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1.
J Pediatr ; 272: 114087, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38705229

RESUMEN

OBJECTIVE: The objective of this study was to examine associations between patient age and medication errors among pediatric inpatients. STUDY DESIGN: Secondary analysis of data sets generated from 2 tertiary pediatric hospitals: (1) prescribing errors identified from chart reviews for patients on 9 general wards at hospital A during April 22 to July 10, 2016, June 20 to September 20, 2017, and June 20 to September 30, 2020; prescribing errors from 5 wards at hospital B in the same periods and (2) medication administration errors assessed by direct prospective observation of 5137 administrations on 9 wards at hospital A. Multilevel models examined the association between patient age and medication errors. Age was modeled using restricted cubic splines to allow for nonlinearity. RESULTS: Prescribing errors increased nonlinearly with patient age (P = .01), showing little association from ages 0 to 3 years and then increasing with age until around 10 years and remaining constant through the teenage years. Administration errors increased with patient age, with no association from 0 to around 8 years and then a steady rise with increasing age (P = .03). The association differed by route: linear for oral, no association for intravenous infusions, and U-shaped for intravenous injections. CONCLUSIONS: Older age is an unrecognized risk factor for medication error on general wards in pediatric hospitals. Contributors to risk may be the clinical profiles of these older children or the general level of attention paid to medication practices for this group. Further investigation may allow the design of more targeted interventions to reduce errors.


Asunto(s)
Hospitales Pediátricos , Errores de Medicación , Humanos , Errores de Medicación/estadística & datos numéricos , Lactante , Preescolar , Niño , Masculino , Femenino , Adolescente , Factores de Edad , Recién Nacido , Estudios Prospectivos , Factores de Riesgo
2.
J Sex Med ; 21(6): 529-532, 2024 May 28.
Artículo en Inglés | MEDLINE | ID: mdl-38660738

RESUMEN

BACKGROUND: Intracavernosal injection therapy (ICI) is a well-established therapeutic strategy for men with erectile dysfunction. Complications are often related to patient error when performong ICI. AIM: The objective of this study was to examine patient errors in an established patient training program for performing ICI and identify factors that could predict major errors. METHODS: Patients enrolled in our ICI program are trained on technical aspects, and dose titration is begun. Patients are given explicit instructions during training, both verbally and in written form. Records were reviewed for men using ICI for ≥6 months. Multivariable analysis was used to define predictors of major errors. OUTCOMES: Errors were listed as minor (zero-response injection, penile bruising, expired medication) and major (errors potentially leading to priapism: dose self-titration, double injecting). RESULTS: Overall, 1368 patients met the inclusion criteria and were included in the analysis. The mean patient age was 66 ± 22 (range 29-91) years. Regarding education, 41% of patients had graduate-level education, 48% had college education, and 11% high school education. Mean follow-up was 3.2 ± 7.6 (range 0.5-12) years. The agents used were trimix (62%), bimix (35%), papaverine (2%), and prostaglandin E1 monotherapy (1%). At least 1 error occurred during self-administration in 42% of patients during their time in the program. Errors included zero response to medication due to technical error (8% of patients), penile bruising (34%), use of an expired bottle (18%), self-titration (5%), and double injecting (4% of patients); 12% of men committed ≥1 error during their time in the program. On multivariable analysis, independent predictors of the occurrence of a major error included: young age, graduate-level education, and <12 months of injection use. CLINICAL IMPLICATIONS: To the best of our knowledge, this is the first reported study to investigate ICI errors and risk factors. The identification of factors predictive of major errors allows for more tailored and intensive training in this subset of patients. STRENGTHS AND LIMITATIONS: Strengths of this study include a large patient population (1386 men) with a considerable follow-up time. Additionally, the rigorous training, education, and monitoring of the participants, as well as the use of formal definitions, enhances the accuracy and reliability of the results. Despite the strengths of the study, recall bias may be a limitation concern. CONCLUSION: The majority of patients were error free, and the majority of the errors were minor in nature. Major errors occurred in <10% of patients. Younger age, graduate-level education, and less experience with ICI were independent predictors of major errors.


Asunto(s)
Disfunción Eréctil , Humanos , Masculino , Adulto , Persona de Mediana Edad , Anciano , Disfunción Eréctil/tratamiento farmacológico , Anciano de 80 o más Años , Inyecciones , Educación del Paciente como Asunto/métodos , Vasodilatadores/administración & dosificación , Errores de Medicación/estadística & datos numéricos , Errores de Medicación/prevención & control , Papaverina/administración & dosificación , Pene/anatomía & histología , Errores Médicos/estadística & datos numéricos , Errores Médicos/prevención & control , Priapismo
3.
Br J Clin Pharmacol ; 90(11): 2705-2712, 2024 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-39257096

RESUMEN

In comparison to the efforts required to bring a new drug or formulation to the clinic, bestowing a name on a medicine is relatively simple. However, if the name we choose causes confusion-by making its contents ambiguous or if it is too alike another drug-it can precipitate clinical errors. This prompted the World Health Organization to set up the International Nonproprietary Naming Committee in the 1970s to select unambiguous names for drugs. Unfortunately, multidrug products-which are becoming increasingly popular-do not fall under the remit of conventional International Non-proprietary Nomenclature. We have identified 26 combination formulations that have been historically named with the co-drug format in the United Kingdom. Most of them have also been prescribed in the United Kingdom in the past year, and although several of them are not prescribed very often, 11 were prescribed more than 2000 times. In this paper, we have explored the literature to identify prescribing errors with co-drug products and found several idiosyncrasies that have caused drug errors in the past. We advocate for a standard nomenclature (state the international nonproprietary name [INN] of each component followed by dose information in the x + y format) for these products on the box and in prescribing resources. We hope that this will enhance clarity and safety during prescribing and administration, particularly for high-volume drugs like paracetamol + codeine (co-codamol), amoxicillin + clavulanic acid (co-amoxiclav) and trimethoprim + sulfamethoxazole (co-trimoxazole).


Asunto(s)
Combinación de Medicamentos , Errores de Medicación , Terminología como Asunto , Humanos , Errores de Medicación/prevención & control , Errores de Medicación/clasificación , Errores de Medicación/estadística & datos numéricos , Reino Unido
4.
Br J Clin Pharmacol ; 90(2): 548-556, 2024 02.
Artículo en Inglés | MEDLINE | ID: mdl-37872107

RESUMEN

AIMS: Errors with prescribing high-risk medicines (HRMs) have a greater propensity to cause harm than with non-HRMs. Prescribing errors arise due to multiple factors and it can be particularly challenging for junior doctors to prescribe safely during the on-call period. Knowledge regarding the challenges of prescribing HRM during the on-call period would be useful to target preventative interventions. The aim of this study was to explore the challenges encountered by foundation doctors (doctors who have graduated medical school within the last 2 years) when prescribing specific HRMs (anticoagulants, insulin and opioids) safely during the on-call period. METHODS: Six focus groups exploring the challenges of prescribing HRMs safely during the on-call period were conducted, 3 with foundation year 1 and 3 with foundation year 2 doctors from across 3 different hospitals. A thematic framework analysis based on the London Protocol was conducted. RESULTS: Doctors described multiple challenges to prescribing HRMs safely during the on-call period including a lack of prescribing support, nursing pressure, complex prescribing tasks, unknown patients as well as individual factors such as lack of knowledge and tiredness. Many of these factors exist to some extent during the day, yet the nature of the on-call period as a fast-paced environment heightened the challenges that prescribers faced. CONCLUSION: There are multiple challenges experienced by foundation doctors when prescribing HRMs during the on-call period. The potentially devastating consequences of errors with HRMs means that closer attention and more concern from healthcare professionals, researchers and policymakers is required to improve safe prescribing of HRMs in hospitals.


Asunto(s)
Errores de Medicación , Médicos , Humanos , Errores de Medicación/prevención & control , Prescripciones de Medicamentos , Competencia Clínica , Pautas de la Práctica en Medicina
5.
Br J Clin Pharmacol ; 90(7): 1615-1626, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38532641

RESUMEN

AIMS: The potential harm associated with medication errors is widely reported, but data on actual harm are limited. When actual harm has been measured, assessment processes are often poorly described, limiting their ability to be reproduced by other studies. Our aim was to design and implement a new process to assess actual harm resulting from medication errors in paediatric inpatient care. METHODS: Prescribing errors were identified through retrospective medical record reviews (n = 26 369 orders) and medication administration errors through direct observation (n = 5137 administrations) in a tertiary paediatric hospital. All errors were assigned potential harm severity ratings on a 5-point scale. Multidisciplinary panels reviewed case studies for patients assigned the highest three potential severity ratings and determined the following: actual harm occurrence and severity level, plausibility of a link between the error(s) and identified harm(s) and a confidence rating if no harm had occurred. RESULTS: Multidisciplinary harm panels (n = 28) reviewed 566 case studies (173 prescribing related and 393 administration related) and found evidence of actual harm in 89 (prescribing = 22, administration = 67). Eight cases of serious harm cases were found (prescribing = 1, administration = 7) and no cases of severe harm. The panels were very confident in 65% of cases (n = 302) where no harm was found. Potential and actual harm ratings varied. CONCLUSIONS: This harm assessment process provides a systematic method for determining actual harm from medication errors. The multidisciplinary nature of the panels was critical in evaluating specific clinical, therapeutic and contextual considerations including care delivery pathways, therapeutic dose ranges and drug-drug and drug-disease interactions.


Asunto(s)
Hospitales Pediátricos , Errores de Medicación , Humanos , Errores de Medicación/estadística & datos numéricos , Errores de Medicación/prevención & control , Niño , Estudios Retrospectivos , Hospitales Pediátricos/normas , Pacientes Internos , Preescolar , Lactante
6.
Br J Clin Pharmacol ; 90(5): 1280-1300, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38369619

RESUMEN

AIMS: In-hospital prescribing errors may result in patient harm, such as prolonged hospitalisation and hospital (re)admission, and may be an emotional burden for the prescribers and healthcare professionals involved. Despite efforts, in-hospital prescribing errors and related harm still occur, necessitating an innovative approach. We therefore propose a novel approach, in-hospital pharmacotherapeutic stewardship (IPS). The aim of this study was to reach consensus on a set of quality indicators (QIs) as a basis for IPS. METHODS: A three-round modified Delphi procedure was performed. Potential QIs were retrieved from two systematic searches of the literature, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. In two written questionnaires and a focus meeting (held between the written questionnaire rounds), potential QIs were appraised by an international, multidisciplinary expert panel composed of members of the European Association for Clinical Pharmacology and Therapeutics (EACPT). RESULTS: The expert panel rated 59 QIs and four general statements, of which 35 QIs were accepted with consensus rates ranging between 79% and 97%. These QIs describe the activities of an IPS programme, the team delivering IPS, the patients eligible for the programme and the outcome measures that should be used to evaluate the care delivered. CONCLUSIONS: A framework of 35 QIs for an IPS programme was systematically developed. These QIs can guide hospitals in setting up a pharmacotherapeutic stewardship programme to reduce in-hospital prescribing errors and improve in-hospital medication safety.


Asunto(s)
Consenso , Técnica Delphi , Errores de Medicación , Indicadores de Calidad de la Atención de Salud , Humanos , Indicadores de Calidad de la Atención de Salud/normas , Errores de Medicación/prevención & control , Encuestas y Cuestionarios , Hospitalización , Hospitales/normas
7.
Br J Clin Pharmacol ; 90(5): 1333-1343, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38403473

RESUMEN

AIMS: The purpose of this work was to assess failures in the advanced prescription of parenteral anticancer agents in an adult day oncology care unit with more than 100 patients per day. METHODS: An a priori descriptive analysis was carried out by using the risk matrix approach. After defining the scope in a multidisciplinary meeting, we determined at each step the failure modes (FMs), their effects (E) and their associated causes (C). A severity score (S) was assigned to all effects and a probability of occurrence (O) to all causes. These S and O indicators, were used to obtain a criticality index (CI) matrix. We assessed the risk control (RC) of each failure in order to define a residual criticality index (rCI) matrix. RESULTS: During risk analysis, 14 FMs were detected, and 61 scenarios were identified considering all possible effects and causes. Nine situations (15%) were highlighted with the maximum CI, 18 (30%) with a medium CI, and 34 (55%) with a negligible CI. Nevertheless, among all these critical situations, only three (5%) had an rCI to process (i.e., missed dose adjustment, multiple prescriptions and abnormal biology data); the others required monitoring only. Clinicians' and pharmacists' knowledge of these critical situations enables them to manage the associated risks. CONCLUSIONS: Advanced prescription of injectable anticancer drugs appears to be a safe practice for patients when combined with risk management. The major risks identified concerned missed dose adjustment, prescription duplication and lack of consideration for abnormal biology data.


Asunto(s)
Antineoplásicos , Humanos , Antineoplásicos/administración & dosificación , Antineoplásicos/efectos adversos , Medición de Riesgo , Errores de Medicación/prevención & control , Errores de Medicación/estadística & datos numéricos , Neoplasias/tratamiento farmacológico , Prescripciones de Medicamentos/estadística & datos numéricos , Prescripciones de Medicamentos/normas , Inyecciones , Instituciones Oncológicas/estadística & datos numéricos , Instituciones Oncológicas/organización & administración , Análisis de Modo y Efecto de Fallas en la Atención de la Salud , Adulto
8.
Ann Pharmacother ; 58(10): 1027-1033, 2024 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-38293819

RESUMEN

BACKGROUND: Missed medication doses are a common and often preventable medication-related error that have been associated with an increased length of stay and mortality. Hemodialysis is a common, relatively predictable reason that patients are unavailable, resulting in missed doses. OBJECTIVE: To evaluate the implications of a pharmacist-led intervention to standardize the medication administration times for patients requiring hemodialysis who were prescribed antihypertensives, antiepileptics, apixaban, and/or antimicrobials. METHODS: A retrospective preanalysis and postanalysis of a pharmacist-led intervention were performed at a single-center, safety net hospital. Patients receiving dialysis and prescribed one of the targeted medications were included. The primary endpoint was the composite of missed and delayed doses. RESULTS: A total of 25 patients receiving 126 dialysis sessions in the preintervention group and 29 patients receiving 80 dialysis sessions in the postintervention group were included for analysis. For the primary endpoint, 118 (18%) versus 57 (9.3%) doses were missed or delayed in the preintervention versus postintervention group, respectively (P < 0.001). The primary endpoint was driven by fewer delayed doses in the postgroup. The number of antimicrobials given on a correct schedule increased in the postintervention group (98.3% vs 99.1%, P = 0.044). CONCLUSION AND RELEVANCE: A pharmacist-led intervention for standard medication administration times in patients requiring hemodialysis increased the number of prescribed medication doses given and given on time. The intervention also led to more antimicrobials administered at appropriate times relative to dialysis sessions.


Asunto(s)
Farmacéuticos , Diálisis Renal , Humanos , Diálisis Renal/métodos , Masculino , Femenino , Estudios Retrospectivos , Anciano , Farmacéuticos/organización & administración , Persona de Mediana Edad , Errores de Medicación/prevención & control , Servicio de Farmacia en Hospital/organización & administración , Servicio de Farmacia en Hospital/métodos , Pacientes Internos , Esquema de Medicación , Anciano de 80 o más Años
9.
Eur J Clin Pharmacol ; 80(9): 1339-1341, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38822846

RESUMEN

PURPOSE: To demonstrate the effective integration of pharmacometrics and pharmacovigilance in managing medication errors, highlighted by a case involving secukinumab in a patient with hidradenitis suppurativa. METHODS: We present the case of a 41-year-old male with progressive hidradenitis suppurativa, unresponsive to multiple antibiotic regimens and infliximab treatment. Due to a medication error, the patient received 300 mg of secukinumab daily for 4 days instead of weekly, totaling 1200 mg. The regional pharmacovigilance center assessed potential toxicity, and a pharmacometric analysis using a population pharmacokinetic model was performed to inform dosing adjustments. RESULTS: Clinical data indicated that the received doses were within a non-toxic range. No adverse effects were observed. Pharmacometric simulations revealed a risk of underexposure due to the dosing error. Based on these simulations, it was recommended to restart monthly secukinumab injections on day 35 after the initial dose. Measured plasma concentrations before re-administration confirmed the model's accuracy. CONCLUSION: This case highlights the crucial collaboration between clinical services, pharmacovigilance, and pharmacometrics in managing medication errors. Such interdisciplinary efforts ensure therapeutic efficacy and patient safety by maintaining appropriate drug exposure levels.


Asunto(s)
Anticuerpos Monoclonales Humanizados , Errores de Medicación , Farmacovigilancia , Humanos , Masculino , Adulto , Anticuerpos Monoclonales Humanizados/efectos adversos , Anticuerpos Monoclonales Humanizados/farmacocinética , Anticuerpos Monoclonales Humanizados/administración & dosificación , Anticuerpos Monoclonales Humanizados/uso terapéutico , Errores de Medicación/prevención & control , Modelos Biológicos
10.
Eur J Clin Pharmacol ; 80(4): 589-595, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38282079

RESUMEN

OBJECTIVE: To analyze the serious medication errors (MEs) on dabigatran, and their related factors, in order to avoid or reduce the occurrence of adverse events. METHODS: Serious MEs related to dabigatran were extracted from the WHO global database of reported potential side effects of medicinal products (VigiBase) by using "Medication errors and other product use errors and issues" High Level Group Term (HLGT) of the international Medical Dictionary for Regulatory Activities (MedDRA). Well-documented reports, vigiGrade completeness score ≥ 0.80, or with an informative narrative were analyzed with a focus on the clinical features of the cases. The PCNE Classification for drug-related problems (DRP) was used to classify medication errors in our analysis of cases. RESULTS: Until January 26, 2020, there were 453 cases with serious MEs related to dabigatran in VigiBase, and 113 were well-documented. Among these, 69 patients (61%) were hospitalized or had prolonged hospitalization, 16 (14%) had life-threatening events, and 12 (11%) died. The MEs occurred in the prescription phase in 77 cases, in administration in 35, and at the dispensing stage in one case. The MEs in prescription were related to a drug selection error in 44 cases (24 concerning contraindications and 20 drug interactions) and to dose error in 33 cases (17 with excessive dose; eight with insufficient frequency; four had an incorrect time; in three, the dose was too low; and in one, too frequent). The MEs in administration were medical-staff-related errors in five cases (three with wrong administration route, one administration omission, and one overdose), patient-related errors in 28 (14 insufficient dose or no administration, seven improper drug storage, four wrong administration method, and three over prescribed dose), and other errors in two (without efficacy monitoring). The dispensing error of a wrong drug strength occurred in a pharmacy. The main adverse events in the 113 patients were haemorrhage in 57 cases (50%) and ischemia in 29 cases (26%). CONCLUSION: Based on the analysis of reports in VigiBase, serious MEs related to dabigatran mainly occurred during prescription and administration. Although the incidence of MEs with clinical consequences in the use of dabigatran cannot be determined, attention should be paid to selection of the appropriate dose to a right patient in the prescription, and to patient compliance and storage in drug administration. The patient harm mainly manifested itself as bleeding or ischemia including fatal outcome in rare patients.


Asunto(s)
Dabigatrán , Sobredosis de Droga , Humanos , Errores de Medicación , Preparaciones Farmacéuticas , Isquemia
11.
Eur J Clin Pharmacol ; 80(4): 575-588, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38282080

RESUMEN

Medication errors are one of the biggest problems in healthcare. The medicines' poor labelling design (i.e. look-alike labels) is a well-recognised risk for potential confusion, wrong administration, and patient damage. Human factors and ergonomics (HFE) encourages the human-centred design of system elements, which might reduce medication errors and improve people's well-being and system performance. OBJECTIVE: The aim of the present study is twofold: (i) to use a human reliability analysis technique to evaluate a medication administration task within a simulated scenario of a neonatal intensive care unit (NICU) and (ii) to estimate the impact of a human-centred design (HCD) label in medication administration compared to a look-alike (LA) label. METHOD: This paper used a modified version of the human error assessment and reduction technique (HEART) to analyse a medication administration task in a simulated NICU scenario. The modified technique involved expert nurses quantifying the likelihood of unreliability of a task and rating the conditions, including medicine labels, which most affect the successful completion of the task. RESULTS: Findings suggest that error producing conditions (EPCs), such as a shortage of time available for error detection and correction, no independent checking of output, and distractions, might increase human error probability (HEP) in administering medications. Results also showed that the assessed HEP and the relative percentage of contribution to unreliability reduced by more than 40% when the HCD label was evaluated compared to the LA label. CONCLUSION: Including labelling design based on HFE might help increase human reliability when administering medications under critical conditions.


Asunto(s)
Unidades de Cuidado Intensivo Neonatal , Errores de Medicación , Recién Nacido , Humanos , Reproducibilidad de los Resultados , Preparaciones Farmacéuticas , Etiquetado de Medicamentos/métodos
12.
Br J Anaesth ; 132(5): 837-839, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38418333

RESUMEN

Medication errors in anaesthesia remain a leading cause of patient harm. Compared with conventional methods, use of the international colour-code standard on syringes and medication trays allows significantly more errors to be detected, and does so under conditions of cognitive load. Testing methods from experimental psychology provide important new insights for human factors research in anaesthesia and health care.


Asunto(s)
Anestesia , Anestesiología , Humanos , Color , Errores de Medicación/prevención & control , Cognición
13.
Br J Anaesth ; 132(5): 911-917, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38336517

RESUMEN

BACKGROUND: Anaesthetic drug administration is complex, and typical clinical environments can entail significant cognitive load. Colour-coded anaesthetic drug trays have shown promising results for error identification and reducing cognitive load. METHODS: We used experimental psychology methods to test the potential benefits of colour-coded compartmentalised trays compared with conventional trays in a simulated visual search task. Effects of cognitive load were also explored through an accompanying working memory-based task. We hypothesised that colour-coded compartmentalised trays would improve drug-detection error, reduce search time, and reduce cognitive load. This comprised a cognitive load memory task presented alongside a visual search task to detect drug errors. RESULTS: All 53 participants completed 36 trials, which were counterbalanced across the two tray types and 18 different vignettes. There were 16 error-present and 20 error-absent trials, with 18 trials presented for each preloaded tray type. Syringe errors were detected more often in the colour-coded trays than in the conventional trays (91% vs 83%, respectively; P=0.006). In signal detection analysis, colour-coded trays resulted in more sensitivity to the error signal (2.28 vs 1.50, respectively; P<0.001). Confidence in response accuracy correlated more strongly with task performance for the colour-coded tray condition, indicating improved metacognitive sensitivity to task performance (r=0.696 vs r=0.447). CONCLUSIONS: Colour coding and compartmentalisation enhanced visual search efficacy of drug trays. This is further evidence that introducing standardised colour-coded trays into operating theatres and procedural suites would add an additional layer of safety for anaesthetic procedures.


Asunto(s)
Anestésicos , Jeringas , Humanos , Color , Anestésicos/farmacología , Errores de Medicación/prevención & control , Cognición
14.
Pharmacoepidemiol Drug Saf ; 33(1): e5743, 2024 01.
Artículo en Inglés | MEDLINE | ID: mdl-38158381

RESUMEN

BACKGROUND: Medication errors (MEs) are a major public health concern which can cause harm and financial burden within the healthcare system. Characterizing MEs is crucial to develop strategies to mitigate MEs in the future. OBJECTIVES: To characterize ME-associated reports, and investigate signals of disproportionate reporting (SDRs) on MEs in the Food and Drug Administration's Adverse Event Reporting System (FAERS). METHODS: FAERS data from 2004 to 2020 was used. ME reports were identified with the narrow Standardised Medical Dictionary for Regulatory Activities® (MedDRA®) Query (SMQ) for MEs. Drug names were converted to the Anatomical Therapeutic Chemical (ATC) classification. SDRs were investigated using the reporting odds ratio (ROR). RESULTS: In total 488 470 ME reports were identified, mostly (59%) submitted by consumers and mainly (55%) associated with females. Median age at time of ME was 57 years (interquartile range: 37-70 years). Approximately 1 out of 3 reports stated a serious health outcome. The most prevalent reported drug class was "antineoplastic and immunomodulating agents" (25%). The most common ME type was "incorrect dose administered" (9%). Of the 1659 SDRs obtained, adalimumab was the most common drug associated with MEs, noting a ROR of 1.22 (95% confidence interval: 1.21-1.24). CONCLUSION: This study offers a first of its kind characterization of MEs as reported to FAERS. Reported MEs are frequent and may be associated with serious health outcomes. This FAERS data provides insights on ME prevention and offers possibilities for additional in-depth analyses.


Asunto(s)
Sistemas de Registro de Reacción Adversa a Medicamentos , Errores de Medicación , Femenino , Estados Unidos , Humanos , Adulto , Persona de Mediana Edad , Anciano , Preparaciones Farmacéuticas , United States Food and Drug Administration , Errores de Medicación/prevención & control , Adalimumab , Farmacovigilancia
15.
Pharmacoepidemiol Drug Saf ; 33(2): e5735, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38357842

RESUMEN

BACKGROUND: Medication error (ME) surveillance in Danish healthcare relies on the mandatory national incident reporting system, the Danish Patient Safety Database (DPSD). Individual case reviews and descriptive statistics with frequency counts are the most often used approaches when analyzing MEs in incident reporting systems, including the DPSD. However, incident reporting systems often generate a large number of reports and may suffer from underreporting; consequently, additional approaches are needed to overcome these challenges. Disproportionality analysis (DPA) is a statistical tool used for signal detection of adverse drug reactions in pharmacovigilance reports, but the evidence for using DPA on ME analysis in safety reporting systems is limited. OBJECTIVES: We aimed to test the feasibility of DPA by analysing harmful MEs reported to DPSD 2014-2018. METHODS: We utilized proportional reporting ratios (PRR) to identify signals of diproportionality. RESULTS: We identified well-known high-risk medicines, including anticoagulants, opioids, insulins, antiepileptic, and antipsychotic drugs, and their association with several ME types and stages in a medication process. CONCLUSION: DPA might be suggested as an additional tool for screening MEs and identifying priority areas for further investigation in safety reporting systems.


Asunto(s)
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Seguridad del Paciente , Humanos , Sistemas de Registro de Reacción Adversa a Medicamentos , Errores de Medicación , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Farmacovigilancia , Dinamarca/epidemiología
16.
Pharmacoepidemiol Drug Saf ; 33(6): e5819, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38783417

RESUMEN

PURPOSE: This study aimed to perform a nationwide analysis of medication errors (MEs) from hospitals using national reporting system data and to compare the ME patterns among different age groups. METHODS: We analyzed medication-related incidents in acute care hospitals reported to the Korean Patient Safety Reporting and Learning System (KOPS), which is a patient safety reporting system, from July 2016 to December 2020. The stages of the medication use process, type of errors, medication class involved in MEs, and degree of harm were analyzed. RESULTS: Among a total of 5071 medication-related incidents, 37.7% (1911 cases) were incidents that caused patient harm and 1.2% caused long-term, permanent, and fatal harm. The proportion of medication-related incidents that resulted in harm was the highest among the <1-year-old age group (67 cases, 51.5%), followed by the elderly (≥ 65 years) (828 cases, 40.9%). The cases leading to patient death were most frequently reported in patients aged ≥65 years. Medication-related incidents occurred mainly in the administration stage (2954 cases, 58.3%), and wrong dose was the most frequently reported ME type. The most prevalent medication class occurring in the 20-64-year age group (256 cases, 11.7%) was 'antibacterials for systemic use', whereas 'contrast media' (236 cases, 11.6%) and 'blood substitutes and perfusion solutions' (98 cases, 19.3%) were the most prevalent drug classes in the ≥65- and <20-year-old age groups, respectively. CONCLUSIONS: It is necessary to establish guidelines for the prevention of medication-related incidents according to the medication use process and patient age group.


Asunto(s)
Errores de Medicación , Seguridad del Paciente , Humanos , Errores de Medicación/estadística & datos numéricos , Anciano , República de Corea/epidemiología , Persona de Mediana Edad , Adulto , Preescolar , Adulto Joven , Niño , Lactante , Factores de Edad , Seguridad del Paciente/estadística & datos numéricos , Adolescente , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Masculino , Hospitales/estadística & datos numéricos , Femenino , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Anciano de 80 o más Años
17.
Anesth Analg ; 139(4): 832-839, 2024 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-38870073

RESUMEN

BACKGROUND: Medication errors in the operating room have high potential for patient harm. While electronic clinical decision support (CDS) software has been effective in preventing medication errors in many nonoperating room patient care areas, it is not yet widely used in operating rooms. The purpose of this study was to determine the percentage of self-reported intraoperative medication errors that could be prevented by CDS algorithms. METHODS: In this retrospective cross-sectional study, we obtained safety reports involving medication errors documented by anesthesia clinicians between August 2020 and August 2022 at a 1046-bed tertiary care academic medical center. Reviewers classified each medication error by its stage in the medication use process, error type, presence of an adverse medication event, and its associated severity and preventability by CDS. Informational gaps were corroborated by retrospective chart review and disagreements between reviewers were resolved by consensus. The primary outcome was the percentage of errors that were preventable by CDS. Secondary outcomes were preventability by CDS stratified by medication error type and severity. RESULTS: We received 127 safety reports involving 80 medication errors, and 76/80 (95%) of the errors were classified as preventable by CDS. Certain error types were more likely to be preventable by CDS than others ( P < .001). The most likely error types to be preventable by CDS were wrong medication (N = 36, 100% rated as preventable), wrong dose (N = 30, 100% rated as preventable), and documentation errors (N = 3, 100% rated as preventable). The least likely error type to be preventable by CDS was inadvertent bolus (N = 3, none rated as preventable). CONCLUSIONS: Ninety-five percent of self-reported medication errors in the operating room were classified as preventable by CDS. Future research should include a randomized controlled trial to assess medication error rates and types with and without the use of CDS.


Asunto(s)
Sistemas de Apoyo a Decisiones Clínicas , Errores de Medicación , Quirófanos , Humanos , Errores de Medicación/prevención & control , Estudios Transversales , Estudios Retrospectivos , Femenino , Masculino , Persona de Mediana Edad , Seguridad del Paciente , Adulto , Anciano
18.
Biol Pharm Bull ; 47(8): 1460-1466, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39198151

RESUMEN

Dispensing errors pose a significant health risk, with drug name similarity being a potential contributory factor. To determine the impact of drug name similarity on dispensing errors within clinical settings, we analyzed 563 dispensing errors at an acute hospital in Japan from April 2015 to June 2018. Drug name similarity between two drugs was classified into Name-Similar and Name-Dissimilar groups using the m2-vwhtfrag index, the value of the drug name similarity. Drug efficacy similarity was categorized into Efficacy-Same, Efficacy-Close, and Efficacy-Far. The drug name similarity and drug efficacy similarity of all possible pair combinations were obtained and similarly classified. The proportion of the number of pairs with dispensing errors per the total number of drug pairs in the hospital's drug formulary in each category was calculated. The highest proportion of the number of pairs with dispensing errors was 36% for the Efficacy-Same and Name-Similar group, and the lowest proportion was 0.022% for the Efficacy-Far and Name-Dissimilar group. The proportion of the number of pairs with dispensing errors was significantly higher in the Name-Similar category than in the Name-Dissimilar category for all drug efficacy categories. Our results indicate that drug name similarity increases the risk of dispensing errors, and that m2-vwhtfrag is a useful indicator to assess dispensing errors in clinical practice. Such drug name and efficacy similarity evaluations can help identify factors causing dispensing errors, and predict the risk of dispensing errors for newly adopted drugs, considering the relationship with the whole drug formulary in the hospital dispensary.


Asunto(s)
Errores de Medicación , Errores de Medicación/prevención & control , Errores de Medicación/clasificación , Humanos , Japón , Servicio de Farmacia en Hospital
19.
Eur J Pediatr ; 183(2): 853-862, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-37875630

RESUMEN

This study aimed to assess the accuracy of liquid drug dose measurements made by caregivers and explore the factors influencing these measurements. Caregivers (n = 176) of children aged less than 8 years, who were treated at the pediatric clinic of a university hospital in Turkey between July and October 2019, were eligible to participate in this study. The caregivers' ability to accurately measure a 2.5-mL dose of medication was observed using standardized measurement instruments, including 15-mL and 30-mL dosing cups, a 3-mL dropper, a 5-mL dose spoon, and a 5-mL oral syringe. A comparison was made with the reference weight determined for the 2.5-mL dose to calculate the margin of error. A dose of ± 20% of the reference value was considered a clinically significant error. The chi-square test was used to examine differences in dose error rates concerning individual characteristics. Caregivers exhibited a dosing error rate exceeding 20%. Specifically, 43% of the errors occurred when using 15-mL cups, 37% with 30-mL cups, 22% with 3-mL droppers, 4.5% with 5-mL spoons, and 4% with 5-mL syringes. In cases where errors were under 20%, the rates were as follows: 1.1% with 15-mL cups, 2.8% with 30-mL cups, 19% with 3-mL droppers, 3.4% with 5-mL spoons, and 4% with 5-mL syringes. The dosing errors were not affected by the role and health literacy level of caregivers, regardless of the type of dosing tool they used (all p values > 0.05). The study found that oral syringes and dosing spoons had the lowest error rates, whereas dosing cups had the highest error rates.  Conclusion: Healthcare providers in family health centers and pediatric clinics should educate caregivers about proper drug administration with oral syringes and dosing spoons, even if dosing cups are included. What is Known: • Dose calculation errors and incorrect measurement tools are the leading factors causing errors. • Liquid medicine bottles are still often accompanied by dosing cups as measuring instruments. • Both the American Academy of Pediatrics (AAP) and the U.S. Food and Drug Administration (FDA) recommend that parents use standard measuring instruments such as oral syringes, droppers, and measuring spoons instead of kitchen spoons for administering the correct dose to children. What is New: • The measuring tool with the maximum errors was the dosing cup, whereas oral syringes and dosing spoons were more accurate. • Individual administering medication at home and the health literacy level had no effect on the accuracy of dose measurement. • Pediatric nurses, in particular, should incorporate safe liquid medication measurement tools into parental education.


Asunto(s)
Alfabetización en Salud , Errores de Medicación , Humanos , Niño , Errores de Medicación/prevención & control , Cuidadores , Padres , Valores de Referencia
20.
Cochrane Database Syst Rev ; 10: CD012594, 2024 Oct 29.
Artículo en Inglés | MEDLINE | ID: mdl-39470185

RESUMEN

BACKGROUND: Adverse drug events, encompassing both adverse drug reactions and medication errors, pose a significant threat to health, leading to illness and, in severe cases, death. Timely and voluntary reporting of adverse drug events by healthcare professionals plays a crucial role in mitigating the morbidity and mortality linked to unexpected reactions and improper medication usage. OBJECTIVES: To assess the effectiveness of different interventions aimed at healthcare professionals to improve the reporting of adverse drug events. SEARCH METHODS: We searched CENTRAL, Embase, MEDLINE and several other electronic databases and trials registers, including ClinicalTrials.gov and WHO ICTRP, from inception until 14 October 2022. We also screened reference lists in the included studies and relevant systematic reviews. SELECTION CRITERIA: We included randomised trials, non-randomised controlled studies, controlled before-after studies, interrupted time series studies (ITS) and repeated measures studies, assessing the effect of any intervention aimed at healthcare professionals and designed to increase adverse drug event reporting. Eligible comparators were healthcare professionals' usual reporting practice or a different intervention or interventions designed to improve adverse drug event reporting rate. We excluded studies of interventions targeted at adverse event reporting following immunisation. Our primary outcome measures were the total number of adverse drug event reports (including both adverse drug reaction reports and medication error reports) and the number of false adverse drug event reports (encompassing both adverse drug reaction reports and medication error reports) submitted by healthcare professionals. Secondary outcomes were the number of serious, high-causality, unexpected or previously unknown, and new drug-related adverse drug event reports submitted by healthcare professionals. We used GRADE to assess the certainty of evidence. DATA COLLECTION AND ANALYSIS: We followed standard methods recommended by Cochrane and the Cochrane Effective Practice and Organisation of Care (EPOC) Group. We extracted and reanalysed ITS study data and imputed treatment effect estimates (including standard errors or confidence intervals) for the randomised studies. MAIN RESULTS: We included 15 studies (eight RCTs, six ITS, and one non-randomised cross-over study) with approximately 62,389 participants. All studies were conducted in high-income countries in large tertiary care hospitals. There was a high risk of performance bias in the controlled studies due to the nature of the interventions. None of the ITS studies had a control arm, so we could not be sure of the detected effects being independent of other changes. None of the studies reported on the number of false adverse drug event reports submitted. There is low-certainty evidence suggesting that an education session, together with reminder card and adverse drug reaction (ADR) report form, may substantially improve the rate of ADR reporting by healthcare professionals when compared to usual practice (i.e. spontaneous reporting with or without some training provided by regional pharmacosurveillance units). These educational interventions increased the number of ADR reports in total (RR 3.00, 95% CI 1.53 to 5.90; 5 studies, 21,655 participants), serious ADR reports (RR 3.30, 95% CI 1.51 to 7.21; 5 studies, 21,655 participants), high-causality ADR reports (RR 2.48, 95% CI 1.11 to 5.57; 5 studies, 21,655 participants), unexpected ADR reports (RR 4.72, 95% CI 1.75 to 12.76; 4 studies, 15,085 participants) and new drug-related ADR reports (RR 8.68, 95% CI 3.40 to 22.13; 2 studies, 7884 participants). Additionally, low-certainty evidence suggests that, compared to usual practice (i.e. spontaneous reporting), making it easier to report ADRs by using a standardised discharge form with added ADR items may slightly improve the total number of ADR reports submitted (RR 2.06, 95% CI 1.11 to 3.83; 1 study, 5967 participants). The discharge form tested was based on the 'Diagnosis Related Groups' (DRG) system for recording patient diagnoses, and the medical and surgical procedures received during their hospital stay. Due to very low-certainty evidence, we do not know if the following interventions have any effect on the total number of adverse drug event reports (including both ADR and ME reports) submitted by healthcare professionals: - sending informational letters or emails to GPs and nurses; - multifaceted interventions, including financial and non-financial incentives, fines, education and reminder cards; - implementing government regulations together with financial incentives; - including ADR report forms in quarterly bulletins and prescription pads; - providing a hyperlink to the reporting form in hospitals' electronic patient records; - improving the reporting method by re-engineering a web-based electronic error reporting system; - the presence of a clinical pharmacist in a hospital setting actively identifying adverse drug events and advocating for the identification and reporting of adverse drug events. AUTHORS' CONCLUSIONS: Compared to usual practice (i.e. spontaneous reporting with or without some training from regional pharmacosurveillance units), low-certainty evidence suggests that the number of ADR reports submitted may substantially increase following an education session, paired with reminder card and ADR report form, and may slightly increase with the use of a standardised discharge form method that makes it easier for healthcare professionals to report ADRs. The evidence for other interventions identified in this review, such as informational letters or emails and financial incentives, is uncertain. Future studies need to assess the benefits (increase in the number of adverse drug event reports) and harms (increase in the number of false adverse drug event reports) of any intervention designed to improve healthcare professionals' reporting of adverse drug events. Interventions to increase the number of submitted adverse drug event reports that are suitable for use in low- and middle-income countries should be developed and rigorously evaluated.


Asunto(s)
Sistemas de Registro de Reacción Adversa a Medicamentos , Sesgo , Personal de Salud , Errores de Medicación , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Errores de Medicación/estadística & datos numéricos , Errores de Medicación/prevención & control , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Análisis de Series de Tiempo Interrumpido , Ensayos Clínicos Controlados no Aleatorios como Asunto , Estudios Controlados Antes y Después
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