The current complex and evolving health care environment is creating challenges for health care educators tasked with ensuring that students and health care professionals have sufficient skills and knowledge to undertake pharmacotherapy and medication management safely. Drug administration is the final step in the “medication process.” The multidisciplinary team shares responsibility of ensuring that medicines are safely administered to patients1; however, medication administration is extremely vulnerable to error, for example, wrong drug, dose, route, patient, or timing2 as well as inappropriate coadministration with food or interacting medicines. Retrospective record reviews indicate that adverse events affect 9.2% [interquartile range (IQR), 4.6%–12.4%] of those admitted to hospital, 15.1% (IQR, 11.9%–20.4%) are drug related, and 43% (IQR, 39.4%–49.6%) are preventable (n = 74,485 patients, 8 studies in the United States, Canada, UK, Australia, and New Zealand).3 When all health care settings are considered, estimates of the incidence of adverse events range from 0.1% to 65.4%, with little difference between countries, settings, or specialties (23,696,252 patients, 156 studies).4 A higher incidence is reported among elderly patients.5 Administration of intravenous medicines is particularly vulnerable to error, with 50% to 70% of doses affected,6,7 and there are reports of nurses failing to administer medicines.8,9 Hence, new and effective teaching methods for promoting safe pharmacotherapy are needed.10,11 One possibility is simulation-based teaching, which may afford appropriate and effective experiential learning for health care students and professionals.12
Previous systematic reviews (Table 1) have examined patient simulation as a teaching tool across a range of disciplines,14 its educational effectiveness,13 and its impact on attitudes toward patient safety outcomes.15 These reviews have focused on teaching perspectives. The main interest of this review is to consider pharmacotherapy and medicines’ management from the perspective of learning outcomes. We use the term patient simulation to mean full-scale high-fidelity simulation (HFS) with a patient simulator or standardized patient and pharmacotherapy to mean the medication process (prescription, administration, and monitoring of medicines) in the treatment of patients or service users by health care professionals, with main interest in administration phase.1,16 The aims of this integrative review were to identify evidence of the use of patient simulation teaching method in pharmacotherapy education and to explore the learning outcomes. We addressed the question “What are health care students’ or professionals’ learning outcomes when high-fidelity patient simulation is used for teaching pharmacotherapy?”
Integrative review methods summarize previous empirical studies with different research designs to provide a comprehensive understanding of a particular phenomenon. This present review is based on the framework reported by Whittemore and Knalf.17 A literature search was conducted in consultation with a librarian, searching databases PubMed, CINAHL, SCOPUS, ERIC, MEDIC (Finnish Medicine and Health Sciences Database), and Cochrane Library to obtain comprehensive search results. Broad search terms (MeSH, Medical Subject Headings) patient simulation and drug therapy were used where available. The key words used were as follows: patient simulation or high-fidelity simulation and drug therapy or drug administration or medication administration or pharmacotherapy. The search was limited to the decade 2003–2013 because of the rapid development in both simulation technology18 and medication competency requirements.19 The inclusion criteria were (1) evaluation of high-fidelity patient simulation; (2) focus on pharmacotherapy; (3) a learning or teaching perspective; (4) published 2003–2013; (5) written in English; and (6) publication in a peer-reviewed journal.17,20 Professional journal publications that were not peer reviewed, theses, opinion articles, and books were excluded.
Retrieval and selection (Fig. 1) were performed in 4 stages by 2 independent researchers. At each stage, discussions between researchers were conducted to reach a consensus over inclusion.
- Duplicates were removed, and the titles of studies were screened according to the inclusion criteria.
- Abstracts were read.
- Studies were read in their entirety.
- Reference lists were scrutinized. This identified one additional article. Altogether, 18 articles were included in the final review.
The methodological quality of each selected study was evaluated by 2 independent researchers, using the assessment form developed by Hawker et al.21 This assessment form comprises 9 sections: abstract and title, introduction and aims, methods and data analysis, sampling, data analysis, ethics and bias, results, transferability or generalizability, as well as implications and usefulness. Each of the sections was graded on a 1- to 4-point scale, where 4 indicated good quality and 1 indicated poor. Therefore, the maximum number of points available in the quality assessment was 36, and the minimum was 9. If the evaluations of the independent researchers differed, consensus was reached by discussion.
The 18 selected research articles were analyzed using qualitative content analysis17,22 tailored to the specific research question. In the first step, combinations of words or meaningful statements such as “opportunity to apply learning” and “knowledge of medication side effects increased” were chosen. Second, data were reduced to codes. Third, similarities and dissimilarities between codes were identified, and similar codes were grouped into classes. Finally, classes were further conceptualized into categories (Fig. 2).
From key word searches, 108 articles were identified; 18 articles met the inclusion criteria and were reviewed (Fig. 1). All selected studies achieved a total quality score of between 23 and 32 points (mean (SD) value, 28.1 (2.9) points) and were accepted for further analysis. The mean (SD) scores of quality for the different sections ranged from 2.2 (0.9) (ethics and bias) to 3.6 (0.5) (method and data). Differences in study methods, quality, and professions (nursing, medical, dental, and pharmacy) precluded combining studies.
Description of Included Studies
In the 18 articles, high-fidelity patient simulation was used in teaching pharmacotherapy or medication administration to nurses, nursing students, medical students or residents, pharmacy students or dental residents, and assistants (Table 2). Two of the studies were conducted in the UK, 1 in Germany, 1 in Canada, and 14 in the United States. All studies were published between 2005 and 2013 (Table 3). The sample sizes ranged from 13 to 222: in 1 study, the sample of 24 participants corresponded to 880 observations. Three participation randomized controlled trials were identified, and 1 study used cluster randomization. One study used qualitative methods, and 17 used quantitative methods; none seemed to be triangulated or mixed methods. The included articles’ designs, tests used, and learning outcomes are presented in Table 4.
Several positive learning outcomes of patient simulation in pharmacotherapy education were identified as follows: (1) commitment to pharmacotherapy learning, (2) development of pharmacotherapy evaluation skills, (3) improvement in pharmacotherapy application, and (4) knowledge and understanding of pharmacotherapy.
Commitment to Pharmacotherapy Learning
Overall, learners seemed to be satisfied with the use of patient simulation in pharmacotherapy teaching. Patient simulation was described as a motivating, a positive learning experience, and a good method for pharmacotherapy learning from the perspective of nursing students,37 dental residents and assistants,40 as well as medical24,38 and pharmacy students.34,36 Medical students reported enhanced commitment to learning when the patient simulation was used,30 and 22 (76%) of 29 of pharmacy students preferred simulation to problem-based learning (PBL) or didactic lectures.26
Development of Pharmacotherapy Evaluation Skills
The development of diagnostic and therapeutic accuracy was reported in 7 studies. Simulations enhanced nursing, medical, and pharmacy students’ and residents’ responses to patients’ needs in simulated clinical situations because of opportunity to practice problem-solving skills, including medication reconciliation, ventricular tachycardia, and overdose of sedatives in dental practice.23,24,26,35,37,38,40 Confidence was enhanced in nursing students’ pediatric medication administration33 and in pharmacy students’ abilities in recognizing, preventing, communicating, and reporting medication errors.32 Improved critical thinking was reported in pharmacy students’ management of critically ill patients34 and acute care pharmacotherapy.26
Improvement in Pharmacotherapy Application
Seven studies reported improvement in medication administration skills.23,25,27,28,30,33,37 Improvement in skills was evidenced by nursing students making fewer medication errors in clinical placements25 and calculating more doses and dilutions for pediatric medication administration safely33; nurses’ performance during cardiac arrest28; and a significant decrease in nurses’ medication administration errors.27 Obstetrics and gynecology residents training for eclampsia and magnesium toxicity management by simulation showed a 75% improvement in potentially harmful actions, including magnesium overdose, compared with lectures alone.23 Similarly, medical students’ medication administration skills improved after an online module and patient simulation teaching compared with lectures alone or lectures plus online module. These skills were retained for 9 months.33
Knowledge and Understanding of Pharmacotherapy
Increased knowledge was reported in several studies, for example, concerning medication safety and medicines’ adverse effects,31,32,36,37 correct dosages and dilutions,33 as well as acute care29 and cardiovascular pharmacotherapy.34,35 Pretest/posttest knowledge scores increased significantly in all studies,29,32–34 including those with active comparators26; however, in study of Ford et al,27 there were no differences between improvement in pretests/posttests of simulation and lecture groups. Wheeler et al30 observed that students who received teaching including simulation were significantly (P = 0.03) more likely to pass the final examination 9 months later.
Because all medicines, however necessary and appropriate, can have adverse effects, sometimes independent of dose administered,41,42 health care professionals’ knowledge remains a cornerstone of safe pharmacotherapy19 and features as a key “individual factor” in all patient safety frameworks and models.43–45 Patient simulation enhances important learning outcomes including commitment to pharmacotherapy learning, evaluation, application, knowledge, and understanding of pharmacotherapy and may decrease medication errors.15,23,25,27 There were no reports of dissatisfaction with simulation teaching methods, and comparisons against other teaching methods were generally favorable.
The Strength of the Evidence
The limitations of the research designs in many of these studies should be considered. Three studies used individual randomization. Two studies randomized students into simulation and lecture23 or PBL arms,26 and in 1 study, students were randomly allocated to simulation and clinical training arms.25 One study was cluster randomized and allocated groups into simulation and lecture arms.24 Three studies had no comparator data (Table 4).
Most studies (n = 10) used pretest/posttest designs, but only 4 had comparator groups.27–30 In 3 of these, medication administration skills were enhanced. In addition, there were improvements in nurses’ medication administration error rates,27 nurses’ medication administration in code blue (cardiac arrest) situations,28 and medical students’ medication administration skills.30 Two of these comparison group studies reported greater and more sustained improvement in knowl edge gain for HFS arms than for lecture arms.29,30 This consistency across settings, professions, and research designs strengthens the evidence for the efficacy of HFS teaching but does not discount either the Hawthorne effect—both teachers and students were aware of being observed46—or the Rosenthal expectancy effect.47 We identified little work on the potential bias in these reports, and further work is needed to explore volunteer bias, response bias, and generalizability.
In all 6 of the 1-group pretest and posttest studies, scores in knowledge-based tests improved.31–36 Studies without comparator groups also reported enhancement of understanding and self-confidence.32,37–40
Educators of health care professionals need to identify best practice in relation to pharmacotherapy and patient safety48 and develop a taxonomy of learning.49 Learning outcomes identified in this review correspond mainly to cognitive learning—knowledge and its application. However, some psychomotor skills, in medication administration, and affective learning (commitment and motivation) domains were evident.50,51
Limitations and Strengths
There are several issues to consider when evaluating this review. In integrative reviews, the complexity of combining diverse methods and multiple research designs can reduce rigor. Systematic methods for comprehensive literature searching and data analysis aim to maintain validity and reduce bias.17 This review focused entirely on HFSs; hence, studies using low- or medium-fidelity simulations were excluded.
The strength of this review is the synthesis of evidence across professions, settings, and study designs. Structured, integrative reviews are an essential component of evaluation of the educational and clinical effectiveness of new teaching methods in areas of the professional curriculum that underpin patient safety.
Wider Implications: An Evidence-Based Curriculum
If health care educators are to move toward an “evidence-based curriculum,” some restructuring of courses may be needed. Priorities should be set and decisions should be made, based on the results of reliable and valid research into the clinical outcomes of education initiatives. To evaluate courses and demonstrate educational effectiveness solely in terms of student satisfaction is not enough; to survive in the world of evidence-based care, educators must also demonstrate their contribution to clinical effectiveness.52 Some of the studies evaluated here adopted rigorous methods and evaluated clinical outcomes. Nonetheless, many studies were small, and most were single site. Resources are needed to ensure that all curriculum components are subjected to adequate scrutiny. However, the scale5,6 and seriousness of medication mismanagement8,9,41 suggest that investment in this area of the curriculum should be prioritized.53 Although further research is needed, the results of this review are encouraging to teachers using simulation methods for pharmacotherapy learning. More research is needed to determine and clarify the precise clinical impact of simulation, and at present, available evidence is too weak54 and insufficient to mandate curriculum reorganization. Health care professionals, particularly doctors, are unlikely to accept change without evidence from clinical trials.55,56 Accordingly, we propose to undertake randomized controlled trials and studies using comparator groups with before, after, and long-term follow-up measurements to test the hypothesis that simulation learning improves knowledge, performance, and clinical outcomes when compared with the “usual education.” In addition, mixed methods-research will enhance the comprehensive development of best practice and the theoretical basis of simulation learning in pharmacotherapy because these methods allow hypothesis testing and theory generation in a single study.57
Adverse events affect 9.2% of inpatients, and 15.1% are drug related.3 Higher incidence among elderly patients and administration of intravenous medicines are also reported.5–7 Thus “medication error and drug incident” problem is a major threat to patient safety,58 and it is extremely important to identify higher risks prone to error among patients, clinical settings, or phase of medication process.2,5–7 In addition, knowledge deficit is recognized as an etiologic factor.44,45 Hence, for the promotion of safe pharmacotherapy and to decrease adverse events, for example, these sectors should be addressed and effective teaching methods should be developed to ensure medication competence for health care students and professionals. On the basis of this study, high-fidelity patient simulation seems to increase cognitive learning, skills, motivation, and commitment to learning, all of which are important in promoting medication and patient safety. The number and size of studies focusing on the use of simulation in pharmacotherapy education is still limited; thus, there is a need for further research in the health disciplines.
We found no evidence of large-scale, multisite research to develop evidence-based learning strategies to remedy the situation. Rather, the field was characterized by local, small-scale initiatives led by dedicated, but underresourced, teachers.
2. Valentin A, Capuzzo M, Guidet B, et al. Errors in administration of parenteral drugs in intensive care units: multinational prospective study. BMJ
2009; 338: b814.
3. de Vries EN, Ramrattan MA, Smorenburg SM, Gouma DJ, Boermeester MA. The incidence and nature of in-hospital adverse events: a systematic review. Qual Saf Health Care
2008; 17: 216–223.
4. Lessing C, Schmitz A, Albers B, Schrappe M. Impact of sample size on variation of adverse events and preventable adverse events: systematic review on epidemiology and contributing factors. Qual Saf Health Care
2010; 19: e24.
5. Shojania KG. The frustrating case of incident-reporting systems. Qual Saf Health Care
2008; 17: 400–402.
6. McDowell SE, Mt-Isa S, Ashby D, Ferner RE. Where errors occur in the preparation and administration of intravenous medicines: a systematic review and Bayesian analysis. Qual Saf Health Care
2010; 19: 341–345.
7. Westbrook JI, Rob MI, Woods A, Parry D. Errors in the administration of intravenous medications in hospital and the role of correct procedures and nurse experience. BMJ Qual Saf
2011; 20: 1027–1034.
8. Andrews J, Butler M. Trusted to Care. An independent Review of the Princess of Wales Hospital and Neath Port Talbot Hospital at Abertawe Bro Morgannwg University Health Board. Available at: http://wales.gov.uk/docs/dhss/publications/140512trustedtocareen.pdf
. Accessed June 26, 2014.
9. Francis R. Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry: Executive Summary. Available at: http://www.midstaffspublicinquiry.com/report
. Accessed June 26, 2014.
10. Choo J, Johnston L, Manias E. Nurses’ medication administration practices at two Singaporean acute care hospitals. Nurs Health Sci
2013; 15: 101–108.
11. Simonsen BO, Johansson I, Daehlin GK, Osvik LM, Farup PG. Medication knowledge, certainty, and risk of errors in health care: a cross-sectional study. BMC Health Serv Res
2011; 11: 175.
12. Zigmont JJ, Kappus LJ, Sudikoff SN. Theoretical foundations of learning through simulation. Semin Perinatol
2011; 35: 47–51.
13. Cant RP, Cooper SJ. Simulation-based learning in nurse education: systematic review. J Adv Nurs
2010; 66: 3–15.
14. Harder BN. Use of simulation in teaching and learning in health sciences: a systematic review. J Nurs Educ
2010; 49: 23–28.
15. Shearer JE. High-fidelity simulation and safety: an integrative review. J Nurs Educ
2013; 52: 39–45.
16. Ministry of Social Affairs and Health. Safe Pharmacotherapy. National Guide for Pharmacotherapy in Social and Health Care. Handbooks of the Ministry of Social Affairs and Health, Finland
. Helsinki, Finland: Yliopistopaino; 2005: 32.
17. Whittemore R, Knalf K. The integrative review: updated methodology. J Adv Nurs
2005; 52: 546–553.
18. Cannon-Diehl MR. Simulation in healthcare and nursing: state of the science. Crit Care Nurs Q
2009; 32: 128–136.
19. Sulosaari V, Suhonen R, Leino-Kilpi H. An integrative review of the literature on registered nurses’ medication competence. J Clin Nurs
2011; 20: 464–478.
20. Evans D, Webb C, Roe B, eds. Integrative Reviews: Overview of Methods, Reviewing Research Evidence for Nursing Practice
. Malden, MA: Blackwell Publishing Ltd; 2007: 137–148.
21. Hawker S, Payne S, Kerr C, Hardey M, Powell J. Appraising the evidence: reviewing disparate data systematically. Qual Health Res
2002; 12: 1284–1299.
22. Huberman A, Miles M, Denzin N, Lincoln Y, eds. Data Management and Analysis Methods, Handbook of Qualitative Research
. Thousand Oaks, CA: Sage Publications; 1994: 428–444.
23. Fisher N, Bernstein PS, Satin A, et al. Resident training for eclampsia and magnesium toxicity management: simulation or traditional lecture? Am J Obstet Gynecol
2010; 203: 379.e1–379.e5.
24. Mueller MP, Christ T, Dobrev D, et al. Teaching antiarrhythmic therapy and ECG in simulator-based interdisciplinary undergraduate medical education. Br J Anaesth
2005; 95: 300–304.
25. Sears K, Goldsworthy S, Goodman WM. The relationship between simulation in nursing education and medication safety. J Nurs Educ
2010; 49: 52–55.
26. Seybert AL, Smithburger PL, Kobulinsky LR, Kane-Gill SL. Simulation-based learning versus problem-based learning in an acute care pharmacotherapy course. Simul Healthc
2012; 7: 162–165.
27. Ford DG, Seybert AL, Smithburger PL, Kobulinsky LR, Samosky JT, Kane-Gill SL. Impact of simulation-based learning on medication error rates in critically ill patients. Intensive Care Med
2010; 36: 1526–1531.
28. Huseman KF. Improving code blue response through the use of simulation. J Nurses Staff Dev
2012; 28: 120–124.
29. Vyas D, Wombwell E, Russell E, Caligiuri F. High-fidelity patient simulation series to supplement introductory pharmacy practice experiences. Am J Pharm Educ
2010; 74: 169.
30. Wheeler DW, Degnan BA, Murray LJ, et al. Retention of drug administration skills after intensive teaching. Anaesthesia
2008; 63: 379–384.
31. Branch C. Pharmacy students’ learning and satisfaction with high-fidelity simulation to teach drug-induced dyspepsia. Am J Pharm Educ
2013; 77: 30.
32. Kiersma ME, Darbishire PL, Plake KS, Oswald C, Walters BM. Laboratory session to improve first-year pharmacy students’ knowledge and confidence concerning the prevention of medication errors. Am J Pharm Educ
2009; 73: 99.
33. Pauly-O’Neill S, Prion S. Using integrated simulation in a nursing program to improve medication administration skills in the pediatric population. Nurs Educ Perspect
2013; 34: 148–153.
34. Seybert AL, Kane-Gill SL. Elective course in acute care using online learning and patient simulation. Am J Pharm Educ
2011; 75: 54.
35. Seybert AL, Kobulinsky LR, McKaveney TP. Human patient simulation in a pharmacotherapy course. Am J Pharm Educ
2008; 72: 37.
36. Tofil NM, Benner KW, Worthington MA, Zinkan L, White ML. Use of simulation to enhance learning in a pediatric elective. Am J Pharm Educ
2010; 74: 21.
37. Bearnson CS, Wiker KM. Human patient simulators: a new face in baccalaureate nursing education at Bringham Young University. J Nurs Educ
2005; 44: 421–425.
38. Lindquist LA, Gleason KM, McDaniel MR, Doeksen A, Liss D. Teaching medication reconciliation through simulation: a patient safety initiative for second year medical students. J Gen Intern Med
2008; 23: 998–1001.
39. Mieure KD, Vincent WR 3rd, Cox MR, Jones MD. A high-fidelity simulation mannequin to introduce pharmacy students to advanced cardiovascular life support. Am J Pharm Educ
2010; 74: 22.
40. Tan GM. A medical crisis management simulation activity for pediatric dental residents and assistants. J Dent Educ
2011; 75: 782–790.
41. Loke YC, Tan SB, Cai Y, Machin D. A Bayesian dose finding design for dual endpoint phase I trials. Stat Med
2006; 25: 3–22.
42. Rogers JF, Nafziger AN, Bertino JS Jr. Pharmacogenetics affects dosing, efficacy, and toxicity of cytochrome P450-metabolized drugs. Am J Med
2002; 113: 746–750.
43. Griffith R, Griffiths H, Jordan S. Administration of medicines. Part 1: the law and nursing. Nurs Stand
2003; 18: 47–53.
44. Reason JT, Vincent C, ed. Understanding Adverse Events: The Human Factor, Clinical Risk Management: Enhancing Patient Safety
. 2nd ed. London, England: BMJ Books; 2001: 9–30.
45. Vincent C, Taylor-Adams S, Stanhope N. Framework for analysing risk and safety in clinical medicine. BMJ
1998; 316 (7138): 1154–1157.
46. Roethlisberger FS, Dickson WJ. Management and the Worker
. Cambridge, MA: Harvard University Press; 1939.
47. Rosenthal R, Jacobson L. Teachers’ expectancies: determinants of pupils’ IQ gains. Psychol Rep
1966; 19: 115–118.
48. Moule P. Simulation in nurse education: past, present and future. Nurs Educ Today
2011; 31: 645–646.
49. Levett-Jones T, Lapkin S, Hoffman K, Arthur C, Roche J. Examining the impact of high and medium fidelity simulation experiences on nursing students’ knowledge acquisition. Nurse Educ Pract
2011; 11: 380–383.
50. Bloom B, Hastings J, Madaus G. Handbook on Formative and Summative Evaluation of Student Learning
. New York: McGraw-Hill Book Company; 1971.
51. Krathwohl D, Bloom B, Masia B. Taxonomy of Educational Objectives. The Classification of Educational Goals. Handbook II: Affective Domain
. New York, NY: David McKay Company Inc; 1964.
52. Jordan S. Educational input and patient outcomes: exploring the gap. J Adv Nurs
2000; 31: 461–471.
53. Jordan S. Should nurses be studying bioscience? A discussion paper. Nurse Educ Today
1994; 14: 417–426.
54. Balshem H, Helfand M, Schünemann HJ, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol
2011; 64: 401–406.
55. Edwards N, Marshall M, McLellan A, Abbasi K. Doctors and managers: a problem without a solution? BMJ
2003; 326 (7390): 609–610.
56. McDonald R, Waring J, Harrison S, Walshe K, Boaden R. Rules and guidelines in clinical practice: a qualitative study in operating theatres of doctors’ and nurses’ views. Qual Saf Health Care
2005; 14: 290–294.
57. Teddlie C, Tashakkori A. Foundations of Mixed Methods Research: Integrating Quantitative and Qualitative Approaches in the Social and Behavioral Sciences
. Thousand Oaks, CA: Sage Publications; 2009.
58. National Patient Safety Agency. Safety in Doses: Medication Safety Incidents in the NHS
London, England: National Patient Safety Agency; 2007.