ORIGINAL ARTICLE
A prospective three-step intervention study to prevent medication errors in drug handling in paediatric care Dorothee Niemann, Astrid Bertsche, David Meyrath, Ellen D Koepf, Carolin Traiser, Katja Seebald, Claus P Schmitt, Georg F Hoffmann, Walter E Haefeli and Thilo Bertsche
Aims and objectives. To prevent medication errors in drug handling in a paediatric ward. Background. One in five preventable adverse drug events in hospitalised children is caused by medication errors. Errors in drug prescription have been studied frequently, but data regarding drug handling, including drug preparation and administration, are scarce. Design. A three-step intervention study including monitoring procedure was used to detect and prevent medication errors in drug handling. Methods. After approval by the ethics committee, pharmacists monitored drug handling by nurses on an 18-bed paediatric ward in a university hospital prior to and following each intervention step. They also conducted a questionnaire survey aimed at identifying knowledge deficits. Each intervention step targeted different causes of errors. The handout mainly addressed knowledge deficits, the training course addressed errors caused by rule violations and slips, and the reference book addressed knowledge-, memory- and rule-based errors. Results. The number of patients who were subjected to at least one medication error in drug handling decreased from 38/43 (88%) to 25/51 (49%) following the third intervention, and the overall frequency of errors decreased from 527 errors in 581 processes (91%) to 116/441 (26%). The issue of the handout reduced medication errors caused by knowledge deficits regarding, for instance, the correct ‘volume of solvent for IV drugs’ from 49–25%.
What does this paper contribute to the wider global clinical community?
• During daily routine in wards,
•
•
drug handling, including drug preparation and drug administration, is prone to medication errors. A detailed assessment of drughandling processes and medication errors such as a monitoring procedure is an appropriate method to detect these errors. A three-step intervention considering the different causes of errors has been developed, implemented and shown effective to prevent medication errors in a controlled study.
Authors: Dorothee Niemann, Pharmacist, Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg and Department of Clinical Pharmacy, University of Leipzig, Leipzig; Astrid Bertsche, MD, Senior Physician, University Children’s Hospital, University of Heidelberg, Heidelberg and Department of Women and Child Health, Hospital for Children and Adolescents, Center for Pediatric Research, University of Leipzig, Leipzig; David Meyrath, Pharmacist, Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg; Ellen D Koepf, Pharmacist, Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg; Carolin Traiser, Pharmacist, Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg; Katja Seebald, Head Nurse, University Children’s Hospital, University of Heidelberg, Heidelberg; Claus P
Schmitt, MD, Senior Physician, University Children’s Hospital, University of Heidelberg, Heidelberg; Georg F Hoffmann, MD, Head of the Paediatric Center, University Children’s Hospital, University of Heidelberg, Heidelberg; Walter E Haefeli, MD, Head of the Department Clinical Pharmacology and Pharmacoepidemiology, Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg; Thilo Bertsche, PhD, Pharmacist and Head of the Department Clinical Pharmacy, Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg and Department of Clinical Pharmacy, University of Leipzig, Leipzig, Germany Correspondence: Thilo Bertsche, Pharmacist and Head, Department of Clinical Pharmacy, University of Leipzig, Eilenburger Strasse 15a, 04317 Leipzig, Germany. Telephone: +49 3 41 9 73 66 00. E-mail: [email protected]
© 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 101–114, doi: 10.1111/jocn.12592
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Conclusion. Paediatric drug handling is prone to errors. A three-step intervention effectively decreased the high frequency of medication errors by addressing the diversity of their causes. Relevance to clinical practice. Worldwide, nurses are in charge of drug handling, which constitutes an error-prone but often-neglected step in drug therapy. Detection and prevention of errors in daily routine is necessary for a safe and effective drug therapy. Our three-step intervention reduced errors and is suitable to be tested in other wards and settings.
Key words: causes of errors, child, drug handling, intervention studies, medication error, nursing, quality of health care Accepted for publication: 14 February 2014
Introduction and background Each year, up to 158,520 children in the USA are treated in the emergency department for adverse drug events (ADEs) (Cohen et al. 2008b). Up to 42,000 paediatric inpatients in the USA experience a preventable ADE (Woods et al. 2005), which may lead to prolongation of hospital stay (Ahuja et al. 2012, Silva et al. 2013). Of these ADEs, up to 21% are caused by medication errors (Woods et al. 2005, Agarwal et al. 2010), which are defined as failure in the treatment process that results in, or has the potential of resulting in, harm to the patient (Ferner & Aronson 2006). Each step in the medication process from drug prescription to drug administration is prone to errors (Phillips et al. 2001, Ferner & Aronson 2006). Much effort has been made to improve drug prescription (Zaal et al. 2013). Studies regarding errors in the drug-handling process, including both the preparation and the administration of drugs, are not common despite the fact that drug handling causes up to 60% of all medication errors (Bertsche et al. 2008a, Berdot et al. 2012). Studies have most often focused on preventing one special type of error such as drug incompatibilities, dosage calculation errors or errors in the type of administration such as intravenous (IV) or peroral (PO) (Bertsche et al. 2008b, 2010, Sherriff et al. 2012, PaulyO’Neill & Prion 2013). Frequently, nurses are in charge of drug handling. Particularly in paediatric care, the complexity of drug-handling processes exceeds that of processes for adult patients. This is mainly caused by a limited number of appropriate dosages and dosage forms for children (Wong et al. 2008) or resulting from refusal of children to take their medicine (Cohen et al. 2008a, van Riet-Nales et al. 2013). Therefore, additional steps in drug handling such as crushing or splitting of tablets become necessary,
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resulting in additional sources of potential medication errors and potential ADEs for the patients (Cornish 2005, Bohomol et al. 2009, Nunn et al. 2013). In a previous study, we assessed the quality of peroral (PO) drug handling in hospitalised children and managed to reduce the high rate of medication errors by up to 80% through a single-step intervention (Bertsche et al. 2010). The intervention, however, was not tailored to a number of possible causes of errors such as knowledge deficits, action-based slips, rule violations and memory-based lapses (Norman 1981, Taxis & Barber 2003a, Ferner & Aronson 2006, Bertsche et al. 2008a, Ndosi & Newell 2009). Knowledge deficits may lead to errors in drug-handling processes due to a lack of necessary knowledge to conduct these processes without faults (Ferner & Aronson 2006, Bertsche et al. 2008a). Memory-based lapses, however, are skill-based errors that occur when nurses carry out a correctly planned action but forget relevant details (Taxis & Barber 2003a, Ferner & Aronson 2006). Action-based slips are also skillbased errors that accidentally occur during an action (Taxis & Barber 2003a, Ferner & Aronson 2006) and are defined as the performance of an action that was not intended (Norman 1981). Rule-based errors, however, occur if an existing rule is violated (rule violation); they can be made unconsciously or consciously (Taxis & Barber 2003a, Ferner & Aronson 2006, Alper et al. 2012, Gill et al. 2012). Given the multitude of causes (Taxis & Barber 2003a, Bertsche et al. 2008a) for medication errors and different dosage forms, it appeared unlikely to maximise success rates with a single intervention. In this study, by contrast, we evaluated the frequency of medication errors in drug-handling processes and developed a three-step intervention considering different dosage forms and causes of errors, to support nurses in daily routine and to prevent medication errors in drug handling. © 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 101–114
Original article
Patients and methods Setting Following the approval of the Ethics Committee of the Faculty of Medicine of the University of Heidelberg, we performed a prospective intervention study on an 18-bed paediatric ward in a 177-bed children’s hospital of a 1918bed university hospital with tertiary care. The ward specialised in kidney, liver and gastroenterological diseases. No strategies aiming at improving the quality of drug prescription and administration such as pharmacy chart review, electronic prescribing tools or a unit dose system had been implemented on this ward.
Study protocol We aimed to comprehensively assess and prevent medication errors in drug-handling processes as defined by any deviation from internal and external drug preparation/ administration guidelines, the corresponding summaries of product characteristics or manufacturers’ recommendations. Processes included all consecutive drug-handling steps carried out by one nurse. All nurses working in the ward during the monitoring were invited to take part in the study. We also included student nurses in the monitoring because they were frequently involved in drug-handling processes, working under supervision of an experienced nurse. Four trained pharmacists monitored and documented drug-handling processes according to a predefined checklist. The checklist was developed and tested by an expert panel of clinical pharmacists, clinical pharmacologists, nurses and paediatricians (n = 21) in consideration of former studies (Bertsche et al. 2008a,b, 2010), actual literature (Schneider et al. 1998, Kaushal et al. 2001, Cornish 2005, Parshuram et al. 2008, Wong et al. 2008), summaries of product characteristics and internal and external guidelines. We monitored drug handling in the morning hours (from 730–10 a.m.) before any intervention was implemented (baseline) and after each of three intervention steps (intervention 1, intervention 2 and intervention 3). Each monitoring phase lasted 20 working days. A senior pharmacist trained the monitors in a two-day course, checked their documentation daily to assure adequate monitoring quality and rated documented errors according to a predefined list of 22 error subcategories (Table 1). The potential clinical relevance of each error subcategory was assessed in an independent survey by the expert panel on a scale from 1 = no clinical relevance, 2 = minor clinical relevance, 3 = clinical relevance to 4 = high clinical relevance. Following the baseline moni© 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 101–114
Preventing drug-handling errors in children
toring, we conducted a questionnaire survey to detect the knowledge of nurses regarding drug handling. The questionnaire included questions about the appropriateness of routine drug-handling processes, knowledge about IV drugs and the necessity of shaking suspensions. Knowledge deficits were defined as wrong or missing answers in the questionnaire. Subsequently, we conducted a three-step intervention of drug-handling processes carried out by nurses, of which each step was tailored to each of the causes of errors identified by analysing the results of the questionnaire. Intervention 1, the issue of a three-page handout, predominantly addressed errors resulting from knowledge deficits and memory-based lapses and included short handling information about drug-handling processes identified by the results of our questionnaire. In intervention 2, offering of a 60-minute training course, the senior pharmacist explained practical handling guidelines and gave background information to existing rules. Intervention 2 aimed at preventing errors that were likely caused by slips, rule violations or memory-based lapses. We offered the course several times during a two-week period in order to provide as many nurses as possible the opportunity to take part in the training course. Intervention 3, the issue of a 56-page comprehensive reference book, included detailed information concerning drug handling. It focused on knowledge-, memory- and rule-based errors. The nurses received the reference book six months after being monitored following their enrolment in intervention 2. The break of six months was chosen to check also the sustainability of the first intervention steps and to give the nurses the possibility to get familiar with the content of interventions 1 and 2.
Outcomes As the primary outcome, we defined the number of patients with at least one identified medication error in the drughandling process before (baseline) and after the three-step intervention. As secondary outcomes, we defined the overall frequency of errors, errors per observed process and errors per patient.
Statistical analysis According to the findings of the preceding test phase and considering the results of our former study (Bertsche et al. 2010), we expected that in at least 80% of patients monitored, a medication error would be identified at baseline. A reduction by half, that is, to ≤40% by the overall (threestep) intervention, was considered clinically relevant (i.e. a frequency of medication errors in ≤50% of the patients).
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104 Drugs were mixed by crushing or suspending before administering the mixture to the patient Moisture- or light-sensitive drugs were removed from the blister more than half an hour too early before administration Tablets and capsules as prepared by the nightshift nurses deviate from patient file, e.g. ibuprofen 200 mg was prescribed as a tablet and the nightshift nurse forgot to prepare this tablet for the patient, or prepared a wrong dose or a wrong dosage form. When the mistake was detected by the morning shift, the monitor documented the deviation The daily dose of PO liquids, especially electrolyte solutions, was prepared in one syringe
Mixing drugs
Taking drugs too early out of the blister
Preparing the dosage for multiple administrations during the day for one patient in one syringe
Incorrect drug preparation by the night shift
Shaking of suspensions (PO liquids) was not done before use
PO drugs were administered via a feeding tube deviating from guidelines, standards, or drug label, e.g. without checking the location of the tube, or without flushing the tube with water between drug administrations The nurses did not dilute small amounts of PO liquids (mostly drops) or diluted them wrongly
The nurse withdrew PO fluids with a syringe directly from the bottle without using a special adapter, or a cup The nurse withdrew too much of a PO liquid and poured excess amounts back into the bottle Tablets or capsules were dissolved/suspended for PO administration deviating from guidelines, standards or drug label Tablets were split that must not be split
Definition
No shaking of suspensions
Incorrect dilution of small amounts of PO fluids
Incorrect administration of drugs via feeding tube
Inappropriate splitting of tablets
Incorrect dissolving/suspending of drugs for PO administration
PO formulations Withdrawing PO fluids with a syringe directly from the bottle Pouring excess fluid back into the bottle
Subcategory
Safety and hygienic problem (increased risk of overdosage and adverse drug reactions caused by administering the daily dose as single dose, e.g. in the morning)
Dosing problem (increased risk of over- and underdosage, adverse drug reactions and inefficacy, e.g. by adsorption of the drug to tubing or syringes) Dosing problem (increased risk of over- and underdosage, adverse drug reactions and inefficacy; change of the concentration of the ingredient in the bottle and therefore risk of incorrect dosages for further patients) Efficacy and safety problem (increased risk of drug incompatibilities, increased toxicity caused by potential chemical reactions, adverse drug reactions, inefficacy) Efficacy and safety problem (increased risk of loss of effectiveness, contamination of the surroundings with the ingredient) Efficacy and safety problem (increased risk of inefficacy, wrong dosages and adverse drug events)
Dosing problem (increased risk of adverse drug reactions, overdosages triggered by dose dumping, inefficacy) Efficacy problem (increased risk of adverse drug reactions, incompatibility, inefficacy, gastritis and plugging of the tube)
Hygienic problem (increased risk of infections, especially in immunosuppressed patients) Hygienic problem (increased risk of infections, especially in immunosuppressed patients) Dosing problem (increased risk of adverse drug reactions, underdosage and inefficacy)
Associated risks
3 (3/4)
4 (4/4)
2 (2/3)
3 (3/4)
4 (3/4)
3 (3/3)
3 (3/4)
4 (4/4)
4 (3/4)
2 (2/3)
2 (2/2)
Median (Q25/Q75) of clinical relevance
Table 1 Subcategories of medication errors in drug handling predefined by the expert panel and their estimated clinical relevance. The clinical relevance of each error type was defined by an independent survey in the expert panel on a scale from 1 = no clinical relevance, 2 = minor clinical relevance, 3 = clinical relevance to 4 = high clinical relevance.
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© 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 101–114
© 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 101–114 The prepared dosage deviated from the prescription in the patient file Guidelines and standards of hygiene were not followed IV drugs being instable when stored were stored after dissolution/opening The nurses administered out-of-date drugs
Incorrect dosage prepared
Incorrect storage after opening
Safety problem (increased risk of confusion of the drug and the patient) Safety problem (increased risk of consequential damage caused by frequent contact with carcinogenic, mutagenic and teratogenic drugs for nurses and family members of the patient) Hygienic and efficacy problem (increased risk of infections caused by uncertainty and further use of potentially out-of -date drugs, increased risk of inefficacy, toxicity and adverse drug reactions) Dosage problem (increased risk of adverse drug reactions, under- and overdosages, inefficacy and toxicity) Hygienic problem (increased risk of infections, especially in immunosuppressed patients) Hygienic and efficacy problem (increased risk of infections, inefficacy, toxicity and adverse drug reactions) Safety problem (increased risk of inefficacy, toxicity and adverse drug reactions) Including safety, efficacy and dosage problems
n.a.
3 (3/4)
4 (3/4)
3 (3/4)
4 (4/4)
3 (2/3)
3 (3/4)
4 (4/4)
n.a., not assessable. Clinical relevance was not assessed in the category ‘others’ because this category includes a range of different medication errors in drug handling, which may have different clinical relevance.
Others
Out-of-date drugs administered
Medication errors that do not fit into the mentioned categories
PO liquids or dissolved IV drugs were not labelled with the date of first opening or dissolution
Date of opening missing
Neglected hygiene
Self-protection, e.g. wearing gloves, was not done while handling or administering immunosuppressive, carcinogenic, mutagenic or teratogenic drugs
Prepared drugs were not labelled or labelled mistakable
3 (3/4)
3 (3/4)
Efficacy and safety problem (increased risk of adverse drug reactions, painful injection/infusion, irritation of veins, erroneous dosages caused by modified dissolving characteristics of the active ingredient) Efficacy and safety problem (increased risk of adverse drug reactions, painful injection/infusion, irritation of veins, erroneous dosages caused by modified dissolving characteristics of the active ingredient)
The IV drug was dissolved in a solvent that deviates from the manufacturers’ recommendation
The IV drug was dissolved in a volume that deviates from the manufacturers’ recommendation
3 (3/4)
Hygienic problem (increased risk of infections, especially in immunosuppressed patients)
Associated risks
Median (Q25/Q75) of clinical relevance
IV drugs not dissolved under aseptic conditions were stored after usage
Definition
No self-protection (occupational exposure risk)
Both formulations Wrong or missing labelling
Incorrect volume of solvent for IV drugs
IV formulations Incorrect storage after dissolving IV drugs (stability of the active ingredient warranted but microbial stability not guaranteed) Incorrect solvent for IV drugs
Subcategory
Table 1 (Continued)
Original article Preventing drug-handling errors in children
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Under those assumptions, a two-sided chi-squared test at a significance level of a = 005 and a sample size of 39 per group will provide a power of 1–b = 080 for the primary endpoint. We estimated that at least 20 working days of monitoring would be required in each period to include this number of patients. Data are presented as median with first and third quartiles (Q25/Q75). Comparisons of two groups were analysed by chi-squared test, Fisher’s exact test or two-sided Mann–Whitney U-test, as appropriate. Multilevel analysis to compare more than two groups was conducted for patients’ characteristics as well as for primary and secondary outcomes by chi-squared test, Kruskal–Wallis test and Steel–Dwass test, as appropriate. A p-value ≤005 was considered significant. Calculations were made using SIGMe, CA, ASTAT for Windows 3.5 (Systat Software, San Jos USA) and KYPLOT, version 2.0 beta 15 (32 bit; KyensLab Incorporated, Tokyo, Japan).
Results Participants All nurses (n = 37 in total of all monitoring periods, among whom 14 are student nurses and 35 are female nurses) who involved in drug handling on the ward at the
moment of monitoring agreed to participate. Of 20 nurses permanently employed on the ward at the moment of the questionnaire survey, 12 responded to the questionnaire (response rate: 60%). These nurses had a median age of 28 years (24/32) and a median (Q25/Q75) professional experience of eight years (3/12), and 83% of them were specialised in paediatric care. Nurses conducted drug-handling processes for 43 patients at baseline, 58 patients after intervention 1, 43 after intervention 2 and 51 after intervention 3. Table 2 presents further characteristics of these patients.
Frequency of medication errors in drug handling The number of patients with at least one medication error in the drug-handling process decreased from 38/43 (88%) at baseline to 25/51 (49%, p < 0001) after intervention 3 (Table 3). Altogether, we identified 1113 medication errors in 1920 drug-handling processes. From those, 527 errors were detected in 581 drug-handling processes at baseline (91%) and 116 errors were detected in 441 processes after intervention 3 (26%, p < 0001, Table 3). The frequency of 10 frequently detected error subgroups and the corresponding knowledge deficits assessed in the questionnaire are shown in Figs 1 and 2. Relating to different drug formula-
Table 2 Characteristics of patients in the baseline group and the intervention groups intervention 1–intervention 3
Patients (n) Female, n (%) Median age (years) (Q25/Q75) Median length of hospital stay (days) (Q25/Q75) Median (Q25/Q75) number of monitoring days per patient (n) Median (Q25/Q75) number of processes per patient Patients with previous transplantation (kidney and/or liver), n (%) Patients on dialysis, n (%) Reason for hospital stay Surgical procedures, n (%) Infections, n (%) Transplantation (kidney and/or liver), n (%)/ preparation of transplantation Biopsy, n (%) Kidney diseases (excluding biopsy, acute renal infection, and transplantation), n (%) Other diseases, n (%)
Baseline (B)
Intervention 1
Intervention 2
Intervention 3
Multilevel analysis
43 22 (51) 76 (24/137) 60 (40/140) 3 (1/6)
58 30 (52) 70 (23/119) 70 (50/135) 2 (1/2)
43 16 (37) 49 (18/148) 90 (50/190) 3 (1/6)
51 22 (43) 50 (19/111) 60 (40/90) 2 (1/4)
– p p p p
40 (20/105)
35 (10/78)
55 (10/115)
40 (20/85)
p = 0223
14 (33)
14 (24)
13 (30)
11 (22)
p = 0591
3 (7)
6 (10)
8 (19)
2 (4)
13 (30) 8 (19) 5 (12)
16 (28) 15 (26) 7 (12)
12 (28) 16 (37) 3 (7)
8 (16) 18 (35) 2 (4)
4 (9) 5 (12)
4 (7) 3 (5)
1 (2) 2 (5)
4 (8) 6 (12)
8 (19)
13 (22)
9 (21)
13 (25)
= = = =
0435 0784 0181 0159
n.a. p = 0337 p = 0179 n.a. n.a n.a. p = 0877
n.a. not assessable. The column ‘Multilevel analysis’ presents p-values of group comparison with Kruskal–Wallis test or chi-squared test with three degrees of freedom as appropriate.
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© 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 101–114
Original article
Preventing drug-handling errors in children
Table 3 Characteristics of processes and frequency of medication administration errors before (baseline) and after the interventions (intervention 1–intervention 3
All witnessed processes (n) Patients with at least one medication error, n (%) (primary outcome) Median (Q25/Q75) number of medication errors per patient (n) Median (Q25/Q75) number of medication errors per monitoring day per patient (n) Frequency of all witnessed medication errors, n (%) Median (Q25/Q75) number of medication errors per process (n)
Frequency of medication errors of clinical relevance category 2 (%) Frequency of medication errors of clinical relevance category 3 (%) Frequency of medication errors of clinical relevance category 4 (%) Processes free of medication errors, n (%)
Baseline (B)
Intervention 1 (I1)
581 38 (88)
400 46 (79)
2 (1/9)
2 (1/5,75)
1 (077/2)
1 (05/175)
Intervention 2 (I2) 498 31 (72)
Intervention 3 (I3)
Multilevel Analysis p-value
441 25 (49)
– B-I3: p < 0001 I1-I3: p < 0001
2 (0/5)
0 (0/15)
05 (0/134)
0 (0/05)
527 (91)
256 (64)
214 (43)
116 (26)
089 (076/107)
060 (044/077)
044 (039/054)
027 (013/035)
161/581 (28)
75/400 (19)
232/581 (40)
108/400 (27)
114/581 (20)
60/400 (15)
65/498 (13) 106/498 (21) 37/498 (7)
32/441 (7)
B-I1: p = 0004 B-I2 B-I3 I1-I3: p < 0001 I2-I3: p = 0002 p < 0001
53/441 (12)
p < 0001
25/441 (6)
p < 0001
211 (36)
191 (48)
319 (64)
341 (77)
Processes with one medication error, n (%)
237 (41)
167 (42)
148 (30)
85 (19)
Processes with two medication errors, n (%)
110 (19)
38 (10)
27 (5)
14 (3)
23 (4)
4 (1)
4 (1)
1 (0)
Processes with at least three medication errors, n (%)
B-I3: p < 0001 I1-I3: p = 0002 I2-I3: p = 0022 B-I2: p = 0033 B-I3: p < 0001 I1-I3 p < 0001 I2-I3: p = 0032 All comparisons p < 0001
B-I1: p = 0002 All other comparisons p < 0001 B-I2: p < 0001 B-I3: p < 0001 I1-I2: p < 0001 I2-I3: p = 0001 I1-I3: p < 0001 B-I1: p < 0001 B-I2: p < 0001 B-I3: p < 0001 I1-I3: p < 0001 n.a.
n.a. not assessable. The column ‘Multilevel analysis’ presents p-values of group comparison with Steel–Dwass test, Kruskal–Wallis test or chi-squared test with three degrees of freedom as appropriate. Comparisons of Steel–Dwass test with no significant p-value are not shown.
tions, medication errors in drug handling were almost twice as frequent in the baseline assessment for PO drugs with 114 medication errors/process (389/341) compared to IV drugs with 059 medication errors/process (138/233; p < 0001). The rate of medication errors decreased to 046 medication errors/process (93/203, p < 0001) for PO drugs and to 009 (22/238; p < 0001) for IV drugs after intervention 3. Only five medication errors were identified in rarely administered formulations such as subcutaneous, topical © 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 101–114
and inhalational drugs. Seven of 581 processes contained these drug formulations at baseline, 6/400 after intervention 1, 4/498 after intervention 2 and 0/441 after intervention 3. Among all drug groups, anti-infective and gastrointestinal agents, the most frequently administered drugs, had the highest error rates (Table 4). Error frequency decreased from 124–046 errors/gastrointestinal drug (p < 0001) and from 095 (baseline) to 023 errors/anti-infective drug (after intervention 3, p < 0001).
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Figure 1 Impact of a three-step training programme on the frequency of ten frequent medication errors in drug handling. Columns represent the frequency of medication errors at baseline (B) and after individual interventions [intervention 1 (I1), intervention 2 (I2) and intervention 3 (I3)]. The number of processes with an opportunity for the corresponding medication error ranged from 14 (‘Incorrect dissolving/suspending of drugs for PO administration’) to 310 (‘Mixing drugs’). Nonsignificant or nonassessable p-values are not shown.
Figure 2 Correlation of knowledge deficits of the nursing staff (%) assessed by the questionnaire with the frequency of medication administration errors at baseline concerning ten frequent subcategories. Medication errors refer to the number of processes with the opportunity for the corresponding medication error ranging from 30 (‘Incorrect dissolving/suspending of drugs for PO administration’) to 310 (‘Mixing drugs’).
Discussion Nearly 90% of our hospitalised children were affected by inappropriate drug handling. Identified errors were even more frequent in children than in adult inpatients (Bertsche
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et al. 2008a), stressing the need for effective interventions particularly for children. We performed a three-step intervention considering potential causes of medication errors in drug handling. The full intervention programme, including the handout, the training course and the reference book, © 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 101–114
Original article
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Table 4 Frequency of medication administration errors concerning the most frequently administered drug groups (more than 10% administered in at least two monitoring steps)
Anti-infective agents, n (%)
Gastrointestinal agents, n (%) Immunosuppressive agents (including glucocorticoids), n (%) Electrolytes (including micronutrients and mineral nutrients), n (%) Anticoagulants, n (%)
Baseline (B)
Intervention 1 (I1)
Intervention 2 (I2)
Intervention 3 (I3)
183/192 (95)
70/119 (59)
43/119 (36)
44/193 (23)
29/45 (64)
41/80 (51)
31/67 (46)
58/102 (57)
49/84 (58)
24/57 (42)
42/77 (55)
34/63 (54)
11/42 (26)
4/79 (5)
5/74 (7)
93/75 (124)
165/225 (73)
59/115 (51)
3/53 (6)
7/49 (14)
Multilevel analysis p-value* B-I1: p < 0001 B-I2: p < 0001 B-I3: p < 0001 I1-I2: p = 0029 I1-I3: p < 0001 B-I1: p < 0001 B-I2: p < 0001 B-I3: p < 0001 B-I3: p = 0031
B-I3: p = 0003 I1-I3: p = 0009 I2-I3: p = 0011 n.s.
*Comparisons of Steel–Dwass test with no significant p-value are not shown.
reduced the number of affected children from 88–49% and the error frequency in total from 91–26%. In adult patients, we detected a frequency of medication errors in drug handling of 61% [833 medication errors in 1376 drug-handling processes (Bertsche et al. 2008a)], which is lower than the observed frequency in children with 91%. However, in other studies that considered drug handling in paediatric patients, the frequency ranged from 19– 49% (Schneider et al. 1998, Bertsche et al. 2010, Ghaleb et al. 2010, Chedoe et al. 2012), which is not completely comparable to our data. These studies, however, often included only one dosage form (Bertsche et al. 2010) or did not monitor and analyse drug-handling processes in such detailed steps as we did, for instance ‘Pouring excess fluid back into the bottle’ (Schneider et al. 1998, Ghaleb et al. 2010, Chedoe et al. 2012). Mostly, IV drugs are known as complicated and error-prone dosage forms with a frequency of errors up to 74% (Kaushal et al. 2001, Anselmi et al. 2007, Parshuram et al. 2008, Westbrook et al. 2011); especially in children, IV drug preparation and administration is often much more complex and potentially more dangerous than in adults, because suitable formulations are frequently lacking (Taxis & Barber 2003a, McDowell et al. 2010, Uppal et al. 2011). Thus, drug preparation includes additional steps such as calculating the right volume of IV drugs, whereby new sources of potential errors are being created. Interestingly, in comparison with previous studies, in our study, particularly medication errors with PO dosage forms were almost twice as frequent as errors with IV drugs (with 114 vs. 059 errors/process). One reason for the higher © 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 101–114
frequency in PO drugs may be that nurses were aware of special requirements for the handling of IV drugs because they were often trained and taught (Taxis & Barber 2003b, Bertsche et al. 2008b, Westbrook et al. 2010). PO drugs, however, also have an high potential for errors, especially in paediatric patients where additional steps such as splitting, crushing or measuring the right dose of PO liquids become necessary (Bertsche et al. 2010, Nunn et al. 2013). We are not aware of any similar additive three-step intervention strategy considering PO and IV drugs as well as diverse detailed subcategories of errors that effectively reduced the high frequency of medication errors in drug handling. As expected, the three intervention steps were not uniformly successful across all error subcategories. To give an example, the frequent subcategory ‘Incorrect volume of solvent for IV drugs’ was associated with a knowledge deficit of 66% and its frequency decreased to 25% by intervention 1, suggesting that this error was mainly caused by knowledge deficits and memory lapses. In contrast, we also detected frequent errors in the absence of knowledge deficits such as ‘No shaking of suspension’ with a baseline error frequency of 63%, which may result in dosage problems (Kwon et al. 1996, Deicke & S€ uverkr€ up 1999, 2000). The frequency decreased to 41% by intervention 1, suggesting that suspensions were not shaken due to memory lapses. Errors in the subcategory ‘No self-protection’, which constitute a safety risk for nurses (DeMeo et al. 1995), however, may be caused by a mix of rule violations and action-based slips, because intervention 1 did not reduce the high frequency (up to 85%). The training course (inter-
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vention 2), which provided backgrounds to existing rules and potential adverse patient outcomes, substantially reduced the frequency of mainly rule-based errors, such as ‘No self-protection’. Issue of the reference book (intervention 3) as a readily and constantly available source of information and a two-week familiarisation phase with the book further reduced the frequency of errors in many subcategories. According to previous studies, our study also highlighted that anti-infective drugs were often involved in medication errors, which may lead to ADEs for the children (Kaushal et al. 2001, Bertsche et al. 2008a, Gonzales 2010). Gastrointestinal therapeutics are also known as error-prone drugs. Errors in drug handling such as crushing proton pump inhibitors (Cornish 2005, Bertsche et al. 2010) or administering undiluted ranitidine may lead to ADEs especially in paediatric patients (Terrin et al. 2011, Summary of product characteristics 2013). In order to be able to identify detailed medication errors, we used monitoring as one of the most reliable detection methods (Mays & Pope 1995, Dean & Barber 2001, Flynn et al. 2002). To minimise the influence of monitors’ expectation on the study data (Rosenthal effect) as well as to avoid fatigue in objective process documentation (Dean & Barber 2001), we performed the monitoring after each intervention by another monitor. A predefined checklist for documentation, training of the monitors and supervision by a senior pharmacist assured quality of the assessments in all study periods. Self-reporting of medication errors, as another often-used detection method (Tang et al. 2007, Alper et al. 2012), largely underestimates the real frequency of errors, and knowledge- and memory-based errors remain undetected (Mays & Pope 1995). Furthermore, special characteristics and practical handling aspects of daily routine on the ward cannot be considered while developing intervention methods. Nurses often did not adhere to guidelines or protocols, which stresses the need for the existence of rules that are feasible to implement in a daily routine by clinical nurses (Davis et al. 2009, Gill et al. 2012, Kim & Bates 2012). Recently, considerable effort has been made to reduce medication errors in drug prescription, for example by implementing computerised physician order entry (CPOE), clinical decision support systems (CDSS) or ward-based pharmacy services (Seidling et al. 2011, Maat et al. 2012, Fernandez-Llamazares et al. 2013, Zaal et al. 2013). Drug handling, however, is often neglected. Due to the growing pharmaceutical market, drug handling becomes ever more complicated. Besides new agents and an increased number of generic products, new dosage forms are also developed
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that may challenge nurses in daily drug handling; especially, dosage forms such as inhalational drugs, pens but also IV and PO forms in paediatric patients require special skills to handle them correctly (Bertsche et al. 2010, Uppal et al. 2011). Pharmaceutical intervention systems or ward-based pharmacy services mainly addressed drug prescription by physicians regarding dosages, double-prescription, side effects, drug–drug interactions or contraindications (Seidling et al. 2010, Maat et al. 2012, Zaal et al. 2013). Unit dose dispensing, as one example for ward-based pharmacy service to support nurses (Poley et al. 2004), is not yet routinely implemented in most of the hospitals (Berdot et al. 2012). Therefore, most of the time nurses are in charge of drug handling, including drug preparation and administration. These processes and problems arising during handling are generally not part of the pharmacy services. We would like to call attention to the need to better support nurses during the drug-handling process. Our three-step intervention system may be one possibility to support nurses and therefore to reduce medication errors in drug handling. To implement such a system in daily routine, we suggest conducting a monitoring phase to scrutinise ward-specific habits of the drug-handling processes in sufficient detail to subsequently tailor targeted interventions. A monitoring phase will be necessary because medication errors may differ from one ward to another, and a questionnaire survey is effective in detecting knowledge deficits. If possible, training courses by a clinical pharmacist should be implemented in daily routine and should contain all relevant details of drug-handling processes. The aim of continuous training courses is to remind and to raise the nurses’ awareness of the need for correct and safe drug handling. A reference book both enhances the training of nurses and supports them in daily routine. The three-step intervention aimed at transferring theoretical knowledge as well as practical skills in daily routine. With this study, we demonstrate that drug-handling processes are particularly prone to errors and nurses should be supported in order to avoid these medication errors, which have the potential of resulting in serious ADEs.
Limitations While this study showed a high frequency of handling errors, we are aware of potential limitations. We focused on medication errors in drug handling and assessed their potential risk, but we did not analyse ADEs caused by these errors. Furthermore, we did not include weekend, evening and night shifts in the monitoring and did not assess errors © 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 101–114
Original article
Preventing drug-handling errors in children
in drug prescription by physicians. Therefore, our frequency likely underestimates the real total frequency of medication errors (Miller et al. 2010). Another limitation may be an observation bias, possibly induced by the presence of a monitor (Hawthorne effect). To minimise this effect, we conducted a test phase on the ward to make the nurses familiar with the monitor before starting the study (Dean & Barber 2001). Additionally, we did not design our study to quantify cost. However, even if the monitoring procedure appears staff-intensive, costs might ultimately be saved if ADEs and subsequent prolongations of hospital stay are avoided (Bates et al. 1997, Classen et al. 1997, Easton et al. 2004) and there is likely no better efficient way to detect handling errors truly occurring in a given setting. This is important because required medication handling skills obviously depend on the type of medication and thus on the patient population, which, however, largely varies between wards.
Conclusion Drug-handling processes in a paediatric ward are remarkably prone to medication errors. A detailed assessment is suitable to reveal this high number of errors. By developing prevention programmes, the multitude of possible causes of errors such as knowledge deficits, action-based slips, rule violations and memory-based lapses must be considered. A three-step intervention consisting of a handout, a training course and a reference book substantially reduced incorrect processes and the number of patients affected by at least one error in drug-handling processes.
found that the frequency and type of medication errors are very much dependent on patient population and setting. However, errors can easily be identified by direct observation (ward monitoring). This way, medication errors are assessable in routine care considering sufficient detail, and therefore, efficient and effective corrective action can be defined. To be successful, however, strategies have to consider that error causes are multifactorial.
Acknowledgement We would like to thank all nurses and physicians who participated in this study for their kind support and Dr. Thomas Weber for language editing of the manuscript.
Disclosure The authors have confirmed that all authors meet the ICMJE criteria for authorship credit (www.icmje.org/ethi cal_1author.html), as follows: (1) substantial contributions to conception and design of, or acquisition of data or analysis and interpretation of data, (2) drafting the article or revising it critically for important intellectual content, and (3) final approval of the version to be published.
Funding This work was founded by the University of Heidelberg, the Free State of Saxony and the Federal State of BadenWuerttemberg. D. Niemann’s work was supported by a grant from the German National Academic Foundation.
Relevance to clinical practice
Conflict of interest
In most hospitals worldwide, nurses are in charge of drug handling, including drug preparation and drug administration. Errors in this field, however, are largely ignored. We
The authors declare that they have no conflict of interest regarding this paper.
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A prospective three-step intervention study to prevent medication errors in drug handling in paediatric care Dorothee Niemann, Astrid Bertsche, David Meyrath, Ellen D Koepf, Carolin Traiser, Katja Seebald, Claus P Schmitt, Georg F Hoffmann, Walter E Haefeli and Thilo Bertsche
Aims and objectives. To prevent medication errors in drug handling in a paediatric ward. Background. One in five preventable adverse drug events in hospitalised children is caused by medication errors. Errors in drug prescription have been studied frequently, but data regarding drug handling, including drug preparation and administration, are scarce. Design. A three-step intervention study including monitoring procedure was used to detect and prevent medication errors in drug handling. Methods. After approval by the ethics committee, pharmacists monitored drug handling by nurses on an 18-bed paediatric ward in a university hospital prior to and following each intervention step. They also conducted a questionnaire survey aimed at identifying knowledge deficits. Each intervention step targeted different causes of errors. The handout mainly addressed knowledge deficits, the training course addressed errors caused by rule violations and slips, and the reference book addressed knowledge-, memory- and rule-based errors. Results. The number of patients who were subjected to at least one medication error in drug handling decreased from 38/43 (88%) to 25/51 (49%) following the third intervention, and the overall frequency of errors decreased from 527 errors in 581 processes (91%) to 116/441 (26%). The issue of the handout reduced medication errors caused by knowledge deficits regarding, for instance, the correct ‘volume of solvent for IV drugs’ from 49–25%.
What does this paper contribute to the wider global clinical community?
• During daily routine in wards,
•
•
drug handling, including drug preparation and drug administration, is prone to medication errors. A detailed assessment of drughandling processes and medication errors such as a monitoring procedure is an appropriate method to detect these errors. A three-step intervention considering the different causes of errors has been developed, implemented and shown effective to prevent medication errors in a controlled study.
Authors: Dorothee Niemann, Pharmacist, Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg and Department of Clinical Pharmacy, University of Leipzig, Leipzig; Astrid Bertsche, MD, Senior Physician, University Children’s Hospital, University of Heidelberg, Heidelberg and Department of Women and Child Health, Hospital for Children and Adolescents, Center for Pediatric Research, University of Leipzig, Leipzig; David Meyrath, Pharmacist, Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg; Ellen D Koepf, Pharmacist, Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg; Carolin Traiser, Pharmacist, Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg; Katja Seebald, Head Nurse, University Children’s Hospital, University of Heidelberg, Heidelberg; Claus P
Schmitt, MD, Senior Physician, University Children’s Hospital, University of Heidelberg, Heidelberg; Georg F Hoffmann, MD, Head of the Paediatric Center, University Children’s Hospital, University of Heidelberg, Heidelberg; Walter E Haefeli, MD, Head of the Department Clinical Pharmacology and Pharmacoepidemiology, Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg; Thilo Bertsche, PhD, Pharmacist and Head of the Department Clinical Pharmacy, Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg and Department of Clinical Pharmacy, University of Leipzig, Leipzig, Germany Correspondence: Thilo Bertsche, Pharmacist and Head, Department of Clinical Pharmacy, University of Leipzig, Eilenburger Strasse 15a, 04317 Leipzig, Germany. Telephone: +49 3 41 9 73 66 00. E-mail: [email protected]
© 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 101–114, doi: 10.1111/jocn.12592
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Conclusion. Paediatric drug handling is prone to errors. A three-step intervention effectively decreased the high frequency of medication errors by addressing the diversity of their causes. Relevance to clinical practice. Worldwide, nurses are in charge of drug handling, which constitutes an error-prone but often-neglected step in drug therapy. Detection and prevention of errors in daily routine is necessary for a safe and effective drug therapy. Our three-step intervention reduced errors and is suitable to be tested in other wards and settings.
Key words: causes of errors, child, drug handling, intervention studies, medication error, nursing, quality of health care Accepted for publication: 14 February 2014
Introduction and background Each year, up to 158,520 children in the USA are treated in the emergency department for adverse drug events (ADEs) (Cohen et al. 2008b). Up to 42,000 paediatric inpatients in the USA experience a preventable ADE (Woods et al. 2005), which may lead to prolongation of hospital stay (Ahuja et al. 2012, Silva et al. 2013). Of these ADEs, up to 21% are caused by medication errors (Woods et al. 2005, Agarwal et al. 2010), which are defined as failure in the treatment process that results in, or has the potential of resulting in, harm to the patient (Ferner & Aronson 2006). Each step in the medication process from drug prescription to drug administration is prone to errors (Phillips et al. 2001, Ferner & Aronson 2006). Much effort has been made to improve drug prescription (Zaal et al. 2013). Studies regarding errors in the drug-handling process, including both the preparation and the administration of drugs, are not common despite the fact that drug handling causes up to 60% of all medication errors (Bertsche et al. 2008a, Berdot et al. 2012). Studies have most often focused on preventing one special type of error such as drug incompatibilities, dosage calculation errors or errors in the type of administration such as intravenous (IV) or peroral (PO) (Bertsche et al. 2008b, 2010, Sherriff et al. 2012, PaulyO’Neill & Prion 2013). Frequently, nurses are in charge of drug handling. Particularly in paediatric care, the complexity of drug-handling processes exceeds that of processes for adult patients. This is mainly caused by a limited number of appropriate dosages and dosage forms for children (Wong et al. 2008) or resulting from refusal of children to take their medicine (Cohen et al. 2008a, van Riet-Nales et al. 2013). Therefore, additional steps in drug handling such as crushing or splitting of tablets become necessary,
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resulting in additional sources of potential medication errors and potential ADEs for the patients (Cornish 2005, Bohomol et al. 2009, Nunn et al. 2013). In a previous study, we assessed the quality of peroral (PO) drug handling in hospitalised children and managed to reduce the high rate of medication errors by up to 80% through a single-step intervention (Bertsche et al. 2010). The intervention, however, was not tailored to a number of possible causes of errors such as knowledge deficits, action-based slips, rule violations and memory-based lapses (Norman 1981, Taxis & Barber 2003a, Ferner & Aronson 2006, Bertsche et al. 2008a, Ndosi & Newell 2009). Knowledge deficits may lead to errors in drug-handling processes due to a lack of necessary knowledge to conduct these processes without faults (Ferner & Aronson 2006, Bertsche et al. 2008a). Memory-based lapses, however, are skill-based errors that occur when nurses carry out a correctly planned action but forget relevant details (Taxis & Barber 2003a, Ferner & Aronson 2006). Action-based slips are also skillbased errors that accidentally occur during an action (Taxis & Barber 2003a, Ferner & Aronson 2006) and are defined as the performance of an action that was not intended (Norman 1981). Rule-based errors, however, occur if an existing rule is violated (rule violation); they can be made unconsciously or consciously (Taxis & Barber 2003a, Ferner & Aronson 2006, Alper et al. 2012, Gill et al. 2012). Given the multitude of causes (Taxis & Barber 2003a, Bertsche et al. 2008a) for medication errors and different dosage forms, it appeared unlikely to maximise success rates with a single intervention. In this study, by contrast, we evaluated the frequency of medication errors in drug-handling processes and developed a three-step intervention considering different dosage forms and causes of errors, to support nurses in daily routine and to prevent medication errors in drug handling. © 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 101–114
Original article
Patients and methods Setting Following the approval of the Ethics Committee of the Faculty of Medicine of the University of Heidelberg, we performed a prospective intervention study on an 18-bed paediatric ward in a 177-bed children’s hospital of a 1918bed university hospital with tertiary care. The ward specialised in kidney, liver and gastroenterological diseases. No strategies aiming at improving the quality of drug prescription and administration such as pharmacy chart review, electronic prescribing tools or a unit dose system had been implemented on this ward.
Study protocol We aimed to comprehensively assess and prevent medication errors in drug-handling processes as defined by any deviation from internal and external drug preparation/ administration guidelines, the corresponding summaries of product characteristics or manufacturers’ recommendations. Processes included all consecutive drug-handling steps carried out by one nurse. All nurses working in the ward during the monitoring were invited to take part in the study. We also included student nurses in the monitoring because they were frequently involved in drug-handling processes, working under supervision of an experienced nurse. Four trained pharmacists monitored and documented drug-handling processes according to a predefined checklist. The checklist was developed and tested by an expert panel of clinical pharmacists, clinical pharmacologists, nurses and paediatricians (n = 21) in consideration of former studies (Bertsche et al. 2008a,b, 2010), actual literature (Schneider et al. 1998, Kaushal et al. 2001, Cornish 2005, Parshuram et al. 2008, Wong et al. 2008), summaries of product characteristics and internal and external guidelines. We monitored drug handling in the morning hours (from 730–10 a.m.) before any intervention was implemented (baseline) and after each of three intervention steps (intervention 1, intervention 2 and intervention 3). Each monitoring phase lasted 20 working days. A senior pharmacist trained the monitors in a two-day course, checked their documentation daily to assure adequate monitoring quality and rated documented errors according to a predefined list of 22 error subcategories (Table 1). The potential clinical relevance of each error subcategory was assessed in an independent survey by the expert panel on a scale from 1 = no clinical relevance, 2 = minor clinical relevance, 3 = clinical relevance to 4 = high clinical relevance. Following the baseline moni© 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 101–114
Preventing drug-handling errors in children
toring, we conducted a questionnaire survey to detect the knowledge of nurses regarding drug handling. The questionnaire included questions about the appropriateness of routine drug-handling processes, knowledge about IV drugs and the necessity of shaking suspensions. Knowledge deficits were defined as wrong or missing answers in the questionnaire. Subsequently, we conducted a three-step intervention of drug-handling processes carried out by nurses, of which each step was tailored to each of the causes of errors identified by analysing the results of the questionnaire. Intervention 1, the issue of a three-page handout, predominantly addressed errors resulting from knowledge deficits and memory-based lapses and included short handling information about drug-handling processes identified by the results of our questionnaire. In intervention 2, offering of a 60-minute training course, the senior pharmacist explained practical handling guidelines and gave background information to existing rules. Intervention 2 aimed at preventing errors that were likely caused by slips, rule violations or memory-based lapses. We offered the course several times during a two-week period in order to provide as many nurses as possible the opportunity to take part in the training course. Intervention 3, the issue of a 56-page comprehensive reference book, included detailed information concerning drug handling. It focused on knowledge-, memory- and rule-based errors. The nurses received the reference book six months after being monitored following their enrolment in intervention 2. The break of six months was chosen to check also the sustainability of the first intervention steps and to give the nurses the possibility to get familiar with the content of interventions 1 and 2.
Outcomes As the primary outcome, we defined the number of patients with at least one identified medication error in the drughandling process before (baseline) and after the three-step intervention. As secondary outcomes, we defined the overall frequency of errors, errors per observed process and errors per patient.
Statistical analysis According to the findings of the preceding test phase and considering the results of our former study (Bertsche et al. 2010), we expected that in at least 80% of patients monitored, a medication error would be identified at baseline. A reduction by half, that is, to ≤40% by the overall (threestep) intervention, was considered clinically relevant (i.e. a frequency of medication errors in ≤50% of the patients).
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104 Drugs were mixed by crushing or suspending before administering the mixture to the patient Moisture- or light-sensitive drugs were removed from the blister more than half an hour too early before administration Tablets and capsules as prepared by the nightshift nurses deviate from patient file, e.g. ibuprofen 200 mg was prescribed as a tablet and the nightshift nurse forgot to prepare this tablet for the patient, or prepared a wrong dose or a wrong dosage form. When the mistake was detected by the morning shift, the monitor documented the deviation The daily dose of PO liquids, especially electrolyte solutions, was prepared in one syringe
Mixing drugs
Taking drugs too early out of the blister
Preparing the dosage for multiple administrations during the day for one patient in one syringe
Incorrect drug preparation by the night shift
Shaking of suspensions (PO liquids) was not done before use
PO drugs were administered via a feeding tube deviating from guidelines, standards, or drug label, e.g. without checking the location of the tube, or without flushing the tube with water between drug administrations The nurses did not dilute small amounts of PO liquids (mostly drops) or diluted them wrongly
The nurse withdrew PO fluids with a syringe directly from the bottle without using a special adapter, or a cup The nurse withdrew too much of a PO liquid and poured excess amounts back into the bottle Tablets or capsules were dissolved/suspended for PO administration deviating from guidelines, standards or drug label Tablets were split that must not be split
Definition
No shaking of suspensions
Incorrect dilution of small amounts of PO fluids
Incorrect administration of drugs via feeding tube
Inappropriate splitting of tablets
Incorrect dissolving/suspending of drugs for PO administration
PO formulations Withdrawing PO fluids with a syringe directly from the bottle Pouring excess fluid back into the bottle
Subcategory
Safety and hygienic problem (increased risk of overdosage and adverse drug reactions caused by administering the daily dose as single dose, e.g. in the morning)
Dosing problem (increased risk of over- and underdosage, adverse drug reactions and inefficacy, e.g. by adsorption of the drug to tubing or syringes) Dosing problem (increased risk of over- and underdosage, adverse drug reactions and inefficacy; change of the concentration of the ingredient in the bottle and therefore risk of incorrect dosages for further patients) Efficacy and safety problem (increased risk of drug incompatibilities, increased toxicity caused by potential chemical reactions, adverse drug reactions, inefficacy) Efficacy and safety problem (increased risk of loss of effectiveness, contamination of the surroundings with the ingredient) Efficacy and safety problem (increased risk of inefficacy, wrong dosages and adverse drug events)
Dosing problem (increased risk of adverse drug reactions, overdosages triggered by dose dumping, inefficacy) Efficacy problem (increased risk of adverse drug reactions, incompatibility, inefficacy, gastritis and plugging of the tube)
Hygienic problem (increased risk of infections, especially in immunosuppressed patients) Hygienic problem (increased risk of infections, especially in immunosuppressed patients) Dosing problem (increased risk of adverse drug reactions, underdosage and inefficacy)
Associated risks
3 (3/4)
4 (4/4)
2 (2/3)
3 (3/4)
4 (3/4)
3 (3/3)
3 (3/4)
4 (4/4)
4 (3/4)
2 (2/3)
2 (2/2)
Median (Q25/Q75) of clinical relevance
Table 1 Subcategories of medication errors in drug handling predefined by the expert panel and their estimated clinical relevance. The clinical relevance of each error type was defined by an independent survey in the expert panel on a scale from 1 = no clinical relevance, 2 = minor clinical relevance, 3 = clinical relevance to 4 = high clinical relevance.
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© 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 101–114
© 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 101–114 The prepared dosage deviated from the prescription in the patient file Guidelines and standards of hygiene were not followed IV drugs being instable when stored were stored after dissolution/opening The nurses administered out-of-date drugs
Incorrect dosage prepared
Incorrect storage after opening
Safety problem (increased risk of confusion of the drug and the patient) Safety problem (increased risk of consequential damage caused by frequent contact with carcinogenic, mutagenic and teratogenic drugs for nurses and family members of the patient) Hygienic and efficacy problem (increased risk of infections caused by uncertainty and further use of potentially out-of -date drugs, increased risk of inefficacy, toxicity and adverse drug reactions) Dosage problem (increased risk of adverse drug reactions, under- and overdosages, inefficacy and toxicity) Hygienic problem (increased risk of infections, especially in immunosuppressed patients) Hygienic and efficacy problem (increased risk of infections, inefficacy, toxicity and adverse drug reactions) Safety problem (increased risk of inefficacy, toxicity and adverse drug reactions) Including safety, efficacy and dosage problems
n.a.
3 (3/4)
4 (3/4)
3 (3/4)
4 (4/4)
3 (2/3)
3 (3/4)
4 (4/4)
n.a., not assessable. Clinical relevance was not assessed in the category ‘others’ because this category includes a range of different medication errors in drug handling, which may have different clinical relevance.
Others
Out-of-date drugs administered
Medication errors that do not fit into the mentioned categories
PO liquids or dissolved IV drugs were not labelled with the date of first opening or dissolution
Date of opening missing
Neglected hygiene
Self-protection, e.g. wearing gloves, was not done while handling or administering immunosuppressive, carcinogenic, mutagenic or teratogenic drugs
Prepared drugs were not labelled or labelled mistakable
3 (3/4)
3 (3/4)
Efficacy and safety problem (increased risk of adverse drug reactions, painful injection/infusion, irritation of veins, erroneous dosages caused by modified dissolving characteristics of the active ingredient) Efficacy and safety problem (increased risk of adverse drug reactions, painful injection/infusion, irritation of veins, erroneous dosages caused by modified dissolving characteristics of the active ingredient)
The IV drug was dissolved in a solvent that deviates from the manufacturers’ recommendation
The IV drug was dissolved in a volume that deviates from the manufacturers’ recommendation
3 (3/4)
Hygienic problem (increased risk of infections, especially in immunosuppressed patients)
Associated risks
Median (Q25/Q75) of clinical relevance
IV drugs not dissolved under aseptic conditions were stored after usage
Definition
No self-protection (occupational exposure risk)
Both formulations Wrong or missing labelling
Incorrect volume of solvent for IV drugs
IV formulations Incorrect storage after dissolving IV drugs (stability of the active ingredient warranted but microbial stability not guaranteed) Incorrect solvent for IV drugs
Subcategory
Table 1 (Continued)
Original article Preventing drug-handling errors in children
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Under those assumptions, a two-sided chi-squared test at a significance level of a = 005 and a sample size of 39 per group will provide a power of 1–b = 080 for the primary endpoint. We estimated that at least 20 working days of monitoring would be required in each period to include this number of patients. Data are presented as median with first and third quartiles (Q25/Q75). Comparisons of two groups were analysed by chi-squared test, Fisher’s exact test or two-sided Mann–Whitney U-test, as appropriate. Multilevel analysis to compare more than two groups was conducted for patients’ characteristics as well as for primary and secondary outcomes by chi-squared test, Kruskal–Wallis test and Steel–Dwass test, as appropriate. A p-value ≤005 was considered significant. Calculations were made using SIGMe, CA, ASTAT for Windows 3.5 (Systat Software, San Jos USA) and KYPLOT, version 2.0 beta 15 (32 bit; KyensLab Incorporated, Tokyo, Japan).
Results Participants All nurses (n = 37 in total of all monitoring periods, among whom 14 are student nurses and 35 are female nurses) who involved in drug handling on the ward at the
moment of monitoring agreed to participate. Of 20 nurses permanently employed on the ward at the moment of the questionnaire survey, 12 responded to the questionnaire (response rate: 60%). These nurses had a median age of 28 years (24/32) and a median (Q25/Q75) professional experience of eight years (3/12), and 83% of them were specialised in paediatric care. Nurses conducted drug-handling processes for 43 patients at baseline, 58 patients after intervention 1, 43 after intervention 2 and 51 after intervention 3. Table 2 presents further characteristics of these patients.
Frequency of medication errors in drug handling The number of patients with at least one medication error in the drug-handling process decreased from 38/43 (88%) at baseline to 25/51 (49%, p < 0001) after intervention 3 (Table 3). Altogether, we identified 1113 medication errors in 1920 drug-handling processes. From those, 527 errors were detected in 581 drug-handling processes at baseline (91%) and 116 errors were detected in 441 processes after intervention 3 (26%, p < 0001, Table 3). The frequency of 10 frequently detected error subgroups and the corresponding knowledge deficits assessed in the questionnaire are shown in Figs 1 and 2. Relating to different drug formula-
Table 2 Characteristics of patients in the baseline group and the intervention groups intervention 1–intervention 3
Patients (n) Female, n (%) Median age (years) (Q25/Q75) Median length of hospital stay (days) (Q25/Q75) Median (Q25/Q75) number of monitoring days per patient (n) Median (Q25/Q75) number of processes per patient Patients with previous transplantation (kidney and/or liver), n (%) Patients on dialysis, n (%) Reason for hospital stay Surgical procedures, n (%) Infections, n (%) Transplantation (kidney and/or liver), n (%)/ preparation of transplantation Biopsy, n (%) Kidney diseases (excluding biopsy, acute renal infection, and transplantation), n (%) Other diseases, n (%)
Baseline (B)
Intervention 1
Intervention 2
Intervention 3
Multilevel analysis
43 22 (51) 76 (24/137) 60 (40/140) 3 (1/6)
58 30 (52) 70 (23/119) 70 (50/135) 2 (1/2)
43 16 (37) 49 (18/148) 90 (50/190) 3 (1/6)
51 22 (43) 50 (19/111) 60 (40/90) 2 (1/4)
– p p p p
40 (20/105)
35 (10/78)
55 (10/115)
40 (20/85)
p = 0223
14 (33)
14 (24)
13 (30)
11 (22)
p = 0591
3 (7)
6 (10)
8 (19)
2 (4)
13 (30) 8 (19) 5 (12)
16 (28) 15 (26) 7 (12)
12 (28) 16 (37) 3 (7)
8 (16) 18 (35) 2 (4)
4 (9) 5 (12)
4 (7) 3 (5)
1 (2) 2 (5)
4 (8) 6 (12)
8 (19)
13 (22)
9 (21)
13 (25)
= = = =
0435 0784 0181 0159
n.a. p = 0337 p = 0179 n.a. n.a n.a. p = 0877
n.a. not assessable. The column ‘Multilevel analysis’ presents p-values of group comparison with Kruskal–Wallis test or chi-squared test with three degrees of freedom as appropriate.
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Table 3 Characteristics of processes and frequency of medication administration errors before (baseline) and after the interventions (intervention 1–intervention 3
All witnessed processes (n) Patients with at least one medication error, n (%) (primary outcome) Median (Q25/Q75) number of medication errors per patient (n) Median (Q25/Q75) number of medication errors per monitoring day per patient (n) Frequency of all witnessed medication errors, n (%) Median (Q25/Q75) number of medication errors per process (n)
Frequency of medication errors of clinical relevance category 2 (%) Frequency of medication errors of clinical relevance category 3 (%) Frequency of medication errors of clinical relevance category 4 (%) Processes free of medication errors, n (%)
Baseline (B)
Intervention 1 (I1)
581 38 (88)
400 46 (79)
2 (1/9)
2 (1/5,75)
1 (077/2)
1 (05/175)
Intervention 2 (I2) 498 31 (72)
Intervention 3 (I3)
Multilevel Analysis p-value
441 25 (49)
– B-I3: p < 0001 I1-I3: p < 0001
2 (0/5)
0 (0/15)
05 (0/134)
0 (0/05)
527 (91)
256 (64)
214 (43)
116 (26)
089 (076/107)
060 (044/077)
044 (039/054)
027 (013/035)
161/581 (28)
75/400 (19)
232/581 (40)
108/400 (27)
114/581 (20)
60/400 (15)
65/498 (13) 106/498 (21) 37/498 (7)
32/441 (7)
B-I1: p = 0004 B-I2 B-I3 I1-I3: p < 0001 I2-I3: p = 0002 p < 0001
53/441 (12)
p < 0001
25/441 (6)
p < 0001
211 (36)
191 (48)
319 (64)
341 (77)
Processes with one medication error, n (%)
237 (41)
167 (42)
148 (30)
85 (19)
Processes with two medication errors, n (%)
110 (19)
38 (10)
27 (5)
14 (3)
23 (4)
4 (1)
4 (1)
1 (0)
Processes with at least three medication errors, n (%)
B-I3: p < 0001 I1-I3: p = 0002 I2-I3: p = 0022 B-I2: p = 0033 B-I3: p < 0001 I1-I3 p < 0001 I2-I3: p = 0032 All comparisons p < 0001
B-I1: p = 0002 All other comparisons p < 0001 B-I2: p < 0001 B-I3: p < 0001 I1-I2: p < 0001 I2-I3: p = 0001 I1-I3: p < 0001 B-I1: p < 0001 B-I2: p < 0001 B-I3: p < 0001 I1-I3: p < 0001 n.a.
n.a. not assessable. The column ‘Multilevel analysis’ presents p-values of group comparison with Steel–Dwass test, Kruskal–Wallis test or chi-squared test with three degrees of freedom as appropriate. Comparisons of Steel–Dwass test with no significant p-value are not shown.
tions, medication errors in drug handling were almost twice as frequent in the baseline assessment for PO drugs with 114 medication errors/process (389/341) compared to IV drugs with 059 medication errors/process (138/233; p < 0001). The rate of medication errors decreased to 046 medication errors/process (93/203, p < 0001) for PO drugs and to 009 (22/238; p < 0001) for IV drugs after intervention 3. Only five medication errors were identified in rarely administered formulations such as subcutaneous, topical © 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 101–114
and inhalational drugs. Seven of 581 processes contained these drug formulations at baseline, 6/400 after intervention 1, 4/498 after intervention 2 and 0/441 after intervention 3. Among all drug groups, anti-infective and gastrointestinal agents, the most frequently administered drugs, had the highest error rates (Table 4). Error frequency decreased from 124–046 errors/gastrointestinal drug (p < 0001) and from 095 (baseline) to 023 errors/anti-infective drug (after intervention 3, p < 0001).
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Figure 1 Impact of a three-step training programme on the frequency of ten frequent medication errors in drug handling. Columns represent the frequency of medication errors at baseline (B) and after individual interventions [intervention 1 (I1), intervention 2 (I2) and intervention 3 (I3)]. The number of processes with an opportunity for the corresponding medication error ranged from 14 (‘Incorrect dissolving/suspending of drugs for PO administration’) to 310 (‘Mixing drugs’). Nonsignificant or nonassessable p-values are not shown.
Figure 2 Correlation of knowledge deficits of the nursing staff (%) assessed by the questionnaire with the frequency of medication administration errors at baseline concerning ten frequent subcategories. Medication errors refer to the number of processes with the opportunity for the corresponding medication error ranging from 30 (‘Incorrect dissolving/suspending of drugs for PO administration’) to 310 (‘Mixing drugs’).
Discussion Nearly 90% of our hospitalised children were affected by inappropriate drug handling. Identified errors were even more frequent in children than in adult inpatients (Bertsche
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et al. 2008a), stressing the need for effective interventions particularly for children. We performed a three-step intervention considering potential causes of medication errors in drug handling. The full intervention programme, including the handout, the training course and the reference book, © 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 101–114
Original article
Preventing drug-handling errors in children
Table 4 Frequency of medication administration errors concerning the most frequently administered drug groups (more than 10% administered in at least two monitoring steps)
Anti-infective agents, n (%)
Gastrointestinal agents, n (%) Immunosuppressive agents (including glucocorticoids), n (%) Electrolytes (including micronutrients and mineral nutrients), n (%) Anticoagulants, n (%)
Baseline (B)
Intervention 1 (I1)
Intervention 2 (I2)
Intervention 3 (I3)
183/192 (95)
70/119 (59)
43/119 (36)
44/193 (23)
29/45 (64)
41/80 (51)
31/67 (46)
58/102 (57)
49/84 (58)
24/57 (42)
42/77 (55)
34/63 (54)
11/42 (26)
4/79 (5)
5/74 (7)
93/75 (124)
165/225 (73)
59/115 (51)
3/53 (6)
7/49 (14)
Multilevel analysis p-value* B-I1: p < 0001 B-I2: p < 0001 B-I3: p < 0001 I1-I2: p = 0029 I1-I3: p < 0001 B-I1: p < 0001 B-I2: p < 0001 B-I3: p < 0001 B-I3: p = 0031
B-I3: p = 0003 I1-I3: p = 0009 I2-I3: p = 0011 n.s.
*Comparisons of Steel–Dwass test with no significant p-value are not shown.
reduced the number of affected children from 88–49% and the error frequency in total from 91–26%. In adult patients, we detected a frequency of medication errors in drug handling of 61% [833 medication errors in 1376 drug-handling processes (Bertsche et al. 2008a)], which is lower than the observed frequency in children with 91%. However, in other studies that considered drug handling in paediatric patients, the frequency ranged from 19– 49% (Schneider et al. 1998, Bertsche et al. 2010, Ghaleb et al. 2010, Chedoe et al. 2012), which is not completely comparable to our data. These studies, however, often included only one dosage form (Bertsche et al. 2010) or did not monitor and analyse drug-handling processes in such detailed steps as we did, for instance ‘Pouring excess fluid back into the bottle’ (Schneider et al. 1998, Ghaleb et al. 2010, Chedoe et al. 2012). Mostly, IV drugs are known as complicated and error-prone dosage forms with a frequency of errors up to 74% (Kaushal et al. 2001, Anselmi et al. 2007, Parshuram et al. 2008, Westbrook et al. 2011); especially in children, IV drug preparation and administration is often much more complex and potentially more dangerous than in adults, because suitable formulations are frequently lacking (Taxis & Barber 2003a, McDowell et al. 2010, Uppal et al. 2011). Thus, drug preparation includes additional steps such as calculating the right volume of IV drugs, whereby new sources of potential errors are being created. Interestingly, in comparison with previous studies, in our study, particularly medication errors with PO dosage forms were almost twice as frequent as errors with IV drugs (with 114 vs. 059 errors/process). One reason for the higher © 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 101–114
frequency in PO drugs may be that nurses were aware of special requirements for the handling of IV drugs because they were often trained and taught (Taxis & Barber 2003b, Bertsche et al. 2008b, Westbrook et al. 2010). PO drugs, however, also have an high potential for errors, especially in paediatric patients where additional steps such as splitting, crushing or measuring the right dose of PO liquids become necessary (Bertsche et al. 2010, Nunn et al. 2013). We are not aware of any similar additive three-step intervention strategy considering PO and IV drugs as well as diverse detailed subcategories of errors that effectively reduced the high frequency of medication errors in drug handling. As expected, the three intervention steps were not uniformly successful across all error subcategories. To give an example, the frequent subcategory ‘Incorrect volume of solvent for IV drugs’ was associated with a knowledge deficit of 66% and its frequency decreased to 25% by intervention 1, suggesting that this error was mainly caused by knowledge deficits and memory lapses. In contrast, we also detected frequent errors in the absence of knowledge deficits such as ‘No shaking of suspension’ with a baseline error frequency of 63%, which may result in dosage problems (Kwon et al. 1996, Deicke & S€ uverkr€ up 1999, 2000). The frequency decreased to 41% by intervention 1, suggesting that suspensions were not shaken due to memory lapses. Errors in the subcategory ‘No self-protection’, which constitute a safety risk for nurses (DeMeo et al. 1995), however, may be caused by a mix of rule violations and action-based slips, because intervention 1 did not reduce the high frequency (up to 85%). The training course (inter-
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vention 2), which provided backgrounds to existing rules and potential adverse patient outcomes, substantially reduced the frequency of mainly rule-based errors, such as ‘No self-protection’. Issue of the reference book (intervention 3) as a readily and constantly available source of information and a two-week familiarisation phase with the book further reduced the frequency of errors in many subcategories. According to previous studies, our study also highlighted that anti-infective drugs were often involved in medication errors, which may lead to ADEs for the children (Kaushal et al. 2001, Bertsche et al. 2008a, Gonzales 2010). Gastrointestinal therapeutics are also known as error-prone drugs. Errors in drug handling such as crushing proton pump inhibitors (Cornish 2005, Bertsche et al. 2010) or administering undiluted ranitidine may lead to ADEs especially in paediatric patients (Terrin et al. 2011, Summary of product characteristics 2013). In order to be able to identify detailed medication errors, we used monitoring as one of the most reliable detection methods (Mays & Pope 1995, Dean & Barber 2001, Flynn et al. 2002). To minimise the influence of monitors’ expectation on the study data (Rosenthal effect) as well as to avoid fatigue in objective process documentation (Dean & Barber 2001), we performed the monitoring after each intervention by another monitor. A predefined checklist for documentation, training of the monitors and supervision by a senior pharmacist assured quality of the assessments in all study periods. Self-reporting of medication errors, as another often-used detection method (Tang et al. 2007, Alper et al. 2012), largely underestimates the real frequency of errors, and knowledge- and memory-based errors remain undetected (Mays & Pope 1995). Furthermore, special characteristics and practical handling aspects of daily routine on the ward cannot be considered while developing intervention methods. Nurses often did not adhere to guidelines or protocols, which stresses the need for the existence of rules that are feasible to implement in a daily routine by clinical nurses (Davis et al. 2009, Gill et al. 2012, Kim & Bates 2012). Recently, considerable effort has been made to reduce medication errors in drug prescription, for example by implementing computerised physician order entry (CPOE), clinical decision support systems (CDSS) or ward-based pharmacy services (Seidling et al. 2011, Maat et al. 2012, Fernandez-Llamazares et al. 2013, Zaal et al. 2013). Drug handling, however, is often neglected. Due to the growing pharmaceutical market, drug handling becomes ever more complicated. Besides new agents and an increased number of generic products, new dosage forms are also developed
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that may challenge nurses in daily drug handling; especially, dosage forms such as inhalational drugs, pens but also IV and PO forms in paediatric patients require special skills to handle them correctly (Bertsche et al. 2010, Uppal et al. 2011). Pharmaceutical intervention systems or ward-based pharmacy services mainly addressed drug prescription by physicians regarding dosages, double-prescription, side effects, drug–drug interactions or contraindications (Seidling et al. 2010, Maat et al. 2012, Zaal et al. 2013). Unit dose dispensing, as one example for ward-based pharmacy service to support nurses (Poley et al. 2004), is not yet routinely implemented in most of the hospitals (Berdot et al. 2012). Therefore, most of the time nurses are in charge of drug handling, including drug preparation and administration. These processes and problems arising during handling are generally not part of the pharmacy services. We would like to call attention to the need to better support nurses during the drug-handling process. Our three-step intervention system may be one possibility to support nurses and therefore to reduce medication errors in drug handling. To implement such a system in daily routine, we suggest conducting a monitoring phase to scrutinise ward-specific habits of the drug-handling processes in sufficient detail to subsequently tailor targeted interventions. A monitoring phase will be necessary because medication errors may differ from one ward to another, and a questionnaire survey is effective in detecting knowledge deficits. If possible, training courses by a clinical pharmacist should be implemented in daily routine and should contain all relevant details of drug-handling processes. The aim of continuous training courses is to remind and to raise the nurses’ awareness of the need for correct and safe drug handling. A reference book both enhances the training of nurses and supports them in daily routine. The three-step intervention aimed at transferring theoretical knowledge as well as practical skills in daily routine. With this study, we demonstrate that drug-handling processes are particularly prone to errors and nurses should be supported in order to avoid these medication errors, which have the potential of resulting in serious ADEs.
Limitations While this study showed a high frequency of handling errors, we are aware of potential limitations. We focused on medication errors in drug handling and assessed their potential risk, but we did not analyse ADEs caused by these errors. Furthermore, we did not include weekend, evening and night shifts in the monitoring and did not assess errors © 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 101–114
Original article
Preventing drug-handling errors in children
in drug prescription by physicians. Therefore, our frequency likely underestimates the real total frequency of medication errors (Miller et al. 2010). Another limitation may be an observation bias, possibly induced by the presence of a monitor (Hawthorne effect). To minimise this effect, we conducted a test phase on the ward to make the nurses familiar with the monitor before starting the study (Dean & Barber 2001). Additionally, we did not design our study to quantify cost. However, even if the monitoring procedure appears staff-intensive, costs might ultimately be saved if ADEs and subsequent prolongations of hospital stay are avoided (Bates et al. 1997, Classen et al. 1997, Easton et al. 2004) and there is likely no better efficient way to detect handling errors truly occurring in a given setting. This is important because required medication handling skills obviously depend on the type of medication and thus on the patient population, which, however, largely varies between wards.
Conclusion Drug-handling processes in a paediatric ward are remarkably prone to medication errors. A detailed assessment is suitable to reveal this high number of errors. By developing prevention programmes, the multitude of possible causes of errors such as knowledge deficits, action-based slips, rule violations and memory-based lapses must be considered. A three-step intervention consisting of a handout, a training course and a reference book substantially reduced incorrect processes and the number of patients affected by at least one error in drug-handling processes.
found that the frequency and type of medication errors are very much dependent on patient population and setting. However, errors can easily be identified by direct observation (ward monitoring). This way, medication errors are assessable in routine care considering sufficient detail, and therefore, efficient and effective corrective action can be defined. To be successful, however, strategies have to consider that error causes are multifactorial.
Acknowledgement We would like to thank all nurses and physicians who participated in this study for their kind support and Dr. Thomas Weber for language editing of the manuscript.
Disclosure The authors have confirmed that all authors meet the ICMJE criteria for authorship credit (www.icmje.org/ethi cal_1author.html), as follows: (1) substantial contributions to conception and design of, or acquisition of data or analysis and interpretation of data, (2) drafting the article or revising it critically for important intellectual content, and (3) final approval of the version to be published.
Funding This work was founded by the University of Heidelberg, the Free State of Saxony and the Federal State of BadenWuerttemberg. D. Niemann’s work was supported by a grant from the German National Academic Foundation.
Relevance to clinical practice
Conflict of interest
In most hospitals worldwide, nurses are in charge of drug handling, including drug preparation and drug administration. Errors in this field, however, are largely ignored. We
The authors declare that they have no conflict of interest regarding this paper.
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