REVIEW ARTICLE
Medication Errors in Pediatric Inpatients: Prevalence and Results of a Prevention Program
Paula Otero, MD, Andrea Leyton, RN, Gonzalo Mariani, MD, Jose´ Marı´a Ceriani Cernadas, MD, and the Patient Safety Committee
Department of Pediatrics, School of Medicine Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
The authors have indicated they have no financial relationships relevant to this article to disclose.
ABSTRACT
OBJECTIVE.The objective of this study was to assess the prevalence and characteristics of medication errors in pediatric and neonatal inpatients and to measure the impact of interventions to reduce medication errors.
METHODS.A preintervention and postintervention cross-sectional study was conducted of a sample of prescriptions that were ordered by physicians and medications that were administered by nurses to patients at the NICU, PICU, and general pediatric settings at the Hospital Italiano de Buenos Aires Department of Pediatrics in 2002 and 2004. Number and type of errors, time shift on which they occurred, and whether they had any kind of adverse event on the patient were recorded. Medication errors were stratified according to physicians’ and nurses’ status. Several interventions, including incorporating a positive safety culture without a punitive management of errors and specific prescribing and drug-administration recommendations were im- plemented between the 2 phases of the study.
RESULTS.A total of 590 prescriptions and 1174 drug administrations for 95 patients in the first phase of the study and 1144 prescriptions with 1588 drug administrations for 92 patients in the second phase were evaluated. The prevalence of medication error rate in the second phase was 7.3% (199 of 2732) and 11.4% (201 of 1764) in the first phase. The risk difference was⫺4.1%.
CONCLUSIONS.The development of a program mainly centered on the promotion of a
cultural change in the approach to medical errors can effectively diminish medication errors in neonates and children.Pediatrics2008;122:e737–e743
E
RRORS ARE FREQUENT in medical practice as a result of its human nature and of the complexity of medical management. According to the Greeks, the main commitment of physicians is to avoid patient harm (primum non nocere, or “first, do no harm”). In modern medicine, errors are still frequent.1–3 Some do not have severe conse- quences, but others produce important injuries and, in some cases, even death. Attitudes toward these events include hiding the errors or even punishing the person who made the mistake. These approaches neither allow the physician to recognize the error nor stimulate the search for the cause, making it difficult to generate a more safety-oriented attitude among health care professionals.4,5Publications on this subject have increased in the past few years.6Errors in medication use constitute the most frequent medical error. In a study conducted at Harvard University1 (a seminal article on this subject), medication errors were the most common cause of iatrogenic adverse events (19.4%). Other studies also identified the high frequency of medication errors. Their results vary widely (1.5%–
35%), depending on many factors, such as type of classification and method to identify the errors.7–12Although the frequency is similar for children and adults, the risks for errors with potential for harm are 3 times as high for children.13Medication errors that result in patient harm also increase the costs of medical care.14,15The most common are errors related to prescription, followed by errors in the administration of drugs or intravenous solutions.16–18Most studies published to date were only descriptive, and just a few of them assessed the impact of adopting preventive practices to avoid medication errors. We conducted a study that was designed to identify both the prevalence and the characteristics of prescription and administration errors to hospitalized newborns and children, before and after the implementation of several preventive interventions.
METHODS
Study Design and Population
This before–after study was performed in 2 phases (June 2002 and May 2004). The population observed included (1) hospitalized patients between 0 and 18 years of age, (2) nurses who prepared and administered the medications and
www.pediatrics.org/cgi/doi/10.1542/
peds.2008-0014
doi:10.1542/peds.2008-0014 Key Words
medication errors, prevalence, prevention, child, newborn
Abbreviations
GPW— general pediatrics ward OR— odds ratio
CI— confidence interval Accepted for publication May 28, 2008 Address correspondence to Paula Otero, MD, Hospital Italiano de Buenos Aires, School of Medicine, Department of Pediatrics, Gascon 450 (1181), Ciudad Autonoma de Buenos Aires, Argentina. E-mail: paula.otero@
hospitalitaliano.org.ar
PEDIATRICS (ISSN Numbers: Print, 0031-4005;
Online, 1098-4275). Copyright © 2008 by the American Academy of Pediatrics
intravenous solutions, and (3) physicians who pre- scribed the drugs and intravenous solutions. The analysis included all prescriptions and administrations of a week- day and a full weekend in both phases.
Setting
The study was conducted at the Department of Pediatrics of the Hospital Italiano de Buenos Aires, a tertiary care university hospital. The Department of Pediatrics has 110 beds and 6500 annual admissions and 3 main inpatient divisions: NICU, PICU, and general pediatrics ward (GPW).
Physician orders are mainly prescribed by residents and fellows. There are specific sheets for each inpatient area.
Orders are handwritten, and all medication orders are re- written every day and also whenever an additional order or change is needed. Drugs and intravenous fluid solutions are prepared and administered by nurses from each area and work shift. A few drugs are prepared at the hospital pharmacy (chemotherapy, parenteral nutrition, oral mor- phine solution, oral caffeine, and dialysis solutions).
Interventions
A single, multifaceted intervention was performed mainly on the basis of an educational program developed by the Patient Safety Committee of the Department of Pediat- rics, addressed to all health care professionals who are devoted to child care. The program was centered on the promotion of a cultural change in the approach to med- ical errors and on the development of a safety-oriented attitude that focuses on patient safety as a priority of medical practice, as in other high-risk human disci- plines.19–21The program focused on health professionals’
education by means of different activities: grand rounds, interdisciplinary meetings at every area of the department, task groups of residents and fellows, information retrieval on bibliographic databases, exchange of information with hospitals from other countries, and creation of a system for the anonymous reporting of errors. The program also considered determining the prevalence of medication errors and the identifying the most common errors. Spe- cific strategies to reduce medication errors were devel- oped. These strategies included (1) a modification in the process of prescription of medications, improving envi- ronment conditions (eg, reducing interruptions, tele- phone calls, change in the time schedule), and direct staff supervision, (2) active interaction with pharmacists during rounds, and (3) implementation of the “10 steps to reduce medication errors” checklist (see Appendix 1).
These recommendations were stated during interdisci- plinary meetings among physicians and nurses. Before the study was begun, a pilot test was performed to assess implementation of the aforementioned checklist. After this pilot test, many items were modified on the check- list, and a plastic pocket card was given to all clinicians to allow them to read the 10 steps to prevent errors in the prescription of medications and, on the other side, the 10 steps to prevent errors in the administration of med- ications. Every physician and every nurse had this card, and a copy of it was also placed where medications were prescribed, prepared, and administered.
Classification of Errors
On the basis of the American Society of Health-System Pharmacists standard definition of medication errors,22we implemented different scales of errors in the prescription and administration of medications. Appendix 2 lists the prescription and administration-error classifications.
Description of the Study
During both phases of the study, every prescription and administration of medications and intravenous solutions was evaluated. All medications prescribed and adminis- tered to patients who were hospitalized at the Depart- ment of Pediatrics were included during a weekday and a whole weekend. The days were chosen at random, and the health care staff (physicians and nurses) were not aware that the study was being conducted. At every ward and ICU, error identification was done by a phy- sician and a nurse who were specially trained (Dr Mari- ani and Ms Leyton). Both of them reviewed every chart together, and a third reviewer participated in case of disagreement (Dr Cernadas). The reviewers were not blinded, and there was not interrater reliability assess- ment. They collected the data only from patients’ med- ical charts, medication prescription sheets, and nurses’
records of medications and intravenous solution admin- istration; no data were obtained through direct observa- tion. The first cross-sectional phase analysis was done in June 2002, before preventive interventions were given;
the second phase took place in May 2004, after imple- mentation of the strategies previously described. During both phases of the study, methods did not change and were performed by the same researchers.
The main outcome variable was prevalence of medi- cation errors during each phase. Secondary outcome variables were patients’ age and gender; inpatient area (NICU, PICU, and GPW), time of the prescription order, and the administration (7:00AM to 1:59PM; 2:00PMto 8:59 PM; 9:00 PM to 6:59 AM); number of written pre- scription orders and medication administrations during each phase of the study; type of identified errors; train- ing level on the basis of postgraduate years of the phy- sician who signed the prescription (junior residents [sec- ond year], senior residents [third and fourth years], or fellow or staff); education level of the nurse who pre- pared and administered the medication (registered nurse
TABLE 1 Patient Data and Clinical Areas in Which Errors Were Evaluated
Parameter 2002 (n⫽95) 2004 (n⫽92) P
Age, y
Mean 4.12 4.02 .44
Median 1.00 0.67
Interquartile range
0.07–7.00 0.15–5.00
Female gender, % 42 42 .22
Clinical areas,n(%)
GPW 35 (36.8) 41 (44.5) .35
PICU 23 (23.2) 20 (21.7) .82
NICU 37 (38.9) 31 (33.7) .55
or licensed practical nurse), and adverse effects as a result of medication errors.
Statistical Analysis
Data were summarized according to a method of descrip- tive analysis. Error rates were estimated every 100 pre- scriptions and administrations. All information was re- corded by using 2⫻2 tables to estimate the odds ratio (OR) with the ␣ error level set at .05 and a 95% confidence interval (CI) to consider the statistical analysis valid.
Logistic regression was used to evaluate variables that potentially were associated with medication errors in each patient included in both phases of the study. The variables that showed an important association with medication errors in the univariate analysis were in-
cluded in the multivariate analysis by using multiple logistic regression.
RESULTS
In the first cross-sectional phase analysis, in 2002, a total of 1764 medications (590 prescriptions and 1174 medi- cation administrations) for 95 patients were evaluated.
In the second cross-sectional phase analysis, in 2004, a total of 2732 medications (1144 prescriptions and 1588 administrations) for 92 patients were analyzed. Table 1 shows data regarding patients’ characteristics and the hospitalization unit.
Prevalence of total errors was significantly lower in 2004 compared with 2002: 11.4% (201 of 1764) vs 7.3%
(199 of 2732). The difference was⫺4.1% (95% CI:⫺2.3
11.4%
7.3%
0%
2%
4%
6%
8%
10%
12%
Medication
2002 2004
17.3%
11.4%
7.3%
9.2%
0%
2%
4%
6%
8%
10%
12%
14%
16%
18%
20%
Prescription Administration
2002 2004
B A
FIGURE 1
A, Prevalence of medication errors in both phases of the study (2002–2004). B, Prevalence of prescription and administration errors in both phases of the study (2002–2004).
TABLE 2 Difference of Medication Error Rate Between the 2 Phases (2002–2004)
Errors 2002,n/N(%) 2004,n/N(%) ARR (95% CI), % OR (95% CI)
Total 201/1764 (11.4) 199/2732 (7.3) ⫺4.1 (⫺2.3 to⫺5.8) 0.61 (0.50 to 0.75) Prescription 102/590 (17.3) 105/1144 (9.2) ⫺8.1 (⫺4.6 to⫺11.6) 0.48 (0.36 to 0.65) Administration 99/1174 (8.4) 94/1588 (5.9) ⫺2.5 (⫺0.5 to⫺4.5) 0.68 (0.51 to 0.91) ARR indicates absolute risk reduction.
to⫺5.8 [P⬍.05]; OR: 0.61 [95% CI: 0.50 to 0.75]; Table 2). The higher differences were observed in the NICU (7.8% [95% CI: 4.7% to 10.9%]; OR: 0.36 [95% CI:
0.25 to 0.52]). Likewise, the prescription error preva- lence was significantly lower in the second phase, and an important reduction in administration errors was also observed (Fig 1, Table 2).
In the second cross-sectional analysis, a reduction of errors was observed in most of the variables related to the category of physicians and nurses, time shift, and area.
Differences are displayed in Table 3. There were no differ- ences between weekday and weekend in neither of the 2 phases.
The most frequent errors were the omission of the prescription order time and not administering a medica- tion (Table 4). There was a significant reduction of po- tentially harmful administration errors in the second phase of the study: wrong dosing 30 (30%) of 99 in 2002 vs 9 (10%) of 95 in 2004 (P⫽.0003) and wrong infu- sion rate 13 (13%) of 99 in 2002 vs 0 of (0%) 95 in 2004 (P⫽.0002; Table 4).
The regression analysis for the whole population in both phases showed that the most important risk factor for prescription error was patient age ⬍2 months, whereas in administration error was patient age ⬍1 TABLE 3 Medication Errors in Both Phases of the Study According to Health Care Professional Category,
Shift, and Working Area
Parameter 2002,n/N(%) 2004,n/N(%) P Difference of
Proportions (95% CI) Prescription
Physician category
Junior resident 10/152 (6.6) 15/148 (10.1) .3000 3.5 (10.2 to⫺2.9)
Senior resident 52/278 (18.7) 38/436 (8.7) .0001 ⫺10 (⫺4.9 to⫺15.5)
Fellow 27/120 (22.5) 47/441 (10.7) .0012 ⫺11.8 (⫺4.5 to⫺20.5)
Staff 13/40 (32.5) 5/119 (4.2) ⬍.0000 ⫺28.3 (⫺14.9 to⫺44)
Shift
Morning 65/530 (12.3) 70/895 (7.8) .0075 ⫺4.5 (⫺1.3 to⫺7.9)
Afternoon 23/34 (67.6) 20/199 (10.1) ⬍.0000 ⫺57.5 (⫺40.1 to⫺71.3)
Night 14/26 (53.8) 15/50 (30.0) .0749 ⫺23.9 (0.9 to⫺44.4)
Area
GPW 43/240 (17.9) 42/443 (9.5) .0022 ⫺8.4 (⫺3.1 to⫺14.3)
NICU 21/181 (22.5) 34/324 (10.5) .0006 ⫺12 (⫺5.2 to⫺19.4)
PICU 38/169 (11.6) 29/377 (7.7) .1700 ⫺3.9 (1.0 to⫺9.9)
Administration Nurse category
Licensed practical nurse 29/214 (13.6) 70/960 (5.9) .0090 ⫺7.7 (⫺2.2 to⫺13.4)
Registered nurse 70/237 (7.3) 80/1351 (5.9) .2180 ⫺1.4 (0.1 to⫺3.5)
Shift
Morning 49/474 (10.3) 30/528 (5.9) .0090 ⫺4.6 (⫺1.3 to⫺8.1)
Afternoon 30/270 (11.1) 35/553 (6.3) .0244 ⫺4.8 (⫺0.8 to⫺9.44)
Night 20/430 (4.7) 29/507 (5.7) .5580 1.1 (3.9 to⫺1.9)
Area
GPW 38/443 (8.6) 42/393 (10.7) .3592 2.1 (6.2 to⫺1.9)
NICU 31/367 (8.2) 24/801 (2.9) .0001 ⫺5.4 (⫺2.4 to⫺8.5)
PICU 30/364 (8.2) 29/394 (7.4) .7514 ⫺0.8 (2.9 to⫺4.7)
TABLE 4 Types of Medication Errors (Prescription and
Administration) Organized According to Phases Before and After Interventions
Type of Error 2002,n/N(%) 2004,n/N(%) Prescription
Omission of time of prescription 43/102 (42) 23/105 (22)
Error in dosing interval 22/102 (22) 8/105 (8)
Omission of prescription 13/102 (13) 33/105 (31)
Wrong dosing 10/102 (10) 9/105 (9)
Illegible order 9/102 (9) 16/105 (15)
Administration
Omission (dose not delivered directly to the patient)
47/99 (47) 67/95 (70)
Wrong dosing 30/99 (30) 10/95 (10)a
Wrong infusion rate 13/99 (13) 0/95 (0)b
Wrong frequency 4/99 (4) 17/95 (18)
Wrong delivery 6/99 (6) 0/95 (0)
aP⫽.0003; OR: 4.15 (95% CI: 1.76 to 10.56).
bP⫽.0002; OR undefined.
TABLE 5 Variables Significantly Associated With Medication Errors in the Logistic Regression Analysis
Variable OR 95% CI
Prescription
Year 2004 0.51 0.37 to 0.70
Night shift (9:00PMto 6:59AM) 3.06 1.71 to 5.48
Age⬍2 mo 6.43 3.13 to 13.2
Resident of third or fourth year or fellow
2.61 1.57 to 4.33
Administration
Year 2004 0.70 0.52 to 0.96
Age⬍1 y 2.61 1.64 to 4.16
Administration by assistants 1.68 1.16 to 2.43
year. Other significant variables are displayed in Table 5.
No adverse effects were identified in either of the 2 phases.
DISCUSSION
Hospitalized children are more susceptible to experienc- ing complications as a result of medication errors than adults,8 but, again, the adverse event rates seem to be similar (based on the limited data available). The reason is that adult patients receive standard doses, whereas newborns and children are medicated according to their weight and clinical condition, a fact that requires several calculations by the physician who writes the prescrip- tion, which increases the likelihood of errors. Moreover, most medicines are intended for adults and are pre- sented as dosage forms that are in unsuitable concentra- tion for children. As a result, clinicians who assist neo- nates, often extremely small, premature infants, have to adapt these drugs for children who cannot take adult dosage forms. This process requires a number of steps that increase the likelihood of mistakes. In other words, the omission of 1 step or a wrong calculation by using decimals can sometimes result in a dose 10 times higher than necessary (10-fold error).23This error can produce severe injury or even death, especially when medication agents have a narrow therapeutic window.
The study was developed in 2 phases. The first phase evaluated the prevalence of medication errors in every hospitalized child to assess the real scope of the problem before the intervention. Just as we have thought, the error rate during this first phase was very high, espe- cially the prescription errors, with 1 mistake every 5 or 6 orders, almost doubling the administration error rate.
Certain studies reported similar rates or even higher.
Marino et al24observed 24% of medication errors, being 84% of the former prescription errors. Other reports, written by pharmacists with a different method, de- scribed lower rates.8,25Nevertheless, Kaushal et al,16in a more recent study, described a medication error rate of 5.7% in 2 academic pediatric institutions.
As in other studies performed, the errors were more frequent in the NICU,16followed by the GPW. It is im- portant to note that in the GPW, 40% of the patients were admitted to the oncology area, where a higher error rate has been reported.26
During the second phase of the study, an important reduction of medication errors was observed. The inter- vention was specifically focused in promoting a cultural change among professionals about error approach. Hid- ing the error has been the predominant culture in med- icine, believing that only incompetent or irresponsible health professionals make mistakes and promoting pu- nitive measures toward them. Traditional models of medical education reinforce the concept of infallibility, assuming that if nurses and doctors have enough knowl- edge and skills, then they will not make mistakes.
Through our program, which included all professionals involved in the care of newborns and children, an im- portant change in the attitude toward the error was achieved. It was the first time that medical error was introduced as a subject in daily child care practices and
rounds. Previous research has shown disparate results:
whereas Bates et al27 did not find positive results of a team intervention on the rate of medication errors, Co- hen et al,28conversely, showed that changes in the atti- tudes of health care personnel toward patient safety can be achieved through a comprehensive program. We be- lieve that this cultural change was the most important achievement of the program. The intervention had a greater effect in the prevention of prescription errors: on the basis of our findings, the number needed to treat was 25 (95% CI: 17 to 43).
No adverse effects related to medication errors were found, perhaps because a cross-sectional study is not the best design to identify a causal association between the error and the adverse event. Other limitations are that the study was conducted at 1 institution in 1 region and that the reviewers who identified the errors were not blinded.
Note also that the time between both phases was longer (2 years) than usual in a cross-sectional study.
Nevertheless, the need to set a cultural change regarding error in medicine, as the main objective of the interven- tion, obliged us to extend the time between phases be- cause it is a slow, complex, and difficult task in the short-term.
CONCLUSIONS
According to our results, intervention through a com- prehensive program for prevention of errors, including all personnel involved in the medication process, achieved an important reduction in the prevalence of medication errors. Similar programs could increase safety in hospitalized children, a more vulnerable group to complications as a result of medications.
APPENDIX 1: 10-STEP CHECKLIST
10.Steps for Reducing Prescription Errors of Medications and Intravenous Solutions
1. Do not write a prescription order during inadequate environmental conditions and during time frames that are more susceptible to distractions.
2. Always verify that
a. the prescription order corresponds to the patient;
and
b. the patient’s name appears in the indication sheet.
3. When writing a prescription order,
a. use legible handwriting (eg, you can use capital letters);
b. indicate the name of the generic drug;
c. state dose, dosage interval, dilution, route of ad- ministration, and infusion time;
d. use a comma instead of a point when writing decimals;
e. do not use abbreviations, corrections, or emen- dations; and
f. indicate the prescription order time.
4. Explain whether there is any incompatibility with other medication or with the diluting liquid.
5. Agree with the nursing staff the best time to admin- ister a medication, to check the patient after medi- cation administration.
6. Do not repeat the indications of the former day writing phrases such as “same indications.” Pre- scription orders must be revised and written again.
7. Use capital letters when writing modified next to a previous indication written the same day, and tell the nurse personally.
8. Repeat the calculations 2 or 3 times when a medi- cation requires various dilutions, and write the di- lution clearly (avoid the 10-fold dose error).
9. To conclude,
a. revise everything that has been written;
b. verify the calculation of the dose;
c. verify whether something important has been omitted or whether there is any confusing indi- cation; and
d. sign the prescription order and write your sur- name clearly.
10. Every prescription, without exception, must be re- vised by another physician before indicating it, and this physician must write “checked by. . . .”
A prescription order is not a routine act. Every time you write a prescription order, review this 10-step checklist.
10.Steps for Reducing Administration Errors of Medications and Intravenous Solutions
1. Do not administer medications or solutions when a. there is a doubt regarding the prescription order;
b. the handwriting is not legible or there are emen- dations; or
c. the time and date of the prescription order are not written.
2. Before administering a medication, a. check the patient;
b. verify that the medication corresponds to this particular patient (pay special attention in the case of patients whose surnames are similar);
and
c. verify the dose, route of administration, and in- fusion time.
3. Do not mix different drugs in syringes, tubing con- nections, or infusion solutions if you are not sure about the compatibility of the drugs.
4. Do not administer a medication when the prescrip- tion order says “same indications.”
5. Always supervise medications that are given by family members. The nurse must record and sign the medication sheet.
6. Check the patient before the administration of the medication and afterward. Record this control in the medication sheet.
7. Be careful when diluting medications. Always re- member that
a. inattentiveness is dangerous; and
b. when more that 1 dilution is necessary, it is imperative that more than 1 person participate in the process (nurse/nurse or nurse/physician).
8. Do not administer a medication when the indication was given orally. If it was an urgent case, then always ask the physician to write down the prescription order afterward.
9. In the end, use legible handwriting to record a. problems during the administration of the med-
ication;
b. unexpected effect of the medication on the pa- tient; and
c. signature, time, and name of the nurse.
10. When you have doubt regarding a particular med- ication, always ask the physicians.
Always read this 10-step checklist before administering a medication. It will contribute to reducing medication errors.
APPENDIX 2
Classification of Prescription Errors 0. No error
1. Wrong medication (eg, is contraindicated for the patient or belongs to another)
2. Wrong dosing: total daily dose or charge and main- tenance; includes errors such as using milligrams (mg) instead of micrograms (g)
3a. Omission of a drug that was being administered and it is not stated that it was suspended
3b. Omission of a written prescription of an adminis- tered medication (verbal orders)
3c. Omission of time an administered drug was pre- scribed
4. Inadequate route of administration 5. Error in dosing interval
6. Inadequate dilution of a drug or solution
7. Inadequate indication or omission of the infusion time of a drug
8. Inadequate intravenous infusion rate 9. Illegible order (based on ref 21)
Classification of Administration Errors 0. No errors
1. Wrong frequency (30 minutes before or 1 hour after the prescribed time)
2. Wrong administration (wrong drug or wrong patient) 3. Wrong delivery route
4. Omission: no administration of a drug 5. Wrong dosing: total or single dose 6. Error in dilution
7. Wrong infusion rate ACKNOWLEDGMENTS
We thank Gabriela Rodrı´guez Loria, MD, for invaluable help in statistical analysis and Pablo Dura´n, MD, for reviewing the manuscript.
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DOI: 10.1542/peds.2008-0014 2008;122;e737 Pediatrics
Paula Otero, Andrea Leyton, Gonzalo Mariani and José María Ceriani Cernadas Prevention Program
Medication Errors in Pediatric Inpatients: Prevalence and Results of a
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DOI: 10.1542/peds.2008-0014 2008;122;e737 Pediatrics
Paula Otero, Andrea Leyton, Gonzalo Mariani and José María Ceriani Cernadas Prevention Program
Medication Errors in Pediatric Inpatients: Prevalence and Results of a
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