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Blockchain in Healthcare Today 2022Regulating and monitoring a traditionally fragmented pharma supply chain has been a global challenge for decades. Without a trusted system and strong collaboration...
Regulating and monitoring a traditionally fragmented pharma supply chain has been a global challenge for decades. Without a trusted system and strong collaboration between stakeholders, threats such as counterfeits can easily intercept the supply chain and cause monumental disruptions. Today, the COVID-19 pandemic has accelerated the need for greater data transparency, better deployment of technology, and improved ways of connecting stakeholder information along the supply chain. There is a need for improved ways of working to help build up supply chain resilience, and one way is by implementing better end-to-end traceability using blockchain technology such as Hyperledger Fabric. This paper will explore the business value that blockchain brings to the pharma supply chain with better end-to-end traceability, using the example of an industry-grade blockchain solution called eZTracker. Through six key features, pharmaceutical manufacturers, patients, and Healthcare Practitioners (HCPs) can now participate in data sharing, with extended use cases of integrating blockchain with warehouse platforms, a patient-facing mobile application, and an interactive dashboard for real-time verification and data transparency. Beyond anti-counterfeit verification, other potential use cases include effective product recall management, cold chain monitoring, e-product information, and more. The effectiveness of a traceability solution is heavily dependent on the amount of data collected and is affected by poor adoption and scalability. Existing limitations that need to be addressed include the lack of mandated serialization in Asia and blockchain interoperability. To maximize the value of blockchain, collaboration is the key. Pharmaceutical manufacturers need to invest in new technologies, such as blockchain, to help them break out of data silos and operationalize data to build supply chain resilience. Pharmaceutical supply chain is the backbone of a US$1.27 trillion industry, but because of its highly complex and fragmented nature, it is hard to regulate and protect, and this makes it a valuable target for opportunistic parties such as counterfeiters looking to profit. As a result of the COVID-19 pandemic, there has been greater emphasis on transparency of data and connecting stakeholders along the pharma supply chain in real-time in the last few years. With the introduction of blockchain technology, companies are now able to implement solutions with more effective track and trace results, providing quality assurance to pharmaceutical manufacturers, patients, and Healthcare Practitioners (HCPs), and even improving operational efficiencies. This paper seeks to explore the positive business impact of end-to-end traceability using blockchain technology, and the effects it brings about, such as improving supply chain resilience and combating counterfeits, as seen in successful live use cases in Asia.
PubMed: 36779026
DOI: 10.30953/bhty.v5.231 -
Journal of Applied Microbiology Apr 2016The aim of this study was to describe the incidence of contamination of pharmaceutical products by melanized fungi and to consider control measures in relation to... (Review)
Review
The aim of this study was to describe the incidence of contamination of pharmaceutical products by melanized fungi and to consider control measures in relation to bioburden and cleanrooms. This study reviews and analyses pharmaceutical product recalls and offers incidence rates of fungal detection from a typical cleanrooms. The recalls include some serious cases which resulted in the loss of life. Of different types of fungal contamination incidences some of the most damaging have been due to melanized fungi ('black mould'), such as Exserohilum rostratum. The focus of the article is with melanized fungi. The study concludes that, from the review of recent pharmaceutical product recalls, fungal contamination is either increasingly common within cleanroom environments or the accuracy of sampling and the level of reporting has risen. The prevalence of melanized fungi in pharmaceutical facilities rests on specific virulence factors particular to these types of fungi, which are outlined. The article identifies a gap in the way that such fungi are screened for using available cultural methods. The article provides some control strategies, including assessing the suitability of disinfectants and biocides, for reducing the risk of melanized fungal incidences within the pharmaceutical facility. Understanding the fungal risk to pharmaceutical products remains a poorly understood and often overlooked aspect of pharmaceutical microbiology. This article helps to identify this risk and offer some guidance to those involved with pharmaceutical products manufacture in relation to bio-contamination control strategies.
Topics: Drug Contamination; Drug Industry; Drug Recalls; Fungi; Humans
PubMed: 26119714
DOI: 10.1111/jam.12888 -
BMC Bioinformatics Dec 2013The goal of many proteomics experiments is to determine the abundance of proteins in biological samples, and the variation thereof in various physiological conditions.... (Comparative Study)
Comparative Study
BACKGROUND
The goal of many proteomics experiments is to determine the abundance of proteins in biological samples, and the variation thereof in various physiological conditions. High-throughput quantitative proteomics, specifically label-free LC-MS/MS, allows rapid measurement of thousands of proteins, enabling large-scale studies of various biological systems. Prior to analyzing these information-rich datasets, raw data must undergo several computational processing steps. We present a method to address one of the essential steps in proteomics data processing--the matching of peptide measurements across samples.
RESULTS
We describe a novel method for label-free proteomics data alignment with the ability to incorporate previously unused aspects of the data, particularly ion mobility drift times and product ion information. We compare the results of our alignment method to PEPPeR and OpenMS, and compare alignment accuracy achieved by different versions of our method utilizing various data characteristics. Our method results in increased match recall rates and similar or improved mismatch rates compared to PEPPeR and OpenMS feature-based alignment. We also show that the inclusion of drift time and product ion information results in higher recall rates and more confident matches, without increases in error rates.
CONCLUSIONS
Based on the results presented here, we argue that the incorporation of ion mobility drift time and product ion information are worthy pursuits. Alignment methods should be flexible enough to utilize all available data, particularly with recent advancements in experimental separation methods.
Topics: DNA-Binding Proteins; Escherichia coli Proteins; Hepatitis C; Humans; Ions; Models, Genetic; Osteoarthritis; Peptide Fragments; Proteomics; Sequence Alignment; Spectrometry, Mass, Electrospray Ionization; Tandem Mass Spectrometry
PubMed: 24341404
DOI: 10.1186/1471-2105-14-364 -
BMC Public Health Sep 2016Negative news media reports regarding potential health hazards of implanted medical devices and pharmaceuticals can lead to a 'negative halo effect,' a phenomenon...
BACKGROUND
Negative news media reports regarding potential health hazards of implanted medical devices and pharmaceuticals can lead to a 'negative halo effect,' a phenomenon whereby judgments about a product or product type can be unconsciously altered even though the scientific support is tenuous. To determine how a 'negative halo effect' may impact the rates of use and/or explantation of medical products, we analyzed the occurrence of such an effect on three implanted medical devices and one drug: 1) intrauterine contraceptive devices (IUDs); 2) silicone gel-filled breast implants (SGBI); 3) metal-on-metal hip implants (MoM); and 4) the drug Tysabri.
METHODS
Data on IUD use from 1965 to 2008 were gathered from the Department of Health and Human Services Vital and Health Statistics and peer-reviewed publications. Data regarding SGBI implant and explantation rates from 1989 to 2012 were obtained from the Institute of Medicine and the American Society of Plastic Surgeons. MoM implant and explantation data were extracted from the England and Wales National Joint Registry and peer-reviewed publications. Tysabri patient data were reported by Elan Corporation or Biogen Idec Inc. Data trends for all products were compared with historical recall or withdrawal events and discussed in the context of public perceptions following such events.
RESULTS
We found that common factors altered public risk perceptions and patterns of continued use. First, a negative halo effect may be driven by continuing patient anxiety despite positive clinical outcomes. Second, negative reports about one product can spill over to affect the use of dissimilar products in the same category. Third, a negative halo effect on an entire category of medical devices can be sustained regardless of the scientific findings pertaining to safety. Fourth, recovery of a product's safety reputation and prevalent use may take decades in the U.S., even while these products may exhibit widespread use and good safety records in other countries.
CONCLUSIONS
We conclude that the 'negative halo effect' associated with a stigma, rather than an objective risk-benefit assessment of medical products can increase negative health outcomes for patients due to reduced or inappropriate product usage.
Topics: Breast Implants; England; Equipment Safety; Female; Hip Prosthesis; Humans; Immunologic Factors; Intrauterine Devices; Male; Mass Media; Metal-on-Metal Joint Prostheses; Natalizumab; Patient Acceptance of Health Care; Physicians; Prostheses and Implants; Silicone Gels; United States; Wales
PubMed: 27630095
DOI: 10.1186/s12889-016-3595-7 -
Journal For Specialists in Pediatric... Apr 2018The purpose of this study was to develop and assess the psychometric properties for two related questionnaires: the Healthy Eating and Physical Activity Self-Efficacy... (Comparative Study)
Comparative Study
Psychometric testing of the healthy eating and physical activity self-efficacy questionnaire and the healthy eating and physical activity behavior recall questionnaire for children.
PURPOSE
The purpose of this study was to develop and assess the psychometric properties for two related questionnaires: the Healthy Eating and Physical Activity Self-Efficacy Questionnaire for Children (HEPASEQ-C) and the Healthy Eating and Physical Activity Behavior Recall Questionnaire for Children (HEPABRQ-C).
DESIGN AND METHODS
HEPASEQ-C and HEPABRQ-C were administered to 517 participating children with 492 completing. Data were analyzed to evaluate for reliability and validity of the questionnaires.
RESULTS
Content validity was established through a 10-person expert panel. For the HEPASEQ-C, item content validity index (CVI) ranged from 0.80 to 1.00. The CVI for the total questionnaire was 1.0. All HEPASEQ-C items loaded on a single factor. Cronbach's alpha was deemed acceptable (.749). For the HEPABRQ-C, item CVI ranged from 0.88 to 1.00. CVI for the total questionnaire was 1.0. Pearson product moment correlation between HEPASEQ-C and HEPABRQ-C scores was significant (r = .501, p = .000).
PRACTICE IMPLICATIONS
The HEPASEQ-C and HEPABRQ-C are easily administered and provide helpful insights into children's self-efficacy and behavior recall. They are easy to use and applicable for upper elementary school settings, in clinical settings for individual patients, and in health promotion settings.
Topics: Age Factors; Child; Diet, Healthy; Exercise; Health Behavior; Humans; Psychometrics; Reproducibility of Results; Self Efficacy; Sex Factors; Surveys and Questionnaires
PubMed: 29316195
DOI: 10.1111/jspn.12207 -
Journal of Diabetes Science and... Sep 2019
Topics: Computer Security; Humans; Insulin Infusion Systems; Safety-Based Medical Device Withdrawals; United States; United States Food and Drug Administration; Wireless Technology
PubMed: 31313589
DOI: 10.1177/1932296819865655 -
The Cochrane Database of Systematic... Oct 2009Editor's note: The anti-inflammatory drug rofecoxib (Vioxx) was withdrawn from the market at the end of September 2004 after it was shown that long-term use (greater... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Editor's note: The anti-inflammatory drug rofecoxib (Vioxx) was withdrawn from the market at the end of September 2004 after it was shown that long-term use (greater than 18 months) could increase the risk of heart attack and stroke in a study of secondary prevention of adenoma recurrence. Further information is available at www.vioxx.com.Rofecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor previously licensed for treating acute and chronic pain; it was associated with fewer gastrointestinal adverse events than conventional NSAIDs. An earlier Cochrane review (Barden 2005) showed that rofecoxib is at least as effective as conventional non-steroidal anti-inflammatory drugs (NSAIDs) for postoperative pain.
OBJECTIVES
To assess the analgesic efficacy and adverse effects of rofecoxib in single oral doses for moderate and severe postoperative pain.
SEARCH STRATEGY
We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database for studies to June 2009.
SELECTION CRITERIA
Randomised, double blind, placebo-controlled trials of single dose orally administered rofecoxib in adults with moderate to severe acute postoperative pain.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial quality and extracted data. Pain relief or pain intensity data were extracted and converted into the dichotomous outcome of number of participants with at least 50% pain relief over 4 to 6 hours, from which relative risk and number needed to treat to benefit (NNT) were calculated. Numbers of participants using rescue medication over specified time periods, and time to use of rescue medication, were sought as additional measures of efficacy. Information on adverse events and withdrawals was collected.
MAIN RESULTS
Twenty new studies and seven from the earlier review met the inclusion criteria. Twenty-four studies were in dental surgery and three in other types of surgery. In total, 2636 participants were treated with rofecoxib 50 mg, 20 with rofecoxib 500 mg, and 1251 with placebo. The NNT for at least 50% pain relief over 4 to 6 hours with rofecoxib 50 mg was 2.2 (2.0 to 2.3) in all studies combined, 1.9 (1.8 to 2.0) in dental studies, and 6.8 (4.6 to 13) in other types of surgery. The median time to use of rescue medication was 14 hours for rofecoxib 50 mg and 2 hours for placebo. Significantly fewer participants used rescue medication following rofecoxib 50 mg than with placebo. Adverse events did not differ from placebo.
AUTHORS' CONCLUSIONS
Rofecoxib 50 mg (two to four times the standard daily dose for chronic pain) is an effective single dose oral analgesic for acute postoperative pain in adults, with a relatively long duration of action.
Topics: Acute Disease; Administration, Oral; Adult; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase 2 Inhibitors; Humans; Lactones; Pain, Postoperative; Randomized Controlled Trials as Topic; Safety-Based Drug Withdrawals; Sulfones
PubMed: 19821329
DOI: 10.1002/14651858.CD004604.pub3 -
Revista de Neurologia Jul 2013
Review
Topics: Benzodiazepines; Biotransformation; Communication; Drug Eruptions; Europe; Humans; Molecular Structure; Occupational Diseases; Occupational Exposure; Pharmacovigilance; Risk Assessment; Safety-Based Drug Withdrawals
PubMed: 23799594
DOI: No ID Found -
Heart Rhythm Jul 2015The number of cardiac implantable electronic device (CIED) recalls and advisories has increased over the past 3 decades, yet no consensus exists on how to best manage... (Meta-Analysis)
Meta-Analysis Review
Complications from prophylactic replacement of cardiac implantable electronic device generators in response to United States Food and Drug Administration recall: A systematic review and meta-analysis.
BACKGROUND
The number of cardiac implantable electronic device (CIED) recalls and advisories has increased over the past 3 decades, yet no consensus exists on how to best manage patients with these CIEDs, partially because rates of complications from prophylactic replacement are unknown.
OBJECTIVE
The purpose of this study was to establish rates of complications when recalled CIED generators are replaced prophylactically.
METHODS
We searched MEDLINE and the Cochrane Controlled Trials Register for reports of prophylactic replacement of recalled CIED generators. Studies with <20 subjects were excluded. We then conducted a meta-analysis of qualifying studies to determine the rates of combined major complications, mortality, and reoperation.
RESULTS
We identified 7 citations that met our inclusion criteria and reported ≥1 end-points of interest. Four were single center, and 3 were multicenter. Six studies collected data retrospectively (n = 1213) and 1 prospectively (n = 222). Using a random effects model to combine data from all included studies, the rate of major complications was 2.5% (95% confidence interval [CI] 1.0%-4.5%). Combining data from 6 studies reporting mortality and reoperation, the rates were 0.5% (95% CI 0.1%-0.9%) and 2.5% (95% CI 0.8%-4.5%), respectively.
CONCLUSION
Prophylactic replacement of recalled CIED generators is associated with a low mortality rate but nontrivial rates of other major complications similar to those reported when CIED generators are replaced for other reasons. Thus, when considering replacing a recalled CIED generator, known risks of elective generator replacement likely apply and can be weighed against risks associated with device failure.
Topics: Defibrillators, Implantable; Device Removal; Equipment Failure; Humans; Medical Device Recalls; Postoperative Complications; Reoperation; Risk Assessment; United States; United States Food and Drug Administration
PubMed: 25847475
DOI: 10.1016/j.hrthm.2015.04.003 -
Journal of Vascular Surgery Dec 2019Authors' Note: On April 30, 2019, Terumo Medical Corporation issued a voluntary product recall for and discontinued manufacturing of the SoloPath Balloon Expandable...
Authors' Note: On April 30, 2019, Terumo Medical Corporation issued a voluntary product recall for and discontinued manufacturing of the SoloPath Balloon Expandable Sheath System, the device used for the procedures outlined in this article. Data collection, data analysis, and manuscript submission occurred prior to notice of this recall. The authors of this article were unaware of adverse events associated with this device and the 15 procedures reviewed for this series were free of events related to the reason for this device recall. Management of iliac artery disease remains a challenging problem in the setting of complex endovascular aortic procedures. In spite of the nonavailability of the device outlined in this article, the authors feel that the value of innovative solutions to this clinical problem (including the use of a balloon expandable sheath) merits public review of this technique and its results. Vascular access complications contribute to the morbidity of fenestrated endovascular aneurysm repair (FEVAR). As the ability to perform these procedures progresses, new techniques emerge to overcome difficult peripheral vascular anatomy and to minimize these complications. We describe our use of a balloon-expandable sheath to accommodate the multiple accesses needed for bridging stent placement during FEVAR in patients with highly calcified, tortuous, or small-diameter access vessels. We used this sheath for successful completion of FEVAR in 15 patients with challenging iliofemoral disease. There was one iliofemoral complication and no limb loss. Given the significant source of morbidity that vascular access complications contribute to endovascular procedures, we believe that a balloon-expandable sheath is a useful adjunct in FEVAR with complex iliac anatomy.
Topics: Aged; Aortic Aneurysm, Abdominal; Balloon Occlusion; Endovascular Procedures; Female; Femoral Artery; Humans; Iliac Artery; Male; Medical Device Recalls; Prosthesis Design; Stents
PubMed: 31353271
DOI: 10.1016/j.jvs.2019.05.030