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Incident study of medication errors in drug use processes: prescription, transcription, validation, preparation, dispensing, and administering in the hospital environment 药物使用过程中用药错误的事件研究:医院环境中的处方、转录、验证、制备、调剂和给药
Pub Date : 2009-01-01 DOI: 10.1016/S2173-5085(09)70091-7
Lourdes Pastó-Cardona , C. Masuet-Aumatell , B. Bara-Oliván , I. Castro-Cels , A. Clopés-Estela , F. Pàez-Vives , J.A. Schönenberger-Arnaiz , M.Q. Gorgas-Torner , C. Codina-Jané

Objective

To determine both the global incident, and the incident for stages of medication errors in 6 Catalonian hospitals, the types of error, and the consequences.

Method

A prospective design, with the global variable of the medication error. Potential errors have been excluded. The patients admitted to each hospital were studied in 2 groups of up to 300 patients and 1500 administrations were observed. The NCCMERP taxonomy was applied.

The prescription error was detected through the review of prescriptions, checking the patient, medication, adherence to protocols, interactions, contraindications, omission, duplicated therapy, doses, frequency, method, and lack of follow-up. During the transcription/validation, it was verified that the prescription matched the original order. In the dispensing process, the content of the drawers was checked, comparing it to the computer generated list, before sending out the single dose trolley. The transcription, preparation and administration were observed on the wards. The information for all the procedures was registered in a specific data sheet. There was moderate concordance amongst the inspectors (kappa=0.525).

Results

Sixteen point ninety-four errors were detected per 100 patients-day and 0.98 errors per patient: sixteen percent in prescription, 27% in transcription/validation, 48% in dispensing, and 9% in administration. Eighty-four point forty-seven percent were category B errors (they did not reach the patient), and <0.5% of the errors were harmful. The population, with an average age of 65, had a male/female ratio of 60/40. The principal therapeutic groups were: agents against peptic ulcer and GERD, antithrombotic agents, and other analgesics and antipyretics, principally in a solid oral drug form (58%). The medications per patient-day were 5.5 and the units of medication were on average 11.21, varying greatly among the institutions. The adjustment of 10 units made the results more uniform. In all the stages, omission was the most frequent error.

Discussion

The different methods used and different areas of the investigations make comparisons difficult. This is evident in the harmful errors, the proportion of which is affected by the detection procedure. The number of mistakes avoided during the execution of this project demonstrates the need to improve the planning of the work systems and to establish safety measures.

目的了解加泰罗尼亚6家医院用药差错的全球发生率、发生阶段、差错类型及后果。方法采用前瞻性设计,以用药差错为全局变量。排除了潜在的错误。每所医院的住院患者分为两组,每组300例,共观察1500次用药。采用NCCMERP分类法。通过核对处方、检查患者、药物、遵守方案、相互作用、禁忌症、遗漏、重复治疗、剂量、频率、方法和缺乏随访来发现处方错误。在转录/验证期间,确认处方与原始订单相符。在配药过程中,检查抽屉的内容,与计算机生成的清单进行比对,然后送出单剂量小车。在病区观察转录、制备和给药情况。所有程序的信息都登记在一个特定的数据表中。检查者之间存在中等程度的一致性(kappa=0.525)。结果每100例患者/天共检出16.94个差错,每例患者检出0.98个差错,其中处方差错占16%,转录/验证差错占27%,调剂差错占48%,给药差错占9%。百分之八点四十七是B类错误(他们没有到达病人),百分之零点五的错误是有害的。人口平均年龄为65岁,男女比例为60/40。主要的治疗组是:抗消化性溃疡和反胃食管反流药物,抗血栓药物,以及其他镇痛和解热药物,主要是固体口服药物形式(58%)。患者日平均用药5.5次,平均用药单位11.21个,各机构间差异较大。10个单位的调整使结果更加均匀。在所有阶段中,遗漏是最常见的错误。使用的不同方法和调查的不同领域使比较变得困难。这在有害错误中是显而易见的,其比例受到检测程序的影响。在执行本项目期间避免的错误数量表明需要改进工作系统的规划和建立安全措施。
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引用次数: 9
Pharmacogenetic analysis of the absorption kinetics of cyclosporine in a population of Spanish cardiac transplant patients 西班牙心脏移植患者对环孢素吸收动力学的药理学分析
Pub Date : 2009-01-01 DOI: 10.1016/S2173-5085(09)70096-6
B. Isla Tejera , M.D. Aumente Rubio , J. Martínez-Moreno , M. Reyes Malia , J.M. Arizón , A. Suárez García

Objective

To determine how single nucleotide polymorphisms located on genes MDR1, CYP3A4, and CYP3A5 affect the absorption kinetics of cyclosporine in cardiac transplant patients.

Method

We selected a sample of 30 adult patients having previously undergone a primary cardiac transplant and who had received cyclosporine as an immunosuppressant. During the first month after the transplant, we performed a pharmacokinetic study of each patient to determine values in the cyclosporine concentration area under the 12-hour curve, steady-state cyclosporine concentration, maximum cyclosporine concentration, and time to reach that concentration. Single nucleotide polymorphisms were genotyped in all patients MDR1 3435C > T, CYP3A4-390A > G, and CYP3A5 6986A > G.

Results

Being a carrier of the T-allele for polymorphism MDR1 3435C > T is associated with higher values in the cyclosporine concentration area under the 12-hour curve (P=.01) and in steady-state cyclosporine concentration (P=.05), compared with those from patients who do not carry that allele.

Discussion

Our results show that genotype differences in MDR1 3435C > T can explain part of the variability in cyclosporine absorption among individuals in the population of Spanish cardiac transplant recipients.

目的探讨MDR1、CYP3A4和CYP3A5基因单核苷酸多态性对心脏移植患者环孢素吸收动力学的影响。方法我们选择了30例曾接受过原发性心脏移植手术并接受过环孢素免疫抑制剂治疗的成年患者。在移植后的第一个月,我们对每位患者进行了药代动力学研究,以确定12小时曲线下的环孢素浓度区域、稳态环孢素浓度、最大环孢素浓度以及达到该浓度所需的时间。所有患者均进行单核苷酸多态性基因分型,MDR1 3435C >T, CYP3A4-390A >G, CYP3A5 6986A >g .结果携带MDR1 3435C >多态性t等位基因;与不携带该等位基因的患者相比,T与12小时曲线下环孢素浓度区域(P= 0.01)和稳态环孢素浓度(P= 0.05)的值较高相关。我们的研究结果表明,MDR1 3435C >这可以部分解释西班牙心脏移植受者群体中个体间环孢素吸收的变异性。
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引用次数: 4
Adjusting the dosage of medication in institutionalised elderly patients with renal failure 住院老年肾功能衰竭患者用药剂量的调整
Pub Date : 2009-01-01 DOI: 10.1016/S2173-5085(09)70068-1
B. Montañés-Pauls , C. Sáez-Lleó , G. Martínez-Romero

Objective

To design a programme for pharmaceutical care for the elderly with renal failure in 3 nursing homes in the region of Valencia.

Method

A 9-month long, prospective study into pharmaceutical interventions was carried out. The study assessed the development of renal function and the effectiveness of drug dosage adjustment with pharmacokinetics affected by renal failure in patients with creatinine clearance below 30 mL/min.

Results

Fifty-two residents of 251 centres presented creatinine clearance lower than 30 mL/ min. Forty-seven out of 74 pharmaceutical interventions were accepted. The drugs which were mainly used were: diuretics, antibiotics, anti-inflammatories, antiemetics, and ranitidine. Although the process of renal disease continued its course, in most cases the follow-up parameters of effectiveness and safety (in terms of renal toxicity) were maintained within the established limits.

Conclusion

The interventions carried out showed, in most cases, to be safe (renal toxicity) and effective, with some exceptions which required more individual follow-up.

目的设计瓦伦西亚地区3家养老院老年肾功能衰竭患者的药学服务方案。方法对药物干预进行为期9个月的前瞻性研究。在肌酐清除率低于30 mL/min的患者中,评估肾功能的发展和药物剂量调整的有效性,以及受肾功能衰竭影响的药代动力学。结果251个中心的52名居民肌酐清除率低于30 mL/ min, 74种药物干预措施中有47种被接受。主要使用的药物有:利尿剂、抗生素、消炎药、止吐药和雷尼替丁。虽然肾脏疾病的过程仍在继续,但在大多数情况下,有效性和安全性(就肾毒性而言)的随访参数保持在既定范围内。结论采取的干预措施在大多数情况下是安全的(肾毒性)和有效的,但也有一些例外,需要更多的个体随访。
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引用次数: 3
Assessment of a pharmaceutical interventional programme in patients on medications with renal risk 对有肾脏风险的药物患者的药物干预方案的评估
Pub Date : 2009-01-01 DOI: 10.1016/S2173-5085(09)70080-2
L. Álvarez Arroyo , E. Climent Grana , N. Bosacoma Ros , S. Roca Meroño , M. Perdiguero Gil , J.P. Ordovás Baines , J. Sánchez Payá

Objective

To compare the adaptation of medical prescriptions according to the dosage guides in patients with renal disease, before and after applying a pharmaceutical intervention programme. The secondary objectives were to prepare a guide to dosing in renal disease and to measure the prevalence of prescription of drugs with renal risk.

Method

Non-randomised, experimental interventional study (before/after) conducted in a general hospital with 800 beds, including hospitalised patients, over the age of 18, with kidney disease and drugs with renal risk prescribed in their pharmaco-therapeutic profile. The study was designed to be carried out in 2 descriptive cross-cutting phases (control group) and a prospective interventional cohort study (intervention group). The primary variable was the percentage non-adaptation according to the stage of renal disease.

Results

The study included 185 patients, 88 in the control group and 97 in the intervention group. In the intervention group, the prevalence of non-compliance before and after the intervention was 18.7% and 2.1%, representing a statistically significant reduction in nonadaptation of the dose. The costs saved with the pharmaceutical intervention programme were 1939.63 euro over 2 months, the average saving per medication intervened amounting to 62.57 euro (95% CI, 23.99–101.14 euro; P=.02).

Conclusions

The results of the study indicate that the application of a pharmaceutical care model based on the prospective validation of drugs with renal risk, very significantly improved the adaptation of dosing regimens in kidney disease.

目的比较肾脏疾病患者在实施药物干预方案前后按剂量指南用药处方的适应性。次要目标是编写肾脏疾病的剂量指南,并衡量有肾脏风险的处方药的流行程度。方法在某综合医院800张床位进行非随机、实验性介入研究(术前/术后),研究对象包括18岁以上、患有肾脏疾病且药物治疗资料中规定有肾脏风险的住院患者。本研究分为两个描述性交叉阶段(对照组)和一个前瞻性干预性队列研究(干预组)。主要变量是根据肾脏疾病分期的不适应百分比。结果共纳入185例患者,对照组88例,干预组97例。在干预组中,干预前后的不顺应率分别为18.7%和2.1%,对剂量的不适应率有统计学意义上的显著降低。药物干预方案在2个月内节省的费用为1939.63欧元,每次药物干预平均节省62.57欧元(95% CI, 23.99-101.14欧元;P = .02点)。结论基于前瞻性肾风险药物验证的药学服务模式的应用,非常显著地提高了肾脏疾病给药方案的适应性。
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引用次数: 6
Correlation, in previously treated HIV-1 positive patients, between hypersensitivity reaction to abacavir and the presence of the HLA-B*5701 allele 在先前治疗过的HIV-1阳性患者中,对阿巴卡韦过敏反应与HLA-B*5701等位基因存在之间的相关性
Pub Date : 2009-01-01 DOI: 10.1016/S2173-5085(09)70081-4
Noemí Pérez Prior , Amparo Rocher Milla , Enrique Soler Company , Juan Flores Cid , Benjamín Sarria Chust

Introduction

Hypersensitivity reaction to abacavir (a powerful inverse transcriptase inhibitor) is a serious adverse effect that limits its use in antiretroviral treatment and requires a high level of clinical surveillance. Certain haplotypes of the primary histocompatibility complex proteins (HLA-B*5701) are very significant predictors of the risk of hypersensitivity to this drug. The purpose of this study is to identify the cases where a probable hypersensitivity reaction to abacavir presented the HLA-B*5701 allele.

Method

A retrospective study was conducted in all HIV-1 positive adult patients infected treated with abacavir between January 2000 and December 2007, in Department 6 of the Agencia Valenciana de Salud (Valencia Health Agency). The adverse effects developed by the patients were collected to determine which cases presented a probable clinically diagnosed hypersensitivity reaction. Finally, these 39 patients were screened for HLA-B*5701.

Results

In total, 323 patients were treated with abacavir between 2000 and 2007. The treatment was discontinued in 12.1% (n=39 patients) presenting a hypersensitivity reaction. Nine (23.1%) of these were HLA-B*5701 positive. Eight patients presented skin rash and positivity was observed in only single patient with gastrointestinal symptoms and fever.

Conclusions

The administration of the HLA-B*5701 gene test may be of benefit in clinical practice, because it prevents diagnostic errors of the hypersensitivity reaction and enables more accurate interpretation of the symptoms.

对阿巴卡韦(一种强效逆转录酶抑制剂)的超敏反应是一种严重的不良反应,限制了其在抗逆转录病毒治疗中的应用,需要高水平的临床监测。原组织相容性复合体蛋白(HLA-B*5701)的某些单倍型是对该药过敏风险的非常重要的预测因子。本研究的目的是确定HLA-B*5701等位基因可能出现阿巴卡韦超敏反应的病例。方法在瓦伦西亚卫生局6司对2000年1月至2007年12月期间接受阿巴卡韦治疗的所有HIV-1阳性成年患者进行回顾性研究。收集患者产生的不良反应,以确定哪些病例可能出现临床诊断的过敏反应。最后对39例患者进行HLA-B*5701筛查。结果2000 - 2007年,323例患者接受阿巴卡韦治疗。12.1% (n=39例)出现过敏反应的患者停止治疗。HLA-B*5701阳性9例(23.1%)。8例患者出现皮疹,仅有1例患者出现胃肠道症状和发热。结论应用HLA-B*5701基因检测可预防超敏反应的诊断错误,并能更准确地解释症状,在临床实践中可能是有益的。
{"title":"Correlation, in previously treated HIV-1 positive patients, between hypersensitivity reaction to abacavir and the presence of the HLA-B*5701 allele","authors":"Noemí Pérez Prior ,&nbsp;Amparo Rocher Milla ,&nbsp;Enrique Soler Company ,&nbsp;Juan Flores Cid ,&nbsp;Benjamín Sarria Chust","doi":"10.1016/S2173-5085(09)70081-4","DOIUrl":"10.1016/S2173-5085(09)70081-4","url":null,"abstract":"<div><h3>Introduction</h3><p>Hypersensitivity reaction to abacavir (a powerful inverse transcriptase inhibitor) is a serious adverse effect that limits its use in antiretroviral treatment and requires a high level of clinical surveillance. Certain haplotypes of the primary histocompatibility complex proteins (HLA-B*5701) are very significant predictors of the risk of hypersensitivity to this drug. The purpose of this study is to identify the cases where a probable hypersensitivity reaction to abacavir presented the HLA-B*5701 allele.</p></div><div><h3>Method</h3><p>A retrospective study was conducted in all HIV-1 positive adult patients infected treated with abacavir between January 2000 and December 2007, in Department 6 of the Agencia Valenciana de Salud (Valencia Health Agency). The adverse effects developed by the patients were collected to determine which cases presented a probable clinically diagnosed hypersensitivity reaction. Finally, these 39 patients were screened for HLA-B*5701.</p></div><div><h3>Results</h3><p>In total, 323 patients were treated with abacavir between 2000 and 2007. The treatment was discontinued in 12.1% (n=39 patients) presenting a hypersensitivity reaction. Nine (23.1%) of these were HLA-B*5701 positive. Eight patients presented skin rash and positivity was observed in only single patient with gastrointestinal symptoms and fever.</p></div><div><h3>Conclusions</h3><p>The administration of the HLA-B*5701 gene test may be of benefit in clinical practice, because it prevents diagnostic errors of the hypersensitivity reaction and enables more accurate interpretation of the symptoms.</p></div>","PeriodicalId":100521,"journal":{"name":"Farmacia Hospitalaria (English Edition)","volume":"33 3","pages":"Pages 155-160"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S2173-5085(09)70081-4","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"56620669","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Consumption of oral analgesics and dosage forms in elderly patients: population based study 老年患者口服镇痛药的使用和剂型:基于人群的研究
Pub Date : 2009-01-01 DOI: 10.1016/S2173-5085(09)70082-6
Antoni Sicras-Mainar , Salomé de Cambra-Florensa , Ruth Navarro-Artieda

Objective

The objective of the study was to describe the consumption of oral analgesics (OA) in people aged ≥65 years, and distinguish between easy-to-swallow (ETS) formulations and solid forms.

Methods

Real data study with a cross sectional design. Electronic anonymous medical records of one year of primary care activity (July 2007–June 2008) were retrospectively reviewed. Inclusion criteria: patients aged ≥65 years receiving OA. Subgroups: institutionalized/non institutionalized. It was considered the oral analgesics use as a principal variable. Study variables: socio-demographic, pharmaceutical formulations (solid and ETS), co morbidities, type of analgesics, geriatric scales (Minimental, Barthel), and poly-medication. Multiple logistic regression analysis models were applied. Program SPSSWIN, statistical signification P<.05.

Results

Overall 78% patients regularly consumed OA. A total of 11 344 patients were studied; mean age 75.1 (7) years; female 61.5%. Two percent of patients were institutionalized and were older (OR=1.2), predominantly female (OR=1.3), had more co morbidity (OR=3.5; P<.001) and lower geriatric scale scores. OA were 13.8% of total drug consumption (95% CI, 13.2- 14.4); NSAIDs 69.5% and opioids 17.6%. Poly-medication 90.6% (96% institutionalized vs 90.5% non institutionalized; P=.019). Thirty-one point one percent of patients used ETS whose use was associated with stroke (OR=2.7), neuropathy (OR=2.4; P<.001), and urinary incontinence. Institutionalized patients consumption of paracetamol, tramadol, and aceclofenac was higher (54.3%, 19%, and 7.6%, respectively).

Conclusions

The use of OA was high, particularly in institutionalized patients. NSAIDs use was higher than expected compared to opioids that were lower than expected. The use of ETS analgesics was lower than expected given the reduced swallowing capacity of elderly patients.

本研究的目的是描述≥65岁人群口服镇痛药(OA)的消费情况,并区分易吞咽(ETS)制剂和固体制剂。方法采用横断面设计对真实资料进行研究。回顾性审查了一年初级保健活动(2007年7月- 2008年6月)的电子匿名医疗记录。纳入标准:年龄≥65岁的OA患者。分组:制度化/非制度化。口服镇痛药的使用被认为是一个主要变量。研究变量:社会人口统计学、药物配方(固体和ETS)、合并症、镇痛药类型、老年量表(Minimental, Barthel)和多种药物。采用多元logistic回归分析模型。程序SPSSWIN,统计学意义P< 0.05。结果78%的患者定期服用OA。共研究了11 344例患者;平均75.1(7)岁;女性61.5%。2%的患者住院,年龄较大(OR=1.2),主要是女性(OR=1.3),有更多的并发症(OR=3.5;P<.001)和较低的老年量表得分。OA占总药物消耗的13.8% (95% CI, 13.2 ~ 14.4);非甾体抗炎药69.5%,阿片类药物17.6%。综合用药90.6%(96%住院vs 90.5%非住院;P = .019)。31.1%使用ETS的患者与卒中(OR=2.7)、神经病变(OR=2.4;P<.001)和尿失禁。住院患者对扑热息痛、曲马多和乙酰氯芬酸的用量较高(分别为54.3%、19%和7.6%)。结论OA的使用率很高,特别是在住院患者中。非甾体抗炎药的使用高于预期,而阿片类药物的使用低于预期。考虑到老年患者吞咽能力下降,ETS镇痛药的使用低于预期。
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引用次数: 7
Cardiotoxicity associated with trastuzumab in normal clinical practice 正常临床实践中与曲妥珠单抗相关的心脏毒性
Pub Date : 2009-01-01 DOI: 10.1016/S2173-5085(09)70085-1
C. Vicente, N. Serrano, M.J. Agustín, V. Alonso, P. Palomo, R. Huarte

Objective

To evaluate the incidence of cardiotoxicity associated with treatment with trastuzumab in clinical practice by describing its characteristics, progress, and associated risk factors.

Methods

Retrospective observational study of patients with HER2-positive breast cancer treated with trastuzumab in the first quarter of 2007 in a tertiary hospital. Follow-up was performed from start of treatment until the end of March 2008. The data sources used were the oncological computer program Oncowin® from the pharmacy department and the patient clinical history. We gathered variables related to patient baseline characteristics, treatment, and safety.

Results

The study included 61 patients. 19 women (32.8%) presented cardiotoxicity, which was the second most common adverse affect of those frequently attributed to the treatment. The average time for toxicity to appear was 7 months, with an average FEVI decrease of 15.6 (9.1) points. In 63.2% of the patients it was symptomatic, and its most frequent manifestation was stress-induced dyspnoea, with a single case of congestive heart failure. Cardiotoxicity led to suspension of treatment in 22.9% of the total patients, which was definitive for 7 out of the 14 patients who interrupted the treatment. No statistically significant differences were found for the possible risk factors.

Conclusions

The incidence of cardiotoxicity in clinical practice is much higher than expected. The important clinical implication of this information and the increasing use of trastuzumab mean that there is a new challenge for the optimal treatment of HER2-positive breast cancer.

目的通过描述曲妥珠单抗的特点、进展和相关危险因素,评估临床实践中与曲妥珠单抗治疗相关的心脏毒性发生率。方法回顾性观察某三级医院2007年第一季度接受曲妥珠单抗治疗的her2阳性乳腺癌患者。从治疗开始至2008年3月底进行随访。数据来源为药剂科的肿瘤学计算机程序Oncowin®和患者的临床病史。我们收集了与患者基线特征、治疗和安全性相关的变量。结果共纳入61例患者。19名妇女(32.8%)出现心脏毒性,这是经常归因于治疗的第二大常见不良反应。出现毒性的平均时间为7个月,FEVI平均下降15.6(9.1)分。63.2%的患者有症状,其最常见的表现是应激性呼吸困难,有一例充血性心力衰竭。22.9%的患者因心脏毒性而暂停治疗,14例中断治疗的患者中有7例是明确的。在可能的危险因素方面没有发现统计学上的显著差异。结论临床中心脏毒性的发生率远高于预期。这一信息的重要临床意义和曲妥珠单抗使用的增加意味着her2阳性乳腺癌的最佳治疗面临新的挑战。
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引用次数: 7
Management of returned anti-neoplastic treatments and their reuse in oncology patients 肿瘤患者复发抗肿瘤治疗的管理及再用药
Pub Date : 2009-01-01 DOI: 10.1016/S2173-5085(09)70087-5
D. Yuste-Vila , A. Albert-Mari , V. Jiménez-Arenas , N.V. Jiménez-Torres

Objective

Analyse the profile of parenteral preparation and treatment (anti-neoplastic and supplementary) that were dispensed and returned to the Pharmacy Department, the reasons why they were not administered, their reuse and the associated direct costs.

Method

Longitudinal study over 8 months (October 2004-May 2005) in a tertiary hospital with centre for preparing anti-neoplastic agents (including supplementary treatment) in its Pharmacy Department. The variables studied, downloaded from the Oncofarm® application, are as follows: a) patients and diagnostics; b) returned treatments, classified by reason returned, pharmaco-therapeutic scheme, cycle, and day; c) returned preparations (anti-neoplastic and supplementary) that were reused; and d) direct costs.

Data is presented with its absolute and relative frequencies and confidence intervals of 95% normalised at 1000 patients/day.

Results

Eighty-four treatments were returned by 66 patients for a total of 139 preparations corresponding to 3429 patients/day. This figure represents 24.5 (95% CI, 19.6-30.2) treatments that were prepared and not administered per 1000 patients/day, mainly due to clinical causes (n=47). Colon neoplasia and treatment with 5-fluorouracil and levofolinic acid presented the highest number of returns. The returned preparations made up 1.45% (95% CI, 1.2-1.7) of those produced. The percentage of reuse is 98%, which results in savings of €10 432.55 (90% of the cost of the treatments that are returned).

Conclusions

The application of quality, effectiveness, and safety criteria to anti-neoplastic treatments that are prepared and returned to the Pharmacy Department allows a more efficient preparation process.

目的分析我院配发后退回药物科的非肠外制剂及治疗(抗肿瘤及补充)的情况、未给药原因、重复使用情况及相关直接费用。方法2004年10月- 2005年5月,在某三级医院药学部设有抗肿瘤药物(含辅助治疗)制备中心,进行为期8个月的纵向研究。从Oncofarm®应用程序下载的研究变量如下:a)患者和诊断;B)返回治疗,按返回原因、药物治疗方案、周期和天数分类;C)退回的重复使用的制剂(抗肿瘤制剂和补充制剂);d)直接成本。数据以绝对频率和相对频率呈现,95%的置信区间以1000例/天归一化。结果66例患者返回84个治疗方案,共139个制剂,对应3429例患者/天。这一数字代表了每1000名患者/天中有24.5 (95% CI, 19.6-30.2)种治疗方法被准备好但没有被使用,主要是由于临床原因(n=47)。结肠肿瘤和5-氟尿嘧啶和左旋亚油酸治疗的复发率最高。返回制剂占生产制剂的1.45% (95% CI, 1.2-1.7)。再利用的百分比为98%,节省了10432.55欧元(90%的处理成本被回收)。结论将质量、有效性和安全性标准应用于制备和返回药房的抗肿瘤药物,可以提高制备过程的效率。
{"title":"Management of returned anti-neoplastic treatments and their reuse in oncology patients","authors":"D. Yuste-Vila ,&nbsp;A. Albert-Mari ,&nbsp;V. Jiménez-Arenas ,&nbsp;N.V. Jiménez-Torres","doi":"10.1016/S2173-5085(09)70087-5","DOIUrl":"10.1016/S2173-5085(09)70087-5","url":null,"abstract":"<div><h3>Objective</h3><p>Analyse the profile of parenteral preparation and treatment (anti-neoplastic and supplementary) that were dispensed and returned to the Pharmacy Department, the reasons why they were not administered, their reuse and the associated direct costs.</p></div><div><h3>Method</h3><p>Longitudinal study over 8 months (October 2004-May 2005) in a tertiary hospital with centre for preparing anti-neoplastic agents (including supplementary treatment) in its Pharmacy Department. The variables studied, downloaded from the Oncofarm® application, are as follows: a) patients and diagnostics; b) returned treatments, classified by reason returned, pharmaco-therapeutic scheme, cycle, and day; c) returned preparations (anti-neoplastic and supplementary) that were reused; and d) direct costs.</p><p>Data is presented with its absolute and relative frequencies and confidence intervals of 95% normalised at 1000 patients/day.</p></div><div><h3>Results</h3><p>Eighty-four treatments were returned by 66 patients for a total of 139 preparations corresponding to 3429 patients/day. This figure represents 24.5 (95% CI, 19.6-30.2) treatments that were prepared and not administered per 1000 patients/day, mainly due to clinical causes (n=47). Colon neoplasia and treatment with 5-fluorouracil and levofolinic acid presented the highest number of returns. The returned preparations made up 1.45% (95% CI, 1.2-1.7) of those produced. The percentage of reuse is 98%, which results in savings of €10 432.55 (90% of the cost of the treatments that are returned).</p></div><div><h3>Conclusions</h3><p>The application of quality, effectiveness, and safety criteria to anti-neoplastic treatments that are prepared and returned to the Pharmacy Department allows a more efficient preparation process.</p></div>","PeriodicalId":100521,"journal":{"name":"Farmacia Hospitalaria (English Edition)","volume":"33 4","pages":"Pages 217-223"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S2173-5085(09)70087-5","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74044753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Efficacy and safety of topical diltiazem 2% in anal fissure 2%地尔硫卓局部治疗肛裂的疗效和安全性
Pub Date : 2009-01-01 DOI: 10.1016/S2173-5085(09)70073-5
M.I. Fernández García, R. Albornoz López, I. Pérez Rodrigo, J. Abellón Ruiz

Objectives

To evaluate the effectiveness and safety of 2% diltiazem ointment in the treatment of anal fissure. To analyse the relationship between healing and diagnosis, and duration of the treatment, and the number of applications.

Methods

A prospective observational study of all patients diagnosed with anal fissure that began treatment with topical diltiazem between January and June in 2007. Diltiazem ointment was prepared in the Pharmacy Service. Effectiveness and safety were assessed by a telephone survey conducted with each patient after 8 weeks of treatment, adding it to the patient's clinical records. The variables that were analysed were healing, adverse effects, diagnosis, duration of treatment, and number of applications, among others. Follow-up was carried out for up to 1 year until complete healing of the fissure. The data analysis was carried out by descriptive statistics, crosstabs, and x2.

Results

A total of 70 patients were included in the study and anal fissure healed in 48.6% of them. Healing occurred in 54.5% of patients with anal fissure and in 33.3% of patients with anal fissure and haemorrhoids. Some adverse effects occurred in 30% of patients. Therapy was abandoned due to adverse reactions for 5.7%. The fissure was cured for 60% of patients who underwent treatment for a month or more. More than twice-daily applications did not lead to improved healing. There were no significant statistical differences in these results.

Conclusions

Despite not having found statistical differences between the analysed variables, treatment of anal fissures with 2% diltiazem ointment has avoided surgery in nearly 50% of patients, with few adverse effects.

目的评价2%地尔硫卓软膏治疗肛裂的有效性和安全性。分析治疗与诊断、治疗持续时间和应用次数之间的关系。方法对2007年1月至6月接受局部地尔硫卓治疗的肛裂患者进行前瞻性观察研究。地尔硫卓软膏是在药房配制的。治疗8周后,通过电话调查对每位患者进行有效性和安全性评估,并将其添加到患者的临床记录中。分析的变量包括愈合、不良反应、诊断、治疗持续时间和应用次数等。随访时间长达1年,直至裂隙完全愈合。采用描述性统计、交叉表和x2进行数据分析。结果本研究共纳入70例患者,肛裂愈合率为48.6%。肛裂患者愈合率为54.5%,肛裂合并痔疮患者愈合率为33.3%。30%的患者出现不良反应。因不良反应放弃治疗的占5.7%。经过一个月或更长时间的治疗,60%的患者治愈了裂缝。每天使用两次以上并不能改善愈合。这些结果没有显著的统计学差异。结论:尽管没有发现分析变量之间的统计学差异,但2%地尔硫卓软膏治疗肛裂可以避免近50%的患者手术,并且几乎没有不良反应。
{"title":"Efficacy and safety of topical diltiazem 2% in anal fissure","authors":"M.I. Fernández García,&nbsp;R. Albornoz López,&nbsp;I. Pérez Rodrigo,&nbsp;J. Abellón Ruiz","doi":"10.1016/S2173-5085(09)70073-5","DOIUrl":"10.1016/S2173-5085(09)70073-5","url":null,"abstract":"<div><h3>Objectives</h3><p>To evaluate the effectiveness and safety of 2% diltiazem ointment in the treatment of anal fissure. To analyse the relationship between healing and diagnosis, and duration of the treatment, and the number of applications.</p></div><div><h3>Methods</h3><p>A prospective observational study of all patients diagnosed with anal fissure that began treatment with topical diltiazem between January and June in 2007. Diltiazem ointment was prepared in the Pharmacy Service. Effectiveness and safety were assessed by a telephone survey conducted with each patient after 8 weeks of treatment, adding it to the patient's clinical records. The variables that were analysed were healing, adverse effects, diagnosis, duration of treatment, and number of applications, among others. Follow-up was carried out for up to 1 year until complete healing of the fissure. The data analysis was carried out by descriptive statistics, crosstabs, and x<sup>2</sup>.</p></div><div><h3>Results</h3><p>A total of 70 patients were included in the study and anal fissure healed in 48.6% of them. Healing occurred in 54.5% of patients with anal fissure and in 33.3% of patients with anal fissure and haemorrhoids. Some adverse effects occurred in 30% of patients. Therapy was abandoned due to adverse reactions for 5.7%. The fissure was cured for 60% of patients who underwent treatment for a month or more. More than twice-daily applications did not lead to improved healing. There were no significant statistical differences in these results.</p></div><div><h3>Conclusions</h3><p>Despite not having found statistical differences between the analysed variables, treatment of anal fissures with 2% diltiazem ointment has avoided surgery in nearly 50% of patients, with few adverse effects.</p></div>","PeriodicalId":100521,"journal":{"name":"Farmacia Hospitalaria (English Edition)","volume":"33 2","pages":"Pages 80-88"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S2173-5085(09)70073-5","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"56620420","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Therapeutic exchange of angiotensin II receptor antagonists in patients hospitalised in a traumatology unit 创伤科住院患者血管紧张素II受体拮抗剂的治疗性交换
Pub Date : 2009-01-01 DOI: 10.1016/S2173-5085(09)70071-1
J.F. Márquez-Peiró , B. Porta-Oltra , C. Borrás-Almenar

Objective

To analyse the proportion of patients whose blood pressure values have remained within the established therapeutic aim, so as to reduce cardiovascular risk following therapeutic exchange of angiotensin II receptor antagonists (AIIRA).

Methods

Analytical, observational, prospective, longitudinal study with pre-post analysis. Patients undergoing AIIRA treatment who were not included in the hospital's pharmacotherapeutic guide were included in the study over those who had undergone a normalised therapeutic exchange of AIIRA. Variable response: proportion of patients whose blood pressure levels (BP levels) remained within the established therapeutic aim for the prevention of cardiovascular accidents. Other variables: systolic and diastolic blood pressure values (SBP and DBP) in the month prior to hospitalisation and after therapeutic exchange, antihypertensive medication, comorbidities.

Results

Thirty-seven patients were included in the study. Following therapeutic exchange, 81.08% maintained BP values within the range established by the European Society of Hypertension-European Society of Cardiology Committee. SBP difference: 4.82 (95% confidence interval [CI], −1.09 to 10.74; P=.107); DBP difference: −0.15 (95% CI, −3.27 to 2.97; P=.924), and therefore not clinically significant.

Conclusions

The normalised procedure for therapeutic exchange of AIIRA is effective and safe for patients in terms of maintaining BP, which allows for adequate control of BP during the hospital stay.

目的分析血管紧张素II受体拮抗剂(AIIRA)治疗后血压值维持在既定治疗目标内的患者比例,以降低心血管风险。方法采用分析性、观察性、前瞻性、纵向研究及前后分析。接受AIIRA治疗的未列入医院药物治疗指南的患者被纳入研究,而那些接受了AIIRA正常治疗交换的患者则被纳入研究。可变反应:血压水平(BP水平)保持在预防心血管事故的既定治疗目标内的患者比例。其他变量:住院前和治疗交换后一个月的收缩压和舒张压值(收缩压和舒张压)、抗高血压药物、合并症。结果37例患者纳入研究。治疗交换后,81.08%的患者血压值维持在欧洲高血压学会-欧洲心脏病学会委员会确定的范围内。收缩压差:4.82(95%置信区间[CI],−1.09 ~ 10.74;P = .107);DBP差异:−0.15 (95% CI,−3.27 ~ 2.97;P=.924),因此没有临床意义。结论在维持血压方面,AIIRA治疗性交换的规范化程序是有效和安全的,可以在住院期间充分控制血压。
{"title":"Therapeutic exchange of angiotensin II receptor antagonists in patients hospitalised in a traumatology unit","authors":"J.F. Márquez-Peiró ,&nbsp;B. Porta-Oltra ,&nbsp;C. Borrás-Almenar","doi":"10.1016/S2173-5085(09)70071-1","DOIUrl":"10.1016/S2173-5085(09)70071-1","url":null,"abstract":"<div><h3>Objective</h3><p>To analyse the proportion of patients whose blood pressure values have remained within the established therapeutic aim, so as to reduce cardiovascular risk following therapeutic exchange of angiotensin II receptor antagonists (AIIRA).</p></div><div><h3>Methods</h3><p>Analytical, observational, prospective, longitudinal study with pre-post analysis. Patients undergoing AIIRA treatment who were not included in the hospital's pharmacotherapeutic guide were included in the study over those who had undergone a normalised therapeutic exchange of AIIRA. Variable response: proportion of patients whose blood pressure levels (BP levels) remained within the established therapeutic aim for the prevention of cardiovascular accidents. Other variables: systolic and diastolic blood pressure values (SBP and DBP) in the month prior to hospitalisation and after therapeutic exchange, antihypertensive medication, comorbidities.</p></div><div><h3>Results</h3><p>Thirty-seven patients were included in the study. Following therapeutic exchange, 81.08% maintained BP values within the range established by the European Society of Hypertension-European Society of Cardiology Committee. SBP difference: 4.82 (95% confidence interval [CI], −1.09 to 10.74; <em>P</em>=.107); DBP difference: −0.15 (95% CI, −3.27 to 2.97; <em>P</em>=.924), and therefore not clinically significant.</p></div><div><h3>Conclusions</h3><p>The normalised procedure for therapeutic exchange of AIIRA is effective and safe for patients in terms of maintaining BP, which allows for adequate control of BP during the hospital stay.</p></div>","PeriodicalId":100521,"journal":{"name":"Farmacia Hospitalaria (English Edition)","volume":"33 2","pages":"Pages 66-71"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S2173-5085(09)70071-1","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75690845","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
期刊
Farmacia Hospitalaria (English Edition)
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