Abstract:
:In Slovenia, the national health insurance system covers almost the whole population. The average patient receives six to seven prescriptions per year with an average value of 15 USD per prescription. This paper presents the systemic conditions necessary for the performance of pharmacoepidemiologic studies. A recent study addressing the use of antiepileptic drugs is an example. The current law on Personal Data Protection, which is compliant with EU Directive 95/46/EC, prevents infringement of personal integrity resulting from inappropriate use of personal data or inappropriate management and use of databases containing personal data. Since July 2000, the Law on Health Care Related Databases has defined the databases and the ways data can be acquired, processed, transferred, and exchanged among persons authorized to perform health care services. When gathering additional data not currently contained in the health care-related databases defined by the law, written consent from participants is required, and study documentation must be submitted for approval to the national Medical Ethics Committee. The main legislation covering clinical and pharmacoepidemiologic research is the Medicinal Products and Medical Devices Act of 1999, together with its by-laws, which is also in accordance with EU Directives.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Primozic S,Kos M,Mrhar A,Ravnik Idoi
10.1002/pds.646keywords:
subject
Has Abstractpub_date
2001-12-01 00:00:00pages
675-8issue
7eissn
1053-8569issn
1099-1557journal_volume
10pub_type
杂志文章abstract:PURPOSE:To describe the concerns raised by health plan members, providers and purchasers related to studying the comparative effectiveness of therapeutics using cluster randomized trials (CRTs) within health plans. An additional goal was to develop recommendations for increasing acceptability. METHODS:Eighty-four qual...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1754
更新日期:2009-07-01 00:00:00
abstract:OBJECTIVE:Outcome misclassification may occur in observational studies using administrative databases. We evaluated a two-step multiple imputation approach based on complementary internal validation data obtained from two subsamples of study participants to reduce bias in hazard ratio (HR) estimates in Cox regressions....
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4223
更新日期:2017-08-01 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
pub_type: 杂志文章
doi:10.1002/pds.4025
更新日期:2016-07-01 00:00:00
abstract:PURPOSE:This study aimed to assess the trends in antipsychotic prescriptions for outpatients in Japan, where a community-based approach to mental healthcare is emphasized. METHODS:This descriptive epidemiological study used claims data from 1038 community pharmacies across Japan. Outpatients who were ≥18 years old and...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4187
更新日期:2017-06-01 00:00:00
abstract:BACKGROUND:Granular clinical and laboratory data available in electronic health record (EHR) databases provide researchers the opportunity to conduct investigations that would not be possible in insurance claims databases; however, for pharmacoepidemiology studies, accurate classification of medication exposure is crit...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4234
更新日期:2017-08-01 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: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:PURPOSE:To examine the association between maternal use of beta-2-adrenergic agonists (β2AAs) and the risk of epilepsy in offspring. METHODS:A nationwide retrospective cohort study was performed based on Danish registries. Children of mothers who used β2AAs during pregnancy were allocated to the exposed group and othe...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4648
更新日期:2018-11-01 00:00:00
abstract:PURPOSE:The strong male predominance of gastro-oesophageal cancer suggests that sex hormones play an important role. 5α-Reductase (5AR) inhibitors have antiandrogen effects and have been shown to decrease cancer cell proliferation and metastasis. We conducted the first epidemiologic investigation into the association b...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4909
更新日期:2020-01-01 00:00:00
abstract:PURPOSE:Some studies have reported reduced risks of advanced, but not early, prostate cancer among statin users, and one study found a reduced risk only among statin users who had also used non-steroidal anti-inflammatory drugs (NSAIDs). We have previously reported no association between statin use and prostate cancer ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1970
更新日期:2010-07-01 00:00:00
abstract:PURPOSE:To evaluate the extent, characteristics and determinants of adverse drug reaction (ADR)-related hospitalisations on a population-based level in 2003. METHODS:We performed a cohort study in the Integrated Primary Care Information (IPCI) database, a general practitioners (GPs) research database with longitudinal...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1565
更新日期:2008-04-01 00:00:00
abstract:INTRODUCTION:The analgesic metamizole (dipyrone) is not recommended during pregnancy due to limited experience. In several countries, metamizole has no market authorization because of agranulocytosis as a rare but severe adverse effect. However, in others, metamizole is available and widely used as a pain reliever, and...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4277
更新日期:2017-10-01 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
pub_type: 杂志文章
doi:10.1002/pds.721
更新日期:2002-07-01 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
pub_type: 杂志文章
doi:10.1002/pds.1832
更新日期:2010-04-01 00:00:00
abstract:PURPOSE:vigiRank is a data-driven predictive model for emerging safety signals. In addition to disproportionate reporting patterns, it also accounts for the completeness, recency, and geographic spread of individual case reporting, as well as the availability of case narratives. Previous retrospective analysis suggeste...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4247
更新日期:2017-08-01 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
pub_type: 杂志文章
doi:10.1002/pds.1795
更新日期:2009-09-01 00:00:00
abstract:BACKGROUND:Poor-quality patient drug information has been identified as a major cause of preventable medication errors in the United States. The US Food and Drug Administration (FDA) has the authority to require marketing authorization holders of medicinal products to implement risk evaluation and mitigation strategies...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4614
更新日期:2018-09-01 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: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
pub_type: 杂志文章
doi:10.1002/pds.943
更新日期:2004-05-01 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
pub_type: 杂志文章
doi:10.1002/pds.2155
更新日期:2011-07-01 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:PURPOSE:To compare birth outcomes between women exposed and unexposed to the antiviral medications oseltamivir or zanamivir during pregnancy. METHODS:This was an observational cohort study including women who gave birth to singletons in Sweden 2005-2007 and their infants. We obtained information from the national heal...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2194
更新日期:2011-10-01 00:00:00
abstract:PURPOSE:To assess the feasibility of using Clinical Practice Research Datalink (CPRD) data for identifying populations of patients with chronic obstructive pulmonary disease (COPD) eligible for a hypothetical pragmatic trial. METHODS:A retrospective multidatabase cohort study using CPRD primary care and linked seconda...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.5188
更新日期:2020-12-27 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
pub_type: 杂志文章
doi:10.1002/pds.3284
更新日期:2013-01-01 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: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
pub_type: 杂志文章
doi:10.1002/pds.5087
更新日期:2020-11-01 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
pub_type: 杂志文章
doi:10.1002/pds.1709
更新日期:2009-04-01 00:00:00
abstract:PURPOSE:We systematically review the cross-national drug utilization studies performed in Latin America (LA) in order to analyze the methods applied and assess the validity of the data to ensure the comparability. METHODS:A systematic search in Medline, Embase, and BIREME was performed. Drug utilization studies includ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.3896
更新日期:2016-01-01 00:00:00
abstract::The current medical care environment has created expectations that exceed its capabilities, one effect of which has been an increasing awareness of lapses in the quality of healthcare, including medical errors. As more new therapies reach clinical application, the expectations on the part of the public are unlikely to...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.699
更新日期:2002-06-01 00:00:00
abstract:PURPOSE:Ejection fraction (EF) is crucial information when studying the use and effectiveness of therapies in patients with heart failure (HF) and myocardial infarction (MI). We aimed to assess the validity of claims data-based definitions of systolic dysfunction (SD). METHODS:We identified 1072 patients with EF recor...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2146
更新日期:2011-07-01 00:00:00