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


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.


Pigeot I,Ahrens W




Has Abstract


2008-03-01 00:00:00












  • Acute kidney injury during concomitant use of valacyclovir and loxoprofen: detecting drug-drug interactions in a spontaneous reporting system.

    abstract:PURPOSE:Little is known about the effects of drug-drug interactions between valacyclovir and non-steroidal anti-inflammatory drugs (NSAIDs). In this study, we analysed the adverse event 'acute kidney injury (AKI)' resulting from a possible interaction between loxoprofen (a non-selective NSAID) and valacyclovir in repor...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章


    authors: Yue Z,Shi J,Jiang P,Sun H

    更新日期:2014-11-01 00:00:00

  • EU postmarket surveillance plans for medical devices.

    abstract:PURPOSE:Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive-reactive postmarket surveillance (PMS) system. Various European Union (EU) national competent authorities have started to focus on strengthening the postmarket risk evaluation. As a consequen...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,评审


    authors: Pane J,Francisca RDC,Verhamme KMC,Orozco M,Viroux H,Rebollo I,Sturkenboom MCJM

    更新日期:2019-09-01 00:00:00

  • Effects of analgesics on bone mineral density: A longitudinal analysis of the prospective SWAN cohort with three-group matching weights.

    abstract:PURPOSE:To examine the effects of analgesics on bone mineral density (BMD), which have not been examined in a longitudinal study with multiple measurements. METHODS:We investigated changes in BMD associated with new use of analgesics in a prospective longitudinal cohort of mid-life women. BMD and medication use were m...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章


    authors: Yoshida K,Yu Z,Greendale GA,Ruppert K,Lian Y,Tedeschi SK,Lin TC,Haneuse S,Glynn RJ,Hernández-Díaz S,Solomon DH

    更新日期:2018-02-01 00:00:00

  • Risk of rhabdomyolysis from 5-α reductase inhibitors.

    abstract:PURPOSE:A recent regulatory warning and case reports have described the development of muscle complications with the use of 5-α reductase inhibitors (5ARIs). We wished to determine if there was a link between rhabdomyolysis and 5ARI usage. METHODS:We used a matched cohort design and linked administrative data from the...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章


    authors: Welk B,McArthur E,Ordon M,Dirk J,Dixon S,Garg AX

    更新日期:2018-03-01 00:00:00

  • Trends in rates of acetaminophen-related adverse events in the United States.

    abstract:PURPOSE:The goal of this study is to summarize trends in rates of adverse events attributable to acetaminophen use, including hepatotoxicity and mortality. METHODS:A comprehensive analysis of data from three national surveillance systems estimated rates of acetaminophen-related events identified in different settings,...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章


    authors: Major JM,Zhou EH,Wong HL,Trinidad JP,Pham TM,Mehta H,Ding Y,Staffa JA,Iyasu S,Wang C,Willy ME

    更新日期:2016-05-01 00:00:00

  • Psychotropic drugs and fatal pulmonary embolism.

    abstract:PURPOSE:To examine the association between the use of psychotropic drugs and fatal pulmonary embolism. METHODS:We conducted a national case-control study of fatal pulmonary embolism. Cases were 75 New Zealand men and women aged 15-59 years who died between 1 January 1990 and 31 December 1998, where the underlying caus...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章


    authors: Parkin L,Skegg DC,Herbison GP,Paul C

    更新日期:2003-12-01 00:00:00

  • National pharmacovigilance programs in Arab countries: A quantitative assessment study.

    abstract:PURPOSES:The aim of the pharmacovigilance (PV) process is to bring together all the much-needed information about various aspects of product safety or, in particular, the safety and vigilance of drugs as pharmaceutical products. This study aimed to investigate and provide an overview on the current situation and activi...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章


    authors: Alshammari TM,Alenzi KA,Ata SI

    更新日期:2020-09-01 00:00:00

  • Methodological gaps in the assessment of risk minimization interventions: a systematic review.

    abstract:INTRODUCTION:Since the introduction of therapeutic risk management regulatory guidance, an increase in the number of risk minimization interventions (RMIs) published in the literature has been observed. Methods used to evaluate their effectiveness remain, however, poorly examined. OBJECTIVE:This paper aimed to conduct...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,评审


    authors: Gridchyna I,Cloutier AM,Nkeng L,Craig C,Frise S,Moride Y

    更新日期:2014-06-01 00:00:00

  • Development of an adverse events reporting form for Korean folk medicine.

    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

    pub_type: 杂志文章


    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

  • 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


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

    更新日期:2010-09-01 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


    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

  • A retrospective study on the usage of cough and cold medications in viral respiratory tract infections in Taiwanese children.

    abstract:OBJECTIVE:We sought to describe the epidemiology of viral respiratory-tract infections and patterns in prescriptions of cough and cold medications among young children who were suffering from viral respiratory tract infections (vRTIs). METHODS:We conducted a cross-sectional study to examine vRTI-episode occurrence and...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,随机对照试验


    authors: Cheng CL,Kao Yang YH,Liu CC,Lee PI

    更新日期:2014-01-01 00:00:00

  • Building a framework for the evaluation of knowledge translation for the Canadian Network for Observational Drug Effect Studies.

    abstract:PURPOSE:The Canadian Network for Observational Drug Effect Studies (CNODES), a network of pharmacoepidemiologists and other researchers from seven provincial sites, provides evidence on the benefits and risks of drugs used by Canadians. The Knowledge Translation Team, one of CNODES' four main teams, evaluates the impac...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章


    authors: Sketris IS,Carter N,Traynor RL,Watts D,Kelly K,following contributing members of the CNODES Knowledge Translation Team: Pierre Ernst, JM Gamble, Brenda Hemmelgarn, Colleen Metge, Michael Paterson, Robert Platt W. and Gary Teare.

    更新日期:2020-01-01 00:00:00

  • Exposure to reactive intermediate-inducing drugs during pregnancy and the incident use of psychotropic medications among children.

    abstract:PURPOSE:Our study aimed to investigate the association between prenatal exposure to reactive intermediate (RI)-inducing drugs and the initiation of psychotropic medications among children. METHODS:We designed a cohort study using a pharmacy prescription database. Pregnant women were considered exposed when they receiv...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章


    authors: Tran YH,Groen H,Bergman JE,Hak E,Wilffert B

    更新日期:2017-03-01 00:00:00

  • Prescription patterns of antiepileptic drugs in young women: development of a tool to distinguish between epilepsy and psychiatric disorders.

    abstract:BACKGROUND:Antiepileptic drugs (AEDs) are also prescribed for therapeutic indications other than epilepsy (EPI), namely, psychiatric disorders (PSY). Our aim was to develop an algorithm able to distinguish between EPI and PSY among childbearing age women based on differences in AED exposure in these patient groups. ME...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章


    authors: Naldi I,Piccinni C,Mostacci B,Renzini J,Accetta G,Bisulli F,Tappatà M,Piazza A,Pagano P,Bianchi S,D'Alessandro R,Tinuper P,Poluzzi E,ESPEA (Emilia-Romagna Study on Pregnancy and Exposure to Antiepileptic drugs) Group.

    更新日期:2016-07-01 00:00:00

  • Statistical visualization for assessing performance of methods for safety surveillance using electronic databases.

    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


    authors: Li X,Hui S,Ryan P,Rosenman M,Overhage M

    更新日期:2013-05-01 00:00:00

  • Use of granulocyte colony-stimulating factor (G-CSF) and outcome in patients with non-chemotherapy agranulocytosis.

    abstract:PURPOSE:The use of granulocyte colony-stimulating factor (G-CSF) in the treatment of non-chemotherapy drug- induced agranulocytosis is controversial. We aimed at assessing the effect of G-CSF on the duration of agranulocytosis. METHODS:To assess the effect of G-CSF on the duration of agranulocytosis, a Cox proportiona...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章


    authors: Ibáñez L,Sabaté M,Ballarín E,Puig R,Vidal X,Laporte JR,Agranulocytosis and Aplastic Anaemia Study Group of Barcelona.

    更新日期:2008-03-01 00:00:00

  • Personalized benefit-risk assessments combining clinical trial and real-world data provide further insights into which patients may benefit most from therapy: Demonstration for a new oral antiplatelet therapy.

    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

    pub_type: 杂志文章


    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

  • 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 (, has...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 撤回出版物



    更新日期:2013-02-01 00:00:00

  • The association between proton pump inhibitor use and the risk of tuberculosis: A case-control study.

    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


    authors: Song HJ,Park H,Park S,Kwon JW

    更新日期:2019-06-01 00:00:00

  • Effectiveness of rosuvastatin compared to other statins for the prevention of cardiovascular events-a cohort study in 395 039 patients from clinical practice.

    abstract:PURPOSE:This study compared the effectiveness of rosuvastatin (RSV) to other statins prescribed in clinical practice in prevention of cardiovascular (CV) events. METHODS:This longitudinal inception cohort study, using Thomson Healthcare's MarketScan databases, included patients aged > or = 18 starting statin therapy d...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章


    authors: Motsko SP,Russmann S,Ming EE,Singh VP,Vendiola RM,Jones JK

    更新日期:2009-12-01 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


    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

  • Steroidal contraceptive use update, United States, 1989-1994.

    abstract:OBJECTIVE:To update United States steroidal contraceptive use data for the period 1989 to 1994. STUDY DESIGN:Pharmaceutical marketing data were used to examine trends in the utilization and distribution of oral contraceptives, Norplant, and Depo-Provera. RESULTS:There were 56.8 million prescriptions for oral contrace...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章


    authors: Gerstman BB,Burke L,Delaney J,McLellan B

    更新日期:1996-05-01 00:00:00

  • Prevalence of risk factors for suicide in patients prescribed venlafaxine, fluoxetine, and citalopram.

    abstract:PURPOSE:Three recent observational studies reported that the risk of fatal overdose is greater with venlafaxine than SSRI use. It is not clear whether patient factors could account for this finding. We evaluated whether risk factors for suicide are more prevalent among patients prescribed venlafaxine than patients pres...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章


    authors: Mines D,Hill D,Yu H,Novelli L

    更新日期:2005-06-01 00:00:00

  • The positive predictive value of a hyperkalemia diagnosis in automated health care data.

    abstract:PURPOSE:Our objectives were to determine performance of coded hyperkalemia diagnosis at identifying (1) clinically evident hyperkalemia and (2) serum potassium>6 mmol/L. METHODS:This retrospective observational study included 8722 patients with diabetes within an integrated healthcare system who newly initiated an ang...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章


    authors: Raebel MA,Smith ML,Saylor G,Wright LA,Cheetham C,Blanchette CM,Xu S

    更新日期:2010-11-01 00:00:00

  • How (not) to inform patients about drug use: use and effects of negations in Dutch patient information leaflets.

    abstract:PURPOSE:Under EU regulations, patient information leaflets (PILs) are required to be clear and understandable. Negations (e.g., not, no) are a linguistic aspect that may impact PIL comprehension, yet go unmentioned in these regulations. We conducted two studies to determine (1) how negations are used in Dutch PILs (stu...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章


    authors: Burgers C,Beukeboom CJ,Sparks L,Diepeveen V

    更新日期:2015-02-01 00:00:00

  • The need for a national infrastructure to improve the rational use of therapeutics.

    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


    authors: Califf RM

    更新日期:2002-06-01 00:00:00

  • Addressing unmeasured confounding in comparative observational research.

    abstract:PURPOSE:Observational pharmacoepidemiological studies can provide valuable information on the effectiveness or safety of interventions in the real world, but one major challenge is the existence of unmeasured confounder(s). While many analytical methods have been developed for dealing with this challenge, they appear u...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,评审


    authors: Zhang X,Faries DE,Li H,Stamey JD,Imbens GW

    更新日期:2018-04-01 00:00:00

  • Trends in potentially inappropriate medication prescribing to nursing home patients: comparison of three cross-sectional studies.

    abstract:PURPOSE:The aim of this study was to examine trends in potentially inappropriate medication (PIM) prescribing in Norwegian nursing homes. METHODS:Patients aged ≥70 years were included from three cross-sectional studies conducted in 1997, 2005 and 2011. PIMs were analyzed according to the Norwegian General Practice-Nur...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章


    authors: Halvorsen KH,Selbaek G,Ruths S

    更新日期:2017-02-01 00:00:00

  • Validation of a coding algorithm for intra-abdominal surgeries and adhesion-related complications in an electronic medical records database.

    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

    pub_type: 杂志文章


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

    更新日期:2016-04-01 00:00:00