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Pharmacovigilance Practices: Knowledge and Attitudes among theHealthcare Professionals at the Volta Regional Hospital of Ghana 药物警戒实践:加纳Volta地区医院卫生保健专业人员的知识和态度
Pub Date : 2017-06-27 DOI: 10.4172/2329-6887.1000229
Sedem Nunyuia Amedom, Dadson Ba
Pharmacovigilance since its inception has been the global medicine safety monitoring tool by all World Health Organization member states. Ghana joined the program as the 65th member in 2001. Pharmacovigilance has mainly relied on spontaneous reports of adverse drug reactions from healthcare professionals. However, under reporting has been reported to be a major challenge. The success of the PV system in Ghana depends greatly on the understanding, active involvement and practices among the country’s healthcare professionals The study evaluated the pharmacovigilance practices among the healthcare professionals at the Volta Regional Hospital, Ho, by assessing their knowledge, attitudes and practices towards the program. A descriptive cross-sectional design was used and a 27-item pre-tested self-administered questionnaire as the research instrument. Convenient and judgmental sampling techniques were used to select an estimated sample of 145 representing, 68.1% of the targeted population. Data was processed and analyzed by the use of Statistical Package for Social Sciences (SPSS) version 20. Using descriptive statistics, frequencies were used to attain the individual and average percentages of responses. High level of awareness (doctors 88%, pharmacists 92.2% and nurses 78%) and positive attitude (doctors 72.4%, pharmacists 83.8% and nurses 68.2) among the respondents on pharmacovigilance was observed. The level of practice was observed to be relatively lower, especially among the doctors and the nurses. As low as 16.7% and 24% of the doctors and the nurses has ever reported ADRs by the use of the Blue form. Continual training on the essence and the use of the reporting forms with increased availability and accessibility of the reporting forms at all departments/units of the hospital coupled with regular public education on ADR reporting are recommended interventions.
药物警戒自成立以来一直是世界卫生组织所有成员国的全球药物安全监测工具。加纳于2001年加入该计划,成为第65个成员国。药物警戒主要依赖于卫生保健专业人员自发报告的药物不良反应。但是,报告不足是一项重大挑战。PV系统在加纳的成功很大程度上取决于该国医疗保健专业人员的理解、积极参与和实践。该研究通过评估他们对该计划的知识、态度和实践,评估了Ho Volta地区医院医疗保健专业人员的药物警戒实践。采用描述性横断面设计,采用27项预测自填问卷作为研究工具。使用方便和判断的抽样技术选择了145个估计样本,占目标人口的68.1%。数据的处理和分析使用社会科学统计软件包(SPSS)第20版。使用描述性统计,频率用于获得个人和平均百分比的回应。调查对象对药物警戒的知晓率(医生88%、药师92.2%、护士78%)较高,态度积极(医生72.4%、药师83.8%、护士68.2)。实践水平相对较低,尤其是在医生和护士中。曾使用蓝色表格报告不良反应的医生和护士分别为16.7%和24%。建议的干预措施是继续对报告表的本质和使用进行培训,增加报告表在医院所有部门/单位的可用性和可及性,同时定期对公众进行关于不良反应报告的教育。
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引用次数: 9
Analyzation and Understanding of Final Rule on Post-marketing Safety Reporting of Combination Products 《组合产品上市后安全报告最终规定》的分析与理解
Pub Date : 2017-06-27 DOI: 10.4172/2329-6887.1000230
A. Gill, Talla Vk
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引用次数: 0
Pharmaceutical Care Services: Indian Scenario 医药保健服务:印度方案
Pub Date : 2017-05-31 DOI: 10.4172/2329-6887.1000E169
J. Patil
The qualified pharmacist in coordination with other health care team works to prevent disease and to assess, monitor, initiate and modify use of medication in order to ensure safe and effective drug therapy regimens. This system is recognized as a patient focused, outcome based pharmaceutical care or pharmacy practice. This system is mainly aimed to optimize the patient health and to achieve positive clinical outcomes through the active involvement of clinical pharmacists in health care organizations. The active involvement of clinical pharmacists in India in this regard is not up to the expected mark in contrary to trends in developed countries. In present day health care trend usage of multiple drugs in drug therapy is common practice and raised the complexity of drug interactions and similar problems. To address such situations and solve the probable problems, existence of pharmaceutical care system in Indian health care organizations is of urgent need.
合格的药剂师与其他保健小组协调工作,预防疾病,评估、监测、启动和修改药物的使用,以确保药物治疗方案的安全和有效。该系统被认为是以病人为中心,以结果为基础的药学服务或药学实践。该系统的主要目的是通过临床药师在卫生保健机构中的积极参与,优化患者的健康状况,取得积极的临床效果。印度临床药师在这方面的积极参与与发达国家的趋势相反,没有达到预期的水平。在当今的医疗保健趋势中,药物治疗中使用多种药物是一种普遍的做法,这增加了药物相互作用的复杂性和类似问题。为了解决这种情况和可能出现的问题,印度卫生保健机构迫切需要药品保健制度的存在。
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引用次数: 0
A Five Years Surveillance on Use of Antimicrobial Therapies in Biella'sGeneral Hospital (Italy): Effective Management to Reduce AntibioticResistance and Improve Outcome 意大利比耶拉总医院抗菌药物使用的五年监测:有效管理以减少抗生素耐药性并改善预后
Pub Date : 2017-04-17 DOI: 10.4172/2329-6887.1000227
S. Ussai, F. D’Aloia, L. Laura, C. Frassati, S. Scarpetta, A. Penña, G. Bonelli
Ussai S1,2*, D’Aloia F4, Lanzone L3, Frassati C4, Scarpetta S2, Penna A2 and Bonelli G2 1Bocconi School of Management, Bocconi University, 20100 Milano, Italy 2Office of the Director General, Biella General Hospital, 13875 Ponderano BI, Italy 3Division of Pharmacy, Biella General Hospital, 13875 Ponderano BI, Italy 4Infection Control Committee, Biella General Hospital, 13875 Ponderano BI, Italy *Corresponding author: Silvia Ussai, Bocconi School of Management, Bocconi University, 20100 Milano, Italy, Tel: +393451700980; E-mail: ussai.silvia@gmail.com
Ussai S1,2*, D 'Aloia F4, Lanzone L3, Frassati C4, Scarpetta S2, Penna A2和Bonelli G2 1博科尼大学博科尼管理学院,201000意大利米兰2意大利比埃拉总医院总干事办公室,13875意大利比埃拉总医院药学部,13875意大利比埃拉总医院感染控制委员会,13875意大利比埃拉总医院*通讯作者:Silvia Ussai,博科尼大学博科尼管理学院,意大利米兰20100,电话:+393451700980;电子邮件:ussai.silvia@gmail.com
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引用次数: 0
A Case Report of ECT and Muscle Spasms 电痉挛治疗肌肉痉挛1例报告
Pub Date : 2017-03-31 DOI: 10.4172/2329-6887.1000226
A. Turner, M. Gunther, M. Husain, Lawrence R. Faziola
Major depressive disorder, a psychiatric condition whereby individuals experience at least one major depressive episode, is a significant health concern in the United States, with the World Health Organization estimating an affected 16 million adults in 2012. Many individuals who seek professional help are successfully treated with pharmacology and/or psychotherapy. For the subset of patients who experience refractory depression, alternative pharmacological treatments are often tried. After a trial of antidepressant medication (lasting at least four weeks and after dose escalation if appropriate) recommendations include atypical antipsychotics, anticonvulsants, and lithium augmentation [1]. Lithium has long been known to be efficacious for the treatment of bipolar disorder, and studies have confirmed its role in unipolar depression, as well as highlighted its anti-suicidal properties [2]. If thorough pharmacological treatment remains ineffective in these patients, Electroconvulsive Therapy (ECT) may be recommended [2]. By nature of this stepwise treatment protocol, a significant number of individuals who require ECT are being prescribed other medications, including lithium. The literature regarding the use of lithium in conjunction with ECT has mixed results, and no clear consensus has been reached [3-5]. This report aims to briefly review the literature regarding lithium use during ECT treatment, as well as present a case of muscle spasms occurring in a patient after receiving short-term lithium treatment with other medications, and co-administered ECT.
重度抑郁症是一种精神疾病,个体至少经历一次重度抑郁症发作,是美国的一个重大健康问题,世界卫生组织估计2012年有1600万成年人受其影响。许多寻求专业帮助的人都成功地接受了药理学和/或心理治疗。对于经历难治性抑郁症的患者,通常会尝试替代药物治疗。在抗抑郁药物试验后(持续至少4周,并在适当的情况下增加剂量),建议包括非典型抗精神病药、抗惊厥药和锂离子增强剂。长期以来,锂一直被认为是治疗双相情感障碍的有效药物,研究证实了它在单极抑郁症中的作用,并强调了它的抗自杀特性。如果彻底的药物治疗对这些患者仍然无效,则可能建议使用电休克疗法(ECT)。根据这种渐进式治疗方案的本质,大量需要ECT治疗的患者正在接受其他药物治疗,包括锂盐。关于锂与ECT联合使用的文献结果好坏参半,尚未达成明确的共识[3-5]。本报告旨在简要回顾有关电痉挛治疗中使用锂的文献,并提出一例患者在接受短期锂治疗与其他药物联合使用电痉挛治疗后发生肌肉痉挛的病例。
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引用次数: 0
Sterility Assurance of Parenteral Products Major Deficiency for Recall 非注射产品的无菌保证主要缺陷召回
Pub Date : 2017-03-24 DOI: 10.4172/2329-6887.1000E168
L. Kolluru
Lack of sterility assurance is a leading contributor to safety alerts and product recalls by Food and Drug Administration (FDA). Table 1 summarizes the safety alerts to parenteral products and drug manufacturers in 2016 [1]. Lack of sterility assurance can be product specific (probably caused by container closure integrity leakage) or manufacturing site specific (caused by poor facility and engineering or improper manufacturing practices) affecting all the drug products manufactured in the affected site. Such instances lead to major deficiencies during FDA facility inspections sometimes even leading to ceasing of all manufacturing operations until rectified [1-5].
缺乏无菌保证是食品和药物管理局(FDA)安全警报和产品召回的主要原因。表1总结了2016年对非注射类产品和药品制造商的安全警告。无菌保证的缺乏可能是特定于产品的(可能是由于容器封闭完整性泄漏造成的)或特定于生产地点的(由不良的设施和工程或不适当的生产规范造成的),会影响在受影响地点生产的所有药品。此类情况导致FDA设施检查期间出现重大缺陷,有时甚至导致停止所有生产操作,直至纠正[1-5]。
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引用次数: 3
Oral Drug Delivery via Chronotherapy Approach: Need of the Day 通过时间疗法口服给药:当今的需要
Pub Date : 2017-03-16 DOI: 10.4172/2329-6887.1000E167
J. Patil
The drug delivery approach aimed to encounter the therapeutic requirements pertaining to particular pathological situations will be a newer research in formulation development area. Chronotherapy is a kind of treatment based on biological stimuli in drug therapy, and this has fetched a novel approach to the design of oral drug delivery systems. Several approaches are being exploited in the development of activated, pulsatile, controlled and programmed drug delivery strategies has exaggerated in recent years. Chronotherapeutics is the area related with drug delivery according to the intrinsic activities of a disease over a certain period of time. Chronotherapy deals with the treatment based on the human daily working cycle that corresponds to biological clock which the intention to enhance the therapeutic benefits and reduce the adverse effects. Chronotherapy mainly works by matching the timing of treatment with the intrinsic timing of illness. This method also refers to a kind of treatment approach in which in vivo drug availability is timed to match rhythms of disease, in order to improve therapeutic outcomes and reduce side effects. Optimal therapy can be achieved when the precise amount of drug is delivered to the correct target organ at the most suitable time. The drug release pattern will be varied based on the circadian rhythms and symptoms of a disease varied. The term chronothrapeutics is mainly novel in the field of drug delivery and in the treatment method. It is defined as an extensive term in which disease follow the circadian rhythm which undergoes the metabolic variations. Chronotehrapeutic strategies currently available control drug delivery by controlling the lag time independent environmental factors such as pH, gastric motility, and biological enzymes. These systems are available both multiple and single units. This delivery approach is considered as a future of oral drug delivery because these are self-programmed and designed to release a specific drug at a specified rate at a particular time. These drug delivery devices are able to maintain required plasma concentrations when placed in the oral cavity and enhance the patient compliances by circumventing frequency of drug administration.
以满足特殊病理条件下的治疗要求为目标的给药方法将是制剂开发领域的一个较新的研究方向。时间疗法是一种基于生物刺激的药物治疗方法,它为口服给药系统的设计提供了一条新的途径。近年来,在开发激活的、脉动的、受控的和程序化的给药策略方面,正在利用几种方法。时间疗法是根据疾病在一定时间内的内在活动来给药的领域。时间疗法是一种基于人体生物钟的日常工作周期的治疗方法,旨在提高治疗效果,减少不良反应。时间疗法主要通过使治疗时间与疾病的内在时间相匹配而起作用。这种方法也指一种治疗方法,其中体内药物的可用性是定时的,以配合疾病的节奏,以改善治疗效果和减少副作用。当在最合适的时间将准确量的药物输送到正确的靶器官时,才能实现最佳治疗。药物释放模式将根据昼夜节律和疾病症状的变化而变化。时间疗法这一术语主要是在药物传递和治疗方法方面的新概念。它被定义为一个广泛的术语,其中疾病遵循经历代谢变化的昼夜节律。目前可用的时间治疗策略通过控制滞后时间无关的环境因素如pH、胃动力和生物酶来控制药物的递送。这些系统可用于多个和单个单元。这种给药方法被认为是口服药物给药的未来,因为它们是自我编程的,设计用于在特定时间以特定速率释放特定药物。这些给药装置放置在口腔内时能够维持所需的血浆浓度,并通过规避给药频率提高患者的依从性。
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引用次数: 0
Oxidative Stress Levels in Buccal Cells Using MAWI Collection Tubes 利用MAWI收集管研究口腔细胞氧化应激水平
Pub Date : 2017-02-28 DOI: 10.4172/2329-6887.1000225
y-Belle Tabbouny, E. Chamoun, N. Pavliuchenko, Marcel Bassil
Background: Oxidative Stress (OS) is defined as an imbalance between oxidants and antioxidants, in favor of oxidants, potentially leading to DNA damage. Benzo[a] pyrene (B(a)P), a representative DNA-damaging mutagenic/ carcinogenic Polycyclic Aromatic Hydrocarbons (PAH), can lead to the final mutagen Benzo(a)Pyrene Diol Epoxide (BPDE). Methods: The extent of oxidative DNA damage is investigated in population studies using easily obtained cells. Buccal cell usage has been shown by many to be a cost effective, non-invasive and safe method to isolate DNA for various biological experiments. In this experimental research of 40 participants, equally divided between industry and academia, we compared the DNA concentration, purity, and associated levels of BPDE-DNA damage. Buccal cells were collected using ISWAB-DNA tubes, and DNA was then extracted to study the extent of DNA damage via ELISA Kit. Results: Results showed pure samples with no DNA degradation. DNA yields were as high as 35.657 μg/mL. In addition, none of the samples showed a presence of BPDE-DNA damage. Conclusions: MAWI collection tubes may not be able to detect BPDE-DNA damage. Other OS markers should be used to eradicate the previous statement.
背景:氧化应激(OS)被定义为氧化剂和抗氧化剂之间的不平衡,有利于氧化剂,可能导致DNA损伤。苯并[a]芘(B(a)P)是一种具有代表性的dna损伤致突变性/致癌性多环芳烃(PAH),可导致最终的诱变剂苯并(a)芘二醇环氧化物(BPDE)。方法:利用易获得的细胞在群体研究中研究DNA氧化损伤的程度。口腔细胞的使用已经被许多人证明是一种经济有效、无创和安全的方法来分离DNA用于各种生物实验。在这项40名参与者的实验研究中,我们比较了DNA浓度、纯度和BPDE-DNA损伤的相关水平。采用ISWAB-DNA管采集颊细胞,提取DNA,通过ELISA Kit研究DNA损伤程度。结果:纯样品无DNA降解。DNA得率高达35.657 μg/mL。此外,没有样本显示存在BPDE-DNA损伤。结论:MAWI收集管可能无法检测BPDE-DNA损伤。应该使用其他操作系统标记来消除前面的语句。
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引用次数: 2
Need of Pharmacovigilance in AYUSH Drugs AYUSH药物警戒的必要性
Pub Date : 2017-01-20 DOI: 10.4172/2329-6887.1000E166
Rajan, D. Chamundeeswari
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引用次数: 6
Regulation of Oncogene Expression via Targeting i-Motif in Nucleic Acids 靶向i-Motif调控核酸中癌基因的表达
Pub Date : 2017-01-05 DOI: 10.4172/2329-6887.1000E165
Prashansa Agrawal
The basic molecules required for sustaining life on earth include carbohydrates, lipids, proteins, and nucleic acids (DNA and RNA). DNA is considered to be the building block of life and can adopt various types of secondary structures. Gehring et al. revealed for the first time that DNA sequences having long cytosine stretch can form unconventional secondary structures called i-Motifs [1]. These i-Motifs are very dynamic intercalated, quadruple-helical structures and known to exist under acidic conditions. These cytosine stretches are not erratically located throughout the genome but enriched in the promoter regions of several oncogenes within the genome and in telomeres, the terminal regions of chromosomes. The formation and stabilization of i-motif may play a crucial role in gene expression [2-4], such as, the stabilization of the human telomeric i-motif by carboxylated single-walled carbon nanotubes inhibit telomerase that leads to telomere uncapping, DNA damage response and apoptosis [5].
维持地球生命所需的基本分子包括碳水化合物、脂质、蛋白质和核酸(DNA和RNA)。DNA被认为是生命的基石,可以采用各种类型的二级结构。Gehring等人首次揭示具有较长胞嘧啶延伸的DNA序列可以形成称为i-Motifs的非常规二级结构[1]。这些i- motif是非常动态的插层四螺旋结构,已知存在于酸性条件下。这些胞嘧啶延伸并不是不规则地分布在整个基因组中,而是在基因组内的几个癌基因的启动子区域和染色体的末端区域端粒中富集。i-motif的形成和稳定可能在基因表达中起着至关重要的作用[2-4],例如,羧化单壁碳纳米管对人类端粒i-motif的稳定可以抑制端粒酶,从而导致端粒脱帽、DNA损伤反应和细胞凋亡[5]。
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引用次数: 0
期刊
Journal of Pharmacovigilance
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