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1.
Am J Obstet Gynecol ; 2024 Aug 26.
Artigo em Inglês | MEDLINE | ID: mdl-39197563

RESUMO

BACKGROUND: The rising trend in maternal mortality over the past 3 decades sets the United States apart from all other high-income countries. Multidisciplinary state and city Maternal Mortality Review Committees conduct comprehensive reviews of maternal deaths, including assessments of preventability and contributing factors. OBJECTIVE: Assess preventability of and contributing factors to maternal mortality in the U.S. STUDY DESIGN: This study is a secondary analysis of cross-sectional, population-based data from the most recent, publicly available Maternal Mortality Review Committee data from 40 state and 2 cities in the U.S. Preventability were analyzed among all deaths during pregnancy or within 1 year postpartum from any cause (pregnancy-associated deaths) and deaths during pregnancy or within 1 year postpartum from causes related to pregnancy or its management, but not from accidental causes (pregnancy-related deaths). We also explored preventability by cause-of-death and contributing factors grouped as community, patient-family, provider, facility, and health system factors. RESULTS: Of deaths that occurred after 2010, between 53% to 93.8% of pregnancy-associated deaths and 45% to 100% of pregnancy-related deaths were deemed preventable across the 42 states and cities. Across the 10 states reporting pregnancy-related death preventability by cause-of-death, Maternal Mortality Review Committees deemed preventable >90% of deaths from preeclampsia-eclampsia and mental health conditions, >80% of deaths from hemorrhage and cardiovascular conditions, about 70% of deaths from infection and thrombotic embolism, and about 40% of deaths from amniotic fluid embolism and stroke. A total of 3345 contributing factors were described in Maternal Mortality Review Committee reports from 14 states in relation to 739 pregnancy-related deaths. While collectively patient-family and provider factors were most frequently noted as contributing to pregnancy-related deaths, the contribution of such factors varied between 6% to 56% and 18% to 42.3%, respectively, across the states. Based on data from 20 Maternal Mortality Review Committees with available information, racism or discrimination were noted in relation to 37.7% of pregnancy-related deaths. CONCLUSION: A large proportion of pregnancy-associated deaths and pregnancy-related deaths in the U.S. are preventable. However, likely due to differences in Maternal Mortality Review Committee membership, available data, and judgement employed to determine preventability, wide variation exists in the proportion of deaths deemed preventable and factors identified as contributing to such deaths across states. There is need to reevaluate the definitions, structure, and outputs for maternal death preventability assessments currently employed by a majority Maternal Mortality Review Committees to adequately inform state and national programming and policies.

2.
Eur J Clin Pharmacol ; 80(9): 1355-1362, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38831143

RESUMO

PURPOSE: Patients with impaired renal function using medication that affects glomerular filtration rate are at increased risk of developing acute kidney injury (AKI) leading to hospital admissions. The risk increases during periods of dehydration due to diarrhoea, vomiting or fever (so-called "sick days"), or high environmental temperatures (heat wave). This study aims to gain insight into the characteristics and preventability of medication-related admissions for AKI and dehydration in elderly patients. METHODS: Retrospective case series study in patients aged ≥ 65 years with admission for acute kidney injury, dehydration or electrolyte imbalance related to dehydration that was defined as medication-related. General practitioner's (GP) patient records including medication history and hospital discharge letters were available. For each admission, patient and admission characteristics were collected to review the patient journey. A case-by-case assessment of preventability of hospital admissions was performed. RESULTS: In total, 75 admissions were included. Most prevalent comorbidities were hypertension, diabetes, and known impaired renal function. Diuretics and RAS-inhibitors were the most prevalent medication combination. Eighty percent of patients experienced non-acute onset of symptoms and 60% had contacted their GP within 2 weeks prior to admission. Around 40% (n = 29) of admissions were considered potentially preventable if pharmacotherapy had been timely and adequately adjusted. CONCLUSION: A substantial proportion of patients admitted with AKI or dehydration experience non-acute onset of symptoms and had contacted their GP within 2 weeks prior to admission. Timely adjusting of medication in these patients could have potentially prevented a considerable number of admissions.


Assuntos
Injúria Renal Aguda , Desidratação , Humanos , Injúria Renal Aguda/induzido quimicamente , Injúria Renal Aguda/prevenção & controle , Injúria Renal Aguda/epidemiologia , Desidratação/prevenção & controle , Idoso , Masculino , Feminino , Idoso de 80 Anos ou mais , Estudos Retrospectivos , Hospitalização/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Admissão do Paciente/estatística & dados numéricos
3.
World J Surg ; 48(4): 863-870, 2024 04.
Artigo em Inglês | MEDLINE | ID: mdl-38381056

RESUMO

AIM: To study the preventable trauma deaths of hospitalized patients in the United Arab Emirates and to identify opportunities for improvement. METHODS: We analyzed the Abu Dhabi Emirate Trauma Registry data of admitted patients who died in the emergency department or in hospital from 2014 to 2019. A panel of experts categorize the deaths into not preventable (NP), potentially preventable (PP), and definitely preventable (DP). RESULTS: A total of 405 deaths were included, and 82.7% were males. The majority (89.1%) were NP, occurring mainly in the emergency department (40.4%) and the intensive care unit (49.9%). The combined potentially preventable and preventable death rate was 10.9%. The median (Interquartile range) age of the DP was 57.5 (37-76) years, compared with 32 (24-42) and 34 (25-55) years for NP and PP, respectively (p = 0.008). Most of the PP deaths occurred in the intensive care unit (55.6%), while the DP occurred mainly in the ward (50%). Falls accounted for 25% of PP and DP. Deficiencies in airway care, hemorrhage control, and fluid management were identified in 25%, 43.2% and 29.5% of the DP/PP deaths, respectively. Seventy-two percent of the Airway deficiencies occurred in the prehospital, while 34.1% of hemorrhage control deficiencies were in the emergency department. Fluid management deficiencies occurred in the emergency department and the operation theater. CONCLUSIONS: DP and PP deaths comprised 10.9% of the deaths. Most of the DP occurred in the emergency department and ward. Prehospital Airway and in-hospital hemorrhage and excessive fluid were the main areas for opportunities for improvement.


Assuntos
Insuficiência Cardíaca , Ferimentos e Lesões , Masculino , Humanos , Pessoa de Meia-Idade , Idoso , Feminino , Hemorragia , Serviço Hospitalar de Emergência , Hospitais , Hospitalização , Ferimentos e Lesões/terapia , Causas de Morte , Centros de Traumatologia , Estudos Retrospectivos
4.
Acta Obstet Gynecol Scand ; 103(9): 1877-1887, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-39021333

RESUMO

INTRODUCTION: Obstetric hemorrhage remains a largely preventable cause of maternal mortality globally. The contribution of uterine atony to hemorrhage-related maternal mortality has decreased in France, while the contribution of other causes of obstetric hemorrhage such as surgical injury during cesarean has been reported to increase. However, little evidence exists regarding the risk factors and care processes of women who died from this cause of hemorrhage. Therefore, we aimed to describe the clinical profile, underlying mechanisms, and preventability factors among women who died from obstetric hemorrhage by surgical injury during cesarean section. MATERIAL AND METHODS: Nationwide analysis of all hemorrhage-related maternal deaths by surgical injury during cesarean in France identified by the nationwide permanent enhanced maternal mortality surveillance system (ENCMM) between 2007 and 2018. We described the characteristics of the women, delivery hospitals, circumstances of hemorrhage, features of obstetric and resuscitation/transfusion care, and main preventability factors. RESULTS: Between 2007 and 2018, hemorrhage-related maternal mortality in France decreased from 1.6/100 000 live births (95% CI 1.1-2.2) (39/2 472 650) in 2007-2009 to 0.8/100 000 live births (95% CI 0.5-1.3) (19/2 311 783) in 2016-2018. Hemorrhage-related maternal mortality ratio due to surgical injury during cesarean increased from 0.08 (95% CI 0.01-0.3) (2/2 472 650) to 0.2 (95% CI 0.07-0.5) (5/2 311 783) per 100 000 live births. Among the 18 women who died from surgical injury during cesarean over the 12-year study period, we report a high prevalence of obesity (67%, 12/18), previous cesarean (72%, 13/18), and second-stage cesareans (56%, 10/18). In 22% (4/18), cesarean section was performed in a hospital providing <1000 births annually, with no blood bank (39%, 7/18) or no adult intensive care (44%, 8/18) on-site. Overall preventability of deaths was 94% (17/18). Main preventability factors were related to delay in hemorrhage diagnosis (77%, 14/18) due to late recognition of abnormal parameters (33%, 6/18) and late bedside ultrasound (56%, 10/18), and delay in management due to insufficient surgical skills (56%, 10/18). CONCLUSIONS: In France, surgical injury during cesarean section is an increasing, largely preventable contributor to hemorrhage-related maternal mortality, as other causes of fatal hemorrhage have become less frequent. The profile of these women showed a high prevalence of obesity, previous cesarean, second-stage cesarean, and delivery in hospitals with limited medical and surgical resources, which suggests explanatory mechanisms for the fatal outcome and opportunities for prevention.


Assuntos
Cesárea , Mortalidade Materna , Hemorragia Pós-Parto , Humanos , Feminino , Cesárea/efeitos adversos , Gravidez , Adulto , França/epidemiologia , Hemorragia Pós-Parto/mortalidade , Fatores de Risco
5.
J Oncol Pharm Pract ; : 10781552241276438, 2024 Sep 05.
Artigo em Inglês | MEDLINE | ID: mdl-39234674

RESUMO

BACKGROUND: Despite treatment modalities for multiple myeloma can cause adverse drug reactions (ADRs), data are scarce about the types, severity and preventability of chemotherapy-related ADRs in Kenya. This study aimed to assess the chemotherapy-related ADRs among multiple myeloma patients at Kenyatta National Hospital (KNH). METHODS: A one-arm retrospective cohort study was carried out among all eligible adult patients with a documented diagnosis of multiple myeloma between 1st January 2017 to 31st December 2023. A data abstraction tool was used to assess sociodemographics, clinical characteristics and chemotherapy-related ADRs. The Schumock and Thornton scale and the modified Hartwig and Siegel severity scale were employed to evaluate the preventability and severity of ADRs, respectively. Data analysis was performed using the Statistical Package for Social Sciences (SPSS) version 29.0 software. The results were presented using mean, frequency and percentage. Binary logistic regression was employed to assess factors influencing ADRs. A p-value of less than 0.05 was considered statistically significant. RESULTS: The prevalence of ADRs in this study was 81.5% with a total of 230 ADRs identified. The primary ADRs identified were peripheral neuropathy (21.7%), nausea and vomiting (14.8%), neutropenia (12.2%) and anemia (11.3%). The majority of the ADRs (51.7%) were moderate in severity, and 29.8% were of mild severity. Preventability assessments of the ADRs showed that most of them (68.2%) were definitely preventable and 13.2% were probably preventable. VRD (Bortezomib/Lenalidomide/Dexamethasone) and VCD (Bortezomib/Cyclophosphamide/Dexamethasone) treatment regimens were responsible for most of the ADRs. VRD (AOR = 11.1, 95% CI = 3.7-32.8, p < 0.001) and VCD treatment regimens (AOR = 4.8, 95% CI = 1.1-20.0, p = 0.033) were the significant factors affecting the occurrence of ADRs. CONCLUSION: Overall, the incidence of chemotherapy-related ADRs in multiple myeloma patients at KNH was notably high (81.5%). Despite the moderate severity of the ADRs, their preventable nature highlights the potential for improved patient outcomes through careful regimen selection and monitoring.

6.
J Stroke Cerebrovasc Dis ; 33(12): 108040, 2024 Sep 28.
Artigo em Inglês | MEDLINE | ID: mdl-39349264

RESUMO

INTRODUCTION: Cardiovascular disease remains a leading cause of morbidity and mortality worldwide, with many individuals presenting with acute ischemic stroke or transient ischemic attack (AIS/TIA) due to underlying vascular risk factors (VRF). While these patients typically undergo routine evaluations for acute treatment, the prevention of these conditions is often underestimated. This study reports the prevalence of non-optimized VRF and estimates their degree of avoidability in a cohort of patients treated in a tertiary care center following AIS/TIA. METHODS: This retrospective study enrolled patients older than 18 years who experienced AIS/TIA over a two-year period. Preventability was defined as the degree to which an acute cerebrovascular event could have been prevented if the VRF had been appropriately treated. Using the variables determined at the onset of AIS or TIA, we developed a 10-point scale to classify the degree of preventability (not preventable [score of 0], low preventability [score of 1-3], and high preventability [score of 4 or higher]). We further defined sub-scores based on the effectiveness of treatment of high blood pressure [HBP] (0-2 points), dyslipidemia [DLP] (0-2 points), atrial fibrillation [AF] (1 point), active smoking [AS] (1 point), obesity (1 point), previous coronary heart disease [CHD] (1 point), and previous AIS/TIA (2 points). Demographic factors, etiologies, and imaging findings were evaluated, tabulated independently, and subsequently correlated with clinical findings extracted from the available patient records. RESULTS: Of the 395 patients (334 with AIS and 61 with TIA), 376 (95.19 %) exhibited some degree of preventability, whereas 19 (4.81 %) presented with a nonpreventable event. In total, 296 (74.94 %) presented a low preventable event, and 80 (20.25 %) presented a high preventable event. Applying the Chi-square test of independence to stroke etiology highlighted cardio-aortic embolism and large artery atherosclerosis as groups with a significantly higher burden of risk factors necessitating intervention, while patients with stroke of other etiologies had more adequate control of VRF. In terms of stroke severity, as determined by the National Institutes of Health Stroke Scale (NIHSS), patients with NIHSS scores >5 were more likely to experience preventable events. According to the ABCD2 score, higher risk scores were significantly associated with a higher preventive factor burden; however, age, sex, vascular territory, and Canadian TIA scores were not related to the prevention of AIS/TIA. CONCLUSIONS: The high percentage of preventable events reflects the need to study other factors that may contribute to unhealthy lifestyles in this population. Potential reasons for poor health include high levels of stress, sleep deprivation, working conditions and an unhealthy diet. Further studies are required to better understand these phenomena.

7.
Br J Clin Pharmacol ; 89(1): 390-400, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-36002314

RESUMO

AIMS: In the last French study in 2007, the incidence of hospital admissions (HAs) related to adverse drug reactions (ADRs) was 3.6%. The objective was to assess the current ADR-HA incidence in France and to describe both its characteristics and preventability. METHODS: A prospective multicentre study was conducted among randomly selected French public hospital medical wards (April-July 2018). Patients admitted during a week period were included. ADR-HA cases were collected by the French Regional Pharmacovigilance Centres network. An independent committee validated potential cases and ADR preventability. RESULTS: ADR-HA incidence was 8.5% (95% confidence interval [CI]: 7.6-9.4%), increasing with age (3.3% [95%CI: 1.8-5.5%] ≤16 y vs. 10.6% [95%CI: 9.3-12.0%] ≥65 y). The most common ADRs were haemorrhagic events (8.8%), haematological disorders (6.5%), acute renal failure (6.3%), fluid and electrolyte disorders (6.0%), and falls (5.2%). New drugs were involved: targeted therapies (22.8% of antineoplastics), direct oral anticoagulants (29.6% of antithrombotics) and incretin-based drugs (20.0% of antidiabetics). ADRs were preventable in 16.1% of cases because the drugs involved had not been used in accordance with monographies, package leaflets or other therapeutic guidelines. The main situations of noncompliance addressed either dose or duration of use (27.9%), warning (23.2%), use precaution (18.6%) and inappropriate self-medication or misuse by patients (11.6%). CONCLUSION: In France, ADR-HA incidence dramatically increased over the last decade. A significant proportion was related to new pharmacological classes and considered as preventable. These findings should lead to in-depth thought on preventive actions on at-risk drug classes.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Humanos , Estudos Prospectivos , Incidência , Hospitalização , França , Hospitais , Sistemas de Notificação de Reações Adversas a Medicamentos
8.
Eur J Epidemiol ; 38(7): 717-728, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37280503

RESUMO

Population attributable risk (PAR%) reflects the preventable fraction of disease. However, PAR% estimates of cancer have shown large variation across populations, methods, data sources, and timing of measurements. Three statistical methods to estimate PAR% were identified from a systematic literature review: the Levin's formula, the comparative incidence rate method, and the comparative risk assessment method. We compared the variations in PAR% of postmenopausal breast cancer in the Nurses' Health Study to evaluate the influence by method choice, source of prevalence data, use of single vs repeated exposure measurements, and potential joint effects of obesity, alcohol, physical activity, fruit and vegetable intake. Across models of the three methods, the estimated PAR% using repeated measurements were higher than that using baseline measurement; overall PAR% for the baseline, simple update, and cumulative average models were 13.8%, 21.1%, 18.6% by Levin's formula; 13.7%, 28.0%, 31.2% by comparative risk assessment; and 17.4%, 25.2%, 29.3% by comparative incidence rate method. The estimated PAR% of the combination of multiple risk factors was higher than the product of the individual PAR%: 18.9% when assuming independence and 31.2% when considering the risk factors jointly. The three methods provided similar PAR% based on the same data source, timing of measurements, and target populations. However, sizable increases in the PAR% were observed for repeated measures over a single measure and for calculations based on achieving all recommendations jointly rather than individually.


Assuntos
Neoplasias da Mama , Fonte de Informação , Humanos , Feminino , Fatores de Risco , Obesidade/epidemiologia , Estilo de Vida , Neoplasias da Mama/epidemiologia , Incidência
9.
Br J Anaesth ; 128(3): 535-545, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-35086685

RESUMO

Literature focused on quantifying or reducing patient harm in anaesthesia uses a variety of labels and definitions to represent patient safety-related events, such as 'medication errors', 'adverse events', and 'critical incidents'. This review extracts and compares definitions of patient safety-related terminology in anaesthesia to examine the scope of this variability and inconsistencies. A structured review was performed in which 36 of the 769 articles reviewed met the inclusion criteria. Similar terms were grouped into six categories by similarities in keyword choice (Adverse Event, Critical Incident, Medication Error, Error, Near Miss, and Harm) and their definitions were broken down into three base components to allow for comparison. Our analysis found that the Medication Error category, which encompasses the greatest number of terms, had widely variant definitions which represent fundamentally different concepts. Definitions of terms within the other categories consistently represented relatively similar concepts, though key variations in wording remain. This inconsistency in terminology can lead to problems with synthesising, interpreting, and overall sensemaking in relation to anaesthesia medication safety. Guidance towards how 'medication errors' should be defined is provided, yet a definition will have little impact on the future of patient safety without organisations and journals taking the lead to promote, publish, and standardise definitions.


Assuntos
Anestesia/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Erros de Medicação/prevenção & controle , Anestesiologia/métodos , Animais , Humanos , Segurança do Paciente , Gestão de Riscos/métodos
10.
Br J Anaesth ; 128(4): 605-607, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-35190175

RESUMO

The definitions of terms related to iatrogenic harm and the potential for iatrogenic harm (e.g. error, medication error, near miss) in the anaesthesia literature are imprecise and variable, resulting in wide discrepancy in conclusions about their rates and potential solutions. Clarification of these terms is both critical and difficult: a concerted effort to achieve expert consensus is warranted.


Assuntos
Anestesia , Anestesiologia , Consenso , Humanos , Erros de Medicação/prevenção & controle , Segurança do Paciente
11.
BMC Cardiovasc Disord ; 22(1): 480, 2022 11 11.
Artigo em Inglês | MEDLINE | ID: mdl-36368954

RESUMO

BACKGROUND: Adverse drug reaction (ADR) of medications remains an obstacle to achieving optimal disease outcomes. This study aimed to assess the prevalence and associated factors of ADR among Heart failure (HF) patients hospitalized at Mbarara Regional and Referral Hospital. METHOD: A prospective observational study was conducted among hospitalized HF patients from November 2021 to January 2022. Univariate and multivariate logistic regression was employed to determine factors associated with the ADR. RESULT: Overall, 118 HF patients were included in the study with a median age of 43 years. A total of 164 ADRs were identified during the follow-up period of 1011 days. The incidence of new ADRs was 106 ADRs/1000 person-days. The prevalence of ADR was 59.3%. Of the 164 ADRs, 118(71.9%) were probable. The gastrointestinal system was the most frequently (27.5%) affected system. Over half (86, 52.4%) of the ADRs were mild and 96(58.5%) were preventable. Age group 19-59(AOR 0.15[0.03-0.35] at 95%CI, p = 0.013), herbal use (AOR 3.07[1.01-9.32] at 95%CI, p = 0.048), poly-pharmacy (AOR 8.7[2.4-15.77] at 95%CI, p < 0.001) and drug-drug interaction (AOR 6.06[2.79-12.5] at 95%CI, p = 0.004) were significantly associated with ADRs among HF patients. CONCLUSION: More than half of the hospitalized HF patients experienced at least one ADR during their hospital stay. The use of herbal medicines, poly-pharmacy, and drug-drug interaction were associated with a high risk of ARDs whereas the age group 19-59 years was less likely to experience ADRs.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Insuficiência Cardíaca , Humanos , Adulto , Adulto Jovem , Pessoa de Meia-Idade , Prevalência , Uganda/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Hospitalização , Hospitais , Insuficiência Cardíaca/induzido quimicamente , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/epidemiologia , Encaminhamento e Consulta
12.
Acta Obstet Gynecol Scand ; 101(12): 1395-1402, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36207816

RESUMO

INTRODUCTION: Pre-viable premature rupture of membranes (pre-viable PROM) is a rare event occurring in less than 1% of pregnancies. Nevertheless, it can be responsible for severe maternal complications, the risk of which needs to be balanced with the possibility to prolong the pregnancy up to viable gestational age. Maternal sepsis was reported in 1%-5% of women who received conservative management and prophylactic antibiotics, but information on maternal mortality is lacking. Our objective was to identify maternal deaths in women who had pre-viable PROM, describe the characteristics of the women, explore preventability factors within the care they received, and estimate the lethality of pre-viable PROM. MATERIAL AND METHODS: We identified all maternal deaths associated with pre-viable PROM from the 2001-2015 French National Confidential Enquiry into Maternal Deaths (NCMM). Data on women's characteristics and the care they received were extracted from the ENCMM database. The lethality was determined after estimating the total number of pregnant women with pre-viable PROM from the national hospital discharge database. RESULTS: Between 2001 and 2015, we identified seven maternal deaths associated with pre-viable PROM, representing 0.6% of all maternal deaths over this period (ie, maternal mortality ratio 0.06/100 000 live births). Six maternal deaths were attributed to sepsis after genital infection by Gram-negative bacilli and one to postpartum hemorrhage due to placenta accreta. Four of these seven cases were considered preventable. The main preventability factors were delayed diagnosis, delayed fetal extraction, and inappropriate antibiotic treatment. The estimated lethality was 4.5/10 000 women with pre-viable PROM. CONCLUSIONS: Maternal death associated with pre-viable PROM is rare but possible. Most of these deaths seem preventable, with areas for improvement related to earlier diagnosis and better treatment of uterine infections, which can evolve rapidly.


Assuntos
Ruptura Prematura de Membranas Fetais , Morte Materna , Nascimento Prematuro , Feminino , Gravidez , Humanos , Morte Materna/etiologia , Mortalidade Materna , Ruptura Prematura de Membranas Fetais/epidemiologia , Ruptura Prematura de Membranas Fetais/terapia , Idade Gestacional
13.
J Clin Pharm Ther ; 47(12): 2014-2019, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-35848069

RESUMO

WHAT IS KNOWN AND OBJECTIVE: Allopurinol, the first-line medication for hyperuricemia is well-known for its association with severe cutaneous adverse reactions, especially Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). In the current study, we analysed the Vietnamese spontaneous reporting database to identify signals and preventability of allopurinol-induced SJS/TEN in Vietnam from 2010 to 2019. METHODS: Signal generation was assessed using the case/non-case method. Reporting odds ratios (RORs) and 95% confidence intervals (95% CI) were calculated. RESULTS: Among 72,822 spontaneous ADR reports submitted to the Vietnam National Drug Information and Adverse Drug Reaction Monitoring Centre, 392 reports were on SJS/TEN, of which, 65 cases (16.6%) were related to allopurinol. The signals of allopurinol-induced SJS/TEN in Vietnam started in 2014 (ROR of 3.531, 95% CI: 1.830-6.810) and annually increased until 2019 (ROR of 11.923, 95% CI: 8.508-16.710). The preventability assessment showed that no allopurinol-induced SJS/TEN case was definitely unpreventable. 61.6% of the SJS/TEN cases were avoidable because they were associated with inappropriate prescribing such as unapproved indications, too high initial dose and even rechallenging in patients with a history of allopurinol allergy. WHAT IS NEW AND CONCLUSION: The signals of allopurinol-induced SJS/TEN in Vietnam started in 2014 and annually increased until 2019. Our first report specifically focusing on the ADR preventability of allopurinol showed that correction of medical errors relating to prescription could prevent more than 60% of SJS/TEN cases in Vietnamese allopurinol users. This is a feasible and practical solution, provided that there would be a systematic change in both healthcare systems and public awareness.


Assuntos
Hiperuricemia , Síndrome de Stevens-Johnson , Humanos , Alopurinol/efeitos adversos , Síndrome de Stevens-Johnson/epidemiologia , Síndrome de Stevens-Johnson/etiologia , Síndrome de Stevens-Johnson/prevenção & controle , Farmacovigilância , Vietnã , Hiperuricemia/tratamento farmacológico
14.
Aust N Z J Obstet Gynaecol ; 62(1): 71-78, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34232517

RESUMO

BACKGROUND: Severe maternal morbidity (SMM) occurs in 1-2% of pregnancies. Despite the knowledge that a SMM event can contribute to poor fetal/neonatal outcomes, little is known about the preventability of these adverse outcomes. AIMS: To examine adverse fetal/neonatal outcomes associated with SMM to determine if these outcomes were potentially preventable. MATERIALS AND METHODS: A New Zealand national retrospective cohort study examining cases of SMM with an adverse fetal/neonatal outcome. Maternity and initial neonatal care were explored by multidisciplinary panels utilising a preventability tool to assess whether the fetal/neonatal harm was potentially preventable. Adverse fetal/neonatal outcomes were defined as fetal or early neonatal death, Apgar score <7 at five minutes, admission to neonatal intensive care unit or special care baby unit and neonatal encephalopathy. RESULTS: Of 85 cases reviewed, adverse fetal/neonatal outcome was deemed potentially preventable in 55.3% of cases (n = 47/85). Preventability was related to maternal antenatal/peripartum care (in utero) in 39% (n = 33/85), to initial neonatal care (ex utero) in 36% (n = 29/80), and to both maternal and neonatal care in 20% (16/80) of cases. Main contributors to potential preventability were factors related to healthcare providers, particularly lack of recognition of high risk, delayed or failure to diagnose, and delayed or inappropriate treatment. CONCLUSIONS: Multidisciplinary panels found that over half of adverse fetal/neonatal harm associated with SMM was potentially preventable. The novel approach of examining both maternal and neonatal care identifies opportunities to improve fetal/neonatal outcomes associated with SMM at multiple points on the perinatal continuum of care.


Assuntos
Serviços de Saúde Materna , Morte Perinatal , Complicações na Gravidez , Feminino , Humanos , Lactente , Recém-Nascido , Gravidez , Complicações na Gravidez/prevenção & controle , Cuidado Pré-Natal , Estudos Retrospectivos
15.
Br J Clin Pharmacol ; 87(4): 1878-1889, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-32991765

RESUMO

AIMS: Intensive monitoring of medical patients for adverse drug reactions (ADRs) to assess prevalence, incidence, risk factors and fatality of ADRs leading to hospital admission or occurring in the hospital. METHODS: Prospective cohort study on 1280 adult patients admitted to the medical wards of a tertiary institution over 12 months. Patients were assessed for ADRs during and throughout admission; causality and preventability of ADRs were assessed. RESULTS: Sixty-seven (5.2%) patients had ADRs, 51 (3.9%) caused hospitalisation while 17(1.3%) occurred during hospitalisation, and 42 (62.7%) of total ADRs were preventable. Nonsteroidal anti-inflammatory drugs, 14 (20.3%), antidiabetics, 12 (17.4%) and antibacterial, 11 (15.8%) were the most implicated drug classes. Gastrointestinal tract (37%), central nervous system (30.2%), and skin (24.7%) were the most affected organ/systems, while upper gastrointestinal bleeding and hypoglycaemia were the most observed ADRs. ADRs led to deaths in 7 (10.4%) patients, with an overall case fatality rate of 0.5%. The highest number of deaths were among patients with Stevens-Johnson syndrome 2/7 (28.6%) and hepatotoxicity 2/7 (28.6%). Risk factors, adjusted odds ratio (AOR [95% confidence interval, CI]) for ADRs leading to hospitalisation was male sex 3.11 (1.11, 8.73) while for ADRs during hospitalisation were number of drugs used before admission (AOR [95% CI] = 6.67 [1.16, 38.47]) and comorbidities (AOR [95% CI] = 3.0 [1.13, 8.01]). Patients admitted with ADRs had prolonged hospital stay (AOR [95% CI] = 3.37 [1.11, 8.71]). CONCLUSION: Preventable ADRs are common and important causes of hospitalisation and inpatients' morbidity and mortality among medical patients in Nigeria. Upper gastrointestinal bleeding and hypoglycaemia, resulting from nonsteroidal anti-inflammatory drugs and antidiabetic drugs were the most observed ADRs.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Adulto , Estudos de Coortes , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Hospitalização , Humanos , Incidência , Masculino , Nigéria , Prevalência , Estudos Prospectivos , Fatores de Risco , Centros de Atenção Terciária
16.
J Surg Res ; 259: 224-229, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-32653242

RESUMO

BACKGROUND: Trauma is the leading cause of pediatric and adolescent morbidity and mortality. Firearm-related injuries and deaths contribute substantially to the overall disease burden. This study described the intent, location, demographics, and outcomes of a nationally representative pediatric population with firearm injuries. We hypothesized that younger patients would have a higher percentage of unintentional and self-inflicted injuries with associated higher mortality rates. MATERIALS AND METHODS: The National Trauma Data Bank, maintained by the American College of Surgeons, from 2010 to 2016 was utilized. All pediatric patients (0-19 y) with firearm injuries who had complete data were analyzed for mechanism, location, demographics, and outcomes. Basic descriptive statistics were used to compare subgroups. Multivariable logistic regression analysis was applied to investigate risk factors for firearm injury-caused mortality. RESULTS: In the study period, 46,039 pediatric patients sustained firearm injuries (median age = 17 y). Males, Blacks, ages 15-19, and the Southern region were the most common injured demographics. However, subgroup analysis showed the demographics differ for self-inflicted and unintentional firearm injuries, which had significantly higher White patients (66.6% and 47.9%, respectively; P < 0.001). Nearly 76% of injuries were related to assaults, 14% were unintentional, 5% were self-inflicted, and 5% were undetermined. The overall mortality was nearly 12%. The youngest population had higher proportion of unintentional injuries and highest mortality rate when compared with other classifications of intent (P < 0.001). CONCLUSIONS: Pediatric firearm injuries have high mortality, especially in the youngest populations. Age-tailored prevention strategies, such as strict child access prevention laws and enforced gun storage violations, may help in reducing firearm injuries and improving health outcomes.


Assuntos
Ferimentos por Arma de Fogo/epidemiologia , Adolescente , Criança , Pré-Escolar , Bases de Dados Factuais , Feminino , Humanos , Lactente , Recém-Nascido , Modelos Logísticos , Masculino , Suicídio/estatística & dados numéricos , Fatores de Tempo , Ferimentos por Arma de Fogo/etnologia , Ferimentos por Arma de Fogo/mortalidade , Adulto Jovem
17.
BJOG ; 128(11): 1762-1773, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34173998

RESUMO

OBJECTIVE: Stillbirths occur 10-20 times more frequently in low-income settings compared with high-income settings. We created a methodology to define the proportion of stillbirths that are potentially preventable in low-income settings and applied it to stillbirths in sites in India and Pakistan. DESIGN: Prospective observational study. SETTING: Three maternity hospitals in Davangere, India and a large public hospital in Karachi, Pakistan. POPULATION: All cases of stillbirth at ≥20 weeks of gestation occurring from July 2018 to February 2020 were screened for participation; 872 stillbirths were included in this analysis. METHODS: We prospectively defined the conditions and gestational ages that defined the stillbirth cases considered potentially preventable. Informed consent was sought from the parent(s) once the stillbirth was identified, either before or soon after delivery. All information available, including obstetric and medical history, clinical course, fetal heart sounds on admission, the presence of maceration as well as examination of the stillbirth after delivery, histology, and polymerase chain reaction for infectious pathogens of the placenta and various fetal tissues, was used to assess whether a stillbirth was potentially preventable. MAIN OUTCOME MEASURES: Whether a stillbirth was determined to be potentially preventable and the criteria for assignment to those categories. RESULTS: Of 984 enrolled, 872 stillbirths at ≥20 weeks of gestation met the inclusion criteria and were included; of these, 55.5% were deemed to be potentially preventable. Of the 649 stillbirths at ≥28 weeks of gestation and ≥1000 g birthweight, 73.5% were considered potentially preventable. The most common conditions associated with a potentially preventable stillbirth at ≥28 weeks of gestation and ≥1000 g birthweight were small for gestational age (SGA) (52.8%), maternal hypertension (50.2%), antepartum haemorrhage (31.4%) and death that occurred after hospital admission (15.7%). CONCLUSIONS: Most stillbirths in these sites were deemed preventable and were often associated with maternal hypertension, antepartum haemorrhage, SGA and intrapartum demise. TWEETABLE ABSTRACT: Most stillbirths are preventable by better care for women with hypertension, growth restriction and antepartum haemorrhage.


Assuntos
Morte Fetal/prevenção & controle , Cuidado Pré-Natal/estatística & dados numéricos , Qualidade da Assistência à Saúde/estatística & dados numéricos , Natimorto/epidemiologia , Adulto , Feminino , Idade Gestacional , Humanos , Índia/epidemiologia , Recém-Nascido , Recém-Nascido Pequeno para a Idade Gestacional , Complicações do Trabalho de Parto/epidemiologia , Paquistão/epidemiologia , Gravidez , Cuidado Pré-Natal/normas , Estudos Prospectivos
18.
Eur J Clin Pharmacol ; 77(4): 643-650, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33188450

RESUMO

PURPOSE: To investigate the characteristics of ADRs in patients admitting at the emergency room of a tertiary hospital. METHODS: We collected the patient records of 1600 emergency room visits of a university hospital in 2018. The patient files were studied retrospectively and all possible ADRs were identified and registered. Patient characteristics, drugs associated with ADRs, causality, severity, preventability, and the role of pharmacogenetics were assessed. RESULTS: There were 125 cases with ADRs, resulting in a 7.8% overall incidence among emergency visits. The incidence was greatest in visits among elderly patients, reaching 14% (men) to 19% (women) in the 80-89 years age group. The most common causative drugs were warfarin, acetylsalicylic acid (ASA), apixaban, and docetaxel, and the most common ADRs were bleedings and neutropenia and/or severe infections. Only two of the cases might have been prevented by pharmacogenetic testing, as advised in Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines. CONCLUSION: The same ATC classes, antithrombotics and cytostatics, were involved in ADRs causing university clinic hospitalizations as those identified previously in drug-related hospital fatalities. It seems difficult to prevent these events totally, as the treatments are vitally important and their risk-benefit-relationships have been considered thoroughly, and as pharmacogenetic testing could have been useful in only few cases.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Serviço Hospitalar de Emergência/estatística & dados numéricos , Hospitais Universitários/estatística & dados numéricos , Adulto , Idoso , Idoso de 80 Anos ou mais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Feminino , Hospitalização , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Adulto Jovem
19.
Br J Clin Pharmacol ; 86(2): 291-302, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31633827

RESUMO

AIM: Our objective was to identify preventable adverse drug events and factors contributing to their development. METHODS: We performed a retrospective chart review combining data from three prospective multicentre observational studies that assessed emergency department patients for adverse drug events. A clinical pharmacist and physician independently reviewed the charts, extracted data and rated the preventability of each adverse drug event. A third reviewer adjudicated all discordant or uncertain cases. We calculated the proportion of adverse drug events that were deemed preventable, performed multivariable logistic regression to explore the characteristics of patients with preventable events, and identified contributing factors. RESULTS: We reviewed the records of 1 356 adverse drug events in 1 234 patients. Raters considered 869 (64.1%) of adverse drug events probably or definitely preventable. Patients with mental health diagnoses (OR 1.8; 95% CI 1.3-2.5) and diabetes (OR 1.7; 95% CI 1.2-2.4) were more likely to present with preventable events. The medications most commonly implicated in preventable events were warfarin (9.4%), hydrochlorothiazide (4.5%), furosemide (4.0%), insulin (3.9%) and acetylsalicylic acid (2.7%). Common contributing factors included inadequate patient instructions, monitoring and follow-up, and reassessments after medication changes had been made. CONCLUSIONS: Our study suggests that patients with mental health conditions and diabetes require close monitoring. Efforts to address the identified contributing factors are needed.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Serviço Hospitalar de Emergência , Humanos , Farmacêuticos , Estudos Prospectivos , Estudos Retrospectivos
20.
BMC Geriatr ; 20(1): 346, 2020 09 14.
Artigo em Inglês | MEDLINE | ID: mdl-32928134

RESUMO

BACKGROUND: Drug-induced liver injury (DILI) represents an increasing morbidity in the general population, but more so in the elderly cohort of patients. Despite this, the concept of its prevention through prospective analysis has largely remained unexamined. We evaluated the utility of recently validated adverse drug reactions (ADR) avoidability tool in a cohort of elderly patients with DILI. METHODS: We examined 38 DILI-drug pairs from n=38 patients in a prospective cohort of patients presenting with adverse drug reactions to a Weill Cornell-affiliated tertiary hospital between February 2019 and January 2020. DILI outcomes were adjudicated by the updated Roussel Uclaf Causality Assessment Method (RUCAM). Two clinical pharmacologists and two general physicians utilized the Liverpool adverse drug reactions avoidability tool (LAAT) and the modified Hallas tools to rate the preventability of DILI-drug pairs. Inter-rater, exact agreement proportions, as well as intraclass correlation coefficients were generated and expressed as ordinal outcomes. RESULTS: The cases examined for the determination of DILI avoidability had probability likelihood of "probable" or "highly probable" by the updated RUCAM scale. Examination of the 38 DILI-drug pairs (n= 38 patients) resulted in a total of 152 ordinal outcome decisions. We found about 32.3% (50/152) and 34.2% (52/152) of DILI-drug pairs were rated as "avoidable" ("probable" or "definite") by the LAAT and the modified Hallas tools respectively. The overall median Krippendorf's kappa with the LAAT was 0.61 (SE 0.12, CI 0.36, 0.85) and for modified Hallas tool was 0.53 (SE 0.18; CI 0.16, 0.89). The inter-rater correlation coefficient (ICC) for the LAAT and modified Hallas were 0.50 [0.32, 0.65] and 0.63 [0.48, 0.76] respectively. Exact pairwise agreement was present in 30/38 (IQR 29.5, 34.5), and 28/38 (IQR 27.5-35.5) of DILI-ADR pairs using the LAAT and modified Hallas tools respectively. CONCLUSION: We found a significant proportion of drug-induced liver injury adjudicated by the updated RUCAM scale in elderly hospitalized cohort of patients were avoidable with significant implication for therapeutic commissioning as well as cost effectiveness interventions in this cohort of patients.


Assuntos
Doença Hepática Induzida por Substâncias e Drogas/etiologia , Doença Hepática Induzida por Substâncias e Drogas/prevenção & controle , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Clínicos Gerais , Fígado/efeitos dos fármacos , Idoso , Idoso de 80 Anos ou mais , Doença Hepática Induzida por Substâncias e Drogas/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Feminino , Humanos , Fígado/metabolismo , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
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