Background
Spontaneous reporting of adverse drug reactions (ADRs) is an important source of information for post-marketing drug safety evaluation. Most countries have public access to reporting ...systems, but patients report only 3% of all ADRs. Little is known about factors affecting patient reporting. Our aim was to explore patients’ experiences reporting ADRs and their views on the usability of the Canadian Vigilance reporting forms on MedEffect.
Methods
An interpretive description qualitative study was used. Adults in Canada, who experienced an ADR, were invited to participate through social media (Kijiji, Facebook, Twitter) and by associations (e.g., Patients Canada or Canadian Arthritis Society). Participants were interviewed in English and French using structured interview guides. Inductive content analysis was used.
Results
Fifteen interviews were conducted from October 2014 to May 2015. Two participants reported ADRs to MedEffect, and others to physicians and/or pharmacists. Motives for reporting were intolerable side effect impacting daily activities and encouragement from others to report (e.g., family, colleagues). Factors that interfered with reporting were physicians normalized or minimized the side effect, confusion on what to report, no feedback after report submission to MedEffect, and previous experience with side effects. MedEffect forms were described as comprehensive and important, but its usability was affected by the number of questions and complexity of some questions.
Conclusions
Most participants were unaware of MedEffect and reported ADRs to physicians and pharmacists. Several barriers and motives affected patients’ reporting of ADRs. MedEffect form could be simplified for use by patients.
Aim
The aim of the present study was to determine the barriers and motives influencing consumer reporting of adverse drug reactions (ADRs).
Methods
A systematic review, guided by the Cochrane ...Handbook, was conducted. Electronic searches included MEDLINE, EMBASE, PsycINFO, CINAHL, PubMed and the Cochrane Database of Systematic Reviews from 1964 to December 2014. Eligible studies addressed patients' perceptions and factors influencing ADR reporting. Studies about healthcare professional (HCP) reporting of ADRs were excluded. Studies were appraised for quality, and results were analysed descriptively.
Results
Of 1435 citations identified, 21 studies were eligible. Studies were primarily conducted in the UK, the Netherlands and Australia. The identified barriers to patient reporting of ADRs (n = 15 studies) included poor awareness, confusion about who should report the ADR, difficulties with reporting procedures, lack of feedback on submitted reports, mailing costs, ADRs resolved and prior negative reporting experiences. The identified motives for patients reporting ADRs (n = 10 studies) were: preventing others from having similar ADRs, wanting personal feedback, improving medication safety, informing regulatory agencies, improving HCP practices, responding to HCPs not reporting their ADRs and having been asked to report ADRs by HCPs.
Conclusions
Most patients were not aware of reporting systems and others were confused about reporting. Patients were mainly motivated to make their ADRs known to prevent similar suffering in other patients. By increasing patient familiarity and providing clear reporting processes, reporting systems could better achieve patient reporting of ADRs.
The major hurdle in recovering from the COVID-19 pandemic would be the safe management of plastic waste generated from personal protective equipment and mitigating a plastic pollution crisis. ...Facemasks were adopted worldwide as the first line of defense against the COVID-19 pandemic, and their demand increased exponentially during the last few years. Through a life cycle assessment, this study aims to evaluate the environmental impacts of various facemasks available in the UAE market. SimaPro software was used to conduct a cradle-to-grave LCA, with a functional unit of "The number of face masks required by a person in UAE over a month (30 days)". Results show that the GWP (in kg CO2 eq) of 1 FU of surgical FM is 0.867, activated carbon FM is 1.11, N95 FM is 1.55, cloth FM is 0.642, and PLA FM is 0.946. Packaging increases the GWP by 36–178%. Long-distance transportation from China to UAE was identified to be a significant hotspot under GWP and FRS. Other hotspots include polypropylene material in filtration layers, aluminum in nosepieces, electricity usage in cloth masks, and disposal scenarios. Multiple supply chain optimizations are suggested, such as the substitution of recycled aluminum in nose pieces, the use of sustainable transportation, and limiting the use of packaging material to a bare minimum to improve the sustainability of the face mask industry.
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•SimaPro software was used to conduct a cradle-to-grave LCA study on facemasks.•N95 facemasks have highest impacts in all categories. Cloth mask has the lowest.•Long distance transportation was a major hotspot for GWP.•Packaging material accounts for 27–70% of total waste; increases GWP by 36–178%.•Supply chain optimization and raw material substitutions can reduce the environmental impacts.
The study aimed to investigate the association between sleeping behavior (specifically sleep duration), body mass index (BMI), eating habits, and psychological mood depression among adolescents in ...the Emirate of Abu Dhabi- UAE. A subsample of three hundred and ninety-five participants (209 females and 186 males) from middle and high schools (aged 12-18 years) in the emirate of Abu Dhabi completed the surveys in the presence of their parents and two research assistants. Measures of daytime sleepiness and other sleep parameters (sleep duration on weekdays and weekends), eating habits, and mood depression questionnaires were reported. Differences in BMI between males and females were statistically significant (26.12 ± 4.5 vs. 24.4 ± 4.3; p < 0.01). There was a negative linear association (p < 0.01) between the students' BMI and the weekday/ weekend sleep duration. The average weekday and weekend sleep duration ranged from 5.7 hours (weekdays) to 9.3 hours(weekend). The study showed that an increase in BMI was correlated to mood depression (r = 0.396, p<0.01). In terms of eating habits, there was a significant association between eating unhealthy food and sleep duration; 72.6% of students who slept less than 6 hours reported unhealthy eating habits (p <0.05). The study showed a clear association between short sleep duration and obesity among adolescents in the UAE. This relationship between sleep duration and obesity is less studied and less understandable. Future research about exploring how sleeping behaviors can affect obesity during adolescence can support understanding this association and create an effective intervention.
The COVID-19 pandemic impacted the psychosocial well-being of the United Arab Emirates UAE population like other communities internationally.
We aimed to identify the factors associated with ...psychological distress, fear, and coping amongst community members across the UAE.
We conducted a cross-sectional online survey across the UAE during November 2020. Adults aged ≥18 years, living in the UAE who were able to respond to an online questionnaire in English or Arabic were considered eligible to participate in the study. We used standard validated tools to measure psychological distress, fear and coping. Kessler Psychological Distress Scale K10 was used to assess psychological distress, Fear of COVID-19 Scale FCV-19S was used to assess the level of fear, and Brief Resilient Coping Scale BRCS was used to assess the coping strategies.
A total of 417 individuals participated in this study with a mean age of 29 ± 10.7 years. More than half of the participants experienced high to very high levels of psychological distress 55% and a quarter experienced high levels of fear of COVID-19 23.3% with almost a third of them 36.2% having low resilient coping. About 37.4% of the participants had work-related mental health impacts and 32.4% were perceived to have moderate to a great deal of distress due to a change of employment status during the pandemic. One in ten participants 9.4% reported increased smoking. Increased smoking AOR 8.66, 95% CIs 1.08-69.1,, increased alcohol drinking AOR 2.39, 95% CIs 1.05-5.47 and higher levels of fear of COVID-19 AOR 2.93, 95% CIs 1.83-4.67 were associated with moderate to very high levels of psychological distress. Being female AOR 1.82, p = 0.030, having a pre-existing mental health condition AOR 9.88, 95% p = 0.027, engaging in high-risk behaviors such as increased smoking AOR 21.14, p = 0.003, increased alcohol drinking AOR 1.48, p = 0.359 in the previous four weeks, and higher levels of fear of COVID-19 AOR 4.18, p <0.001 were associated with moderate to very high levels of psychological distress. Also, being a smoker AOR, 0.840, p = 0.011, and having a high level of fear AOR 0.372, p = 0.001 were found to be associated with low resilient coping.
Community members in the UAE are at a higher risk of psychosocial distress and fear during the COVID-19 pandemic. Thus, healthcare providers and policymakers would need to be more alert to provide specific mental health support strategies for their wellbeing.
Background
Monitoring adverse drug reactions (ADRs) through pharmacovigilance are vital to patient safety. Spontaneous ADR reporting is one method of pharmacovigilance, and in Canada all reporter ...types admitted to report an ADR to the Canadian Vigilance Program at Health Canada. Reports are submitted to Health Canada by post, telephone, or via the internet. The Canada Vigilance Program electronically records submitted information to detect medication safety alerts. Although previous studies have shown differences between patients and healthcare professionals (HCPs) on the types of drugs and reactions reported, relatively little is known about the importance of patient reports to pharmacovigilance activities. This article proposed a multi-method approach to evaluate the importance of patient ADR reporting on pharmacovigilance activities, by systematically review the available literature, comparing patient—versus HCPs-generated ADR reports that were submitted to the Canada Vigilance Program, and exploring patient views and experiences regarding the Canadian ADR reporting system.
Methods
Guided by a risk-perception theoretical lens, the proposed multi-methods research study will involve three phases. Phase I is a systematic review of all studies that analyse the factors influence ADR reporting by patients to the pharmacovigilance schemes. Phase II is a descriptive statistical analysis of all ADR reports received by the Canada Vigilance Program database between 1 January 2000 and 31 December 2014 from patients and HCPs to compare ADRs reported by patients with those reported by HCP reports in terms of ADR seriousness, ADR classification by system organ class, and the medication involved based on the anatomical therapeutic class system. In phase III, an interpretative descriptive approach will be used to explore patient’s views and experiences on ADR reporting and usability of the Canadian Vigilance ADR report. Participants will be purposefully selected to ensure diverse backgrounds and experiences. Interviews will be digitally-recorded, transcribed verbatim, and inductively analysed to identify themes. Patients will be interviewed until theoretical saturation is achieved.
Discussion
Findings from this research will highlight the role of the patients in directly reporting ADRs, and provide information that may guide streamline and optimizing patient ADR reporting. Policy makers, public health officials, and regulatory agencies will require this critical information in order to improve medication safety in Canada and worldwide.
Abstract
The unprecedented COVID-19 pandemic has caused socioeconomic, physical, mental, and environmental upheaval. Personal protective equipment, such as face masks, was mandatory to curb the ...spread of the virus. The unexpected increase in demand for face masks resulted in an alarming increase in plastic waste globally. The non-biodegradable nature of the raw materials and the potential threat of microplastic pollution amplify the problem. This puts a lot of pressure on policymakers and the global supply chain to develop long-term plans to make face masks less harmful. By reviewing existing life cycle assessment studies, this study aims to provide an overview on how sustainable face masks are. Various challenges in the facemask industry such as microplastic pollution and waste management are discussed. A critical analysis on the various process hotspots is also conducted. Recommendations from this study can motivate focused research into an important field and enable the transitions towards a sustainable facemask industry.
Some anthropometric, laboratory, and genetic variations, such as patatin-like phospholipase domain-containing protein 3 (PNPLA3) genetic variants, have been associated with nonalcoholic fatty liver ...disease (NAFLD). Liver biopsy is the most accurate NAFLD diagnostic method, but it is invasive; hence, noninvasive diagnostics are required for the early diagnosis and assessment of NAFLD.
This prospective case-control study included 107 NAFLD patients and 107 healthy controls. All individuals underwent anthropometric measurements, abdominal ultrasonography, laboratory tests, and evaluation for PNPLA3 polymorphisms.
Patients with NAFLD had higher levels of C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-α), and interleukin-6 (IL-6) than healthy individuals (p = 0.03, p < 0.0001). Additionally, patients with NAFLD had substantially lower albumin (P = 0.01) and leptin (P < 0.0001) levels than healthy individuals. BMI leptin and CRP levels were independent indicators of NAFLD severity (p = 0.05–0.004). GG is the most prevalent genotype in patients with moderate to severe NAFLD. A novel model based on four markers (leptin, CRP, BMI, and PNPLA3 polymorphism) was developed. The AUC values for distinguishing between the healthy subjects and those with varying degrees of NAFLD severity (mild, moderate, and severe) were 0.99, 0.99, and 1.0, respectively.
Anthropometric measurements, such as BMI and laboratory results, including liver enzymes, CRP, inflammatory markers, lipid parameters, and genetic markers, especially PNPLA3 polymorphisms, can provide an accurate, sensitive, and specific noninvasive approach for the early identification and assessment of NAFLD and can guide its management. This may minimize the need for liver biopsy to assess NAFLD. Further large-scale studies are needed to confirm these findings and verify the model in larger studies.
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