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Basic & Clinical Pharmacology &... Apr 2021Adverse drug reactions (ADRs) for all drugs in Europe are described in the legally approved Summary of Product Characteristics (SmPC). An overview of all ADRs of the... (Review)
Review
Adverse drug reactions (ADRs) for all drugs in Europe are described in the legally approved Summary of Product Characteristics (SmPC). An overview of all ADRs of the patients' drug list can support healthcare staff to link patient symptoms to possible ADRs. We review the possibilities and challenges to extract ADR information from SmPCs or American Structured Product Labels and present the development of our semi-automated procedure for extraction of ADRs from the tabulated section in the SmPCs to create a database, named Bikt, which is regularly updated and used at point of care in Sweden. The existence of five major table formats for ADRs used in the SmPCs required the development of different parsing scripts. Manual checks for correctness for all content have to be performed. The quality of extraction was investigated for all SmPCs by measuring precision, recall and F1 scores and compared with other methods published. We conclude that it is possible to semi-automatically extract ADR information from SmPCs. However, clear technical and content guidelines and standards for ADR tables and terms from drug registration authorities would lead to improved extraction and usability of ADR information at point of care.
Topics: Adverse Drug Reaction Reporting Systems; Drug Labeling; Drug-Related Side Effects and Adverse Reactions; Europe; Humans; Point-of-Care Systems
PubMed: 33523597
DOI: 10.1111/bcpt.13564 -
JAMA Internal Medicine Feb 2020Timely and complete disclosure of medical device defects is necessary to manage patient care safely and effectively.
IMPORTANCE
Timely and complete disclosure of medical device defects is necessary to manage patient care safely and effectively.
OBJECTIVES
To determine if the manufacturer's recommendations following the recall of a medical device were timely and complete, the follow-up information and data provided to patients and physicians were adequate for managing patient care, and the actions taken by the US Food and Drug Administration (FDA) regarding the recall were appropriate.
DESIGN, SETTING, AND PARTICIPANTS
This single-center retrospective case series included 90 of 448 patients who were implanted with a cardiac resynchronization therapy pacemaker at the Minneapolis Heart Institute from May 2003 through January 2011; this pacemaker was recalled in November 2015. In addition, returned product reports submitted by the manufacturer to the FDA via the Manufacturer and User Facility Device Experience (MAUDE) database from January 2008 through December 2018 were analyzed.
MAIN OUTCOMES AND MEASURES
Clinical outcomes were serious adverse clinical events that occurred before and after the November 2015 recall notifying physicians and patients that the device's battery could fail unexpectedly because of high internal impedance. Technical outcomes were signs and causes of failure.
RESULTS
Five of 90 patients observed during 2015 experienced syncope when their pacemakers stopped pacing owing to battery or wire connection defects prior to the recall. Of the 90 patients, 37 (41%) were men, and the median (interquartile range) age at implantation was 71.3 (66.1-78.2) years. Analysis of the MAUDE data revealed that battery failures prior to the recall were associated with serious adverse events that included 1 death, 1 cardiac arrest, 5 syncopal attacks, and 6 heart failure exacerbations; 3 additional prerecall syncopal events were caused by wire connection defects. The manufacturer and the FDA were aware of the battery and wire connection defects for 19 months before issuing the recall, yet the wire connection problem was not included in the advisory and physicians were not informed that interrogating the pacemaker could result in loss of pacing. The FDA classified the recall as class II rather than the more critical class I.
CONCLUSIONS AND RELEVANCE
This case series study of patients implanted with a defective pacemaker found that the pacemaker recall was delayed and that subsequent communications did not include all critical information needed for safe and effective patient care. These findings should prompt reforms in how the medical device industry and the FDA manage future medical device recalls.
Topics: Aged; Cardiac Resynchronization Therapy Devices; Disclosure; Disease Progression; Equipment Failure; Female; Heart Arrest; Heart Failure; Humans; Information Dissemination; Male; Medical Device Recalls; Mortality; Retrospective Studies; Syncope; Time Factors; United States; United States Food and Drug Administration
PubMed: 31860011
DOI: 10.1001/jamainternmed.2019.5171 -
BMJ Open Jul 2022To evaluate the pattern of substandard and falsified pharmaceutical products recall in Nepal. (Review)
Review
OBJECTIVES
To evaluate the pattern of substandard and falsified pharmaceutical products recall in Nepal.
SETTING
We analysed drug recall notices issued by the Department of Drug Administration (DDA), Nepal, and systematically reviewed peer-reviewed research articles during January 2010 to December 2020.
PARTICIPANTS
This study did not include human participants. However, data were collected from 72 drug recall notices issued by DDA and four research papers.
RESULTS
A total of 346 pharmaceutical products were recalled during the reported period. The number of recalled pharmaceutical products has increased significantly over the past decade in Nepal. The most frequently recalled drugs were antimicrobials followed by gastrointestinal medicines, vitamins and supplements and pain and palliative medicines among others. Number of imported recalled drugs were slightly higher (42.2%) than domestic recalled drugs (40.7%). Sixty-two percentage of recalled drugs were substandard, 11% were falsified and remaining 27% were not registered at the DDA. Similarly, higher number of modern drugs (62%) were recalled than traditional ones (35%). Hand sanitisers used to minimise COVID-19 transmission contributed significantly to the list of recalled pharmaceutical products in 2020. Most of these sanitisers contained significant amounts of methanol (as high as 75% v/v) instead of appropriate amount of ethyl or isopropyl alcohol. The peer-reviewed research papers reported issues with labelling, unregistered drugs and drugs failed in several laboratory testing.
CONCLUSION
Our analysis showed that number of recalls of substandard and falsified drugs are increasing in Nepal. Since the recall data in this paper did not include number of samples tested and location of samples collected, more studies to understand the prevalence of substandard and falsified drugs in Nepal is recommended.
Topics: COVID-19; Counterfeit Drugs; Drug Recalls; Humans; Nepal; Pharmaceutical Preparations
PubMed: 35788073
DOI: 10.1136/bmjopen-2021-053479 -
JAMA Dermatology May 2021In February 2019, the US Food and Drug Administration issued a proposed rule (84 FR 6204), an amendment to the Sunscreen Innovation Act of 2014, that would require...
IMPORTANCE
In February 2019, the US Food and Drug Administration issued a proposed rule (84 FR 6204), an amendment to the Sunscreen Innovation Act of 2014, that would require listing active ingredients on the principal display panel of sunscreens to allow consumers to "more readily compare products and either select or avoid a given product accordingly."
OBJECTIVE
To understand consumers' perceived importance of active ingredients in sunscreen and their ability to recall these ingredients when comparing, avoiding, or selecting sunscreen products.
DESIGN, SETTING, AND PARTICIPANTS
In this qualitative study, participants were recruited from Fors Marsh Group and User Works, Inc consumer panels and interviewed in person in November and December 2019. Eligible participants were 18 years or older, reported sunscreen use in the past 12 months, and were residents of the Washington, DC, area. After viewing 2 mock sunscreen labels (1 that meets current US Food and Drug Administration requirements and 1 designed to meet proposed requirements), participants were asked questions to assess their perceived importance of active ingredients in sunscreen products, whether they could recall any of the active ingredients on the labels, and whether they typically looked for active ingredients on a sunscreen label.
MAIN OUTCOMES AND MEASURES
The main outcomes were the sunscreen label information used by participants to select a sunscreen and their ability to recall the active ingredients after viewing 2 mock sunscreen labels.
RESULTS
The mean (SD) age of the 47 participants was 42.8 (13.6) years, 32 (68%) were women, and 40 (85%) had a bachelor's or graduate degree. Of the total, 13 (28%) participants stated that sunscreen ingredients influenced their sunscreen selection, but only 5 (11%) said it was the most important information. Instead, 34 (72%) participants stated that the sun protection factor rating was the most important information. After viewing the mock sunscreen labels, only 5 (11%) participants recalled any of the active ingredients, although 10 (21%) reported typically looking at active ingredients when choosing a sunscreen.
CONCLUSIONS AND RELEVANCE
This qualitative study investigated the US Food and Drug Administration's proposed new rule requiring that active ingredients be listed on the front of sunscreen labels to facilitate product comparison for consumers. However, active ingredients were not reported to be a primary reason for consumers' sunscreen selection. Recall of active ingredients was low, and few consumers reported typically looking at the active ingredients, which were more commonly used to avoid ingredients rather than to select a sunscreen. Therefore, listing active ingredients on the front label alone may not have the intended usefulness for consumers.
Topics: Adult; Consumer Behavior; Female; Health Knowledge, Attitudes, Practice; Humans; Male; Mental Recall; Middle Aged; Product Labeling; Self Concept; Skin Neoplasms; Sun Protection Factor; Sunscreening Agents
PubMed: 33760056
DOI: 10.1001/jamadermatol.2020.5394 -
The International Journal, Advanced... 2023Surface defects are a common issue that affects product quality in the industrial manufacturing process. Many companies put a lot of effort into developing automated...
Surface defects are a common issue that affects product quality in the industrial manufacturing process. Many companies put a lot of effort into developing automated inspection systems to handle this issue. In this work, we propose a novel deep learning-based surface defect inspection system called the forceful steel defect detector (FDD), especially for steel surface defect detection. Our model adopts the state-of-the-art cascade R-CNN as the baseline architecture and improves it with the deformable convolution and the deformable RoI pooling to adapt to the geometric shape of defects. Besides, our model adopts the guided anchoring region proposal to generate bounding boxes with higher accuracies. Moreover, to enrich the point of view of input images, we propose the random scaling and the ultimate scaling techniques in the training and inference process, respectively. The experimental studies on the Severstal steel dataset, NEU steel dataset, and DAGM dataset demonstrate that our proposed model effectively improved the detection accuracy in terms of the average recall (AR) and the mean average precision (mAP) compared to state-of-the-art defect detection methods. We expect our innovation to accelerate the automation of industrial manufacturing process by increasing the productivity and by sustaining high product qualities.
PubMed: 37073280
DOI: 10.1007/s00170-023-11087-9 -
Experimental Psychology Jan 2022Reading some words aloud during presentation, that is, producing them, and reading other words silently generate a large memory advantage for words that are produced....
Reading some words aloud during presentation, that is, producing them, and reading other words silently generate a large memory advantage for words that are produced. This robust within-list production effect is in contrast with the between-lists condition in which all words are read aloud or silently. In a between-lists condition, produced items are better recognized, but not better recalled. The lack of a between-lists production effect with recall tasks has often been presented as one of its defining characteristics and as a benchmark for evaluating models. Recently, Cyr et al. (2021) showed that this occurs because item production interacts with serial positions: Produced items are less well recalled on the first serial positions than silently read items, while the reverse pattern is observed for the recency portion of the curve. However, this pattern was observed with a repeated-measures design, and it may be a by-product of compensatory processes under the control of participants. Here, using a between-participants design, we observed the predicted interaction between production and serial positions. The results further support the Revised Feature Model (RFM) suggesting that produced items are encoded with more modality-dependent distinctive features, therefore benefiting recall. However, the production of the additional distinctive features would disrupt rehearsal.
Topics: Humans; Learning; Mental Recall; Reading; Serial Learning
PubMed: 35272478
DOI: 10.1027/1618-3169/a000540 -
PLoS Computational Biology Feb 2022Bursting is one of the fundamental rhythms that excitable cells can generate either in response to incoming stimuli or intrinsically. It has been a topic of intense... (Review)
Review
Bursting is one of the fundamental rhythms that excitable cells can generate either in response to incoming stimuli or intrinsically. It has been a topic of intense research in computational biology for several decades. The classification of bursting oscillations in excitable systems has been the subject of active research since the early 1980s and is still ongoing. As a by-product, it establishes analytical and numerical foundations for studying complex temporal behaviors in multiple timescale models of cellular activity. In this review, we first present the seminal works of Rinzel and Izhikevich in classifying bursting patterns of excitable systems. We recall a complementary mathematical classification approach by Bertram and colleagues, and then by Golubitsky and colleagues, which, together with the Rinzel-Izhikevich proposals, provide the state-of-the-art foundations to these classifications. Beyond classical approaches, we review a recent bursting example that falls outside the previous classification systems. Generalizing this example leads us to propose an extended classification, which requires the analysis of both fast and slow subsystems of an underlying slow-fast model and allows the dissection of a larger class of bursters. Namely, we provide a general framework for bursting systems with both subthreshold and superthreshold oscillations. A new class of bursters with at least 2 slow variables is then added, which we denote folded-node bursters, to convey the idea that the bursts are initiated or annihilated via a folded-node singularity. Key to this mechanism are so-called canard or duck orbits, organizing the underpinning excitability structure. We describe the 2 main families of folded-node bursters, depending upon the phase (active/spiking or silent/nonspiking) of the bursting cycle during which folded-node dynamics occurs. We classify both families and give examples of minimal systems displaying these novel bursting patterns. Finally, we provide a biophysical example by reinterpreting a generic conductance-based episodic burster as a folded-node burster, showing that the associated framework can explain its subthreshold oscillations over a larger parameter region than the fast subsystem approach.
Topics: Action Potentials; Animals; Computational Biology; Ducks; Mathematics
PubMed: 35202391
DOI: 10.1371/journal.pcbi.1009752 -
Cardiovascular Drugs and Therapy Aug 2020Beginning in July of 2018, the FDA issued a voluntary recall regarding the presence of a contaminant found in the manufacturing of valsartan. What would ensue has become... (Review)
Review
PURPOSE
Beginning in July of 2018, the FDA issued a voluntary recall regarding the presence of a contaminant found in the manufacturing of valsartan. What would ensue has become a largely unprecedented sequence of alarming events since the FDA began reporting public recalls, withdrawals and safety alerts on their website in 2016. Since then, the United States has been significantly impacted by drug recalls affecting angiotensin receptor blockers. This report arms clinicians with additional guidance and provides a framework for responding appropriately to future similar incidents and includes an overview of the angiotensin receptor blockers, and their effects and safety profiles.
METHODS
This report includes a review of data from all pertinent clinical and scientific sources including information from the FDA's inspection documents and recall website. Additional information is provided on the specific bottles including all lot numbers, expiration dates, etc. RESULTS: The recalls/withdrawals are attributable to the presence of cancer-causing contaminants identified during the manufacturing process from drug manufacturers abroad. The root causes behind the recalls and subsequent shortage appear multifactorial, and stem to a certain extent from the outsourcing of medication manufacturing overseas and lack of quality checks and appropriate oversight.
CONCLUSIONS
This inherent issue is not likely to resolve soon and has eroded the public trust of/in the healthcare system and the pharmaceutical industry. Patients and healthcare providers are significantly affected and should have a full understanding of the matter in order to guide appropriate response and actions.
Topics: Angiotensin II Type 1 Receptor Blockers; Carcinogens; Drug Approval; Drug Contamination; Drug Industry; Drug Recalls; Humans; Patient Safety; Quality Control; Risk Assessment; Risk Factors; United States; United States Food and Drug Administration
PubMed: 32318933
DOI: 10.1007/s10557-020-06976-0 -
Tobacco Control Jan 2020The current paper describes the PhenX (Phenotypes and eXposures) Toolkit Tobacco Regulatory Research Agent specialty area and the Agent Working Group's (WG's) 6-month...
The current paper describes the PhenX (Phenotypes and eXposures) Toolkit Tobacco Regulatory Research Agent specialty area and the Agent Working Group's (WG's) 6-month consensus process to identify high-priority, scientifically supported measures for cross-study comparison and analysis. Eleven measures were selected for inclusion in the Toolkit. Eight of these are interviewer-administered or self-administered protocols: history of switching to lower tar and nicotine cigarettes, passive exposures to tobacco products, tobacco brand and variety (covering cigars, cigarettes and smokeless tobacco separately), tobacco product adulteration (vent-blocking or filter-blocking) and tobacco warning label exposure and recall. The remaining three protocols are either laboratory-based or visual inspection-based: measurement of nicotine content in smoked or smokeless tobacco products and the physical properties of these two classes of products. Supplemental protocols include a biomarker of exposure and smoking topography. The WG identified the lack of standard measurement protocols to assess subjective ratings of tobacco product flavours and their appeal to consumers as a major gap. As the characteristics of tobacco products that influence perception and use are tobacco regulatory research priorities, the reliable assessment of flavours remains an area requiring further development.
Topics: Advisory Committees; Consensus; Data Collection; Epidemiological Monitoring; Humans; Inhalation Exposure; Product Labeling; Research Design; Smoking; Smoking Devices; Software; Tobacco Use
PubMed: 31992660
DOI: 10.1136/tobaccocontrol-2019-054976