Tricyclic Antidepressant Overdose Manikin Simulation in Student Pharmacists

Abstract

Background: Pharmacists must be knowledgeable of medication use within the scope of both typical dosing and atypical dosing. In the United States, antidepressants are the fourth most common substance in overdose situations and are ranked first for serious exposures per year. Objective: The purpose of this study is to design, implement, and assess the efficacy of an antidepressant overdose simulation using a high-fidelity manikin. Methods: This was a single-center, prospective, observational, cross-sectional study of third-year student pharmacists in spring 2021. This study was determined to be exempt by the institutional review board. Students who did not participate in the manikin simulation or complete both the pre- and postsimulation surveys were excluded. Student pharmacists were expected to identify the type of overdose, identify probable offending agent, and evaluate the hemodynamic status. Primary objectives compared student pharmacist knowledge, confidence in recognizing overdose, and confidence in managing overdose pre- and post-antidepressant overdose manikin simulation. Results: Twenty-three students completed both surveys and participated in the simulation. The knowledge total score was 2.1 ± 1.3 in the presimulation and 2.9 ± 0.9 in the postsimulation (P < 0.001). The recognition confidence was 2.0 ± 1.3 in the presimulation and 3.7 ± 0.7 in the postsimulation (P < 0.001). The management confidence was 1.8 ± 1.0 in the presimulation and 3.5 ± 0.5 in the postsimulation (P < 0.001). Limitations in this study were small sample size, lack of rubric, and a case prompt. Conclusion: The outcomes were statistically significant postsimulation. Manikin simulations may have a larger impact on a pharmacy curriculum.

Background

Pharmacists must be knowledgeable of medication use within the scope of both typical dosing and atypical dosing (eg, overdose). An adverse drug event (ADE) is harm experienced by a patient because of exposure to a medication. There are patient-specific, drug-specific, and clinician-specific risk factors for ADEs. The Institute for Safe Medication Practices is an organization focused on preventing medication errors, whereas the Food and Drug Administration collects reports of ADEs.

Budnitz et al ¹ characterized emergency department visits in the United States from 2017 to 2019 due to medication harms. Of the total 96 925 cases, 30.9% involved nontherapeutic use. Adverse drug events cause approximately 1.3 million emergency department visits each year and 350 000 patients each year need to be hospitalized for further treatment. ² From 2019 to 2020, Centers for Disease Control and Prevention reports 759 349 accidental drug overdose deaths and 101 861 intentional drug overdose deaths. ³

Overdoses can present with various forms of symptoms, including abnormal vital signs, mental status change, pupil size change, and organ dysfunction. Initial identification of a specific overdose requires a physical examination, differential diagnosis, and laboratory testing. Poison control centers are a resource that provides information regarding potential poisonings and treatment management. From 2020 to 2022, the Poison Control Center triaged 11 108 cases for antidepressants. ⁴ The 2020 annual report of the American Association of Poison Control Centers’ National Poison Data System indicates antidepressants over a 10-year period ranked as the fourth most common substance accounting for 136 266 cases (5.3% of total exposures). ⁵ In addition, antidepressants ranked first in increasing serious exposures per year, defined as moderate effect, major effect, and death. ⁵ In the 2019 American Association of Poison Control Centers’ National Poison Data System Annual report, tricyclic antidepressants (TCAs) accounted for 3817 single exposures and 15 deaths. ⁶ The TCA most frequently ingested was amitriptyline (2381 exposures and 10 deaths), followed by doxepin (592 exposures and no deaths) and nortriptyline (360 exposures, 1 death). ⁶

TCAs may be used for the treatment of multiple diseases, including major depressive disorder (MDD), insomnia, and pain conditions such as headache, neuropathy, and fibromyalgia. At least one episode of MDD was experienced approximately 8.4% of all adults in the United States in 2020 and 4.9% had serious thoughts of suicide. ⁷ Although TCAs can be a useful therapeutic option for MDD, these agents are not recommended first line due to tolerability issues, including serious adverse effects when present at supratherapeutic levels. In overdose situations, TCAs can inhibit sodium channel currents and delay cardiac depolarization, which can ultimately lead to fatal arrhythmia. ⁸ Emergent management of TCA overdose varies based on time since ingestion, symptoms, and other patient-specific factors but may involve administering sodium bicarbonate. ⁹ It is critical that pharmacists understand the risks associated with TCA use and, if faced with a potential overdose case, know how to act to minimize harm. The TCA overdose is a type of critical care situation and the ability to act in these instances requires not only knowledge of how to respond but also intrinsic characteristics that allow an individual to maintain their composure in a challenging environment.

Grit is one way to assess focus and perseverance in completing tasks. ¹⁰ Measured using the Short Grit Scale (Grit-S), grit was found to be significantly associated with academic success in student pharmacists ¹¹ and acceptance into postgraduate training programs. ¹² Furthermore, grit has been evaluated in the pursuit of pharmacy residency programs, including postgraduate year 1 (PGY-1) and year 2 (PGY-2). Palisoc and colleagues ¹² found higher Grit-S scores among students who pursued and attained a PGY-1 compared with not applying for postgraduate training. Conversely, Gruenberg et al ¹³ observed a negative association between Grit-S score and pursuit of PGY-1 training. However, approximately two-thirds of their eligible final-year student cohort participated and 77% of those who participated pursued a PGY-1, which suggests a selection bias may have existed and these findings may not be generalizable to most schools of pharmacy. In a cohort of PGY-1 pharmacy residents, Hammond et al ¹⁴ found higher Grit-S scores in those who matched and early committed for PGY-2. Both studies by Palisoc et al and Hammond et al demonstrated higher Grit-S scores were more likely to obtain a PGY-1 or PGY-2 program. Interestingly, Smithgall et al ¹⁵ found higher grit scores in PGY-1 residents who scrambled compared with matched residents. However, higher traditional traits such as depth of pharmacy knowledge, being a team player, and problem-solving skills were found in PGY-1-matched residents compared with scrambled residents. Further studies are needed to fully elucidate this relationship, including longitudinal evaluation.

The American Association of Colleges of Pharmacy, the Accreditation Council for Pharmacy Education (ACPE), and the Center for the Advancement of Pharmacy Education frame patient safety from the perspective of medication management, which is also the current focus of pharmacy education and training. ¹⁶ With the growing appreciation that diagnostic errors represent an urgent and actionable patient safety concern, the National Academy of Medicine has recommended diagnostic safety training for all health care professions. ¹⁶ The Society to Improve Diagnosis in Medicine has worked with an interprofessional consensus group to identify a set of 12 key competencies necessary to achieve diagnostic quality and safety that focuses on individual, team-based, and system-related competencies. ¹⁶ Much of this already exists in pharmacy education, but pharmacy training programs need to give graduates more guidance on how they contribute to the diagnostic process and the prevention and detection of diagnostic errors. ¹⁶

The ACPE requires toxicology to be taught in the pharmacy curriculum and recommends manikin simulations to provide early exposure to pharmacy practice in a controlled environment with learning experiences difficult to replicate in practice. ¹⁷ Previous studies found manikin simulations to have a positive impact for medical and student pharmacists.^{18 -21} A survey of 90 medical schools and 64 teaching hospitals identified manikin simulations in medical education were utilized for instilling educational skills and competency assessments. ²² Kane-Gill and Smithburger ²³ reviewed simulations conducted in student pharmacists. Simulation-based learning provides students an opportunity to apply previously acquired knowledge and skills in a realistic clinical setting that is a safe and controlled educational environment. ²³ The purpose of this study is to design, implement, and assess the efficacy of an active learning pedagogy for antidepressant overdose in a doctor of pharmacy curriculum using a high-fidelity manikin.

Methods

This was a single-center, prospective, observational, cross-sectional study of third-year student pharmacists who were enrolled in the Pharmacotherapy IV course offered during the spring 2021 semester at High Point University Fred Wilson School of Pharmacy. Students were administered a presimulation survey assessing objective knowledge and confidence in their ability to manage TCA overdose prior to the simulation activity. The same survey was administered following the activity. Participation in the surveys was optional and anonymous. All students were assigned unique identifiers to pair presimulation and postsimulation survey results without using identifying information. Students who did not participate in the manikin simulation or complete both the presimulation and postsimulation surveys were excluded.

All student pharmacists previously received lectures for depression, hemodynamic support, respiratory support, pain, agitation, delirium, shock, acid-base, electrolyte disturbances, toxicology, and advanced cardiovascular life support. Following the toxicology lecture, the students participated in an antidepressant overdose simulation activity using high-fidelity manikins. The simulation was comprised of a facilitator and groups of 4 to 5 student pharmacists. Two CAE Ares high-fidelity manikins were manually programmed to simulate an amitriptyline overdose. To control for group contamination bias, all participants were given a case prompt, listed in Table 1, immediately prior to entering the simulation room briefly explaining the patient’s history, materials available during the simulation, and current state of the patient prior to entering the simulation. The students were orientated to the room with the manikin lying down on a hospital bed, a patient monitor, and a code cart. Manikins were programmed to show signs of a tricyclic antidepressant toxicity on the CAE Touch Pro Patient Monitor with hypotension (82/56 mmHg), tachycardia (137 bpm), normal oxygen saturation (99%), a wide QRS interval (133 ms), and T wave changes. The code cart contained epinephrine 1 mg/10 mL, calcium chloride 10% 1 g/10 mL, sodium bicarbonate 8.4% 50 mE1/50 mL, lidocaine 2% 100 mg/5 mL, dextrose 50% 25 g/50 mL, amiodarone 150 mg/3 mL, vasopressin 20 units/mL, atropine 1 mg/10 mL, adenosine 6 mg/2 mL, furosemide 20 mg/2 mL, normal saline 0.9% 1000 mL, lactated ringers 1000 mL, 3 mL syringes, 23G needles, and alcohol pads.

Table 1.

Case Prompt.

Situation The medical resident caring for the patient asks if you think this could be a medication overdose and requests your help with management. You are an inpatient clinical pharmacist staffing in the emergency department at your hospital. A 28-year-old male patient is brought in by ambulance after being found down in their home following a welfare check called in by a friend.

History  • Medical = major depressive disorder, chronic migraines, insomnia, asthma  • Social = worked as a bartender but was laid off during the COVID-19 pandemic and has been unemployed for approximately 6 months, recently broke up with girlfriend of 5 years and now lives alone, has been posting concerning messages on social media for the last few weeks, stopped responding to text messages today

Home medications  • Duloxetine 120 mg 1 cap by mouth daily—last filled #30 on 12/6/20  • Amitriptyline 50 mg 1 tab by mouth at bedtime - last filled #90 on 4/10/21  • Trazodone 100 mg 1-2 tabs by mouth at bedtime as needed for sleep - last filled #60 on 2/13/21  • Albuterol 90 μg 2 puffs inhaled every 4-6 hours as needed for shortness of breath—last filled on 1/27/21

Vital signs  • Blood pressure = 82/56 mmHg  • Heart rate = 137 beats/min  • Electrocardiogram = sinus tachycardia, QRS 133 ms, T wave changes

Student pharmacists were expected to identify and differentiate the type of overdose presented during the simulation, rule out toxidromes (anti-cholinergic, cholinergic, sympathomimetic, and opioid), sedative/hypnotics, acetaminophen, serotonin syndrome, and sulfonylurea toxicities and address the overdose by identifying the probable offending agent, evaluating airway, breathing, circulation, recognizing an abnormal cardiac rhythm, and administering sodium bicarbonate.

After completion of the simulation, each group was debriefed by the corresponding faculty facilitator to provide feedback and discuss opportunities for improvement. After debriefing, students completed the postsurvey. All survey questions incorporated a 0- to 5-point Likert scale (0 = do not know/unsure, 1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree). The primary outcome compared student pharmacist knowledge, recognition confidence, and management confidence pre- and post-antidepressant overdose simulation. The secondary outcome compared the change in scores between students with above-average grit with those with average to below-average grit.

Statistical Analysis

This study was determined to be exempt by High Point University Institutional Review Board. Presimulation demographics collected included sex, age, and grit score. An a priori α level of less than or equal to .05 was considered statistically significant. A paired t test was used to compare pre- and postsimulation cumulative survey scores for overall knowledge, confidence in ability to recognize, and confidence in ability to manage TCA overdose. Subgroup analysis was performed using independent t testing to determine whether students with higher-than-average grit (> 4.0 in the study population) experienced different impacts on their knowledge and/or confidence after the simulation compared with those with average or below-average grit scores. All descriptive statistics were reported for all study variables where appropriate.

Results

Twenty-three students completed both surveys and participated in the simulation. The mean age of the students was 24.5 ± 3.7 (25-40). Females accounted for 16/23 (69.6%) participants. The mean grit score was 4.0 ± 0.5 (3.1-5.0). Following the simulation, knowledge about TCA overdose significantly increased, as well as confidence in recognition and management (Table 2). Students with above-average grit scores experienced greater increases in knowledge and confidence, but these findings were not statistically significant (Table 3).

Table 2.

Outcomes.

	Presimulation	Postsimulation	P value
Knowledge total score	2.1 ± 1.3	2.9 ± 0.9	<0.001
Recognition confidence	2.0 ± 1.3	3.7 ± 0.7	<0.001
Management confidence	1.8 ± 1.0	3.5 ± 0.5	<0.001

Table 3.

Subgroup Analysis.

	Grit ≤ 4.0	Grit > 4.0	P value
Knowledge total score change	0.7 ± 0.7	0.8 ± 0.8	0.683
Recognition confidence change	1.2 ± 0.8	2.2 ± 1.3	0.069
Management confidence change	1.6 ± 1.0	1.9 ± 1.2	0.617

Discussion

Toxicology and drug-induced disease states are important topics for health care professionals to know. Toxicology involves human poisonings from natural and synthetic toxins. Establishing a correlation between symptoms and a patient’s history is pivotal to identifying the offending cause. Pharmacists play an important role in identifying ADEs. Although a traditional pharmacy curriculum discusses drug efficacy and safety, a minority of time is dedicated to reviewing the impact of overdose management and differentiating disease states. Although pharmacists do not have the scope of practice to diagnose medical conditions, they can provide their assistance in drug information.

There was no statistically significant difference between students with grit scores of ≤4 and >4 on gain in knowledge, recognition confidence, and management confidence following the simulation. However, related to ability to recognize a TCA overdose, students with above-average grit experienced a greater increase in their confidence (1.2 ± 0.8 vs 2.2 ± 1.3, p = 0.069) that may be meaningful despite the lack of statistical significance in the small study sample. The relationship between grit and student pharmacist performance in laboratory activities has previously been studied and similarly yielded no statistically significant association. ²⁴ While students with higher grit may perform better in the didactic setting, it appears that this may not translate into the experiential setting.

In this study, students with above-average grit tended to rate their presimulation confidence in their abilities to recognize (1.27 ± 1.10 vs 2.67 ± 1.12, P = 0.013) and manage (1.56 ± 1.13 vs 1.90 ± 0.88, P = 0.473) antidepressant overdose lower than those who had average or below-average grit. It is possible that those students with higher grit were more accurate in their self-assessment skills and did not overestimate their abilities. Studies in undergraduate students have demonstrated that high levels of confidence can mitigate the positive impact of grit on academic performance. ²⁵

Our study found a statistically significant difference in knowledge score, recognition confidence, and management confidence. We expected the total knowledge score and recognition confidence to increase after repeated exposure of toxicology management through application of course content. Consequently, the management confidence increasing was a combination of working together as classmates in groups and being situational aware of the patient’s current condition. Group activity can improve confidence through sharing of ideas and working together to solve problems. Our students were familiar with working in groups, which likely expedited their communication to identify and develop a treatment plan.

Practical skills learned in a didactic setting can be impactful to revisiting these skills again in practice. Holzman and colleagues ²⁶ evaluated anesthesiology residents and their practice skills in resource management and decision-making during a crisis in practice. Their goals were to familiarize the participants with the process of dynamic decision-making and enhance their knowledge responding to critical events. ²⁶ The process of teaching crisis resource management skills provides the opportunity to learn the elements of dealing with some specific crisis situations. Multistep, complex skills such as advanced cardiovascular support require multiple scenarios, training, and time to familiarize practitioners to crisis management. Critical care scenarios are stressful and can lead to errors, which is why further training is needed to be proficient in such skills. Our study introduced a low-risk, high-stakes stressful environment to pharmacy students to prepare them for what they may encounter when they leave the didactic setting.

One study evaluated the experience of student pharmacists on an interprofessional toxicology rotation. ¹⁹ During this rotation, student pharmacists were tasked with evaluating an acute poisoning scenario utilizing a manikin simulation. This study found an improvement in closed-loop communication and feedback that clinical pharmacists should be involved in the differential diagnosis. Our study did not formally measure communication during our manikin simulation, but the facilitators did acknowledge communication played a key role with the efficiency of each group. Communication is an important skill both as an individual and in interprofessional settings. After our study, we have identifying team communication and dynamics as an important competency assessment and have added to group activity rubrics. Debriefing is one method to help practitioners identify opportunities for improvement, which will impact their treatment decisions directly impacting patient care.

Moreover, Lin et al ²⁷ discussed the advantages and disadvantages of incorporating manikin simulations in health care. These advantages include identifying clinical competency gaps, structured feedback, and faster time to competence. The disadvantages include focusing on specific competencies, requires full engagement of the learner, and resources needed. Resources utilized in our study included 4 faculty facilitators, 2 manikins, 2 patient monitors, 2 code carts and corresponding supplies, 8 hours of class preparation, and 3 hours of manikin training. Although this activity was time- and resource-intensive to prepare, we felt the students had an invaluable experience.

This study had several limitations. First, this was a small sample of third-year student pharmacists, which may limit the generalizability to other years of student pharmacists and might introduce selection bias. Second, there was no standardized rubric to evaluate students individually or as a group. The facilitators involved in evaluating the students were content experts and faculty members who wrote the case and were familiar with the appropriate approach of the simulation, thus limiting confounds and bias. Third, the case prompted the students what to expect instead of the students interpreting the patient’s condition upon arrival. Although we felt this experience invaluable for student pharmacists, we recognize these students may not encounter a similar experience in practice. One experience may not be a valid measure of crisis management effectiveness. Despite these limitations, the results of our study showed relevant utility to utilizing manikin simulation to reinforce a specific type of overdose. Future research can investigate evaluating manikin simulation impact on other types of overdoses and identifying other utilities of grit score in the pharmacy curriculum. Areas of future studies can include demonstration of an active learning session of other types of overdoses using a manikin simulation and the impact on student pharmacist education.

Conclusion

This study evaluated the impact of an amitriptyline overdose manikin simulation on third-year student pharmacists. The knowledge score, recognition confidence, and management confidence were statistically significant postsimulation. Manikin simulations may have a larger impact on a pharmacy curriculum as a supplemental activity to reinforce content application.