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Adverse Drug Events: Evidence-Based Project


An issue of adverse drug events is a crucial point in nursing practice. Having substantial knowledge about the ways of predicting the negative outcomes of the problem allows a nurse to provide the best care for the patients. The current paper presents a narrative description of ten peer-reviewed articles dedicated to the problem of adverse drug events and suggests intervention campaigns which may be employed to enhance the nursing practice.

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Narrative Description of the Articles

The article by Eguale et al. (2015) presents a substantial research on off-label drug prescription and its contribution to adverse drug events. The scholars study prescriptions of a cohort of 46 021 patients from primary care facilities in Quebec. The research incorporates high-quality evidence as it includes a vast number of research samples and many participants. The study is significant because its results suggest a systematic evaluation of the dangers presented by off-label drug use and allow to eliminate the adverse outcomes of such drug prescriptions. The article is relevant to my practice site as I work in a family practice setting and I care about the health quality of my patients. A proposed intervention is an educational campaign for nurses instructing them how to avoid off-label drug prescription. Additionally, the nurses should learn how to teach their patients about the danger of the off-label use of prescription drugs.

Research by Gertler, Coralic, López, Stein, and Sarkar (2014) suggests an investigation of the reasons for emergency department visits caused by the patients’ self-administering of drugs in the home environment. The study goals are to obtain patient and caregiver outlook on ambulatory adverse drug events and perform root cause examination methodology to find cross-cutting problems among these issues. The evidence presented in the research is rather relevant to my field of practice as it is crucial for me to make sure that my patients do not harm themselves by self-administering of drugs the impact of which they do not know. Gertler et al. (2014) investigate environmental, agent, and host factors leading to people’s decision to choose self-administering of drugs. An intervention I would use based on this research is an educational program for patients about the risks presented to their health and life in a case if they self-administer any drugs.

Hamblin, Rumbaugh, and Miller (2012) dedicate their research to finding out the core outcomes of prevention of adverse drug events by clinical pharmacy services. The authors aim at identifying the net cost reserve connected with their contribution to the integrative trauma service. To perform their research, Hamblin et al. (2012) organized a retrospective analysis of clinical interventions and pharmacy activities managed by an integrative team. The researchers managed to assess cost-saving measures for the work process of trauma pharmacy. The evidence presented in the article is essential as it allows to enhance the healthcare system by means of decreasing the expenditures. The outcomes of the article are crucial for my practice as they present valuable information for helping the patients to avoid extra costs on drugs and prevent from adverse drug events. The intervention proposals based on Hamblin et al.’s (2012) research are the following: the enhancement of pharmacotherapy treatment and the change of antibiotics and discontinuation of medications.

Harpaz et al. (2014) suggest an unusual approach to detecting and evaluating adverse drug events. They employ a tool of text mining which involves singling out essential data from big amount of text which is not structured. Text mining is used to leverage disadvantaged sources of data which can enhance pharmacovigilance. Harpaz et al. (2014) suggest a survey of current breakthroughs in pharmacovigilance caused by the employment of text mining. The quality of evidence presented by the authors is justified by using various data sources. For instance, they investigate clinical narratives, social media, biomedical literature, product labeling, and Web search logs. The benefit of this research for my practice is that it allows to single out essential information about adverse drug events from various sources. An intervention based on this study could be an educational campaign for nurses to employ the method of text mining while looking for data concerned with adverse drug use.

A study performed by Kale, Keohane, Maviglia, Gandhi, and Poon (2012) investigates the adverse drug events caused by crucial medication administration mistakes. The authors aim at identifying the frequency with which crucial errors concerned with medication administration result in serious harm to patients’ health. Kate et al. (2014) emphasize that while a lot or errors have the power to bring harm, it is not clear how often such errors actually bring harmful outcomes. The significance of the evidence is revealed via the number of observed medication administrations by the authors. The results of the study are crucial for my practice as it is vital to know about the hazards presented by wrong medication administration. The intervention proposal is an educational campaign for the nurses which would instruct them about the danger or medication administration errors and the ways of preventing these errors.

Adverse drug events risk factors in critically ill patients are the subject of study of Kane-Gill, Kirisci, Verrico, and Rothschild (2012). The authors performed a retrospective case-control study which involved the analysis of healthcare outcomes of the patients admitted to the intensive care unit in a period of seven years and a half. As a result of the study, Kabe-Gill et al. (2014) were able to identify and evaluate twenty-nine implicated risk factors including laboratory values, patient features, and drug characteristics. The significance of this study for my practice is evident, as any family practice nurse may have a case of a critically ill person. Thus, the knowledge about risk factors for such patients is crucial. As an intervention, I would suggest an educational program for nurses to get them acquainted with the ways of identifying risk factors for adverse drug events in the patients who are critically ill.

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Kongkaew et al. (2013) investigate the association of adverse drug events with hospital admission risk factors. The aim of the research is to establish the predictors of hospital admissions in connection with adverse drug events. The quality of evidence is justified by a considerable number of the participants. The cases were determined by clinical pharmacists by employing a medical record review method accompanied by interviews with the patients who were diagnosed as having adverse drug events. The research by Kongkaew et al. (2013) presents a solid material for my practice as predicting the adverse drug events connected with hospital admission risk factors allows to eliminate the negative outcomes for the patients. An intervention I would suggest based on this research is the promotion of an educational program for nurses where they would be instructed about identifying the risk factors occurring during hospital admission.

Lampela et al. (2013) examine the impact of adverse drug events on such vulnerable population as elderly people. The study performed by Lampela et al. (2013) is aimed at finding whether the serum anticholinergic activity evaluation scores and results is connected with anticholinergic adverse drug events in elderly patients. The reliability of evidence is revealed through a considerable number of participants and integrated assessment of patient’s functions such as mood, vision, cognition, and functional capacity. While the study’s key objective is not adverse drug events but rather their combination with other issues, the research is still crucial for the practice. A family practitioner deals with elderly people among other population categories, and learning about various adverse impacts on this population is vital. Intervention, in this case, would be an education campaign about the impact of adverse drug events of elderly people.

Nanji, Patel, Shaikh, Seger, and Bates (2016) evaluate the ratios of adverse drug events and perioperative medication errors as a proportion of medication administration. The authors aim at finding ways of preventing these errors and solutions to them. While my practice does not presuppose surgical operations, the article is still valuable as it investigates adverse drug events. The quality of evidence is justified by a large sample size. An intervention based on this study is an observational program which, however, is not likely to be employed in family practice nursing.

In their research, Shehab et al. (2016) focus on updating and detailing data specifying the adverse drug events as an important element in national patient protection efforts. The aim of the study is to delineate the peculiarities of emergency department visits for adverse drug events. The quality of evidence is justified by a large sample (over forty-two thousand). The most common emergency department visits caused by adverse drug events are connected with diabetes agents, antibiotics, and anticoagulants. The data presented in Shehab et al.’s research is valuable for my practice as it allows to focus on the aspects of treatment which are most likely to bring adverse drug event. An intervention based on this study could be an educational program for nurses teaching them about the most frequent causes of emergency department visits.


The discussed articles investigate various aspects of adverse drug events and suggest approaches to eliminating the negative outcomes of the issue. The proposed interventions are aimed at providing the necessary educational measures for healthcare workers to teach them how to identify adverse drug events and eliminate their negative impact on the patients.

Synthesis Table

1 2 3 4 5 6 7 8 9 10
Level I: Systematic review or meta-analysis x
Level II: Randomized controlled trial
Level III: Controlled trial without randomization
Level IV: Case-control or cohort study x x
Level V: Systematic review of qualitative or
descriptive studies
x x x
Level VI: Qualitative or descriptive study
(includes evidence implementation
x x x x
Level VII: Expert opinion or consensus
1 2 3 4 5 6 7 8 9 10
1 Educational campaign for nurses x x x x x x x
2 Educational campaign for patients x
3 Enhancement of pharmacotherapy treatment x
4 Observational program x
Studies Design Sample Outcome
1 Eguale et al. (2015) Cohort study 3484 ADEs were found in the 46 021 study patients; incidence rate was 13.2 per 10 000 person-months The risks for ADEs for drugs approved from 1981 to 1995: 14.4 / 10 000 person-months; AHR, 1.62; 95%CI, 1.45-1.80; for those used by women: 14.3 / 10 000 person-months; AHR, 1.17; 95%CI, 1.06-1.28; patients with a 1-unit increase in the continuity of care index had a 19% increase in ADEs: AHR, 1.19; 95%CI, 1.12-1.26.
2 Gertler, Coralic, López, Stein, and Sarkar (2014) Root cause analysis 63 patients; 41 after exclusion The most implicated medications: hypoglycemic agents (41%), followed by warfarin (12%), antibiotics (12%), bupropion (12%), and other medications (6%)
3 Hamblin, Rumbaugh, and Miller (2012) Evidence-based study 2,331 patients admitted to the entire trauma unit; 836 patients admitted to the TICU Involvement of cardiovascular medications in 24% to 33% of errors/events; sedatives or analgesics in up to 26% of errors/events; anticoagulants in up to 20% of errors/events.
4 Harpaz et al. (2014) Overview article Pharmacovigilance data Detecting data with the help of text mining
5 Kale, Keohane, Maviglia, Gandhi, and Poon (2012) Retrospective chart review 1271 medication administration errors discovered; 133 had the potential to cause harm Ten (7.5% (95% CI 6.98 to 8.01)) actual ADEs resulted from the 133 serious and life-threatening potential ADEs
6 Kane-Gill et al. (2012) Retrospective case-control study 29 suspected risk factors Patients with kidney injury, thrombocytopenia,
and those admitted emergently were 16-times, 3-times, and 2-times more likely to have an adverse drug event, respectively;
patients administered intravenous medications had a 3% higher risk of having an adverse drug event
7 Kongkaew et al. (2013) Prospective observational study 3904 adults admitted to the two hospitals between June
2006 and November 2007
Of the 3904 patients, 439 (11.2%) experienced ADEs;
of these, 209 patients (47.6%) experienced preventable
8 Lampela et al. (2013) Population-based study 621 patients at Geriatric Multidisciplinary Good Care of
the Elderly Study in Kuopio, Finland
Scores received from ranked lists of anticholinergic
drugs were associated with clinically significant
anticholinergic ADEs;
SAA was not connected with clinically significant
anticholinergic ADEs
9 Nanji, Patel, Shaikh, Seger, and Bates (2016) Prospective observational study 277 operations observed with 3,671 medication administrations: 193 (5.3%; 95% CI, 4.5
to 6.0) involved an ME and/or ADE;
of these, 153 (79.3%) were preventable, and 40 (20.7%) were nonpreventable
One in 20 perioperative medication administrations included an ME and/or ADE
10 Shehab et al. (2016) Descriptive study 42 585 cases Estimated 4.0 (95%CI, 3.1-5.0) ED visits for adverse drug events occurred per 1000 individuals annually in 2013 and 2014; 27.3% (95%CI, 22.2%-32.4%) of ED visits for adverse drug events resulted in hospitalization


Eguale, T., Buckeridge, D. L., Verma, A., Winslade, N. E., Benedetti, A., Hanley, J. A., & Tamblyn, R. (2015). Association of off-label drug use and adverse drug events in an adult population. JAMA, 176(1), E1-E9.

Gertler, S. A., Coralic, Z., López, A., Stein, J. C., & Sarkar, U. (2014). Root cause analysis of ambulatory adverse drug events that present to the emergency department. Journal of Patient Safety, 12(3), 119-124.

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Hamblin, S., Rumbaugh, K., & Miller, R. (2012). Prevention of adverse drug events and cost savings associated with PharmD interventions in an academic Level I trauma center: An evidence-based approach. Journal of Trauma and Acute Care Surgery, 73(6), 1484-1490.

Harpaz, R., Callahan, A., Tamang, S., Low, Y., Odgers, D., Finlayson, S…. Shah, N. H. (2014). Text mining for adverse drug events: the promise, challenges, and state of the art. Drug Safety, 37(10), 777-790.

Kale, A., Keohane, C. A., Maviglia, S., Gandhi, T. K., & Poon, E. G. (2012). Adverse drug events caused by serious medication administration errors. BMJ Quality & Safety, 21(11), 933-938.

Kane-Gill, S. L., Kirisci, K., Verrico, M M., & Rothschild, J. M. (2012). Analysis of risk factors for adverse drug events in critically ill patients. Critical Care Medicine, 40(3), 823-828.

Kongkaew, C., Hann, M., Mandal, J., Williams, S. D., Metcalfe, D., Noyce, P. R., & Ashcroft, D. M. (2013). Risk factors for hospital admissions associated with adverse drug events. Pharmacotherapy, 33(8), 827-837.

Lampela, P., Lavikainen, P., Garcia-Horsman, J. A., Bell, J. S., Huupponen, R., & Hartikainen, S. (2013). Anticholinergic drug use, serum anticholinergic activity, and adverse drug events among older people: A population-based study. Drugs Aging, 30(5), 321-330.

Nanji, K. C., Patel, A., Shaikh, S., Seger, D. L., & Bates, D. W. (2016). Evaluation of perioperative medication errors and adverse drug events. Anesthesiology, 124(1), 25-34.

Shehab, N., Lovegrove, M. C., Geller, A. I., Rose, K. O., Weidle, N. J., & Budnitz, D. S. (2016). US Emergency Department visits for outpatient adverse drug events, 2013-2014. JAMA, 316(20), 2115-2125.

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