Public understanding of drug therapy.

Knowing some basic principles about medicines would help patients to understand drug therapy and to help and encourage them to use it well. These principles relate to the categories and names of drugs, their different uses, how they reach the site of action (absorption, distribution, fate), how they produce their effects, both beneficial and harmful, the time courses of drug actions, how the pattern and intensity of the effects of a drug depend on dose and timing, drug interactions, how drug effects are demonstrated and investigated and sources of information and their trustworthiness. These basic principles are an essential part of health literacy and understanding them would enable individuals to comprehend better the information that they are likely to receive about medicines that they will take. Different populations need different types of education. For schoolchildren, the principles could fit into biology and domestic science teaching, starting in the later years of primary school or early in secondary school. A teaching package would also be needed for their teachers. For adults, web-based learning seems the most practical option. Web-based programmes could be supported by the NHS and professional bodies and through public libraries and local community health services. Specific groups for targeting could include young mothers and carers of chronically ill people. For retired people, one could envisage special programmes, perhaps in collaboration with the University of the Third Age. Conversations between patients and professionals would then become more effective and help shared decision making.

[Patients reported adverse drug reactions: what's happening in Europe]. / Adverse drug reactions riportate direttamente dai pazienti: cosa succede in Europa.

This contribution in based on a report that describes the European situation regarding patient reported Adverse Drug reactions (DPR) and analyzes the literature on the topic. In 7 European countries DPRs are accepted, and used for decision making. Patients reports in general are more vivid that those of health care workers and report information that professional reporters can never be expected to provide. Moreover, DPRs are reliable and comparable to those of professional reporters.

Oestrogens and progestins for preventing and treating postpartum depression.

BACKGROUND: Postpartum depression is a common complication of childbirth, affecting approximately 13% of women. A hormonal aetiology has long been hypothesised due to the sudden and substantial fluctuations in concentrations of steroid hormones associated with pregnancy and the immediate postpartum period. There is also convincing evidence that oestrogens, progestins, and related compounds have important central nervous system activity at physiological concentrations. OBJECTIVES: The primary objective of this review was to assess the effects of oestrogens and progestins, including natural progesterone and synthetic progestogens, compared with placebo or usual antepartum, intrapartum, or postpartum care in the prevention and treatment of postpartum depression. SEARCH STRATEGY: We searched The Cochrane Pregnancy and Childbirth Group trials register (June 2004), the Cochrane Depression Anxiety and Neurosis Group trials register (July 2004), the Cochrane Central Register of Controlled Trials (July 2004), MEDLINE (1966 to 2004), EMBASE (1980 to 2004), and CINAHL (1982 to 2004). We scanned secondary references and contacted experts in the field. SELECTION CRITERIA: All published and unpublished randomised controlled trials comparing an oestrogen and progestin intervention with a placebo or usual antepartum, intrapartum, or postpartum care among pregnant women or new mothers recruited within the first year postpartum. DATA COLLECTION AND ANALYSIS: Two review authors participated in the evaluation of methodological quality, data extraction, and data analysis. Results are presented using relative risk for categorical data and weighted mean difference for continuous data. MAIN RESULTS: Two trials, involving 229 women, met the selection criteria. Norethisterone enanthate, a synthetic progestogen, administered within 48 hours of delivery was associated with a significantly higher risk of developing postpartum depression. Oestrogen therapy was associated with a greater improvement in depression scores than placebo among women with severe depression. AUTHORS' CONCLUSIONS: Synthetic progestogens should be used with significant caution in the postpartum period. The role of natural progesterone in the prevention and treatment of postpartum depression has yet to be evaluated in a randomised, placebo-controlled trial. Oestrogen therapy may be of modest value for the treatment of severe postpartum depression. Its role in the prevention of recurrent postpartum depression has not been rigorously evaluated. Further research is warranted.

How patients' experiences contribute to decision making: illustrations from DIPEx (personal experiences of health and illness).

AIM: To describe how people use their and other people's experiences ('experiential evidence') in making health care decisions. BACKGROUND: People faced with health decisions may employ not only clinical evidence and advice, but also their own previous experiences and the experiences of others who have faced similar decisions. Professionals have taken little notice of people's use of such experiential evidence and its importance in practice; acknowledging it would improve communication with patients. METHODS: The data come from the DIPEx (personal experiences of health and illness) project, which involves rigorous analysis of narrative interviews of people with particular conditions, chosen to represent the widest practicable range of experiences of each condition. Each collection consists of 40-50 interviews. RESULTS: The analyses of people's experiences are summarized for patients and professionals on a website (http://www.dipex.org) and illustrated by clips (video, audio or written) from the interviews. We draw on the qualitative research conducted for DIPEx to consider some of the different ways that people integrate experiential information when they face decisions about antenatal screening, childhood immunization and treatment for cancer. CONCLUSIONS: Other patients' experiences are an important part of the evidence that people use when making decisions about health care. People are naturally drawn to other people's stories, which add salience to medical information and make facts palatable and memorable. Patients' experiences are not an alternative to the evidence base - they are part of it; to dismiss them as 'anecdotes' is a serious misunderstanding. There are established methods, grounded in social science traditions, which can be used to research and report patients' experiences. Health professionals, as well as patients, need to consider and value this experiential evidence. IMPLICATIONS FOR NURSING MANAGEMENT: Managers and clinicians can help patients by guiding them to information resources, such as DIPEx, that present evidence-based health information through patients' experiences.

Systematic reviews of adverse effects: framework for a structured approach.

BACKGROUND: As every healthcare intervention carries some risk of harm, clinical decision making needs to be supported by a systematic assessment of the balance of benefit to harm. A systematic review that considers only the favourable outcomes of an intervention, without also assessing the adverse effects, can mislead by introducing a bias favouring the intervention. Much of the current guidance on systematic reviews is directed towards the evaluation of effectiveness; but this differs in important ways from the methods used in assessing the safety and tolerability of an intervention. A detailed discussion of why, how and when to include adverse effects in a systematic review, is required. METHODS: This discussion paper, which presupposes a basic knowledge of systematic review methodology, was developed by consensus among experienced reviewers, members of the Adverse Effects Subgroup of The Cochrane Collaboration, and supplemented by a consultation of content experts in reviews methodology, as well as those working in drug safety. RESULTS: A logical framework for making decisions in reviews that incorporate adverse effects is provided. We explore situations where a comprehensive investigation of adverse effects is warranted and suggest strategies to identify practicable and clinically useful outcomes. The advantages and disadvantages of including observational and experimental study designs are reviewed. The consequences of including separate studies for intended and unintended effects are explained. Detailed advice is given on designing electronic searches for studies with adverse effects data. Reviewers of adverse effects are given general guidance on the assessment of study bias, data collection, analysis, presentation and the interpretation of harms in a systematic review. CONCLUSION: Readers need to be able to recognize how strategic choices made in the review process determine what harms are found, and how the findings may affect clinical decisions. Researchers undertaking a systematic review that incorporates adverse effect data should understand the rationale for the suggested methods and be able to implement them in their review.

Advertising and disclosure of funding on patient organisation websites: a cross-sectional survey.

BACKGROUND: Patient organisations may be exposed to conflicts of interest and undue influence through pharmaceutical industry (Pharma) donations. We examined advertising and disclosure of financial support by pharmaceutical companies on the websites of major patient organisations. METHOD: Sixty-nine national and international patient organisations covering 10 disease states were identified using a defined Google search strategy. These were assessed for indicators of transparency, advertising, and disclosure of Pharma funding using an abstraction tool and inspection of annual reports. Data were analysed by simple tally, with medians calculated for financial data. RESULTS: Patient organisations websites were clear about their identity, target audience and intention but only a third were clear on how they derived their funds. Only 4/69 websites stated advertising and conflict of interest policies. Advertising was generally absent. 54% of sites included an annual report, but financial reporting and disclosure of donors varied substantially. Corporate donations were itemised in only 7/37 reports and none gave enough information to show the proportion of funding from Pharma. 45% of organisations declared Pharma funding on their website but the annual reports named more Pharma donors than did the websites (median 6 vs. 1). One third of websites showed one or more company logos and/or had links to Pharma websites. Pharma companies' introductions were present on 10% of websites, some of them mentioning specific products. Two patient organisations had obvious close ties to Pharma. CONCLUSION: Patient organisation websites do not provide enough information for visitors to assess whether a conflict of interest with Pharma exists. While advertising of products is generally absent, display of logos and corporate advertisements is relatively common. Display of clear editorial and advertising policies and disclosure of the nature and degree of corporate donations is needed on patient organisations' websites. An ethical code to guide patient organisations and their staff members on how to collaborate with Pharma is also necessary, if patient organisations are to remain independent and truly represent the interests and views of patients. As many organizations rely on Pharma donations, self-regulation may not suffice and independent oversight bodies should take the lead in requiring this.

Who are you, and who are we? Looking through some key words.

The terminology used to describe individuals who come into contact with health services is problematic. Many of the most commonly used words, for example, patient, consumer, user, carry overtones or imply characteristics, which may be misleading or unacceptable to those to whom they are applied.

The use of patients' stories by self-help groups: a survey of voluntary organizations in the UK on the register of the College of Health.

OBJECTIVE: First-hand accounts of illness experience are believed to provide important insights for other patients and their carers. We report the results of a survey that explored how patients' stories are being collected and used by self-help and voluntary groups. METHODS: The annual College of Health survey contacts 2 458 addresses, which includes many self-help groups and voluntary associations. A brief questionnaire for the self-help groups on the register was attached to the summer 1999 survey on behalf of the DIPEx (database of individual patient experience) project. RESULTS: DIPEx received replies from 309 organizations representing a wide range of interests and conditions. These indicated that 202 (65%) of the groups currently use patients' stories in various ways. A further 59 (19%) of the groups reported that although they are not currently using them, they would like to in the future. Organizations that use patients' stories were invited to describe how they use them and provide examples, if applicable. Content analysis of the free text descriptions revealed 22 distinct uses among the 202 organizations using patient stories. The most frequent uses are the inclusion of patient stories in interviews or articles for the group newsletter (74 or 37%) and the use of stories for inclusion in newspaper articles or media broadcasts (31 or 15%). Some form of database of patients' stories was maintained by 23 groups (12%). CONCLUSIONS: These findings suggest that patients' stories are widely collected and used to support a wide range of the recognized functions of self-help and voluntary groups. This is encouraging to the DIPEx project's efforts to collect and analyse accounts of illness experience, which will be presented with evidence-based information about the effects of treatments.

Adverse effects of the antimalaria drug, mefloquine: due to primary liver damage with secondary thyroid involvement?

BACKGROUND: Mefloquine is a clinically important antimalaria drug, which is often not well tolerated. We critically reviewed 516 published case reports of mefloquine adverse effects, to clarify the phenomenology of the harms associated with mefloquine, and to make recommendations for safer prescribing. PRESENTATION: We postulate that many of the adverse effects of mefloquine are a post-hepatic syndrome caused by primary liver damage. In some users we believe that symptomatic thyroid disturbance occurs, either independently or as a secondary consequence of the hepatocellular injury. The mefloquine syndrome presents in a variety of ways including headache, gastrointestinal disturbances, nervousness, fatigue, disorders of sleep, mood, memory and concentration, and occasionally frank psychosis. Previous liver or thyroid disease, and concurrent insults to the liver (such as from alcohol, dehydration, an oral contraceptive pill, recreational drugs, and other liver-damaging drugs) may be related to the development of severe or prolonged adverse reactions to mefloquine. IMPLICATIONS: We believe that people with active liver or thyroid disease should not take mefloquine, whereas those with fully resolved neuropsychiatric illness may do so safely. Mefloquine users should avoid alcohol, recreational drugs, hormonal contraception and co-medications known to cause liver damage or thyroid damage. With these caveats, we believe that mefloquine may be safely prescribed in pregnancy, and also to occupational groups who carry out safety-critical tasks. TESTING: Mefloquine's adverse effects need to be investigated through a multicentre cohort study, with small controlled studies testing specific elements of the hypothesis.

Jet lag.

INTRODUCTION: Jet lag is a syndrome caused by disruption of the 'body clock', and affects most air travellers crossing five or more time zones; it is worse on eastward than on westward flights. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical question: What are the effects of interventions to prevent or minimise jet lag? We searched: Medline, Embase, The Cochrane Library, and other important databases up to January 2014 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: We found five studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. CONCLUSIONS: In this systematic review, we present information relating to the effectiveness and safety of the following interventions: hypnotics, lifestyle and environmental adaptations, and melatonin.

Interaction between antidepressants and alcohol: signal amplification by multiple case reports.

BACKGROUND: Alcohol use and antidepressant prescription are prevalent in many countries, but little is known about their combined effects. OBJECTIVE: Having been surprised by selective serotonin reuptake inhibitor (SSRI) antidepressant-treated patients who became prone to pathological intoxication, we examined this association, searching for relevant literature and cases. METHODS: A detailed literature search showed little or no interaction between SSRIs and alcohol in laboratory studies, and inconsistent effects of these drugs in problem drinkers. We collected cases to study from our own and colleagues' practices, regulatory agencies and web-based discussion fora, and considered evidence for interactions according to standard criteria. RESULTS: Pathological intoxication, characterized by unexpected and often gross disinhibition, was identified in 100 of 201 reports that provided enough detail to be evaluated. Memory impairment was prominent in just over half (53/100) of these. Outcomes included serious violence; homicide occurred in 8 cases, including two double and one triple homicide (12 deaths). CONCLUSIONS: Multiple lines of evidence amplify a thus far barely recognized signal of interactions of SSRI and related antidepressants with alcohol. Systematic collection of further data is required to further characterize this syndrome, but in the meantime effective warnings must be introduced to alert prescribers and patients to the serious risk of pathological intoxication during antidepressant treatment.

Case histories as evidence.

In courts case histories play a central part when a crime may have resulted from an effect of a prescribed drug; in civil cases where a person may have suffered damage from a drug; and in coroners' enquiries into the cause of unexplained deaths. The court must decide two important questions: 1. Can the suspected medication(s) cause this kind of effect? 2. Did it (or they) do so in this particular case? Many judges and coroners have not addressed these questions clearly and have not used expert witnesses consistently, on occasion disregarding scientific evidence. Courts need to appoint experts to explain and interpret the scientific evidence. Few judges are equipped to resolve contradictions between different experts. Brief accounts of five cases from four countries illustrate these points. The reluctance of legal processes to implicate drugs as a possible cause of violent behaviour leads to injustice. Courts must be required to obtain appropriate expert evidence, and be given independent data on which drugs can cause such behaviour.

Unexpected aggressive behaviour: interaction of bupropion and alcohol.

A healthy policeman was prescribed bupropion in 2002 to help him stop smoking. It worked but after 18 months he relapsed. Though it had given him headaches and insomnia he tried using it again in 2009, [corrected] taking 150 mg/day. Three days after starting the tablets he took his wife out for dinner. They shared a bottle of wine and he also had other drinks. After walking home they quarrelled, he slapped her, she slapped him. He threw the phone at her saying 'call the police!'. They came and charged him with assault; he was suspended. An expert report attributed the aggressive outburst to an interaction between bupropion and alcohol; the accused was a social drinker and had never been violent. An expert advising the police agreed, and 14 months after the event the court dismissed the case.