Establishment of a pharmacoepidemiological database in Germany: methodological potential, scientific value and practical limitations.

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 reflects basic demographic characteristics and hospitalisation rates of the general population. METHODS:Files of three SHIs were linked with drug dispensation data from a pharmacies' electronic data processing centre on an individual basis using the unique subject identification number (ID) at a trusted third party centre. Plausibility checks and descriptive analyses were carried out. RESULTS:The database covers 3.6 million SHI-members, provides drug utilisation data and data on hospitalisations. SHI membership is fairly stable over time. Our data indicate marked differences in socio-demographic characteristics between SHIs. Hospital admission rates standardised for age vary between 0.164 and 0.229 per person year, which is in good agreement with official statistics (0.20). The age distribution shows good agreement for men and some underrepresentation for women above the age of 60 as compared to the general population. CONCLUSIONS:Confounder information on medical conditions, concomitant medications and socio-demographic variables can be obtained from the database, while the assessment of confounders related to lifestyle requires supplementary data collection. The database allows for a population-based approach and reflects daily practice including off-label use of drugs. Independent recording of exposure and outcome data prevents reporting bias on medication or outcome. Legal conditions that allow continuous updating of the database need to be settled.

authors

Pigeot I,Ahrens W

doi

10.1002/pds.1545

subject

Has Abstract

pub_date

2008-03-01 00:00:00

pages

215-23

issue

3

eissn

1053-8569

issn

1099-1557

journal_volume

17

pub_type

杂志文章
  • Report of the UK DURG regional meeting on New Horizons in Pharmacovigilance.

    abstract::The UK Drug Utilization Research Group's (DURG) Regional Meeting 'New Horizons: Pharmacovigilance' was hosted by the Drug Safety Research Unit (DSRU) at Southampton on 19 May 2000. Opening the meeting, Dr Keith Beard, UK DURG chairman, welcomed delegates and speakers and thanked the DSRU team for hosting the meeting. ...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/1099-1557(200009/10)9:5<429::AID-PDS528>3.

    authors: Barnes J

    更新日期:2000-09-01 00:00:00

  • Antidepressant drugs: prevalence, incidence and indication of use in general practice of Southern Italy during the years 2003-2004.

    abstract:PURPOSE:To estimate 1-year prevalence, 1-year incidence and indication of use of antidepressant (AD) drug treatment in general practice of Southern Italy during the years 2003-2004. METHODS:Among 142,346 individuals registered in the lists of 119 general practitioners of Southern Italy, we identified users of differen...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1303

    authors: Trifirò G,Barbui C,Spina E,Moretti S,Tari M,Alacqua M,Caputi AP,UVEC group.,Arcoraci V

    更新日期:2007-05-01 00:00:00

  • Pattern of use of complementary/alternative medicine (CAM) in epileptic patients in a tertiary care hospital in India.

    abstract:PURPOSE:Many patients use complementary/alternative medicine (CAM) for their health problems especially where long-term treatment is required. Epilepsy is the most prevalent neurological disorder requiring long-term treatment and compliance. The purpose of the study was to establish the pattern of use of CAM in epilept...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.731

    authors: Tandon M,Prabhakar S,Pandhi P

    更新日期:2002-09-01 00:00:00

  • The comparative effectiveness of fourth-line drugs in resistant hypertension: An application in electronic health record data.

    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

    authors: Sinnott SJ,Smeeth L,Williamson E,Perel P,Nitsch D,Tomlinson LA,Douglas IJ

    更新日期:2019-09-01 00:00:00

  • Validity and completeness of the General Practice Research Database for studies of inflammatory bowel disease.

    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

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

    更新日期:2002-04-01 00:00:00

  • Use of psychotropic drugs and analgesics among users of antiobesity drugs--a population based study.

    abstract:AIM:The aim of the present study was to investigate to what extent patients using prescription antiobesity drugs (orlistat, sibutramine and rimonabant) concomitantly or concurrently used psychotropic drugs and analgesics and the association between this drug use and the patients' gender and age. An additional aim was t...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1896

    authors: Amundsen MO,Engdahl B,Berg C,Nordeng H

    更新日期:2010-03-01 00:00:00

  • Strategies for identifying pregnancies in the automated medical records of the General Practice Research Database.

    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

    pub_type: 杂志文章

    doi:10.1002/pds.935

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

    更新日期:2004-11-01 00:00:00

  • Trends in the consumption of antidepressants in Castilla y León (Spain). Association between suicide rates and antidepressant drug consumption.

    abstract:OBJECTIVE:To learn the evolution of antidepressant and lithium use in Castilla y León (Central Spain) and its relationship with suicide rates. METHODS:A search in the ECOM (Especialidades Consumo de Medicamentos) database of the Spanish Ministry of Health for antidepressants and lithium was carried out for the period ...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1944

    authors: Arias LH,Lobato CT,Ortega S,Velasco A,Carvajal A,del Pozo JG

    更新日期:2010-09-01 00:00:00

  • Assessment of maternal drug intake by urinary bio monitoring during pregnancy and postpartally until the third perinatal year.

    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

    pub_type: 杂志文章

    doi:10.1002/pds.3943

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

    更新日期:2016-04-01 00:00:00

  • Use of benzodiazepines in the general population and their involvement in acute self-poisoning cases.

    abstract::Benzodiazepines belong to the most widely prescribed group of drugs and are involved in a large proportion of the acute poisonings seen in emergency departments. The aim of the study was to examine whether a relationship exists between the number of poisonings with different types of benzodiazepines and the number of ...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/(SICI)1099-1557(199811/12)7:6<403::AID-PDS

    authors: Verstraete AG,Buylaert WA,Blondeel L

    更新日期:1998-11-01 00:00:00

  • Bayesian hierarchical methods in the detection of potentially teratogenic first-trimester medications.

    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

    pub_type: 杂志文章

    doi:10.1002/pds.4948

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

    更新日期:2020-03-01 00:00:00

  • High use of health services in patients with suboptimal asthma drug regimens: a population-based assessment in British Columbia, Canada.

    abstract:BACKGROUND:Despite numerous clinical guidelines on asthma management, patients often receive suboptimal drug therapy. This study identified patients who received suboptimal regimens according to the National Heart, Lung and Blood Institute (NHLBI) Guidelines for the Diagnosis and Management of Asthma in a complete popu...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.3444

    authors: Zhang T,Smith MA,Camp PG,Carleton BC

    更新日期:2013-07-01 00:00:00

  • Proactive safety surveillance.

    abstract::Growth in health information systems presents opportunities to enhance postmarketing safety surveillance of medical products. Spontaneous suspected side effect reports provide the foundation, but we need to 'proactively' improve their quality and our strategies to seek signals. In our more familiar 'reactive' mode, we...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,评审

    doi:10.1002/pds.587

    authors: Bortnichak EA,Wise RP,Salive ME,Tilson HH

    更新日期:2001-05-01 00:00:00

  • Predicting prolonged dose titration in patients starting warfarin.

    abstract:PURPOSE:Patients initiating warfarin therapy generally experience a dose-titration period of weeks to months, during which time they are at higher risk of both thromboembolic and bleeding events. Accurate prediction of prolonged dose titration could help clinicians determine which patients might be better treated by al...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4069

    authors: Finkelman BS,French B,Bershaw L,Brensinger CM,Streiff MB,Epstein AE,Kimmel SE

    更新日期:2016-11-01 00:00:00

  • Vaccines and changes in coagulation parameters in adults on chronic warfarin therapy: a cohort study.

    abstract:PURPOSE:Warfarin is commonly used among patients who receive influenza, pneumococcal, and tetanus and diphtheria toxoid vaccines, and persons on warfarin therapy may also receive Hepatitis A vaccine. There has been concern that vaccinations could potentially alter coagulation parameters in patients on warfarin therapy....

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1386

    authors: Jackson ML,Nelson JC,Chen RT,Davis RL,Jackson LA,Vaccine Safety Datalink investigators.

    更新日期:2007-07-01 00:00:00

  • Treatment with montelukast and antidepressive medication-a symmetry analysis.

    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

    pub_type: 杂志文章

    doi:10.1002/pds.4638

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

    更新日期:2018-12-01 00:00:00

  • Association between drug-specific indicators of prescribing quality and quality of drug treatment: a validation study.

    abstract:PURPOSE:To evaluate the concurrent validity of three European sets of drug-specific indicators of prescribing quality METHODS:In 200 hip fracture patients (≥65 years), consecutively recruited to a randomized controlled study in Sahlgrenska University Hospital in 2009, quality of drug treatment at study entry was asses...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,随机对照试验

    doi:10.1002/pds.3827

    authors: Wallerstedt SM,Belfrage B,Fastbom J

    更新日期:2015-09-01 00:00:00

  • Trends in antihypertensives use among Moroccan patients.

    abstract:PURPOSE:In this study, we analyzed the consumption trends of antihypertensives in Morocco during the 1991-2010 period and the impacts after the institution of Mandatory Health Insurance and the marketing of generic drugs. METHODS:We used sales data from the Moroccan subsidiary of IMS Health "Intercontinental Marketing...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.3288

    authors: Berrada El Azizi G,Ahid S,Ghanname I,Belaiche A,Hassar M,Cherrah Y

    更新日期:2012-10-01 00:00:00

  • A critical review of methods to evaluate the impact of FDA regulatory actions.

    abstract:PURPOSE:To conduct a synthesis of the literature on methods to evaluate the impacts of FDA regulatory actions and identify best practices for future evaluations. METHODS:We searched MEDLINE for manuscripts published between January 1948 and August 2011 that included terms related to FDA, regulatory actions, and empiri...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,评审

    doi:10.1002/pds.3480

    authors: Briesacher BA,Soumerai SB,Zhang F,Toh S,Andrade SE,Wagner JL,Shoaibi A,Gurwitz JH

    更新日期:2013-09-01 00:00:00

  • Quality circles to improve prescribing of primary care physicians. Three comparative studies.

    abstract:PURPOSE:To determine the effectiveness of quality circles on prescribing patterns of primary care physicians in Germany and to explore the influence of specific factors on changes. METHODS:Three large non-randomised comparative studies were performed in primary care in Germany, with baseline measurements in 2001 and f...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1778

    authors: Wensing M,Broge B,Riens B,Kaufmann-Kolle P,Akkermans R,Grol R,Szecsenyi J

    更新日期:2009-09-01 00:00:00

  • Use of albumin in three French university hospitals: is prescription monitoring still useful in 2004?

    abstract:PURPOSE:Use of albumin (indications and quantities involved) has not been assessed in France since major changes occurred after the publication of Cochrane group meta-analysis. The objectives of this study were to measure the repartition of albumin indications in three French university hospitals in 2004 and to assess ...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1328

    authors: Pradel V,Tardieu S,Micallef J,Signoret A,Villano P,Gauthier L,Vanelle P,Blin O,Albumin Study Group.

    更新日期:2007-01-01 00:00:00

  • Impact of cancer-related fatigue on chemotherapy-induced nausea and vomiting in Asian cancer patients.

    abstract:INTRODUCTION:Cancer-related fatigue (CRF) has been suggested to be associated with the occurrence of chemotherapy-induced nausea and vomiting (CINV). This study aims to evaluate the potential of CRF in predicting the occurrence of CINV. METHOD:This is a prospective, observational study. Recruited patients received mod...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.3516

    authors: Poon KS,Un MK,Low XH,Cheung YT,Yap KY,Chan A

    更新日期:2013-12-01 00:00:00

  • Prenatal triptan exposure and parent-reported early childhood neurodevelopmental outcomes: an application of propensity score calibration to adjust for unmeasured confounding by migraine severity.

    abstract:PURPOSE:Triptan medications are serotonin agonists used to treat migraine, a chronic pain condition highly prevalent in women of reproductive age. Data on the safety of triptans during pregnancy are scant. We sought to quantify the association of prenatal triptan exposure on neurodevelopment in 3-year-old children. ME...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.3902

    authors: Wood ME,Frazier JA,Nordeng HM,Lapane KL

    更新日期:2016-05-01 00:00:00

  • Asthma drug use and the development of Churg-Strauss syndrome (CSS).

    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

    pub_type: 杂志文章

    doi:10.1002/pds.1353

    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

  • Population-based incidence of diabetic ketoacidosis in type 2 diabetes: medical claims data analysis in Japan.

    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

    authors: Takeuchi M,Kawamura T,Sato I,Kawakami K

    更新日期:2018-01-01 00:00:00

  • Algorithms to estimate the beginning of pregnancy in administrative databases.

    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

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

    更新日期:2013-01-01 00:00:00

  • The use of angiotensin converting enzyme inhibitors in general practice--appropriate or inappropriate?

    abstract:AIMS:To evaluate the pattern of prescribing of angiotensin-converting enzyme (ACE) inhibitors in general practice, related to the primary clinical diagnosis and concomitant medication. DESIGN:A descriptive survey of general practitioners' prescribing habits, presumptive diagnosis and patient demography over a period o...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/(SICI)1099-1557(199809/10)7:5<331::AID-PDS

    authors: Connolly JP,Silke B,McGavock H,Wilson-Davies K

    更新日期:1998-09-01 00:00:00

  • Provider risk factors for medication administration error alerts: analyses of a large-scale closed-loop medication administration system using RFID and barcode.

    abstract:PURPOSE:To determine the risk factors and rate of medication administration error (MAE) alerts by analyzing large-scale medication administration data and related error logs automatically recorded in a closed-loop medication administration system using radio-frequency identification and barcodes. METHODS:The subject h...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4068

    authors: Hwang Y,Yoon D,Ahn EK,Hwang H,Park RW

    更新日期:2016-12-01 00:00:00

  • Changing profile in the use of anti-asthma drugs.

    abstract::Data regarding the total number of anti-asthma drugs dispensed via community pharmacies within Northern Ireland from 1980 to 1997 were collected and analysed. The use of anti-asthma drugs within this population increased markedly over the study period from 19.84 DDDs/1000/day to 84.07 DDDs/1000/day. With the exception...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/(SICI)1099-1557(199910/11)8:6<385::AID-PDS

    authors: Bell HM,McElnay JC,Hughes CM

    更新日期:1999-10-01 00:00:00

  • Retraction. "Epidemiological evaluation of intraoperative antibiosis as a protective agent against endophthalmitis after cataract surgery" by F. Krummenauer, S. Kurz and H.B. Dick.

    abstract::The following article from Pharmacoepidemiology and Drug Safety, “Epidemiological evaluation of intraoperative antibiosis as a protective agent against endophthalmitis after cataract surgery” by F. Krummenauer, S. Kurz and H.B. Dick, published online on July 11 2006 inWiley Online Library (wileyonlinelibrary.com), has...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 撤回出版物

    doi:

    authors:

    更新日期:2013-02-01 00:00:00