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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 -
Comprehensive Reviews in Food Science... May 2024The importance of food quality and safety lies in ensuring the best product quality to meet consumer demands and public health. Advanced technologies play a crucial role... (Review)
Review
The importance of food quality and safety lies in ensuring the best product quality to meet consumer demands and public health. Advanced technologies play a crucial role in minimizing the risk of foodborne illnesses, contamination, drug residue, and other potential hazards in food. Significant materials and technological advancements have been made throughout the food supply chain. Among them, quantum dots (QDs), as a class of advanced nanomaterials with unique physicochemical properties, are progressively demonstrating their value in the field of food quality and safety. This review aims to explore cutting-edge research on the different applications of QDs in food quality and safety, including encapsulation of bioactive compounds, detection of food analytes, food preservation and packaging, and intelligent food freshness indicators. Moreover, the modification strategies and potential toxicities of diverse QDs are outlined, which can affect performance and hinder applications in the food industry. The findings suggested that QDs are mainly used in analyte detection and active/intelligent food packaging. Various food analytes can be detected using QD-based sensors, including heavy metal ions, pesticides, antibiotics, microorganisms, additives, and functional components. Moreover, QD incorporation aided in improving the antibacterial and antioxidant activities of film/coatings, resulting in extended shelf life for packaged food. Finally, the perspectives and critical challenges for the productivity, toxicity, and practical application of QDs are also summarized. By consolidating these essential aspects into this review, the way for developing high-performance QD-based nanomaterials is presented for researchers and food technologists to better capitalize upon this technology in food applications.
Topics: Food Contamination; Food Microbiology; Food Packaging; Food Quality; Quantum Dots
PubMed: 38578165
DOI: 10.1111/1541-4337.13339 -
CNS Spectrums Aug 2014Beyond its formal indications (epilepsy, bipolar disorder, and migraine), valproate sodium (VPA) is widely used in a number of other clinical conditions. Recently,... (Review)
Review
Beyond its formal indications (epilepsy, bipolar disorder, and migraine), valproate sodium (VPA) is widely used in a number of other clinical conditions. Recently, however, the U.S. Food and Drug Administration (FDA) issued a warning regarding a decrease in IQ scores in children prenatally exposed to the drug. For patients with migraine, the pregnancy labeling of VPA will be changed from Category "D" to "X." VPA products will remain in pregnancy category "D" for treating epilepsy and manic episodes associated with bipolar disorder. Thus, this article aims to assess (through a computerized Medline/PubMed search) the neurobehavioral teratogenicity of valproate monotherapy, in order to evaluate alternative regulatory decisions. Reviewed information suggests a detrimental impact of antenatal valproate exposure on the global child neurodevelopment. Affected areas include not just reduced IQ scores, but also behavioral problems and a potential increase in the risk for a future diagnosis of attention-deficit/hyperactivity disorder. An increased risk of developing autism-spectrum disorders has also been reported. Thus, in my opinion, VPA should be assigned definitively to the Category "X," independent of any considerations about its clinical indications, and should be strictly avoided during pregnancy, due to the demonstrated risk of both neurobehavioral and neurocognitive teratogenicity.
Topics: Anticonvulsants; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Bipolar Disorder; Drug Labeling; Epilepsy; Female; Humans; Intellectual Disability; Migraine Disorders; Pregnancy; Pregnancy Complications; Prenatal Exposure Delayed Effects; Teratogenesis; United States; United States Food and Drug Administration; Valproic Acid
PubMed: 24571806
DOI: 10.1017/S1092852913000990 -
JMIR Public Health and Surveillance Jan 2024Drug-induced suicide (DIS) is a severe adverse drug reaction (ADR). Although clinical trials have provided evidence on DIS, limited investigations have been performed on... (Review)
Review
BACKGROUND
Drug-induced suicide (DIS) is a severe adverse drug reaction (ADR). Although clinical trials have provided evidence on DIS, limited investigations have been performed on rare ADRs, such as suicide.
OBJECTIVE
We aimed to systematically review case reports on DIS to provide evidence-based drug information.
METHODS
We searched PubMed to obtain case reports regarding DIS published until July 2021. Cases resulting from drugs that are no longer used or are nonapproved, substance use, and suicidal intentions were excluded. The quality of each case report was assessed using the CASE (Case Reports) checklist. We extracted data regarding demographics, medication history, suicide symptoms, and symptom improvement and evaluated the causality of DIS using the Naranjo score. Furthermore, to identify the potential suicidal risk of the unknown drugs, we compared the results of the causality assessment with those of the approved drug labels.
RESULTS
In 83 articles, we identified 152 cases involving 61 drugs. Antidepressants were reported as the most frequent causative drugs of DIS followed by immunostimulants. The causality assessment revealed 61 cases having possible, 89 cases having probable, and 2 cases having definite relationships with DIS. For approximately 85% of suspected drugs, the risk of suicidal ADRs was indicated on the approved label; however, the approved labels for 9 drugs, including lumacaftor/ivacaftor, doxycycline, clozapine, dextromethorphan, adalimumab, infliximab, piroxicam, paclitaxel, and formoterol, did not provide information about these risks.
CONCLUSIONS
We found several case reports involving drugs without suicide risk information on the drug label. Our findings might provide valuable insights into drugs that may cause suicidal ADRs.
Topics: Humans; Doxycycline; Drug Labeling; Drug-Related Side Effects and Adverse Reactions; Suicidal Ideation; Suicide; Case Reports as Topic
PubMed: 38289650
DOI: 10.2196/49755 -
Age and Ageing Oct 2022Difficulty opening medication packaging can have serious consequences that can lead to patient harm via medication mismanagement or poor adherence. However, the quality...
Difficulty opening medication packaging can have serious consequences that can lead to patient harm via medication mismanagement or poor adherence. However, the quality of literature pertaining to these issues has yet to be collated and critiqued. This systematic review examined cross-sectional studies that objectively examined the ability of participants to open different medication packaging. Of the 8,692 studies identified, 12 met the inclusion criteria, all of which were direct observational studies given that prior research has identified a mismatch between self-report and actual ability. Scoring via the Appraisal Tool for Cross Sectional Studies revealed that the methodological quality of included studies was typically low. Study samples mostly consisted of older adults. All studies reported a non-negligible proportion of participants unable to open packaging, with the most difficulty associated with child-resistant containers. Several studies examined associations; however, no factor was consistently found to be significantly associated with the ability to open packaging. Despite these studies spanning >40 years, the packaging types examined remained largely the same. This suggests that, despite decades of research demonstrating that packaging is problematic, there has been a stagnation in medication packaging development. Whether this is attributed to a paucity of high-quality research, and therefore a lack of strong evidence that change is needed, is unclear. Future research should strive for better methodological quality, with generalisable cohorts assessed via observation in their home. If the problems identified in prior research persist, this may provide the impetus for change that is overdue in the medication packaging industry.
Topics: Humans; Aged; Cross-Sectional Studies; Drug Packaging; Medication Adherence
PubMed: 36273346
DOI: 10.1093/ageing/afac225 -
Progress in Neuro-psychopharmacology &... Aug 2018The empirical approach to drug choice and dosing in depression often results into inadequate response and side effects. Pharmacogenetic (PGx) testing appears a promising... (Comparative Study)
Comparative Study
The empirical approach to drug choice and dosing in depression often results into inadequate response and side effects. Pharmacogenetic (PGx) testing appears a promising way to implement personalized treatments. A systematic review was performed to identify available PGx tests, compare the genes they include with clinical guidelines and drug labels, and assess the quality of published clinical studies. ~40 commercial PGx tests are available and potential benefits were estimated for nine of them by clinical studies. The most part of studies are observational (9/21) or non-randomized case-control trials that compared standard care with PGx-guided treatment (6/21), six randomized controlled trials (RCTs) are available. The only genes included in all the available PGx tests and with recommendations in current clinical guidelines and drug labels are CYP2D6 and CYP2C19. There is heterogeneity among outcome measures across studies (response, remission, improvement, health care utilization, medication tolerability), as well as in trial design. Relatively weak clinical benefits were reported by RCTs and higher clinical benefits by non-RCTs, but the last group showed greater risk of bias. Lack of patient and rater's blindness, retrospective design and possible confounders (concomitant medications and medical diseases, lack of wash out prior to inclusion, no assessment of compliance etc.) were the main issues. Estimations of cost savings provided heterogeneous findings. Variants in CYP2D6 and CYP2C19 have already adequate support for clinical application. The development of future PGx tests should include best practices for clinical evidence development and for health economic assessment.
Topics: Clinical Trials as Topic; Depression; Drug Labeling; Genetic Testing; Humans; Pharmacogenetics; Practice Guidelines as Topic
PubMed: 29777729
DOI: 10.1016/j.pnpbp.2018.05.007 -
PloS One 2021Correct interpretation of drug labels instructions (DLIs) is needed for safe use and better adherence to prescribed drugs. DLIs are often too difficult for patients,...
INTRODUCTION
Correct interpretation of drug labels instructions (DLIs) is needed for safe use and better adherence to prescribed drugs. DLIs are often too difficult for patients, especially for those with limited health literacy. What is yet unknown, is how specific textual elements in DLIs (e.g., the presentation of numbers, or use of medical jargon) and patients' health literacy skills are related to the comprehension of DLIs. In order to provide concrete directions for health professionals on how to optimize drug prescriptions, we performed a systematic review to summarize the available research findings on which textual elements facilitate or hinder the correct interpretation of DLIs in relation to patients' health literacy.
METHOD
A systematic search was performed in PubMed, EMBASE, PsychINFO, and Smartcat (until April 2019) to identify studies investigating textual elements that facilitate or hinder the correct interpretation of DLIs in relation to patients' health literacy.
RESULTS
A total of 434 studies were identified of which 28 studies met our inclusion criteria. We found that textual elements contributing to the correct interpretation of DLIs were: using explicit time periods in dosage instructions, using plain language, presenting numbers in a numerical format, and providing DLIs in patients' native language. Multistep instructions per instruction line, using abbreviations and medical jargon seem to hinder the correct interpretation of DLIs. Although health literacy was taken into account in a majority of the studies, none of them assessed the effectiveness of specific textual elements on patients' comprehensibility of DLIs.
CONCLUSION
Based on our findings, we provide an overview of textual elements that contribute to the correct interpretation of DLIs. Optimizing the textual instruction on drug labels may increase the safety and adherence to prescribed drugs, taking into account that a significant proportion of patients has low health literacy.
Topics: Comprehension; Drug Labeling; Health Literacy; Humans; Medical Writing
PubMed: 34010291
DOI: 10.1371/journal.pone.0250238 -
Hu Li Za Zhi the Journal of Nursing Aug 2017Anti-cancer chemotherapy may cause skin-toxicity reactions. Different types of cooling packages affect chemotherapy-induced skin toxicity reactions differently. (Review)
Review
BACKGROUND
Anti-cancer chemotherapy may cause skin-toxicity reactions. Different types of cooling packages affect chemotherapy-induced skin toxicity reactions differently.
PURPOSE
To evaluate the effects of cooling packing care on chemotherapy-induced skin toxicity reactions in cancer patients receiving chemotherapy.
METHODS
A systematic review approach was used. Searches were conducted in databases including Cochrane Library, Embase, MEDLINE, PubMed and Airiti Library using the keywords "chemotherapy cutaneous toxicity", "chemotherapy skin reaction", "chemotherapy skin toxicity", "frozen glove", "frozen sock", "cooling packaging care", "ice gloves", "ice socks", "usual care", "severity", "comfort", "satisfaction", "severity", and "comfort". The search focused on articles published before December 2016. Based on the inclusion and exclusion criteria, 5 articles involving relevant randomized controlled trials were extracted for review.
RESULTS
Elasto-Gel ice gloves or ice socks that were chilled to -25°C- -30°C and used for 15 mins during initial chemotherapy, for one hour during chemotherapy infusion, and for 15 mins after chemotherapy were shown to improve the frequency and severity of chemotherapy-induced skin toxicity reactions. Several studies were limited by small sample sizes and different types of cooling packing programs, temperature, timing, and frequency. Thus, further research is recommended to verify the effects of cooling packing care.
CONCLUSIONS / IMPLICATIONS FOR PRACTICE
Cancer patients who were treated with docetaxel or PLD and who used ice gloves or ice socks that were chilled to -25°C- -30°C for 15 mins during initial chemotherapy, for one hour during chemotherapy infusion, and for 15 mins after chemotherapy improved significantly in terms of the frequency and severity of their chemotherapy-induced skin toxicity reactions. Local cooling packing care is a non-pharmacotherapy approach that is low cost and free of side effects. This review is intended to provide a reference for clinical care.
Topics: Antineoplastic Agents; Cold Temperature; Humans; Neoplasms; Skin
PubMed: 28762226
DOI: 10.6224/JN.000055 -
Zhongguo Zhong Yao Za Zhi = Zhongguo... Sep 2016To systematically review the medication safety of Xiyanping injection in conformity with indications of package inserts. Eight databases at home and abroad were searched... (Review)
Review
To systematically review the medication safety of Xiyanping injection in conformity with indications of package inserts. Eight databases at home and abroad were searched for studies on the safety of Xiyanping injection. Literature screening, quality assessment, data extraction and analysis were performed according to internationally recognized inclusion and exclusion criteria. There were 118 clinical studies included, and 94 studies were finally studied, including 70 randomized controlled trials and eight non-randomized controlled trials, involving 16 case reports, and 4 716 patients treated with Xiyanping injection, with 148 adverse drug reactions(ADR) and no adverse event(AE). Among them, 15 cases reported serious adverse drug reactions, including 1 vegetative state, 4 allergic shock and other general cardiovascular damages. Diarrhea was the most commonly reported ADR among the 133 general adverse reactions, accounting for 30.12%, which was followed by rash. Most of the studies adopted the dosage set forth in package inserts. Some current evidences showed that irrational combined administration and use of Xiyanping may cause some ADRs. Because the most of studies didn't report the medication process and patient conditions, we can't infer the relations between the ADR and the age or solvent. Clinicians shall judge the causality according to relevant provisions and standards, and report ADRs, so as to provide more evidences for evaluating the safety of the drug.
Topics: Diarrhea; Drug Labeling; Drug-Related Side Effects and Adverse Reactions; Drugs, Chinese Herbal; Humans; Injections; Non-Randomized Controlled Trials as Topic; Randomized Controlled Trials as Topic
PubMed: 28925133
DOI: 10.4268/cjcmm20161824 -
Patient Education and Counseling Aug 2018To present evidence supporting best-practices for prescription drug labeling and educational materials.
OBJECTIVE
To present evidence supporting best-practices for prescription drug labeling and educational materials.
METHODS
Articles were selected from three online databases (PubMed, Embase, CINAHL). Eligible manuscripts were: 1) English-language, 2) randomized, controlled trials, and 3) focused on improving prescription drug labeling practices.
RESULTS
Forty-nine articles were reviewed, and included both regulated label materials and pharmacy or health systems-generated tools. Best-practices included use of plain language principles, typographic cues, quantitative descriptors, and standardized formats, when applicable. Common outcomes included preference and comprehension, while few studies examined actual medication use (e.g. adherence, harms) or clinical health outcomes. Approximately half of studies directly engaged patients' perspectives in intervention development, which may have helped increase tool effectiveness.
CONCLUSIONS
Several best practices were apparent in the literature, particularly for written materials and pharmacy-generated container labeling. Design principles for supplemental instructions and multimedia tools were less cohesive, albeit less researched. The impact of patient involvement in tool design is promising, though requiring further study.
PRACTICE IMPLICATIONS
Definitive studies to inform practice standards on how to best communicate medication information to consumers are needed, especially as communication modalities continue to evolve. Increased research on if and how to incorporate patient-centered decision-making into the development process should be considered.
Topics: Drug Labeling; Humans; Patient Education as Topic; Patient Participation; Prescription Drugs
PubMed: 29548600
DOI: 10.1016/j.pec.2018.03.012