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The Cochrane Database of Systematic... Apr 2005Unit-dose packaging of antimalarial drugs may improve malaria cure by making it easier for patients to take their treatment correctly. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Unit-dose packaging of antimalarial drugs may improve malaria cure by making it easier for patients to take their treatment correctly.
OBJECTIVES
To summarize the effects of unit-dose packaged treatment on cure and treatment adherence in people with uncomplicated malaria.
SEARCH STRATEGY
We searched the Cochrane Infectious Diseases Group Specialized Register (November 2004), CENTRAL (The Cochrane Library Issue 4, 2004), MEDLINE (1966 to November 2004), EMBASE (1980 to November 2004), LILACS (November 2004), conference proceedings, and reference lists of articles. We also contacted pharmaceutical companies, organizations, and researchers in the field.
SELECTION CRITERIA
Randomized controlled trials (RCTs), cluster-RCTs, quasi-RCTs, and controlled before-and-after studies of unit-dose packaged drugs for treating uncomplicated malaria.
DATA COLLECTION AND ANALYSIS
We independently assessed study eligibility and methodological quality, and extracted data for an intention to treat analysis, where possible. We combined binary data using relative risk (RR) and the fixed-effect model, and presented them with 95% confidence intervals (CI). We attempted to contact study authors for additional information.
MAIN RESULTS
Three quasi-RCTs (895 participants) and one cluster-RCT (6 health facilities) met the inclusion criteria. Trials were of poor methodological quality, and none adequately assessed treatment failure. Unit-dose packaged drugs (in conjunction with prescriber training and patient information) appeared to be associated with higher participant-reported treatment adherence in all trials.A meta-analysis of two trials (596 participants) showed that participant-reported treatment adherence was higher with blister-packed tablets compared with tablets in paper envelopes (RR 1.18, 1.12 to 1.25). Two trials using tablets in sectioned polythene bags as the intervention also noted an increase in participant-reported treatment adherence: the cluster-RCT (6 clusters) compared it with tablets in paper envelopes, and the other trial compared it with syrup in bottles (RR 2.15, 1.76 to 2.61; 299 participants).
AUTHORS' CONCLUSIONS
There is insufficient evidence to determine the effect of unit-dose packaged antimalarial drugs on treatment failure. Unit-dose packaging supported by prescriber training and patient information appears to improve participant-reported treatment adherence, but these data come from trials with methodological limitations.
Topics: Antimalarials; Drug Packaging; Humans; Malaria; Patient Compliance; Randomized Controlled Trials as Topic
PubMed: 15846723
DOI: 10.1002/14651858.CD004614.pub2 -
Systematic Reviews Oct 2018Comparisons between narrative synthesis and meta-analysis as synthesis methods in systematic reviews are uncommon within the same systematic review. We re-analysed a... (Meta-Analysis)
Meta-Analysis
Just how plain are plain tobacco packs: re-analysis of a systematic review using multilevel meta-analysis suggests lessons about the comparative benefits of synthesis methods.
BACKGROUND
Comparisons between narrative synthesis and meta-analysis as synthesis methods in systematic reviews are uncommon within the same systematic review. We re-analysed a systematic review on the effects of plain packaging of tobacco on attractiveness. We sought to compare different synthesis approaches within the same systematic review and shed light on the comparative benefits of each approach.
METHODS
In our re-analysis, we included results relating to attractiveness in included reports. We extracted findings from studies and converted all estimates of differences in attractiveness to Cohen's d. We used multilevel meta-analysis to account for clustering of effect sizes within studies.
RESULTS
Of the 19 studies reporting results on attractiveness, seven studies that included between-subjects analyses could be included in the meta-analysis. Plain packs were less attractive than branded packs (d = - 0.59, 95% CI [- 0.71, - 0.47]), with negligible but uncertain between-studies heterogeneity (I = 0%, 95% CI [0.00, 70.81]) and high within-study heterogeneity (I = 92.6%, 95% CI [91.04, 93.90]).
CONCLUSIONS
The meta-analysis found, similar to the narrative synthesis, that respondents typically rated plain packaging as less attractive than alternative (e.g. branded) tobacco packs. However, there were several trade-offs between analysis methods in the types and bodies of evidence each one contained and in the difference between partial precision and breadth of conclusions. Analysis methods were different in respect of the role of judgement and contextual variation and in terms of estimation and unexpected effect modification. In addition, we noted that analysis methods were different in how they accounted for heterogeneity and consistency.
Topics: Drug Packaging; Humans; Marketing; Smoking; Tobacco Products
PubMed: 30290842
DOI: 10.1186/s13643-018-0821-7 -
The Cochrane Database of Systematic... Apr 2014Many systematic reviews exist on interventions to improve safe and effective medicines use by consumers, but research is distributed across diseases, populations and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Many systematic reviews exist on interventions to improve safe and effective medicines use by consumers, but research is distributed across diseases, populations and settings. The scope and focus of such reviews also vary widely, creating challenges for decision-makers seeking to inform decisions by using the evidence on consumers' medicines use.This is an update of a 2011 overview of systematic reviews, which synthesises the evidence, irrespective of disease, medicine type, population or setting, on the effectiveness of interventions to improve consumers' medicines use.
OBJECTIVES
To assess the effects of interventions which target healthcare consumers to promote safe and effective medicines use, by synthesising review-level evidence.
SEARCH METHODS
We included systematic reviews published on the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects. We identified relevant reviews by handsearching databases from their start dates to March 2012.
SELECTION CRITERIA
We screened and ranked reviews based on relevance to consumers' medicines use, using criteria developed for this overview.
DATA COLLECTION AND ANALYSIS
We used standardised forms to extract data, and assessed reviews for methodological quality using the AMSTAR tool. We used standardised language to summarise results within and across reviews; and gave bottom-line statements about intervention effectiveness. Two review authors screened and selected reviews, and extracted and analysed data. We used a taxonomy of interventions to categorise reviews and guide syntheses.
MAIN RESULTS
We included 75 systematic reviews of varied methodological quality. Reviews assessed interventions with diverse aims including support for behaviour change, risk minimisation and skills acquisition. No reviews aimed to promote systems-level consumer participation in medicines-related activities. Medicines adherence was the most frequently-reported outcome, but others such as knowledge, clinical and service-use outcomes were also reported. Adverse events were less commonly identified, while those associated with the interventions themselves, or costs, were rarely reported.Looking across reviews, for most outcomes, medicines self-monitoring and self-management programmes appear generally effective to improve medicines use, adherence, adverse events and clinical outcomes; and to reduce mortality in people self-managing antithrombotic therapy. However, some participants were unable to complete these interventions, suggesting they may not be suitable for everyone.Other promising interventions to improve adherence and other key medicines-use outcomes, which require further investigation to be more certain of their effects, include:· simplified dosing regimens: with positive effects on adherence;· interventions involving pharmacists in medicines management, such as medicines reviews (with positive effects on adherence and use, medicines problems and clinical outcomes) and pharmaceutical care services (consultation between pharmacist and patient to resolve medicines problems, develop a care plan and provide follow-up; with positive effects on adherence and knowledge).Several other strategies showed some positive effects, particularly relating to adherence, and other outcomes, but their effects were less consistent overall and so need further study. These included:· delayed antibiotic prescriptions: effective to decrease antibiotic use but with mixed effects on clinical outcomes, adverse effects and satisfaction;· practical strategies like reminders, cues and/or organisers, reminder packaging and material incentives: with positive, although somewhat mixed effects on adherence;· education delivered with self-management skills training, counselling, support, training or enhanced follow-up; information and counselling delivered together; or education/information as part of pharmacist-delivered packages of care: with positive effects on adherence, medicines use, clinical outcomes and knowledge, but with mixed effects in some studies;· financial incentives: with positive, but mixed, effects on adherence.Several strategies also showed promise in promoting immunisation uptake, but require further study to be more certain of their effects. These included organisational interventions; reminders and recall; financial incentives; home visits; free vaccination; lay health worker interventions; and facilitators working with physicians to promote immunisation uptake. Education and/or information strategies also showed some positive but even less consistent effects on immunisation uptake, and need further assessment of effectiveness and investigation of heterogeneity.There are many different potential pathways through which consumers' use of medicines could be targeted to improve outcomes, and simple interventions may be as effective as complex strategies. However, no single intervention assessed was effective to improve all medicines-use outcomes across all diseases, medicines, populations or settings.Even where interventions showed promise, the assembled evidence often only provided part of the picture: for example, simplified dosing regimens seem effective for improving adherence, but there is not yet sufficient information to identify an optimal regimen.In some instances interventions appear ineffective: for example, the evidence suggests that directly observed therapy may be generally ineffective for improving treatment completion, adherence or clinical outcomes.In other cases, interventions may have variable effects across outcomes. As an example, strategies providing information or education as single interventions appear ineffective to improve medicines adherence or clinical outcomes, but may be effective to improve knowledge; an important outcome for promoting consumers' informed medicines choices.Despite a doubling in the number of reviews included in this updated overview, uncertainty still exists about the effectiveness of many interventions, and the evidence on what works remains sparse for several populations, including children and young people, carers, and people with multimorbidity.
AUTHORS' CONCLUSIONS
This overview presents evidence from 75 reviews that have synthesised trials and other studies evaluating the effects of interventions to improve consumers' medicines use.Systematically assembling the evidence across reviews allows identification of effective or promising interventions to improve consumers' medicines use, as well as those for which the evidence indicates ineffectiveness or uncertainty.Decision makers faced with implementing interventions to improve consumers' medicines use can use this overview to inform decisions about which interventions may be most promising to improve particular outcomes. The intervention taxonomy may also assist people to consider the strategies available in relation to specific purposes, for example, gaining skills or being involved in decision making. Researchers and funders can use this overview to identify where more research is needed and assess its priority. The limitations of the available literature due to the lack of evidence for important outcomes and important populations, such as people with multimorbidity, should also be considered in practice and policy decisions.
Topics: Communication; Drug Prescriptions; Evidence-Based Medicine; Humans; Medication Adherence; Patient Education as Topic; Patient Participation; Patient-Centered Care; Review Literature as Topic; Self Care
PubMed: 24777444
DOI: 10.1002/14651858.CD007768.pub3 -
Implementation Science : IS Mar 2019To meet emergent healthcare needs, innovations need to be implemented into routine clinical practice. Community pharmacy is increasingly considered a setting through... (Meta-Analysis)
Meta-Analysis
BACKGROUND
To meet emergent healthcare needs, innovations need to be implemented into routine clinical practice. Community pharmacy is increasingly considered a setting through which innovations can be implemented to achieve positive service and clinical outcomes. Small-scale pilot programmes often need scaled up nation-wide to affect population level change. This systematic review aims to identify facilitators and barriers to the national implementation of community pharmacy innovations.
METHODS
A systematic review exploring pharmacy staff perspectives of the barriers and facilitators to implementing innovations at a national level was conducted. The databases Medline, EMBASE, PsycINFO, CINAHL, and Open Grey were searched and supplemented with additional search mechanisms such as Zetoc alerts. Eligible studies underwent quality assessment, and a directed content analysis approach to data extraction was conducted and aligned to the Consolidated Framework for Implementation Research (CFIR) to facilitate narrative synthesis.
RESULTS
Thirty-nine studies were included: 16 were qualitative, 21 applied a questionnaire design, and 2 were mixed methods. Overarching thematic areas spanning across the CFIR domains were pharmacy staff engagement (e.g. their positive and negative perceptions), operationalisation of innovations (e.g. insufficient resources and training), and external engagement (e.g. the perceptions of patients and other healthcare professionals, and their relationship with the community pharmacy). Study participants commonly suggested improvements in the training offered, in the engagement strategies adopted, and in the design and quality of innovations.
CONCLUSIONS
This study's focus on national innovations resulted in high-level recommendations to facilitate the development of successful national implementation strategies. These include (1) more robust piloting of innovations, (2) improved engagement strategies to increase awareness and acceptance of innovations, (3) promoting whole-team involvement within pharmacies to overcome time constraints, and (4) sufficient pre-implementation evaluation to gauge acceptance and appropriateness of innovations within real-world settings. The findings highlight the international challenge of balancing the professional, clinical, and commercial obligations within community pharmacy practice. A preliminary theory of how salient factors influence national implementation in the community pharmacy setting has been developed, with further research necessary to understand how the influence of these factors may differ within varying contexts.
TRIAL REGISTRATION
A protocol for this systematic review was developed and uploaded onto the PROSPERO international prospective register of systematic reviews database (Registration number: CRD42016038876 ).
Topics: Advertising; Community Pharmacy Services; Diffusion of Innovation; Drug Packaging; Health Knowledge, Attitudes, Practice; Health Policy; Humans; Implementation Science; Interprofessional Relations; Motivation; Organizational Policy; Pharmacists; Pharmacy Technicians; Professional Role; Research Design
PubMed: 30832698
DOI: 10.1186/s13012-019-0867-5 -
BMC Health Services Research Oct 2008Studies carried out in the community enable researchers to understand access to medicines, affordability, and barriers to use from the consumer's point of view, and may... (Review)
Review
BACKGROUND
Studies carried out in the community enable researchers to understand access to medicines, affordability, and barriers to use from the consumer's point of view, and may stimulate the development of adequate medicines policies. The aim of the present article was to describe methodological and analytical aspects of quantitative studies on medicine utilization carried out at the household level.
METHODS
Systematic review of original papers with data collected in studies in which the household was a sampling unit, published between 1995 and 2008. The electronic review was carried out in Medline/Pubmed, Scielo and Lilacs. The reference lists of the papers identified were examined, as well as other publications by their authors. Studies on the utilization of specific pharmacological groups, or those including only respondents with a given disease were excluded.
RESULTS
Out of 4852 papers initially identified in the literature search, 61 fulfilled our inclusion criteria. Most studies were carried out in Europe and North America and used a cross-sectional approach. More than 80% used face-to-face interviews for data collection, and the most frequently used recall period for assessing medicine utilization was 14-15 days. In 59% of the studies, interviewers were trained to request the packaging of the medicines reported by the subjects; medical prescriptions were requested less frequently (15% of the studies).
CONCLUSION
These data will be useful for updating researchers on what methods their peers are currently using. Such information may help overcome challenges in the planning and analyses of future studies. Moreover, this publication may contribute to the improvement of the quality of medicine use data obtained in household surveys.
Topics: Databases, Bibliographic; Drug Therapy; Drug Utilization Review; Family Characteristics; Health Care Surveys; Humans; Mental Recall; Patient Acceptance of Health Care; Surveys and Questionnaires
PubMed: 18976465
DOI: 10.1186/1472-6963-8-222 -
Basic & Clinical Pharmacology &... Jan 2022Current data on use of antihistamines during breastfeeding and risks to the breastfed infant are insufficient. The aim of this systematic review was to provide an...
Current data on use of antihistamines during breastfeeding and risks to the breastfed infant are insufficient. The aim of this systematic review was to provide an overview of studies measuring the levels of antihistamines in human breast milk, estimating the exposure for breastfed infants and/or reporting possible adverse effects on the breastfed infant. An additional aim was to review the antihistamine product labels available in the European Union (EU) and the United States. We searched seven online databases and identified seven human lactation studies that included 25 mother-infant pairs covering cetirizine, clemastine, ebastine, epinastine, loratadine, terfenadine and triprolidine. In addition, one study investigated the impact of chlorpheniramine or promethazine on prolactin levels among 17 women, and one study investigated possible adverse drug reactions in 85 breastfed infants exposed to various antihistamines. The relative infant dose was below 5% for all antihistamines, ranging from 0.3% for terfenadine to 4.5% for clemastine. Most product labels of the 10 antihistamines with available information in both the EU and the United States reported lack of evidence and recommended to avoid use during breastfeeding. The knowledge gap on antihistamines and lactation is extensive, and further human studies are warranted to ensure optimal treatment of breastfeeding women with allergy.
Topics: Breast Feeding; Drug Labeling; European Union; Female; Histamine H1 Antagonists; Humans; Infant; Lactation; Milk, Human; United States
PubMed: 34587362
DOI: 10.1111/bcpt.13663 -
European Journal of Clinical... Aug 2018Unclear labeling has been recognized as an important cause of look-alike medication errors. The aim of this literature review is to systematically evaluate the current... (Meta-Analysis)
Meta-Analysis
PURPOSE
Unclear labeling has been recognized as an important cause of look-alike medication errors. The aim of this literature review is to systematically evaluate the current evidence on strategies to minimize medication errors due to look-alike labels.
METHODS
A literature search of PubMed and EMBASE for all available years was performed independently by two reviewers. Original studies assessing strategies to minimize medication errors due to look-alike labels focusing on readability of labels by health professionals or consumers were included. Data were analyzed descriptively due to the variability of study methods.
RESULTS
Sixteen studies were included. Thirteen studies were performed in a laboratory and three in a healthcare setting. Eleven studies evaluated Tall Man lettering, i.e., capitalizing parts of the drug name, two color-coding, and three studies other strategies. In six studies, lower error rates were found for the Tall Man letter strategy; one showed significantly higher error rates. Effects of Tall Man lettering on response time were more varied. A study in the hospital setting did not show an effect on the potential look-alike sound-alike error rate by introducing Tall Man lettering. Color-coding had no effect on the prevention of syringe-swaps in one study.
CONCLUSIONS
Studies performed in laboratory settings showed that Tall Man lettering contributed to a better readability of medication labels. Only few studies evaluated other strategies such as color-coding. More evidence, especially from real-life setting is needed to support safe labeling strategies.
Topics: Drug Labeling; Health Personnel; Hospitals; Humans; Medication Errors; Product Labeling; Reaction Time
PubMed: 29754215
DOI: 10.1007/s00228-018-2471-z -
European Journal of Clinical... Feb 2021Medicines regulatory authorities advise that patient information leaflets (PILs) should provide specific advice on what actions to take if one or more doses are missed....
PURPOSE
Medicines regulatory authorities advise that patient information leaflets (PILs) should provide specific advice on what actions to take if one or more doses are missed. We aimed to assess the content in this regard, of PILs and Summaries of Product Characteristics (SmPCs) of prescription only medicines (POMs) marketed in the UK.
METHODS
PILs and SmPCs were accessed via the electronic Medicines Compendium. The following terms were used in the advanced search facility: miss(ed), omit(ted), adhere(d), delay(ed), forgot, forget, lapse. Identified documents were screened for instructions on missed doses which were categorised according to level of specificity, and cross-referenced to the National Patient Safety Agency (NPSA) grading of risk of harm from omitted and delayed medicines. Any supporting clinical or pharmacological evidence was identified from SmPCs.
RESULTS
Two thousand two hundred eighty-four documents were identified from 7248 PILs and SmPCs relating to 1501 POMs. Seven hundred eighty-three (52%) POMs had SmPCs or PILs with no instructions on missed doses; 487 POMs (32%) included non-specific advice (e.g. "take as soon as possible"); 138 (9%) provided specific instructions; and 93 (6%) referred patients to seek medical advice. SmPCs for only 13/138 (9%) of those which included specific instructions provided any supporting clinical or pharmacological evidence. Instructions were absent for several medicines where the NPSA assessed that dose omissions may result in significant risk of harm.
CONCLUSIONS
Advice on missed doses is generally inadequate. Pharmaceutical companies and regulatory authorities should produce clear and concise instructions on what patients should do if they miss doses, with supporting evidence where necessary.
Topics: Drug Administration Schedule; Drug Labeling; Humans; Medication Adherence; Prescription Drugs; United Kingdom
PubMed: 32989529
DOI: 10.1007/s00228-020-03003-x