Association between Periodontal Treatment and Healthcare Costs in Patients with Coronary Heart Disease: A Cohort Study Based on German Claims Data.

There is empirical evidence of an association between periodontitis and coronary heart disease (CHD). However, it is uncertain whether periodontal treatment in CHD patients might lead to reduced healthcare costs. This study aims to assess the association between periodontal treatment and healthcare costs in newly diagnosed CHD patients. Data from 21,263 adults who were continuously insured between 2011 and 2016 and who were newly diagnosed with CHD in 2013 were selected from a German claims database. The study population was differentiated by the utilization of periodontal treatment. The average treatment effect (ATE) of periodontal treatment on healthcare costs (total, inpatient, outpatient, drugs) was investigated using weighted Poisson regression models conditional on covariates and is shown as a ratio (of geometric means). Periodontal treatment was documented for 4.7% of the persons in the study population. Newly diagnosed CHD patients showed an ATE of 0.98 for total healthcare cost (95% CI 0.90-1.06), 0.79 for inpatient costs (95% CI 0.61-1.04), and 0.95 for drug costs (95% CI 0.87-1.04). A statistically significant 7% increase in outpatient costs was shown (95% CI 1.01-1.13). Despite a lack of statistical significance in most cases, the study provides evidence of a meaningful decrease in inpatient costs after periodontal treatment. Further studies are needed.

Assessing the effect of a regional integrated care model over ten years using quality indicators based on claims data - the basic statistical methodology of the INTEGRAL project.

BACKGROUND: The regional integrated health care model "Healthy Kinzigtal" started in 2006 with the goal of optimizing health care and economic efficiency. The INTEGRAL project aimed at evaluating the effect of this model on the quality of care over the first 10 years. METHODS: This methodological protocol supplements the study protocol and the main publication of the project. Comparing quality indicators based on claims data between the intervention region and 13 structurally similar control regions constitutes the basic scientific approach. Methodological key issues in performing such a comparison are identified and solutions are presented. RESULTS: A key step in the analysis is the assessment of a potential trend in prevalence for a single quality indicator over time in the intervention region compared to the corresponding trends in the control regions. This step has to take into account that there may be a common - not necessarily linear - trend in the indicator over time and that trends can also appear by chance. Conceptual and statistical approaches were developed to handle this key step and to assess in addition the overall evidence for an intervention effect across all indicators. The methodology can be extended in several directions of interest. CONCLUSIONS: We believe that our approach can handle the major statistical challenges: population differences are addressed by standardization; we offer transparency with respect to the derivation of the key figures; global time trends and structural changes do not invalidate the analyses; the regional variation in time trends is taken into account. Overall, the project demanded substantial efforts to ensure adequateness, validity and transparency.

The impact of periodontal treatment on healthcare costs in newly diagnosed diabetes patients: Evidence from a German claims database.

AIMS: There is sufficient scientific evidence for the bidirectional association between periodontal diseases and diabetes. In this context, we hypothesized that periodontal treatment leads to lower healthcare costs in newly diagnosed diabetes patients by promoting a milder disease course. METHODS: A total of 23,771 persons were investigated who were continuously insured by German health insurances between 2011 and 2016, 18 years or older, and newly diagnosed with diabetes in 2013. The study population was divided into a periodontal treatment and control group (no periodontal treatment). The average treatment effect of a periodontal treatment on various types of healthcare costs (inpatient, outpatient, drug costs) was analyzed by a doubly robust method. RESULTS: Finally, 5.3% of the study population could be assigned to the treatment group. In newly diagnosed diabetes patients with periodontal treatment, a reduction in total healthcare costs (0.96, 95%CI 0.89; 1.04), inpatient costs (0.87, 95%CI 0.69; 1.08), diabetes-related drug costs (0.93, 95%CI 0.84; 1.03) and other drug costs (0.97, 95%CI 0.89; 1.05) could be shown compared to the control group. CONCLUSIONS: This study provides evidence that periodontal treatment for diabetes patients reduces healthcare costs. Fewer diabetes-specific complications and hospitalizations are expected.

Mental disorders and utilization of mental health services in newly diagnosed cancer patients: An analysis of German health insurance claims data.

OBJECTIVE: People with cancer are often confronted not only with the burdens of medical treatment but also with psychological strain, which can lead to mental disorders (MD). To date, the prevalence of MD in newly diagnosed cancer patients and their utilization of mental health services (MHS) are mainly estimated through data of primary studies than considering healthcare-related claims data. METHODS: Statutory health insurance claims data of the AOK/KV Hesse from 2011 to 2014 was analyzed. The number of incident cancer patients with MD and the utilization of MHS within the period of the quarter of incident cancer diagnosis and three subsequent quarters were determined. For incident cancer patients with an incident MD, the predictive values of sex, age group, and tumor entity on the documentation of MD diagnosis and utilization were investigated. RESULTS: The 12-month prevalence of MD in incident cancer patients was 31.1% for depression, 11.2% for anxiety disorders, and 9.2% for post-traumatic stress/adjustment disorder (PTSD/AD). Of these, 65.9% received outpatient psychotherapy and 43.0% at least one psychopharmacological drug prescription. Men had a significantly lower chance of receiving an MD diagnosis following cancer. CONCLUSIONS: The prevalence of MD observed was higher for depression and lower for PTSD/AD compared to meta-analyses of clinical trials. Male cancer patients had a lower chance of receiving an MD diagnosis than females, which coincides with existing results.

[Internal diagnostic validation of patients with a chronic wound: possibilities of identification on the basis of routine data]. / Interne Diagnosevalidierung von Patienten mit einer floriden chronischen Wunde - Möglichkeiten der Identifizierung auf der Basis von Routinedaten.

OBJECTIVE: There are still few epidemiological data on patients with chronic wounds (leg ulcers, diabetic foot ulcers and pressure ulcers). Statutory health insurance (SHI) data is increasingly being used for questions relating to healthcare science. When using this data, which is primarily collected for billing purposes, the methodological procedure for defining cases must be presented transparently. Here, it must be checked whether the target group can be validly defined using the coded diagnoses and, if necessary, further information from routine data. Therefore, the aim of this contribution is, on the one hand, to develop criteria with the help of which patients with a florid (active) chronic wound can be identified safely or as doubtful cases in routine data and, on the other hand, to determine the corresponding frequency estimates. METHODS: Initially, a literature research was carried out to identify parameters relevant to care in patients with chronic wounds. In the next step, these were divided into specific, less specific and non-specific criteria (visual validity) in a multi-stage consensus procedure with regard to the specificity for wound care. On this basis, three different case definitions are used to identify florid chronic wounds. Based on an SHI sample of insured persons, frequency estimates were made for various case definitions (safe and questionable cases). RESULTS: Of the 21 parameters identified in the literature, eight were classified as specific, six as less specific and eight as non-specific criteria for the identification of patients with chronic florid wounds. Using diagnostic coding alone for the target diseases, an administrative prevalence of chronic wounds of 1.13% was observed for the year 2010. If a case is defined using the less specific and/or the specific criteria, prevalence drops to 0.79%; if only the specific criteria are used, prevalence drops only marginally to 0.78%. These changes were observed in patients with leg ulcers and diabetic foot ulcers, but not in patients with pressure ulcers. Here, the lowest administrative prevalence (0.18%) can be seen when only looking at the diagnoses, but this increases slightly when taking wound-relevant treatments into account (specific and less specific criteria: 0.25%). CONCLUSION: It is possible to define patients with a chronic florid wound on the basis of wound-relevant treatments using SHI data and to make estimates of administrative prevalence. Depending on the question, the criteria for defining cases can be narrowed down or broadened. The comparison provides information on the internal validity of diagnostic coding. However, further studies are needed to verify external validity.

Comparison of Different Strategies to Measure Medication Adherence via Claims Data in Patients With Chronic Heart Failure.

Medication adherence correlates with morbidity and mortality in patients with chronic heart failure (CHF), but is difficult to assess. We conducted a retrospective methodological cohort study in 3,808 CHF patients, calculating adherence as proportion of days covered (PDC) utilizing claims data from 2010 to 2015. We aimed to compare different parameters' influence on the PDC of elderly CHF patients exemplifying a complex chronic disease. Investigated parameters were the assumed prescribed daily dose (PDD), stockpiling, and periods of hospital stay. Thereby, we investigated a new approach using the PDD assigned to different percentiles. The different dose assumptions had the biggest influence on the PDC, with variations from 41.9% to 83.7%. Stockpiling and hospital stays increased the values slightly. These results queries that a reliable PDC can be calculated with an assumed PDD. Hence, results based on an assumed PDD have to be interpreted carefully and should be presented with sensitivity analyses to show the PDC's possible range.

Impact of EU risk assessment process and administrative regulations for manufacturers of combined hormonal contraceptive prescribing. An analysis of developments in Germany and the implications.

OBJECTIVE: Combined hormonal contraceptives (CHC) exhibit differing risks for cardiovascular and thrombotic events (VTE). A European referral process confirmed higher VTE risks for 3rd generation gestagens and drospirenone. CHC are now grouped in risk classes (RC) I, II, and III, with RC III having a higher risk than RC I and X (risk not yet known). Marketing authorization holders were obliged to implement pharmacovigilance measures and risk minimization measures including changes of prescribing information. The study assessed whether these activities induced changes in prescription patterns. METHODS: German prescription data for 1.1 million women below 20 years of age were used to analyze the effects of interventions and potential influence factors using logistic regression. Descriptive statistics were calculated for prescriptions for 3.3 million women from January 2011 to March 2016. RESULTS: Shares of RC I and RC X recipients rose substantially over the observation period, while RC III recipient share showed a steady decrease. The referral induced a slightly faster decrease in RC III and increase in RC X. The implementation of pharmacovigilance measures manifested no additional effect. CONCLUSION: The decrease in RC III share already observed before the referral process can be explained with pre-existing discussions around CHC. The effect attributable to the referral was statistically significant, although very small. While evidence for a connection between interventions and prescription change is only indirect, the study shows that routine data are suitable for impact analyses, and monitoring prescribing patterns can be recommended as feedback after regulatory or political interventions. This is being followed up.

Statin-associated myopathy. Assessment of frequency based on data of all statutory health insurance funds in Germany.

Aim of the study was to assess the incidence of statin-associated myopathy (SAM) under real-life conditions in Germany. DATABASE: Administrative data (master data, diagnoses, prescriptions) for all individuals in Germany insured with the Statutory Health Insurance. Basic population: individuals 18 years and older who have been insured continually from 2009 to 2011 (52.9 million; 29.9 million men, 23.9 million women). Data access is provided by the German Institute of Medical Documentation and Information, DIMDI) according to the Data Transparency Regulation of 2012. Statins: identification with the ATC-Codes: C10AA, C10BA and C10BX. STUDY POPULATION: incident statin users in 2010 with a diagnosis of lipid disorders (ICD-10-GM E78, excluding patients with: E78.1, E78.3, E78.6 in eight quarters before index prescription. Definition of SAM: documentation of myopathy (ICD-10-GM G72.0, G72.8; G72.9, M60.8, M60.9, M79.1) in the first statin prescription quarter or in one of the three following quarters. The first event is considered for the incidence estimate. The daily doses included in a package were classified as "days under therapy" (by assuming one DDD) and taken as exposition time. SAM was found in 1.9% of 531 672 incident statin users. The percentage differs according to the patterns of statin use: the lowest incidence is observed in those with only one prescription (1.3%), the highest incidence with 5.0% is observed in those who not only stopped the treatment within 365 days, but who also had their statin changed. Administrative data including diagnoses from ambulatory care provide a realistic estimate of SAM frequency in every day practice.

[Prevalence of dementia of insured persons with and without German citizenship : A study based on statuatory health insurance data]. / Prävalenz von Demenz bei Versicherten mit und ohne deutsche Staatsangehörigkeit : Eine Studie auf Basis von Daten der gesetzlichen Krankenversicherung.

BACKGROUND: Elderly people with a non-German background are a fast growing population in Germany. OBJECTIVES: Is administrative prevalence of dementia and uptake of nursing-home care similar in the German and non-German insured? MATERIALS AND METHODS: Based on routine data, administrative prevalence rates for dementia were calculated for 2013 from a full census of data from one large sickness fund. Patients with dementia (PWD) were identified via ICD-10 codes (F00; F01; F03; F05; G30). RESULTS: Administrative prevalence of dementia was 2.67% in the study population; 3.06% in Germans, and 0.96% in non-Germans (p value <0.001). Age and sex adjusted prevalence was comparable in the insured with and without German citizenship, except in women aged 80-84 (17.2 vs. 15.4) and for men in the age groups 80-84 (16.5 vs. 14.2), 85-89 years (23.4 vs. 21.5), and above 90 years of age (32.3 vs. 26.3). Standardized to the population of all investigated insured, 31.4% of all Germans with dementia had no longterm care entitlement vs. 35.5% of all patients without German citizenship. Of German patients, 55.1% were institutionalized vs. 39.5% of all patients without German citizenship. CONCLUSIONS: There was a higher prevalence of dementia in the very old insured without German citizenship compared to those with German citizenship, especially in men. Non-Germans showed lower uptake of nursing home care compared to Germans. Additionally, Germans had slightly higher nursing care entitlements. It should be investigated further how much of the difference is due to underdiagnosis, cultural differences, or lack of adequate diagnostic work-up.

[Severity assessment strategies based on administrative data using stroke as an example]. / Möglichkeiten zur Einschätzung des Schweregrades einer Erkrankung auf der Basis von Routinedaten am Beispiel des Schlaganfalls.

BACKGROUND AND OBJECTIVES: Information on disease severity is relevant for many studies with claims data in health service research, but only limited information is available in routine data. Stroke serves as an example to analyse whether the combination of different information in claims data can provide insight into the severity of a disease. METHOD: As a first step, a literature search was conducted. Strategies to assess the severity of a disease by means of routine data were examined with regard to approval and applicability to German sickness fund data. In order to apply and extend the identified procedures, the statutory health insurance sample AOK Hessen/KV Hessen (VSH) served as data source. It is an 18.75 % random sample of persons insured by the AOK Hessen, with 2013 being the most recent year. Stroke patients were identified by the ICD-10 GM code I63 and I64. Patients with said diagnoses being coded as a hospital discharge diagnosis in 2012 were included due to an acute event in 2012 (n=944). The follow-up time was one year. RESULTS: Ten studies covering seven different methods to assess stroke severity were identified. Codes for coma (4.2 % of stroke patients in the SHI sample) as well as coma and/or the application of a PEG tube (9.8 % of the stroke patients) were applied as a proxy for disease severity of acute cases. Taking age, sex and comorbidity into consideration, patients in a coma show a significantly increased risk of mortality compared to those without coma. Three operationalisations were chosen as possible proxies for disease severity of stroke in the further course of disease: i) sequelae (hemiplegia, neurological neglect), ii) duration of the index inpatient stay, and iii) nursing care/ care level 3 for the first time after stroke. The latter proxy has the highest explanatory value for SHI costs. CONCLUSION: The studies identified use many variables mainly based on hospital information in order to describe disease severity. With the exception of coma, these proxies were neither validated nor did the authors provide more detailed grounds for their use. An identified score for stroke severity could not be applied to SHI data. To develop a comparable score requires a linkage of clinical and administrative data. Since routine data include information from all sectors of care, it should be explored whether these data (for example, the patients' care needs) are suitable to assess disease severity. For validation, separate databases and, optimally, primary patient data are necessary.

Predictors of non-drug psychiatric/psychotherapeutic treatment in children and adolescents with mental or behavioural disorders.

Children and adolescents with mental health problems need effective and safe therapies to support their emotional and social development and to avoid functional impairment and progress of social deficits. Though psychotropic drugs seem to be the preferential treatment, psychotherapy and psychosocial interventions are essential in mental health care. For Germany, current data on the utilization of psychotherapy and psychosocial interventions in children with mental health problems is lacking. To analyse why certain children and adolescents with mental or behavioural disorders do and others do not receive non-drug treatment, we assessed predictors associated with specific non-drug psychiatric/psychotherapeutic treatment including psychosocial interventions, psychotherapy and other non-drug treatments. The study is based on data of two large German health insurance funds, AOK and TK, comprising 30 % of the German child and adolescent population. Predictors of non-drug psychiatric/psychotherapeutic treatment were analysed for 23,795 cases and two controls for every case of the same age and sex in children aged 0-17 years following a new diagnosis of mental or behavioural disorder in 2010. Predictors were divided according to Andersen's behavioural model into predisposing, need and enabling factors. The most prominent and significant predictors positively associated with non-drug psychiatric/psychotherapeutic treatment were the residential region as predisposing factor; specific, both ex- and internalizing, mental and behavioural disorders, psychiatric co-morbidity and psychotropic drug use as need factors; and low area deprivation and high accessibility to outpatient physicians and inpatient institutions with non-drug psychiatric/psychotherapeutic department as enabling factors. In conclusion, the present study suggests that the residential region as proxy for supply of therapist and socioeconomic situation is an influencing factor for the use of psychotherapy. The analysis sheds further light on predisposing, need and enabling factors as predictors of non-drug psychotherapeutic/psychiatric treatment in children and adolescents with mental or behavioural health disorders in Germany. More research is needed to further understand the factors promoting the gap between the need and utilization of mental health care.

Heterogeneous Effects of a Nonlinear Price Schedule for Outpatient Care.

Nonlinear price schedules generally have heterogeneous effects on health-care demand. We develop and apply a finite mixture bivariate probit model to analyze whether there are heterogeneous reactions to the introduction of a nonlinear price schedule in the German statutory health insurance system. In administrative insurance claims data from the largest German health insurance plan, we find that some individuals strongly react to the new price schedule while a second group of individuals does not react. Post-estimation analyses reveal that the group of the individuals who do not react to the reform includes the relatively sick. These results are in line with forward-looking behavior: Individuals who are already sick expect that they will hit the kink in the price schedule and thus are less sensitive to the co-payment. Copyright © 2016 John Wiley & Sons, Ltd.

[Time Trends in the Frequencies of ADHD and Stimulant Medication]. / Zeitliche Trends bei den Häufigkeiten für Aufmerksamkeitsdefizit-/Hyperaktivitätsstörungen (ADHS) und Stimulanzienbehandlung.

Time-trends in the frequencies of mental disorders represent specific challenges for the planning of services. The present review addresses the specific question whether or not there are time changes in terms of an increase of prevalence and incidence rates of attention-deficit hyperactivity disorders (ADHD) based on findings from international epidemiological studies from several decades. While there is no evidence that prevalence rates of ADHD have systematically increased, various national and international incidence studies on ADHD but also prevalence and incidence studies on prescribed medication indicate that the number of treated people with ADHD has increased significantly in the recent past. This increase remains even after adjusting for the general increase in the number of persons admitted to psychiatry for any disorder. Thus, the gap between those in need of treatment and those who actually receive treatment for ADHD has narrowed over time. However, after years of an increase, in recent years German studies dealing with prescriptions of medications have shown also a declining trend.

[Pursuing the triple aim: evaluation of the integrated care system Gesundes Kinzigtal: population health, patient experience and cost-effectiveness]. / Triple Aim - Evaluation in der Integrierten Versorgung Gesundes Kinzigtal - Gesundheitszustand, Versorgungserleben und Wirtschaftlichkeit.

BACKGROUND: The integrated care system Gesundes Kinzigtal (ICSGK), one of the most comprehensive population-based ICS in Germany, started its work nearly 9 years ago. The ICSGK is pursuing the Triple Aim: improving the health of the population, improving the individual's experience of care, and at the same time reducing the per capita costs of care. OBJECTIVES: To evaluate the impact of the ICSGK on the Triple Aim. MATERIALS AND METHODS: The ICSGK is being evaluated externally and internally via a mix of diverse quantitative and qualitative methods. This paper presents selected results for each Triple Aim dimension. RESULTS AND CONCLUSIONS: Regarding population health, most of the quality indicators examined by the external scientific evaluation show positive development. For example, the prevalence of patients with fractures among all insurants with osteoporosis is presented. In 2011, this prevalence was approximately 26 % in the "Kinzigtal" population (aged ≥ 20 years old) in comparison to 33 % in the control group. As far as patient experience is concerned, to the question "Would you recommend becoming a member of Gesundes Kinzigtal to your friends or relatives?" 92.1 % of those questioned answered "Yes, for sure" or "Yes, probably." Twenty-four percent of those questioned further stated that they would now live "more healthy" than before enrolment in the ICSGK. In the subgroup of questioned insurants who had objective agreements with their doctors 45.4 % answered in this way. On the subject of cost-effectiveness, for both participating socil health insurance schemes, cost savings relative to the costs normally expected for the ICSGK population concerned are observed every year. In the seventh intervention year (2012) the total is 4.56 million Euros for the AOK Baden-Württemberg (BW), which is a contribution margin of 146 Euros per insurant for the 31.156 insurants concerned (LKK BW = 322 Euros per insurant relative to cost savings). The results presented in this paper indicate positive effects in all three Triple Aim dimensions. Further longitudinal studies are recommended to validate those first results together with a detailed analysis to obtain in-depth insights into the specific influence of subcomponents of the total intervention.

Risk of hyperkalemia and combined use of spironolactone and long-term ACE inhibitor/angiotensin receptor blocker therapy in heart failure using real-life data: a population- and insurance-based cohort.

PURPOSE: Clinical trials and few observational studies report increased hyperkalemia risks in heart failure patients receiving aldosterone blockers in addition to standard therapy. The aim of this study is to assess the hyperkalemia risk and combined use of spironolactone and long-term ACE (angiotensin-converting enzyme) inhibitor/angiotensin receptor blocker (ARB) therapy for heart failure in a real-life setting of a heterogeneous population. METHODS: Using claims data of the statutory health insurance fund AOK, covering 30% of the German population, we performed a nested case-control study in a cohort of heart failure patients receiving continuous ACE/ARB therapy (n = 1,491,894). Hyperkalemia risk associated with concurrent use of spironolactone and ACE/ARB was calculated by conditional logistic regression in 1062 cases and 10,620 risk-set-sampling-matched controls. RESULTS: Risk of hyperkalemia in heart failure patients was significantly associated with spironolactone use (odds ratio (OR) (95% confidence interval (CI)) = 13.59 (11.63-15.88) in all and 11.05 (8.67-14.08) in those with information on New York Heart Association (NYHA) stage of disease). In the NYHA subpopulation, higher risk estimates were observed in short-term as compared with long-term users (OR (95%CI) = 13.00 (9.82-17.21) and 9.12 (6.78-12.26), respectively). Moreover, the association was stronger in older (≥70 years of age) as compared with younger patients (<70 years of age) (OR (95%CI) = 12.32 (9.35-16.23) and 8.73 (5.05-15.08), respectively), although interaction was not significant (pinteraction = 0.07). CONCLUSIONS: Hyperkalemia risk associated with combined use of spironolactone and ACE/ARB is much stronger in real-life practice than observed in clinical trials. Careful potassium level monitoring in concomitant users of spironolactone and ACE/ARB is necessary.

Prevalence of inflammatory bowel disease: estimates for 2010 and trends in Germany from a large insurance-based regional cohort.

OBJECTIVE: A worldwide increase in prevalence of inflammatory bowel disease (IBD) has been reported. For Germany, latest publications not restricted to actively treated disease present data of the 1980s. This study estimates the administrative 1-year period IBD prevalence in 2010 and investigates the trend in prevalence of actively treated disease between 2001 and 2010. MATERIAL AND METHODS: Utilizing an insurance-based cohort (n = 311,001 in 2001 to 265,102 in 2010), case definition was based on ICD-10 codes. The prevalence of active treatment was based on internally validated IBD cases of the respective year. The 1-year period prevalence in 2010 accounts for cases actively treated in at least one of the years between 2001 and 2010. Estimates were directly standardized by age and sex to the population of Germany. The change in prevalence of actively treated disease over the years was evaluated by means of Poisson regression. RESULTS: The IBD prevalence in 2010 was 744 (95% confidence interval [CI]: 707-775) per 100,000 (Crohn's disease: 322 [95% CI: 302-346], ulcerative colitis: 412 [95% CI: 389-436] per 100,000). The prevalence of actively treated disease increased significantly between 2001 (344 [95% CI: 324-364] per 100,000) and 2010 (493 [95% CI: 464-519] per 100,000; increase in prevalence by 42% [95% CI: 31%-53%], p trend = 6.0 × 10(-19)). CONCLUSION: In line with worldwide reports, our results based on a large insurance cohort suggest a considerable increase in IBD prevalence in Germany since the 1980s. The significant increase in prevalence of actively treated disease in our cohort highlights the need to adapt healthcare services and deal with the burden associated with increasing numbers of IBD patients.

Risk of bleeding and antibiotic use in patients receiving continuous phenprocoumon therapy. A case-control study nested in a large insurance- and population-based German cohort.

There is major concern about coumarins interacting with various drug classes and increasing the risk of overanticoagulation. The aim of the study was to assess bleeding risk in patients with concurrent use of antibiotics and phenprocoumon, the most widely prescribed coumarin in many European countries. We conducted a nested-case-control study within a cohort of 513,338 incident and continuous phenprocoumon users ≥ 18 years of age using claims data of the statutory health insurance company AOK, covering 30% of the German population. Bleeding risk associated with current use of antibiotics for systemic use (antibacterials/antimycotics) was calculated using conditional logistic regression in 13,785 cases with a bleeding event and 55,140 risk-set sampling-matched controls. Bleeding risk associated with any antibacterial use in phenprocoumon users was significantly increased [odds ratio (OR) 2.37, 95% confidence interval (CI) 2.20-2.56]. The association was stronger for gastrointestinal than for cerebral bleeding (OR 2.09, 95% CI 1.84-2.38 and OR 1.34, 95% CI 1.03-1.74, respectively) and highest for other/unspecified bleeding (OR 2.92, 95% CI 2.62-3.26). Specific antibiotic classes were strongly associated with bleeding risk, e.g. cotrimoxazole (OR 3.86, 95% CI 3.08-4.84) and fluorquinolones (OR 3.13, 95% CI 2.74-3.59), among those highest for ofloxacin (OR 5.00, 95% CI 3.01-8.32). Combined use of phenprocoumon and antimycotics was not significantly associated with bleeding risk. Risk was not significantly modified by age (pint=0.25) or sex (pint=0.96). The association was stronger the closer the antibiotic exposure was to the bleeding event. Among continuous phenprocoumon users, antibiotics - particularly quinolones and cotrimoxazole - should be prescribed after careful consideration due to an increased bleeding risk. Close monitoring of international normalised ratio levels after prescription is recommended.

Increase in opiate prescription in Germany between 2000 and 2010: a study based on insurance data.

BACKGROUND: Insufficient data have been available to date on the prevalence of opioid treatment in Germany, physicians' prescribing habits, and the percentages of cancer patients and non-cancer patients among those receiving opioids for an evaluation of the quality of care and an assessment of possible underuse or misuse. METHODS: The data analyzed in this study were derived from the statutory health insurance sample of the AOK health insurance company in the German state of Hesse / ASHIP Hesse for the years 2000-2010. For the purpose of this study, prevalence was defined as the percentage of insurees who received at least one outpatient prescription of an opioid (ATC N02A, excluding codeine, levomethadone and methadone). In order to control for population aging, the prevalence was standardized to the German population on December 31(st) of the preceding year and to the age-structure of the population as it was in 1999. Opioid prescribing for cancer was assumed when a cancer diagnosis was documented in the same year in which the opioid prescription was issued. RESULTS: The percentage of insurees receiving at least one opioid prescription rose over the period of the study from 3.31% in 2000 to 4.53% in 2010, a relative gain of 37%. Opioids were mostly prescribed to patients with non-cancer pain (2010: about 77% of opioid recipients). The percentage of non-cancer patients receiving long-term opioid treatment has also increased over the period of the study. CONCLUSION: As opioids are frequently prescribed for non-cancer pain, it cannot be inferred from the observed increase in opioid prescribing that cancer patients are now receiving better opioid treatment than they were before. Further issues of concern are the observed increases in the prescribing of potent immediate release opioids and in the long-term opioid treatment for non-cancer patients, the benefit of which is currently debated.