Development of pharmacovigilance system in Ukraine: first results.

abstract：BACKGROUND:Laboratory technicians, laboratory supervisors, decontamination/remediation workers, and environmental investigators are at increased risk for repeated occupational exposure to Bacillus anthracis. In 2002, the Advisory Committee on Immunization Practices (ACIP) recommended pre-exposure vaccination for these ...

journal_title：Pharmacoepidemiology and drug safety

authors： Fowler GL,Baggs JM,Weintraub ES,Martin SW,McNeil MM,Gust DA

更新日期：2006-12-01 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:Our study addresses how the information in the labels differed between United States (US) and Japan, what factors were associated with the decision to place the boxed warning on the label, and the relation of both countries in terms of drug label policy. METHODS:We investigated adverse drug reactions (ADRs) in...

journal_title：Pharmacoepidemiology and drug safety

authors： Jayaputra K,Ono S

更新日期：2017-02-01 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：OBJECTIVE:This study quantified the overall merit of adjunctive aripiprazole in major depressive disorder (MDD). METHODS:Global benefit-risk (GBR) analysis quantified the benefit and risk differences between adjunctive aripiprazole and antidepressant (ADT) monotherapy. Three hundred and fifty six patients receiving AD...

journal_title：Pharmacoepidemiology and drug safety

authors： Wisniewski SR,Chen CC,Kim E,Kan HJ,Guo Z,Carlson BX,Tran QV,Pikalov A

更新日期：2009-10-01 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:Drug induced Torsades de Pointes (TdP) is a major concern for new drugs seeking regulatory approval. Prolongation of QT intervals greater than 60 millisecond or to longer than 500 millisecond in an individual patient has been considered to be associated with a higher risk. The purpose of this study is to identi...

journal_title：Pharmacoepidemiology and drug safety

authors： Lin YL,Kung MF

更新日期：2009-03-01 00:00:00

abstract：PURPOSE:Little is known about opioid use after bariatric surgery among patients who did not use opioids chronically before surgery. Our purpose was to determine opioid use the year after bariatric surgery among patients who did not use opioids chronically pre-surgery and to identify pre-surgery characteristics associat...

journal_title：Pharmacoepidemiology and drug safety

authors： Raebel MA,Newcomer SR,Bayliss EA,Boudreau D,DeBar L,Elliott TE,Ahmed AT,Pawloski PA,Fisher D,Toh S,Donahoo WT

更新日期：2014-12-01 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: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 investigate suicide-related over-the-counter (OTC) analgesic medication exposures among individuals ≥6 years old reported to United States (US) poison control centers. METHODS:Data from the National Poison Data System for the years 2000-2018 were retrospectively analyzed. RESULTS:From 2000 to 2018, US pois...

journal_title：Pharmacoepidemiology and drug safety

authors： Hopkins AG,Spiller HA,Kistamgari S,Zhu M,Michaels NL,Funk AR,Smith GA

更新日期：2020-09-01 00:00:00

abstract：BACKGROUND:High-grade cervical dysplasia or cervical intraepithelial neoplasia grade 2 or worse has been widely used as a surrogate endpoint in cervical cancer screening or prevention trials. METHODS:To identify high-grade cervical dysplasia and cervical cancer, we developed claims-based algorithms that incorporated a...

journal_title：Pharmacoepidemiology and drug safety

authors： Kim SC,Gillet VG,Feldman S,Lii H,Toh S,Brown JS,Katz JN,Solomon DH,Schneeweiss S

更新日期：2013-11-01 00:00:00

abstract：:Analysing duration of treatment episodes has become a standard task in many pharmacoepidemiological studies. However, such analyses are often carried out in a rather simplistic manner and more subtle issues are often ignored. In this paper, methods of analysing duration treatment episodes beyond simple analyses allowi...

journal_title：Pharmacoepidemiology and drug safety

authors： Gichangi A,Andersen M,Kragstrup J,Vach W

更新日期：2006-03-01 00:00:00

abstract：OBJECTIVES:The purpose of this study was to generate data regarding the drug utilization pattern in pediatric population of our tertiary care hospital so that we could generate an essential medicine list (EML). BACKGROUND:Drug therapy accounts for a major portion of expenditure toward health care. Reduction in health ...

journal_title：Pharmacoepidemiology and drug safety

authors： Singh I,Mittal R,Shafiq N,Bharati B,Nigah RK,Pandhi P,Chaudhary RR,Malhotra S

更新日期：2010-04-01 00:00:00

abstract：PURPOSE:We developed an adverse events (AEs) reporting form for Korean folk medicine. METHODS:The first version of the form was developed and tested in the clinical setting for spontaneous reporting of AEs. Additional revisions to the reporting form were made based on collected data and expert input. RESULTS:We devel...

journal_title：Pharmacoepidemiology and drug safety

authors： Park JH,Choi SM,Moon S,Kim S,Kim B,Kim MK,Lee S

更新日期：2017-05-01 00:00:00

abstract：PURPOSE:We aim to derive an internationally applicable data set to improve prescription safety of psychiatric drugs. METHODS:We performed an in-depth analysis of the concordance of prescribing information of 10 key psychiatric drugs across four major drug markets with regard to indications, warnings and precautions, a...

journal_title：Pharmacoepidemiology and drug safety

authors： Pfistermeister B,Schenk C,Kornhuber J,Bürkle T,Fromm MF,Maas R

更新日期：2013-03-01 00:00:00

abstract：:Rosiglitazone has previously been widely used to treat patients with type 2 diabetes mellitus, but its safety in terms of cardiovascular morbidity and mortality had been called into question. Recently, there have been doubts raised about the meta-analytic evidence with the regulatory authorities relaxing its restricti...

journal_title：Pharmacoepidemiology and drug safety

authors： Stone JC,Furuya-Kanamori L,Barendregt JJ,Doi SA

更新日期：2015-03-01 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

authors： Van Ganse E,Jones JK,Moore N,Parc JM,Wall R,Schneid H

更新日期：2005-04-01 00:00:00

abstract：PURPOSE:The aims of the present study were to evaluate the use of drugs with anticholinergic properties in elderly patients and to identify risk factors that increase the patient's chance of being given such medications. METHODS:The study was performed on a sample of 1636 patients aged ≥65 years hospitalised during th...

journal_title：Pharmacoepidemiology and drug safety

authors： Wawruch M,Macugova A,Kostkova L,Luha J,Dukat A,Murin J,Drobna V,Wilton L,Kuzelova M

更新日期：2012-02-01 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：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:To assess the prevalence of adverse drug reactions (ADRs) occurring in patients with Alzheimer's disease (AD) or other dementia in France. METHODS:A cross-sectional multicentre study was conducted by the French network of the 31 regional pharmacovigilance centres on a given day. The subjects were selected by r...

journal_title：Pharmacoepidemiology and drug safety

authors： Laroche ML,Perault-Pochat MC,Ingrand I,Merle L,Kreft-Jais C,Castot-Villepelet A,Durrieu G,Gras V,Guy C,Jean-Pastor MJ,Jonville-Béra AP,Merlet-Chicoine I,Miremont-Salamé G,Nourhashemi F,Charmes JP,French Centres of Pharmacov

更新日期：2013-09-01 00:00:00

abstract：PURPOSE:Fear of discontinuing concomitant anti-epileptic drugs (AEDs) may lead to potentially unnecessary and perhaps unsafe polypharmacy. The effect of withdrawing concomitant AEDs on epilepsy control was therefore studied in long-term users of levetiracetam. METHODS:The EULEV cohort followed patients initiating leve...

journal_title：Pharmacoepidemiology and drug safety

authors： Droz-Perroteau C,Marchal C,Dureau-Pournin C,Lassalle R,Jové J,Robinson P,Lavernhe G,Vespignani H,Moore N,Fourrier-Réglat A,Eulev Study Group.

更新日期：2012-11-01 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：:There is an increasing reliance on databases of healthcare records for pharmacoepidemiology and other medical research, and such resources are often accessed over a long period of time so it is vital to consider the impact of changes in data, access methodology and the environment. The authors discuss change in commun...

journal_title：Pharmacoepidemiology and drug safety

authors： Bourke A,Bate A,Sauer BC,Brown JS,Hall GC

更新日期：2016-07-01 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: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 study adult height in children that grew up with asthma before inhaled steroids became first-line therapy. METHODS:Data from the Swedish Medical Birth Register (self-reported asthma) and the Hospital Discharge Register (first hospitalization for asthma) were used, to compare adult height for asthmatic and n...

journal_title：Pharmacoepidemiology and drug safety

authors： Norjavaara E,Gerhardsson de Verdier M,Lindmark B

更新日期：2001-03-01 00:00:00

abstract：PURPOSE:To investigate the association between socioeconomic position and use of lipid-lowering drugs and ACE-inhibitors after an acute myocardial infarction (AMI) when simultaneously considering participation in the national quality register RIKS-HIA (Register of Information and Knowledge about Swedish Heart Intensive...

journal_title：Pharmacoepidemiology and drug safety

authors： Ohlsson H,Rosvall M,Hansen O,Chaix B,Merlo J

更新日期：2010-04-01 00:00:00

abstract：:Sixteen pathologically confirmed and 14 suspected cases of a new disease entity, fibrosing colonopathy, have been described in the UK and the US in children with cystic fibrosis since 1991. The patterns of use of pancreatic enzyme supplements in cases were compared with use in controls and in the market, in the 2 year...

journal_title：Pharmacoepidemiology and drug safety

authors： Bakowski MT,Prescott P

更新日期：1997-09-01 00:00:00