RESUMO
OBJECTIVE: Development and internal validation of a clinical tool for assessment of the risk of adverse drug reactions (ADR) in hospitalized patients. METHODOLOGY: Nested case-control study in an open cohort of all patients admitted to a general hospital. Cases of ADR were matched to two controls. Eighty four patient variables collected at the time of the ADR were analyzed by conditional logistic regression. Multivariate logistic regression with clustering of cases in a random sample of 2/3 of the cases and respective controls, with baseline odds-ratio corrected with an estimate of ADR incidence, was used to obtain regression coefficients for each risk factor and to develop a risk score. The clinical tool was validated in the remaining 1/3 observations. The study was approved by the institution's research ethics committee. RESULTS: In the 8060 hospitalized patients, ADR occurred in 343 (5.31%), who were matched to 686 controls. Fourteen variables were identified as independent risk factors of ADR: female, past history of ADR, heart rate ≥72 bpm, systolic blood pressure≥148 mmHg, diastolic blood pressure <79 mmHg, diabetes mellitus, serum urea ≥ 67 mg/dL, serum sodium ≥141 mmol/L, serum potassium ≥4.9 mmol/L, main diagnosis of neoplasia, prescription of ≥3 ATC class B drugs, prescription of ATC class R drugs, prescription of intravenous drugs and ≥ 6 oral drugs. In the validation sample, the ADR risk tool based on those variables showed sensitivity 61%, specificity 73% and area under the ROC curve 0.73. CONCLUSION: We report a clinical tool for ADR risk stratification in patients hospitalized in general wards based on 14 variables.
Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Medicamentos sob Prescrição/efeitos adversos , Adulto , Idoso , Estudos de Casos e Controles , Estudos de Coortes , Prescrições de Medicamentos/estatística & dados numéricos , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Incidência , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Quartos de Pacientes/estatística & dados numéricos , Curva ROC , Medição de Risco/métodos , Fatores de RiscoRESUMO
OBJECTIVE: To identify risk factors for potential Drug-Related Problems (DRP) at admission in hospitalized patients. METHODOLOGY: Prospective cohort study conducted in adults patients hospitalized (May 2016 to May 2018) in a general tertiary care hospital in Brazil. Potential DRP were detected by daily review of 100% of electronic medication orders by hospital pharmacists and classified by the Pharmaceutical Care Network Europe classification system (PCNE version 6.2). For the identification of risk factors of potential DRP, backward stepwise logistic regression was used to identify the set of independent predictors among over 120 variables collected in the initial 48 hours after admission in a training set consisting of 2/3 of the study population. The model was validated in the remaining sample. RESULTS: The study population consisted of 1686 patients aged 52.0+/- 18.3 years-old, 51.4% females, with a median length of stay of 3.24 days, and 4.5% in-hospital mortality. The cumulative incidence of potential DRP was 14.5%. Admission for elective surgery and main diagnosis of disease of the circulatory system were associated with reduced risk of DRP (OR 0.41 and 0.57, respectively, p<0.05). The independent risk factors of DRP are heart rate ≥ 80 bpm (OR 1.41, p = 0.05), prescription of more than seven drugs in day 2 (OR 1.63, p = 0.05), prescription in day 1 of drugs of the Anatomical Therapeutic Chemical Code (ATC) class A (alimentary tract and metabolism, OR 2.24, p = 0.003), prescription in day 2 of two or more ATC class A drugs (OR = 3.52, p<0.001), and in day 1 of ATC class J drugs (antiinfectives for systemic use, OR 1.97, p = 0.001). In the validation set, the c-statistic of the predictive model was 0.65, the sensitivity was 56.1% and the specificity was 65.2%. CONCLUSION: This study identified seven independent risk factors of potential DRP in patients hospitalized in a general hospital that have fair predictive performance for utilization in clinical practice.
Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Mortalidade Hospitalar , Hospitais Gerais , Centros de Atenção Terciária , Adulto , Idoso , Brasil/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/mortalidade , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Registros Eletrônicos de Saúde , Feminino , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Assistência Farmacêutica , Fatores de RiscoRESUMO
OBJECTIVES: To evaluate the incidence and types of drug-related problems (DRP) in a general teaching hospital and to evaluate the acceptability of pharmaceutical interventions by the medical team. DESIGN: Prospective cohort study during 2 years. SETTING: Conducted in a Brazilian University Hospital. PARTICIPANTS: The patient cohort consisted of 9303 patients with a total of 12 286 hospitalisation episodes. PRIMARY OUTCOME MEASURES: DRP detected by pharmacists' review of 100% medication orders using Pharmaceutical Care Network Europe 6.2 classification. RESULTS: Patients with a mean age of 52.6±17.7 years and 50.9% females. A total of 3373 DRP in 1903 hospital episodes were identified, corresponding to a cumulative incidence of 15.5%. 'Treatment ineffectiveness' (11.5%) and 'Treatment costs' (5.90%) were the most common DRP and 'Drug use process' (18.4%) and 'Treatment duration' (31.0%) the main causes of DRP. The medicines involved most often involved in DRP were anti-infectives (36.0%), mainly cephalosporins (20.2%), antiulcer (38.6%), analgesics/antipyretics (61.2%), propulsives (51.2%), opioids (38.5%) and antiemetics (57.4%). From 1939 pharmaceutical interventions, at least, 21.4% were not approved by the medical team. CONCLUSION: DRP detected by 100% medication order review by hospital pharmacists occur in a significant proportion of hospital episodes, the most frequent being related to treatment effectiveness and treatment costs. The medications mostly involved were cephalosporins, penicillins, antidyspeptics, analgesics, antipyretics, opioids and antiemetics. Pharmaceutical interventions had low acceptability by the medical staff.
Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Preparações Farmacêuticas , Serviço de Farmácia Hospitalar , Adulto , Idoso , Brasil , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Europa (Continente) , Feminino , Hospitais Gerais , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Farmacêuticos , Estudos ProspectivosRESUMO
BACKGROUND: Commonly used drugs in pregnant women include antihypertensives, hypoglycemic agents, analgesics, antimicrobials, antiemetics and antispasmodics but the use of medicines during pregnancy, especially in high-risk pregnancy, may be associated with high risk of adverse drug reactions (ADR). The objective of this study was to determine the risk of an adverse drug reaction in hospitalized high-risk pregnant women and the factors associated with their occurrence. METHODS: The study received IRB approval and all patients gave written informed consent. Observational cohort study conducted from September 2015 to November 2016 in 1070 pregnant women consecutively admitted to the high risk sector of the University Maternity Januário Cicco in Brazil. ADR were detected through daily active search. Risk factors for the occurrence of ADR were determined using multivariate logistic regression. RESULTS: The mean age of the study population was 26.2 ± 7.2 years and gestational age was 31.2 ± 7.2 weeks. The average number of previous pregnancies was 2.4 ± 1.8 and 46.4% reported cases of previous abortion/miscarriage. ADR were observed in 10.7% of women. The main medicines involved, with the incidence rate of ADR per 100 prescriptions of the drug (IR), were parenteral scopolamine (IR 14.9%), methyldopa (IR 15.9%), insulin (IR 8.46%), oral scopolamine (IR 3.58%), captopril (IR 2.38%) and ceftriaxone (IR 18.4%). Multivariate analysis showed that only gestational age in weeks (odds-ratio 0.97, 95% confidence interval 0.95-0.98) was related to the occurrence of adverse reactions. CONCLUSION: Lower gestational age is a risk factor for high-risk pregnant women, increasing the likelihood of adverse reactions, with parenteral medications being those that have the highest potential risk of harm.