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Pharmacoepidemiology and Drug Safety

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https://www.readbyqxmd.com/read/27921360/mortality-in-patients-who-discontinue-low-dose-acetylsalicylic-acid-therapy-after-upper-gastrointestinal-bleeding
#1
Antonio González-Pérez, María Eugenia Sáez, Saga Johansson, Péter Nagy, Luis A García Rodríguez
PURPOSE: Discontinuing low-dose acetylsalicylic acid (ASA) therapy after upper gastrointestinal bleeding (UGIB) may increase the risk of cardiovascular-related death. Our aim was to compare mortality in UK primary care patients who discontinue ASA after UGIB with that in patients who continue therapy. METHODS: ASA users at the time of UGIB and who were alive 30 days after were selected using The Health Improvement Network. Predictors of survival were assessed using adjusted Cox proportional hazards regression models...
December 6, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27910218/octreotide-use-and-safety-in-infants-with-hyperinsulinism
#2
Ann W McMahon, Gerold T Wharton, Paul Thornton, Diva D De Leon
BACKGROUND: Octreotide is a synthetic peptide analog of naturally occurring somatostatin. Octreotide is used off-label in children <6 years of age for hyperinsulinism, chylothorax, and gastrointestinal bleeding. There is a lack of controlled data on efficacy or potential adverse events from this off-label use. METHODS: Three pediatric hospitals participated in this study. Patients were hospitalized January 2007-December 2010 and administered octreotide for congenital hyperinsulinism (CHI) at least 1 day...
December 2, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27910177/comparison-of-pharmacy-based-and-diagnosis-based-comorbidity-measures-from-medical-administrative-data
#3
Sébastien Cortaredona, Elodie Pambrun, Hélène Verdoux, Pierre Verger
PURPOSE: Health status is sometimes quantified by chronic condition (CC) scores calculated from medical administrative data. We sought to modify two pharmacy-based comorbidity measures and compare their performance in predicting hospitalization and/or death. The reference was a diagnosis-based score. METHODS: One of the two measures applied an updated approach linking specific ATC codes of dispensed drugs to 22 CCs; the other used a list of 37 drug categories, without linking them to specific CCs...
December 2, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27891698/vaccination-and-unexplained-sudden-death-risk-in-taiwanese-infants
#4
Wan-Ting Huang, Robert T Chen, Yu-Chen Hsu, John W Glasser, Philip H Rhodes
PURPOSE: In March 1992, eight infants who had died within 36 hours of receiving whole-cell pertussis vaccine (diphtheria, tetanus, and whole-cell pertussis [DTwP]) prompted the Taiwan health authorities to suspend its use. We conducted an investigation of vaccination and sudden unexplained infant death (SUID) and repeated it more recently after Taiwan switched to acellular pertussis vaccine (diphtheria, tetanus, and acellular pertussis [DTaP]) in 2010. METHODS: All SUIDs aged 31-364 days during 1990-1992 and 1996-2013 were selected from the death registration databases...
November 28, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27889931/new-use-of-prescription-drugs-prior-to-a-cancer-diagnosis
#5
Anton Pottegård, Jesper Hallas
PURPOSE: Cancers often have considerable induction periods. This confers a risk of reverse causation bias in studies of cancer risk associated with drug use, as early symptoms of a yet undiagnosed cancer might lead to drug treatment in the period leading up to the diagnosis. This bias can be alleviated by disregarding exposure for some time before the cancer diagnosis (lag time). We aimed at assessing the duration of lag time needed to avoid reverse causation bias. METHODS: We identified all Danish patients with incident cancer between 2000 and 2012 (n = 353 087)...
November 27, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27878889/decision-making-in-drug-safety-a-literature-review-of-criteria-used-to-prioritize-newly-detected-safety-issues
#6
Alexandra C Pacurariu, Preciosa M Coloma, Liana Gross-Martirosyan, Miriam C Sturkenboom, Sabine M Straus
PURPOSE: In drug safety, there is a lack of guidance on how prioritization of safety issues should be performed. The aim of this literature review is to provide an overview of criteria used for signal prioritization and of the associated decision support frameworks. METHODS: A search strategy was constructed to identify relevant articles in Medline/Embase databases from the period from 1 January 1995 to 31 August 2015. The prioritization criteria were extracted and classified in relevant categories...
November 23, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27868282/validation-of-stevens-johnson-syndrome-or-toxic-epidermal-necrolysis-diagnoses-in-the-clinical-practice-research-datalink
#7
Noel Frey, Andreas Bircher, Michael Bodmer, Susan S Jick, Christoph R Meier, Julia Spoendlin
PURPOSE: To evaluate the validity of recorded diagnoses of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) in the Clinical Practice Research Datalink (CPRD). METHODS: We identified patients with a diagnosis of SJS or TEN between 1995 and 2013 in the CPRD. We reviewed information from patient records, free text, and hospital episode statistics (HES) data, and excluded patients with no indication of a secondary care referral. Remaining patients were classified as probable, possible, or unlikely cases of SJS/TEN by two specialised clinicians or based on pre-defined classification criteria...
November 20, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27868278/differences-in-vigibase%C3%A2-reporting-of-aminoglycoside-and-capreomycin-suspected-ototoxicity-during-tuberculosis-treatment
#8
Evans L Sagwa, Patrick C Souverein, Inês Ribeiro, Hubert G M Leufkens, Aukje K Mantel-Teeuwisse
PURPOSE: To evaluate the association between the use of streptomycin, amikacin, kanamycin and capreomycin in tuberculosis (TB) treatment and the pharmacovigilance reporting of ototoxicity (deafness or hearing loss, tinnitus and vertigo). Second, to analyze patient demographic and geographic factors that influence the reporting of ototoxicity in TB treatment. METHODS: A case/non-case disproportionality analysis of the VigiBase® individual case safety reports (ICSRs) of patients treated for TB using multidrug regimens that contain either of streptomycin, amikacin, kanamycin or capreomycin...
November 20, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27868277/outpatient-antidepressant-drug-use-in-children-and-adolescents-in-germany-between-2004-and-2011
#9
Carsten Schröder, Michael Dörks, Bianca Kollhorst, Tilo Blenk, Ralf W Dittmann, Edeltraut Garbe, Oliver Riedel
PURPOSE: Recent studies on the utilization of antidepressant drugs in minors are scarce, methodologically limited, and do not factor in off-label use sufficiently. Beyond that, little is known about the short treatment durations that have been observed for many young antidepressant users. The present study examined antidepressant use in pediatric patients aged 0 to 17 years over time, investigated changes regarding the prescribed drugs, analyzed underlying diagnoses, and assessed the rate of off-label use...
November 20, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27868275/effectiveness-and-safety-of-drugs-used-for-stroke-prevention-in-a-cohort-of-non-valvular-atrial-fibrillation-patients-from-a-primary-care-electronic-database
#10
Maria Giner-Soriano, Albert Roso-Llorach, Cristina Vedia Urgell, Xavier Castells, Dolors Capellà, Ignacio Ferreira-González, Josep Maria Elorza-Ricart, Marc Casajuana, Amelia Troncoso Mariño, Eduard Diògene, Bonaventura Bolíbar, Concepció Violan, Rosa Morros
PURPOSE: The aim of this study was to assess effectiveness and safety of antithrombotics for stroke prevention in non-valvular atrial fibrillation in real-use conditions. METHODS: We used a population-based retrospective cohort study. Information emerges from SIDIAP, a database containing anonymized information from electronic health records from 274 primary healthcare centres of the Catalan Health Institute, Catalonia (Spain), with a reference population of 5 835 000 people...
November 20, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27859947/long-term-use-of-proton-pump-inhibitors-and-prevalence-of-disease-and-drug-related-reasons-for-gastroprotection-a-cross-sectional-population-based-study
#11
Susanna M Wallerstedt, Johan Fastbom, Johannes Linke, Sigurd Vitols
PURPOSE: To analyse the prevalence of long-term use of proton pump inhibitors (PPI) with respect to underlying diseases and drugs, and to find predictors for such treatment when an evident rationale for the PPI treatment is lacking. METHODS: The study cohort consisted of individuals, ≥65 years in 2010, residing in the Region Västra Götaland during 2005-2010. For individuals with and without long-term use of PPI in 2010, we investigated the prevalence of an underlying diagnosis, that is, an acid-related disease during the five preceding years, as well as concomitant long-term use of antiplatelet agents or cyclooxygenase inhibitors...
November 16, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27859924/older-adults-with-heart-failure-treated-with-carvedilol-bisoprolol-or-metoprolol-tartrate-risk-of-mortality
#12
Sylvie Perreault, Simon de Denus, Michel White, Brian White-Guay, Michel Bouvier, Marc Dorais, Marie-Pierre Dubé, Jean-Lucien Rouleau, Jean-Claude Tardif, Sarah Jenna, Benjamin Haibe-Kains, Richard Leduc, Denis Deblois
PURPOSE: The long-term use of β-blockers has been shown to improve clinical outcomes among patients with heart failure (HF). However, a lack of data persists in assessing whether carvedilol or bisoprolol are superior to metoprolol tartrate in clinical practice. We endeavored to compare the effectiveness of β-blockers among older adults following a primary hospital admission for HF. METHODS: We conducted a cohort study using Quebec administrative databases to identify patients who were using β-blockers, carvedilol, bisoprolol, or metoprolol tartrate after the diagnosis of HF...
November 16, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27859873/impact-of-an-intervention-on-the-prescription-of-aliskiren-after-new-evidence-on-safety-reported
#13
Isabel Rosich Martí, Alejandro Allepuz, Gemma Rodriguez Palomar, Francesca Ortin Font, Maria Soler Cera
PURPOSE: The purpose of the study is to analyze the impact of an intervention to disseminate safety alerts on the utilization of Aliskiren added to angiotensin converting enzyme inhibitor (ACEI) or an angiotensin-receptor blocker (ARB). METHODS: Quasi-experimental design (non-randomized intervention) comparing the utilization of Aliskiren + ACEI or ARB in a primary care area-intervention (PCA-I) with a primary care area-control (PCA-C) following a safety alert...
November 16, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27862597/impact-of-an-opioid-risk-reduction-initiative-on-motor-vehicle-crash-risk-among-chronic-opioid-therapy-patients
#14
Ryan N Hansen, Rod L Walker, Susan M Shortreed, Sascha Dublin, Kathleen Saunders, Evette J Ludman, Michael Von Korff
PURPOSE: Although prescription opioids have been associated with higher motor vehicle crash (MVC) risk, it is unknown whether health system initiatives to better manage chronic opioid therapy (COT) can reduce MVC risk at the population level. METHODS: We conducted an interrupted time series population-level cohort study at Group Health (GH), between January 2006 and September 2014, comparing MVC risk among COT patients who were GH members receiving care in either group practice or contracted care settings...
November 14, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27862587/are-non-allergic-drug-reactions-commonly-documented-as-medication-allergies-a-national-cohort-of-veterans-admissions-from-2000-to-2014
#15
Kevin W McConeghy, Aisling R Caffrey, Haley J Morrill, Amal N Trivedi, Kerry L LaPlante
PURPOSE: Adverse drug reactions (ADRs) including medication allergies are not well-described among large national cohorts. This study described the most common documented medication allergies and their reactions among a national cohort of Veterans Affairs (VA) inpatients. METHODS: We evaluated inpatient admissions in any VA Medical Center from 1 January 2000 to 31 December 2014. Each admission was linked with allergy history preceding or upon admission. Individual drugs were aggregated into drug class category including: penicillins, sulfonamides, angiotensin converting enzyme (ACE) inhibitors, opiates, HMG-CoA reductase inhibitors ("statins") and non-steroidal anti-inflammatory inhibitors (NSAID)...
November 13, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27859943/a-comparison-of-entropy-balance-and-probability-weighting-methods-to-generalize-observational-cohorts-to-a-population-a-simulation-and-empirical-example
#16
Raymond A Harvey, Jennifer D Hayden, Pravin S Kamble, Jonathan R Bouchard, Joanna C Huang
PURPOSE: We compared methods to control bias and confounding in observational studies including inverse probability weighting (IPW) and stabilized IPW (sIPW). These methods often require iteration and post-calibration to achieve covariate balance. In comparison, entropy balance (EB) optimizes covariate balance a priori by calibrating weights using the target's moments as constraints. METHODS: We measured covariate balance empirically and by simulation by using absolute standardized mean difference (ASMD), absolute bias (AB), and root mean square error (RMSE), investigating two scenarios: the size of the observed (exposed) cohort exceeds the target (unexposed) cohort and vice versa...
November 13, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27862608/assessing-prescription-drug-abuse-using-functional-principal-component-analysis-fpca-of-wastewater-data
#17
Stefania Salvatore, Jo Røislien, Jose A Baz-Lomba, Jørgen G Bramness
BACKGROUND: Wastewater-based epidemiology is an alternative method for estimating the collective drug use in a community. We applied functional data analysis, a statistical framework developed for analysing curve data, to investigate weekly temporal patterns in wastewater measurements of three prescription drugs with known abuse potential: methadone, oxazepam and methylphenidate, comparing them to positive and negative control drugs. METHODS: Sewage samples were collected in February 2014 from a wastewater treatment plant in Oslo, Norway...
November 11, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27862588/comparative-analysis-of-the-cost-and-effectiveness-of-generic-and-brand-name-antibiotics-the-case-of-uncomplicated-urinary-tract-infection
#18
Yu-Shiuan Lin, I-Shiow Jan, Shou-Hsia Cheng
PURPOSE: Generic medications used for chronic diseases are beneficial in containing healthcare costs and improving drug accessibility. However, the effects of generic drugs in acute and severe illness remain controversial. This study aims to investigate treatment costs and outcomes of generic antibiotics prescribed for adults with a urinary tract infection in outpatient settings. METHODS: The data source was the Longitudinal Health Insurance Database of Taiwan. We included outpatients aged 20 years and above with a urinary tract infection who required one oral antibiotic for which brand-name and generic products were simultaneously available...
November 8, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27807907/trends-in-incident-use-of-benzodiazepines-and-z-drugs-in-france-from-2006-to-2012-a-population-based-study
#19
Anne Bénard-Laribière, Pernelle Noize, Elodie Pambrun, Fabienne Bazin, Hélène Verdoux, Marie Tournier, Bernard Bégaud, Antoine Pariente
PURPOSE: To study trends in incident use of benzodiazepines in France between 2006 and 2012. METHODS: A cross-sectional study repeated yearly was conducted using data from the French national healthcare insurance system. New benzodiazepine users were defined as users without any benzodiazepine dispensing in the year prior to the first dispensing of benzodiazepine in each year. Relative changes in incidence of use were calculated with the year 2006 as reference; confidence intervals for changes were estimated using the bootstrap method...
November 3, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27804174/monitoring-safety-in-a-phase-iii-real-world-effectiveness-trial-use-of-novel-methodology-in-the-salford-lung-study
#20
Sue Collier, Catherine Harvey, Jill Brewster, Nawar Diar Bakerly, Hanaa F Elkhenini, Roxana Stanciu, Claire Williams, Jacqui Brereton, John P New, John McCrae, Sheila McCorkindale, David Leather
BACKGROUND: The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once-daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. OBJECTIVE: The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS...
November 1, 2016: Pharmacoepidemiology and Drug Safety
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