Abstract:
PURPOSE:To assess the validity of dispensed prescription to classify exposure to medications used episodically during pregnancy, and to explore individual trajectories of episodic medication use across pregnancy, using triptans for migraine as the motivating example. METHODS:We compared self-reported triptan use during pregnancy in The Norwegian Mother, Father and Child Cohort Study (MoBa) to dispensed prescriptions in The Norwegian Prescription Database and calculated Cohen's kappa coefficient (κ), sensitivity, specificity and predictive values using MoBa as reference standard. We used group-based trajectory modeling to estimate exposure trajectories in MoBa according to probability of triptan use across pregnancy. RESULTS:We identified 6051 pregnancies where mothers filled at least one triptan prescription or reported migraine or triptan use in the 6 months before or during pregnancy. Sensitivity of prescribed triptans during pregnancy was low (39.1%), but specificity was quite high (95.4%). Agreement between the two data sources was fair (κ 0.36). We identified three trajectory groups in MoBa including constant-high, decreasing-medium and decreasing-low probability of triptan use across pregnancy. CONCLUSIONS:Using dispensed prescriptions rather than self-report to classify exposure to triptans during pregnancy is likely to result in substantial under-estimation of exposure. In this study, traditional definitions of ever-exposed vs never-exposed failed to capture variations in drug utilization during pregnancy.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Harris GE,Wood M,Nordeng Hdoi
10.1002/pds.5089subject
Has Abstractpub_date
2020-09-01 00:00:00pages
1111-1119issue
9eissn
1053-8569issn
1099-1557journal_volume
29pub_type
杂志文章abstract:PURPOSE:Medicaid programs are concerned about inappropriate, potentially hazardous, and costly off-label use of second-generation antipsychotics (SGAs). Several states are exploring policies aimed at managing low-dose quetiapine, commonly prescribed for off-label conditions. This study aimed to characterize longitudina...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3538
更新日期:2014-01-01 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
pub_type: 杂志文章
doi:10.1002/pds.955
更新日期:2004-06-01 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
pub_type: 杂志文章
doi:10.1002/pds.4623
更新日期:2018-11-01 00:00:00
abstract:PURPOSE:In pharmacoepidemiology, one of the main concerns is analysis of drug exposure time. However, in real-life settings, patient's behavior is complex and characterized by drug exposure dynamics. Multi-state models allow assessing the probabilities of various patterns, instead of just continuous use and/or disconti...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3835
更新日期:2015-09-01 00:00:00
abstract::Schizophrenia is a life-threatening disease associated with mortality rates that are two to three times higher than those expected/observed in the general population. It is associated with high levels of suicide, particularly in young male patients soon after diagnosis. Delays in treating schizophrenia could contribut...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.1496
更新日期:2007-12-01 00:00:00
abstract:AIM:To determine the appropriate size of risk windows in both exposed and unexposed sub-cohorts. METHOD:Data was taken from a previous study of upper gastrointestinal haemorrhage and perforation. The length of each prescription for NSAIDs was estimated. The risk was calculated for the duration of a prescription plus i...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199807/08)7:4<275::AID-PDS
更新日期:1998-07-01 00:00:00
abstract:BACKGROUND:Previous reports have suggested that new evidence of the comparative effectiveness of different medication classes from randomized controlled trials (RCTs) does not always alter treatment decisions for first-line anti-hypertensive therapy. OBJECTIVES:To evaluate the association of RCT evidence in December 2...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1788
更新日期:2009-09-01 00:00:00
abstract:PURPOSE:We aimed to describe time-trends in the use of NOACs among a group of ambulatory patients with nonvalvular atrial fibrillation (NVAF) in Colombia and to describe treatment patterns and user characteristics. METHODS:Using the Audifarma S.A administrative healthcare database in Colombia, we identified 10 528 pat...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.5124
更新日期:2020-10-15 00:00:00
abstract::We review the concept of time-dependent confounding by using the example in paper "Comparative effectiveness of individual angiotensin receptor blockers on risk of mortality in patients with chronic heart failure" by Desai et al. and illustrate how to adjust for it by using inverse probability of treatment weighting t...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 评论,杂志文章
doi:10.1002/pds.2306
更新日期:2012-03-01 00:00:00
abstract:PURPOSE:Our objective was to examine the numbers and characteristics of US pediatric adverse events (AEs) reported to the Food and Drug Administration (FDA)'s adverse event reporting system (AERS) for 5 years following implementation of the Best Pharmaceuticals for Children Act (BPCA) in 2002. METHODS:We analyzed repo...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1679
更新日期:2009-01-01 00:00:00
abstract:PURPOSE:Determination of the incidence rate of diabetic ketoacidosis (DKA) in type 2 diabetes mellitus (T2DM) is urgent, in response to the safety issue with use of the glucose lowering drugs, sodium-glucose cotransporter-2 inhibitors, and DKA. METHODS:We extracted data of adult patients with T2DM from a medical claim...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4271
更新日期:2018-01-01 00:00:00
abstract:PURPOSE:In Spain, a human papillomavirus (HPV) vaccine was firstly marketed in 2006 and mainly administered in primary care (PC) practices for girls/women or schools. As for all vaccines, a valid data source is required for research on observational effectiveness or safety. The objective of this study is to identify an...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4674
更新日期:2019-02-01 00:00:00
abstract:PURPOSE:To examine the utility of electronic health records from a routine care setting in assessing comparative effectiveness of fourth-line anti-hypertensive drugs to treat resistant hypertension. METHODS:We conducted a cohort study using the Clinical Practice Research Datalink: a repository of electronic health rec...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4808
更新日期:2019-09-01 00:00:00
abstract:BACKGROUND:Tramadol is a weak opioid analgesic, which is generally considered to be safe. However, conflicting data exist on the dependence potential of tramadol. OBJECTIVE:The aim of this study was to investigate occurrence of tramadol dependence and associated risk factors using spontaneously reported adverse drug r...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1838
更新日期:2009-12-01 00:00:00
abstract:PURPOSE:Oral morphine is the first-choice opioid for moderate to severe cancer pain. Transdermal fentanyl is an alternative in patients with stable requirements of high-potency opioids (HPO) or if drugs cannot be taken orally. Drug regulatory authorities have issued several alerts to use transdermal fentanyl only for c...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2164
更新日期:2012-02-01 00:00:00
abstract:PURPOSE:The objective of this study was to evaluate the validity and completeness of the General Practice Research Database (GPRD) as a tool for research into inflammatory bowel disease epidemiology. METHODS:Patients diagnosed with inflammatory bowel disease were identified from GPRD. Mailed surveys were sent to the g...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.698
更新日期:2002-04-01 00:00:00
abstract:BACKGROUND:The Food and Drug Administration (FDA) became aware of lead fracture and inappropriate shock events related to Sprint Fidelis leads in January 2007. The manufacturer announced a voluntary market withdrawal in October 2007. AIM:Our aim was to retrospectively evaluate this safety signal using disproportionali...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2261
更新日期:2012-01-01 00:00:00
abstract:PURPOSE:Administration of pegylated interferon-alpha (IFN-alpha) and ribavirin in adults with chronic hepatitis C (CHC) is a recommended therapeutic standard. Nevertheless, this therapeutic regimen rises numerous controversies. The aim of this study was to analyze adverse effects during the treatment with pegylated IFN...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1458
更新日期:2007-10-01 00:00:00
abstract:PURPOSE:Several studies indicate that the medical burden of fatal adverse drug reactions (FADRs) is significant, but the preventability of FADRs in the general population is largely unknown. The aim of this study was to determine the proportion of preventable FADRs and preventable fatal drug poisonings (FDPs) in a Swed...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1890
更新日期:2010-02-01 00:00:00
abstract:PURPOSE:Innovative methods are needed to assess risks related to treatment for common medical conditions, where therapy is usually patient-directed or over-the-counter (OTC), and where tolerability, i.e. patient experienced events, may affect patterns of use. A large-scale, blinded, randomised trial was conducted to co...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1002/pds.1083
更新日期:2005-04-01 00:00:00
abstract:PURPOSE:Days supply (prescription duration) values are commonly used to estimate drug exposure and quantify adherence to therapy, yet accuracy is not routinely assessed, and potential inaccurate reporting has been previously identified. We examined the impact of cleaning days supply values on the measurement of adheren...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3718
更新日期:2015-01-01 00:00:00
abstract::The ability to manage risk depends critically on an understanding of the degree to which a known risk is balanced by the probability of a clinical benefit. Despite the massive emphasis on risk and risk management in the past few years and the long-term focus on defining benefit in the regulatory system, considerable u...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.1215
更新日期:2007-01-01 00:00:00
abstract:PURPOSE:We developed a computerized system for signal detection in spontaneous reporting system (SRS) of Shanghai. Data acquisition, data mining could be carried out automatically and the process of data preprocessing and cleaning could be facilitated. This system was expected to detect signals from SRS after drug lice...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1695
更新日期:2009-02-01 00:00:00
abstract:PURPOSE:The study aimed to evaluate the comparative risk of oral ulcerations among antipsychotic medications. METHODS:We analyzed the National Health Insurance Research Database of Taiwan and included patients newly initiated with a single antipsychotic agent including haloperidol, sulpiride, olanzapine, quetiapine, r...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3903
更新日期:2016-02-01 00:00:00
abstract:PURPOSE:The success of an epidemiological study for drug safety surveillance or comparative effectiveness depends largely on design and analysis strategies besides data quality. The Observational Medical Outcomes Partnership (OMOP) methods community implemented a collection of statistical methods with extensive paramet...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3419
更新日期:2013-05-01 00:00:00
abstract:PURPOSE:Determining the nature of the relationship between cumulative duration of exposure to an agent and the hazard of an adverse outcome is an important issue in environmental and occupational epidemiology, public health and clinical medicine. The Cox proportional hazards regression model can incorporate time-depend...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3607
更新日期:2014-08-01 00:00:00
abstract:PURPOSE:Increased post-marketing reports of 'interstitial pneumonia' as an adverse drug reaction (ADR) from the use of gefitinib, irinotecan, or leflunomide among patients in Japan have not been noted in other countries. The WHO International Drug Monitoring Database was analyzed to examine Japan's pattern of reporting...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1071
更新日期:2005-11-01 00:00:00
abstract::In 1978, a systematic collection of adverse drug reactions (ADRs) was set up in a hospital including several departments and continued for more than 18 years. Quarterly meetings were organized gathering clinicians, students, nurses and pharmacologists to discuss the clinical cases collected each quarter. Approximately...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(sici)1099-1557(199808)7:1+
更新日期:1998-08-01 00:00:00
abstract:PURPOSE:Few studies have reported an association between proton pump inhibitor (PPI) use and tuberculosis. Tuberculosis incidence is relatively high in Asian people, and an increase in PPI prescriptions has been reported in South Korea. Thus, we investigated the association between PPI use and tuberculosis development....
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4773
更新日期:2019-06-01 00:00:00
abstract:PURPOSE:The purposes of the study are to compare safety specifications between Japan and the European Union (EU) and to identify the factors affecting categorization of important identified or potential risks. METHODS:Safety specifications were collected from orphan and nonorphan drugs approved in Japan between 2014 a...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4646
更新日期:2018-11-01 00:00:00