Table 2.
Summary of study characteristics.
| Studies addressing one step in the medication use process | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First author (country, year) | Error type(s) | Study design, study centers | Setting | Methods | Intervention | Single/bundle intervention | Results | Error rate CG/IG | Absolute risk reduction (reported level of significance) |
| Campino et al. (Spain, 2016) (56) | Drug administration errors | UBA, multicenter | 10 NICU and one hospital pharmacy | Assessment of randomly collected intravenous dilutions of vancomycin, gentamicin, phenobarbital, and caffeine citrate to investigate calculation and accuracy errors during preparation; most dilutions contained vancomycin or gentamicin (75% and 71%, respectively) | (1) Standardized preparation protocol with no need for calculation; (2) Educational program, developed by pharmacists, nurses, and physicians including preinterventional results, basic rules for medication preparation, weak points of medication preparation, and new preparation protocols; education was repeated several times |
Bundle | Calculation errors: CG: 6, IG:0; all NICUs/hospital pharmacy benefited from the intervention (but to different degrees); total: 266 accuracy errors (underdosing/overdosing)/504 preparations, IG: 67/332 | 52.78%/21.99% | 30.79% (significantly positive results) |
| Chedoe et al. (Netherlands, 2012) (57) | Drug administration errors | UBA, single center | NICU | Direct observation of ward-based preparation and application of drugs by trained pharmacy students for 10 consecutive days (24 h/day; preinterventional and post-interventional, respectively); development of a standardized data collection form in pilot phase; each medication dose observation could contain more than one error | Educational program consisting of an 1-h teaching session and 30-min individual practical training for preparation and administration of commonly used medications; education was repeated three times | Single | CG: 151 doses with ≥1 error/311 observed doses; IG: 87/284; clinical relevance was assessed by three experts (pharmacist, neonatologist, neonatological nurse); interventional effects addressed administration errors mainly | 48.55%/30.63% | 17.92% (significantly positive results) |
| Chua et al. (Malaysia, 2017) (58) | Drug administration errors | UBA, single center | Pediatric ward | Direct observation of drug administration by pharmacists on two pediatric wards for 40 days preintervention and post-intervention, respectively | Pharmacist-led presentation of preintervention drug administration errors to pediatric physicians and nurses, followed by discussion (repeated six times) | Single | Pre: 1,284 doses observed for 217 patients (5.9 doses per patient) with 569 doses containing at least one error (852 errors total); post: 1,401 doses for 208 patients (6.7 doses per patient) with 400 doses containing at least one error (496 errors total) | 44.31%/28.55% | 15.76% (significantly positive results) |
| Davis et al. (USA, 2017) (59) | Dispensing errors | UBA, single center | Hospital pharmacy | Implementation of an electronic work flow management system. The system interfaced with the computerized physician order entry | Electronic workflow management system | Single | Pre: 9.8 errors per 10,000 doses dispensed; post: 8.2 errors per 10,000 doses | 0.098%/0.082% | 0.016% (significantly positive results) |
| Marconi et al. (USA, 2012) (60) | Drug administration errors | UBA, single center | EP | Assessment of missed or delayed (>1 h later than scheduled time) medication administrations in the emergency department; separation of medications into “urgent” (medication for patients' chief complaint or acute diagnosis) and non-urgent medications | Emergency department pharmacist | Single | CG: 29 urgent and 169 non-urgent medications/723 medications; IG: 21 urgent and 64 non-urgent medications/851 medications | Missed or delayed medications total: 27.39%/9.99% | Missed or delayed medications total: 17.40% (significantly positive results) |
| Niemann et al. (Germany, 2015) (61) | Drug administration errors | UBA, single center | Pediatric ward | Direct observation by four trained pharmacists using a predefined 22-item list of drug-handling processes; monitoring in the morning (7:30–10:00 a.m.) for 20 working days | Three-step educational intervention: three-page handout (addressed knowledge deficits and memory-based lapses), 60-min pharmacist-led education (background information and drug-handling guidelines), and 56-page comprehensive reference book (detailed information about drug-handling) | Single | Patients: CG: 38/43 patients suffered ≥1 ME within the observed processes; IG: 25/51; processes: CG: 370/581 observed processes contained ≥1 error; IG: 100/441 | Patients: 88.37%/49.02%; processes: 63.68%/22.68% | Patients: 39.35%; processes: 41.00% (significantly positive results) |
| Niemann et al. (Germany, 2014) (62) | Drug administration errors | UBA, single center | PICU | Direct observation by five trained pharmacists using a pre-defined 24-item-list of drug-handling processes; monitoring between 7:00–9:00 a.m. and 11:00 a.m. to 1:00 p.m. for 26 working days | Three-step educational intervention: three-page handout, 60-min pharmacist-led education, and 76-page comprehensive reference book | Single | Patients: CG: 36/38 patients suffered ≥1 ME within the observed processes; IG: 42/47; processes: CG: 384/668 observed processes contained ≥1 error; IG: 445/883 | Patients: 94.74%/89.36%; processes: 57.49%/50.40% | Patients: 5.38%; processes: 7.09% (mixed results) |
| Ozkan et al. (Turkey, 2013) (63) | Drug administration errors | UBA, single center | Pediatric ward | Direct Observation of medication administration (observation period between 10:00 a.m. – 6:00 p.m. and 10:00 p.m. – 6:00 a.m.); assessment of a deviation between the physician's order and the administered medication | (1) Written alerts displayed on the door of the preparation room (2) Signaling arm bands for the medication preparing and administration nurses (3) Earlier medication delivery by pharmacy (4) Preparation and administration guidelines (5) Increase of nurse/patient-ratio |
Bundle | CG: 475 errors/1,686 observed medication doses; IG: 313/1,460; workload determined as leading cause for administration errors (no significant difference between CG and IG) | 28.17%/21.44% | 6.73% (significantly positive results) |
| Studies addressing multiple steps in the medication use process (combined medication errors) | |||||||||
| Abuelsoud (Egypt, 2019) (64) | Combined medication errors (prescribing, drug administration, monitoring errors) | UBA, single center | Pediatric ward | FOCUS-PDCA technique (Plan-Do-Study-Act cycle); 100 medical files were randomly selected on a pediatric medical ward per month over a period of 9 months; it was aimed at reducing drug-related problems in each of the three selected steps of the medication use process prescribing, administration, and monitoring steps to ≤ 15% within 9 months | (1) Conducting an educational program to pediatric staff (physicians and nurses) (2) Implementation of a clinical pharmacist into the medical team (3) Establishment of drug information center (4) Establishment of IV admixture unit (5) Using auxiliary labels |
Bundle | 900 medical files reviewed (100 files per month); prescribing errors: CG (1st month): 47 errors/ 100 files, IG (9th month): 10 errors/ 100 files; drug administration errors: CG (1st month): 60 errors/ 100 files, IG (9th month): 10 errors/ 100 files; monitoring errors: CG (1st month): 56 errors/ 100 files, IG (9th month): 15 errors/ 100 files | Administration errors: 60%/10%; monitoring errors: 56%/15% | Administration errors: 50%; monitoring errors: 41% (significantly positive results) |
| Benkelfat et al. (Canada, 2013) (65) | Combined medication errors (prescribing errors, drug administration errors) | CCT, single center | EP | Retrospective ME analysis of medical records (drug choice, dosage deviation >10% of recommended dosing, frequency, and route of administration) for children <18 years, who were treated for anaphylaxis in the emergency department | Standard order form for medications used in anaphylaxis | Single | CG: 18 medical charts with ≥1 error/30 medical charts; IG: 16/29; dosing errors were significantly reduced, but not errors in total | 60.00%/55.17% | 4,83% (significantly positive results) |
| Ernst et al. (USA, 2017) (66) | Combined medication errors (prescribing errors, drug administration errors) | UBA, single center | NICU | A retrospective EMR chart review of children with a birth weight <2 kg and a hospitalization of ≥58 days were included in the time range of 2009–2013. The 2-month immunization status was investigated for the seven vaccines recommended | An electronic immunization alert was introduced into the EMR. It was shown from days 56 to 67 on the beginning of the day to the physicians and nurses separately | Single | CG: 35 infants partially immunized or unimmunized/121 infants; IG: 6 infants partially immunized or unimmunized/140 infants | 29%/6% | 23% (significantly positive results) |
| Fawaz et al. (Egypt, 2017) (67) | Combined medication errors (prescribing, transcribing, and drug administration errors) | UBA, single center | Operating room | Pharmacist observed drug handling in the operating room and reviewed prescribed medications | Pharmacist-led educational program consisting of detection, reporting, and prevention of medication errors | Single | Pre: 312 medication errors were detected in 110 patients with 936 medication orders (6.2 medication orders per patient); post: 224 medication errors in 112 patients with 693 medication orders (8.5 medication orders per patient) | 33.33%/32.32% | 1.01% (non-significant positive results) |
| Foster et al. (USA, 2013) (68) | Combined medication errors (prescribing errors, drug administration errors) | ITS, single center | EP | Ward pharmacist reviewed medication orders in the emergency department on weekdays from 3 to 11 pm; assessment of ME rates in three 3-month intervals | 3-h educational program for emergency department residents, led by an attending physician and the ward pharmacist | Single | 2 of 10 investigated drug-related problems showed significant improvements (dose adjustment and order clarification) | N/A | N/A (mixed results) |
| Keiffer et al. (USA, 2015) (69) | Combined medication errors (prescribing errors, drug administration errors) | UBA, single center | Pediatric cardiothoracic intensive care unit | Analysis of MEs that resulted in patient harm (NCC MERP type D-I) through assessment of voluntary reports by pharmacists, trigger tools, and hospital-wide voluntary incident reports by hospital-wide and unit-based quality leaders | (1) Quality process education (“the 5-rights”) (2) Nursing independent double check using a standardized checklist; (3) Hands-free communication with wearable voice-controlled devices (4) ME huddles (5) A “distraction-free zone” consisting of a physical mat in front of the PYXIS and signs placed on the computers in the unit (6) Bedside medication barcoding |
Bundle | 33 pADEs that resulted in patient harm in 2010; 3 pADEs in 2011; 6 pADEs in 2012; and 4 pADEs in 2013; harm-causing pADEs were reduced from 0.43 to 0.05 per 1,000 administered medication doses | N/A [88% error reduction from CG (2010) to IG (2013)] | N/A (significantly positive results) |
| Maaskant et al. (Netherlands, 2018) (70) | Combined medication errors (prescribing, drug administration, monitoring errors) | ITS, single center | PICU | Clinical records and the incident reporting system of a PICU were reviewed for medication errors. When an error was suspected, a pediatric intensivist, and a clinical pharmacist reviewed the case. Six timepoints preintervention and post-intervention, respectively | Pharmacist-led structured medication audit and feedback to pediatric intensivists on a PICU. A clinical pharmacist was present on ward 3 h 5 days per week. PICU-patients with “(a) reduced renal and/or hepatic clearance, (b) oncological diagnoses, (c) high-alert medication prescriptions, (d) receiving more than 5 medications, and (e) medication prescriptions with which the PICU professionals felt unfamiliar” were included. | Single | Pre: within 1 year, 254 patients were admitted to the PICU with 153 medication errors (2.27 medication errors per 100 prescriptions; 23 harmful medication errors); post: within 1 year, 230 patients were admitted with 90 medication errors (1.74 medication errors per 100 prescriptions; 6 harmful medication errors), 75 of these 230 patients were audited by the pharmacist: the prevalence of medication errors was found significantly lower in patients with medication audit | 2.27%/1.74% | 0.53% (significantly positive results) |
| Martin et al. (USA, 2017) (71) | Combined medication errors (prescribing, drug administration, monitoring errors) | UBA, single center | Operating room | Anesthesiologists were directly observed for 2 months regarding the drug handling and medication errors in the operating room. Using this data, a failure-mode-and-effect analysis was performed to develop interventions, followed by a reobservation | (1) Medication tray reorganization (pharmacy-prepared trays, reorganization with colors and sequesters; due to high-risk medications, and according to the frequency of usage) (2) Medication cart top template (standardized organization of common medications) (3) Syringe labeling (standard nomenclature and color-coding) (4) Infusion double check (independent double check, documented with preprinted labeling tape on the infusion) (5) Medication practice guideline (developed and posted in every operating room: syringe labeling, medication preparation) |
Bundle | Pre: 368 syringes for 68 patients were audited with 101 labeling errors within 2 months; 17 infusion pumps were checked with 13-times double-check error. No standardized workspace organization was found; post: 402 syringes for 61 patients were audited with 16 labeling errors within 2 months. 17 infusion pumps were checked with 7-times double-check error | Labeling error: 27.4%/4.0%; infusion double check: 76.5%/41.2% | Labeling error: 23.5%; infusion double check: 35.3% (mixed results) |
| McClead et al. (USA, 2014) (72) | Combined medication errors (prescribing-, drug administration-, dispensing errors) | UBA, single center | Entire hospital | Within a pediatric hospital, a quality improvement initiative was implemented to reduce harm-causing medication errors (NCC MERP D-I) in a 4-year study period. The initiative rendered interventions to all aspects of the medication use process with a special focus on administration errors. Error data was recorded from voluntary incident reporting, trigger tool analysis, reversal agent review, and clinical pharmacist interventions | (1) Independent double-check policy for high-risk medications (2) Implementation of a wireless nurse communication system (3) Smart syringes and pumps with drug libraries (4) Safety nurse-led audits of the compliance to the 5 rights medication administration (5) Implementation of a barcoded medication administration (6) Pharmacy has more pneumatic tubes for faster delivery of compounded urgent medications |
Bundle | In the 1st quarter 2010, the number of pADEs maximized to 85 within 3 months (0.171 pADE per 1000 dispensed doses). In the last investigated quarter (2nd quarter 2013), this number was reduced to 22 pADEs within 3 months (0.040 pADE per 1000 dispensed doses) | 0.017%/0.004% | 0.013% (significantly positive results) |
| Mekory et al. (Israel, 2017) (73) | Combined medication errors (prescribing errors, drug administration errors) | UBA, single center | Pediatric ward/emergency department | The Joint Commission International (JCI) accreditation in 2014 was sought. Therefore, a training program for the JCI standards to preclude prescribing and administration errors was implemented, and a prereview and post-review of handwritten emergency department and pediatric ward medical charts were performed | Educational program consisting of lectures, a personal handbook, and an educational software. Topics discussed were prescribing of an accurate order, filling it by the nurse, supervising it by the nurse and pharmacist, and handling of a medication error | Single | Pre: during 1 month, 183 patients were included, they got 937 prescription and 924 administration orders; 61 prescribing and 104 administration errors occurred; post: during 1 month, 183 patients were included; they got 961 prescription and 958 administration orders. 41 prescribing and 114 administration errors occurred | Administration errors: 11.3%/11.9% | Administration errors: −0.6% (non-significant negative results) |
| Migowa et al. (Kenya, 2018) (74) | Combined medication errors (prescribing and dispensing errors) | UBA, single center | EP, hospital pharmacy | Retrospective chart review of 1 year of prescriptions and medication dispensing records of physicians and pharmacists in an emergency department of a tertiary hospital | A voice recognition system was installed at one computer in the emergency department. A medical dictionary was developed and stored in a computer database; voice profiles were installed; training with the system was provided for the users | Single | Only duration of preinterventional and post-interventional phase submitted: 1 year; pre: 1,196 prescriptions were written for 1,196 patients with 889 errors. In the same period, 1,111 dispensations with 1,030 errors were documented; post: 501 prescriptions were written for 501 patients with 329 errors. In the same period, 356 dispensations with 332 errors were documented; most prescribing error reduction was seen in the dose prescription. pharmacists criticized that no drug database existed—this may have been contributed to the high error rate | Dispensing errors: 92.7%/93.3% | Dispensing errors: −0.5% (non-significant negative results) |
| Watts et al. (USA, 2013) (75) | Combined medication errors (prescribing, dispensing, administration errors) | UBA, single center | Oncology | Multidisciplinary chemotherapy safety team that met every 6 months to analyze all chemotherapy MEs and derive process optimizations | Optimizations included: (1) Routine order checking by pharmacist and administration nurse (2) Pharmacy standardization of drug dilutions |
Bundle | 2008: 33 chemotherapy errors/8,517 dispensed chemotherapy medications; 2009: 15/6,277; 2010: 23/9,523; 2011: 18/9,794; CG (2008): 3.9 errors/1,000 medications, IG (2011): 1.8/1,000 | 0.39%/0.18% | 0.21% (significantly positive results) |
CCT, controlled clinical trial; CG, control group; EMR, electronic medical record; EP, emergency department; IG, intervention group; ITS, interrupted time–series study; ME, medication error; N/A, not available/not applicable; NICU, neonatal intensive care unit; pADE, preventable adverse drug event; PICU, pediatric intensive care unit; UBA, uncontrolled before–after study.