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.     

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。     

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.     

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.     

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.     

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。     

基层医院开展临床药学服务的实践与体会

目的探讨基层医院开展临床药学服务的方法和体会。方法通过用药咨询、处方点评、临床合理用药指导和药物不良反应监测等模式有力推进该院临床药学工作的深入开展。结果通过近年来的实践与摸索,该院的临床药学服务模式已具雏形。结论临床药学服务的开展切实提高了医院的合理用药水平。     

国外药品临床试验中的伦理学现状及思考

药品临床试验为保障受试者的权益 ,必须考虑到医学伦理学问题。赫尔辛基宣言是受试者的一种保护性精神特质。参与临床试验病人的权益意识已增强 ,但宣言所规定的权利范围尚有不足之处 ,且某些方面还存在模棱两可的解释。从伦理学角度看 ,安慰剂对照还存在争议。FDA认为安慰剂对照属于“金标准”,但尚无合理科学依据。循证医学的兴起及其强调证据的可靠性对药品临床试验提出更高的要求 ,同时这种要求却触及了相关的伦理学问题。对以上问题进行讨论和分析 ,有助于管理者从伦理学角度管理好药品临床试验     

我院临床药师参与一例感染病例会诊实践

目的介绍我院药师参与病原菌不明感染性病例会诊的情况,探讨临床药师在感染性病例药物治疗过程中的作用。方法回顾性分析我院临床药师参与的1例感染性病例药物治疗过程。结果临床药师通过干预用药,配合医生为患者提供最佳用药方案,患者感染得到有效控制。结论临床药师参与感染性疾病的药物治疗,可确保抗菌药物的合理应用,提高了抗菌药物的疗效。     

Factors influencing the length of hospitalisation in intensive care units: a prospective observational study

INTRODUCTION: The length of stay (LOS) in patients admitted to intensive care units (ICUs) is influenced by the clinical history of the patient, so the main factors affecting clinical outcome are logical candidates to be predictors of LOS. Since there is still limited information about which factors can influence LOS in these patients, we undertook this observational study in Italian hospitals. MATERIALS AND METHODS: From 1 August to 31 October 2001 we enrolled a maximum of 10 consecutive patients admitted to ICUs in 16 Italian hospitals. The following information was recorded from each patient: date of admission; APACHE II score on admission; active sepsis and/or septic shock on admission; sepsis and/or septic shock developed during the stay in ICU; Glasgow coma scale on the third day; date and clinical outcome upon discharge from the hospital (alive or dead). RESULTS: In the study 131 patients were enrolled; 31 (23.7%) had active sepsis upon admission to ICU and 10 (7.6%) had septic shock; 12 (9.2%) developed sepsis during hospitalization and 12 (9.2%) developed septic shock. At the end of the study, 101 patients were alive and 30 had died. The overall mean LOS was 12 days. The mean LOS was 18.3 days for the subgroup with sepsis and 8.3 days in the subgroup without sepsis. Sepsis was the only factor that significantly influenced the LOS (P = 0.016). CONCLUSIONS: Our study was aimed to analyse the factors that influence the LOS in ICU patients and found that among the variables that affected LOS, sepsis had the greatest impact. Other studies had evaluated the impact of some variables on LOS and identified sepsis and infection as a determinant prolonging LOS.     

Antidepressants in clinical practice: limitations of assessment methods and drug response

There is a recognized gap between knowledge derived from 'efficacy' data - based on usually brief randomized controlled trials and findings in natural practice 'effectiveness' studies. In considering the limitations of current antidepressants in clinical practice, we have selected three clinically important issues to examine in a natural practice data base that has been in existence for several years. These relate to: (1) Diagnostic heterogeneity and potential advances using functional brain imaging; (2) Variability of outcome measures during treatment and (3) Time to response and prediction of outcome. Copyright 2001 John Wiley & Sons, Ltd.     

Setting standards of practice in therapeutic drug monitoring and clinical toxicology: a North American view

Standards for therapeutic drug monitoring (TDM) must address the factors required for a valid TDM result. These are that the test be ordered with an appropriate indication, samples be obtained at the appropriate time, analysis be precise and accurate, and the result be interpreted and used correctly. General indications for ordering drug concentrations are to assess patient compliance, lack of response, adverse effects, initial or new baseline concentration after steady state has been achieved, and drug interactions. In establishing standards for clinical toxicology testing, the following points need to be considered: relatively few drugs will be involved in the majority of overdoses in a given location, the majority of drug overdoses and poisonings are treated symptomatically and supportively, and there are a relatively small number of drugs the testing of which may provide useful information in the emergency setting. An effective toxicology screen can be designed by first developing a list of candidate drugs that have antidotes, require specific treatment, are frequently encountered, or have a delayed onset of toxicity. Once such a list is in hand, it can be further evaluated to determine whether qualitative or quantitative testing is most appropriate and if rapid, convenient methods of analysis are available.