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1.
Int J Clin Pharm ; 2020 Feb 11.
Artigo em Inglês | MEDLINE | ID: mdl-32048122

RESUMO

Like other countries, China has been experiencing drug shortages during the past years, including drugs on the National Essential Medicine List and emergency drugs. Drug shortages have raised public concerns in China and have severe impacts on all stakeholders in the supply chain, especially patients and hospitals. Recently, Chinese governments have ramped up several measures to ensure a steady supply of essential and first-aid drugs. In this commentary, we share our experiences of addressing drug shortages at Hunan Province, central China. We focus on the establishment of a provincial drug shortage monitoring center, and the Center's efforts to standardize practices on the management of drug shortages and identify therapeutic alternatives for drugs in short supply based on international best practices.

2.
Int J Clin Pharm ; 2020 Jan 09.
Artigo em Inglês | MEDLINE | ID: mdl-31919733

RESUMO

Background Over the last few years, pharmacists in China have been searching for effective strategies to expand their roles in pharmaceutical care. In September 2012, the Beijing Chaoyang Hospital was the first in China to establish the Chief-Pharmacist System aimed to let pharmacists be a responsible part of the multi-disciplinary care team. Objective To describe the Chief-Pharmacist System and explore its impact on drug expenditures and rational drug use. Setting A tertiary hospital in Beijing, China. Method Chief-Pharmacist System oriented specific measures were implemented and evaluated. Data on medical services quantity, quality and drug expenses during the periods of pre-implementation (from September 1, 2011 to August 31, 2012) and post implementation (from September 1, 2012 to August 31, 2016) were collected. Main outcome measure Healthcare quality indicators, drug expenditures, selected drug use indicators of outpatient and antibiotic use. Results With the implementation of the Chief-Pharmacist System and the participation of pharmacists in pharmaceutical care, drug expenses were reduced significantly. The total drug expenses, outpatient drug expenses per visit and inpatient drug expenses per admission decreased by an average of US $34.3 million, US $8.9 and US $ 303.9, respectively, compared to the pre-implementation period. Meanwhile, selected drug use indicators in post-implementation period were significantly improved. All results were achieved without sacrificing clinical quality and quantity. Conclusion The study illustrates that the Chief-Pharmacist System achieves substantial reductions in drug expenditures and promotion of rational drug use. It provides a model for other hospitals in China and other low- and middle-income countries.

3.
J Pharm Biomed Anal ; 177: 112890, 2020 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-31563756

RESUMO

Various immunoassay methods have been developed and used for the therapeutic drug monitoring (TDM) of cyclosporine (CsA). However, there is no report on the application of a time-resolved fluoroimmunoassay (TRFIA) in routine CsA TDM. The aim of this study was to evaluate the feasibility and validate the performance of a newly developed TRFIA method for CsA analysis in human whole blood. The TRFIA method was then compared with the method of chemiluminescent microparticle immunoassay (CMIA). The calibration range of the CsA-TRFIA method was 0-1000 ng/mL. The linear range and correlation coefficients were 30-1000 ng/mL and more than 0.990, respectively. The accuracy, precision, and inter-batch range were 90.0%-110.0%, less than 10%, and no more than 15%, respectively. The lowest limit of detection was less than 10 ng/mL. The linear regression equation was YCMIA = 0.961XTRFIA + 3.357, which showed that the measurements of CMIA and TRFIA were strongly correlated (r = 0.980). The results demonstrate that TRFIA is a precise and reproducible method for detecting the CsA concentration and can be used for routinely CsA TDM.

4.
Int J Clin Pharm ; 41(6): 1507-1515, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31705457

RESUMO

Background Data are lacking about the extent of drug-related problems in hospitalized patients with COPD in China. Objective Identify types and causes of drug-related problems and assess interventions performed by pharmacists. Setting Study was conducted in an academic teaching hospital in Shanghai, China. Method Between June 2017 and July 2018, 393 patients admitted to hospital for acute exacerbation of COPD hospitalized were enrolled. Patient demographics and clinical characteristics were collected. The drug-related problems and interventions were recorded and analyzed based on the Pharmaceutical Care Network Europe (PCNE)-DRP V 8.02 classification. Main outcome measures The number, types, causes, interventions, and outcomes of the problems were analyzed. Results A total of 640 DRPs, with 763 corresponding causes, were identified for 393 patients. "Treatment safety P2" was the most common type of problem (54.2%; 347/640), and the most common causes were "drug selection C1" (24.2%; 185/763), "dose selection C3" (21.5%; 164/763) and "treatment duration C4" (17.7%; 135/763). Antibiotics, corticosteroids, and proton pump inhibitors were the three primary medication classes associated with DRPs. Patients, hospitalized for more than eight days, taking ten or more drugs or having renal dysfunctions were more likely to have drug-related problems. Pharmacists totally proposed 1557 interventions to address the problems. Most interventions (91.0%; 1418/1557) were accepted, and 91.6% of the problems were solved. Conclusion The prevalence of drug-related problems among the studied COPD patients was high. Pharmacists can have an important role in addressing the problems and optimizing the safety and effectiveness of therapies for hospitalized COPD patients.

5.
Int J Clin Pharm ; 41(5): 1133-1137, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31468253

RESUMO

This article reviews the current status of the overuse of intravenous (IV) infusions in China and implications to patient safety, and analyzes factors associated with the overuse. Although many factors contribute to the overuse of IV infusions in China, we focus on the construction of an IV infusion management system and tackling cultural problems as the first step to address issues of IV therapy in this commentary.

6.
Epilepsy Behav ; 98(Pt A): 14-18, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31299527

RESUMO

There is limited information on the impact of active education by a pharmacist in the population of pediatric patients with epilepsy (PWE) in China. The objective of this study was to assess the effect of education by pharmacists on medication adherence and percentage of valproic acid (VPA) samples reaching therapeutic reference range in these patients. This study was conducted at two teaching hospitals in Changsha, China. Patients were retrospectively identified from January 2016 to December 2017. Active education by a pharmacist in both oral and written formats was provided at the intervention hospital whereas standard passive pharmacist service (dispensing and answering questions) was provided at the control hospital. Medication adherence was assessed by the simplified medication adherence questionnaire (SMAQ), and serum concentrations of VPA were collected. The correlation between pharmacist education and medication adherence and percentage of VPA samples reaching therapeutic reference range were analyzed. A total of 2165 patients and 4343 serum VPA concentrations were included in the analysis. For the first therapeutic drug monitoring (TDM) measurement, there was no statistical difference between the two hospitals: 41.3% of VPA samples reached therapeutic range at the intervention hospital compared with 45.4% at the control hospital (χ2 = 3.686, P > 0.05). After pharmacist intervention at the intervention hospital, however, there were significant differences in the percentage of therapeutic VPA samples reaching therapeutic range between the first and the second, third, fourth, and fifth TDM measurements (χ2 = 9.756, P < 0.01; χ2 = 22.840, P < 0.01; χ2 = 15.816, P < 0.01; χ2 = 27.613, P < 0.01). Based on the SMAQ adherence assessment, adherence increased from a minimum of 56.0% to a maximum of 73.9% with stabilization during the last six months of follow-up at the intervention hospital. Both the medication adherence rate and the percentage of VPA samples reaching therapeutic range increased as the result of active education by a pharmacist, suggesting that continuous pharmacist intervention had a positive impact in outpatient pediatric PWE.

7.
Asia Pac J Clin Nutr ; 28(2): 246-251, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31192553

RESUMO

BACKGROUND AND OBJECTIVES: The participation of a nutrition support pharmacist (NSP) in a multidisciplinary team (MDT) for patients receiving nutrition support therapy (NST) may lead to more favourable outcomes and fewer complications and adverse events. However, few studies have demonstrated the role of NSPs in MDTs in China. To investigate pharmacy interventions and physician acceptance of these interventions for patients receiving NST in an intensive care unit (ICU). METHODS AND STUDY DESIGN: A prospective study over a 12-month period was conducted in an ICU at an academic hospital in China. Interventions were documented and divided into the following categories: indication of NST, parenteral nutrition (PN) prescription and delivery, enteral nutrition (EN) route and formulation, fluids and electrolytes, laboratory test monitoring, nutritional supplements, and other medication-related problems. Data regarding the intervention categories, timing, acceptance rates, and methods of communication to discuss pharmacy interventions were collected. RESULTS: In total, 247 interventions for 120 patients were identified. The overall acceptance rate of interventions was 85.0% (210/247), and more than half of the interventions (143, 57.9%) were performed during daily follow-up. The most common intervention categories were PN prescription and delivery (81/247, 32.8%), EN route and formula (33/247, 13.4%), indication of NST (33/247, 13.4%), and nutritional supplements (30/247, 12.1%). The most accepted intervention category was PN prescription and delivery (79/81, 97.5%), and the most common method of communication was oral communication during MDT rounds (201/247, 81.4%). CONCLUSIONS: This study demonstrated the unique perspectives offered and importance of having pharmacists as members of MDTs.


Assuntos
Cuidados Críticos/métodos , Estado Terminal/terapia , Estado Nutricional , Apoio Nutricional/métodos , Farmacêuticos , Papel Profissional , China , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
8.
Clin Ther ; 41(8): 1631-1637.e4, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31174860

RESUMO

This study categorizes the types of inappropriate intravenous prescriptions in hospitalized patients in China. Prescription data from 2016 were retrospectively analyzed based on predefined categories of inappropriateness. Of the 123,521 patients included, 89.2% received intravenous medications, contributing to 80% of the patients' hospital medication costs. Of significant concern, antibiotics and traditional Chinese medicines were administered to 44.3% and 14.5% of hospitalized patients, respectively. Overall, 11.4% of all intravenous prescriptions were classified as inappropriate, with improper diluent and diluent volumes being the primary cause. A team-based collaborative approach is necessary to address this widespread issue in China.

9.
Int J Clin Pract ; 73(5): e13331, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30809871

RESUMO

AIMS: A recent large epidemiological study found fluoroquinolone use is associated with an increased risk of aortic aneurysm or dissection. We aimed to examine fluoroquinolone (ciprofloxacin, levofloxacin and moxifloxacin) associated aortic aneurysm or dissection through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS). METHODS: Reports to the FAERS from 1 January 2004 to 31 December 2016 were analysed. Pharmacovigilance tools were used for quantitative detection of signals that is, drug-associated adverse events, including reporting odds ratio, proportional reporting ratio, information component given by a Bayesian confidence propagation neural network and empirical Bayes geometric mean. Sensitivity analyses that limited the data by gender and adverse event date also showed similar trends. RESULTS: Based on 3721 adverse event reports, all three fluoroquinolones are associated with aortic aneurysm, and levofloxacin is associated with aortic dissection. The risk of aortic aneurysm is higher than the aortic dissection. Oral administration of fluoroquinolones is more likely to produce these adverse events. CONCLUSION: The results obtained herein are consistent with clinical observations, suggesting the necessity for further clinical research on aortic aneurysm and dissection associated with fluoroquinolones.


Assuntos
Aneurisma Dissecante/induzido quimicamente , Aneurisma da Aorta Torácica/induzido quimicamente , Fluoroquinolonas/efeitos adversos , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Idoso , Teorema de Bayes , Criança , Pré-Escolar , Ciprofloxacino/efeitos adversos , Mineração de Dados , Feminino , Humanos , Lactente , Recém-Nascido , Levofloxacino/efeitos adversos , Masculino , Pessoa de Meia-Idade , Moxifloxacina/efeitos adversos , Farmacovigilância , Estados Unidos , United States Food and Drug Administration , Adulto Jovem
10.
Diagn Microbiol Infect Dis ; 93(4): 386-392, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30638947

RESUMO

Combined intravenous and local intrathecal administration of meropenem in patients after craniotomy is widely used to treat intracranial infections. However, the optimal dosing regimen of meropenem has not been investigated, posing a risk to treatment efficacy. We aimed to identify significant factors associated with inter-individual variability in cerebrospinal fluid (CSF) pharmacokinetics of meropenem and to evaluate potential intravenous and intrathecal meropenem dosing regimens for the treatment of patients with intracranial infections. After the diagnosis of intracranial infection, 15 patients with an indwelling drain tube received intravenous and intrathecal administration of meropenem. Blood and cerebrospinal fluid (CSF) samples were obtained at the scheduled time to measure meropenem concentration. Plasma and CSF concentration-time data were fit simultaneously using a nonlinear mixed-effects modeling approach. A 3-compartmental model was selected to characterize the in vivo behavior of meropenem. Through population modeling, multiple covariates were tested about their impact on the meropenem pharmacokinetics. Considering CSF outflow via drain tube leading to a drug loss, the drug clearance in CSF (CLCSF) was added to describe this drug loss. The covariate selection indicated that the drainage volume (mL/d) had a significant positive correlation with CLCSF. Bootstrap and visual predictive check suggested a robust and reliable pharmacokinetic model was structured. The established final population model was useful to apply with simulation to identify meropenem dosing regimens for the treatment of patients with intracranial infections. With the goal of CSF concentrations exceeding the minimum inhibitory concentration during the therapy, we created a simple to use dosage regimen table to guide clinicians with drug dosing.


Assuntos
Antibacterianos/administração & dosagem , Antibacterianos/farmacocinética , Líquido Cefalorraquidiano/química , Meropeném/administração & dosagem , Meropeném/farmacocinética , Plasma/química , Administração por Inalação , Administração Intravenosa , Pequim , Feminino , Humanos , Masculino , Testes de Sensibilidade Microbiana , Procedimentos Neurocirúrgicos/efeitos adversos , Infecção da Ferida Cirúrgica/tratamento farmacológico , Fatores de Tempo
11.
Int J Clin Pharm ; 41(1): 13-17, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30610549

RESUMO

Background Data is lacking on types and severities of drug-related problems (DRPs) in hospitalized surgical patients in China. Objective To identify and categorize types and causes of DRPs, and to assess severities of these DRPs. Setting An academic teaching hospital in Chongqing, China. Method We retrospectively reviewed all medication orders for patients in six surgical departments during a six-month period. DRPs were classified using the Pharmaceutical Care Network Europe (PCNE) classification, and the severity ratings of these DRPs were based on the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) classification. Main outcome measure The number, types, causes and severities of the DRPs. Results A total of 291,944 medication orders in 10,643 patients were reviewed, and 3548 DRPs were identified. The average DRP number per patient was 0.3. The most common problem was treatment effectiveness (39.9%) and the major cause of the problems was dose selection (47.0%). Total 80.1% of the DRPs were rated at severity categories B to D (causing no or potential harm), whereas 19.9% were rated as categories E to H (causing actual harm). Conclusion DRPs are common in surgical patients, and prospective pharmacist medication order review services are needed to improve patients' pharmaceutical care.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/classificação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Hospitalização/tendências , Centro Cirúrgico Hospitalar/classificação , Centro Cirúrgico Hospitalar/tendências , Adulto , Idoso , China/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
12.
Drug Res (Stuttg) ; 69(1): 23-31, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29791922

RESUMO

BACKGROUND AND STUDY AIM: Some studies have reported an association between P2Y12 gene polymorphisms and clopidogrel adverse outcomes with inconsistent results. We aimed to explore the relationship between P2Y12 polymorphisms and the risk of adverse clinical events in patients treated with clopidogrel through a meta-analysis. METHODS: A systematic search of PubMed, Web of Science and the Cochrane Library was conducted. Retrieved articles were comprehensively reviewed and eligible studies were included, and the relevant data was extracted for this meta-analysis. All statistical tests were performed by the Review Manager 5.3 software. RESULTS: A total of 14 studies involving 8,698 patients were included. In the Han Chinese population, ischemic events were associated with P2Y12 T744C polymorphism in the CC vs TT+CT genetic model (OR=3.32, 95%CI=1.62-6.82, P=0.001), and the events were associated with P2Y12 C34T polymorphism in the TT+TC vs CC genetic model (OR=1.70, 95%CI=1.22-2.36, P=0.002). However, ischemic events were not related to P2Y12 G52T polymorphism (TT+TG vs GG: OR=1.13, 95%CI=0.76-1.68, P=0.56; TT vs GG+TG: OR=2.02, 95%CI=0.65-6.28, P=0.22). The associations between the P2Y12 polymorphism and ischemic events were not significant in T744C, G52T and C34T genotype for another subgroup of the Caucasian population (P>0.05). Only two studies referring to bleeding events were included in this analysis of C34T polymorphism, and no significant association was found (TT+TC vs CC: OR=1.07, 95%CI=0.37-3.15, P=0.90). CONCLUSIONS: In the Caucasian population, P2Y12 gene polymorphisms are not associated with clinical events. However, in the Chinese Han population, P2Y12 T744C and C34T polymorphisms are significantly associated with adverse clinical events.


Assuntos
Clopidogrel/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/genética , Inibidores da Agregação de Plaquetas/efeitos adversos , Polimorfismo Genético/genética , Receptores Purinérgicos P2Y12/genética , Estudos de Casos e Controles , Genótipo , Humanos , Risco
13.
Biomed Chromatogr ; 33(3): e4440, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30456910

RESUMO

Valproic acid (VPA) pharmacokinetics is highly variable and monitoring of blood levels is necessary to determine its appropriate dosage. This study aimed to establish and validate a novel derivatization method for the determination of VPA. The method was based on the catalytic effect of tetramethylammonium hydroxide using 2,4'-dibromoacetophenone as a derivatization reagent. After derivatization, samples were injected into the HPLC system for analysis. The method showed a good linearity in the range of 1.0-200.7 µg mL-1 , and the limit of quantification was 1 µg mL-1 . All values of the accuracy and relative standard deviations were acceptable for the analyses of biological samples. The recoveries were in the range from 91.6 to 97.4% for VPA with RSD <3.9%. A novel and high conversion-rate derivatization method has been developed and validated for the determination of VPA in human serum. It can be applied to the analysis of VPA in clinic serum samples.


Assuntos
Cromatografia Líquida de Alta Pressão/métodos , Compostos de Amônio Quaternário/química , Ácido Valproico/sangue , Humanos , Limite de Detecção , Modelos Lineares , Reprodutibilidade dos Testes , Ácido Valproico/química
14.
Xenobiotica ; 49(11): 1344-1351, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30457423

RESUMO

1. This study aimed to evaluate the pharmacokinetic interaction of shuanghuanglian (SHL) and azithromycin in rats, and to provide experimental support for rational drug use in clinics. 2. High-performance liquid chromatography with ultraviolet detection (HPLC-UV) and high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) approaches were respectively developed to detect the forsythiaside (active component of SHL) and azithromycin concentrations. Both non-compartmental and compartmental analyzes were employed to calculate pharmacokinetic parameters. A nonlinear mixed-effects modeling method was applied to fit the drug concentration-time data. The influence of drug coadministration on pharmacokinetic parameters was tested using forward inclusion and backward elimination procedures. 3. After drug co-administration, areas under the drug concentration-time curve (AUC) and half-lives (T1/2) of both azithromycin and forsythiaside increased significantly, meanwhile, the drug clearance (CL) decreased compared to single drug administration. Both forsythiaside and azithromycin exposures increased after coadministration. Two-compartment models were suitable to describe the in vivo behavior of both azithromycin and forsythiaside. The coadministration of SHL could significantly decrease the central volume of azithromycin (VCA) and forsythiaside clearance (CLF) decreased after co-intravenous administration of azithromycin. 4. Co-intravenous administration of forsythiaside and azithromycin could significantly increase drug exposures for both drugs. Lower dose can provide sufficient drug exposure to obtain antibacterial activity. The coadministration may be a potential method to increase therapy efficiency while decrease adverse drug reactions.

15.
Drug Res (Stuttg) ; 69(4): 185-193, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30193394

RESUMO

BACKGROUND AND STUDY AIM: Genetic polymorphisms may play a role in muscular injury associated with simvastatin, but results were inconclusive. This study aimed to summarize evidence from the literature investigating the effects of genetic polymorphism on simvastatin-induced myopathy. METHODS: Studies regarding the association between genetic polymorphisms and simvastatin-induced myopathy were retrieved through electronic databases from February 1, 1990 to March 15, 2018. Two authors independently extracted data, including PMID, author, publication year, country, race, age, population characteristics, drugs, definition of case and control, gene, allele, SNP position, Hardy-Weinberg equilibrium, number of genotypes (case and control), minor allele frequency of cases and controls, association, study type and the Newcastle-Ottawa scale. Due to high heterogeneity in study design and outcome measurements among the included articles, a narrative synthesis of the evidence was conducted. RESULTS: A total of 10 association studies were identified in this study, including SLCO1B1, ABCB1, GATM, HTR3B, HTR7, RYR2 and HLA-DRB1. The evidence linking myopathy to rs4149056 in SLCO1B1 is of high quality, and this association has been reproduced in randomized trials and clinical practice-based cohorts. As for other candidate genetic markers, the evidences are limited or controversial, and additional well-designed studies with larger sample sizes, are required to further elucidate this association. CONCLUSION: SLCO1B1 genotype is a useful biomarker for predicting an increased risk of simvastatin-induced myopathy.


Assuntos
Doenças Musculares/induzido quimicamente , Doenças Musculares/genética , Polimorfismo de Nucleotídeo Único/genética , Sinvastatina/efeitos adversos , Idoso , Alelos , Estudos de Casos e Controles , Estudos de Coortes , Feminino , Frequência do Gene/genética , Marcadores Genéticos/genética , Genótipo , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto
16.
Curr Pharm Des ; 24(34): 4044-4050, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30569848

RESUMO

BACKGROUND: Atorvastatin is the best-selling statin in the market. However, some patients have to reduce drug doses or discontinue atorvastatin therapy mainly due to adverse drug reactions (ADRs). Genetic factors play an important role in the occurrence of ADRs. AIM: This study aimed to investigate the association between SLCO1B1 polymorphisms (c.521T>C or c.388A>G) and atorvastatin safety and efficacy. METHODS: We systematically searched PubMed, Web of Science and Embase to screen relevant studies published before Sep 2018. This meta-analysis was performed to identify the relationship between SLCO1B1 c.521T>C or c.388A>G polymorphisms and atorvastatin-related ADRs by the odds ratios (ORs) and 95% confidence intervals (CIs). The relationship of SLCO1B1 polymorphisms and lipid-lowering effects [low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC)] was assessed in pooled data by calculating the mean difference (MD) with 95% CIs. All statistical tests were performed by the Review Manager 5.3 software. RESULTS: A total of 13 studies involving 1,550 atorvastatin users were included in this analysis. There was a significant association between the SLCO1B1 c.521T>C polymorphism and atorvastatin-related ADRs associated with risk allele C (dominant model: OR=1.57, P=0.01). Allele C is associated with increased lipid-lowering efficacy in people with Hyperlipidemias as compared to allele T (LDL-C/dominant model: MD=6.19, P<0.00001 and (TC)/dominant model: MD=2.07, P=0.008). No association between the SLCO1B1 c.388A>G polymorphism and ADRs or efficacy was observed (P>0.05). CONCLUSION: SLCO1B1 c.521T>C polymorphism is a valuable biomarker for the evaluation of atorvastatin safety and efficacy.


Assuntos
Atorvastatina/efeitos adversos , Atorvastatina/farmacologia , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Inibidores de Hidroximetilglutaril-CoA Redutases/farmacologia , Transportador 1 de Ânion Orgânico Específico do Fígado/genética , Polimorfismo de Nucleotídeo Único/genética , Animais , Humanos
17.
Int J Clin Pharm ; 40(4): 823-831, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30051225

RESUMO

Background Rational drug use and drug safety are becoming increasingly important concerns in China with the increasing public access to drugs and the health-care system, and this has led to the development of pharmacovigilance in China. Aim of the review To provide a brief introduction about pharmacovigilance in China in terms of system development, utilization and challenges. Method Relevant studies on pharmacovigilance related to the study aim was undertaken through literature search to synthesize the extracted data. Results The creation and evolvement of China's pharmacovigilance system spans across 30 years since 1989. The system consists of four progressing administrative layers: county, municipal, provincial and national levels. China has passed over 20 laws and regulations related to pharmacovigilance covering the processes of drug development, manufacture, distribution and use with the aim to guard drug safety. An online spontaneous self-reporting Adverse Drug Reaction (ADR) Monitoring System was established in 2003. ADRs are mainly reported by medical institutions, pharmaceutical manufacturers, and drug distributors. Currently there is no mandatory ADR reporting requirement for pharmaceutical manufacturers, and a proposed regulation under public comment will likely change this. China has started to build active pharmacovigilance surveillance programs in addition to the passive ADR reporting system. The China Food and Drug Administration has established the intensive Safety Monitoring Program and the National Adverse Drug Reaction Monitoring Sentinel Alliance Program based on electronic health records to further the efforts of ADR reporting, monitoring and analysis. Conclusion The practice of ADR monitoring and pharmacovigilance in China have made great progress. More efforts are needed both in system building, and creation of laws and regulations to strengthen the safe use of medicines.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Controle de Medicamentos e Entorpecentes , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Farmacovigilância , Sistemas de Notificação de Reações Adversas a Medicamentos/legislação & jurisprudência , Sistemas de Notificação de Reações Adversas a Medicamentos/organização & administração , China/epidemiologia , Controle de Medicamentos e Entorpecentes/legislação & jurisprudência , Controle de Medicamentos e Entorpecentes/organização & administração , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Regulamentação Governamental , Humanos , Segurança do Paciente , Formulação de Políticas , Avaliação de Programas e Projetos de Saúde , Medição de Risco , Fatores de Risco
18.
Int J Clin Pharm ; 40(4): 921-927, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30051226

RESUMO

Background Traditional Chinese medicine (TCM) is one of the major triggers for drug-induced anaphylaxis (DIA). Objective We aimed to use the Beijing pharmacovigilance database (BPD) to analyze TCM-induced DIAs in Beijing, China. Setting Drug allergy case reports from the BPD provided by the Beijing Center for Adverse Drug Reaction Monitoring. Method Drug allergy cases from January 2004 to December 2014 were adjudicated. DIA triggered by TCMs were analyzed and compared with those triggered by non-TCM drugs by calculating the reported risk ratio (RRR). We also calculated the RRRs based on severe DIA and death outcomes. Main outcome measure TCMs implicated in DIAs were identified and compared with non-TCM drugs. Results TCMs accounted for 1651 (18.2%) of the total 9074 allergic cases, in which 84.4% (1393/1651) were triggered by injections. Of the TCM allergic cases, 8.5% (141) were DIAs and 7.3% (120) were severe DIAs, and three patients died from injections. The RRR between TCMs and non-TCM-induced DIAs was 0.63. When anaphylactic cases were compared between TCMs to the top four non-TCM drug triggers, RRRs were 0.73 (95% CI 0.61-0.87) for antibiotics, 0.36 (95% CI 0.29-0.44) for radiocontrast agents, 0.55 (95% CI 0.43-0.68) for chemotherapeutics, and 0.29 (95% CI 0.23-0.37) for biologics. Compared to TCM oral or topic formulations, TCM injections had higher RRRs in each of the above comparisons. Conclusion TCM was associated with a decreased risk of DIA compared to non-TCM drugs in drug allergy cases, and the risk was higher for TCM injections.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Anafilaxia/induzido quimicamente , Medicamentos de Ervas Chinesas/efeitos adversos , Medicina Tradicional Chinesa/efeitos adversos , Farmacovigilância , Administração Oral , Administração Tópica , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anafilaxia/diagnóstico , Anafilaxia/epidemiologia , Criança , Pré-Escolar , China/epidemiologia , Bases de Dados Factuais , Medicamentos de Ervas Chinesas/administração & dosagem , Feminino , Humanos , Lactente , Injeções , Masculino , Pessoa de Meia-Idade , Segurança do Paciente , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Adulto Jovem
19.
Patient Prefer Adherence ; 12: 783-791, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29785093

RESUMO

Purpose: Warfarin is a widely used anticoagulant with a narrow therapeutic index, and it requires close monitoring and adequate patient education. We aimed to assess the knowledge level regarding warfarin therapy among its users and to identify the factors that significantly influence anticoagulation control. Patients and methods: Patients attending the Warfarin Clinic at the Beijing Tiantan Hospital were enrolled in this study. Patients' knowledge on warfarin was assessed using a validated Anticoagulation Knowledge Assessment (AKA) questionnaire. Patients' responses to each question were analyzed to identify areas of improvement in current warfarin education. International normalized ratio (INR) control was defined by the time in therapeutic range (TTR) calculated using the Rosendaal method. Spearman correlation analysis was used to investigate the association between TTR and the independent variables. Results: A total of 65 patients were enrolled in this study. Eleven questions were answered correctly by <50% of the patients. A total of 858 INR results were recorded; 432 INR values (50.3%) reached the predefined goals, and the mean TTR was 49.8%±24.8%. There were significant associations between TTR and patients' AKA scores (R=0.356, P=0.004) and between TTR and patients' educational levels (R=0.339, P=0.006). No significant association was observed between other factors (age and duration of anticoagulation) and TTR. The INR outcome measure was positively associated with patients' knowledge on warfarin and their educational levels. Conclusion: Areas for improvement in patient education have been identified, and processes for educational modification are currently in development.

20.
Patient Prefer Adherence ; 12: 529-537, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29692604

RESUMO

Background: Previous studies have demonstrated that medication adherence has an impact on health-related quality of life (HRQoL). However, other medication-related factors that may influence HRQoL have not been extensively studied, especially factors based on the Medication-Risk Questionnaire (MRQ), and such studies are mostly done in Western countries. Our objective was to explore risk factors associated with HRQoL among community-dwelling elderly with chronic diseases in mainland China, especially the medication-related risk factors regarding MRQ. Methods: The study was conducted in a community health service center through surveys to eligible patients. The main outcomes of HRQoL were assessed by the EuroQol-5D (EQ-5D) scale and EQ-visual analog scale (EQ-VAS). Medication-related risk factors according to MRQ associated with HRQoL were identified using a multiple linear regression. Results: A total of 311 patients were analyzed, averaging 71.19±5.33 years, and 68.8% were female. The mean EQ-5D index was 0.72±0.09, and the mean EQ-VAS score was 71.37±11.97. The most prevalent problem was pain/discomfort, and 90.0% believed that they could take care of themselves without any problems. Sex, age, educational level, frailty, function status, and certain medication-related factors regarding MRQ were found to be significant factors impacting the HRQoL. A multivariate analysis showed that MRQ factors of polypharmacy, multimorbidity, feeling difficultly with taking medicines as prescribed, and taking medicines with narrow therapeutic index had negative impacts on the quality of life. Conclusion: Patient's internal characteristics and medication-related risk factors according to MRQ were associated with quality of life. The results of the MRQ is an indicator of quality of life that can identify patients who need interventions.

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