Patient-centered pharmacovigilance: priority actions from the inherited bleeding disorders community.

Pharmacovigilance, the science and practice of monitoring the effects of medicinals and their safety, is the responsibility of all stakeholders involved in the development, manufacture, regulation, distribution, prescription, and use of drugs and devices. The patient is the stakeholder most impacted by and the greatest source of information on safety issues. It is rare, however, for the patient to take a central role and exert leadership in the design and execution of pharmacovigilance. Patient organizations in the inherited bleeding disorders community are among the most established and empowered, particularly in the rare disorders. In this review, two of the largest bleeding disorders patient organizations, Hemophilia Federation of America (HFA) and National Hemophilia Foundation (NHF), offer insights into the priority actions required of all stakeholders to improve pharmacovigilance. The recent and ongoing increase in incidents raising safety concerns and a therapeutic landscape on the cusp of unprecedented expansion heighten the urgency of a recommitment to the primacy of patient safety and well-being in drug development and distribution. Plain Language Summary: Patients at the center of product safety Every medical device and therapeutic product has potential benefits and harms. The pharmaceutical and biomedical companies that develop them must demonstrate that they are effective, and the safety risks are limited or manageable, for regulators to approve them for use and sale. After the product has been approved and people are using it in their daily lives, it is important to continue to collect information about any negative side effects or adverse events; this is called pharmacovigilance. Regulators, like the United States (US) Food and Drug Administration, the companies that sell and distribute the products, and healthcare professionals who prescribe them are all required to participate in collecting, reporting, analyzing, and communicating this information. The people with the most firsthand knowledge of the benefits and harms of the drug or device are the patients who use them. They have an important responsibility to learn how to recognize adverse events, how to report them, and to stay informed of any news about the product from the other partners in the pharmacovigilance network. Those partners have a crucial responsibility to provide clear, easy-to-understand information to patients about any new safety concerns that come to light. The community of people with inherited bleeding disorders has recently encountered problems with poor communication of product safety issues, prompting two large US patient organizations, National Hemophilia Foundation and Hemophilia Federation of America, to hold a Safety Summit with all the pharmacovigilance network partners. Together they developed recommendations to improve the collection and communication of information about product safety so that patients can make well-informed, timely decisions about their use of drugs and devices. This article presents these recommendations in the context of how pharmacovigilance is supposed to work and some of the challenges encountered by the community.

Maternal emotional feeding practices and adolescent daughters' emotional eating: Mediating roles of avoidant and preoccupied coping.

The current study examined the link between early childhood emotional feeding and adolescent girls' emotional eating, using maladaptive coping styles as the underlying mechanisms mediating these associations. We examined adolescent girls' and mothers' retrospective reports of emotional feeding during childhood, as well as adolescent girls' current reports of their coping behaviors (i.e., preoccupied and avoidant) and emotional eating. Findings showed that adolescent girls' and mothers' retrospective reports of early emotional feeding were positively associated with adolescent girls' emotional eating. Preoccupied coping, but not avoidant coping, mediated the associations between early emotional feeding (reported by adolescents and mothers) and adolescents' current emotional eating. In conclusion, findings suggest that early childhood feeding experiences are linked to the development of maladaptive coping and emotional eating among adolescent girls.

Long-term aging and degradation of microplastic particles: Comparing in situ oceanic and experimental weathering patterns.

Polypropylene, low-density polyethylene, and high-density polyethylene pre-production plastic pellets were weathered for three years in three experimental treatments: dry/sunlight, seawater/sunlight, and seawater/darkness. Changes in chemical bond structures (hydroxyl, carbonyl groups and carbon-oxygen) with weathering were measured via Fourier Transform Infrared (FTIR) spectroscopy. These indices from experimentally weathered particles were compared to microplastic particles collected from oceanic surface waters in the California Current, the North Pacific Subtropical Gyre, and the transition region between the two, in order to estimate the exposure time of the oceanic plastics. Although chemical bonds exhibited some nonlinear changes with environmental exposure, they can potentially approximate the weathering time of some plastics, especially high-density polyethylene. The majority of the North Pacific Subtropical Gyre polyethylene particles we measured have inferred exposure times>18months, with some >30months. Inferred particle weathering times are consistent with ocean circulation models suggesting a long residence time in the open ocean.

Scales of spatial heterogeneity of plastic marine debris in the northeast pacific ocean.

Plastic debris has been documented in many marine ecosystems, including remote coastlines, the water column, the deep sea, and subtropical gyres. The North Pacific Subtropical Gyre (NPSG), colloquially called the "Great Pacific Garbage Patch," has been an area of particular scientific and public concern. However, quantitative assessments of the extent and variability of plastic in the NPSG have been limited. Here, we quantify the distribution, abundance, and size of plastic in a subset of the eastern Pacific (approximately 20-40°N, 120-155°W) over multiple spatial scales. Samples were collected in Summer 2009 using surface and subsurface plankton net tows and quantitative visual observations, and Fall 2010 using surface net tows only. We documented widespread, though spatially variable, plastic pollution in this portion of the NPSG and adjacent waters. The overall median microplastic numerical concentration in Summer 2009 was 0.448 particles m(-2) and in Fall 2010 was 0.021 particles m(-2), but plastic concentrations were highly variable over the submesoscale (10 s of km). Size-frequency spectra were skewed towards small particles, with the most abundant particles having a cross-sectional area of approximately 0.01 cm(2). Most microplastic was found on the sea surface, with the highest densities detected in low-wind conditions. The numerical majority of objects were small particles collected with nets, but the majority of debris surface area was found in large objects assessed visually. Our ability to detect high-plastic areas varied with methodology, as stations with substantial microplastic did not necessarily also contain large visually observable objects. A power analysis of our data suggests that high variability of surface microplastic will make future changes in abundance difficult to detect without substantial sampling effort. Our findings suggest that assessment and monitoring of oceanic plastic debris must account for high spatial variability, particularly in regards to the evaluation of initiatives designed to reduce marine debris.

Gooseneck barnacles (Lepas spp.) ingest microplastic debris in the North Pacific Subtropical Gyre.

Substantial quantities of small plastic particles, termed "microplastic," have been found in many areas of the world ocean, and have accumulated in particularly high densities on the surface of the subtropical gyres. While plastic debris has been documented on the surface of the North Pacific Subtropical Gyre (NPSG) since the early 1970s, the ecological implications remain poorly understood. Organisms associated with floating objects, termed the "rafting assemblage," are an important component of the NPSG ecosystem. These objects are often dominated by abundant and fast-growing gooseneck barnacles (Lepas spp.), which predate on plankton and larval fishes at the sea surface. To assess the potential effects of microplastic on the rafting community, we examined the gastrointestinal tracts of 385 barnacles collected from the NPSG for evidence of plastic ingestion. We found that 33.5% of the barnacles had plastic particles present in their gastrointestinal tract, ranging from one plastic particle to a maximum of 30 particles. Particle ingestion was positively correlated to capitulum length, and no blockage of the stomach or intestines was observed. The majority of ingested plastic was polyethylene, with polypropylene and polystyrene also present. Our results suggest that barnacle ingestion of microplastic is relatively common, with unknown trophic impacts on the rafting community and the NPSG ecosystem.

An introduction to social media for scientists.

Online social media tools can be some of the most rewarding and informative resources for scientists-IF you know how to use them.

Increased oceanic microplastic debris enhances oviposition in an endemic pelagic insect.

Plastic pollution in the form of small particles (diameter less than 5 mm)--termed 'microplastic'--has been observed in many parts of the world ocean. They are known to interact with biota on the individual level, e.g. through ingestion, but their population-level impacts are largely unknown. One potential mechanism for microplastic-induced alteration of pelagic ecosystems is through the introduction of hard-substrate habitat to ecosystems where it is naturally rare. Here, we show that microplastic concentrations in the North Pacific Subtropical Gyre (NPSG) have increased by two orders of magnitude in the past four decades, and that this increase has released the pelagic insect Halobates sericeus from substrate limitation for oviposition. High concentrations of microplastic in the NPSG resulted in a positive correlation between H. sericeus and microplastic, and an overall increase in H. sericeus egg densities. Predation on H. sericeus eggs and recent hatchlings may facilitate the transfer of energy between pelagic- and substrate-associated assemblages. The dynamics of hard-substrate-associated organisms may be important to understanding the ecological impacts of oceanic microplastic pollution.

Is knowledge translation adequate? A quality assurance study of staging investigations in early stage breast cancer patients.

After primary surgery, patients diagnosed with early stage breast cancer undergo radiological investigations based on pathologic stage of disease to rule out distant metastases. Published guidelines can aid clinicians in determining which tests are appropriate based on stage of disease. We wished to assess the consistency of radiological staging in an academic community oncology setting with standard guidelines and to determine the overall impact of non-adherence to these guidelines. A retrospective cohort study was conducted for new breast cancer patients seen at a single institution between January 2009 and April 2010. Patients were included if initial diagnosis and primary surgery was at this institution. Pathologic stage and radiological tests completed were recorded. A literature review was performed and the results were compared with those from this study to determine overall adherence rates. Subsequently, a cost analysis was performed to determine the financial impact at this centre. 231 patients met eligibility criteria for inclusion in this study. A large proportion of patients were over-staged with 129 patients (55%) undergoing unnecessary investigations according to guidelines. Specifically, 59% of stage I patients and 58% of stage II patients were over-investigated. Distant metastases at the time of diagnosis were found in three patients, all of whom had stage III disease (1.3%). The literature reviewed revealed similar non-adherence rates in other centres. The estimated cost of such non-adherence is in the range of $78 (CDN) per new early stage breast cancer patient seen at this centre. This oncology centre has a low adherence to practice guidelines for staging investigations in breast cancer patients, with 55% of patients undergoing unnecessary tests. Very few patients had metastases at diagnosis, and all had pathological stage III disease. Efforts may need to focus on improving knowledge translation across clinical oncology settings to increase guideline adherence.