Facilitating ethical, legal, and professional deliberations to resolve dilemmas in daily healthcare practice: A case of driver with breakthrough seizures

Epilepsy & Behavior 102 (2020) 106703

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Epilepsy & Behavior journal homepage: www.elsevier.com/locate/yebeh

Facilitating ethical, legal, and professional deliberations to resolve dilemmas in daily healthcare practice: A case of driver with breakthrough seizures Ramzi Shawahna ⁎ Department of Physiology, Pharmacology and Toxicology, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine An-Najah BioSciences Unit, Centre for Poisons Control, Chemical and Biological Analyses, An-Najah National University, Nablus, Palestine

a r t i c l e

i n f o

Article history: Received 25 October 2019 Revised 10 November 2019 Accepted 11 November 2019 Available online xxxx Keywords: Epilepsy Breakthrough seizures Counseling Ethics Driving Pharmacists

a b s t r a c t Objective: The present study was conducted among pharmacy students to use an 8-step systematic approach to facilitate discussions, deliberations, and decision-making on what to do when facing a dilemma of a patient with epilepsy who drives while having breakthrough seizures. Methods: A hypothetical case was developed using the 12-tips for developing dilemma case-based assessments in health education. A mixed method was used in this study. A serial group discussions based on the nominal group technique (NGT) method were applied. A thorough review of the literature and interviews with key experts in the domain (n = 12) were conducted to obtain pertinent data to inform discussions, deliberations, and decision-making. The analytic hierarchy process (AHP) was used to pairwise compare countervailing arguments and alternative courses of action. Results: In this study, 3 nominal groups were held, and for each 3, discussion rounds were conducted. A total of 27 panelists took part in the nominal groups. Compared with other alternative courses of action, significantly higher weight scores (p-value b 0.001) were given to the course action, “the pharmacist could counsel/educate the patient on the dangers/risks of driving while experiencing breakthrough seizures, inform the patient to refrain from driving in this period, and make a shared decision with the patient to refrain from driving in this period and inform the state authorities”. Conclusion: This study demonstrates that the 8-step approach when combined with the AHP can be a handy method in facilitating decision-making while addressing and resolving ethical/legal/professional dilemmas in daily healthcare practice. © 2019 Elsevier Inc. All rights reserved.

1. Introduction Epilepsy is one of the most prevalent neurological disorders of the central nervous system that is characterized by unprovoked and recurrent epileptic seizures. Epilepsy is commonly diagnosed in early childhood or adolescence, and the risk of developing epilepsy increases drastically in older age. Ip et al. reported that the average annual prevalence rate of epilepsy was 15.2 per 1000 and the average annual incidence rate was 6.1 per 1000 in Medicare beneficiaries [1]. According to the latest estimates, more than 65 million people live with epilepsy (PWE) around the globe [1–3]. The World Health Organization (WHO) estimated that 10% of PWE live in the Eastern Mediterranean region

⁎ Department of Physiology, Pharmacology and Toxicology, Faculty of Medicine & Health Sciences, An-Najah National University, New Campus, Building: 19, Office: 1340, P.O. Box 7, Nablus, Palestine. E-mail address: [email protected].

https://doi.org/10.1016/j.yebeh.2019.106703 1525-5050/© 2019 Elsevier Inc. All rights reserved.

[4]. The incidence rate of epilepsy in Palestine was estimated at 10.4 to 11.3 per 100,000 [5]. Epilepsy inflicts people from both genders, different cultural backgrounds, socioeconomic classes, and educational levels [1,6,7]. However, studies have reported that epilepsy is more commonly prevalent in countries with low and middle income compared with countries with higher income [8–10]. Studies have shown that the majority (70–80%) of PWE with new-onset seizures would experience remission and would become seizure-free if they adhere to optimal therapy using appropriately selected antiepileptic drugs (AEDs) [11–13]. However, a considerable number of PWE would experience recurrent seizures or breakthrough seizures as a result of improperly selected AEDs, lack of adherence to taking the appropriately selected AEDs, drug–drug interactions, disease progression, and/or resistance to therapy [13,14]. Epilepsy is more than a neurological disorder, and caring for PWE can be a great challenge to PWE themselves, their families, healthcare providers, state authorities, and the society at large [6,7,13,15,16]. In addition to healthcare challenges, PWE often face serious social and

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cultural challenges. These challenges are not limited to gender-related issues like child bearing, teratogenicity, contraception, sexuality, and bone health [15,16], but many extend to all other aspects of their lives like education, employment, social life, and their productive participation in the societies they live in [17,18]. Misconceptions with regard to epilepsy and seizures have prevailed for a quite long time. Epileptic seizures were attributed to demonic and supernatural forces [19]. Even today, misconceptions and stigmas with regard to epilepsy and PWE are still prevalent in many societies and cultures [19–22]. Probably, these persistent misconceptions and stigmas have contributed to limiting opportunities for PWE to productive participation in the society. As a result, PWE have consistently expressed concerns with regard to the social consequences of seizures with particular emphasis on driving, independence, employment, and social embarrassment [21,22]. Having seizure while driving has long been considered as a substantial risk to public and traffic safety as early as the first driving licenses were issued by state authorities in early 1900s [23]. As a result, historically, a blanket ban from driving was applied to all PWE in all nations [24]. Urbanization and introduction of effective AEDs that resulted in a considerable proportion of PWE whose seizures were under control have encouraged state authorities to liberalize some driving restrictions for PWE [25,26]. Today, PWE can drive in many countries around the world including Palestine. In the US, PWE are able to drive in all 50 states [27,28]. State authorities assess PWE for fitness to drive based on seizure type, seizure provoking factors, comorbidities, compliance with treatment, auras, pattern (timing, and frequency) of seizures, and driving record of the applicant [29]. Requirements of the seizure-free interval (SFI) vary greatly from a country to another and within states in the same country. In the US, the median SFI is 6 months, and the majority of the states require an SFI of 3 months [17]. In most countries and states, it is the responsibility of the patient to report seizures to state authorities. In the US, 44 states require patients to self-report seizures to the appropriate licensing authorities whose responsibility is to determine eligibilities for driving privileges [18]. Some countries and states mandate physicians to report the names of PWE to the appropriate licensing authorities [18,27,28,30–32]. In other countries, voluntary notification systems are available to physicians upon discretion to report disobedient PWE who continue to drive unlawfully or against advice [33]. People with epilepsy often receive healthcare from epileptologists/ neurologists in tertiary healthcare facilities or in clinics in the private sector. As the number of PWE is expected to increase, sustainable epileptologist-/neurologist-based model of care would not be possible [3]. Moreover, many PWE do not have a condition that warrants receiving a highly skilled care from epileptologists/neurologists [2,28]. Therefore, many PWE are cared for in primary healthcare settings [34–36]. In recent years, the pharmacy profession has witnessed a dramatic shift from product-oriented to patient-oriented. Consequently, many pharmacists were integrated into the primary healthcare sector as interhealthcare professional models are increasingly promoted. In contemporary healthcare practice, pharmacists are fulfilling a wide range of continuously expanding duties [37]. As a result, pharmacists are increasingly interacting with patients including PWE. During encounters with patients, pharmacists, as healthcare providers, are mandated to counsel/educate patients on their disease, the optimal way to make the most out of their AEDs, adherence to taking AEDs, evaluate doses of AEDs, explain adverse effects, screen for, and alert physicians of possible drug–drug, drug-nutrient, and drug-disease interactions [7,16,29,38]. With the passage of time, it is expected that emerging and new roles/responsibilities of pharmacists will unfold as professional organizations in Canada, the US, and the UK have supported and advocated the roles that pharmacists can assume in primary healthcare practice [39]. Pharmacists are responsible to provide pharmaceutical care to patients receiving healthcare in primary healthcare practice [37]. Recent studies have portrayed primary healthcare roles of pharmacists in epilepsy clinics [18,40]. Services provided by pharmacists included

assessing mental status, monitoring levels of AEDs, ordering and reviewing laboratory tests, screening for and explaining adverse effects of AEDs, preparing and maintaining patient records, presenting data to follow neurologists, interviewing of patients, and counseling/educating patient on AEDs and disease [41–44]. In general, trust and rapport have been maintained in the relationship between pharmacists and PWE [45,46]. As pharmacists are expected to play a greater role in caring for PWE, they are increasingly expected to face ethical/legal/professional challenges; therefore, there have been calls to reformulate the professional values of pharmacy to meet the new emerging roles that pharmacists are expected to play [47]. Leaders of the medicine and nursing professions have recognized the need to raise awareness and install commitment to professional values [48,49]. As a result, these values were taught to medical and nursing students to ensure the creation of a shared culture of future practice. In pharmacy profession, values of practice appear implicit. Pharmacy graduates often take public oaths inspired by the Hippocratic Oath of the medicine graduates [50]. In the Netherlands, the Royal Dutch Pharmacists Association adopted a consensus-based professional core values for pharmacists working in different areas of practice like community pharmacy, hospital, industry, research, development, and government [51]. The values included the following: 1) commitment to the well-being of the patient, 2) providing reliable care, 3) pharmaceutical expertise, 4) being socially responsible, and 5) maintaining professional autonomy. Kruijtbosch et al. qualitatively analyzed 128 moral dilemmas collected from Doctor of Pharmacy (Pharm.D) students and entrant pharmacists who experienced such dilemmas in daily practice [47]. These 128 dilemmas were categorized under commitment to the patient's well-being, reliable and caring, pharmaceutical expertise, and responsibility to society. Studies elsewhere have reported that pharmacists face ethical/legal/professional dilemmas in their daily practice [52–54]. Although the majority of pharmacists reported familiarity with the professional codes, the majority did not think that these codes helped them face and resolve dilemmas in their daily practice [52]. Many pharmacists reported that they were not adequately educated/trained to address and resolve ethical/legal/ professional dilemmas. Resolving dilemmas require weighing merits against demerits of potential alternative courses of action. Although the ethical, legal, and professional aspects of daily practice are either explicit or implicit, guidelines are not always available to promote or facilitate ethical, legal, and professional discussions, deliberations, and weighing merits against demerits in daily practice [55]. Little was narrated on how to conduct ethical, legal, and professional deliberations and weigh merits against demerits for resolving dilemmas encountered in daily practice. In the Netherland, the Dutch Centre for Bioethics and Health Law has proposed a method that was proven useful in ethical and professional deliberations, especially when no prima facie decisions can be made [56–58]. Combining qualitative and quantitative approaches might help mitigate the complexity of weighing merits against demerits and might permit ranking/ prioritizing certain merits and demerits to facilitate decisions [59]. Different multicriteria decision analysis (MCDA) methods that can be used to facilitate decisions were reported in the literature [60]. Among those, the analytic hierarchy process (AHP) has emerged as one of the most commonly used methods. As the AHP allows explicitly integrating and weighing merits against demerits of a decision, this method also enables transparent decision-making process in which the decision-makers understand the grounds on which their decisions were based [61]. Decision-makers can later easily explain and justify their decisions. In this study, the AHP was combined to and used in an 8-step systematic approach to facilitate on deciding what to do when facing and resolving a dilemma of a PWE who drives while having breakthrough seizures.

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2. Methods 2.1. Context of the study Ethics and Professionalism in Pharmacy is a 1 credit hour course (16 meeting hours) offered to pharmacy students during their study/ training program at An-Najah National University, Nablus. Ethics and professionalism were combined in one course because the two subjects were interconnected. In this course, students are taught the different principles of pharmacy and biomedical ethics. The intended learning outcomes of the two interconnected subjects were designed in accordance with the cognitive domain of the Taxonomy of Educational Objectives [62], which has been amended in [63]. Engaging students is required on the different levels of Bloom's taxonomy. In this course, teaching and learning strategies are delivered accordingly [64]. The course is taught through face-to-face lectures during which materials are presented to the students. Students are often provided materials to read in advance and are required to engage in discussions. Oftentimes, case studies are presented in the class, and students are encouraged to engage in ethical/legal/professional discussions and deliberations. The following aims of these discussions and deliberations were multifold: to ensure students' engagement, target higher cognitive functions with reference to Bloom's taxonomy, and train future pharmacists to face and resolve ethical/legal/professional dilemmas and challenges in their daily practice because in real practice settings, pharmacists often face ethical/legal/professional dilemmas [47,52–54]. Ethical/legal/professional discussions, deliberations, and decisionmaking can be a real challenge in daily practice. Systematic approaches to facilitate ethical/legal/professional discussions, deliberations, and decision-making can be very useful while dealing with real situations in daily practice [65,66].

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of a driver with epilepsy who experienced multiple breakthrough seizures was developed and presented to the participants during the nominal group meetings to facilitate discussions, deliberations, and decision-making on justifiable course(s) of action that a pharmacist can take. An 8-step systematic approach involved weighing countervailing arguments in favor of and against each potential course of action in which the AHP was used (Fig. 1). 2.3. Participants in the nominal groups Pharmacy students who undertook Ethics and Professionalism in Pharmacy were invited to participate in this study. A purposive sampling technique was used to compose 3 nominal groups, each of 9 participants. 2.4. Development of the case study The case used in this study was developed using the 12-tips for developing a case-based dilemma for assessments in medical education and training [70]. The tips were as follows: 1) selecting an issue that is appropriate for practice/ethics, 2) emphasis on a true dilemma in the case, 3) high-level cognitive tasks should be targeted while addressing the dilemma, 4) a list of key components should be developed, 5) a central theme should be provided, 6) a scoring system that is understandable to the participants should be devised, 7) all modifier factors in the case should be important and plausible, 8) the case should be clear, 9) the participants should be qualified as stakeholders (concerned parties), 10) validation and piloting steps should be conducted, 11) limitations should be considered, and finally, 12) the one who develops the case should be sufficiently knowledgeable of the concept being tested. 2.5. The case developed and used in the study

2.1.1. Preface In Palestine, individuals with disabilities, including PWE, are allowed to drive under certain conditions. When an individual applies for a private driving license, the applicant is seen by an ophthalmologist or optometrist for visual acuity. Applicants are not asked to declare any medical conditions in the application form. In case the applicant had a clearly visible disability or wished to declare one, he/she is examined for fitness to drive by a medical advisory committee. The medical advisory committee might seek advice from neurologists or epileptologists in case the applicant had epilepsy. Decisions are often discretionary and could be informed by favorable and unfavorable modifiers like those disseminated by the American Academy of Neurology [67]. 2.2. Study design The study was conceived and designed by RS who held an associate professor position at the time of the study and had experience in conducting research on the role of pharmacists in caring for PWE [6,7,13,16]. A mixed method was used in this study. Group discussions and deliberations based on the nominal group technique (NGT) method were applied in serial meetings that were held for this study. The NGT was used as a tool to achieve consensus on an ethically/legally/ professionally justifiable course of action among the study participants. The NGT was used in this study because it resembles how discussions, deliberations, and decisions in medical advisory committees and ethical/legal/professional advisory boards are made [68]. To ensure rigor of the methodology adopted for this study, the checklist created by Humphrey-Murto et al. was adhered to [69]. The AHP was used to weigh arguments in favor of or against potential alternative courses of action. During the meetings, RS played the role of discussion facilitator. RS did not participate in the weighing process, and his opinions did not influence those of the participants. For this study, a hypothetical case that mirrored an ethical/legal/ professional dilemma that a pharmacist might face in real life practice

Mr. B, 32 years old and married with no kids, presents with a prescription for valproic acid to refill and receive counseling/education. Mr. B was diagnosed with juvenile myoclonic epilepsy when he was 14 years old. He has been seizure-free until he started his new job as a sales manager in one of the major companies in the country. In many occasions, he is required to work for late night and make travels to different regions across the country. While discussing with him, he informed you that lately, he was concerned with the dropping volumes of sales and he had to make more efforts to achieve his target sales. As a result, he did work more than he usually does and made more travels. Consequently, he missed doses of his antiepileptic medication and experienced 3 breakthrough generalized tonic–clonic seizures in the last month. You realized that he commuted to your practice using his car. When you brought the issue of driving, he informed you that he commutes to his office and oversees the sales activities using his car. He told you that he does not want to stop driving in this period and expressed concerns over the inconveniences of relying on taxis, car sharing, or having somebody driving him. 2.6. The 8-step systematic approach The 8-step systematic approach was originally devised as a useful reflective tool to facilitate deliberations and promote making justifiable decisions when professionals face and resolve ethical/legal/professional dilemmas in daily practice [58,66]. Ethical/legal/professional discussions and deliberations are often initiated with questions that guide actions like, “what should I do?”, that might inform a solid advice. Ethical/ legal/professional decisions can be easily justified when they are made through a systematic and transparent approach. The systematic approach used in this study considered the pertinent normative views and opinions that pharmacists, patients, and other third-party stakeholders could have held while deliberating on an ethical/legal/professional dilemma in daily practice. The use of this 8-step systematic approach

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Development of the hypothetical case

The 12-tips for developing a case-based dilemma for assessments in medical education and training was used.

Discussions and deliberations

The Analytical Hierarchy Process

• Identification of the ethical/legal/profession al issue/question in the case. • Identification of potential courses of action. • Collection of pertinent data/information. • Perspectives of stakeholders. • Arguments in favor of and against each course of action.

The Analytical Hierarchy Process was used to pairwise compare countervailing arguments and alternative courses of action.

Preferred course of action

The preferred course of action was determined by higher weight scores (%).

How to implement the preferred course of action Further discussions and deliberations were conducted to provide suggestions how the preferred course of action can be implemented.

Fig. 1. Flowchart of the different stages of the study.

might appeal to pharmacists, physicians, and/or other healthcare providers as the approach has a limited number of questions to pose while deliberating on an ethical/legal/professional dilemma. This approach makes use of the following questions: 1) what was the ethical/legal/professional issue/ question in the case?, 2) what were the potential courses of action in this case?, 3) what pertinent data/information that needed to be gathered and considered in this case?, 4) who were the stakeholders in this case and what were their perspectives?, 5) what were the arguments for and/or against each potential alternative course of action?, 6) how strong were the arguments in this case?, 7) based on the arguments considered, which alternative course(s) of action were preferred?, and finally, 8) how the preferred course (s) of action can be implemented?. The 8-step approach was taught by RS to the students who took the course Ethics and Professionalism in Pharmacy. In this approach, questions (1–5) are related to ethical/legal/professional discussions and deliberations; question (6) is related to the weighing process; question (7) is related to the decision-making; and question (8) is related to how the preferred decision(s) can be implemented. The hypothetical case was presented to students by RS in the first meeting, and the NGT was explained to the study participants. The participants were given the opportunity to ask questions on the case, the 8-step approach, and/or the AHP. The aim of this step was to explain the methodology to be followed in the study and was not intended to influence the opinions of the participants in the subsequent steps. After this introduction session, the participants were asked the opening question. 2.6.1. What was the ethical/legal/professional issue/question in the case? Although it was obvious that the case presented can lead to multiple ethical/legal/professional avenues, the opening question was “what the pharmacist should do?”, in other words, “should the pharmacist counsel the patient on driving issues, encourage the patient to report his seizures to the state authorities, report the patient to state authorities, or not?”. The opening question was purposefully posed in neutral tone and concrete manner. The question did not contain any ethical/legal/ professional arguments. At this stage, the participants were not given any guidance on how broad/narrow their discussions/focus should be. 2.6.2. What were the potential courses of action in this case? Participants in the nominal groups were asked to identify and mention all potential courses of action that could be made in this case without highlighting any preferences or making any final decisions. All potential alternative courses of action identified by the participants

were recorded and noted. Responses of the participants were analyzed for their contents. Themes were identified from the content of the responses and finally were grouped. It was obvious that making an immediate decision on ethically/ legally/professionally justifiable course of action was not possible as more data/information and priorities needed to be considered before any final decision can be made. 2.6.3. What pertinent data/information that needed to be gathered and considered in this case? In daily practice, ethical/legal/professional decisions should be informed and substantiated by pertinent data/information. Consequently, all pertinent data/information about driving and epilepsy should be collected and thoroughly understood before making any decision on ethically/legally/professionally justifiable course(s) of action. 2.6.3.1. Collection of pertinent information. To address and resolve the dilemma presented, answers to the following questions were needed: Are PWE allowed to drive? If yes, under what conditions?; Who is supposed to report seizures to the state authorities?; Are PWE aware of their driving restrictions?; How do PWE feel about these restrictions?; Are PWE obedient to these restrictions?; Why some PWE who are restricted from driving disobey the rules and drive?; Why do those PWE need to drive?; What are the consequences of disobedience to driving restrictions?; Do PWE experience seizures while driving?; Are PWE more prone to traffic accidents than other drivers?; What are the responsibilities of healthcare providers with regard to compliance of PWE with driving laws?; Are healthcare providers aware of driving restrictions for PWE?; How do healthcare providers feel about these restrictions?; Are healthcare providers mandated to report noncompliant drivers to state authorities?; Do healthcare providers report PWE to state authorities?; Alternatively, should healthcare providers counsel PWE on driving?; Does counseling patients on driving issues ensure disclosure to state authorities?; and finally, In case a PWE made a traffic accident, could healthcare providers become liable to legal/disciplinary actions? 2.6.3.1.1. Searching the literature. For this study, a thorough search of the literature was conducted to identify and collect data/information to answer the above listed questions (Fig. 1). Even though a systematic review of the literature was not conducted in this study, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was adhered to whenever possible [71] as shown in the Supplementary materials (Supplementary Table S1). The literature search was conducted in the following databases: Excerpta Medica

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dataBASE (EMBASE) through PubMed, Cumulative Index to Nursing and Allied Health Literature (CInAHL) through Elton B. Stephens Company (EBSCO), and Scopus. Gray literature was searched through the search engine Google Scholar. Key and Medical Subject Headings (MeSH) terms like “epilepsy”, “seizure”, “seizure disorder”, “loss of consciousness”, “unconsciousness”, “unconscious”, “driving”, “automobile driving”, “automobile driver examination”, “driver”, “restriction”, “distracted driving”, “traffic accidents”, “motor vehicle accident”, “driving accident”, “road accidents”, “car accident”, “car crash”, “driving safety”, “driving risk”, “counseling”, “advice”, “recommendation”, “patient education”, “health personnel”, “neurologist”, “epileptologist”, “physician”, “doctor”, “report”, “reporting”, “whistleblowing”, “alert”, and “duty to warn” were used. The search strategy combined terms using the Boolean operators “AND” and “OR”. To supplement the results obtained from the databases and the search engine, bibliographic references of the retrieved articles were manually searched. The literature was searched as late as October 10, 2019. To decide if articles retrieved from the search warranted a full-text review, their titles and abstracts were manually screened before. Results included original articles, review articles, reports, and opinions with relevant data/information on the questions listed above. Articles with whose titles were closely related to the questions above were given a priority for a full-text review. The search was limited to English language and human studies. Articles in languages other than English were excluded. The search was not restricted for any study design, year of publication, and status of publication. Duplicate results were removed before screening the titles and abstracts for eligibility for a full-text review. To ensure that results were reproducible, the process was repeated trice. Another researcher reviewed the included/excluded results. Conflicts/discrepancies were resolved by further discussion and consensus. 2.6.3.1.1.1. Collection of data/information. An Excel spreadsheet (Microsoft Inc.) was used as a data/information collection form. Data/ information collected from the retrieved documents were entered into the collection form. Another researcher reviewed the data/information collected and entered into the collection form independently. Conflicts/discrepancies were resolved by further discussion and consensus. Duplicate data/information were removed. 2.6.3.1.2. Interviews with key contacts. Because most of the data/ information were collected from articles/documents produced elsewhere, interviews were conducted with key contact experts in the domain to ensure that all questions were answered in the context of the Palestinian practice. The consolidated criteria for reporting qualitative research (COREQ) were adhered to whenever possible [72] as shown in the Supplementary materials (Supplementary Table S2). The key contact experts who were interviewed in this study were identified through personal contacts in the domain. The key contacts were approached, invited, and recruited to the study using a judgmental sampling technique. Phone calls were made to potential participants to take their initial verbal consent before formally inviting them to take part in the study. Objectives of the study were explained to potential participants. In this study, 15 key contacts were invited for interviews. The key contacts were physicians who were senior members of medical advisory committees who examined drivers for fitness to drive, neurologists who often treat PWE, internists who often see PWE, pharmacists who interacted with more than 5 PWE per month, and PWE who had a valid driving license. The sample size used in this study was informed by previous studies conducted to complement data/information extracted from the literature [6,7,66,73–77]. Before conducting the interviews, all key contacts were informed that the interviews were conducted as a part of a research study in order to put the information obtained from the literature into the Palestinian context. At the beginning of the interviews, the interviewer declared no conflicts of interests or desire to influence the opinions or views of the study participants. The interviewer was male [Doctor

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of Philosophy (PhD)] and possessed prior knowledge and experience in conducting interviews and other qualitative studies. At the time of the interviews, the interviewer worked as an academician at a major teaching university in Palestine. The interviewees had extensive knowledge of epilepsy and driving rules and regulations. Interviews were conducted in one-on-one sessions in a private and calm place. The interviewees provided their sociodemographic and experience details. The interviewees were asked the questions listed in the Collection of pertinent information section. Answers were recorded, noted, and interpreted. Transcripts were returned to the interviewees for review and approval. The interviewees were given the opportunity to correct/ clarify interpretations of their answers. They had the opportunity to add more details in case they wished to do so. Interviews were conducted once and were not repeated. Transcripts were analyzed for their contents. Analysis was performed and repeated until all data/ information were grouped. Grouping was derived from the data/ information provided by the interviewees and guided by the questions posed during the interviews. Data/information collected from the literature and interviews were formulated into brief statements. These statements were then used as informational input to the nominal groups. 2.6.4. Who were the stakeholders in this case and what were their perspectives? Participants of the nominal groups were asked to identify the stakeholders in this case and use group discussions to deliberate on the perspectives of the different stakeholders who were involved in this case. 2.6.5. What were the arguments for and/or against each potential alternative course of action? Participants of the nominal groups were asked to make group discussions and deliberate on arguments that could be considered in favor of or against each identified alterative course of action. The participants were encouraged to use the different principles of pharmacy and biomedical ethics and code of ethics for pharmacists to make the arguments in favor of or against each identified alterative course of action using the informational input from the literature review and the interviews. 2.6.6. How strong were the arguments in this case? To determine how strong were the arguments in favor of or against each identified alterative course of action, the AHP was used as a multiple criterion decision-support instrument. In this method, pairwise comparisons are used to calculate weight scores (%) for alternative courses of action and to facilitate making ethically/legally/professionally justifiable decision(s). In the present study, the objective was to calculate relative weight scores (%) of arguments in favor of and against each alternative course of action to finally arrive at an ethically/ legally/professionally justifiable course of action. Participants were given summaries of arguments in favor of and against each alternative course of action. The participants were requested to make pairwise comparisons using a Likert-scale of 1–9 on each pairwise comparison. When a higher numerical value was given to an argument/course of action, this meant a higher relative weight of that argument/course of action in comparison with the other argument/course of action. The study participants were encouraged to take into consideration relevance to the different principles of pharmacy and biomedical ethics and code of ethics for pharmacists while making the pairwise comparisons. Scores of the participants were used into the matrices to calculate the relative weight scores (%) [78]. The mathematical formulas/ equations that were originally developed by Saaty were used to calculate the relative weight scores (%) and the consistency ratios [79].

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2.7. Statistical analysis of the relative weight scores (%) Scores were excluded from the final analysis when their consistency ratios were N0.1. Scores were entered into GraphPad Prism 6.0 for Windows (GraphPad Software). To determine if relative weight scores (%) were statistically different, one-way analysis of variance (ANOVA) with Tukey's multiple comparisons tests was employed to compare the relative weight scores (%). When the p-value was b 0.05, results were considered statistically different. 2.8. Ethical approval This study received ethical approval from the Institutional Review Board (IRB) of An-Najah National University. The study participants provided verbal consents before participation. Scores of all the participants weighed equally. 3. Results 3.1. Participants in the nominal groups In this study, 3 nominal groups were held, and for each 3, subsequent discussion rounds were conducted. A total of 27 participants took part in the nominal groups. Of those, 18 (66.7%) were female; 19 (70.4%) were Bachelor of Science (BSc) pharmacy students; and the rest were Pharm.D students. The mean age of the study participants was 20.0 ± 1.2 years. 3.2. The potential courses of action identified by the study participants The potential alternative courses of action identified by the study participants were grouped as follows: 1) the pharmacist could have ignored the issue of driving, in this case, the pharmacist would not counsel/educate the patient on the dangers/risks of driving while experiencing breakthrough seizures, nor inform the patient to notify the state authorities by himself, and the pharmacist would not opt to voluntarily report the patient to the state authorities; 2) the pharmacist could counsel/educate the patient on the dangers/risks of driving while experiencing breakthrough seizures and leave the decision to inform the state authorities to the patient himself; 3) the pharmacist could counsel/educate the patient on the dangers/risks of driving while experiencing breakthrough seizures, inform the patient to refrain from driving in this period, and make a shared decision with the patient to inform the state authorities; and 4) the pharmacist could counsel/educate the patient on the dangers/risks of driving while experiencing breakthrough seizures, informs the patient to alert the state authorities, and voluntarily files a separate report to the state authorities. 3.3. Data/information pertinent to this case 3.3.1. Literature search results Search of the literature resulted in a total of 1524 documents identified. After removing duplicates and ineligible documents based on screening titles/abstracts, data/information were extracted from 33 documents [2,3,15,17,18,22–40,80–88]. 3.3.2. Interviewees In this study, 15 key contact experts were contacted and invited for interviews. Of those, 12 (80.0%) were finally interviewed, and 3 (20.0%) were not immediately available for interviews because of time constrains and personal reasons. The 12 interviewees were 3 physicians who were senior members of medical advisory committees who examined drivers for fitness to drive, 2 neurologists who often treat PWE, 2 internists who often see PWE, 3 pharmacists who interacted with more than 5 PWE per month, and 2 PWE who had valid driving license. The interviewees were from all subgroups who were purposively invited to take part in the study. Details of their sociodemographic and

Table 1 Sociodemographic and practice details of the interviewees (n = 12). Variable Gender Male Female Age (years) b40 ≥40 Academic qualifications BSc PhD MD Pharm.D Specialty/profession Physician Neurologist Internist Pharmacist PWE who drive Employer Government Clinic/private practice Othera

n

%

8 4

66.7 33.3

5 7

41.7 58.3

3 1 7 1

25.0 8.3 58.3 8.3

3 2 2 3 2

25.0 16.7 16.7 25.0 16.7

3 7 2

25.0 58.3 16.7

BSc: Bachelor of Science, MD: Doctor of Medicine, Pharm.D: Doctor of Pharmacy, PhD: Doctor of Philosophy. a For the 2 drivers with epilepsy.

practice details are shown in Table 1. Interviews lasted for a mean of 38 ± 13 min. 3.3.3. Data/information gathered and used as input to the nominal groups The data/information pertinent to the following: if PWE were allowed to drive and under what conditions, who was supposed to report seizures to the state authorities; if PWE were aware of their driving restrictions, feelings of PWE about these restrictions; if PWE were obedient to these restrictions, reasons why some PWE who were restricted from driving disobey the rules and drive, reasons why PWE need to drive, consequences of disobedience to driving restrictions; if PWE experienced seizures while driving; if PWE were more prone to traffic accidents than other drivers, responsibilities of healthcare providers with regard to compliance of PWE with driving laws, awareness of healthcare providers of driving restrictions for PWE, feelings of healthcare providers about these restrictions; if healthcare providers were mandated to report noncompliant drivers to state authorities; if healthcare providers actually reported PWE to state authorities; if healthcare providers had to counsel PWE on driving restrictions; if counseling patients on driving issues ensured disclosure to state authorities; and finally, if healthcare providers could become liable to legal/disciplinary actions in case a PWE made a traffic accident, were collected and presented as informational input to the nominal groups. 3.3.4. Stakeholders and their perspectives on the case The study participants identified the stakeholders in this case as the driver himself (Mr. B), the pharmacist as a healthcare provider with knowledge of the case, state authorities as a regulatory body, and the society at large. Perspectives of the stakeholders were identified by the participants in the nominal groups as follows: 3.3.4.1. Perspectives of the driver. “Mr. B needs to maintain his job, commutes to wherever he needs to travel, and performs all the activities demanded by his job” … 19 years-old male pharmacy student. “Restrictions from driving might negatively impact his independence, autonomy, employment, economic status, quality of life, socialization, and self-esteem” … 20 years-old female Pharm.D student. “On the other hand, restricting his driving might spare his severe health, legal, moral, social, and economic consequences” … 21 yearsold female pharmacy student.

R. Shawahna / Epilepsy & Behavior 102 (2020) 106703

7

Table 2 Arguments in favor of and against counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities. Principle Perceived responsibility/duty

Health maximization

#

Arguments in favor of counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities

1 In modern healthcare delivery, the duty of the pharmacist goes beyond merely dispensing medications. As advocates for patients, pharmacists are supposed to act in the best interests of their patients. Therefore, counseling/educating PWE on the risks/dangers of driving while having breakthrough seizures can be equally important to counseling/educating PWE on their disease/AEDs. Driving while having breakthrough seizures has the potential to kill/harm the patient himself, other passengers, users of the road, and/or can cause damage to property. Although pharmacists are not legally mandated to report disobedient drivers to state authorities, pharmacists are a group of healthcare providers who should exhibit exemplary behavior and safeguard the interests of the patients and the society at large. This might be fostered by counseling/educating PWE on the risks/dangers of driving while having seizures or in some cases reporting disobedient drivers to state authorities. 2 Some studies have shown that PWE are at higher risk of making traffic accidents compared with drivers without epilepsy. More importantly, PWE whose seizures are not under control are strictly prohibited from driving in all states. Authorities in states with mandatory reporting are better informed of seizures in PWE who drive than authorities in states without mandatory reporting and thus are in a better position to design interventions to reduce traffic accidents caused by PWE.

Respecting autonomy

3

Justice

4

Trust/relationship

5

Efficiency

6

Proportionality

7

Respecting privacy/confidentiality

8

Legal liability

9

Nonmaleficence

10

Avoidance of killing

11

Beneficence

12

Arguments against counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities Counseling/educating patients on how to make the best out of their medications is the primary responsibility/duty of the pharmacist. Pharmacists are not law enforcement officers, and legally, they are not mandated to report disobedient drivers to state authorities. Counseling/educating patients on social aspects/implications of their medications/diseases might go beyond the responsibility of the pharmacist. Spending time on counseling/educating PWE on driving issues might distract the pharmacist and might render the encounter with PWE futile. In this case, the pharmacist should focus on counseling/educating the patient on how to make the best out of his AEDs and how to control his seizures, and the pharmacist should not waste the time of the encounter on counseling/educating PWE on driving issues.

There is no strong evidence supporting a conclusion that PWE are more prone to traffic accidents compared with other patient groups or the general population. Restricting PWE from driving does not seem to reduce traffic accidents as traffic accident rates in states with mandatory reporting states were not shown to be higher than those in states without mandatory reporting. Moreover, counseling/educating PWE on the dangers of driving while having seizures or even reporting disobedient drivers does not ensure obedience to restrictions by state authorities. In many cases, it is ethically, legally, and/or professionally justifiable Adult patients who are mentally competent are independent and autonomous. They can lead the lives they wanted and, subsequently, to override the autonomy of some patients to safeguard their are responsible for their own lives and choices. In general, well-being and the well-being of others or the society at large. pharmacists should foster free choices of their patients. Because Because pharmacists are trusted healthcare providers who are supposed to act in the best interests of their patients and advocate for pharmacists are healthcare providers, PWE might feel manipulated, coerced, and/or threatened of being reported to state authorities or their well-being, in many instances, pharmacists are in key position to help their patients make better choices concerning their health and becoming less independent and autonomous in case the pharmacists decided to counsel/educate them on the risks of driving or the well-being. necessity of reporting their seizures to state authorities. Restricting driving for PWE might entail stigma and discrimination as State authorities impose driving restrictions on patients other than they are not the only drivers with increased risk of traffic accidents. PWE. Almost all patients with conditions that might impact their State authorities have been criticized because PWE seemed to be safety as drivers have restrictions on driving. Informing state authorities of all PWE promotes justice in restricting drivers who are singled out of patients with other neurological or cardiovascular at higher risk of causing traffic accidents, and state authorities might disorders and driving restrictions have been imposed more strictly upon them. become in a better position to impose restrictions on other patients who are at an increased risk of making traffic accidents. Informing state authorities might erode trust between PWE and their Pharmacists as healthcare providers should adhere to the code of their profession and its ethics. A norm should be fostered by acting in healthcare providers and might subsequently lead to healthcare provider “shopping”. the best interests of the patients. Informing state authorities might foster in patients that healthcare providers act in the best interests of the patients and the society at large. There is no evidence that restricting PWE from driving is Authorities in states who receive reports on seizures affecting cost-effective. PWE are in better position to evaluate the long term and overall costs of restrictions than authorities in states who do not receive reports. Acting in the best interests of the patient might justify infringing Reporting patients to state authorities is not the least infringing of some principles in the patient–healthcare provider relationship. other means available to pharmacists to safeguard the interests of their patients and the society. State authorities have the right to protect the well-being of The patient has the right to keep his privacy/confidentiality and individuals and the society at large. In many cases, it is ethically, protect his personal information. Reporting the patient or informing legally, and/or professionally justifiable to breach the the patient to report his seizures to state authorities can breach the privacy/confidentiality of the patient in order to safeguard the privacy/confidentiality of the patient. well-being of the patient himself and/or others who could be at risk of harm if the patient's privacy/confidentiality was maintained. In case the patient made a traffic accident, prosecution might accuse In case the patient made a traffic accident and harms others or the pharmacist as a healthcare provider of malpractice or negligence, property, it is not clear if the pharmacist would be accused of malpractice or negligence, and the pharmacist might not be held and it is possible that the court might decide to hold the pharmacist liable to the damage caused by the patient. liable to the damage caused by the patient. Reporting the patient to state authorities might result in depriving Restricting driving privileges of the patient might be in the best interests of the patient himself, others, and property that could be at the patient from driving privileges. This will limit his autonomy, risk of harm in case the patient had seizures while driving and made a independence, ability to perform his job duties, social life, and quality of life. traffic accident. There is no evidence that reporting PWE to state authorities saves Informing state authorities and restricting the patient from driving lives and reduces damage to property. privileges might avoid death/harm of/to the patient himself, others who could be passengers, or drivers on the road and might also avoid damage to property. Restricting driving privileges of the patient might safeguard the Preserving driving privileges of the patient fosters his autonomy, integrity of the patient, others, and property that could be harmed. independence, abilities to perform his job duties, social life, and quality of life. (continued on next page)

8

R. Shawahna / Epilepsy & Behavior 102 (2020) 106703

Table 2 (continued) Principle

#

Arguments in favor of counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities

Veracity

13 In this case, the pharmacist did not make any explicit promise to the patient. In many circumstances, healthcare providers might find it ethically, legally, and/or professionally justifiable to break promises made to patients for safeguarding the well-being of the patient and/or others who could be at risk of harm if such promises are kept.

“In case he made a traffic accident, he might kill or injure himself and/or others” … “He might also damage property” … 20 years-old female pharmacy student. “He could face criminal persecution as a result of disobedience to legal requirements of not driving while his seizures were not under control” … 19 years-old female Pharm.D student. “He might be accused of manslaughter in case he killed somebody or might face severe legal punishment in case he caused injuries to other individuals or property” … 22 years-old male pharmacy student. “Insurance might not be liable for covering the damages by a disobedient driver who was driving illegally” … 19 years-old female Pharm.D student. 3.3.4.2. Perspectives of the pharmacist. “As a healthcare provider and advocate for the patient, the pharmacist needs to counsel/educate the

Arguments against counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities Patients provide information to healthcare providers with an implicit promise to keep such information confidential. Reporting the patient to state authorities entails breaking such promises.

patient on the dangers/risks of driving while experiencing breakthrough seizures” … 19 years-old female Pharm.D student. “The pharmacist might be accused of malpractice or negligence and might be found liable to damages to the patient or other parties in case the patient was involved in a traffic accident that resulted in injuries to the patient or others or damages to property” … 20 years-old male pharmacy student. 3.3.4.3. Perspectives of the state authorities. “State authorities are supposed to set rules and regulations to ensure safety of the general public and protect individuals and property from unnecessary injurers and damage” … 21 years-old pharmacy student. 3.3.4.4. Perspectives of the society at large. “The society needs safer roads and less avoidable deaths, injuries, and damage to property” … 20 years-old female pharmacy student.

Table 3 Weight scores (%) of arguments in favor of counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities. #

Principle

1

Avoidance of killing

Argument

Informing state authorities and restricting the patient from driving privileges might avoid death/harm of/to the patient himself, others who could be passengers, or drivers on the road and might also avoid damage to property. 2 Nonmaleficence Restricting driving privileges of the patient might be in the best interests of the patient himself, others, and property that could be at risk of harm in case the patient had seizures while driving and made a traffic accident. 3 Beneficence Restricting driving privileges of the patient might safeguard the integrity of the patient, others, and property that could be harmed. 4 Perceived In modern healthcare delivery, the duty of the pharmacist goes beyond merely dispensing medications. As advocates for patients, responsibility/duty pharmacists are supposed to act in the best interests of their patients. Therefore, counseling/educating PWE on the risks/dangers of driving while having breakthrough seizures can be equally important to counseling/educating PWE on their disease/AEDs. Driving while having breakthrough seizures has the potential to kill/harm the patient himself, other passengers, users of the road, and/or can cause damage to property. Although pharmacists are not legally mandated to report disobedient drivers to state authorities, pharmacists are a group of healthcare providers who should exhibit exemplary behavior and safeguard the interests of the patients and the society at large. This might be fostered by counseling/educating PWE on the risks/dangers of driving while having seizures or in some cases reporting disobedient drivers to state authorities. 5 Health maximization Some studies have shown that PWE are at higher risk of making traffic accidents compared with drivers without epilepsy. More importantly, PWE whose seizures are not under control are strictly prohibited from driving in all states. Authorities in states with mandatory reporting are better informed of seizures in PWE who drive than authorities in states without mandatory reporting and thus are in a better position to design interventions to reduce traffic accidents caused by PWE. 6 Trust/relationship Pharmacists as healthcare providers should adhere to the code of their profession and its ethics. A norm should be fostered by acting in the best interests of the patients. Informing state authorities might foster in patients that healthcare providers act in the best interests of the patients and the society at large. 7 Respect for In many cases, it is ethically, legally, and/or professionally justifiable to override the autonomy of some patients to safeguard their autonomy well-being and the well-being of others or the society at large. Because pharmacists are trusted healthcare providers who are supposed to act in the best interests of their patients and advocate for their well-being, in many instances, pharmacists are in key position to help their patients make better choices concerning their health and well-being. 8 Efficiency Authorities in states who receive reports on seizures affecting PWE are in better position to evaluate the long term and overall costs of restrictions than authorities in states who do not receive reports. 9 Legal liability In case the patient made a traffic accident, prosecution might accuse the pharmacist as a healthcare provider of malpractice or negligence, and it is possible that the court might decide to hold the pharmacist liable to the damage caused by the patient. 10 Justice State authorities impose driving restrictions on patients other than PWE. Almost all patients with conditions that might impact their safety as drivers have restrictions on driving. Informing state authorities of all PWE promotes justice in restricting drivers who are at higher risk of causing traffic accidents, and state authorities might become in a better position to impose restrictions on other patients who are at an increased risk of making traffic accidents. 11 Proportionality Acting in the best interests of the patient might justify infringing some principles in the patient–healthcare provider relationship. 12 Veracity In this case, the pharmacist did not make any explicit promise to the patient. In many circumstances, healthcare providers might find it ethically, legally, and/or professionally justifiable to break promises made to patients for safeguarding the well-being of the patient and/or others who could be at risk of harm if such promises are kept. 13 Respect for privacy/ State authorities have the right to protect the well-being of individuals and the society at large. In many cases, it is ethically, legally, confidentiality and/or professionally justifiable to breach the privacy/confidentiality of the patient in order to safeguard the well-being of the patient himself and/or others who could be at risk of harm if the patient's privacy/confidentiality was maintained.

Weight score (%) Mean SD

n

19.7

6.9

27

16.3

4.4

27

12.9 10.6

4.2 3.4

27 27

7.8

2.3

27

6.0

2.1

27

5.2

2.1

27

4.4

1.9

27

4.2

1.9

27

4.0

1.8

27

3.1 3.1

1.85 27 1.9 27

2.7

1.3

27

R. Shawahna / Epilepsy & Behavior 102 (2020) 106703

3.3.5. Arguments in favor of and against counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities The panelists in the nominal groups identified arguments in favor of or against counseling/educating PWE on the dangers/risks of driving while having breakthrough seizures or reporting PWE to state authorities. Arguments were grouped by principles of pharmacy and biomedical ethics as shown in Table 2. There were 13 arguments in favor of counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities and 13 countervailing arguments against counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities identified by the participants in the nominal group. 3.3.6. Weight scores (%) of arguments in this case 3.3.6.1. Weight scores (%) of arguments in favor of counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities. Weight scores (%) of arguments in favor of counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities are shown in Table 3. Multiple comparisons of weight scores (%) on each argument in favor of counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities are shown in Supplementary Table S3 (Supplementary materials). 3.3.6.2. Weight scores (%) of arguments against counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities. Weight scores (%) of arguments against counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities are shown in Table 4. Multiple comparisons of weight scores

9

(%) on each argument against counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities are shown in Supplementary Table S4 (Supplementary materials). 3.3.6.3. Weight scores (%) of principles in favor of versus against counseling/ educating patients on the dangers/risks of driving or reporting patients to state authorities. Weight scores (%) of principles in favor of versus against counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities are shown in Table 5. When arguments in favor of versus against counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities were compared, significantly higher weight scores (%) were given to arguments in favor of counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities with regard to perceived responsibility/duty (p-value b 0.001), avoidance of killing (p-value b 0.001), beneficence (p-value b 0.001), nonmaleficence (p-value b 0.001), legal liability (p-value b 0.001), efficiency (p-value b 0.001), health maximization (p-value b 0.001), proportionality (p-value b 0.001), veracity (p-value b 0.001), and justice (p-value b 0.05). However, significantly higher weight scores (%) were given to arguments against counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities with regard to trust/relationship (p-value b 0.001), respect for autonomy (p-value b 0.001), and respect for privacy/confidentiality (p-value b 0.001). 3.3.6.4. Overall weight scores (%) of principles in favor of or against counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities. The overall weight scores (%) of principles

Table 4 Weight scores (%) of arguments against counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities. #

Principle

1

Beneficence

Argument

Weight score (%) Mean

Preserving driving privileges of the patient fosters his autonomy, independence, abilities to perform his job duties, social life, and 22.1 quality of life. 2 Nonmaleficence Reporting the patient to state authorities might result in depriving the patient from driving privileges. This will limit his 15.8 autonomy, independence, ability to perform his job duties, social life, and quality of life. 3 Proportionality Reporting patients to state authorities is not the least infringing of other means available to pharmacists to safeguard the 11.0 interests of their patients and the society. 7.5 4 Respect for Adult patients who are mentally competent are independent and autonomous. They can lead the lives they wanted and, autonomy subsequently, are responsible for their own lives and choices. In general, pharmacists should foster free choices of their patients. Because pharmacists are healthcare providers, PWE might feel manipulated, coerced, and/or threatened of being reported to state authorities or becoming less independent and autonomous in case the pharmacists decided to counsel/educate them on the risks of driving or the necessity of reporting their seizures to state authorities. 6.5 5 Perceived Counseling/educating patients on how to make the best out of their medications is the primary responsibility/duty of the responsibility/duty pharmacist. Pharmacists are not law enforcement officers, and legally, they are not mandated to report disobedient drivers to state authorities. Counseling/educating patients on social aspects/implications of their medications/diseases might go beyond the responsibility of the pharmacist. Spending time on counseling/educating PWE on driving issues might distract the pharmacist and might render the encounter with PWE futile. In this case, the pharmacist should focus on counseling/educating the patient on how to make the best out of his AEDs and how to control his seizures, and the pharmacist should not waste the time of the encounter on counseling/educating PWE on driving issues. 6 Avoidance of killing There is no evidence that reporting PWE to state authorities saves lives and reduces damage to property. 6.7 6.3 7 Health maximization There is no strong evidence supporting a conclusion that PWE are more prone to traffic accidents compared with other patient groups or the general population. Restricting PWE from driving does not seem to reduce traffic accidents as traffic accident rates in states with mandatory reporting states were not shown to be higher than those in states without mandatory reporting. Moreover, counseling/educating PWE on the dangers of driving while having seizures or even reporting disobedient drivers does not ensure obedience to restrictions by state authorities. 8 Trust/relationship Informing state authorities might erode trust between PWE and their healthcare providers and might subsequently lead to 5.3 healthcare provider “shopping”. 9 Respect for privacy/ The patient has the right to keep his privacy/confidentiality and protect his personal information. Reporting the patient or 4.8 confidentiality informing the patient to report his seizures to state authorities can breach the privacy/confidentiality of the patient. 10 Veracity Patients provide information to healthcare providers with an implicit promise to keep such information confidential. Reporting 4.4 the patient to state authorities entails breaking such promises. 3.4 11 Justice Restricting driving for PWE might entail stigma and discrimination as they are not the only drivers with increased risk of traffic accidents. State authorities have been criticized because PWE seemed to be singled out of patients with other neurological or cardiovascular disorders and driving restrictions have been imposed more strictly upon them. 12 Legal liability In case the patient made a traffic accident and harm others or property, it is not clear if the pharmacist would be accused of 3.3 malpractice or negligence, and the pharmacist might not be held liable to the damage caused by the patient. 13 Efficiency There is no evidence that restricting PWE from driving is cost-effective. 2.9

SD

n

6.4

27

5.7

27

5.2

27

4.1

27

3.6

27

3.2 3.1

27 27

2.9

27

2.5

27

2.2

27

2.1

27

2.0

27

1.8

27

10

R. Shawahna / Epilepsy & Behavior 102 (2020) 106703

Table 5 Weight scores (%) of principles in favor of or against counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities. #

Principle

1 2 3 4 5 6 7 8 9 10 11 12 13

Perceived responsibility/duty Avoidance of killing Beneficence Nonmaleficence Legal liability Efficiency Health maximization Proportionality Veracity Justice Trust/relationship Respect for autonomy Respect for privacy/confidentiality

In favor of counseling/educating reporting

Against counseling/educating reporting

Weight score (%)

Weight score (%)

Mean

SD

n

Mean

SD

n

64.3 88.4 86.3 80.6 72.4 64.8 61.4 60.9 54.6 52.1 41.6 39.2 32.8

11.5 14.2 13.6 14.3 13.2 11.1 9.5 9.6 8.2 7.6 8.2 7.6 8.2

27 27 27 27 27 27 27 27 27 27 27 27 27

35.7 11.6 13.7 19.4 27.6 35.2 38.6 39.1 45.4 47.9 58.4 60.8 67.2

7.6 3.6 4.5 6.3 4.5 6.4 6.5 5.8 6.7 7.1 9.6 12.1 13.2

27 27 27 27 27 27 27 27 27 27 27 27 27

in favor of or against counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities are shown in Table 6. When arguments in favor of versus against counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities were compared, significantly higher weight scores (%) were given to arguments in favor of counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities (p-value b 0.001). 3.4. Based on the arguments considered, which alternative course(s) of action was/were preferred? 3.4.1. Weight scores (%) of the alternative courses of action When weight scores (%) were given to the alternative courses of action, significantly higher scores were given to the course action #3 “the pharmacist could counsel/educate the patient on the dangers/risks of driving while experiencing breakthrough seizures, inform the patient to refrain from driving in this period, and make a shared decision with the patient to inform the state authorities” (p-value b 0.001). The weight scores (%) of the alternative courses of action are shown in Table 7. Multiple comparisons of weight scores (%) on each alternative course of action are shown in Supplementary Table S5 (Supplementary materials).

p-Value

b0.0001 b0.0001 b0.0001 b0.0001 b0.0001 b0.0001 b0.0001 b0.0001 b0.0001 b0.05 b0.0001 b0.0001 b0.0001

4. Discussion This study investigated how pharmacy students could use systematic approaches to discuss, deliberate, and make decisions to face and resolve dilemma that could be encountered in future practice. In this study, an 8-step systematic approach was used to facilitate discussions, deliberations, and decision-making while facing and resolving a dilemma. During the 8-step approach, the AHP was used as an MCDA technique to weigh countervailing arguments and alternative potential courses of action. Decisions made through systematic approaches could be more easily justified ethically/legally/professionally. It has been argued that healthcare professionals might need to use sophisticated forms of ethical/legal/professional discussions and deliberations to make judgements in daily clinical practice, especially, when evident decisions do not appear prima facie [89,90]. Previous research paid little efforts to investigate how such hidden discussions and deliberations take place [66]. This study investigated for the first time how ethically/legally/professionally justifiable decisions can be made, especially in the presence of countervailing arguments in favor of and against different courses of action. The current study demonstrated that the use of such systematic methods can be handy and appealing in practice. The use of such systematic approaches might substantiate

Table 6 Overall weight scores (%) of principles in favor of or against counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities.

Overall

In favor of counseling/educating reporting

Against counseling/educating reporting

Weight score (%)

Weight score (%)

p-Value

Mean

SD

n

Mean

SD

n

73.5

14.6

27

26.5

11.1

27

b0.0001

Table 7 Weight scores (%) of the alternative courses of action. #

Course of action

Weight score (%)

1

2.7 The pharmacist could have ignored the issue of driving, in this case, the pharmacist would not counsel/educate the patient on the dangers/risks of driving while experiencing breakthrough seizures, nor inform the patient to notify the state authorities by herself, and the pharmacist would not opt to voluntarily report the patient to the state authorities. The pharmacist could counsel/educate the patient on the dangers/risks of driving while experiencing breakthrough seizures and leave the decision to 19.6 inform the state authorities to the patient himself. The pharmacist could counsel/educate the patient on the dangers/risks of driving while experiencing breakthrough seizures, inform the patient to refrain 52.3 from driving in this period, and make a shared decision with the patient to inform the state authorities. The pharmacist could counsel/educate the patient on the dangers/risks of driving while experiencing breakthrough seizures, informs the patient to alert 25.4 the state authorities, and voluntarily files a separate report to the state authorities.

Mean SD

2 3 4

n

1.3 27

5.8 27 14.3 27 9.3 27

R. Shawahna / Epilepsy & Behavior 102 (2020) 106703

and demonstrate that the underpinnings of the decision-making procedure were transparent and clear to different stakeholders. The present study was conducted using a mixed method (Fig. 1). A thorough search of the literature was conducted to gather all pertinent data/information relevant to the case presented. Interviews were conducted with key contact experts in the field to put the data/information that were gathered from the literature into the Palestinian context. In this study, a systematic review was not conducted for this study. The decision to conduct a thorough search instead of a systematic review was informed by the objectives of the study, nature of the questions that needed answers, problem/population, intervention, comparison, outcome (PICO), and the nature and number of documents that needed to be reviewed [91]. The number of interviewees was informed by previous studies with the objective of supplementing information to a list of items retrieved from the literature [6,66,73–76,92–102]. The interviewees were of both genders, of different age groups, of different professions, and from different specialties. The number of panelists invited to the nominal group was informed by previous studies in which the NGT was used [103]. Again, the panelists were of both gender and included BSc pharmacy and Pharm.D students. This diversity might add strength and validity to the method used in this study. When facing dilemmas in daily practice, decisions often do not appear prima facie, and gold standard in making decisions and resolving dilemmas does not exist. However, the use of systematic approaches in addressing dilemmas and making ethically/legally/professionally justifiable decisions might be appealing to healthcare professionals who face ethical/legal/professional dilemmas in daily practice. In the present study, countervailing arguments in favor of and against each potentially alternative course of action were taken into consideration during the weighing process. In light of the findings of this study, decisions might become more transparently justifiable in daily practice on the grounds of the relative weights of these arguments. In this study, the AHP was used to pairwise compare countervailing arguments and potential alternative decisions. In a previous study, the AHP and a systematic approach were combined and used to make a decision either to use ginger for a pregnant woman with other comorbidities or not [66]. The AHP as an MCDA method was also used to facilitate decisions in issues related to healthcare, regulatory affairs, and in the context of other situation [59,104,105]. This study was conducted among pharmacy students who would be future pharmacists. Pertinent data/information relative to the case presented were collected from the literature and from the interviews with key contact experts in the field. Data/information collected from the literature were put into context through the interviews. Arguments in favor of and against each course of action were grouped by the different principles that underpin pharmacy and biomedical ethics. Again, countervailing arguments in favor of or against each course of action were grouped by the different principles that underpin pharmacy and biomedical ethics. Making ethically justifiable decisions in practice could be complicated by multiple countervailing arguments for and against potentially alternative courses of action. Findings of this study are probably supportive of the emerging and new roles of pharmacists as a healthcare provider with increasing roles in providing direct healthcare services to patients, including PWE. 4.1. How the preferred course(s) of action can be implemented? Considering the overall scores, the panelists were generally in favor of counseling/educating patients on the dangers/risks of driving or reporting patients to state authorities. The panelists gave higher weight scores to course of action #3 “the pharmacist could counsel/educate the patient on the dangers/risks of driving while experiencing breakthrough seizures, inform the patient to refrain from driving in this period, and make a shared decision with the patient to inform the state authorities”. In this case, the pharmacist should probably discuss/review with the patient the dangers/risks of driving while experiencing breakthrough

11

seizures. The pharmacist should ensure that the patient understands the dangers/risks. The patient should be advised to refrain from driving in this period, and the pharmacist should make sure that the patient understands why he should not drive. The pharmacist might also need to inform and encourage the patient to report his seizures to state authorities. It is noteworthy mentioning that the pharmacist might stress that the decision on the patient fitness to drive or maintaining driving privileges/license is not made by the pharmacist but by the concerned state authorities. It could be important for the pharmacist to help the patient recognize the role of the pharmacist as a healthcare provider and advocate for the patient. The counseling/educational session should be clear and transparent, and the pharmacist should document the discussion and the information, including any informational/educational materials, provided to the patient. The pharmacist might inform the patient that he/she will check in the next visit if the patient was still driving and had reported his seizures to the state authorities or not. The pharmacist might also consider reporting dangerous and/or disobedient drivers to the state authorities. In case the patient was not convinced or challenged the counseling/educational tips provided by the pharmacist, the pharmacist then might consider referring the patient to a neurologist or other healthcare provider who could convince the patient. 4.2. Strengths and limitations of the study One of the major strengths of this study is the use of a mixed method. The case presented to the participants was developed using the 12-tips for developing a case-based dilemma for assessments in medical education and training [70]. Data/information were gathered after a thorough search of the literature and through interviews with key contact experts in the field. The 8-step approach was not used before among students to address and resolve dilemmas with ethical/ legal/professional component. The AHP was combined to the 8-step approach. The use of the AHP was proven handy in facilitating decision-making [59,104,105]; additionally, the 8-step approach was proven handy in facilitating discussions and deliberations. This study can serve as a useful example to be consulted when ethical/ legal/professional deliberations are needed to address and resolve dilemmas facing healthcare professionals in their daily practice. It is noteworthy mentioning that the findings of this study are not meant to be applied for other cases in a different context; however, they may serve as a good example on how dilemmas can be resolved in a systematic manner and using a limited number of steps. In other words, findings of this study are not generalizable to other cases as arguments relevant to the principles of bioethics might differ in a different context. It is important to keep in mind that weight scores and priorities might change with the introduction of new inputs into the case. Again, it is noteworthy mentioning that such methods do not replace additional judgements that can be used in daily practice. The 8-step approach used in this study might furnish a structured framework to explicitly consider weights and priorities of arguments and countervailing arguments while deliberating on ethical/legal/professional dilemmas. The present study has limitations. First, a thorough search of the literature was followed as opposed to a systematic review. Systematic review of the literature is generally preferable method of literature reviews. Second, the search was done by one author. However, another researcher verified the results. It would have been better if more than one researcher conducted the search independently. Third, the interviews were conducted once and were not repeated. More data/ information could have been obtained if the interviews were repeated. Fourth, the experts who were interviewed were sampled using a judgmental sampling method. This sampling method has long been criticized as biased. However, it was not possible to use other probability sampling methods because of the nature and objectives of this study. Fifth, the AHP was used to weigh arguments against each other [59,107]. The AHP can be a time-consuming process, especially when

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R. Shawahna / Epilepsy & Behavior 102 (2020) 106703

there are multiple subcriteria that need to be considered in the weighing process. Finally, the size of the panel used was relatively small. However, the size was informed by previous studies in which the NGT and the AHP were used [6,66,74–76,92–103]. 5. Conclusion In conclusion, the present study demonstrates that the 8-step approach when combined with a suitable MCDA technique like the AHP can be a handy method in facilitating decision-making while addressing ethical/legal/professional dilemmas in daily healthcare practice. More studies are still needed to investigate the practicality of using such method in daily practice. Funding None. Declaration of competing interest None. Acknowledgments RS would like to thank the interviewees and the students who took part in the different stages of the study. An-Najah National University is acknowledged for making this study possible. Appendix A. Supplementary data Supplementary data to this article can be found online at https://doi. org/10.1016/j.yebeh.2019.106703. References [1] Ip Q, Malone DC, Chong J, Harris RB, Labiner DM. An update on the prevalence and incidence of epilepsy among older adults. Epilepsy Res 2018;139:107–12. [2] Somerville ER, Black AB, Dunne JW. Driving to distraction–certification of fitness to drive with epilepsy. Med J Aust 2010;192:342–4. [3] Ooi WW, Gutrecht JA. International regulations for automobile driving and epilepsy. J Travel Med 2000;7:1–4. [4] WHO. Epilepsy in the WHO Eastern Mediterranean region: bridging the gap In ; 2010. [5] Bhalla D, Lotfalinezhad E, Timalsina U, Kapoor S, Kumar KS, Abdelrahman A, et al. A comprehensive review of epilepsy in the Arab world. Seizure 2016;34:54–9. [6] Shawahna R. Which information on women's issues in epilepsy does a community pharmacist need to know? A Delphi consensus study. Epilepsy Behav 2017;77: 79–89. [7] Shawahna R. Development of key performance indicators to capture in measuring the impact of pharmacists in caring for patients with epilepsy in primary healthcare: a Delphi consensual study. Epilepsy Behav 2019;98:129–38. [8] Saetre E, Abdelnoor M. Incidence rate of sudden death in epilepsy: a systematic review and meta-analysis. Epilepsy Behav 2018;86:193–9. [9] Fiest KM, Sauro KM, Wiebe S, Patten SB, Kwon CS, Dykeman J, et al. Prevalence and incidence of epilepsy: a systematic review and meta-analysis of international studies. Neurology 2017;88:296–303. [10] Ngugi AK, Kariuki SM, Bottomley C, Kleinschmidt I, Sander JW, Newton CR. Incidence of epilepsy: a systematic review and meta-analysis. Neurology 2011;77: 1005–12. [11] Murthy JM. New-onset focal epilepsy in adults: antiepileptic drug treatment. Neurol India 2017;65:S78–82. [12] Schmidt D, Schachter SC. Drug treatment of epilepsy in adults. BMJ 2014;348:g254. [13] Shawahna R, Atrash A, Jebril A, Khalaf A, Shaheen E, Tahboosh H. Pharmacists' knowledge of issues in pharmacotherapy of epilepsy using antiepileptic drugs: a cross-sectional study in Palestinian pharmacy practice. Epilepsy Behav 2017;67: 39–44. [14] Zhang L, Zhu X, Zou X, Chen L. Factors predicting uncontrolled seizures in epilepsy with auditory features. Seizure 2019;65:55–61. [15] Tatum WO, Worley AV, Selenica ML. Disobedience and driving in patients with epilepsy. Epilepsy Behav 2012;23:30–5. [16] Shawahna R, Atrash A, Jebril A, Khalaf A, Shaheen E, Tahboosh H. Evaluation of pharmacists' knowledge of women's issues in epilepsy: a cross-sectional study in Palestinian pharmacy practice. Seizure 2017;46:1–6. [17] Krumholz A, Hopp JL, Sanchez AM. Counseling epilepsy patients on driving and employment. Neurol Clin 2016;34:427–42 [ix].

[18] Noe K. Counseling and management of the risks of living with epilepsy. Continuum (Minneap Minn) 2019;25:477–91. [19] Kaddumukasa M, Kaddumukasa MN, Buwembo W, Munabi IG, Blixen C, Lhatoo S, et al. Epilepsy misconceptions and stigma reduction interventions in sub-Saharan Africa, a systematic review. Epilepsy Behav 2018;85:21–7. [20] Goodall J, Salem S, Walker RW, Gray WK, Burton K, Hunter E, et al. Stigma and functional disability in relation to marriage and employment in young people with epilepsy in rural Tanzania. Seizure 2018;54:27–32. [21] Chen J, Li Q, Tong X, Ssu M, Wang C, Zhou D. Epilepsy-related concerns among patients with epilepsy in West China. Epilepsy Behav 2018;82:128–32. [22] Gilliam F, Kuzniecky R, Faught E, Black L, Carpenter G, Schrodt R. Patient-validated content of epilepsy-specific quality-of-life measurement. Epilepsia 1997;38:233–6. [23] Matsuura M. Epilepsy and driving. Brain Nerve 2013;65:67–75. [24] Berg AT, Vickrey BG, Sperling MR, Langfitt JT, Bazil CW, Shinnar S, et al. Driving in adults with refractory localization-related epilepsy. Multi-center study of epilepsy surgery. Neurology 2000;54:625–30. [25] Xu Y, Zhou Z, Shanthosh J, Hackett ML, Anderson CS, Glozier N, et al. Who is driving and who is prone to have traffic accidents? A systematic review and meta-analysis among people with seizures. Epilepsy Behav 2019;94:252–7. [26] Naik PA, Fleming ME, Bhatia P, Harden CL. Do drivers with epilepsy have higher rates of motor vehicle accidents than those without epilepsy? Epilepsy Behav 2015;47:111–4. [27] Mahmud S, Hwang ST. Understanding variability in driving recommendations for patients with seizures. Epilepsy Behav 2017;77:44–9. [28] Vogtle LK, Martin R, Russell Foushee H, Edward Faught R. A comparison of physicians' attitudes and beliefs regarding driving for persons with epilepsy. Epilepsy Behav 2007;10:55–62. [29] McLachlan RS, Jones MW. Epilepsy and driving: a survey of Canadian neurologists. Can J Neurol Sci 1997;24:345–9. [30] Caruana P, Hughes AR, Lea RA, Lueck CJ. Australian driving restrictions: how well do neurologists know them? Intern Med J 2018;48:1144–9. [31] Fang J, Jirsch J, Wang S, Zhou D, Mu J, An D, et al. Neurologists' attitudes toward driving among persons with epilepsy in China: a pilot electronic survey. Epilepsy Behav 2019;94:47–51. [32] Algahtani H, Shirah B, Algahtani R, Algahtani R. Epilepsy and driving: local experience from Saudi Arabia. Epilepsy Behav 2019;99:106401. [33] Inoue Y, Ito M, Kurihara M, Morimoto K, Commission on Legal Affairs JES. Epilepsy and driving in Japan. Epilepsia 2004;45:1630–5. [34] Classen S, Crizzle AM, Winter SM, Silver W, Eisenschenk S. Evidence-based review on epilepsy and driving. Epilepsy Behav 2012;23:103–12. [35] Pinchi V, Norelli GA, Bartolini V. Ethical implications of Italian legislation on 'epilepsy and driving'. J Med Ethics 2014;40:552–7. [36] Kass JS, Rose RV. Driving and epilepsy: ethical, legal, and health care policy challenges. Continuum (Minneap Minn) 2019;25:537–42. [37] Elgar NJ, Esterman AJ, Antic NA, Smith BJ. Self-reporting by unsafe drivers is, with education, more effective than mandatory reporting by doctors. J Clin Sleep Med 2016;12:293–9. [38] Brodtkorb E, Brathen G, Bovim G, Helde G. Disagreement about epilepsy and driving. Tidsskr Nor Laegeforen 2004;124:1100–2. [39] Siddiqi M, Jirsch J. Counseling at a seizure clinic does not ensure disclosure to the transportation registry. Can J Neurol Sci 2015;42:230–4. [40] Salinsky MC, Wegener K, Sinnema F. Epilepsy, driving laws, and patient disclosure to physicians. Epilepsia 1992;33:469–72. [41] Bradley PM, Lindsay B, Fleeman N. Care delivery and self-management strategies for adults with epilepsy. Cochrane Database Syst Rev 2016;2016. [42] Brown C. Improving quality of care for epilepsy patients using a pharmacist review service. Prog Neurol Psychiatry 2012;16:12–6. [43] Kootsikas ME, Hayes G, Thompson JF, Perlman S, Brinkman JH. Role of a pharmacist in a seizure clinic. Am J Hosp Pharm 1990;47:2478–82. [44] Reis TM, Campos M, Nagai MM, Pereira L. Contributions of pharmacists in the treatment of epilepsy: a systematic review. Am J Pharm Benefits 2016;8:e55–60. [45] McAuley JW, Miller MA, Klatte E, Shneker BF. Patients with epilepsy's perception on community pharmacist's current and potential role in their care. Epilepsy Behav 2009;14:141–5. [46] McAuley JW, Casey J, Long L. An evaluation of pharmacists' knowledge of women's issues in epilepsy. Epilepsy Behav 2009;14:243–6. [47] Kruijtbosch M, Gottgens-Jansen W, Floor-Schreudering A, van Leeuwen E, Bouvy ML. Moral dilemmas reflect professional core values of pharmacists in community pharmacy. Int J Pharm Pract 2019;27:140–8. [48] Shaw HK, Degazon C. Integrating the core professional values of nursing: a profession, not just a career. J Cult Divers 2008;15:44–50. [49] Wynia MK, Papadakis MA, Sullivan WM, Hafferty FW. More than a list of values and desired behaviors: a foundational understanding of medical professionalism. Acad Med 2014;89:712–4. [50] Powell V. President's message: oath of a pharmacist. J Pharm Pract 2010;23:79. [51] Association RDP. Charter professionalism of the pharmacist: foundation for acting professionally and ethically In ; 2012. [52] Vukovic Rodriguez J, Juricic Z. Perceptions and attitudes of community pharmacists toward professional ethics and ethical dilemmas in the workplace. Res Social Adm Pharm 2018;14:441–50. [53] Sim TF, Sunderland B, Hattingh HL. Exploring influences on pharmacists' and students' ethical reasoning in a changing practice landscape in Australia. Int J Clin Pharmacol 2019;41:280–8. [54] Saw PS, Chuah LH, Lee SWH. A practical approach toward teaching ethics to community pharmacists. Int J Clin Pharmacol 2018;40:1131–6. [55] Cooper RJ, Bissell P, Wingfield J. Ethical decision-making, passivity and pharmacy. J Med Ethics 2008;34:441–5.

R. Shawahna / Epilepsy & Behavior 102 (2020) 106703 [56] Marie M, Marie M, Edwards S, Gandini G, Reiss M, von Borell E. Animal bioethics: principles and teaching methods. The Netherlands: Wageningen Academic Publishing; 2005. [57] Bolt I, Verweij M, Delden Jv. Ethiek in praktijk. . 7th ed.Van Gorcum; 2010. [58] Bolt I, van den Hoven M, Blom L, Bouvy M. To dispense or not to dispense? Ethical case decision-making in pharmacy practice. Int J Clin Pharmacol 2015;37:978–81. [59] Maruthur NM, Joy SM, Dolan JG, Shihab HM, Singh S. Use of the analytic hierarchy process for medication decision-making in type 2 diabetes. PLoS One 2015;10: e0126625. [60] Guo JJ, Pandey S, Doyle J, Bian B, Lis Y, Raisch DW. A review of quantitative riskbenefit methodologies for assessing drug safety and efficacy-report of the ISPOR risk-benefit management working group. Value Health 2010;13:657–66. [61] Dolan JG, Isselhardt Jr BJ, Cappuccio JD. The analytic hierarchy process in medical decision making: a tutorial. Med Decis Making 1989;9:40–50. [62] Bloom BS. Taxonomy of educational objectives. New York: David McKay, Inc.; 1956. [63] Krathwohl DR, Anderson LW. A taxonomy for learning, teaching, and assessing: a revision of Bloom's taxonomy of educational objectives. New York: Longman; 2009. [64] Gallagher CT. Building on Bloom: a paradigm for teaching pharmacy law and ethics from the UK. Curr Pharm Teach Learn 2011;3:71–6. [65] Veatch RM, Haddad AM, Last E. Case studies in pharmacy ethics. Oxford University Press; 2017. [66] Shawahna R. Combining and using the Utrecht method and the analytic hierarchy process to facilitate professional and ethical deliberation and decision making in complementary and alternative medicine: a case study among a panel of stakeholders. Evid Based Complement Alternat Med 2018;2018:2315938. [67] American Academy of Neurology AES, Epilepsy Foundation of America. Consensus statements, sample statutory provisions, and model regulations regarding driver licensing and epilepsy. American Academy of Neurology, American Epilepsy Society, and Epilepsy Foundation of America. Epilepsia 1994;35:696–705. [68] Sondergaard E, Ertmann RK, Reventlow S, Lykke K. Using a modified nominal group technique to develop general practice. BMC Fam Pract 2018;19:117. [69] Humphrey-Murto S, Varpio L, Wood TJ, Gonsalves C, Ufholz LA, Mascioli K, et al. The use of the Delphi and other consensus group methods in medical education research: a review. Acad Med 2017;92:1491–8. [70] Tsai TC. Twelve tips for the construction of ethical dilemma case-based assessment. Med Teach 2017;39:341–6. [71] Moher D, Liberati A, Tetzlaff J, Altman DG, Group P. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. J Clin Epidemiol 2009;62:1006–12. [72] Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. International J Qual Health Care 2007;19:349–57. [73] Shawahna R, Al-Atrash M. What do primary healthcare providers and complementary and alternative medicine practitioners in Palestine need to know about exercise for cancer patients and survivors: a consensual study using the Delphi technique. Evid Based Complement Alternat Med 2019;2019:7695818. [74] Shawahna R, Haddad A, Khawaja B, Raie R, Zaneen S, Edais T. Medication dispensing errors in Palestinian community pharmacy practice: a formal consensus using the Delphi technique. Int J Clin Pharmacol 2016;38:1112–23. [75] Shawahna R, Masri D, Al-Gharabeh R, Deek R, Al-Thayba L, Halaweh M. Medication administration errors from a nursing viewpoint: a formal consensus of definition and scenarios using a Delphi technique. J Clin Nurs 2016;25:412–23. [76] Shawahna R, Odeh M, Jawabreh M. Factors promoting clinical inertia in caring for patients with dyslipidemia: a consensual study among clinicians who provide healthcare to patients with dyslipidemia. J Natl Med Assoc 2019;111:18–27. [77] Shawahna R. Merits, features, and desiderata to be considered when developing electronic health records with embedded clinical decision support systems in Palestinian hospitals: a consensus study. BMC Med Inform Decis Mak 2019;19:216. [78] Padilla-Garrido N, Aguado-Correa F, Cortijo-Gallego V, Lopez-Camacho F. Multicriteria decision making in health care using the analytic hierarchy process and Microsoft Excel. Med Decis Making 2014;34:931–5. [79] Saaty TL. The analytic hierarchy process: planning, priority setting, resource allocation. McGraw-Hill International Book Company; 1980. [80] Arcot Jayagopal L, Samson KK, Taraschenko O. Driving with drug-resistant and controlled seizures from a patient's perspective: assessment of attitudes and practices. Epilepsy Behav 2018;81:101–6.

13

[81] Bielen I, Hajnsek S, Krmpotic P, Petelin Z, Susak R, Sepic-Grahovac D, et al. Impact of partial liberalization of driver's license regulations on the driving behavior of people with epilepsy: experience from Croatia. Epilepsy Behav 2011;21:459–61. [82] Chen J, Yan B, Lu H, Ren J, Zou X, Xiao F, et al. Driving among patients with epilepsy in West China. Epilepsy Behav 2014;33:1–6. [83] De Stefano P, Novy J, Seeck M. Driving rules: first seizure and epilepsy. Rev Med Suisse 2019;15:866–9. [84] Dickey W, Morrow JI. Epilepsy and driving: attitudes and practices among patients attending a seizure clinic. J R Soc Med 1993;86:566–8. [85] Okumura A, Abe S, Nakazawa M, Ikeno M, Igarashi A, Takasu M, et al. Attitudes toward driver's licenses for people with epilepsy: 2012 versus 2014. Pediatr Int 2017;59:185–9. [86] Okumura A, Abe S, Nakazawa M, Shimizu T. Is attitude toward epilepsy and driving affected by media coverage? Pediatr Int 2014;56:759–62. [87] Willems LM, Reif PS, Knake S, Hamer HM, Willems C, Kramer G, et al. Noncompliance of patients with driving restrictions due to uncontrolled epilepsy. Epilepsy Behav 2019;91:86–9. [88] Zis P, Siatouni A, Kimiskidis VK, Verentzioti A, Kefalonitis G, Triantafyllou N, et al. Disobedience and driving in patients with epilepsy in Greece. Epilepsy Behav 2014;41:179–82. [89] Riepe MW. Clinical preference for factors in treatment of geriatric depression. Neuropsychiatr Dis Treat 2015;11:25–31. [90] Tomba E, Fava GA. Treatment selection in depression: the role of clinical judgment. Psychiatr Clin North Am 2012;35:87–98. [91] Robinson P, Lowe J. Literature reviews vs systematic reviews. Aust N Z J Public Health 2015;39:103. [92] Page A, Potter K, Clifford R, McLachlan A, Etherton-Beer C. Prescribing for Australians living with dementia: study protocol using the Delphi technique. BMJ Open 2015;5:e008048. [93] McKenna HP. The Delphi technique: a worthwhile research approach for nursing? J Adv Nurs 1994;19:1221–5. [94] Duffield C. The Delphi technique: a comparison of results obtained using two expert panels. Int J Nurs Stud 1993;30:227–37. [95] Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Adv Nurs 2000;32:1008–15. [96] Shawahna R, Taha A. Which potential harms and benefits of using ginger in the management of nausea and vomiting of pregnancy should be addressed? A consensual study among pregnant women and gynecologists. BMC Complement Altern Med 2017;17:204. [97] Shawahna R, Zyoud A, Dwikat J, El-Helo M, Yacoub B, Hilal H. Breast milk lead levels in 3 major regions of the West Bank of Palestine. J Hum Lact 2016;32:455–61. [98] Shawahna R, Rahman NU, Ahmad M, Debray M, Yliperttula M, Decleves X. Electronic prescribing reduces prescribing error in public hospitals. J Clin Nurs 2011; 20:3233–45. [99] Ghaleb MA, Barber N, Dean Franklin B, Wong IC. What constitutes a prescribing error in paediatrics? Qual Saf Health Care 2005;14:352–7. [100] Dean B, Barber N, Schachter M. What is a prescribing error? Qual Health Care 2000;9:232–7. [101] Boulkedid R, Abdoul H, Loustau M, Sibony O, Alberti C. Using and reporting the Delphi method for selecting healthcare quality indicators: a systematic review. PLoS One 2011;6:e20476. [102] Junger S, Payne SA, Brine J, Radbruch L, Brearley SG. Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: recommendations based on a methodological systematic review. Palliat Med 2017;31:684–706. [103] McMillan SS, King M, Tully MP. How to use the nominal group and Delphi techniques. Int J Clin Pharmacol 2016;38:655–62. [104] Liberatore MJ, Nydick RL. The analytic hierarchy process in medical and health care decision making: a literature review. Eur J Oper Res 2008;189:194–207. [105] Huang IB, Keisler J, Linkov I. Multi-criteria decision analysis in environmental sciences: ten years of applications and trends. Sci Total Environ 2011;409:3578–94. [106] Danner M, Vennedey V, Hiligsmann M, Fauser S, Gross C, Stock S. How well can analytic hierarchy process be used to elicit individual preferences? Insights from a survey in patients suffering from age-related macular degeneration. Patient 2016;9:481–92.