Heterogeneity in the evaluation of observational studies by Italian ethics committees

Objective and method In Italy, observational research is rarely brought to the attention of ethics committees (ECs). This study assessed to what extent the observational studies conducted within the Careggi Hospital (2000 beds) and retrieved from MEDLINE after their publication could be traced back from the registries of our EC. Another aim was to compare the different opinions expressed by 28 ECs throughout Italy about the same multi-centre clinical protocol (an oncologic observational study).Results Our analysis shows that, in this sample of observational studies, the rate of submission to the EC is 0%. In the second part of our study, the evaluations of the same protocol by the different ECs were extremely different and ranged from unconditioned approval to rejection.Conclusion Our proposal is that clinicians should always notify their observational studies to ECs. On the other hand, ECs should simply accept the observational protocols (without introducing any modifications except cases of macroscopic errors). The heterogeneity in the evaluation of a single protocol by different ECs raises the need to develop some forms of intervention to solve this source of inconsistency.     

British and Canadian views on the ethics of paediatric clinical trials

Background Ethical problems are quoted as a reason not to perform clinical trials in children. Little is known about the views of researchers regarding ethics. Objectives A pilot study was conducted to assess the applicability of a questionnaire design containing trial scenarios to examine views regarding the use of children in drug trials and to elicit possible international differences. Setting Paediatricians and researchers in the United Kingdom and Canada. Methods Responders were presented with a questionnaire containing direct questions and six trial scenarios, each containing an ethical dilemma. Responders were asked regarding their own approval and their perceived opinion of whether an ethical review board (ERB) would approve. Results One hundred questionnaires (50 each country) were received. Few responders had research ethics training (14% United Kingdom and 8% Canada). Most (80 and 88%) felt children could be harmed by participation in trials and half (47 and 59%) felt children should only participate if they receive direct benefit. Many (58 and 61%) disagreed with payments beyond travel expenses. In the trial scenarios, 34% of responders were willing to enter healthy children in a pharmacokinetics study of an antibiotic for cystic fibrosis and 22% considered their ERBs would approve. Only a third (33%) would enter children in an analgesia trial that was placebo-controlled. Conclusion Using healthy children and placebos in trials caused concern. Similar views were found between the two countries. The majority had no training in research ethics. The study highlights the usefulness of a questionnaire with clinical trial scenarios to try to elicit views on the ethics of conducting research in children.     

提高结核病病人用药依从性临床药学工作模式探索

目的 探索提高结核病患者用药依从性的临床药学工作模式,提高药物治疗效果,减少耐药.方法 结合问卷调查与文献分析明确结核科医护人员对临床药学服务的需求,制定基于结核科需求的临床药学工作模式.结果 明确结核科对临床药学服务的需求集中在提高患者用药依从性,建立提高结核科患者用药依从性临床药学服务模式.结论 临床药师通过提高结...     

Drug use as a ‘practice of the self’: is there any place for an ‘ethics of moderation’ in contemporary drug policy?

This paper offers a series of critical interrogations of the principles and practice of harm minimisation. This critique draws from Michel Foucault's account of ethics, pleasure and moderation in pointing to some significant gaps and conceptual problems within Australia's National Drug Strategy. I argue that this strategy has had only indirect impacts upon the ways in which illicit drugs are consumed in Australia, and on the behaviour of individual users. Part of this problem lies in the ways in which the cultures and the contexts of illicit drug use have been conceptualised within contemporary drug policy. Following Foucault, I argue that drug use ought to be conceptualised as a distinctive ‘practice of the self’. I argue further that Foucault's work on pleasure and ethics offers important new ways of understanding the changing nature of drug use for young people, as well as providing new conceptual bases for the design and delivery of harm minimisation strategies within those settings and contexts in which drug use takes place.     

Implementing and evaluating Social Behaviour and Network Therapy in drug treatment practice in the UK: a feasibility study

This paper reports on the implementation and preliminary evaluation of Social Behaviour and Network Therapy (SBNT) within drug treatment services. SBNT was initially developed and evaluated as part of a trial for alcohol treatment in the UK (UKATT). For the study reported in this paper SBNT was adapted for application with drug users. Therapists (N=20) from community drug services in Birmingham, UK, were trained to deliver the intervention. Training methods were supported by a treatment manual and included a two-day workshop followed by video supervision and monitoring. Following training therapists were asked to implement the treatment within the services in which they worked. Twelve of the therapists that were trained delivered SBNT to 24 clients within the study period of 8 months. Baseline and 3-month follow-up measures were administered using both quantitative and qualitative methods. This paper reports the quantitative results including drug use, levels of dependence, drug users' social network variables and family environment. Results suggest that it was feasible to train a number of therapists to deliver SBNT, and preliminary outcome results are encouraging. Further evaluation is needed in order to continue developing this promising social intervention.     

临床药师参与1例特发性肺纤维化治疗的药学实践

目的：评价药师参与特发性肺纤维化治疗的药学实践及对治疗效果的改善情况。方法：药师与医师密切配合,参考《热病》和相关文献及指南,根据患者病情变化和治疗效果及时调整药物治疗方案,密切观察疗效。结果：患者病情较前好转。结论：临床药师参与药物治疗全过程,将药学理论与临床实践有机结合,减少不良反应,促进合理用药。     

The ethics of dietary supplements and natural health products in pharmacy practice: A systematic documentary analysis

Objectives Many natural health products and dietary supplements are purchased in pharmacies and it has been argued that pharmacists are in the best position to provide patients with evidence‐based information about them. This study was designed to identify how the pharmacist's role with respect to natural health products and dietary supplements is portrayed in the literature. Method A systematic search was conducted in a variety of health databases to identify all literature that pertained to both pharmacy and natural health products and dietary supplements. Of the 786 articles identified, 665 were broad‐coded and 259 were subjected to in‐depth qualitative content analysis for emergent themes. Key findings Overwhelmingly, support for the sale of natural health products and dietary supplements in pharmacies is strong. Additionally, a role for pharmacist counselling is underscored. But another recurrent theme is that pharmacists are ill‐equipped to counsel patients about these products that are available on their shelves. This situation has led some to question the ethics of pharmacists selling natural health products and dietary supplements and to highlight the existence of an ethical conflict stemming from the profit‐motive associated with sales of natural health products and dietary supplements. Conclusions This analysis raises concerns about the ethics of natural health products and dietary supplements being sold in pharmacies, and about pharmacists being expected to provide counselling about products of which they have little knowledge.     

Impact of drug policy on the use of parenteral cephalosporins in Italy

Objective: To evaluate the effects of the 1998 revision of CUF Note 55 on doctors" prescribing behaviour and drug costs with regard to intramuscularly administered cephalosporins.Method: National data on drug use between January 1998 and June 2000 were provided by the Drug Utilisation Monitoring Centre of the Ministry of Health. The Anatomic Therapeutic Chemical classification and the Defined Daily Dose methodology, as well as population estimates obtained from the Italian National Statistics Institute were used to define consumption as the number of defined daily doses per 1000 inhabitants per day. The cost of these antibiotic medications was determined using the wholesale price reported in Informatore Farmaceutico. Italian inflation rates were used to annuitize the expenditure. STATA 6.0 software was used for all statistical analyses.Results: The use of cefonicid rose dramatically after the revision (+ 136.3%), whereas the utilisation of the other active ingredients decreased. A decrease of 5.6% in the expenditure for all parenteral cephalosporins was observed in this period while the same figure increased by 2.3% after one year.Conclusion: The exclusion of cefonicid from a restricted list appears to have significantly affected doctors' prescribing practices, while the effect on drug expenditure was contradictory.     

Differential diagnosis in pharmacy practice: Time to adopt clinical reasoning and decision making

The delivery of healthcare in most developed countries is under increasing pressure. Ageing populations with increasingly complex needs, coupled with financial constraints and imbalances in workforce, mean that healthcare policies look to contain cost and utilise resource as effectively as possible. Self-care is now widely advocated as a mechanism to manage acute presentations with pharmacy identified as a key resource to support such policy. Pharmacy teams are ideally positioned to facilitate the management of patients who present with acute illness. However, current evidence suggests that patient assessment and establishing a differential diagnosis could be better. It appears that how pharmacists are taught at Schools of Pharmacy adopts a protocol driven approach, which assumes presentation of low acuity conditions, and we argue that this method must be replaced with a curriculum that adopts clinical reasoning. This paper sets out the process of clinical reasoning and how the profession could embrace this as a better model in establishing a diagnosis.     

Hepatic adverse drug reactions: a case/non-case study in Italy

OBJECTIVE: Adverse drug reactions (ADRs) can involve all tissues and organs. Liver injuries are considered among the most serious and are a cause for concern among physicians and patients. To assess the extent of drug-induced liver injuries in Italy we compared the number of cases of hepatic ADRs with reports of all other drug-related reactions present in the same database. METHODS: Spontaneous reports from six Italian Regions collected from January 1990 to May 2005 were analysed. Adverse reactions were classified according to WHO Adverse Reaction Terminology for causality assessment, and only those with "certain", "probable" or "possible" causality assessment were included. Association between drugs and hepatic ADRs was assessed using the case/non case method, calculating the ADR reporting odds ratio (ROR) as a measure of disproportionality. RESULTS: On May 2005, the database contained 35,767 ADR reports, of which 11,829 were excluded because they were unclassifiable or unlikely in terms of causality assessment. Therefore, the analysis was carried out on 23,938 reports, of which 1,069 concerned hepatic ADRs (cases) and 22,869 concerned non-cases. The proportion of serious ADRs was about 40% in the overall database, and about 74% among cases. The drug classes with the highest number of cases were statins (ROR = 2.9, 95% CI 2.4-3.5), antiplatelet agents (ROR = 3.5; 95% CI 2.6-4.6), NSAIDs (ROR = 2.9; 95% CI 2.1-3.9) and macrolides (ROR = 1.7; 95% CI 1.2-2.3). CONCLUSION: Hepatic adverse drug reactions remain a serious concern for several drugs widely used in clinical practice. Monitoring hepatic enzymes on a monthly basis for the first 6 months of treatment has been suggested for patients taking medications known to be hepatotoxic. A better knowledge of the epidemiology and mechanisms of hepatic ADRs may contribute to minimising their occurrence.     

中药临床药师在神经内科开展中药临床药学服务的探索与实践

中药临床药师是合理用药的倡导者、实践者和监督者,承担着临床中药合理用药的具体任务。为促进临床合理用药,提高中药临床药师服务质量,为医护人员和患者提供优质的中药临床药学服务,文章介绍了某院中药临床药师在面临挑战和机遇时,正在开展的中药临床药师药学服务现状,从药学查房、中药处方点评、中药不良反应上报、中药用药教育、中药用药咨询和药物治疗监护等内容出发,阐述了该院神经内科中药临床药师在开展有关中药合理用药药学服务的主要内容,探讨当前工作模式下中药临床药师深入临床、服务临床的切入点,在实践中探索科学、合理的中药临床药师药学服务模式。     

基于有效性及伦理学原则探讨新药Ⅱ、Ⅲ期临床试验的设计思路与方法

基于新药临床研究中选择阳性药物为对照存在可能无法真实评价新药疗效的可能性,以及新药临床试验本身存在的广义伦理学问题,提出新药临床研究过程中,至少应在Ⅱ期选择安慰剂作为对照组,视研究目标疾病情况可以选择病情较轻的受试者参加试验,在首先验证新药的绝对有效性的基础上安排Ⅱ期二阶段和Ⅲ期临床试验:Ⅱ期二阶段可以采用add-on研究模式,适当扩大适应征;Ⅲ期临床试验可以选择安慰剂,也可以选择合适的阳性药物作为对照组,从而既保证了新药的绝对有效性,又使新药临床试验更加符合伦理学原则。     

Pharmacists' perceptions of their practice: a comparison between Alberta and Northern Ireland

Objective To explore how community pharmacists from Alberta, Canada, and Northern Ireland, UK, describe what a pharmacist does and to compare their responses. Methods Two hundred community pharmacists were interviewed using the telephone. The interviewer who introduced himself as a researcher asked two questions about the period over which the participants had been practising pharmacy and the way they describe what a pharmacist does. Responses were categorised into three categories: patient‐centred, product‐focused and ambiguous. Word‐cloud analysis was used to assess the use of patient‐care‐related terms. Key findings Of the responses from community pharmacists in Alberta, 29% were categorised as patient‐centred, 45% as product‐focused and 26% as ambiguous. In Northern Ireland, 40% of the community pharmacists' responses were categorised as patient‐centred, 39% as product‐focused and 21% as ambiguous. Community pharmacists in Northern Ireland provided more patient‐centred responses than community pharmacists in Alberta (P = 0.013). The word‐cloud analysis showed that ‘medicine’ and ‘dispense’ were the most frequently reported terms. It also highlighted a relative lack of patient‐care‐related terms. Conclusions The findings of the present study are suggestive of some movement towards patient‐centredness; however, product‐focused practice still predominates within the pharmacy profession in Alberta and Northern Ireland. The relative lack of patient‐care‐related terms suggests that patient care is still not the first priority for pharmacists in both Alberta and Northern Ireland.     

生物类似药临床应用的循证评价及循证指南制定方案

生物类似药的临床应用面临诸多问题,临床长期应用的有效性与安全性监测、未获批适应证的外推应用、互换用药及药物警戒等方面亟待规范。目前国内外尚无基于循证医学证据的生物类似药用药指南,制定一部循证指南对规范生物类似药的临床全流程应用十分必要。本文对现有生物类似药相关指导文件和系统评价进行全面检索与循证分析,结合生物类似药临床应用现状,对《中国生物类似药临床应用循证指南》制定方案进行详细介绍。本指南由北京大学第三医院药剂科发起,中国药学会循证药学专业委员会、中国药学会医院药学专业委员会、中国药理学会治疗药物监测研究专业委员会、海峡两岸医药卫生交流协会医院药学专业委员会批准制定。指南已在国际实践指南注册平台注册,注册号：IPGRP-2020CN172。指南制定过程将基于循证医学证据,严格参照世界卫生组织指南制定手册的制定步骤,参考美国医学研究所最新指南定义、GRADE工具、指南研究与评价工具及卫生保健实践指南报告条目标准,并由多学科多地域专家共同完成。本指南的制定旨在为生物类似药临床应用全流程提供循证指导,以提高生物类似药用药的安全性、有效性与经济性。