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Sexually Transmitted Diseases Dec 2020The majority of research on patient-delivered partner therapy (PDPT) has focused on its impact on reinfections. This study aimed to systematically review the evidence...
BACKGROUND
The majority of research on patient-delivered partner therapy (PDPT) has focused on its impact on reinfections. This study aimed to systematically review the evidence regarding the acceptability of PDPT by patients and partners for chlamydia infection.
METHODS
Three electronic databases were searched in March 2019 using terms related to PDPT. Studies were included if they reported on patient or partner acceptance of PDPT for chlamydia and were conducted in high-income countries. Actual and perceived acceptabilities of PDPT were assessed.
RESULTS
Thirty-three studies were included: 24 quantitative, 3 qualitative, and 6 mixed methods. Most were clinic based. Quantitative data showed that participants' perceived willingness to give PDPT to their partner(s) ranged from 44.7% to 96.3% (median, 84%), and 24% to 71% (median, 65%) of people who offered PDPT for their partner(s) accepted it. Partners' perceived willingness to accept ranged from 42.7% to 67% (median, 62%), and actual acceptance ranged from 44.7% to 80% (median, 77%). Those in longer-term relationships were generally more likely to accept PDPT; however, beyond this, we identified few clear trends. Qualitative studies found that convenience of PDPT and assurance of partner treatment were benefits, whereas partners not seeing a health care professional was viewed as a downside. Packaging that appeared legitimate and coaching on delivering PDPT were facilitators.
CONCLUSIONS
Because patients bear responsibility for the success of PDPT, this information is crucial in clinical settings. Acceptance, perceived and real, of PDPT was generally high. Patients are best placed to determine whether PDPT is appropriate for them, and it should be offered as an option.
Topics: Ambulatory Care Facilities; Anti-Bacterial Agents; Chlamydia; Chlamydia Infections; Chlamydia trachomatis; Contact Tracing; Gonorrhea; Humans; Pregnant Women; Sexual Partners
PubMed: 32740451
DOI: 10.1097/OLQ.0000000000001260 -
BMC Public Health Jul 2020The United States (US) Food and Drug Administration (FDA), under the 2009 Family Smoking Prevention and Tobacco Control Act, banned characterizing flavors in cigarettes;...
BACKGROUND
The United States (US) Food and Drug Administration (FDA), under the 2009 Family Smoking Prevention and Tobacco Control Act, banned characterizing flavors in cigarettes; however, mentholated tobacco products were exempt. Since 2009, over 20 US jurisdictions and numerous countries around the world have extended this restriction to menthol. Currently, the FDA is reconsidering its position on a nation-wide menthol cigarette ban. However, the effects of such a ban remain unclear. We conducted a scoping review to explore the impact of a menthol cigarette ban on individual behaviors (initiation, cessation, and product switching), sales, and compliance.
METHODS
We conducted a search of the international literature using PubMed, EBSCO, and Web of Science (to November 25, 2019). We retrieved articles relevant to the impacts of an implemented or hypothetical menthol ban. We also included studies of flavored tobacco product bans due to their potential relevance in gauging compliance and product substitutability.
RESULTS
The search identified 493 articles, of which 24 were included. Studies examined the effects of implemented menthol bans (n = 6), hypothetical menthol bans (n = 12) and implemented flavor bans that exclude menthol (n = 6). Menthol bans were found to reduce sales and increase smoking cessation with only partial substitution for non-menthol cigarettes. US smokers' reactions to a hypothetical ban indicate that about 25-64% would attempt to quit smoking and 11-46% would consider switching to other tobacco products, including 15-30% to e-cigarettes. Flavor ban studies indicate reductions in initiation of 6%. Ban compliance was high, but studies indicate that the tobacco industry and retailers have attempted to circumvent their impact via packaging changes and online sales.
CONCLUSION
Our review finds that extending the US cigarette flavor ban to menthol products would promote smoking cessation and reduce initiation. This evidence supports further action by the FDA towards mentholated tobacco products. However, few studies have been conducted in the vaping era.
Topics: Cigarette Smoking; Commerce; Flavoring Agents; Humans; Menthol; Smoking Cessation; Taste; Tobacco Industry; Tobacco Products; United States; United States Food and Drug Administration
PubMed: 32641026
DOI: 10.1186/s12889-020-09055-z -
Journal of Patient Safety Dec 2021The aim of the study was to evaluate the effectiveness of interventions designed to reduce problems with readability and comprehensibility in drug labels.
OBJECTIVE
The aim of the study was to evaluate the effectiveness of interventions designed to reduce problems with readability and comprehensibility in drug labels.
METHODS
A systematic review of observational and experimental studies was conducted using MEDLINE (via PubMed), Embase, and Scopus databases. Two independent reviewers selected articles and collected data about study design, interventions, and outcomes.
RESULTS
Of 1786 studies screened, 17 were included in this systematic review. The main findings were described according to the type of intervention in the drug package or label: color-coded labels (7 studies); changes in information layout (5 studies); changes in font size (3 studies); and interventions involving look-alike/sound-alike (LASA) drugs (3 studies). Color changes were important both for healthcare professionals to improve safety in hospital practice and for medication users to differentiate between the types of insulin. Layout changes were effective and included highlighting key information, such as medication name, dose, and instructions. Increased font size yielded good results in the recognition and identification of medications mainly for the population with impaired vision. This review was limited by the heterogeneity of interventions and populations studied, as well as the small number of high-quality studies, which prevented meta-analysis across any one intervention or outcome.
CONCLUSIONS
All studies reported positive results for the proposed interventions. In the case of LASA drug names, the use of resources beyond Tall Man lettering (such as color and highlighting) reduced recognition errors, which may contribute to the development of new strategies to improve safety in the use of LASA drugs.
Topics: Comprehension; Drug Labeling; Drug Packaging; Humans; Male; Pharmaceutical Preparations; Product Labeling
PubMed: 32251242
DOI: 10.1097/PTS.0000000000000619 -
Pharmacotherapy May 2020Among pharmacodynamic and pharmacokinetic drug-drug interactions (DDIs), psychotropic drug-drug interactions (pDDIs) are of particular interest because...
Among pharmacodynamic and pharmacokinetic drug-drug interactions (DDIs), psychotropic drug-drug interactions (pDDIs) are of particular interest because psychopharmacologic agents mark one of the fastest growing therapeutic drug classes over the past 2 decades, and prescribing multiple psychotropic drugs has become increasingly prevalent in clinical practice. However, the documentation of pDDIs across drug references has lacked consistency. Thus we set out to review the primary evidence directly supporting 58 pDDIs that were uniformly reported as "major" or "contraindicated" in three prominent drug references: Clinical Pharmacology, Micromedex, and Lexicomp. We identified 134 citations from Micromedex in December 2017 and 4251 citations from Medline in March 2018 involving any of the 58 pDDIs. The included articles directly observed a clinical adverse effect or effects on drug plasma concentrations from the concomitant use of the two listed drugs in each pDDI. These articles were classified as controlled studies (e.g., randomized controlled trials, clinical trials, or observational studies) or uncontrolled studies (case reports). A total of 124 studies with 2716 patients were included in this review. Commonly evaluated adverse effects related to the studied pDDIs included decreased effectiveness, central nervous system depression, neurotoxicity, QT-interval prolongation, and serotonin syndrome. Among the 58 pDDIs, 18 (31%) were not supported by any primary studies. Among the remaining 35 pDDIs supported by studies on clinical adverse effects, only 14 (40%) included evidence from controlled study designs. Only 7 (12.1%) of the 58 pDDIs had evidence from studies with a combined sample size of more than 100 patients. This literature review highlights the poor quality of evidence supporting major or contraindicated psychotropic DDI warnings. Most DDIs lacked support from controlled studies that evaluated clinically significant adverse effects, leaving uncertainty about the clinical relevance of the warning. More postmarketing studies are needed to evaluate the safety of psychotropic combination therapy.
Topics: Drug Interactions; Drug Labeling; Drug-Related Side Effects and Adverse Reactions; Humans; Psychotropic Drugs
PubMed: 32107798
DOI: 10.1002/phar.2382 -
Journal of Gerontological Nursing Mar 2020Poor adherence to complex medication regimens is a global problem that affects the treatment of chronic diseases, which involves polypharmacy and requires long-term...
Poor adherence to complex medication regimens is a global problem that affects the treatment of chronic diseases, which involves polypharmacy and requires long-term administration of medications. The most significant barrier to medication adherence in older adults is patient-related factors. The purpose of this study was to find evidence from the current literature to evaluate the effectiveness of electronic medication packaging (EMP) devices on improving medication adherence in older patients. MEDLINE and EMBASE databases were searched based on inclusion/exclusion criteria, focusing on medication adherence and EMP devices with specific technological features. Search results included studies with experiences of patients with four different devices and various medical conditions. Study results indicated that EMP devices may improve medication adherence in older patients. However, due to insufficient evidence that supports their effectiveness specifically in the aging population, further clinical validation in older adults is recommended to draw strong conclusions. [Journal of Gerontological Nursing, 46(3), 27-36.].
Topics: Aged; Aged, 80 and over; Chronic Disease; Drug Packaging; Electronics; Female; Humans; Male; Medication Adherence; Reminder Systems
PubMed: 32083699
DOI: 10.3928/00989134-20200129-01 -
Pharmacoepidemiology and Drug Safety Mar 2020The need for drug-related safety warnings is undisputed, and their impact should also be evaluated. This systematic review investigates and assesses the impact of safety...
PURPOSE
The need for drug-related safety warnings is undisputed, and their impact should also be evaluated. This systematic review investigates and assesses the impact of safety warnings on drug therapy.
METHODS
Studies published in English between January 1998 and December 2018 were searched in EMBASE and MEDLINE, complemented by manual search. Randomised controlled trials, cohort studies with a before/after component, and case-control studies were included, selected to predefined criteria, and assessed for their reporting and methodological quality.
RESULTS
Out of 7454 references identified, 72 studies were included. A total of 28/72 (39%) studies described the impact of safety warnings on drug therapy as being effective, whereas 12/72 (17%) studies did not. Further, 26/72 (36%) studies described a partial implementation of the warnings (one part of the warning had an impact on drug therapy and another did not). Unintended effects were investigated in 6/72 (8%) studies. While 34 (47%) studies examined safety warnings on psychotropic drugs using an interrupted time series (ITS) design (53%), a before/after (26%), and a time series design (21%), 38 (53%) studied other substances using an ITS design (34%), a before/after (40%), and a time series design (26%). The proportion of an effective impact on drug therapy was lower in the "psychotropic drugs" group (23%) than in the "others" group (53%).
CONCLUSION
Drug-related safety warnings induce intended and unintended effects. The included studies are of broadly varying methodological quality. To better compare their effectiveness, studies should be conducted using standardised procedures.
Topics: Case-Control Studies; Drug Labeling; Drug-Related Side Effects and Adverse Reactions; Humans; Interrupted Time Series Analysis; Pharmaceutical Preparations
PubMed: 32045502
DOI: 10.1002/pds.4968 -
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 -
Expert Review of Clinical Pharmacology Apr 2019Research on medication use aims at assessing how much of current pharmacotherapy is rational. In neonates, this is hampered by extensive off-label drug use and limited...
Research on medication use aims at assessing how much of current pharmacotherapy is rational. In neonates, this is hampered by extensive off-label drug use and limited knowledge. Areas covered: We report on medication use research and have conducted a systematic review of observational studies on medication use to provide an updated overview on characteristics, objectives, methods, and patterns in hospitalized neonates. Moreover, a review on aspects of medication use for opioids, anti-epileptics, gastric acid-related disorders and respiratory stimulants with emphasis on trends and impact of interventions is presented, illustrating how research on medication use can contribute to improved neonatal pharmacotherapy and more focused research. Medication use reports describe patterns and provide signals on irrational use, benchmarking, or can guide research priorities. Moreover, this may generate information on how neonatal health topics and their pharmacotherapy are handled over time or across regions. Expert opinion: Research on medicine utilization is relevant, since it will inform us on aspects like trends, variability, or about the impact and pattern of implementation of guidelines in neonates. Further progress necessitates to merge datasets on medication use with clinical characteristics, and perinatal drug use remains an area in need of additional research.
Topics: Drug Labeling; Humans; Infant, Newborn; Infant, Newborn, Diseases; Intensive Care Units, Neonatal; Off-Label Use; Pharmaceutical Preparations; Practice Guidelines as Topic; Practice Patterns, Physicians'
PubMed: 30741041
DOI: 10.1080/17512433.2019.1580569 -
Journal of Pharmaceutical and... Mar 2019In recent years, there has been a very active debate about the stability of drug products especially after exceeding the expiry dates. The regulatory authorities require...
In recent years, there has been a very active debate about the stability of drug products especially after exceeding the expiry dates. The regulatory authorities require comprehensive stability data for market approval. The shelf-life obtained determines the expiry date, which is typically between 1 and 5 years and commonly set in a conservative manner. Conducting stability studies is a resource- and time-consuming matter for the pharmaceutical manufacturer. Short shelf-lives of drug products are also a challenge for managers of hospitals, nursing homes, and strategic national stockpile agencies which have to dispose of large quantities of outdated medicines every year. This conflict raises the question whether shelf-lives are often longer than the labeled one. In the past years, the FDA has launched several programs for shelf-life extension in order to defer replacement costs and to prevent drug shortages due to supply disruption. The aim of this review was to bring together the available literature of expired drug products as well as historical pharmaceutical relicts with an age of more than 80 years and to discuss the actual shelf-life with regard to the respective dosage form and the affiliation of the drug class. It seems to be reasonable for a large portion of drugs to extend the expiry dates far beyond five years.
Topics: Dosage Forms; Drug Labeling; Drug Stability; Pharmaceutical Preparations; Quality Control; Time Factors
PubMed: 30660807
DOI: 10.1016/j.jpba.2019.01.016 -
The American Journal of Forensic... Mar 2019A systematic review of the literature regarding drug packaging methods in body packing and materials used is presented, with the aim (a) to summarize data regarding the...
A systematic review of the literature regarding drug packaging methods in body packing and materials used is presented, with the aim (a) to summarize data regarding the packaging methods adopted by drug trafficking organizations, (b) to support forensic pathologists and police forces to classify and describe drug packages, (c) to propose a new classification for drug packaging techniques, and (d) to better clarify the impact of packaging methods on radiological detectability.Packaging methods have been described in 2981 cases, permitting us to summarize the different materials used and to propose a new classification for packaging method based on the materials used. Information concerning the affiliation of body packers and pushers with major (or not) drug trafficking organizations and techniques used to reduce the radiological detectability of the concealed drugs have also been collected.Besides the packaging methods described over the years, our study suggests a standardized approach for the description of drug packages based on the use of different materials and packaging procedures, which provide a possible insight to the type of drug trafficking organization involved.
Topics: Body Packing; Drug Packaging; Drug Trafficking; Foreign Bodies; Forensic Medicine; Humans; Illicit Drugs
PubMed: 30308547
DOI: 10.1097/PAF.0000000000000436