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Pharmacoepidemiology and Drug Safety

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https://www.readbyqxmd.com/read/28722244/risk-of-liver-decompensation-with-cumulative-use-of-mitochondrial-toxic-nucleoside-analogues-in-hiv-hepatitis-c-virus-coinfection
#1
Vincent Lo Re Rd, Bret Zeldow, Michael J Kallan, Janet P Tate, Dena M Carbonari, Sean Hennessy, Jay R Kostman, Joseph K Lim, Matthew Bidwell Goetz, Robert Gross, Amy C Justice, Jason A Roy
PURPOSE: Among patients dually infected with human immunodeficiency virus (HIV) and chronic hepatitis C virus (HCV), use of antiretroviral therapy (ART) containing mitochondrial toxic nucleoside reverse transcriptase inhibitors (mtNRTIs) might induce chronic hepatic injury, which could accelerate HCV-associated liver fibrosis and increase the risk of hepatic decompensation and death. METHODS: We conducted a cohort study among 1747 HIV/HCV patients initiating NRTI-containing ART within the Veterans Aging Cohort Study (2002-2009) to determine if cumulative mtNRTI use increased the risk of hepatic decompensation and death among HIV-/HCV-coinfected patients...
July 19, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28722235/analysis-of-safety-related-regulatory-actions-by-japan-s-pharmaceutical-regulatory-agency
#2
Chieko Ishiguro, Takashi Misu, Eiko Iwasa, Tadashi Izawa
PURPOSE: To evaluate the safety-related regulatory actions implemented by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in 2012. METHODS: We analyzed serious safety issues appended to drug package inserts (PIs) in Japan in 2012. The issues were characterized according to drug class, adverse event, years since drug approval, initiator of regulatory actions, revised section of PI, and evidence source. We also quantified the durations from signal detection to tentative decision and from tentative decision to regulatory action...
July 19, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28722211/using-prescription-monitoring-program-data-to-characterize-out-of-pocket-payments-for-opioid-prescriptions-in-a-state-medicaid-program
#3
Daniel M Hartung, Sharia M Ahmed, Luke Middleton, Joshua Van Otterloo, Kun Zhang, Shellie Keast, Hyunjee Kim, Kirbee Johnston, Richard A Deyo
BACKGROUND: Out-of-pocket payment for prescription opioids is believed to be an indicator of abuse or diversion, but few studies describe its epidemiology. Prescription drug monitoring programs (PDMPs) collect controlled substance prescription fill data regardless of payment source and thus can be used to study this phenomenon. OBJECTIVE: To estimate the frequency and characteristics of prescription fills for opioids that are likely paid out-of-pocket by individuals in the Oregon Medicaid program...
July 19, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28722207/antihypertensive-drug-associated-angioedema-effect-modification-by-race-ethnicity
#4
Marsha E Reichman, Michael Wernecke, David J Graham, Jiemin Liao, John Yap, Yoganand Chillarige, Mary Ross Southworth, Stephine Keeton, Margie R Goulding, Katrina Mott, Jeffrey A Kelman
PURPOSE: Assess angioedema risk with exposure to angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) compared with beta-blockers, by race/ethnicity. METHODS: New-user cohorts of Medicare beneficiaries 65 years or older initiating ACEI, ARB, or beta-blocker treatment from March 2007 to March 2014 were constructed. Angioedema incidence rates by drug and race/ethnicity were computed for 1-30 and 31-365 days of treatment. Cox proportional hazards regression was used to examine angioedema risk between cohorts...
July 19, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28696023/mcda-swing-weighting-and-discrete-choice-experiments-for-elicitation-of-patient-benefit-risk-preferences-a-critical-assessment
#5
Tommi Tervonen, Heather Gelhorn, Sumitra Sri Bhashyam, Jiat-Ling Poon, Katharine S Gries, Anne Rentz, Kevin Marsh
PURPOSE: Multiple criteria decision analysis swing weighting (SW) and discrete choice experiments (DCE) are appropriate methods for capturing patient preferences on treatment benefit-risk trade-offs. This paper presents a qualitative comparison of the 2 methods. METHODS: We review and critically assess similarities and differences of SW and DCE based on 6 aspects: comprehension by study participants, cognitive biases, sample representativeness, ability to capture heterogeneity in preferences, reliability and validity, and robustness of the results...
July 11, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28691203/previously-undiagnosed-risk-factors-and-medication-nonadherence-are-prevalent-in-young-adults-with-first-ever-stroke
#6
Sheng-Feng Sung, Edward Chia-Cheng Lai, Darren Philbert Wu, Cheng-Yang Hsieh
PURPOSE: The incidence of stroke and prevalence of traditional vascular risk factors (VRFs) in young adults (age < 55 y) are both increasing. Young patients tend to be unaware of their VRFs and to have lower medication adherence. We examined how age affects the prevalence of previously undiagnosed VRFs and the extent of medication nonadherence among stroke patients. METHODS: Using Taiwan's National Health Insurance Research Database, we identified consecutive adult patients with first-ever stroke between 2000 and 2013...
July 10, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28691404/-delisting-oxycontin%C3%A2-to-reduce-prescription-opioid-related-harms-in-ontario-canada-gauging-effects-5%C3%A2-years-later
#7
Benedikt Fischer, Lenka Vojtila, Paul Kurdyak
No abstract text is available yet for this article.
July 9, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28691251/postmarketing-withdrawal-of-human-medicinal-products-because-of-adverse-reactions-in-animals-a-systematic-review-and-analysis
#8
Igho J Onakpoya, Carl J Heneghan, Jeffrey K Aronson
PURPOSE: We have identified human medicinal products for which animal data were used as evidence for withdrawal, determined whether the adverse reactions were reported in humans, established whether confirmatory human studies were conducted, and explored the withdrawal patterns over time. METHODS: We searched the World Health Organization's Consolidated List of [Medicinal] Products, drug regulatory authorities' websites, PubMed, Google Scholar, and selected textbooks to identify medicinal products withdrawn from 1950 to June 2016...
July 9, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28665012/prescribing-trends-and-indications-of-antipsychotic-medication-in-hong-kong-from-2004-to-2014-general-and-vulnerable-patient-groups
#9
Kim S J Lao, Anthony W Y Tam, Ian C K Wong, Frank M C Besag, Kenneth K C Man, Celine S L Chui, Esther W Chan
PURPOSE: Antipsychotic-prescribing patterns remain unclear in Asia. The aims of our study were to investigate prescribing trends of antipsychotic medication in the general population, children, and older patients by drug generation (first or second), the prescribing trend in pregnant women, the probable indication for antipsychotic prescription, and the prescribing trend by dosage form. METHODS: This descriptive study identified and included all patients prescribed with antipsychotic in Hong Kong from 2004 to 2014 using the Clinical Data Analysis and Report System...
June 30, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28657162/codemapper-semiautomatic-coding-of-case-definitions-a-contribution-from-the-advance-project
#10
Benedikt F H Becker, Paul Avillach, Silvana Romio, Erik M van Mulligen, Daniel Weibel, Miriam C J M Sturkenboom, Jan A Kors
BACKGROUND: Assessment of drug and vaccine effects by combining information from different healthcare databases in the European Union requires extensive efforts in the harmonization of codes as different vocabularies are being used across countries. In this paper, we present a web application called CodeMapper, which assists in the mapping of case definitions to codes from different vocabularies, while keeping a transparent record of the complete mapping process. METHODS: CodeMapper builds upon coding vocabularies contained in the Metathesaurus of the Unified Medical Language System...
June 28, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28653802/safety-profile-of-h1-antihistamines-in-pediatrics-an-analysis-based-on-data-from-vigibase
#11
Domenico Motola, Monia Donati, Chiara Biagi, Elisabetta Calamelli, Francesca Cipriani, Mauro Melis, Luca Monaco, Alberto Vaccheri, Giampaolo Ricci
PURPOSE: H1-antihistamines are commonly used in infants and children for the relief of histamine-mediated symptoms in a variety of conditions. Little is known about their safety profile in these patients. We performed a comparative analysis of the safety profiles of H1-antihistamines using data from the WHO database (VigiBase). METHODS: We selected adverse drug reaction (ADR) reports on H1-antihistamines in children (0-16 years) up to June 2014 from VigiBase. ADRs were codified according to MedDRA terminology...
June 27, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28653790/vigirank-for-statistical-signal-detection-in-pharmacovigilance-first-results-from-prospective-real-world-use
#12
Ola Caster, Lovisa Sandberg, Tomas Bergvall, Sarah Watson, G Niklas Norén
PURPOSE: vigiRank is a data-driven predictive model for emerging safety signals. In addition to disproportionate reporting patterns, it also accounts for the completeness, recency, and geographic spread of individual case reporting, as well as the availability of case narratives. Previous retrospective analysis suggested that vigiRank performed better than disproportionality analysis alone. The purpose of the present analysis was to evaluate its prospective performance. METHODS: The evaluation of vigiRank was based on real-world signal detection in VigiBase...
June 27, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28653782/changes-in-drug-use-patterns-reported-on-the-web-after-the-introduction-of-adf-oxycontin-findings-from-the-researched-abuse-diversion-and-addiction-related-surveillance-radars-system-web-monitoring-program
#13
Suzanne Vosburg, Colleen Haynes, Andrea Besharat, Jody L Green
This qualitative study summarizes information that individuals shared online about use of OxyContin following the August 2010 introduction of the abuse deterrent formulation (ADF). PURPOSE: The primary objective was to study online posts that endorsed continued use of OxyContin or a switch from OxyContin to another formulation of oxycodone or another substance altogether following the introduction of the ADF. A secondary objective was to determine whether posts revealed that the ADF led to cessation of OxyContin use...
June 27, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28620909/pregabalin-and-heart-failure-a-population-based-study
#14
Joanne M-W Ho, Erin M Macdonald, Jin Luo, Tara Gomes, Tony Antoniou, Muhammad M Mamdani, David N Juurlink
PURPOSE: The anticonvulsant pregabalin is increasingly prescribed for pain, seizures, and psychiatric disorders. Although evidence suggests pregabalin can cause edema and heart failure, its cardiac safety profile in clinical practice is unknown. We sought to examine the risk of heart failure among older patients receiving pregabalin compared to those receiving gabapentin. METHODS: We conducted a population-based cohort study of Ontarians aged 66 and older with a history of seizure who received pregabalin or gabapentin between April 2013 and March 2014...
June 16, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28612964/has-cost-inhibited-the-uptake-of-more-potent-statins-in-england
#15
Stephen R Chapman, Raymond W Fitzpatrick, Mohammed I Aladul
BACKGROUND: The use of statins has increased substantially over the last 2 decades in England and represents a significant cost burden to the National Health Service. Therefore, it is important to understand what influences prescribers' choice. OBJECTIVES: This study examines the changes in use pattern of all statins in England (1998-2015). The study focuses on the use of simvastatin and atorvastatin before and after their patent expiry and rosuvastatin, to investigate the impact of the reduced acquisition costs on prescribing...
June 14, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28612945/comparative-study-of-the-number-of-report-and-time-to-onset-of-the-reported-adverse-event-between-the-biosimilars-and-the-originator-of-filgrastim
#16
Tetsu Kobayashi, Izumi Kamada, Junko Komura, Satoshi Toyoshima, Akiko Ishii-Watabe
PURPOSE: The objective of this study is to specify the most reported adverse events as preferred terms (PTs) and to compare the reported adverse events about some properties including the number of report and time-to-onset (TTO) distribution of the originator of filgrastim Neupogen® and its biosimilars in Europe, using VigiBase®. METHODS: We identified the biosimilar which was reported as the suspected drug in more than 100 individual case safety reports in Europe...
June 14, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28608510/agreement-and-validity-of-electronic-health-record-prescribing-data-relative-to-pharmacy-claims-data-a-validation-study-from-a-us-electronic-health-record-database
#17
Christopher G Rowan, James Flory, Tobias Gerhard, John K Cuddeback, Nikita Stempniewicz, James D Lewis, Sean Hennessy
BACKGROUND: Granular clinical and laboratory data available in electronic health record (EHR) databases provide researchers the opportunity to conduct investigations that would not be possible in insurance claims databases; however, for pharmacoepidemiology studies, accurate classification of medication exposure is critical. OBJECTIVE: The aim of this study was to evaluate the validity of classifying medication exposure using EHR prescribing (EHR-Rx) data. METHODS: We conducted a retrospective cohort study among patients with linked claims and EHR data in OptumLabs™ Data Warehouse...
June 12, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28594145/use-of-antidepressant-medication-in-pregnancy-and-adverse-neonatal-outcomes-a-population-based-investigation
#18
Anna Cantarutti, Luca Merlino, Carlo Giaquinto, Giovanni Corrao
BACKGROUND: Untreated depression and antidepressant use during pregnancy may have negative consequences for births. There are still conflicting data on the potential harmful effects of prenatal antidepressant treatment on child health. OBJECTIVE: To investigate the relationship between the use of antidepressant medication during pregnancy and selected neonatal outcomes. METHODS: A population-based cohort study including 9825 deliveries exposed to an antidepressant between 9 months before last menstrual date through to delivery, from January 2005 to December 2010 in the Lombardy region of Italy, was conducted...
June 8, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28594077/trends-in-antidepressant-prescribing-to-children-and-adolescents-in-canadian-primary-care-a-time-series-analysis
#19
Rachael Morkem, Tyler Williamson, Scott Patten, John A Queenan, Sabrina T Wong, Donna Manca, David Barber
PURPOSE: The purpose of this study was to describe the trends and patterns of antidepressant (AD) prescribing to children and adolescents in Canadian primary care before and after the black-box warning in 2004. METHODS: Prescription data from the Canadian Primary Care Sentinel Surveillance Network, a repository of primary care data on over 1 million patients, was used to analyze AD prescribing to children (8-11 y) and adolescents (12-18 y) between 2000 and 2014...
June 8, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28594076/the-future-of-safety-science-is-happening-now-the-modernization-of-the-benefit-risk-paradigm
#20
Fabio Lievano, Linda Scarazzini, Frank Shen, James Duhig, Jeremy Jokinen
The future of safety science is happening now and has the potential to improve patient outcomes through an evolving approach to benefit-risk assessment. Three building blocks for the future of safety science, cognitive and behavioral systems, medical assessment, and data science, individually and collaboratively advance and modernize the benefit-risk paradigm. Incorporating the patient perspective and patient experiences will help identify tools that are useful in real-world practice. Medical assessment teams will bring together the study of toxicity and toxicogenomics, biomarkers, and special populations to personalize the benefit-risk profile...
June 8, 2017: Pharmacoepidemiology and Drug Safety
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