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Preventive Medicine Feb 2017We aimed to investigate the effects of special packaging (child-resistant, adult-friendly) and tamper-resistant packaging on health and behavioral outcomes in order to... (Review)
Review
OBJECTIVE
We aimed to investigate the effects of special packaging (child-resistant, adult-friendly) and tamper-resistant packaging on health and behavioral outcomes in order to identify research gaps and implications for packaging standards for tobacco products.
METHODS
We searched seven databases for keywords related to special and tamper-resistant packaging, consulted experts, and reviewed citations of potentially relevant studies. 733 unique papers were identified. Two coders independently screened each title and abstract for eligibility. They then reviewed the full text of the remaining papers for a second round of eligibility screening. Included studies investigated a causal relationship between type of packaging or packaging regulation and behavioral or health outcomes and had a study population composed of consumers. Studies were excluded on the basis of publication type, if they were not peer-reviewed, and if they had low external validity. Two reviewers independently coded each paper for study and methodological characteristics and limitations. Discrepancies were discussed and resolved.
RESULTS
The review included eight studies: four assessing people's ability to access the contents of different packaging types and four evaluating the impact of packaging requirements on health-related outcomes. Child-resistant packaging was generally more difficult to open than non-child-resistant packaging. Child-resistant packaging requirements have been associated with reductions in child mortality.
CONCLUSIONS
Child-resistant packaging holds the expectation to reduce tobacco product poisonings among children under six.
Topics: Humans; Product Packaging; Social Control, Formal; Nicotiana
PubMed: 27939602
DOI: 10.1016/j.ypmed.2016.11.013 -
Journal of Clinical Pharmacy and... Dec 2016When considering acute care settings, such as the neonatal intensive care unit (NICU), the inappropriate use of medicines poses a great risk to vulnerable babies at the... (Review)
Review
WHAT IS KNOWN AND OBJECTIVES
When considering acute care settings, such as the neonatal intensive care unit (NICU), the inappropriate use of medicines poses a great risk to vulnerable babies at the start of their lives. However, there is limited published literature that explores the current medication management practices in NICUs and where the main misuse issues lie. Therefore, the purpose of this review was to give an overview of medicine use in NICUs worldwide and identify therapeutic areas requiring more targeted pharmaceutical care. Specific objectives include the following: identifying the most commonly used medicines, comparing these to the A-PINCH (Anti-infectives, Potassium and other electrolytes, Insulin, Narcotics and sedatives, Chemotherapy agents, Heparin and other anticoagulants), high-risk medicines list, and determining whether there are any differences in medicine use between countries.
METHOD
Quasi-systematic literature review.
SEARCH STRATEGY
Google Scholar, MEDLINE/PubMed, Scopus and EMBASE were searched utilizing selected MeSH terms.
RESULTS
A total of 19 articles from 12 countries were reviewed. Medication use between countries was very similar with no discernible differences in types of medicines prescribed. The most commonly used medicines included gentamicin, ampicillin, caffeine, furosemide and vitamin K. The median number of medicines prescribed per patient ranged from 3 to 11, and an inverse relationship was identified between gestational age and the number of medications that were prescribed. Nine of the 20 most commonly used medicines were listed as A-PINCH medicines, and included antibiotics, fentanyl, morphine and heparin. Inappropriate prescribing, as well as the high use of off-label/unlicensed medicines, was highlighted as areas of practice that require consideration to improve medication safety and minimize the potential risk for medication errors.
WHAT IS NEW AND CONCLUSION
Overall, the types of medicines used in NICUs worldwide are similar, with consistent reports on the common use of antibiotics, caffeine and vitamins. However, it cannot be definitively stated that the findings of the review accurately depict current practice in NICUs, due to the limited amount of published literature available. There are several areas of concern that warrant further investigation to improve rational use of medicines in the neonatal populations, including high use of antibiotics and off-label and unlicensed medicines.
Topics: Drug Labeling; Drug Utilization; Humans; Intensive Care Units, Neonatal; Medication Errors; Practice Patterns, Physicians'
PubMed: 27578606
DOI: 10.1111/jcpt.12440 -
Research in Social & Administrative... 2016Health literacy is a barrier to accurately understanding medication information. Current medication information is too difficult to understand for low health literate... (Review)
Review
BACKGROUND
Health literacy is a barrier to accurately understanding medication information. Current medication information is too difficult to understand for low health literate populations, which imposes a higher risk of misinterpreting prescription label instructions, dosage, duration, frequency, warning labels, written information and verbal pharmacist counseling.
OBJECTIVES
The primary objective of this paper was to systematically review the evidence on interventions for improving medication knowledge and adherence for low health literate populations.
METHODS
A database search of PubMed, Embase, International Pharmaceutical Abstracts, Web of Science, Cochrane Library, CINAHL, PsycINFO, and Scopus databases from the start of each database to studies published prior to March 30, 2015. Studies were included if they explicitly stated they included low health literate populations, included outcome measures for knowledge and/or adherence, focused on medication information, were written in English and were available in full text. Full text papers were excluded if there was no clear mention of an intervention being studied, if the intervention had no focus on any of the domains of health literacy, and if the authors did not specify the inclusion of patients with low health literacy.
RESULTS
The review identified 1553 titles, 1009 abstracts, and 168 full text articles and included 47 articles in the final review. Of the 47 included studies, 70.2% (33/47) were published in the United States and 87.2 (41/47) were published between 2005 and 2014. Studies were grouped into six different types of interventions 1) written information 2) visual information 3) verbal information 4) label/medication bottle 5) reminder systems and 6) educational programs and services. Results demonstrate significant improvement of knowledge in 27 of 37 interventions and a significant improvement of adherence in 19 of 26 interventions.
CONCLUSIONS
Interventions designed to support low health literate populations can improve patients' medication knowledge and adherence. The most effective interventions include additional aids that enforce written information, information that is personalized, information that is easy to navigate and tools that can be accessed when needed.
Topics: Drug Labeling; Health Knowledge, Attitudes, Practice; Health Literacy; Humans; Medication Adherence; Patient Education as Topic; Pharmaceutical Services; Pharmacists; Prescription Drugs; Professional Role; Reminder Systems
PubMed: 26926671
DOI: 10.1016/j.sapharm.2015.12.001 -
BMC Health Services Research Jul 2016Suboptimal medication adherence is a significant threat to public health and resources. Devices that organise weekly doses by time and day are commonly used to reduce... (Review)
Review
BACKGROUND
Suboptimal medication adherence is a significant threat to public health and resources. Devices that organise weekly doses by time and day are commonly used to reduce unintentional non-adherence. However, there is limited evidence to support their use. This systematic review was conducted to evaluate current evidence for their efficacy, safety and costs.
METHODS
A pre-defined search of electronic databases from inception to January 2013 augmented with hand-searching was conducted. No limits were placed on publication date. Studies that compared organisation devices used by patients administering their own medication with standard medication packaging regardless of study design were eligible for inclusion. Studies that solely explored dispensing aspects of organisation devices were included whether or not they compared this to standard care. Screening of articles for inclusion and data extraction were completed independently by two reviewers with disagreements resolved by discussion. Outcomes were categorised into impact on health, medication adherence, healthcare utilisation, dispensing errors, supply procedures and costs. Risk of bias was also assessed.
RESULTS
Seventeen studies met the inclusion criteria. Health outcomes were investigated in seven studies of which three reported a positive effect associated with organisation devices. Medication adherence was reported in eight studies of which three reported a positive effect. Three studies reported health care utilisation data but overall results are inconclusive. No optimal dispensing or supply procedures were identified. Economic assessment of the impact of organisation devices is lacking. All studies were subject to a high risk of bias.
CONCLUSIONS
Evidence regarding the effects of medication organisation devices was limited, and the available evidence was susceptible to a high risk of bias. Organisation devices may help unintentional medication non-adherence and could improve health outcomes. There is a strong need for more studies that explore the impact of such devices on patients, and an equally pressing need for studies that explore the impacts on healthcare services.
TRIAL REGISTRATION
This systematic review is registered with PROSPERO (Registration number CRD42011001718 ).
Topics: Drug Packaging; Humans; Medication Adherence; Medication Errors; Pharmacies; Quality of Life; Reminder Systems; Treatment Outcome
PubMed: 27381448
DOI: 10.1186/s12913-016-1446-y -
Current Hypertension Reports Dec 2015This systematic review applied meta-analytic procedures to synthesize medication adherence interventions that focus on adults with hypertension. Comprehensive searching... (Meta-Analysis)
Meta-Analysis Review
This systematic review applied meta-analytic procedures to synthesize medication adherence interventions that focus on adults with hypertension. Comprehensive searching located trials with medication adherence behavior outcomes. Study sample, design, intervention characteristics, and outcomes were coded. Random-effects models were used in calculating standardized mean difference effect sizes. Moderator analyses were conducted using meta-analytic analogues of ANOVA and regression to explore associations between effect sizes and sample, design, and intervention characteristics. Effect sizes were calculated for 112 eligible treatment-vs.-control group outcome comparisons of 34,272 subjects. The overall standardized mean difference effect size between treatment and control subjects was 0.300. Exploratory moderator analyses revealed interventions were most effective among female, older, and moderate- or high-income participants. The most promising intervention components were those linking adherence behavior with habits, giving adherence feedback to patients, self-monitoring of blood pressure, using pill boxes and other special packaging, and motivational interviewing. The most effective interventions employed multiple components and were delivered over many days. Future research should strive for minimizing risks of bias common in this literature, especially avoiding self-report adherence measures.
Topics: Humans; Hypertension; Medication Adherence; Risk Factors; Treatment Outcome
PubMed: 26560139
DOI: 10.1007/s11906-015-0606-5 -
Life Sciences Jan 2016Endocrine disrupting chemicals (EDC) are released into environment from different sources. They are mainly used in packaging industries, pesticides and food... (Review)
Review
Endocrine disrupting chemicals (EDC) are released into environment from different sources. They are mainly used in packaging industries, pesticides and food constituents. Clinical evidence, experimental models, and epidemiological studies suggest that EDC have major risks for human by targeting different organs and systems in the body. Multiple mechanisms are involved in targeting the normal system, through estrogen receptors, nuclear receptors and steroidal receptors activation. In this review, different methods by which xenobiotics stimulate signaling pathways and genetic mutation or DNA methylation have been discussed. These methods help to understand the results of xenobiotic action on the endocrine system. Endocrine disturbances in the human body result in breast cancer, ovarian problems, thyroid eruptions, testicular carcinoma, Alzheimer disease, schizophrenia, nerve damage and obesity. EDC characterize a wide class of compounds such as organochlorinated pesticides, industrial wastes, plastics and plasticizers, fuels and numerous other elements that exist in the environment or are in high use during daily life. The interactions and mechanism of toxicity in relation to human general health problems, especially endocrine disturbances with particular reference to reproductive problems, diabetes, and breast, testicular and ovarian cancers should be deeply investigated. There should also be a focus on public awareness of these EDC risks and their use in routine life. Therefore, the aim of this review is to summarize all evidence regarding different physiological disruptions in the body and possible involved mechanisms, to prove the association between endocrine disruptions and human diseases.
Topics: Animals; Carcinogens, Environmental; Cardiovascular System; Endocrine Disruptors; Environmental Exposure; Environmental Pollutants; Hormones; Humans; Nervous System; Obesity; Reproduction
PubMed: 26497928
DOI: 10.1016/j.lfs.2015.10.022 -
The Annals of Pharmacotherapy Nov 2015Problematic prescription drug labeling has been cited as a root cause of patient misunderstanding, medication errors, and nonadherence. Although numerous studies have... (Review)
Review
OBJECTIVE
Problematic prescription drug labeling has been cited as a root cause of patient misunderstanding, medication errors, and nonadherence. Although numerous studies have recently been conducted to identify and test labeling best practices, the last systematic review on this topic was conducted a decade ago. The objective of this review was, therefore, to examine, summarize, and update best practices for conveying written prescription medication information and instructions to patients.
DATA SOURCES
English-language articles published from June 2005 to June 2015 were identified in MEDLINE and CINAHL by searching the following text words: 'medication OR prescription OR drug' AND 'label OR leaflet OR brochure OR pamphlet OR medication guide OR medication insert OR drug insert OR medication information OR drug information OR instructions' AND 'patient OR consumer.' Reference mining and secondary searches were also performed.
STUDY SELECTION AND DATA EXTRACTION
A total of 31 articles providing evidence on how to improve written, prescription drug labeling for patient use were selected. Two reviewers independently screened articles, rated their quality, and abstracted data.
DATA SYNTHESIS
Identified best practices included the use of plain language, improved formatting and organization, and more explicit instructions to improve patient comprehension. The use of icons had conflicting findings, and few studies tested whether practices improved knowledge or behaviors with patients' actual prescribed regimens.
CONCLUSIONS
Future studies are needed to determine how specific modifications and improvements in drug labeling can enhance patient knowledge and behavior in actual use. Synthesizing best practices across all patient materials will create a more useful, coordinated system of prescription information.
Topics: Comprehension; Drug Labeling; Humans; Medication Adherence; Medication Errors; Patient Education as Topic; Prescription Drugs
PubMed: 26354048
DOI: 10.1177/1060028015602272 -
Revista de Saude Publica 2015OBJECTIVE To review studies on the readability of package leaflets of medicinal products for human use. METHODS We conducted a systematic literature review between 2008... (Review)
Review
OBJECTIVE To review studies on the readability of package leaflets of medicinal products for human use. METHODS We conducted a systematic literature review between 2008 and 2013 using the keywords "Readability and Package Leaflet" and "Readability and Package Insert" in the academic search engine Biblioteca do Conhecimento Online, comprising different bibliographic resources/databases. The preferred reporting items for systematic reviews and meta-analyses criteria were applied to prepare the draft of the report. Quantitative and qualitative original studies were included. Opinion or review studies not written in English, Portuguese, Italian, French, or Spanish were excluded. RESULTS We identified 202 studies, of which 180 were excluded and 22 were enrolled [two enrolling healthcare professionals, 10 enrolling other type of participants (including patients), three focused on adverse reactions, and 7 descriptive studies]. The package leaflets presented various readability problems, such as complex and difficult to understand texts, small font size, or few illustrations. The main methods to assess the readability of the package leaflet were usability tests or legibility formulae. Limitations with these methods included reduced number of participants; lack of readability formulas specifically validated for specific languages (e.g., Portuguese); and absence of an assessment on patients literacy, health knowledge, cognitive skills, levels of satisfaction, and opinions. CONCLUSIONS Overall, the package leaflets presented various readability problems. In this review, some methodological limitations were identified, including the participation of a limited number of patients and healthcare professionals, the absence of prior assessments of participant literacy, humor or sense of satisfaction, or the predominance of studies not based on role-plays about the use of medicines. These limitations should be avoided in future studies and be considered when interpreting the results.
Topics: Comprehension; Consumer Health Information; Drug Labeling; Drug Packaging; Humans; Language
PubMed: 25741660
DOI: 10.1590/s0034-8910.2015049005559 -
Current Medical Research and Opinion Jan 2015Inadequate medication adherence is a widespread problem that contributes to increased chronic disease complications and health care expenditures. Packaging interventions... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Inadequate medication adherence is a widespread problem that contributes to increased chronic disease complications and health care expenditures. Packaging interventions using pill boxes and blister packs have been widely recommended to address the medication adherence issue. This meta-analysis review determined the overall effect of packaging interventions on medication adherence and health outcomes. In addition, we tested whether effects vary depending on intervention, sample, and design characteristics.
RESEARCH DESIGN AND METHODS
Extensive literature search strategies included examination of 13 computerized databases and 19 research registries, hand searches of 57 journals, and author and ancestry searches. Eligible studies included either pill boxes or blister packaging interventions to increase medication adherence. Primary study characteristics and outcomes were reliably coded. Random-effects analyses were used to calculate overall effect sizes and conduct moderator analyses.
RESULTS
Data were synthesized across 22,858 subjects from 52 reports. The overall mean weighted standardized difference effect size for two-group comparisons was 0.593 (favoring treatment over control), which is consistent with the mean of 71% adherence for treatment subjects compared to 63% among control subjects. We found using moderator analyses that interventions were most effective when they used blister packs and were delivered in pharmacies, while interventions were less effective when studies included older subjects and those with cognitive impairment. Methodological moderator analyses revealed significantly larger effect sizes in studies reporting continuous data outcomes instead of dichotomous results and in studies using pharmacy refill medication adherence measures compared with studies with self-report measures.
CONCLUSIONS
Overall, meta-analysis findings support the use of packaging interventions to effectively increase medication adherence. Limitations of the study include the exclusion of packaging interventions other than pill boxes and blister packs, evidence of publication bias, and primary study sparse reporting of health outcomes and potentially interesting moderating variables such as the number of prescribed medications.
Topics: Drug Packaging; Humans; Medication Adherence
PubMed: 25333709
DOI: 10.1185/03007995.2014.978939 -
JAMA Sep 2014Medication nonadherence, which has been estimated to affect 28% to 31% of US patients with hypertension, hyperlipidemia, and diabetes, may be improved by electronic... (Review)
Review
IMPORTANCE
Medication nonadherence, which has been estimated to affect 28% to 31% of US patients with hypertension, hyperlipidemia, and diabetes, may be improved by electronic medication packaging (EMP) devices (adherence-monitoring devices incorporated into the packaging of a prescription medication).
OBJECTIVES
To investigate whether EMP devices are associated with improved adherence and to identify and describe common features of EMP devices.
EVIDENCE REVIEW
Systematic review of peer-reviewed studies testing the effectiveness of EMP systems in the MEDLINE, EMBASE, PsycINFO, CINAHL, International Pharmaceutical Abstracts, and Sociological Abstracts databases from searches conducted to June 13, 2014, with extraction of associations between the interventions and adherence, as well as other key findings. Each study was assessed for bias using the Cochrane Handbook for Systematic Reviews of Interventions; features of EMP devices and interventions were qualitatively assessed.
FINDINGS
Thirty-seven studies (32 randomized and 5 nonrandomized) including 4326 patients met inclusion criteria (10 patient interface-only "simple" interventions and 29 "complex" interventions integrated into the health care system [2 qualified for both categories]). Overall, the effect estimates for differences in mean adherence ranged from a decrease of 2.9% to an increase of 34.0%, and the those for differences in the proportion of patients defined as adherent ranged from a decrease of 8.0% to an increase of 49.5%. We identified 5 common EMP characteristics: recorded dosing events and stored records of adherence, audiovisual reminders to cue dosing, digital displays, real-time monitoring, and feedback on adherence performance.
CONCLUSIONS AND RELEVANCE
Many varieties of EMP devices exist. However, data supporting their use are limited, with variability in the quality of studies testing EMP devices. Devices integrated into the care delivery system and designed to record dosing events are most frequently associated with improved adherence, compared with other devices. Higher-quality evidence is needed to determine the effect, if any, of these low-cost interventions on medication nonadherence and to identify their most useful components.
Topics: Drug Packaging; Electronics; Humans; Medical Informatics; Medication Adherence; Prescription Drugs; Randomized Controlled Trials as Topic; Reminder Systems
PubMed: 25247520
DOI: 10.1001/jama.2014.10059