Why there is a need for pharmacovigilance.

abstract：PURPOSE:Determine the relative risk of cancer users of commonly prescribed antihypertensive drugs with a focus on documenting risk in long-term users (>7.5 years). METHODS:We conducted a nested case-control study using the Saskatchewan Health databases. Cancer risks in users of beta-blockers, calcium channel blockers ...

journal_title：Pharmacoepidemiology and drug safety

authors： Assimes TL,Elstein E,Langleben A,Suissa S

更新日期：2008-11-01 00:00:00

abstract：PURPOSE:This study aimed to describe incidence, risk factors, and outcomes of warfarin-associated major bleeding (WAMB) in Thai patients. METHOD:A nested case-control study was conducted in a cohort of adult patients receiving ≥6 months of warfarin therapy who were prospectively followed up at a tertiary care hospital...

journal_title：Pharmacoepidemiology and drug safety

authors： Priksri W,Rattanavipanon W,Saejear W,Tanyasaensook K,Phrommintikul A,Chulavatnatol S,Nathisuwan S

更新日期：2019-07-01 00:00:00

abstract：:Adverse drug reaction surveillance conducted by the US Federal Food and Drug Administration (FDA) is important for detecting new safety information about pharmaceuticals. FDA has sought to stimulate reporting of reactions by practitioners and manufacturers. Over the five years from 1989 to 1993, reporting more than do...

journal_title：Pharmacoepidemiology and drug safety

authors： Faich GA

更新日期：1996-11-01 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: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

authors： Machado-Alba JE,Gaviria-Mendoza A,Machado-Duque ME,Tovar-Yepes C,Ruigómez A,García Rodríguez LA

更新日期：2020-10-15 00:00:00

abstract：PURPOSE:Adverse drug events (ADEs) are an important cause of preventable hospitalizations among elderly individuals taking high-risk medications. The objective of the study was to identify health care system factors that affect the risk of digoxin toxicity for older adults on digoxin. METHODS:We conducted a prospectiv...

journal_title：Pharmacoepidemiology and drug safety

authors： Haynes K,Hennessy S,Localio AR,Cohen A,Leonard CE,Kimmel SE,Feldman HI,Strom BL,Metlay JP

更新日期：2009-01-01 00:00:00

abstract：PURPOSE:Epidemiological data on adhesion-related complications following intra-abdominal surgery are limited. We tested the accuracy of recording of these surgeries and complications within The Health Improvement Network (THIN), a primary care database within the UK. METHODS:Individuals within THIN from 1995 to 2011 w...

journal_title：Pharmacoepidemiology and drug safety

authors： Scott FI,Mamtani R,Haynes K,Goldberg DS,Mahmoud NN,Lewis JD

更新日期：2016-04-01 00:00:00

abstract：PURPOSE:We present a new population-based pharmacoepidemiological (PE) database obtained from statutory health insurances (SHIs) that is able to generate signals, to monitor prescribed drugs and to describe drug utilisation. We discuss methodological features of the database and we assess to which degree this database ...

journal_title：Pharmacoepidemiology and drug safety

authors： Pigeot I,Ahrens W

更新日期：2008-03-01 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

authors： McMahon AD,Evans JM,McGilchrist MM,McDevitt DG,MacDonald TM

更新日期：1998-07-01 00:00:00

abstract：PURPOSE:To assess the effect of moderate alcohol consumption on Adverse Drug Reactions (ADRs) among older adults admitted to acute care hospitals and to examine the consistency of this effect across gender and age groups. METHODS:We used the GIFA (Italian Group of Pharmacoepidemiology in the Elderly) database, which i...

journal_title：Pharmacoepidemiology and drug safety

authors： Onder G,Landi F,Della Vedova C,Atkinson H,Pedone C,Cesari M,Bernabei R,Gambassi G,GIFA Study.

更新日期：2002-07-01 00:00:00

abstract：BACKGROUND/AIM:The number of patients receiving amiodarone will increase in future years. As clinically significant hepatotoxicity associated with oral amiodarone is infrequent and difficult to predict, a new Bayesian-developed model is proposed to help in the causality assessment of amiodarone-induced liver injury. M...

journal_title：Pharmacoepidemiology and drug safety

authors： Llanos L,Moreu R,Peiró AM,Pascual S,Francés R,Such J,Horga JF,Pérez-Mateo M,Zapater P

更新日期：2009-04-01 00:00:00

abstract：PURPOSE:In post-marketing drug safety surveillance, data mining can potentially detect rare but serious adverse events. Assessing an entire collection of drug-event pairs is traditionally performed on a predefined level of granularity. It is unknown a priori whether a drug causes a very specific or a set of related adv...

journal_title：Pharmacoepidemiology and drug safety

authors： Kulldorff M,Dashevsky I,Avery TR,Chan AK,Davis RL,Graham D,Platt R,Andrade SE,Boudreau D,Gunter MJ,Herrinton LJ,Pawloski PA,Raebel MA,Roblin D,Brown JS

更新日期：2013-05-01 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

authors： Johann-Liang R,Wyeth J,Chen M,Cope JU

更新日期：2009-01-01 00:00:00

abstract：PURPOSE:To enhance automated methods for accurately identifying opioid-related overdoses and classifying types of overdose using electronic health record (EHR) databases. METHODS:We developed a natural language processing (NLP) software application to code clinical text documentation of overdose, including identificat...

journal_title：Pharmacoepidemiology and drug safety

authors： Hazlehurst B,Green CA,Perrin NA,Brandes J,Carrell DS,Baer A,DeVeaugh-Geiss A,Coplan PM

更新日期：2019-08-01 00:00:00

abstract：PURPOSE:The objective of this study was to determine the fraction of variance in patient-level medication adherence accounted for by prescribers and pharmacies. METHODS:We used prescription drug claims paid between January 2010 and July 2011 to a national pharmacy benefits manager to define implementation during persi...

journal_title：Pharmacoepidemiology and drug safety

authors： Genberg BL,Rogers WH,Lee Y,Qato DM,Dore DD,Hutchins DS,Brennan T,Matlin OS,Wilson IB

更新日期：2016-07-01 00:00:00

abstract：:Before a medicine can be recommended for a marketing authorization research must be provided to regulators that convincingly supports the benefit-risk of the product in the claimed indication. The established criteria for such research are usually expressed in terms of evidence from randomized controlled trials (RCT)....

journal_title：Pharmacoepidemiology and drug safety

authors： Slattery J,Kurz X

更新日期：2020-10-01 00:00:00

abstract：PURPOSE:Meta-analysis is a quantitative approach to summarize the findings from several studies and has been applied with increasing frequency to clinical trials. Because of their sample size and duration limitations, experimental studies (ESs) could not be able to detect late or rare adverse events (AEs), which may be...

journal_title：Pharmacoepidemiology and drug safety

authors： Alves C,Batel-Marques F,Macedo AF

更新日期：2012-01-01 00:00:00

abstract：PURPOSE:To describe the characteristics of new users of cilostazol in Europe with the aim to support the evaluation of its benefit/risk as used in regular clinical practice before the implementation of labeling changes recommended by the European Medicines Agency. METHODS:New users of cilostazol were identified in pop...

journal_title：Pharmacoepidemiology and drug safety

authors： Castellsague J,Perez-Gutthann S,Calingaert B,Bui C,Varas-Lorenzo C,Arana A,Prados-Torres A,Poblador-Plou B,Gonzalez-Rubio F,Giner-Soriano M,Roso-Llorach A,Linder M,Citarella A,Scholle O,Blenk T,Garbe E

更新日期：2017-06-01 00:00:00

abstract：PURPOSE:Pre-licensure studies have limited ability to detect rare adverse events (AEs) to vaccines, requiring timely post-licensure studies. With the increasing availability of electronic health records (EHR) near real-time vaccine safety surveillance using these data has emerged as an option. We reviewed methods curre...

journal_title：Pharmacoepidemiology and drug safety

authors： Leite A,Andrews NJ,Thomas SL

更新日期：2016-03-01 00:00:00

abstract：PURPOSE:Quantitative benefit-risk (B-R) assessments are used to characterize treatment by combining key benefits and risks into a single metric but have historically been done for the "average" patient. Our aim was to conduct an individualized assessment for the oral antiplatelet vorapaxar by combining trial and real-w...

journal_title：Pharmacoepidemiology and drug safety

authors： Pinto CA,Tervonen T,Marsh K,Lambrelli D,Schultze A,Tershakovec A,Hyacinthe J,Prawitz T,Hammad TA

更新日期：2019-04-01 00:00:00

abstract：AIM:To determine the contribution of patients' adverse drug reaction (ADR) reports to signals detection, through a study of the signals sent by Lareb to the Dutch Medicines Evaluation Board. METHODS:The percentage of patient's ADR reports contributing to generate signals of adverse drug reactions was determined. A cas...

journal_title：Pharmacoepidemiology and drug safety

authors： van Hunsel F,Talsma A,van Puijenbroek E,de Jong-van den Berg L,van Grootheest K

更新日期：2011-03-01 00:00:00

abstract：PURPOSE:Drug treatment of idiopathic Parkinson's disease (IPD) is a difficult task, and comorbidity and comedication add to its complexity. Since in IPD there is little information about drug use, this study investigated drug prescribing and indications in IPD patients. METHODS:From June 1997 to April 1998, a cross-se...

journal_title：Pharmacoepidemiology and drug safety

authors： Leoni O,Martignoni E,Cosentino M,Michielotto D,Calandrella D,Zangaglia R,Riboldazzi G,Oria C,Lecchini S,Nappi G,Frigo G

更新日期：2002-03-01 00:00:00

abstract：OBJECTIVES:This study quantifies the incidence of liver enzyme abnormalities in the general population of central Massachusetts. METHODS:Computerized data files from a health maintenance organization were used to ascertain potential subjects during the study period of 1 July 1992-30 June 1993. Medical records and labo...

journal_title：Pharmacoepidemiology and drug safety

authors： Duh MS,Walker AM,Kronlund KH Jr

更新日期：1999-07-01 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：PURPOSE:Bayesian hierarchical models (BHMs) have been used to identify adverse drug reactions, allowing information sharing amongst adverse reactions and drugs expected to have similar properties. This study evaluated the use of BHMs in the routine signal detection analyses of potential first-trimester teratogens, wher...

journal_title：Pharmacoepidemiology and drug safety

authors： Cavadino A,Prieto-Merino D,Morris JK

更新日期：2020-03-01 00:00:00

abstract：PURPOSE:Proton pump inhibitor (PPI) may suppress adrenal cortical steroid synthesis and release, thereby leading to electrolyte disturbances. Both hyponatremia and hyperkalemia in the setting of PPI therapy have been documented in case reports. The objective of this study was to examine the association between serum po...

journal_title：Pharmacoepidemiology and drug safety

authors： Gau JT,Heh V,Acharya U,Yang YX,Kao TC

更新日期：2009-09-01 00:00:00

abstract：PURPOSE:Case reports suggest that leukotriene modifier use may be associated with the onset of Churg-Strauss syndrome (CSS). Using pooled data from two nested case-control studies, we examined the association between asthma drug use and the development of CSS. METHODS:The study was performed in three US managed care o...

journal_title：Pharmacoepidemiology and drug safety

authors： Harrold LR,Patterson MK,Andrade SE,Dube T,Go AS,Buist AS,Chan KA,Weller PF,Wechsler ME,Yood RA,Davis KJ,Platt R,Walker AM

更新日期：2007-06-01 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

authors： Lewis JD,Brensinger C,Bilker WB,Strom BL

更新日期：2002-04-01 00:00:00

abstract：PURPOSE:To conduct a systematic review of current evidence regarding the use of health information technology (HIT) interventions to improve drug monitoring in ambulatory care. METHODS:We searched PubMed, CINAHL, the Cochrane Library, and other computerized databases from 1 January 1998 to 30 June 2008 using the key w...

journal_title：Pharmacoepidemiology and drug safety

authors： Hayward GL,Parnes AJ,Simon SR

更新日期：2009-12-01 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

authors： Boucherie Q,Pauly V,Frauger E,Thirion X,Pradel V,Micallef J

更新日期：2015-09-01 00:00:00