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Pharmacoepidemiology

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https://www.readbyqxmd.com/read/29136628/incidence-of-multiple-sclerosis-in-germany-a-cohort-study-applying-different-case-definitions-based-on-claims-data
#1
Niklas Schmedt, Laura Khil, Klaus Berger, Oliver Riedel
BACKGROUND: Data on the incidence of multiple sclerosis (MS) on the national level is scarce. We aimed to estimate the incidence of MS in Germany and to compare different MS case definitions based on claims data. METHODS: We conducted a cohort study with the German Pharmacoepidemiological Research Database in 2012 and calculated age- and gender-standardized incidence rates (sIRs) for 3 case definitions. In addition, the effect of stepwise reduction of the look-back period without MS diagnosis on the incidence rate was evaluated...
November 14, 2017: Neuroepidemiology
https://www.readbyqxmd.com/read/29128115/chronic-use-of-proton-pump-inhibitors-adverse-events-and-potential-biological-mechanisms-a-translational-analysis
#2
Farid Kheloufi, Diane Frankel, Elise Kaspi, Marion Lepelley, Michel Mallaret, Quentin Boucherie, Patrice Roll, Joelle Micallef
Proton pump inhibitors (PPIs) are among the most frequently prescribed drugs. Even if PPI are usually considered as safe, there is a growing concern for a range of adverse effects of chronic PPI therapy often in the absence of appropriate indications. We propose, after a summary of renal, cardiovascular and neurological complications (dementia, chronic kidney disease, myocardial infarction and stroke), an integrative overview of the potential biological mechanisms involved. Eleven positive pharmacoepidemiological studies, mainly based on health insurance database linkage to hospital database, reported an increased risk of complications associated to PPI use and often a graded association suggesting also a possible dose-response relationship...
October 14, 2017: Thérapie
https://www.readbyqxmd.com/read/29121851/outputs-and-growth-of-primary-care-databases-in-the-united-kingdom-bibliometric-analysis
#3
Zain Chaudhry, Fahmida Mannan, Angela Gibson-White, Usama Syed, Shirin Ahmed, Antonis Kousoulis, Azeem Majeed
BACKGROUND: Electronic health database (EHD) data is increasingly used by researchers. The major United Kingdom EHDs are the 'Clinical Practice Research Datalink' (CPRD), 'The Health Improvement Network' (THIN) and 'QResearch'. Over time, outputs from these databases have increased, but have not been evaluated. OBJECTIVE: This study compares research outputs from CPRD, THIN and QResearch assessing growth and publication outputs over a 10-year period (2004-2013)...
October 17, 2017: Journal of Innovation in Health Informatics
https://www.readbyqxmd.com/read/29114538/the-risk-of-hospitalizations-with-injury-diagnoses-in-a-matched-cohort-of-children-and-adolescents-with-and-without-attention-deficit-hyperactivity-disorder-in-germany-a-database-study
#4
Christina Lindemann, Ingo Langner, Tobias Banaschewski, Edeltraut Garbe, Rafael T Mikolajczyk
Background: Attention deficit/hyperactivity disorder (ADHD) is a common neuropsychiatric disorder in children and adolescents worldwide, and children with ADHD have elevated risk of injuries. Our aim was to assess the risk of hospitalizations with injury diagnoses and their various subtypes in children and adolescents with newly diagnosed ADHD compared to those without ADHD, as well as to study sex effects on this risk in the setting of the German health care system. Methods: The German Pharmacoepidemiological Research Database, in which 20 million insured from four statutory health insurances in Germany are included, was used to set up a matched cohort study of 3- to 17-year-old children and adolescents with and without ADHD...
2017: Frontiers in Pediatrics
https://www.readbyqxmd.com/read/29109938/a-day-in-the-life-of-a-pharmacovigilance-case-processor
#5
Ritesh Bhangale, Sayali Vaity, Niranjan Kulkarni
Pharmacovigilance (PV) has grown significantly in India in the last couple of decades. The etymological roots for the word "pharmacovigilance" are "Pharmakon" (Greek for drug) and "Vigilare" (Latin for to keep watch). It relies on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The PV data processing cycle starts with data collection in computerized systems followed by complete data entry which includes adverse event coding, drug coding, causality and expectedness assessment, narrative writing, quality control, and report submissions followed by data storage and maintenance...
October 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/29099415/analgesic-drug-prescription-after-carpal-tunnel-surgery-a-pharmacoepidemiological-study-investigating-postoperative-pain
#6
Régis Fuzier, Isabelle Serres, Robert Bourrel, Aurore Palmaro, Maryse Lapeyre-Mestre
BACKGROUND AND OBJECTIVES: Carpal tunnel syndrome is a frequent cause of neuropathic pain of the upper limb. Surgery is often proposed in second-line treatment, leading to an expected decrease in analgesic drug consumption. The main objective of this study was to investigate the variations in analgesic drug prescriptions, with a special focus on constant or increasing prescription patterns, before and after surgery for carpal tunnel syndrome. METHODS: We designed a retrospective cohort study of French beneficiaries from the health insurance system in Midi-Pyrénées area...
November 2, 2017: Regional Anesthesia and Pain Medicine
https://www.readbyqxmd.com/read/29075805/the-effect-of-insulin-on-bone-mineral-density-among-women-with-type-2-diabetes-a-swan-pharmacoepidemiology-study
#7
K Ruppert, J Cauley, Y Lian, J C Zgibor, C Derby, D H Solomon
This was a longitudinal study examining the effects of insulin use on bone mineral density loss. Insulin use was found to be associated with greater bone mineral density loss at the femoral neck among women with diabetes mellitus. INTRODUCTION: Women with diabetes mellitus (DM) have higher bone mineral density (BMD) and experience slower BMD loss but have an increased risk of fracture. The data regarding the effect of insulin treatment on BMD remains conflicted. We examined the impact of insulin initiation on BMD...
October 27, 2017: Osteoporosis International
https://www.readbyqxmd.com/read/29075800/correction-to-pharmacoepidemiology-resources-in-ireland-an-introduction-to-pharmacy-claims-data
#8
Sarah-Jo Sinnott, Kathleen Bennett, Caitriona Cahir
In the 3rd paragraph and 2nd line of the Conclusion section the correct sentence should be: It is now important to encourage policy and decision makers to facilitate and accommodate future linkage of data.
October 26, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29061293/methylphenidate-gender-trends-in-adult-and-pediatric-populations-over-a-7year-period
#9
Carole Ehrhardt, Quentin Boucherie, Vanessa Pauly, David Braunstein, Eléonore Ronflé, Xavier Thirion, Elisabeth Frauger, Joelle Micallef
OBJECTIVE: Methylphenidate (MPH) is a prescription-stimulant medication which is authorized in France for two indications: attention-deficit hyperactivity disorder in children (aged≥6years) and narcolepsy in cases where modafinil is ineffective (for children and adults). MPH use has increased worldwide in the past 2 decades in children and adults. Different pharmacoepidemiological Europeans studies have described MPH patterns of use. To our knowledge, few pharmacoepidemiological studies have described MPH patterns of use in France...
July 21, 2017: Thérapie
https://www.readbyqxmd.com/read/29047196/to-what-extent-do-data-from-pharmaceutical-claims-under-estimate-opioid-analgesic-utilisation-in-australia
#10
Natasa Gisev, Sallie-Anne Pearson, Emily A Karanges, Briony Larance, Nicholas A Buckley, Sarah Larney, Timothy Dobbins, Bianca Blanch, Louisa Degenhardt
PURPOSE: Although pharmaceutical claims are an essential data source for pharmacoepidemiological studies, these data potentially under-estimate opioid utilisation. Therefore, this study aimed to quantify the extent to which pharmaceutical claims from Australia's national medicines subsidy programs (Pharmaceutical Benefits Scheme [PBS] and Repatriation Schedule of Pharmaceutical Benefits [RPBS]) under-estimate prescription-only and total national opioid utilisation across time and for different opioids...
October 19, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29039367/availability-of-computerised-medical-record-system-data-to-compare-models-of-child-health-care-in-primary-care-across-europe
#11
Harshana Liyanage, Uy Hoang, Filipa Ferreira, Denise Alexander, Michael Rigby, Mitch Blair, Simon De Lusignan
Computerised medical record (CMR) system data can be used to compare different models of health care for children. We identified sources of data from the Models of Child Health Appraised (MOCHA) project that compares family doctor led with paediatrician led and mixed models of child care using index conditions. Asthma and immunisation coverage are the first of these. We explored the extent to which an established Patient Registries Initiative (PARENT); MOCHA's own survey (MIROI); the European Centre for Disease Control (ECDC) immunisation information system survey and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) registry of data sources provided data to make comparisons of child health care...
2017: Studies in Health Technology and Informatics
https://www.readbyqxmd.com/read/29024218/using-probability-of-drug-use-as-independent-variable-in-a-register-based-pharmacoepidemiological-cause-effect-study-an-application-of-the-reverse-waiting-time-distribution
#12
Jesper Hallas, Anton Pottegård, Henrik Støvring
BACKGROUND: In register-based pharmacoepidemiological studies, each day of follow-up is usually categorized either as exposed or unexposed. However, there is an underlying continuous probability of exposure, and by insisting on a dichotomy, researchers unwillingly force a nondifferential misclassification into their analyses. We have recently developed a model whereby probability of exposure can be modeled, and we tested this on an empirical case of nonsteroidal anti-inflammatory drug (NSAID)-induced upper gastrointestinal bleeding (UGIB)...
October 12, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28991858/large-registry-epidemiology-in-ibd
#13
Charles N Bernstein
There are different types of large registries which can be harnessed for inflammatory bowel disease research. Not one registry can answer all types of research questions. It is important for both the researchers using the registries and readers of the reports generated, to be aware of the different strengths and weaknesses of each registry and whether the questions posed can reliably be answered. In this review, the use of large administrative databases/registries are discussed in the context of studying descriptive epidemiology, outcomes of inflammatory bowel disease, pharmacoepidemiology, and etiologic research...
November 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28984477/pediatric-pharmacoepidemiology-safety-and-effectiveness-of-medicines-for-adhd
#14
Antonio Clavenna, Maurizio Bonati
Attention-deficit hyperactivity disorder (ADHD) is a common neurobehavioral disorder in children and adolescents that comprises core symptoms of developmentally inappropriate levels of inattention and/or hyperactivity and impulsivity. Stimulant (methylphenidate, amphetamines) and non stimulant (atomoxetine, clonidine and guanfacine) are the treatment usually prescribed for ADHD. Area covered: This review covers the safety of ADHD medications in children and adolescents. MEDLINE, EMBASE and PsycINFO databases were searched with the aim to retrieve prospective studies that monitored the incidence of adverse events (AEs) in children receiving drug therapy for ADHD...
October 12, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28964430/good-practices-for-real-world-data-studies-of-treatment-and-or-comparative-effectiveness-recommendations-from-the-joint-ispor-ispe-special-task-force-on-real-world-evidence-in-health-care-decision-making
#15
Marc L Berger, Harold Sox, Richard J Willke, Diana L Brixner, Hans-Georg Eichler, Wim Goettsch, David Madigan, Amr Makady, Sebastian Schneeweiss, Rosanna Tarricone, Shirley V Wang, John Watkins, C Daniel Mullins
PURPOSE: Real-world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making. METHODS: The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies...
September 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28950039/pharmacovigilance-assessment-of-immune-mediated-reactions-reported-for-checkpoint-inhibitor-cancer-immunotherapies
#16
Ayad K Ali, David E Watson
STUDY OBJECTIVE: Ipilimumab, pembrolizumab, and nivolumab are checkpoint inhibitors (CPIs) that activate T-cell-mediated immune response. CPI can provide durable benefits to some cancer patients with melanoma, renal cell cancer, non-small cell lung cancer, or a growing list of other cancers. However, CPI treatment is also associated with adverse immune-mediated reactions (IMRs) that can be life-threatening. This pharmacovigilance analysis aims to characterize IMR signals in relation to CPI treatment...
September 26, 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/28942181/novel-adverse-events-of-vortioxetine-a-disproportionality-analysis-in-usfda-adverse-event-reporting-system-database
#17
Viswam Subeesh, Hemendra Singh, Eswaran Maheswari, Elsa Beulah
BACKGROUND: Signal detection is one of the most advanced and emerging field in pharmacovigilance. It is a modern method of detecting new reaction (which can be desired or undesired) of a drug. It facilitates early adverse drug reaction detection which enables health professionals to identify adverse events that may not have been identified in pre-marketing clinical trials. Vortioxetine, the first mixed serotonergic antidepressant was initially approved by the US Food and Drug Administration (USFDA) on September 30, 2013 for the treatment of adults with Major Depressive Disorder (MDD)...
September 14, 2017: Asian Journal of Psychiatry
https://www.readbyqxmd.com/read/28933701/a-cross-sectional-descriptive-study-of-medication-use-among-persons-with-a-gastrointestinal-stoma
#18
Bianca Augusta Pereira de Paula, Geisa Cristina da Silva Alves, Álvaro PercÍnio, Mariana Linhares Pereira, Juliano Teixeira Moraes, Cristina Sanches
Research on the use of medications in people with intestinal stomas is lacking, creating gaps in knowledge of pharmacoepidemiology in these patients. A cross-sectional, descriptive study was conducted over a period of 4 months in Divinópolis, Brazil to describe the profile of medication use among people enrolled in the Health Support Service for People with Stoma - Level II (SSPS II) of a municipality in the state of Minas Gerais, Brazil. All patients from SSPS II with a colostomy or ileostomy were invited by phone to participate; those with incomplete registration data and/or who were <18 years old, hospitalized for any reason, or had their stoma reversed were excluded from participation...
September 2017: Ostomy/wound Management
https://www.readbyqxmd.com/read/28927372/potentially-inappropriate-medication-use-in-nursing-homes-an-observational-study-using-the-norgep-nh-criteria
#19
Gunhild Nyborg, Mette Brekke, Jørund Straand, Svein Gjelstad, Maria Romøren
BACKGROUND: Frail residents in the nursing home sector call for extra care in prescribing. The Norwegian General Practice Nursing Home (NORGEP-NH) list of 34 explicit criteria for potentially inappropriate medication use in nursing homes was developed explicitly for this population. The aim of this study was to employ the NORGEP-NH Criteria to study the extent of potentially inappropriate medication use among nursing home residents and explore possible associated factors. METHODS: Cross-sectional observational pharmacoepidemiological study from residents in nursing homes in the county of Vestfold, Norway...
September 19, 2017: BMC Geriatrics
https://www.readbyqxmd.com/read/28925019/inclusion-of-pregnant-and-breastfeeding-women-in-research-efforts-and-initiatives
#20
Sílvia M Illamola, Christina Bucci-Rechtweg, Maged M Costantine, Ekaterini Tsilou, Catherine M Sherwin, Anne Zajicek
Pregnant and breastfeeding women have been rendered therapeutic orphans as they have been historically excluded from clinical trials. Labelling for most approved drugs does not provide information about safety and efficacy during pregnancy. This lack of data is mainly due to ethico-legal challenges that have remained entrenched in the post-diethylstilbestrol and thalidomide era, and that have led to pregnancy being viewed in the clinical trial setting primarily through a pharmacovigilance lens. Policy considerations that encourage and/or require the inclusion of pregnant or lactating women in clinical trials may address the current lack of available information...
September 19, 2017: British Journal of Clinical Pharmacology
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