events, yet despite extensive recommendations to curb such errors, rates have not decreased in the past decade (Banning, 2006; McLeod, Barber, & Franklin, 2013; Rinke, Shore, Morlock, Hicks, & Miller, 2007). Incident rates of MEs vary between 1.5% and 90% of hospitalized patients (Alsulami, Conroy, & Choonara, 2012; Karthikeyan & Lalitha, 2013; Kopp, Erstad, Allen, Theodorou, & Priestley, 2006; Kunac, Kennedy, Austin, & Reith, 2009). The discrepancy in

incident rates is attributed to methodological variations in reporting (per patient admission vs per patient days), in the route of administration (oral vs intravenous), in the kind of drug administered, in the population studied (adults vs children), and in the country where the study was conducted (Lewis et al., 2009; McLeod et al., 2013). An ME is defined as inappropriate use of a drug that may or may not result in patient harm (National Coordinating Council for Medication Error Reporting and Prevention, 2009; Nebeker, Barach, & Samore, 2004) while an ADE is defined as an injury resulting from the administration of a drug (Holdsworth et al., 2003). For the purposes of this, the term ME will be used to indicate any activity taken by a health care professional that may or may not have resulted in a clinical consequence 1

American University of Beirut, Beirut, Lebanon Azusa Pacific University, Azusa, CA, USA 3 Independent Researcher, Islamic University of Lebanon, Lebanon 2

Corresponding Author: Lina Kurdahi Badr, PhD, RN CPNP, FAAN, School of Nursing, Azusa Pacific University, 700 E. Foothill Avenue, Azusa, CA, 91701, USA. Email: [email protected]

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(Bürkle et al., 2013). Medication errors can occur at any stage from the ordering/prescribing, transcribing/verifying, dispensing/delivering, to administering (Antonow, Smith, & Silver, 2000). All the stages if recognized by a caregiver will be included in this study. Although any medication is susceptible to errors, chemotherapy is considered very dangerous because of its narrow therapeutic index, its toxicity even at therapeutic dosages, and its complexity (Müller, 2003). In comparison with MEs in the general population, MEs in oncology patients are much higher especially in the pediatric population (Lustig, 2000; Rinke et al., 2007; Taylor, Winter, Geyer, & Hawkins, 2006; Walsh et al., 2013). Children face additional challenges as studies from several countries report that MEs occur 2 or 3 times more frequently in the pediatric population compared with the adult population (Ghaleb, Barber, Franklin, & Wong, 2010; Ferranti, Horvath, Cozart, Whitehurst, & Eckstrand, 2008; Fernandez & Gillis-Ring, 2003; Otero, Leyton, Mariani, & Ceriani Cernadas, 2008; Walsh et al., 2009). A recent study in Lebanon of seven hospitals found that MEs occurred mostly in the pediatric population reaching up to 50% (Al-Hajje et al., 2012). The likelihood of injury or harm is also higher in children because of several reasons. One is the availability of different dosage forms of the same medication, such as various liquid concentrations and multiple medication formulations (Payne, Smith, Newkirk, & Hicks, 2007). Another reason is the lack of standardized dosing, which is often based on body weight and requires a dosage calculation (Gonzales, 2010). A study from New Zealand on 495 children admitted to a university hospital, found that 46% of MEs were classified as being serious; 15% were deemed to result in persistent disability or were classified as life threatening (Kunac et al., 2009). In terms of pediatric patients receiving chemotherapy, one study reported errors to occur in around 19% of all patients (Walsh et al., 2009). Therefore, pediatric oncology patients are at a double jeopardy; an increased risk because of their immature development and the toxicity of chemotherapy drugs.

Recommendations Related to Safety In efforts to limit MEs in the pediatric population, several recommendations have been adopted such as multidisciplinary safety checks, pediatric satellite pharmacies, support for incident and error reporting, root cause analysis, automated calculations, and education for caregivers and patients (France, Cartwright, Jones, Thompson, & Whitlock, 2004; Schwappach & Wernli, 2010a). A few studies have also noted that parental education can decrease MEs (Beckett, Tyson, Carroll, Gooding, & Kelsall, 2012; Li, Lacher, & Crain, 2000).

Studies have found that patients can identify adverse events affecting their care that are not captured by the hospital incident reporting system (Friedman, Provan, Moore, & Hanneman, 2008; Weingart et al., 2005). Very few studies have assessed the attitudes of patients in engaging in error prevention activities, especially when such participation is challenging or uncomfortable (Davis, Koutantji, & Vincent, 2008; Davis, Sevdalis, & Vincent, 2011; Waterman et al., 2006). A recent review concluded that patients’ perceptions of their status as subordinate to that of clinicians are the most important barriers to their involvement in error reduction (Klinkenberg et al., 2011). It is worth noting that in terms of oncology patients, only 2 studies by the same authors have assessed the role of patients in preventing MEs (Schwappach & Wernli, 2010b, 2010c). These studies found that patients acknowledge the benefit of error monitoring and reporting, however, they may not feel comfortable or confident in communicating their concerns. Patients were more likely to communicate their safety concerns if they feel that staff expects them to do so (Schwappach & Wernli, 2010b, 2010c). No study to date was found that focused on caregivers of pediatric oncology patients’ perception and their willingness to participate in error detection. Therefore, the main purpose of this study was to assess whether caregivers of children with cancer are willing to be involved in ME prevention and to describe their perceptions regarding medication safety. The assumption was that caregivers of pediatric oncology patients possess adequate awareness and knowledge of the medications their children receive to be able to intercept MEs. The research questions for this study were Research Question 1: What are caregivers’ perceptions regarding medication safety and their strategies to protect their child? Research Question 2: Are caregivers willing to be involved in error prevention strategies and what are their attitudes toward such strategies? Research Question 3: What are the characteristics of caregivers who are willing to be involved in error prevention?

Method A cross-sectional design with a survey was used. The study was conducted at the Children Cancer Center of Lebanon (CCCL) outpatient unit that is affiliated with St. Jude Children’s Research Hospital in Memphis, Tennessee, USA. It is located at the American University of Beirut Medical Center (AUBMC) in Lebanon. The scope of service covers hematology–oncology pediatric patients until 21 years of age. On average, 43 patients are treated daily.

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Participants

Data Analysis

A total of 110 caregivers were approached and informed about the nature of the study. Of the 110 approached, 100 agreed to participate (91% response rate). Caregivers were defined as those visiting the center from December 2011 to January 2012, who were the main care providers of pediatric oncology patients on chemotherapy and who were willing to participate in the study. Inclusion criteria for the caregivers were (1) a primary family member who was, (2) aware of the patient’s medication regimen, and (3) able to read and write Arabic. Patients were excluded if the patient did not need any assistance in taking his/her medication. A sample size of 100 was considered sufficient to detect a significant difference between groups on the dependent variable (willingness). For this study, the level of significance was set as α = .05, and the power was set as (1 − β) = .80 (Polit & Beck, 2008).

Quantitative data were analyzed using the Statistical Package for Social Sciences (SPSS) for Windows version 20. Cronbach’s alpha was used to test the reliability of the CPMEP. Since 96% of the participants indicated their willingness to participate in protecting their child from MEs, comparison between the variables of interest and the dependent variables could not be performed, thus descriptive results were performed with t tests examining caregivers’ characteristics that may affect their willingness to participate.

Data Collection Caregivers who showed interest in participating were briefed about the study, the value of their participation, as well as the measures taken to ensure their confidentiality. Caregivers were given time to ask questions and to clarify concerns. They were then given a packet containing 2 envelopes: one contained the consent form (approved by the IRB of the institution) and one contained the survey. To assure confidentiality, the surveys were returned to a box in the CCCL unit. A nurse researcher collected the envelopes, separated the consent forms from the surveys and numbered the surveys before giving them to the principal investigator (NH). The questionnaire, Caregiver Partnership in Medication Error Prevention (CPMEP) was based on previous instruments and studies related to adult chemotherapy patients and adopted for the pediatric population (eg, Schwappach & Wernli, 2010a). The questionnaire was answered either on a Likert-type scale of 1 to 5 or by a yes/no response. The questionnaire was translated to Arabic and back-translated according to the guidelines for instrument linguistic validation (Bowden & Fox-Rushby, 2003). The caregivers’ survey covered the following variables: (1) demographic characteristics of caregivers and the complexity and severity of the cancer, (2) perception of medication administration safety, (3) recognition for potential MEs, (4) strategies used to protect their child from potential errors, (5) recognition of safety measures taken by nurses, and (6) willingness and attitudes regarding involvement in error prevention. The questionnaire was pilot tested on 10 caregivers before it was administered. No revisions to the questionnaire were deemed necessary.

Results The response rate of caregivers was 91%, which is considered, high implying an interest among caregivers in the study subject. Females accounted for 76% of the sample. Their ages ranged between 36 and 45 years, with 38% having attended college. Acute lymphoblastic leukemia (ALL) patients accounted for the majority of the cancers (51%), with 32% being diagnosed in less than 1 year, and 66% of caregivers considered that their child’s treatment was of moderate severity (see Table 1). The Cronbach’s alpha for the 6 categories of the CPMEP scale ranged from .43 to .85. Cronbach’s alpha for the whole scale was .64. Research Question 1: What are caregivers’ perceptions regarding medication safety and their strategies to protect their child? Table 2 provides the percentage of caregivers who witnessed a ME. As seen from the table, 5 caregivers (5%) witnessed an actual ME, 21% witnessed a potential ME. Seventy-three percent indicated that they have strategies to prevent MEs. The majority of caregivers (67%) did not consider that a ME may occur and the majority (86%) indicated that if they were informed about the side effects of chemotherapy, they would watch for any adverse side effects. More than half the caregivers (58%) said they would worry if the nurse did not perform medication safety checks, with 22% indicating that they always worry about the possibility of a ME. Caregivers’ strategies to prevent a ME are found in Table 3. In all the strategies listed, most caregivers were cognizant of the treatment protocol, the safety checks the nurses should perform, and were willing to ask for further explanations. Sixteen caregivers (21.91%) relied on their prior experience to detect any potential error and 19 (26.03%) indicated their trust for nurses/doctors and would not follow any strategy to detect any ME. (Table 3). Research Question 2: Are caregivers willing to be involved in an error prevention strategy and what are their attitudes toward such strategies?

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Table 1.  Characteristics of Study Participants (n = 100). Characteristics Gender  Female  Male Age (years)  18-25  26-35  36-45  >46 Education  Primary  Secondary  College Types of cancer   Acute lymphoblastic leukemia   Other leukemias  Lymphoma  Retinoblastoma   Brain tumor  Sarcoma  Neuroblastoma Date of diagnosis   3 years ago Complexity of treatment   Moderate severity  Severe

Number/Percentage 76 24 7 34 46 13 37 28 38 51 3 10 4 19 11 2 32 25 16 27 66 34

The majority (96%) of caregivers reported their willingness to be involved in protecting their children from a ME and expressed their readiness to speak up (94%) if they felt that there was an error during a medication administration (Table 4). Seventy-three percent indicated that they would welcome being able to stop a doctor/ nurse from following the right protocol. Although the majority of caregivers said that if they were informed about certain strategies or safety checks it would help protect their children from an ME and create a partnership with the health professionals, 55% were weary of shifting the responsibility to them and 46% were afraid that such strategies may lead to conflict. Research Question 3: What are the characteristics of caregivers who are willing to be involved in error prevention? Since 96% of the caregivers were “willing” to participate in error prevention strategies, we were not able to compare the differences in caregiver characteristics and their “willingness” or “unwillingness” to participate in

error prevention. However, we looked at the caregivers’ characteristics and their willingness to participate in error prevention. Results revealed that females and caregivers between 26 and 45 years of age were more involved in protecting their child from a ME than caregivers in other age ranges (χ2 = 5.942, P < .01 and χ2 = 9.58, P < .05, respectively). Caregivers whose children had ALL were more willing to participate compared with caregivers of children with other cancers (χ2 = 17, P < .05). Caregivers’ educational level, the length of time the child had been diagnosed with cancer, and the complexity of treatment were not found to be significantly related to the willingness indicator.

Discussion To the best of our knowledge, this was the first study that assessed the perceptions and involvement of caregivers of pediatric oncology patients in preventing MEs. The surveyed population is characterized by mostly females with more than one third who attended college. About half the children were diagnosed with ALL, one third were diagnosed for less than 1 year, and the complexity of treatment was considered moderate. The Cronbach reliabilities for the 6 categories ranged between r = .43 and r = .85, which is adequate though some items were lower than the .70 accepted reliability rate. The reliability on the whole survey was .64, which is also shy of the .70 acceptable levels (Polit & Beck, 2008). However, this is an expected finding as the categories were not necessarily meant to measure the same concept. Five percent of caregivers reported witnessing an ME. Compared with what is reported in the literature in developed countries (Gandhi et al., 2005; Rinke et al., 2007), we noted a much lower rate. This could be explained by the fact that the majority of errors are not detected by caregivers, despite their willingness to be involved (96% willing) in error prevention. It also could be explained by the fact the CCCL being affiliated with St. Jude in Memphis provides extensive education to nurses in terms of chemotherapy and treatment modalities, which may have limited the number of MEs. The majority of caregivers (67%) did not consider the possibility that an ME might occur, yet most worried about the possibility of such an error. This mirrors a level of trust in the staff or lack of information related to the potential risks of chemotherapy. Prior studies with adult clients likewise indicate an underestimation of the risks and harms of medical errors (Blendon et al., 2002). An exploratory study with adult patients noted that patients appeared willing to ask general questions about their health care management, but less willing to undertake more challenging actions. Thus, patients may be willing to be involved in their care, but they may not be willing to confront nurses or doctors

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Hariss et al. Table 2.  Caregivers’ Perception of Medication Administration Safety (n = 100). Number/Percentage Question

Yes

No

1.  Have you witnessed an actual medication error (ME)? 2.  Have you witnessed a potential ME? 3.  Do you have a strategy to protect your child from a ME? 4.  Did you ever consider the possibility that a ME occurring? 5.  If you were given explanations about the side effects of a medication what would you do?   (a)  Refuse giving the medication to my child.   (b)  Give the medication and watch for side effects.   (c)  Give the medication without paying attention to the side effects. 6. Would you worry if a nurse did not perform medication safety checks? 7.  Extent of worry regarding the possibility of medication error   (a)  Never worry   (b)  Sometimes worry   (c)  Always worry

5 21 73 33

95 79 27 67

9 86 5 58

91 14 95 42

35 43 22

65 57 88

Table 3.  What Strategies do Caregivers Follow to Protect Their Child From a Medication Error (ME), n = 73).a

1.  I check the medicine’s name 2.  I check my child’s name on the medicine bag/syringe 3.  I check the treatment protocol 4.  I ask for further explanations from the doctors/nurses 5.  I make sure the nurse checks my child’s name on the bracelet 6.  I make sure the nurse checks the catheter IV site for patency 7.  I rely on my prior experience 8.  I do not do anything I trust the doctors/nurses

Number

Percentage

49 44 46 34 51 41 16 19

67.12 60.27 63.01 46.57 69.86 56,17 21.91 26.03

a. Percentages do not add up to 100% because caregivers gave more than one answer.

Table 4.  Caregivers’ Willingness and Attitudes Regarding Their Partnership With the Health Professionals to Protect Their Child From Medication Errors (MEs), n = 100. Percentage Willingness and Attitudes

Yes

No

1.  Would you be willing to be involved in protecting your child from ME? 96 2.  How would you feel if you had to stop your nurse/doctor form not following the right protocol?   (a) I would be offended; it is not my job. 12   (b) I would welcome it and feel encouraged to participate in my child’s care. 73   (c) I have no preference, regarding this issue. 15 3. During your child’s treatment did you feel that you can speak up if there was an 94 error during medication administration? 4. Would you be interested in learning more about preventing a ME? 94 5.  What is your attitude toward learning error prevention strategies to protect your child:   Strategies will help me protect my child against a ME. 87   Strategies will increase my partnership with the nurse/doctor. 83   Strategies will help me be more knowledgeable in protecting my child. 93   Strategies may shift the responsibility from the nurse/doctor to me. 55   Strategies may lead to conflict between me and the nurse/doctor. 46

4

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88 27 85 6 6 13 17 7 45 54

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with problems or errors (Davis et al., 2011). Although only 5% of caregivers witnessed an ME and 21% witnessed a potential ME, 73% developed strategies to protect their children. These findings lend further support to the necessity for accurate and detailed information to be given to caregivers. The majority of caregivers indicated that if properly informed they would agree to give medications despite their side effects and would be ready to monitor their child for the side effect. This suggests that “information” is a key element and that educated caregivers can have a prospective role in error prevention strategies. These findings are supported by studies with adult patients where an effective element in the participation of cancer patients in error prevention was information and communication (Fortescue et al., 2003; Unruh, & Pratt, 2007). Providing information, however, should be done with caution as some patients may become anxious when faced with complex facts (Stebbing, Wong, Kaushal, & Jaffe, 2007). Although the general consensus is that information provision is crucial to patients’ understanding of their treatment and their well-being (Sørlie, Busund, Sexton, Sexton, & Sørlie, 2007; Veronovici, Lasiuk, Rempel, & Norris, 2013), few studies report no such benefits (eg, Goodman et al., 2008). This could be because of the heterogeneity of patients who participated in such studies. Some patients are capable of understanding health-related information, while others may not be capable or willing to absorb the information provided causing them undue anxiety. In addition, cultural factors should not be ignored. Patients in industrialized and postindustrialized countries may be more open and willing to benefit from complex medical information while patients in developing countries may not want to take on the responsibility of their care. This is well-demonstrated in a study in Lebanon where preoperative education provided to a group of 57 patients before cardiac surgery, resulted in more anxiety than the group who did not receive education (Deyirmenjian, Karam, & Salameh, 2006). Thus, when information is provided, it should be customized to the needs of each patient. The results of this study indicate that caregivers were well-aware of safety checks to be conducted by nurses before administering medications and acted as watchful observers and when any deviations from the routine were noted. An earlier study found that worry about medical errors was a good predictor of intentions to take preventive actions (Peters, Slovic, Hibbard, & Tusler, 2006). Ninety-six of the caregivers were willing to be involved in protecting their child from an ME and most felt that they could stop a doctor/nurse if they did not follow safety practices. On the other hand, about half the caregivers indicated that they did not want to take responsibility for their child’s care as this may shift

responsibility from the doctor/nurse to them. An earlier study reveals that while the majority of adult patients agree that they could help in error prevention, they do not want to be engaged in controlling their own safety (Schwappach & Wernli, 2010a). Thus, education about treatments and medications should be provided in a professional manner with clear explanations that the responsibility is not being shifted from the provider to the client (Awé & Lin, 2003; Schwappach, Hochreutener, & Wernli, 2010). It was interesting to note that 94% of caregivers felt that could speak up if any error was suspected and were ready to learn more about how to protect or prevent potential errors. This is similar to published findings, which reveal that adult patients expect to be informed about safety issues and are willing to learn and engage in their safety (Schwappach, 2010). Clinicians can foster this process by effectively engaging patients or caregivers in the role of vigilant partners by teaching them about what is being done and why, and by providing simple yet detailed information. Clinicians should also be encouraged to reduce barriers by creating a relationship of trust where even reports of potential errors that turn out to be “false alarms” are appreciated (Gonzales, 2010). Caregivers’ educational level and the length of time the child had been diagnosed with cancer and complexity of treatment were not found to be significantly related to their willingness to protect their child from an ME, which is unlike most published studies, where patients who were unemployed or not educated were markedly less willing to question doctors and nurses about their treatment (Davis, Jacklin, Sevdalis & Vincent, 2007). This could be explained by the fact that the CCCL is affiliated with St. Jude, Memphis and provides extensive education to families whereby most of even the least educated are well informed of their children’s treatments, and by the fact that 30% of the participants had a college degree.

Limitations A few limitations to the research study exist. First, the patients were recruited from one hospital and were not randomly selected, which affects the generality of the results. Second, although the response rate was satisfactory, the vast majority of “caregivers” (96%) were willing to participate in the error prevention strategy, thus preventing bivariate analysis. Third, the potential for bias may also have affected the caregivers’ answers to the survey. Their responses may have been based on social desirability rather than actual intentions. Future research is needed to further support the findings of this study in other facilities and with larger samples.

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Conclusions This study revealed a prepared population of caregivers of pediatric oncology patients who are ready to participate in medication error prevention strategies. Caregivers described an impressive trust in the staff since the majority did not consider any potential harm occurring and they did not give much weight to the risk of an error. The only negative attitude was the fear of shifting responsibility from the staff to themselves. Providing caregivers with the necessary information is a key element in helping caregivers to be alert for any deviations in medication administration errors. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.

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Author Biographies Nariman Harris is a registered nurse at the Children’s Cancer Center in Beirut Lebanon. Lina Kurdahi Badr is a professor of nursing at Azusa Pacific University in Azusa California. Raya Saab is an assistant professor of Pediatrics at the American University of Beirut Medical Center. Aziza Khalidi is an independent researcher at the Islamic University in Lebanon.

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Caregivers' perception of drug administration safety for pediatric oncology patients.

Medication errors (MEs) are reported to be between 1.5% and 90% depending on many factors, such as type of the institution where data were collected a...
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