Adverse drug reaction monitoring: comparing doctor and patient reporting for new drugs.

abstract：PURPOSE:To describe a bias that can occur in the analysis of data from certain randomized trials. METHODS AND RESULTS:Although randomized trials are effective at preventing confounding, a potentially strong confounding can arise in certain therapeutic drug trials in which follow-up is extended in an open-label phase t...

journal_title：Pharmacoepidemiology and drug safety

authors： Rothman KJ

更新日期：2004-05-01 00:00:00

abstract：PURPOSE:Leukotriene receptor antagonists are used in asthma and rhinitis treatment. Pharmacovigilance data have suggested an association between montelukast and depression, but the association has not been established in controlled study designs. We described the association between initiation of montelukast and depres...

journal_title：Pharmacoepidemiology and drug safety

authors： Winkel JS,Damkier P,Hallas J,Henriksen DP

更新日期：2018-12-01 00:00:00

abstract：PURPOSE:We aimed to investigate the association between psychotropic treatment and risk of burn injury in individuals with mental illness. METHODS:A nested case-control study was conducted by using the National Health Insurance Research Database in Taiwan. A total of 3187 cases with burn injury under International Cla...

journal_title：Pharmacoepidemiology and drug safety

authors： Chang CM,Wu KY,Chiu YW,Wu HT,Tsai YT,Chau YL,Tsai HJ

更新日期：2016-08-01 00:00:00

abstract：:The cost of drugs represents 10% of the National Health Service (NHS) budget in the UK and this fraction is increasing. Because the NHS is centrally funded and because there is a budgetary limit, prioritization in health care is required. The National Institute for Clinical Excellence in England and Wales and the Heal...

journal_title：Pharmacoepidemiology and drug safety

authors： Beard K

更新日期：2001-08-01 00:00:00

abstract：PURPOSE:We sought to determine the incidence and risks for severe thrombocytopenia (platelets < 50,000/μL) in United States Veteran patients treated with pegylated interferon (PEG-IFN) plus ribavirin for hepatitis C virus-positive (HCV) chronic liver disease (CLD). METHODS:Using a retrospective, observational cohort s...

journal_title：Pharmacoepidemiology and drug safety

authors： Hermos JA,Quach L,Gagnon DR,Weber HC,Altincatal A,Cho K,Lawler EV,Grotzinger KM

更新日期：2014-05-01 00:00:00

abstract：PURPOSE:Economic factors, market dynamics, and safety issues are largely responsible for decisions to withdraw pharmaceutical products from the market. In this study, new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) were examined in the USA from 1980 to 2009. METHODS:Data were obtained ...

journal_title：Pharmacoepidemiology and drug safety

authors： Qureshi ZP,Seoane-Vazquez E,Rodriguez-Monguio R,Stevenson KB,Szeinbach SL

更新日期：2011-07-01 00:00:00

abstract：OBJECTIVE:To assess the extent, characteristics and determinants of benzodiazepine prescription in outpatient Primary Health Care. METHODS:A clinical audit of a stratified random sample of Primary Health Care Centres in the seven islands and 1.6 million inhabitants region of 'Canarias' in Spain was carried out. From t...

journal_title：Pharmacoepidemiology and drug safety

authors： de las Cuevas C,Sanz E,de la Fuente JA,Cabrera C,Mateos A

更新日期：1999-05-01 00:00:00

abstract：PURPOSE:Poor adherence and persistence to blood pressure lowering (BPL) agents leads to increased risk of morbidity and mortality. The aim of this study was to investigate the long-term adherence, persistence, and re-initiation of BPL agents among older Australians (aged ≥65 years). METHODS:We utilised the Pharmaceuti...

journal_title：Pharmacoepidemiology and drug safety

authors： Si S,Ofori-Asenso R,Briffa T,Sanfilippo FM,Ilomaki J,Qin X,Tacey M,Reid CM,Liew D

更新日期：2019-06-01 00:00:00

abstract：PURPOSE:To evaluate whether the risk of coronary heart disease (CHD) differs among adult diabetic patients treated with thiazolidinediones (TZDs) and similar patients treated with combined oral metformin and sulfonylurea (M + S) therapy. METHODS:We conducted a retrospective cohort study involving 25 140 diabetic patie...

journal_title：Pharmacoepidemiology and drug safety

authors： Johannes CB,Koro CE,Quinn SG,Cutone JA,Seeger JD

更新日期：2007-05-01 00:00:00

abstract：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...

journal_title：Pharmacoepidemiology and drug safety

authors： González-Pérez A,Sáez ME,Johansson S,Nagy P,García Rodríguez LA

更新日期：2017-02-01 00:00:00

abstract：PURPOSE:First-in-class (FIC) drugs with novel modes of action pose concerns regarding important postmarketing safety issues. The purpose of this study was to analyze the factors related to the occurrence of postmarketing safety-related regulatory actions (PSRAs) for drugs approved in the United States (US), with a focu...

journal_title：Pharmacoepidemiology and drug safety

authors： Ikeda J,Kaneko M,Narukawa M

更新日期：2018-12-01 00:00:00

abstract：PURPOSE:De-implementation of low-value services among patients with limited life expectancy is challenging. Robust mortality prediction models using routinely collected health care data can enhance health care stakeholders' ability to identify populations with limited life expectancy. We developed and validated a claim...

journal_title：Pharmacoepidemiology and drug safety

authors： Lund JL,Kuo TM,Brookhart MA,Meyer AM,Dalton AF,Kistler CE,Wheeler SB,Lewis CL

更新日期：2019-05-01 00:00:00

abstract：PURPOSE:To develop a method for identifying the beginning and ending records of pregnancies in the automated medical records of the General Practice Research Database (GPRD). METHODS:Women's records from 1991 to 1999 were searched for codes from 17 pregnancy marker and 7 pregnancy outcome categories. Using the retriev...

journal_title：Pharmacoepidemiology and drug safety

authors： Hardy JR,Holford TR,Hall GC,Bracken MB

更新日期：2004-11-01 00:00:00

abstract：PURPOSE:The use of granulocyte colony-stimulating factor (G-CSF) in the treatment of non-chemotherapy drug- induced agranulocytosis is controversial. We aimed at assessing the effect of G-CSF on the duration of agranulocytosis. METHODS:To assess the effect of G-CSF on the duration of agranulocytosis, a Cox proportiona...

journal_title：Pharmacoepidemiology and drug safety

authors： Ibáñez L,Sabaté M,Ballarín E,Puig R,Vidal X,Laporte JR,Agranulocytosis and Aplastic Anaemia Study Group of Barcelona.

更新日期：2008-03-01 00:00:00

abstract：:Pharmaceutical manufacturers are faced with the challenge of when and how to conduct pharmacoeconomic (PE) evaluations to satisfy formulary decision-makers. To illustrate the usefulness of decision analysis for strategic planning in drug development, a model was created to compare the cost-benefit of three PE design o...

journal_title：Pharmacoepidemiology and drug safety

authors： Ungar W

更新日期：1997-11-01 00:00:00

abstract：:Erythromycin is commonly used to treat simple community-acquired pneumonia. We measured the prolongation in QT(c) intervals in EKGs associated with intravenous erythromycin administration among patients hospitalized for simple pneumonia (DRGs 89 and 90). We reviewed the medical records of 50 patients who received at l...

journal_title：Pharmacoepidemiology and drug safety

authors： Freeman J,Platt R

更新日期：1997-01-01 00:00:00

abstract：PURPOSE:This paper aimed to systematically review algorithms to identify transfusion-related ABO incompatibility reactions in administrative data, with a focus on studies that have examined the validity of the algorithms. METHODS:A literature search was conducted using PubMed, Iowa Drug Information Service database, a...

journal_title：Pharmacoepidemiology and drug safety

authors： Carnahan RM,Kee VR

更新日期：2012-01-01 00:00:00

abstract：PURPOSE:Research using healthcare databases often includes patients frequently excluded from clinical trials; yet it is not known whether commonly used data represents the overall population or specific sub-populations of interest. We aimed to examine population representativeness from data sources in recent research s...

journal_title：Pharmacoepidemiology and drug safety

authors： Kaviani P,Landi SN,McKethan A,Brookhart MA,McGrath LJ

更新日期：2020-11-01 00:00:00

abstract：PURPOSE:Although sales of prescribed and over-the-counter (OTC) medication are rising, little is known about individual drug intake. This study was aimed to obtain complementary information about drug intake. METHOD:Information on drug utilization was obtained in a female cohort for five different time points (TP): 36...

journal_title：Pharmacoepidemiology and drug safety

authors： Hoeke H,Roeder S,Bertsche T,Borte M,von Bergen M,Wissenbach DK

更新日期：2016-04-01 00:00:00

abstract：OBJECTIVES:The aim of this study was to examine epidemiologic characteristics of Adverse Drug Events (ADEs) among children and adolescents presenting to an Emergency Department (ED) in Newfoundland and Labrador (NL), Canada. MATERIALS AND METHODS:This study was conducted in three phases and included an ED chart review...

journal_title：Pharmacoepidemiology and drug safety

authors： Sikdar KC,Alaghehbandan R,Macdonald D,Barrett B,Collins KD,Gadag V

更新日期：2010-02-01 00:00:00

abstract：PURPOSE:Postmarketing drug safety surveillance relies upon measures of disproportionate reporting in spontaneous reporting systems. It has been hypothesized that products or events reported frequently may "mask" signals. METHODS:We analyzed the masking effect of vaccines in pediatrics in the EudraVigilance database by...

journal_title：Pharmacoepidemiology and drug safety

authors： Dodd C,Pacurariu A,Osokogu OU,Weibel D,Ferrajolo C,Vo DH,Becker B,Kors JA,Sturkenboom M

更新日期：2018-11-01 00:00:00

abstract：PURPOSE:The role of administrative databases for research on drug safety during pregnancy can be limited by their inaccurate assessment of the timing of exposure, as the gestational age at birth is typically unavailable. Therefore, we sought to develop and validate algorithms to estimate the gestational age at birth us...

journal_title：Pharmacoepidemiology and drug safety

authors： Margulis AV,Setoguchi S,Mittleman MA,Glynn RJ,Dormuth CR,Hernández-Díaz S

更新日期：2013-01-01 00:00:00

abstract：PURPOSE:To examine and compare the quality of drug prescribing for older patients in nursing homes and home nursing services. METHODS:Cross-sectional study comprising 11,254 patients aged ≥ 65 years in nursing homes (n = 2986) and home nursing services (n = 8268). Potentially inappropriate medications were identified ...

journal_title：Pharmacoepidemiology and drug safety

authors： Halvorsen KH,Granas AG,Engeland A,Ruths S

更新日期：2012-09-01 00:00:00

abstract：PURPOSE:To examine the association between the use of psychotropic drugs and fatal pulmonary embolism. METHODS:We conducted a national case-control study of fatal pulmonary embolism. Cases were 75 New Zealand men and women aged 15-59 years who died between 1 January 1990 and 31 December 1998, where the underlying caus...

journal_title：Pharmacoepidemiology and drug safety

authors： Parkin L,Skegg DC,Herbison GP,Paul C

更新日期：2003-12-01 00:00:00

abstract：:Not everything is known about a medicine when it receives its licence for marketing. The merits of a new drug, balancing its beneficial and its untoward effects, become only established after sufficient experience has been gained from its use in real practice. Part of the reason for this is that our extensive phase II...

journal_title：Pharmacoepidemiology and drug safety

authors： Amery WK,ISPE.

更新日期：1999-01-01 00:00:00

abstract：PURPOSE:Bias analysis methods are developed for application to 2 x 2 tables, which may be crude or stratified data. Methods for application to associations adjusted for multiple covariates, such as associations from regression modeling, are rarely seen. We have developed probabilistic methods to evaluate bias from dise...

journal_title：Pharmacoepidemiology and drug safety

authors： Lash TL,Schmidt M,Jensen AØ,Engebjerg MC

更新日期：2010-06-01 00:00:00

abstract：PURPOSE:Pharmacoepidemiologic studies of acute effects of episodic exposures often must control for many time-dependent confounders. Marginal structural models permit this and provide unbiased estimates when confounders are on the causal pathway. However, if causal pathway confounding is minimal, analyses with time-dep...

journal_title：Pharmacoepidemiology and drug safety

authors： Ray WA,Liu Q,Shepherd BE

更新日期：2015-01-01 00:00:00

abstract：PURPOSE:To determine the prevalence of purchase of prescribed antihypertensive and/or serum lipid-reducing pharmaceutical preparations among different age groups, from the age of 45, in the Swedish population. Further, to calculate the percentage of the population, from the age of 60, who purchased these pharmaceutical...

journal_title：Pharmacoepidemiology and drug safety

authors： Silwer L,Lundborg CS,Petzold M

更新日期：2008-01-01 00:00:00

abstract：BACKGROUND:To determine the prevalence of drug consumption and the impact of workplace demands and burdens for substance use, we conducted a survey in a representative sample of Tyrolean employees. METHODS:This analysis was restricted to the 700 respondents (395 male, 305 female; age 18-60 years) in the year 2001 by t...

journal_title：Pharmacoepidemiology and drug safety

authors： Traweger C,Kinzl JF,Traweger-Ravanelli B,Fiala M

更新日期：2004-06-01 00:00:00

abstract：PURPOSE:The purpose of this study is to quantify the impact of the different outcomes and definitions of suicidality on the association between antiepileptic drugs (AEDs) and suicidality. METHODS:Retrospective cohort studies of selected AEDs (carbamazepine, gabapentin, lamotrigine, phenytoin, pregabalin, topiramate an...

journal_title：Pharmacoepidemiology and drug safety

authors： Schuerch M,Gasse C,Robinson NJ,Alvarez Y,Walls R,Mors O,Christensen J,Hesse U,de Groot M,Schlienger R,Reynolds R,Klungel O,de Vries F

更新日期：2016-03-01 00:00:00