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Pharmacoepidemiology and Drug Safety

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https://www.readbyqxmd.com/read/28924994/workshop-on-evaluation-of-pediatric-long-term-neurocognitive-development-and-medical-products
#1
Ann W McMahon, Leonard P Kapcala, Philip H Sheridan
No abstract text is available yet for this article.
September 19, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28924989/media-attention-regarding-sudden-cardiac-death-associated-with-domperidone-use-does-not-affect-in-hospital-ecg-recording
#2
Florine Berger, Selma Saâïd, Teun van Gelder, Bruno Stricker, Matthijs Becker, Patricia van den Bemt
PURPOSE: In March 2013, regulatory warnings concerning the potential risks of domperidone caused considerable media attention in the Netherlands. The aim of the study was to assess the effect of regulatory warnings and the resulting media hype on the frequency of electrocardiogram (ECG) monitoring of inpatients using domperidone. We also studied the effect on the frequency of prescribing domperidone by physicians. METHODS: A 2-centre, observational, retrospective cohort study was performed...
September 19, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28924986/supplementing-electronic-health-records-through-sample-collection-and-patient-diaries-a-study-set-within-a-primary-care-research-database
#3
Rebecca M Joseph, Jamie Soames, Mark Wright, Kirin Sultana, Tjeerd P van Staa, William G Dixon
PURPOSE: To describe a novel observational study that supplemented primary care electronic health record (EHR) data with sample collection and patient diaries. METHODS: The study was set in primary care in England. A list of 3974 potentially eligible patients was compiled using data from the Clinical Practice Research Datalink. Interested general practices opted into the study then confirmed patient suitability and sent out postal invitations. Participants completed a drug-use diary and provided saliva samples to the research team to combine with EHR data...
September 19, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28905438/research-to-support-optimization-of-prescription-drug-monitoring-programs
#4
Sheri Doyle, Gillian Leichtling, Christi Hildebran, Cynthia Reilly
PURPOSE: Research is needed to evaluate the impact of prescription drug monitoring programs (PDMPs). This paper describes research priorities for PDMPs that were initially discussed at a 2015 meeting of PDMP administrators, researchers, public health officials, and other stakeholders. METHODS: Meeting participants defined the current landscape of PDMP research and identified research gaps. Research priorities were grouped by theme. RESULTS: Prescription drug monitoring program research priorities were identified for 3 key areas: individual patient health outcomes, prescriber use and decision making, and population-level outcomes...
September 14, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28895247/the-prevalence-of-pain-and-analgesia-use-in-the-australian-population-findings-from-the-2011-to-2012-australian-national-health-survey
#5
April Miller, Kristy Sanderson, Raimondo Bruno, Monique Breslin, Amanda L Neil
BACKGROUND: Opioid analgesic use and associated adverse events have increased over the last 15 years, including in Australia. Whether this is associated with increased chronic pain prevalence in the Australian population is unknown. This study aimed to estimate (1) the prevalence of chronic pain and analgesia use in the Australian population by age and sex; (2) the severity of pain in the population with chronic pain by sex; and (3) the distribution of recent pain severity in those using analgesia by age and sex...
September 12, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28879660/national-trends-in-long-term-use-of-prescription-opioids
#6
Ramin Mojtabai
PURPOSE: This study examined recent trends and correlates of prescription opioid use and long-term use in the United States. METHODS: Data were from 47 356 adult participants of National Health and Nutrition Survey from 1999-2000 to 2013-2014. Participants were asked about prescription medications used in the past 30 days. Long-term use of prescription opioids was defined by use for 90 days or longer. RESULTS: The prevalence of prescription opioid use increased from 4...
September 6, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28857419/bisphosphonate-use-and-the-risk-of-breast-cancer-a-meta-analysis-of-observational-studies
#7
Ying-Ju Ou, Hui-Fen Chiu, Yun-Hong Wong, Chun-Chien Yang, Yi-Hsin Yang
PURPOSE: To summarize current evidence of the association of bisphosphonate use with breast cancer risk, we used a systematic review and meta-analysis of observational studies to explore this issue. METHODS: A comprehensive search was conducted on PubMed, EMBASE, and the Cochrane Library. Pooled relative risk (RR) estimates and 95% confidence intervals (CIs) were calculated using the random effects model. RESULTS: Bisphosphonate use was associated with a 16% lower breast cancer risk (pool RR0...
August 31, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28857309/impact-of-the-black-triangle-label-on-prescribing-of-new-drugs-in-the-united-kingdom-lessons-for-the-united-states-at-a-time-of-deregulation
#8
Daniel B Horton, Tobias Gerhard, Amy Davidow, Brian L Strom
PURPOSE: Newly approved novel drugs in Europe receive a black triangle label to promote pharmacovigilance. With growing momentum for earlier drug approvals and reliance on real-world evidence, we studied if the black triangle label promotes more judicious prescribing. METHODS: We examined whether general practitioners prescribed escitalopram, tadalafil, and vardenafil with a black triangle more cautiously than the same or similar drugs without a black triangle in The Health Improvement Network (UK)...
August 31, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28856767/risks-of-newly-onset-hemorrhagic-stroke-in-patients-with-neovascular-age-related-macular-degeneration
#9
Wan-Ju Annabelle Lee, Ching-Lan Cheng, Cheng-Han Lee, Yea-Huei Kao Yang, Swu-Jane Lin, Cheng-Yang Hsieh
PURPOSE: Age-related macular degeneration (AMD) is an eye disease causing blindness in the elderly. It shares many common possible pathogenic mechanisms with cardiovascular diseases. Many studies have discussed the association between AMD and stroke, but the results were inconsistent. Our aim was to determine the associations between neovascular AMD and the risk of stroke in the Taiwanese population. METHODS: This is a retrospective cohort study. We used claims data from National Health Insurance Research Database...
August 30, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28856756/validity-of-the-days-supply-field-in-pharmacy-administrative-claims-data-for-the-identification-of-blister-packaging-of-medications
#10
Christine Leong, Jitender Sareen, William D Leslie, Murray W Enns, James Bolton, Silvia Alessi-Severini, Laurence Y Katz, Sarvesh Logsetty, Carolyn Snider, Jason Berry, Heather J Prior, Dan Chateau
PURPOSE: Pharmacy claims data is often used in pharmacoepidemiology studies, but no studies to date have examined whether it was possible to identify the use of blister packs in these databases. We aimed to determine whether medications dispensed in days divisible by 7 are more likely to be blister packed than medications dispensed in other quantities. METHODS: Community pharmacies in Manitoba were invited to participate in a mail-out survey to identify the use of blister packaging for up to 25 patients who had a solid oral medication dispensed from April 1, 2012 to March 31, 2014...
August 30, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28840629/extent-and-risks-of-antidepressant-off-label-use-in-children-and-adolescents-in-germany-between-2004-and-2011
#11
Carsten Schröder, Michael Dörks, Bianca Kollhorst, Tilo Blenk, Ralf W Dittmann, Edeltraut Garbe, Oliver Riedel
PURPOSE: So far, only little is known about antidepressant off-label use in pediatric patients. This is the first study examining the prevalence and the risks of off-label antidepressant prescriptions in minors over time in Germany and analyzing patterns regarding age, sex, drug class, and type of off-label use. METHODS: We used claims data of about two million individuals (<18 y) to calculate the share of off-label antidepressant prescriptions for the years 2004 to 2011, stratified by age, sex, and drug class...
August 24, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28840621/controlling-confounding-by-frailty-when-estimating-influenza-vaccine-effectiveness-using-predictors-of-dependency-in-activities-of-daily-living
#12
Henry T Zhang, Leah J McGrath, Richard Wyss, Alan R Ellis, Til Stürmer
PURPOSE: To improve control of confounding by frailty when estimating the effect of influenza vaccination on all-cause mortality by controlling for a published set of claims-based predictors of dependency in activities of daily living (ADL). METHODS: Using Medicare claims data, a cohort of beneficiaries >65 years of age was followed from September 1, 2007, to April 12, 2008, with covariates assessed in the 6 months before follow-up. We estimated Cox proportional hazards models of all-cause mortality, with influenza vaccination as a time-varying exposure...
August 24, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28833803/important-statistical-considerations-in-the-evaluation-of-post-market-studies-to-assess-whether-opioids-with-abuse-deterrent-properties-result-in-reduced-abuse-in-the-community
#13
Kunthel By, Jana K McAninch, Stephine L Keeton, Alex Secora, Cynthia J Kornegay, Catherine S Hwang, Thomas Ly, Mark S Levenson
PURPOSE: Abuse, misuse, addiction, overdose, and death associated with non-medical use of prescription opioids have become a serious public health concern. Reformulation of these products with abuse-deterrent properties is one approach for addressing this problem. FDA has approved several extended-release opioid analgesics with abuse-deterrent labeling, the bases of which come from pre-market studies. As all opioid analgesics must be capable of delivering the opioid in order to reduce pain, abuse-deterrent properties do not prevent abuse, nor do pre-market evaluations ensure that there will be reduced abuse in the community...
August 23, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28833745/pharmacoepidemiology-of-testosterone-curbing-off-label-prescribing
#14
David J Handelsman
OBJECTIVES: To estimate the impact of the first year of new Pharmaceutical Benefits Scheme (PBS) prescribing criteria that dictate eligibility for national health scheme subsidy of testosterone prescribing. DESIGN: Analysis of cumulative PBS data. SETTING: Retrospective analysis of testosterone prescribing from PBS data. PARTICIPANTS: Nil MAIN OUTCOME MEASURES: PBS expenditure analysed by total expenditure, by state, and by product type as well as the age, indication, and prescriber type for new testosterone treatment...
August 23, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28815982/bridge-the-gap-the-need-for-harmonized-regulatory-and-ethical-standards-for-postmarketing-observational-studies
#15
REVIEW
Hisashi Urushihara, Louise Parmenter, Shimon Tashiro, Kenji Matsui, Nancy Dreyer
Drug safety issues do not respect national borders. Hence, addressing a safety question may necessitate globally coordinated efforts between regulatory authorities and market authorization holders (MAHs) to draw reliable conclusions. Regulatory authorities have shared responsibility with MAHs sponsoring postmarketing nonintervention studies in determining study goals and design. Their shared accountabilities include what will be investigated and how the data will be retrieved to ensure appropriate study quality required for regulatory decision making...
August 16, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28815803/validity-of-cancer-diagnosis-in-the-national-health-insurance-database-compared-with-the-linked-national-cancer-registry-in-taiwan
#16
Wei-Heng Kao, Ji-Hong Hong, Lai-Chu See, Huang-Ping Yu, Jun-Te Hsu, I-Jun Chou, Wen-Chi Chou, Meng-Jiun Chiou, Chun-Chieh Wang, Chang-Fu Kuo
PURPOSE: We aimed to evaluate the validity of cancer diagnosis in the National Health Insurance (NHI) database, which has routinely collected the health information of almost the entire Taiwanese population since 1995, compared with the Taiwan National Cancer Registry (NCR). METHODS: There were 26,542,445 active participants registered in the NHI database between 2001 and 2012. National Cancer Registry and NHI database records were compared for cancer diagnosis; date of cancer diagnosis; and 1, 2, and 5 year survival...
August 16, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28815800/a-method-for-data-driven-exploration-to-pinpoint-key-features-in-medical-data-and-facilitate-expert-review
#17
Kristina Juhlin, Kristina Star, G Niklas Norén
PURPOSE: To develop a method for data-driven exploration in pharmacovigilance and illustrate its use by identifying the key features of individual case safety reports related to medication errors. METHODS: We propose vigiPoint, a method that contrasts the relative frequency of covariate values in a data subset of interest to those within one or more comparators, utilizing odds ratios with adaptive statistical shrinkage. Nested analyses identify higher order patterns, and permutation analysis is employed to protect against chance findings...
August 16, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28815799/characterization-of-opioid-use-in-sickle-cell-disease
#18
Jin Han, Jifang Zhou, Santosh L Saraf, Victor R Gordeuk, Gregory S Calip
PURPOSE: Opioid analgesics are commonly used to treat vaso-occlusive pain episodes in sickle cell disease (SCD), but comprehensive evidence characterizing opioid use in this patient population is limited. Our objective was to characterize opioid use patterns among SCD patients using a large nationwide database. METHODS: A large, US medical claims database was utilized to identify a cohort of 3882 SCD patients, and characteristics of opioid use were analyzed. Clinical variables including age, gender, medication use, health care utilization, and medical history were evaluated for correlations with opioid use...
August 16, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28815791/risk-of-preeclampsia-after-gestational-exposure-to-selective-serotonin-reuptake-inhibitors-and-other-antidepressants-a-study-from-the-norwegian-mother-and-child-cohort-study
#19
Angela Lupattelli, Mollie Wood, Kate Lapane, Olav Spigset, Hedvig Nordeng
PURPOSE: To describe the risk of early- and late-onset preeclampsia across pregnancies exposed to antidepressants and to evaluate the impact of timing and length of gestational exposure to antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs), on preeclampsia. METHODS: The Norwegian Mother and Child Cohort, a prospective population-based study, and the Medical Birth Registry of Norway provided information on antidepressant exposure, depression, and anxiety symptoms in pregnancy, preeclampsia diagnoses, and important covariates...
August 16, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28812323/a-comparison-of-methods-for-estimating-the-temporal-change-in-a-continuous-variable-example-of-hba1c-in-patients-with-diabetes
#20
Therese Sheppard, Robyn Tamblyn, Michal Abrahamowicz, Mark Lunt, Matthew Sperrin, William G Dixon
PURPOSE: To compare the more complex technique, functional principal component analysis (FPCA), to simpler methods of estimating values of sparse and irregularly spaced continuous variables at given time points in longitudinal data using a diabetic patient cohort from UK primary care. METHODS: The setting for this study is the Clinical Practice Research Datalink (CPRD), a UK general practice research database. For 16,034 diabetic patients identified in CPRD, with at least 2 measures in a 30-month period, HbA1c was estimated after temporarily omitting (i) the final and (ii) middle known values using linear interpolation, simple linear regression, arithmetic mean, random effects, and FPCA...
August 15, 2017: Pharmacoepidemiology and Drug Safety
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