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NP-015 Quality assessment of 3D printed sildenafil and furosemide tablets for the paediatric population using an innovative extrusion-based technique 使用创新的挤压技术对用于儿科人群的3D打印西地那非和速尿片进行质量评估
Pub Date : 2021-03-01 DOI: 10.1136/EJHPHARM-2021-EAHPCONF.362
I. Lafeber, J. Tichem, Hcm Bijleveld-Olierook, DM Kweekel, Pph Le Brun, H. Guchelaar, Kjm Schimmel
Background and importance Commercially available tablets often don’t meet patients’ needs, as is the case for children. Three-dimensional (3D) printing can possibly achieve this. However, most investigated 3D printing techniques for production of pharmaceutical preparations may not be suitable for chemically unstable drugs. In addition, quality requirements are not well established. Aim and objectives A proof-of-principle study was conducted using a low heat, solvent-free extrusion-based 3D printing technique. Furosemide and sildenafil immediate release tablets containing paediatric appropriate dosages were the model products. The quality requirements as stated by the European Pharmacopoeia (EP) were evaluated. Materials and methods Formulations containing furosemide, 2 mg or 10 mg per tablet, or sildenafil, 4 mg per tablet, were slightly heated to a semi-solid to allow printing. The tablets were analysed for weight distribution (EP 2.9.5.), content uniformity (EP 2.9.40.) and dissolution profile (EP 2.9.3.), using an analytical balance, high-performance liquid chromatography ultraviolet and UV/VIS spectrophotometry, respectively. Content uniformity and dissolution analyses were performed in triplicate. Linear regression analysis was performed to assess tablet mass and content. Results The weight distribution met the requirements of EP 2.9.5 with a relative standard deviation of 1.26%. The acceptance values of the content uniformity of furosemide 2 mg, 10 mg and sildenafil 4 mg ranged between 4.2–10.6, 4.8–8.9 and 6.6–9.2, respectively, where a maximum value of 15 was accepted. A linear correlation between tablet mass and content was found. Furosemide 10 mg and sildenafil 4 mg showed a dissolved content of >80% after 45 minutes, indicating an immediate release profile. For furosemide 2 mg batches, the second testing level had to be used. This preparation also met the requirement of an immediate release profile. Additionally, the tablets should also have sufficient microbiological stability (EP 5.4.1.) and mechanical strength (EP 2.9.7. and 2.9.8.), though an adjusted test for mechanical strength is necessary for applicability to 3D printed tablets. Conclusion and relevance This proof-of-principle study shows lower temperature 3D printing can be useful in enabling production of personalised tablets. Further investigation of suitable quality tests for 3D printed tablets will be performed in further studies.
背景和重要性市售的片剂常常不能满足病人的需要,儿童也是如此。三维(3D)打印有可能实现这一点。然而,大多数用于生产药物制剂的3D打印技术可能不适合化学不稳定的药物。此外,质量要求没有很好地建立。目的和目的使用低热量、无溶剂挤压的3D打印技术进行了原理验证研究。以小儿适当剂量的速泻米和西地那非速释片为模型产品。按照欧洲药典(EP)规定的质量要求进行评价。材料和方法配方中含有速尿,每片2毫克或10毫克,或西地那非,每片4毫克,稍微加热到半固体,以便打印。采用高效液相色谱法、紫外分光光度法和紫外/可见分光光度法分别对所制片剂的重量分布(EP 2.9.5.)、含量均匀度(EP 2.9.40.)和溶出度(EP 2.9.3.)进行分析。含量均匀性和溶出度分析为三份。采用线性回归分析评价片剂质量和含量。结果重量分布符合EP 2.9.5的要求,相对标准偏差为1.26%。速尿2 mg、10 mg和西地那非4 mg的含量均匀度接受值分别为4.2-10.6、4.8-8.9和6.6-9.2,其中接受的最大值为15。片剂质量与含量呈线性相关。速尿10 mg和西地那非4 mg在45分钟后溶出含量>80%,表明立即释放。对于呋塞米2mg批次,必须使用第二个测试水平。这种制备也满足了立即释放的要求。此外,片剂还应具有足够的微生物稳定性(EP 5.4.1.)和机械强度(EP 2.9.7.)。和2.9.8.),但为了适用于3D打印片剂,需要对机械强度进行调整测试。结论和相关性这项原理验证研究表明,低温3D打印在个性化平板电脑的生产中是有用的。在进一步的研究中,将对3D打印片剂的合适质量测试进行进一步的调查。
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引用次数: 0
5PSQ-226 Analysis of high alert medication prescriptions in a nursing home 5PSQ-226某养老院高危用药处方分析
Pub Date : 2021-03-01 DOI: 10.1136/EJHPHARM-2021-EAHPCONF.345
R. S. D. Moral, I. G. Giménez, A. Bejarano, Emilio Barrientos
Background and importance High alert medications are those that, when they are not being properly used, are more likely to cause serious or even fatal harm to patients. Chronic patients are especially vulnerable to these possible errors because of their comorbidity and polypharmacy. The Ministry of Health, Social Services and Equality of Spain promotes the implementation of improving safe practices for those patients. In 2014, a panel of experts developed a list of high alert drugs for chronic patients to prioritise practices for improving safety in these patients. This list was named the HAMC list (high alert medications for patients with chronic illnesses) and was published by the Ministry of Health, Social Services and Equality of Spain. Aim and objectives To analyse the prevalence of prescribed medications included in the HAMC list in a nursing home. Material and methods A descriptive, transversal, retrospective study was carried out in September 2020 that included all residents with chronic illnesses in a nursing home assigned to our pharmacy service. Variables recorded were: demographic data, number of prescribed medicaments, and number and type of prescribed medicaments included in the HAMC list. Results 81 patients were included (59 men) with a mean age of 72 (56–94) years. 721 drugs were prescribed, and 186 were included in the HAMC list. At least 1 HAMC was prescribed in 86% of patients, with a mean of 3 HAMC per patient (1–7). The therapeutic groups of the drugs on the HAMC that were prescribed were: benzodiazepines (63% of patients), inhibitors of platelet aggregation (36%), antipsychotics (26%), beta-adrenergic blockers (26%), oral hypoglycaemics agents (26%), loop diuretics (19%), oral anticoagulants (11%), antiepileptics (9%), opioids (9%), including minor and major opioids, insulin (7%), eplerenone/spironolactone (7%), immunosuppressants (1%) and non-steroidal anti-inflammatory drugs (1%). Conclusion and relevance HAMC were widely prescribed. Benzodiazepines were the therapeutic group most prescribed from the HAMC list in our population, followed by antiplatelets and antipsychotics. The HAMC list is a useful tool for a first approach in the detection of patients who may be at a higher risk of serious harms if medication errors occur. Implementation of specific safe practices for those drugs could reduce potential or real errors in these patients. References and/or acknowledgements Conflict of interest No conflict of interest
背景和重要性高度警戒药物是指那些如果使用不当,更有可能对患者造成严重甚至致命伤害的药物。慢性患者尤其容易受到这些可能的错误,因为他们的合并症和多药。西班牙卫生、社会服务和平等部促进实施改进这些病人的安全做法。2014年,一个专家小组制定了一份针对慢性患者的高警惕性药物清单,以优先考虑提高这些患者安全性的做法。这份清单被命名为HAMC清单(针对慢性疾病患者的高度警惕药物),由西班牙卫生、社会服务和平等部公布。目的和目的分析疗养院HAMC清单中处方药的流行情况。材料和方法2020年9月进行了一项描述性、横向、回顾性研究,纳入了分配给我们药房服务的养老院所有患有慢性疾病的居民。记录的变量包括:人口统计数据、处方药物数量、HAMC清单中包含的处方药物数量和类型。结果81例患者(男性59例),平均年龄72岁(56 ~ 94岁)。处方药品721种,纳入HAMC清单186种。86%的患者至少开了1次HAMC,平均每位患者3次HAMC(1 - 7)。HAMC上处方药物的治疗组为:苯二氮卓类药物(占患者的63%)、血小板聚集抑制剂(36%)、抗精神病药(26%)、β -肾上腺素能阻滞剂(26%)、口服降糖药(26%)、环利尿剂(19%)、口服抗凝剂(11%)、抗癫痫药(9%)、阿片类药物(9%),包括小阿片类和大阿片类药物、胰岛素(7%)、依普利酮/螺内酯(7%)、免疫抑制剂(1%)和非甾体抗炎药(1%)。结论:HAMC被广泛应用。在我们的人群中,苯二氮卓类药物是HAMC列表中最常用的治疗组,其次是抗血小板药物和抗精神病药物。HAMC清单是一种有用的工具,可作为检测患者的第一种方法,如果发生药物错误,这些患者可能面临更高的严重危害风险。对这些药物实施特定的安全操作可以减少这些患者潜在或实际的错误。参考文献和/或致谢利益冲突无利益冲突
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引用次数: 0
4CPS-378 Oral therapy adherence and satisfaction in patients with multiple myeloma 多发性骨髓瘤患者口服治疗的依从性和满意度
Pub Date : 2021-03-01 DOI: 10.1136/EJHPHARM-2021-EAHPCONF.210
M. Solano, C. Faure, C. Pain, P. Loriod, A. Maes, P. Marguet, M. Kroemer, A. Rumpler, É. Daguindau, S. Limat, A. Clairet
Background and importance The transition to oral therapies in patients with multiple myeloma (MM) offers potential benefits to patients, however they must self-manage their medications and adherence can become an issue. It has been shown that patient satisfaction with medication has a strong positive correlation with adherence in chronic diseases. To date, there is no standard method of measuring adherence. Aim and objectives The aim of this study was to estimate the adherence rate of oral antimyeloma therapies using two indirect methods and to identify risk factors for medication non-adherence. A secondary aim was to explore patients’ and caregivers’ perceptions of their medications. Material and methods We carried out a cross sectional, observational, prospective, multicentre survey based on a self-reported questionnaire. All consecutive MM patients, with at least 3 months of oral therapy prescriptions were included. The structured and validated 6 item Girerd Scale and the medication possession ratio (MPR) were used for measuring medication adherence, and the SATMED-Q questionnaire was used for measuring patient satisfaction with the medication. An analysis of risk factors for non-adherence to oral therapy was performed using univariate analysis. Patients’ and caregivers’ opinions about their medications were assessed with a score from 0 (no importance) to 10 (highest importance). Results 101 of 116 analysed patients participated in the survey, giving a response rate of 87%. The prevalence of adherence to oral antimyeloma therapy was estimated at 51.5% using the questionnaire, corresponding to a high level of adherence (ie, score=6). According to the MPR, adherence was evaluated at 96%, which was also considered high (ie, MPR ≥0.80). With both methods combined, adherence was estimated at 50.5%. One risk factor for non-adherence to oral antimyeloma therapy was identified: Eastern Cooperative Oncology Group Performance Status (ECOG-PS) >2 (p value=0.007). One predictive factor for good adherence to oral antimyeloma therapy was also identified: high satisfaction with treatment (p=0.01). No statistically significant difference was observed between patients and caregivers’ perceptions of their medications. Conclusion and relevance Determining risk factors that influence adherence could be helpful to better identify patients at a higher risk for non-adherence, to personalise therapeutic information and education, and to improve the quality of healthcare overall. References and/or acknowledgements Conflict of interest No conflict of interest
背景和重要性多发性骨髓瘤(MM)患者向口服治疗的过渡为患者提供了潜在的益处,然而他们必须自我管理他们的药物和依从性可能成为一个问题。研究表明,慢性疾病患者对药物的满意度与依从性有很强的正相关。到目前为止,还没有衡量依从性的标准方法。目的和目的本研究的目的是使用两种间接方法估计口服抗骨髓瘤治疗的依从率,并确定药物不依从性的危险因素。第二个目的是探索患者和护理人员对他们的药物的看法。材料和方法我们采用了一项基于自述问卷的横断面、观察性、前瞻性、多中心调查。所有连续接受至少3个月口服治疗处方的MM患者被纳入研究。采用结构化且经过验证的6项Girerd量表和药物占有率(MPR)测量用药依从性,采用SATMED-Q问卷测量患者用药满意度。采用单变量分析对不坚持口服治疗的危险因素进行分析。患者和护理人员对其药物的看法以0分(不重要)到10分(最重要)进行评估。结果116例患者中有101例参与调查,有效率为87%。根据调查问卷,口服抗骨髓瘤治疗的依从性估计为51.5%,对应于高水平的依从性(即得分=6)。根据MPR,依从性评估为96%,也被认为是高依从性(即MPR≥0.80)。两种方法相结合,依从性估计为50.5%。发现不坚持口服抗骨髓瘤治疗的一个危险因素:东部合作肿瘤组绩效状态(ECOG-PS) >2 (p值=0.007)。对口服抗骨髓瘤治疗的良好依从性的一个预测因素也被确定:对治疗的高满意度(p=0.01)。患者和护理人员对药物的认知没有统计学上的显著差异。结论和相关性确定影响依从性的危险因素有助于更好地识别不依从性风险较高的患者,个性化治疗信息和教育,并提高整体医疗保健质量。参考文献和/或致谢利益冲突无利益冲突
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引用次数: 0
4CPS-328 Biological drugs for the treatment of moderate-to-severe plaque psoriasis: analysis according to the mechanism of action 4CPS-328治疗中重度斑块型银屑病的生物药物:根据作用机制分析
Pub Date : 2021-03-01 DOI: 10.1136/EJHPHARM-2021-EAHPCONF.160
I. Solazzi, M. Guidi, P. Abrate, EC Zinetti
Background and importance In the past years, many biological drugs have been approved for the treatment of moderate-to-severe plaque psoriasis. Aim and objectives We aimed to describe the population of outpatients treated with biological drugs for moderate-to-severe plaque psoriasis according to the number and type of therapeutic shifts. Material and methods We identified patients treated with a biological drug for moderate-to-severe plaque psoriasis (code ICD-9-CM 696.1 other psoriasis) from February 2017 to September 2020. Data were collected from drug refills by our pharmacy and electronically recorded. Biological drugs were considered according to the mechanism of action: anti-TNF-α (adalimumab, certolizumab, etanercept), anti-IL-17 (brodalumab, ixekizumab, secukinumab) and anti-IL-23 (guselkumab, risankizumab, tildrakizumab and ustekinumab). The therapeutic shift was intended as a change in the active substance, regardless of changes from an originator to its biosimilar/s, the pharmaceutical form (pen or syringe) or the dose. Results From February 2017 to September 2020, 357 patients were treated with at least one biological drug for plaque psoriasis. Median age was 50.7 years (range 5.9–91.7) and 221 (61.9%) patients were men. 282 patients (79%) were treated with only one biological drug: 75 patients with anti-TNF-α, 132 with anti-IL-17 and 75 with anti-IL-23. 65 patients (18.2%) were treated with two biological drugs in sequence (table 1). Conclusion and relevance More than 97% of patients were treated with only one (79%) or two (18.2%) biological drugs for moderate-to-severe plaque psoriasis, with a prevalence of anti-IL-17. Further investigation of the causes for the change from one to another biological drug is needed. These could include adverse events, ineffectiveness or other reasons. References and/or acknowledgements Conflict of interest No conflict of interest
背景和重要性在过去的几年中,许多生物药物已被批准用于治疗中重度斑块性银屑病。目的和目的:我们的目的是根据治疗班次的数量和类型描述使用生物药物治疗中重度斑块性银屑病的门诊患者人群。材料和方法研究人员选取了2017年2月至2020年9月期间接受生物药物治疗的中重度斑块性银屑病(代码ICD-9-CM 696.1其他银屑病)患者。数据由我们的药房收集并以电子方式记录。根据作用机制考虑生物药物:抗tnf -α(阿达木单抗、certolizumab、依那西普)、抗il -17 (brodalumab、ixekizumab、secukinumab)和抗il -23 (guselkumab、risankizumab、tildrakizumab和ustekinumab)。治疗转变是指活性物质的变化,无论从原料药到其生物仿制药、药物形式(笔或注射器)或剂量的变化。结果2017年2月至2020年9月,357例斑块型银屑病患者接受了至少一种生物药物治疗。中位年龄为50.7岁(范围5.9-91.7),男性221例(61.9%)。282例患者(79%)只用一种生物药物治疗:抗tnf -α 75例,抗il -17 132例,抗il -23 75例。65例患者(18.2%)按顺序使用两种生物药物治疗(表1)。结论及相关性超过97%的患者仅使用一种(79%)或两种(18.2%)生物药物治疗中重度斑块性银屑病,其抗il -17患病率较高。需要进一步调查从一种生物药物转变为另一种生物药物的原因。这些可能包括不良事件、无效或其他原因。参考文献和/或致谢利益冲突无利益冲突
{"title":"4CPS-328 Biological drugs for the treatment of moderate-to-severe plaque psoriasis: analysis according to the mechanism of action","authors":"I. Solazzi, M. Guidi, P. Abrate, EC Zinetti","doi":"10.1136/EJHPHARM-2021-EAHPCONF.160","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.160","url":null,"abstract":"Background and importance In the past years, many biological drugs have been approved for the treatment of moderate-to-severe plaque psoriasis. Aim and objectives We aimed to describe the population of outpatients treated with biological drugs for moderate-to-severe plaque psoriasis according to the number and type of therapeutic shifts. Material and methods We identified patients treated with a biological drug for moderate-to-severe plaque psoriasis (code ICD-9-CM 696.1 other psoriasis) from February 2017 to September 2020. Data were collected from drug refills by our pharmacy and electronically recorded. Biological drugs were considered according to the mechanism of action: anti-TNF-α (adalimumab, certolizumab, etanercept), anti-IL-17 (brodalumab, ixekizumab, secukinumab) and anti-IL-23 (guselkumab, risankizumab, tildrakizumab and ustekinumab). The therapeutic shift was intended as a change in the active substance, regardless of changes from an originator to its biosimilar/s, the pharmaceutical form (pen or syringe) or the dose. Results From February 2017 to September 2020, 357 patients were treated with at least one biological drug for plaque psoriasis. Median age was 50.7 years (range 5.9–91.7) and 221 (61.9%) patients were men. 282 patients (79%) were treated with only one biological drug: 75 patients with anti-TNF-α, 132 with anti-IL-17 and 75 with anti-IL-23. 65 patients (18.2%) were treated with two biological drugs in sequence (table 1). Conclusion and relevance More than 97% of patients were treated with only one (79%) or two (18.2%) biological drugs for moderate-to-severe plaque psoriasis, with a prevalence of anti-IL-17. Further investigation of the causes for the change from one to another biological drug is needed. These could include adverse events, ineffectiveness or other reasons. References and/or acknowledgements Conflict of interest No conflict of interest","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89181584","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: 0
An investigation into prescribing errors made by independent pharmacist prescribers and medical prescribers at a large acute NHS hospital trust: a cross-sectional study 调查处方错误的独立药剂师处方者和医疗处方者在一个大型急性NHS医院信托:横断面研究
Pub Date : 2020-03-11 DOI: 10.1136/ejhpharm-2019-002074
Emily Turner, M. Kennedy, Abigail Barrowcliffe
Introduction Pharmacists in the UK can register as independent pharmacist prescribers (IPPs) on completion of appropriate higher education training. IPPs have had the same prescribing privileges as medical doctors since 2009. Despite the years since their introduction, there are little data available to demonstrate the frequency and type of errors made by IPPs. Furthermore, there is no literature available comparing IPPs to doctors with regards to prescribing safety. This study aimed to start to fill this gap in the literature. Methods Pharmacists working in one National Health Service (NHS) Trust, in areas with a large proportion of prescribing undertaken by IPPs, were purposefully recruited to collect data over a 1-week period in May 2018. They collected data on all prescription items validated that were prescribed by IPPs and doctors. Errors that were identified were recorded in detail. Data collection forms and error definitions were taken from the EQUIP Study, a large study looking at prescribing errors by junior doctors in the hospital setting. Results 5840 prescriptions items were recorded; 1026 (17.6%) were prescribed by an IPP. 479 errors were recorded in total. Experienced IPPs, had a 1% error rate (seven errors); IPPs with less experience had a 0% error rate. Overall the error rate for pharmacists was 0.7% (95% CI 0.0% to 1.0%). In comparison, doctors made an average of 9.8% errors (95% CI 9.0% to 11.0%). Pharmacists made significantly less prescribing errors than doctors (p<0.01). 85.7% of IPP errors were recorded as minor in significance, compared with an average of 31.7% for all doctor’s prescribing errors. Actual patient harm occurred from 0.04% of all prescriptions. Conclusion In a single NHS Trust, pharmacists make significantly less prescribing errors than doctors. Embedding IPPs with more integrated roles in the multidisciplinary team is recommended. Further large trials are required to validate the results of this study.
在英国,药剂师在完成适当的高等教育培训后可以注册为独立药剂师开处方者(ipp)。自2009年以来,ipp享有与医生相同的开药特权。尽管ipp引入已有多年,但几乎没有数据可以证明ipp所犯错误的频率和类型。此外,在处方安全性方面,没有文献对ipp和医生进行比较。本研究旨在填补这一文献空白。方法2018年5月,有目的地招募一家国家卫生服务信托机构(NHS Trust)的药剂师,收集为期1周的数据,这些地区的药剂师主要是由ipp承担处方。他们收集了所有经过ipp和医生验证的处方项目的数据。详细记录了已识别的错误。数据收集表格和错误定义来自EQUIP研究,这是一项针对医院初级医生处方错误的大型研究。结果共记录处方5840张;1026例(17.6%)由IPP开具处方。总共记录了479个错误。经验丰富的ipp有1%的错误率(7个错误);经验较少的ipp的错误率为0%。药师的总体错误率为0.7% (95% CI 0.0% ~ 1.0%)。相比之下,医生的平均错误率为9.8% (95% CI 9.0%至11.0%)。药师的处方错误率明显低于医生(p<0.01)。85.7%的IPP错误被记录为轻微错误,而所有医生处方错误的平均比例为31.7%。实际对患者造成伤害的处方占所有处方的0.04%。结论在单一的NHS信托中,药剂师的处方错误明显少于医生。建议在多学科团队中嵌入具有更综合作用的ipp。需要进一步的大型试验来验证这项研究的结果。
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引用次数: 6
Medication review versus usual care to improve drug therapies in hospitalised older patients admitted to internal medicine wards 药物回顾与常规护理改善内科病房住院老年患者的药物治疗
Pub Date : 2020-03-09 DOI: 10.1136/ejhpharm-2019-002072
M. Aiezza, A. Bresciani, G. Guglielmi, Marida Massa, Elena Tortori, R. Marfella, Emilio Aliberti, A. Iannuzzi
Objectives Older adults are a vulnerable and growing segment of the population with a high burden of comorbid conditions. As a consequence of increased co-morbidity, drug use in older adults is high, and polypharmacy has been linked to higher risk of adverse drug–drug interactions, morbidity, and mortality. The aim of the study was to evaluate the prevalence and nature of potentially inappropriate medications (PIMs) in a group of hospitalised older patients, and verify whether the use of ‘Beers criteria’ and/or ‘START & STOPP’ criteria could lead to deprescribing of drugs and reduce the length of stay in the hospital. Methods Two hundred acutely ill patients aged ≥65 with multimorbidity admitted to the Division of Internal Medicine were enrolled in the study. Enrolled patients were admitted as medical emergencies and observed during their hospitalisation at the Emergency Department and subsequently at the Division of Internal Medicine. The pharmacological treatments taken by patients at home, during hospitalisation and at discharge, were examined, identifying inappropriate prescriptions (IPs), according to ‘Beers criteria’ and ‘START and STOPP’ criteria. Results There were 487 IPs: 175 according to the Beers criteria; 50 according to the STOPP criteria; one according to the START criteria; 107 major interactions; 152 minor interactions; one off-label drug; and one duplicated pharmacotherapy. Twenty-three adverse drug reactions (ADRs) were recorded: the most frequent were abnormalities of serum electrolytes (35%); haemorrhagic events (22%); and accidental falls from benzodiazepine use (9%). The correct application of these criteria decreased IPs by 38% and reduced the number of drugs prescribed by the physician during the stay in the medical ward and at discharge by 19%. Conclusions The use of criteria that detect IPs reduced PIMs and ADRs, increased safety in older patients, and reduced the number of drugs prescribed but did not reduce the length of stay in hospital.
老年人是人口中一个易受伤害且日益增长的群体,其合并症负担较高。由于合并症的增加,老年人的药物使用率很高,多种用药与药物不良相互作用、发病率和死亡率的风险较高有关。本研究的目的是评估一组住院老年患者中潜在不适当药物(PIMs)的患病率和性质,并验证使用“Beers标准”和/或“START & STOPP”标准是否可以减少药物处方并缩短住院时间。方法选取我院内科收治的200例年龄≥65岁的多病急性患者作为研究对象。登记的病人作为急诊住院,并在急诊科和随后的内科住院期间进行观察。根据“比尔斯标准”和“开始和停止”标准,检查患者在家中、住院期间和出院时采取的药物治疗,确定不适当的处方(ip)。结果共有487例IPs:按Beers标准为175例;50个根据STOPP标准;一个符合START标准;107个主要互动;152次次要互动;一种超说明书药物;还有一个重复的药物治疗。记录了23例药物不良反应(adr):最常见的是血清电解质异常(35%);出血性事件(22%);使用苯二氮卓类药物意外摔倒(9%)。正确应用这些标准可使IPs降低38%,并使医生在住院期间和出院时开出的药物数量减少19%。结论使用检测IPs的标准降低了PIMs和adr,增加了老年患者的安全性,减少了处方药物的数量,但没有减少住院时间。
{"title":"Medication review versus usual care to improve drug therapies in hospitalised older patients admitted to internal medicine wards","authors":"M. Aiezza, A. Bresciani, G. Guglielmi, Marida Massa, Elena Tortori, R. Marfella, Emilio Aliberti, A. Iannuzzi","doi":"10.1136/ejhpharm-2019-002072","DOIUrl":"https://doi.org/10.1136/ejhpharm-2019-002072","url":null,"abstract":"Objectives Older adults are a vulnerable and growing segment of the population with a high burden of comorbid conditions. As a consequence of increased co-morbidity, drug use in older adults is high, and polypharmacy has been linked to higher risk of adverse drug–drug interactions, morbidity, and mortality. The aim of the study was to evaluate the prevalence and nature of potentially inappropriate medications (PIMs) in a group of hospitalised older patients, and verify whether the use of ‘Beers criteria’ and/or ‘START & STOPP’ criteria could lead to deprescribing of drugs and reduce the length of stay in the hospital. Methods Two hundred acutely ill patients aged ≥65 with multimorbidity admitted to the Division of Internal Medicine were enrolled in the study. Enrolled patients were admitted as medical emergencies and observed during their hospitalisation at the Emergency Department and subsequently at the Division of Internal Medicine. The pharmacological treatments taken by patients at home, during hospitalisation and at discharge, were examined, identifying inappropriate prescriptions (IPs), according to ‘Beers criteria’ and ‘START and STOPP’ criteria. Results There were 487 IPs: 175 according to the Beers criteria; 50 according to the STOPP criteria; one according to the START criteria; 107 major interactions; 152 minor interactions; one off-label drug; and one duplicated pharmacotherapy. Twenty-three adverse drug reactions (ADRs) were recorded: the most frequent were abnormalities of serum electrolytes (35%); haemorrhagic events (22%); and accidental falls from benzodiazepine use (9%). The correct application of these criteria decreased IPs by 38% and reduced the number of drugs prescribed by the physician during the stay in the medical ward and at discharge by 19%. Conclusions The use of criteria that detect IPs reduced PIMs and ADRs, increased safety in older patients, and reduced the number of drugs prescribed but did not reduce the length of stay in hospital.","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"75 1","pages":"160 - 164"},"PeriodicalIF":0.0,"publicationDate":"2020-03-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86175630","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: 3
Therapeutic drug monitoring of voriconazole: validation of a high performance liquid chromatography method and comparison with an ARK immunoassay 伏立康唑的治疗药物监测:高效液相色谱法的验证及与ARK免疫分析法的比较
Pub Date : 2020-03-09 DOI: 10.1136/ejhpharm-2019-002155
S. Blanco-Dorado, M. D. Bellés Medall, Ó. Pascual-Marmaneu, M. Campos‐Toimil, F. Otero-Espinar, Rafael Rodríguez-Riego, T. Rodríguez-Jato, I. Zarra-Ferro, M. Lamas, A. Fernández-Ferreiro
Objective Voriconazole is an antifungal agent used in the treatment of aspergillosis and fluconazole-resistant Candida infections. Therapeutic drug monitoring (TDM) of voriconazole is recommended to optimise clinical results. The aim of this study was the development and validation of a high performance liquid chromatography (HPLC) method for measuring voriconazole in human serum, and comparison with an ARK immunoassay method. Methods Linearity, precision, accuracy and stability of the HPLC method were validated according to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. The method was applied to the analysis of 58 trough serum samples from patients treated with voriconazole, and the HPLC-UV (ultraviolet) method was compared with an ARK immunoassay. The correlation of both methods was studied by the Pearson regression coefficient and the concordance of the values was evaluated by the Bland-Altman and Passing-Bablok methods. Results All validation parameters met the criteria set out in the FDA and EMA guidelines. The standard curve was linear over a concentration range of 0.25–16 µg/mL with a limit of quantification of 0.125 µg/mL. No interactions between voriconazole and other drugs was observed and voriconazole was stable after 1 month at −80°C. Comparison of the HPLC method and the enzyme immunoassay method showed a linear correlation with a systematic error of −0.61 µg/mL between both methods. Conclusion The method developed is simple and fast and can be easily applied for routine therapeutic drug monitoring of voriconazole. The HPLC-UV method was more sensitive than the immunoassay method and there was concordance with the immunoassay. Consequently both methods could be used, considering the correlation between them.
目的伏立康唑是一种治疗曲霉病和耐氟康唑念珠菌感染的抗真菌药物。建议伏立康唑的治疗药物监测(TDM)以优化临床结果。本研究的目的是建立和验证一种高效液相色谱(HPLC)测定人血清中伏立康唑的方法,并与ARK免疫分析法进行比较。方法按照美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA)的指导方针,对HPLC法的线性度、精密度、准确度和稳定性进行验证。将该方法应用于伏立康唑治疗的58例谷血清样本的分析,并与ARK免疫分析法进行比较。采用Pearson回归系数研究两种方法的相关性,并采用Bland-Altman和Passing-Bablok方法评价两种方法的一致性。结果所有验证参数均符合FDA和EMA指南中规定的标准。标准曲线在0.25 ~ 16µg/mL范围内呈线性,定量限为0.125µg/mL。伏立康唑与其他药物无相互作用,伏立康唑在−80℃下放置1个月后保持稳定。HPLC法与酶免疫法比较,两种方法的系统误差均为- 0.61µg/mL,线性相关。结论该方法简便、快速,可用于伏立康唑的常规治疗药物监测。HPLC-UV法灵敏度高于免疫分析法,且与免疫分析法结果一致。因此,考虑到它们之间的相关性,这两种方法都可以使用。
{"title":"Therapeutic drug monitoring of voriconazole: validation of a high performance liquid chromatography method and comparison with an ARK immunoassay","authors":"S. Blanco-Dorado, M. D. Bellés Medall, Ó. Pascual-Marmaneu, M. Campos‐Toimil, F. Otero-Espinar, Rafael Rodríguez-Riego, T. Rodríguez-Jato, I. Zarra-Ferro, M. Lamas, A. Fernández-Ferreiro","doi":"10.1136/ejhpharm-2019-002155","DOIUrl":"https://doi.org/10.1136/ejhpharm-2019-002155","url":null,"abstract":"Objective Voriconazole is an antifungal agent used in the treatment of aspergillosis and fluconazole-resistant Candida infections. Therapeutic drug monitoring (TDM) of voriconazole is recommended to optimise clinical results. The aim of this study was the development and validation of a high performance liquid chromatography (HPLC) method for measuring voriconazole in human serum, and comparison with an ARK immunoassay method. Methods Linearity, precision, accuracy and stability of the HPLC method were validated according to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. The method was applied to the analysis of 58 trough serum samples from patients treated with voriconazole, and the HPLC-UV (ultraviolet) method was compared with an ARK immunoassay. The correlation of both methods was studied by the Pearson regression coefficient and the concordance of the values was evaluated by the Bland-Altman and Passing-Bablok methods. Results All validation parameters met the criteria set out in the FDA and EMA guidelines. The standard curve was linear over a concentration range of 0.25–16 µg/mL with a limit of quantification of 0.125 µg/mL. No interactions between voriconazole and other drugs was observed and voriconazole was stable after 1 month at −80°C. Comparison of the HPLC method and the enzyme immunoassay method showed a linear correlation with a systematic error of −0.61 µg/mL between both methods. Conclusion The method developed is simple and fast and can be easily applied for routine therapeutic drug monitoring of voriconazole. The HPLC-UV method was more sensitive than the immunoassay method and there was concordance with the immunoassay. Consequently both methods could be used, considering the correlation between them.","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"34 1","pages":"154 - 159"},"PeriodicalIF":0.0,"publicationDate":"2020-03-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90362383","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: 6
4CPS-068 Effectiveness of dolutegravir and lamivudine therapy in a two drug regimen in a third level hospital 多替格拉韦和拉米夫定两种药物治疗方案在某三级医院的疗效观察
Pub Date : 2020-03-01 DOI: 10.1136/ejhpharm-2020-eahpconf.169
C. Fernández Zamora, T. Rodríguez Martínez, MA Meroño Saura, S. Clavijos Bautista, J. Plaza Aniorte, P. Pacheco López, MÁ Carvajal Sánchez, J. Ibáñez Caturla, MD Nájera Pérez
Background and importance Simplification of antiretroviral treatments (ART) improves adherence and comfort, and may prevent some adverse effects caused by ART. Aim and objectives To assess the effectiveness (plasma viral load (PVL test) <50 copies/mL) of the combination of dolutegravir (DTG) and lamivudine (3TC) without a third antiretroviral drug in patients diagnosed with HIV infection who were previously treated with a three drug regimen of ART. Material and methods In January 2019, we studied a cohort of patients who were undergoing treatment with DTG+3TC in a two drug regimen. Once these patients were selected, we carried out a prospective study of the PVL test after 6 months of treatment. Results Thirty-three patients were receiving treatment with the DTG+3TC combination in January 2019. Patients were aged 24–72 years (mean 46.27 years). The previous PVL test was undetectable in 69.70% of patients, detectable (<50 copies/mL) in 27.27% of patients and 1 patient (3.03%) had a viral load of >50 copies/mL. After 6 months of treatment, the PVL test was undetectable in 75.75% of patients, detectable (<50 copies/mL) in 15.15% and detectable (>50 copies/mL) in 3.03%. Two patients discontinued treatment. Conclusion and relevance The combination of DTG+3TC seemed to be an effective alternative to other ART when we re-evaluated patients after 6 months of treatment. We found a PVL <50 copies/mL in 96.96% and 90.90% of patients before and after the change in ART. References and/or acknowledgements 1. Cahn P, Madero JS, Arribas JR, et al. GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet 2019;393:143–155. No conflict of interest.
背景和重要性简化抗逆转录病毒治疗可提高依从性和舒适度,并可预防抗逆转录病毒治疗引起的一些不良反应。目的与目的评价血浆病毒载量(PVL)检测50拷贝/mL的有效性。治疗6个月后,75.75%的患者PVL检测不出,3.03%的患者可检测出(50拷贝/mL)。两名患者停止治疗。结论与意义在治疗6个月后对患者进行再评估时,DTG+3TC联合治疗似乎是其他ART的有效替代方案。我们发现在ART改变前后分别有96.96%和90.90%的患者PVL <50拷贝/mL。参考文献和/或致谢Cahn P, Madero JS, Arribas JR等。双子座研究小组。多替格拉韦联合拉米夫定与多替格拉韦联合富马酸替诺福韦二氧吡酯和恩曲他滨治疗HIV-1感染的未接受抗逆转录病毒治疗的成人(GEMINI-1和GEMINI-2):两项多中心、双盲、随机、非劣效性3期试验的48周结果。《柳叶刀》2019年;393:143 - 155。没有利益冲突。
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引用次数: 0
3PC-039 Optimisation of mixing an oral powder mixture of codeine prepared in the hospital pharmacy for filling into hard capsules 医院药房制备的可待因口服粉状混合物用于硬胶囊填充的混合优化
Pub Date : 2020-03-01 DOI: 10.1136/ejhpharm-2020-eahpconf.86
J. Valor, Jl Revuelta, MS Pernía López, A. H. Alonso, M. S. Sáez, Gregorio Marañón
Background and importance Codeine mixed with calcium salts filled into capsules is used to treat chronic diarrhoea in transplant, oncological and geriatric patients, and in patients with irritable bowel disease. At least 11 500 hard capsules are regularly prepared from a manually blended powder mixture in the hospital pharmacy per month. Turbula 2F2 blender has been introduced into the hospital pharmacy to optimise the mixing process. Aim and objectives To establish optimal blending time and speed for mixing of codeine with the Turbula 2F2 blender and to verify homogeneity by determining the amount of codeine in the samples, a validated spectrophotometric analytical method was used. Material and methods The total amount of prepared mixture was 245.7 g containing 4.5 g of codeine phosphate (1.83%). The optimal rotation speed of Turbula was established as 49 rounds per min (RPM) based on visual analysis with colourant instead of codeine. A 2 litre polyethylene container for homogenisation was used. Calcium carbonate was premixed with colloidal silica, and codeine and tricalcium phosphate added. Five samples for analysis were taken from different places in the container after 5, 10, 15 and 20 min of mixing. Expression of relative standard deviation (RSD) was used to evaluate the homogeneity of codeine in the mixture. Results The results are summarised in table 1.Abstract 3PC-039 Table 1 Time of mixing at 49 RPM Sample No Content of codeine (%) RSD 5 min 1 1.84 2.47 2 1.79 3 1.77 4 1.79 5 1.89 10 min 6 1.75 1.91 7 1.72 8 1.74 9 1.72 10 1.81 15 min 11 1.59 3.82 12 1.73 13 1.76 14 1.62 15 1.64 20 min 16 1.58 5.47 17 1.69 18 1.74 19 1.49 20 1.67 Conclusion and relevance Based on the results, the optimal time of 10 min was estimated for mixing of the codeine mixture at 49 RPM. The use of the Turbula 2F2 mixer was beneficial in reducing pharmacy staff exposure to powder particles of hazardous drugs and in reducing the risk of cross contamination in the laboratory. References and/or acknowledgements No conflict of interest.
背景和重要性可待因与钙盐混合填充胶囊用于治疗移植、肿瘤和老年患者以及肠易激病患者的慢性腹泻。每月在医院药房定期用手工混合的粉末混合物制备至少11 500粒硬胶囊。湍流2F2搅拌器已被引入医院药房,以优化混合过程。目的建立湍流2F2混合器混合可待因的最佳混合时间和混合速度,并通过测定样品中可待因的含量来验证样品的均匀性。材料与方法制备的混合物总量为245.7 g,含磷酸可待因4.5 g(1.83%)。用着色剂代替可待因进行视觉分析,确定了湍流的最佳转速为49转/分(RPM)。使用2升聚乙烯容器进行均质。将碳酸钙与胶体二氧化硅预混,加入可待因和磷酸三钙。在混合5、10、15和20分钟后,从容器的不同位置取5个样品进行分析。采用相对标准偏差(RSD)表达法评价混合物中可待因的均匀性。结果结果汇总见表1。文摘3表1 pc - 039混合时间49 RPM样本没有可待因含量(%)为5分钟1 1.79 1.77 1.84 1.79 2.47 - 2 3 4 5 1.89 10分钟6 1.81 1.72 1.75 1.74 1.91 1.72 7 8 9 10 15分钟11 1.64 1.59 1.62 1.76 3.82 1.73 12 13 14 15 20分钟16 1.67 1.58 1.49 1.74 5.47 1.69 17 18 19 20和基于结果的相关性结论,10分钟的最佳时间估计在49 RPM可待因混合的混合物。紊流2F2混合器的使用有利于减少药房工作人员接触危险药物的粉末颗粒和减少实验室交叉污染的风险。参考文献和/或致谢无利益冲突。
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引用次数: 0
NP-001 Impact of an oral nutrition protocol in patients treated with elective radical cystectomy: a long term follow-up 口服营养方案对选择性根治性膀胱切除术患者的影响:长期随访
Pub Date : 2020-03-01 DOI: 10.1136/ejhpharm-2020-eahpconf.459
P. Declercq, F. V. D. Aa, L. Pourcq, Isabel Spriet
Background and importance Before we implemented an oral nutrition protocol, parenteral nutrition (PN) was standard of care after elective radical cystectomy (RC) patients in our hospital. PN is expensive, with often metabolic and infectious complications. Aim and objectives The main objective of this study was to explore the impact of the introduction of an oral nutrition protocol on catheter-related bloodstream infection (CRBSI) incidence. Besides, length of stay and parenteral nutrition (PN) associated costs were compared. Materials and methods In this large retrospective case-control study, before (PN group) and after the implementation of the oral nutrition protocol (since March 2010), two cohorts of 549 patients who underwent an elective RC were included. A central venous catheter was present in every patient, which is standard of care. The incidence of a CRBSI, the length of stay and PN associated costs were compared. Results In both the control (June 2000–March 2010) and the case (March 2010–December 2017) group, an equal number of 549 patients were included. CRBSI was reduced from 22 (4%) to 10 (1.8%) (p=0.031). The median length of stay between both groups, 20 [17 – 25] days before vs. 17 [14 – 21] days after the implementation of the oral nutrition protocol, also differed significantly (p<0.001). Implementing the oral nutrition protocol resulted in a parenteral nutrition associated cost saving of €470 per patient. Conclusion and relevance This large follow-up study showed that an oral nutrition protocol is associated with a reduction in CRBSI. Besides, postponing PN in favour of oral nutrition enhances recovery and is associated with cost savings. In conclusion, we believe that the clinically relevant results of our study are confirming that oral nutrition should be standard of care in elective regular RC patients.
背景和重要性在我们实施口服营养方案之前,肠外营养(PN)是我院选择性根治性膀胱切除术(RC)患者术后的标准护理。PN费用昂贵,常伴有代谢和感染并发症。目的和目的本研究的主要目的是探讨引入口服营养方案对导管相关血流感染(CRBSI)发生率的影响。此外,比较住院时间和肠外营养(PN)相关费用。材料和方法在这项大型回顾性病例对照研究中,在实施口服营养方案之前(PN组)和之后(自2010年3月起),纳入了两组549例选择性口服营养方案患者。每个病人都有中心静脉导管,这是标准的护理。比较CRBSI的发生率、住院时间和PN相关费用。结果对照组(2000年6月- 2010年3月)和病例组(2010年3月- 2017年12月)共纳入549例患者。CRBSI从22(4%)降至10 (1.8%)(p=0.031)。两组患者的中位住院时间(实施口服营养方案前20[17 - 25]天,实施口服营养方案后17[14 - 21]天)也有显著差异(p<0.001)。实施口服营养方案导致每位患者节省了470欧元的肠外营养相关费用。结论和相关性这项大型随访研究表明,口服营养方案与CRBSI的降低有关。此外,推迟PN而选择口服营养可促进康复,并可节约成本。总之,我们相信我们研究的临床相关结果证实口服营养应该成为选择性常规RC患者的标准护理。
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引用次数: 0
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European Journal of Hospital Pharmacy
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