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Pharmacoepidemiology

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https://www.readbyqxmd.com/read/28927372/potentially-inappropriate-medication-use-in-nursing-homes-an-observational-study-using-the-norgep-nh-criteria
#1
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
#2
Sílvia M Illamola, Christina Bucci-Rechtweg, Maged M Costantine, Katerina Tsilou, Catherine M Sherwin, Anne Zajicek
Pregnant and breastfeeding women have been rendered therapeutic orphans as they have been historically excluded from clinical trials. Labeling 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
https://www.readbyqxmd.com/read/28921488/report-from-the-first-european-dermato-epidemiology-network-forum
#3
A Ascott, S M Langan, I García-Doval, M A Descalzo, S A J Schmidt, T Nijsten, L M Hollestein
The first European Dermato-Epidemiology Network (EDEN) forum was held on 30-31 March 2017 in Madrid, Spain. Dermatoepidemiology describes the study of causes, prevention, health services research and evaluation of interventions of skin diseases. EDEN aims to promote high-quality research, share expertise and facilitate collaboration. These aims were achieved during the EDEN forum by including a preconference course on skin cancer epidemiology; having excellent world-leading guest speakers on causality, quality of care, pharmacoepidemiology and missing data analysis; and including delegates who presented and discussed innovative research findings...
September 17, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28913966/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
#4
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: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28904801/hypnotics-use-in-children-0-18%C3%A2-months-moderate-agreement-between-mother-reported-survey-data-and-prescription-registry-data
#5
Ingvild Holdø, Jørgen G Bramness, Marte Handal, Leila Torgersen, Ted Reichborn-Kjennerud, Eivind Ystrøm, Hedvig Nordeng, Svetlana Skurtveit
BACKGROUND: Different methods in pharmacoepidemiology can be used to study hypnotic use in children. But neither questionnaire-based data nor prescription records can be considered a "gold standard". This study aimed to investigate the agreement between mother-reported questionnaire-based data and prescription record data for hypnotic drugs in children aged 0-18 months. The agreement was compared to the agreement for a group of antiepileptic drugs. METHODS: Prescription record data were collected from the Norwegian prescription database for 47,413 children also surveyed in the Norwegian mother and child cohort between 2005 and 2009...
2017: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/28903545/the-road-from-development-to-approval-evaluating-the-body-of-evidence-to-confirm-biosimilarity
#6
Paul Declerck, Mourad Farouk Rezk
Biosimilars are products that contain a similar version of the active substance of an already authorized original biologic medicinal product (reference medicinal product). Their development requires special consideration, as similarity to the reference agent needs to be established through a comprehensive comparability exercise. Given the complex nature of these agents, minor structural differences may emerge, but the process of biosimilarity determination is designed to ascertain that the nature and impact of these differences are not clinically significant...
August 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28894902/development-and-validation-of-a-medicines-comorbidity-index-for-older-people
#7
Sujita W Narayan, Prasad S Nishtala
PURPOSE: An index for estimating multimorbidity based on prescription claims data is important for predicting health outcomes for older people in pharmacoepidemiological studies. We aimed to develop a Medicines Comorbidity Index (MCI) based on nationwide prescription claims data and evaluate its performance in predicting adverse outcomes in older individuals. METHODS: The index was developed on a retrospective cohort comprising of all individuals aged ≥ 65 years old, captured in the claims dataset from 1st January to 31st December 2012...
September 11, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28890137/secular-trends-of-use-of-anti-osteoporosis-treatments-in-spain-a-population-based-cohort-study-including-over-1-5million-people-and-more-than-12years-of-follow-up
#8
Elisa Martín-Merino, Consuelo Huerta-Álvarez, Daniel Prieto-Alhambra, Arturo Álvarez-Gutiérrez, Dolores Montero-Corominas
OBJECTIVE: Different regulatory actions for anti-osteoporosis medication (AOM) were taken during the last years, including marketing of new drugs, safety warnings, or restrictions on the indications. We aimed to characterise the secular trends of AOM use in Spain from 2001 to 2013. METHODS: A cohort study using the Spanish Database for Pharmacoepidemiological Research in Primary Care (BIFAP), was performed. BIFAP includes anonym records for 4million patients. Participants entered the study when aged ≥50years in 2001-2013 and after 1year of data available, and were followed to an AOM prescription (including alendronate, other bisphosphonates, SERM (selective estrogen receptor modulators), strontium ranelate, teriparatide or denosumab), death, lost or the end of December 2013...
September 7, 2017: Bone
https://www.readbyqxmd.com/read/28888842/evidence-refuting-the-existence-of-autoimmune-autoinflammatory-syndrome-induced%C3%A2-by-adjuvants-asia
#9
Rohan Ameratunga, David Gillis, Michael Gold, Allan Linneberg, J Mark Elwood
Autoimmune/autoinflammatory syndrome induced by adjuvants (ASIA) was described in 2011. Over time the condition and its triggers have broadened to include several autoimmune disorders, the macrophagic myofasciitis syndrome, the Gulf war syndrome, the sick building syndrome, siliconosis, and the chronic fatigue syndrome. The aluminum-containing adjuvants in the hepatitis B vaccine and the human papillomavirus vaccine in particular have been stated to be the major causes of the disorder. Here, we review the specificity of the diagnostic criteria for ASIA...
September 6, 2017: Journal of Allergy and Clinical Immunology in Practice
https://www.readbyqxmd.com/read/28886089/drug-exposure-in-register-based-research-an-expert-opinion-based-evaluation-of-methods
#10
Antti Tanskanen, Heidi Taipale, Marjaana Koponen, Anna-Maija Tolppanen, Sirpa Hartikainen, Riitta Ahonen, Jari Tiihonen
BACKGROUND: In register-based pharmacoepidemiological studies, construction of drug exposure periods from drug purchases is a major methodological challenge. Various methods have been applied but their validity is rarely evaluated. Our objective was to conduct an expert-opinion based evaluation of the correctness of drug use periods produced by different methods. METHODS: Drug use periods were calculated with three fixed methods: time windows, assumption of one Defined Daily Dose (DDD) per day and one tablet per day, and with PRE2DUP that is based on modelling of individual drug purchasing behavior...
2017: PloS One
https://www.readbyqxmd.com/read/28864947/immortal-time-bias-in-pharmacoepidemiological-studies-on-cancer-patient-survival-empirical-illustration-for-beta-blocker-use-in-four-cancers-with-different-prognosis
#11
Janick Weberpals, Lina Jansen, Myrthe P P van Herk-Sukel, Josephina G Kuiper, Mieke J Aarts, Pauline A J Vissers, Hermann Brenner
Immortal time bias (ITB) is still seen frequently in medical literature. However, not much is known about this bias in the field of cancer (pharmaco-)epidemiology. In context of a hypothetical beneficial beta-blocker use among cancer patients, we aimed to demonstrate the magnitude of ITB among 9876 prostate, colorectal, lung and pancreatic cancer patients diagnosed between 1998 and 2011, which were selected from a database linkage of the Netherlands Cancer Registry and the PHARMO Database Network. Hazard ratios (HR) and 95% confidence intervals from three ITB scenarios, defining exposure at a defined point after diagnosis (model 1), at any point after diagnosis (model 2) and as multiple exposures after diagnosis (model 3), were calculated to investigate the association between beta-blockers and cancer prognosis using Cox proportional hazards regression...
September 1, 2017: European Journal of Epidemiology
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
#12
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/28854991/validation-and-incidence-of-community-acquired-pneumonia-in-patients-with-type-2-diabetes-in-the-bifap-database
#13
L C Saiz, J Garjón, J Gorricho, J Erviti, M J Gil-García, E Martín-Merino
Oral anti-diabetic drugs (OADs) have been associated with community-acquired pneumonia (CAP). We aimed to validate the recording of CAP in the Spanish Database for Pharmacoepidemiological Research in Primary Care (BIFAP) for the future evaluation of OAD-CAP association. The incidence rate (IR/1000 person-years) of CAP in type 2 diabetes mellitus (T2DM) was also determined. In total, 2966 pneumonia records (2040 listed as diagnosis and 926 as identified from comments added by physicians) were identified from 76 009 patients with T2DM after the first OAD in 2002-2013...
August 31, 2017: Epidemiology and Infection
https://www.readbyqxmd.com/read/28853000/discontinuation-of-preventive-medicines-in-older-people-with-limited-life-expectancy-a-systematic-review
#14
REVIEW
Sujita W Narayan, Prasad S Nishtala
BACKGROUND: In the presence of multimorbidity and limited life expectancy (LLE), the need for continued use of preventive medicines becomes uncertain as they may neither improve health nor confer continued health benefits. OBJECTIVE: Our objective was to systematically review the literature to examine the discontinuation of preventive medicines in older people with LLE. METHODS: A systematic literature search was conducted using the Ovid MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, and the Cochrane Central Register databases...
August 29, 2017: Drugs & Aging
https://www.readbyqxmd.com/read/28833745/pharmacoepidemiology-of-testosterone-curbing-off-label-prescribing
#15
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/28823072/prevalence-and-predictors-of-digoxin-utilization-among-heart-failure-patients-with-reduced-ejection-fraction-in-qatar
#16
Alaa Abdullah Rahhal, Ahmed Awaisu, Kawthar M Tawengi, Safae AbuYousef, Lylia Mekideche
Background Digoxin is a cardiac glycoside that is recommended by clinical practice guidelines to be used in patients with heart failure with reduced ejection fraction (HFrEF) who still have persistent symptoms despite optimal medical therapy. However, this recommendation is based on limited and old trial data. Moreover, pharmacoepidemiologic studies are important in determining the prevalence of digoxin use and factors influencing this. Objective This study aimed to determine the prevalence and the predictors of digoxin utilization among patients with HFrEF with or without atrial fibrillation (AF) in Qatar...
August 19, 2017: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/28819675/pharmacoepidemiology-resources-in-ireland-an-introduction-to-pharmacy-claims-data
#17
Sarah-Jo Sinnott, Kathleen Bennett, Caitriona Cahir
INTRODUCTION: Administrative health data, such as pharmacy claims data, present a valuable resource for conducting pharmacoepidemiological and health services research. Often, data are available for whole populations allowing population level analyses. Moreover, their routine collection ensures that the data reflect health care utilisation in the real-world setting compared to data collected in clinical trials. SETTING AND METHODS: The Irish Health Service Executive-Primary Care Reimbursement Service (HSE-PCRS) community pharmacy claims database is described...
August 17, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28815480/evaluation-of-electronic-healthcare-databases-for-post-marketing-drug-safety-surveillance-and-pharmacoepidemiology-in-china
#18
Yu Yang, Xiaofeng Zhou, Shuangqing Gao, Hongbo Lin, Yanming Xie, Yuji Feng, Kui Huang, Siyan Zhan
INTRODUCTION: Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. METHODS: Three major types of EHDs in China (i.e., a regional community-based database, a national claims database, and an electronic medical records [EMR] database) were selected for evaluation. Forty core variables were derived based on the US Mini-Sentinel (MS) Common Data Model (CDM) as well as the data features in China that would be desirable to support drug safety surveillance...
August 16, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28811926/postinjection-delirium-sedation-syndrome-in-patients-with-schizophrenia-receiving-olanzapine-long-acting-injection-results-from-a-large-observational-study
#19
Kristin J Meyers, Himanshu P Upadhyaya, John L Landry, Rashna Chhabra-Khanna, Deborah M Falk, Balasubramanya Seetharama Rao, Meghan E Jones
BACKGROUND: Postinjection delirium/sedation syndrome (PDSS) has been reported uncommonly during treatment with olanzapine long-acting injection (LAI), a sustained-release formulation of olanzapine. AIMS: The primary aim of the study was to estimate the incidence per injection and per patient of PDSS events in adult patients with schizophrenia who were receiving olanzapine LAI in real-world clinical practice. Secondary aims were to further characterise the clinical presentation of PDSS events, to identify potential risk factors associated with PDSS events and to characterise hospitalisations at baseline and post-baseline...
July 2017: BJPsych Open
https://www.readbyqxmd.com/read/28792563/-initiating-an-antipsychotic-drug-treatment-for-schizophrenia-the-situation-in-quebec-canada-from-1998-to-2006
#20
Jean-Daniel Carrier, Lucie Blais, Alan Cohen, Josiane Courteau, Pasquale Roberge, Annie Larouche, Sylvain Grignon, Marie-Josée Fleury, Alain Lesage, Marie-France Demers, Marc-André Roy, André Delorme, Alain Vanasse
Objectives To describe factors associated with the following characteristics of the first prescription of an antipsychotic drug treatment (ADT): 1) prescribing physician type (psychiatrist vs. general practitioner); 2) second-generation vs. first-generation antipsychotic drug; 3) in conjunction with at least one additional antipsychotic drug (multitherapy); 4) never renewed by the patient.Methods This is a pharmacoepidemiologic study using administrative data from the Régie de l'assurance maladie du Québec (RAMQ), the public healthcare insurer in Quebec, Canada...
2017: Santé Mentale Au Québec
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