Roman Gerlach

Bio: Roman Gerlach is an academic researcher from National Association of Statutory Health Insurance Physicians. The author has contributed to research in topics: Medicine & Ambulatory care. The author has an hindex of 7, co-authored 11 publications receiving 81 citations.

Costs of coordinated versus uncoordinated care in Germany: results of a routine data analysis in Bavaria

Abstract: Objectives The efficiency of a gatekeeping system for a health system, as in Germany, remains unclear particularly as access to specialist ambulatory care is not restricted. The aim was to compare the costs of coordinated versus uncoordinated patients (UP) in ambulatory care; with additional subgroup analysis of patients with mental disorders. Design Retrospective routine data analysis of patients with statutory health insurance, using claims data held by the Bavarian Association of Statutory Health Insurance Physicians. A patient was defined as uncoordinated if he or she visited at least 1 specialist without a referral from a general practitioner within a quarter. Outcomes were compared with propensity score matching analysis. Participants The study encompassed all statutorily insured patients in Bavaria contacting at least 1 ambulatory specialist in the first quarter of 2011 (n=3 616 510). Primary and secondary outcome measures Primary outcome was total costs of ambulatory care; secondary outcomes were financial claims of general physicians, specialists and for medication. Results The average age was 55.3 years for coordinated patients (CP, n=1 629 302), 48.3 years for UP (n=1 825 840). CP more frequently had chronic diseases (85.4%) as compared with UP (67.5%). The total unadjusted financial claim per patient was higher for UP (€234.52) than for CP (€224.41); the total adjusted difference was −€9.65 (95% CI −11.64 to −7.67), indicating lower costs for CP. The cost differences increased with increasing age. Total adjusted difference per patient with mental diseases as documented with an International Classification of Diseases (ICD)-10 F-diagnosis, was −€20.31 (95% CI −26.43 to −14.46). Conclusions Coordination of care is associated with lower ambulatory healthcare expenditures and is of particular importance for patients who are more vulnerable to medical interventions, especially for elderly and patients with mental disorders. The role of general practitioners as coordinators should be strengthened to improve care for these patients as this could also help to frame a more efficient health system.

Utilisation and off-label prescriptions of respiratory drugs in children.

Abstract: Respiratory drugs are widely used in children to treat labeled and non-labeled indications but only some data are available quantifying comprehensively off-label usage. Thus, we aim to analyse drug utilisation and off-label prescribing of respiratory drugs focusing on age- and indication-related off-label use. Patients aged ≤18 years documented in the Bavarian Association of Statutory Health Insurance Physicians database (approx. 2 million children) between 2004 and 2008 were included in our study. Annual period prevalence rates (PPRs) per 10,000 children and the proportion of age- and indication-related off-label prescriptions were calculated and stratified by age and gender. Within the study period, highest PPRs were found for the fixed combination of clenbuterol/ambroxol (between 374–575 per 10,000 children) and the inhaled short acting beta-2-agonist salbutamol (between 378–527 per 10,000 children). Highest relative PPR increase was found for oral salbutamol (approx. 39-fold) whereas the most distinct decrease was found for oral long-acting beta-2-agonist clenbuterol (−97%). Compound classes most frequently involved in off-label prescribing were inhaled bronchodilative compounds (91,402; 37.3%) and oral beta-2-agonists (26,850; 22.5%). The highest absolute number of off-label prescriptions were found for inhaled salbutamol (n = 67,084; 42.0%) and oral clenbuterol/ambroxol (fixed combination, n = 18,897; 20.7%). Off-label prescribing due to indication was of much greater relevance than age-related off-label use. Most frequently, bronchodilative compounds were used off-label to treat respiratory tract infections. Highest off-label prescription rates were found in the youngest patients without relevant gender-related differences. Off-label prescribing of respiratory drugs is common especially in young children. Bronchodilative drugs were most frequently used off-label for treating acute bronchitis or upper respiratory tract infections underlining the essential need for a more rational prescribing in this area.

Tiotropium Respimat® vs. HandiHaler®: real‐life usage and TIOSPIR trial generalizability

Abstract: Aim Two inhaler devices (Respimat® and HandiHaler®) are available for tiotropium, a long acting anticholinergic agent. We aimed to analyze drug utilization, off-label usage and generalizability of the TIOSPIR trial results for both devices. Methods Patients aged ≥18 years exhibiting at least one documented prescription of tiotropium in the database of the Association of Statutory Health Insurance Physicians, Bavaria, Germany, were included (years 2004–2008). Annual period prevalence rates (PPRs) were calculated stratified by age, gender and inhaler devices. Off-label usage (patients lacking a chronic obstructive pulmonary disease (COPD) diagnosis) and the proportion of patients meeting the inclusion and exclusion criteria of the TIOSPIR trial were analyzed. Results Between 2004 and 2008, PPRs increased and varied between 49.2 and 74.5 per 10 000 persons for HandiHaler® and between 1.5 and 9.3 per 10 000 persons for Respimat®. Small differences regarding patient characteristics existed between the two inhaler devices. Only about 30% (HandiHaler® 32.1%, Respimat® 30.0%) of the database patients receiving tiotropium could be theoretically included in the TIOSPIR trial. Conclusions Comparing the two tiotropium devices, no clinically relevant differences regarding patient and prescribing characteristics were revealed. Results of the TIOSPIR trial were generalizable only to a minority of our study patients, underlining the need for real-life data.

Time Trends of Period Prevalence Rates of Patients with Inhaled Long-Acting Beta-2-Agonists-Containing Prescriptions: A European Comparative Database Study

Abstract: Background: Inhaled, long-acting beta-2-adrenoceptor agonists (LABA) have well-established roles in asthma and/or COPD treatment. Drug utilisation patterns for LABA have been described, but few studies have directly compared LABA use in different countries. We aimed to compare the prevalence of LABA-containing prescriptions in five European countries using a standardised methodology. Methods: A common study protocol was applied to seven European healthcare record databases (Denmark, Germany, Spain, the Netherlands (2), and the UK (2)) to calculate crude and age- and sex-standardised annual period prevalence rates (PPRs) of LABA-containing prescriptions from 2002–2009. Annual PPRs were stratified by sex, age, and indication (asthma,COPD, asthma and COPD). Results: From 2002–2009, age- and sex-standardised PPRs of patients with LABA-containing medications increased in all databases (58.2%-185.1%). Highest PPRs were found in men >80 years old and women 70–79 years old. Regarding the three indications, the highest ageand sex-standardised PPRs in all databases were found in patients with “asthma and COPD” but with large inter-country variation. In those with asthma or COPD, lower PPRs and smaller inter-country variations were found. For all three indications, PPRs for LABAcontaining prescriptions increased with age. Conclusions: Using a standardised protocol that allowed direct inter-country comparisons, we found highest rates of LABA-containing prescriptions in elderly patients and distinct differences in the increased utilisation of LABA-containing prescriptions within the study period throughout the five European countries.

Impact of regional socioeconomic variation on coordination and cost of ambulatory care: investigation of claims data from Bavaria, Germany.

Abstract: Objectives A considerable proportion of regional variation in healthcare use and health expenditures is to date still unexplained. The aim was to investigate regional differences in the gatekeeping role of general practitioners and to identify relevant explanatory variables at patient and district level in Bavaria, Germany. Design Retrospective routine data analysis using claims data held by the Bavarian Association of Statutory Health Insurance Physicians. Participants All patients who consulted a specialist in ambulatory practice within the first quarter of 2011 (n=3 616 510). Outcomes measures Of primary interest is the effect of district-level measures of rurality, physician density and multiple deprivation on (1) the proportion of patients with general practitioner (GP) coordination of specialist care and (2) the mean amount in Euros claimed by specialist physicians. Results The proportion of patients whose use of specialist services was coordinated by a GP was significantly higher in rural areas and in highly deprived regions, as compared with urban and less deprived regions. The hierarchical models revealed that increasing age and the presence of chronic diseases are the strongest predictive factors for coordination by a GP. In contrast, the presence of mental illness, an increasing number of medical condition categories and living in a city are predictors for specialist use without GP coordination. The amount claimed per patient was €10 to €20 higher in urban districts and in regions with lower deprivation. Hierarchical models indicate that this amount is on average higher for patients living in towns and lower for patients in regions with high deprivation. Conclusion The present study shows that regional deprivation is closely associated with the way in which patients access primary and specialist care. This has clear consequences, both with respect to the role of the general practitioner and the financial costs of care.

European Position Paper on Rhinosinusitis and Nasal Polyps 2020

Abstract: The European Position Paper on Rhinosinusitis and Nasal Polyps 2020 is the update of similar evidence based position papers published in 2005 and 2007 and 2012. The core objective of the EPOS2020 guideline is to provide revised, up-to-date and clear evidence-based recommendations and integrated care pathways in ARS and CRS. EPOS2020 provides an update on the literature published and studies undertaken in the eight years since the EPOS2012 position paper was published and addresses areas not extensively covered in EPOS2012 such as paediatric CRS and sinus surgery. EPOS2020 also involves new stakeholders, including pharmacists and patients, and addresses new target users who have become more involved in the management and treatment of rhinosinusitis since the publication of the last EPOS document, including pharmacists, nurses, specialised care givers and indeed patients themselves, who employ increasing self-management of their condition using over the counter treatments. The document provides suggestions for future research in this area and offers updated guidance for definitions and outcome measurements in research in different settings. EPOS2020 contains chapters on definitions and classification where we have defined a large number of terms and indicated preferred terms. A new classification of CRS into primary and secondary CRS and further division into localized and diffuse disease, based on anatomic distribution is proposed. There are extensive chapters on epidemiology and predisposing factors, inflammatory mechanisms, (differential) diagnosis of facial pain, allergic rhinitis, genetics, cystic fibrosis, aspirin exacerbated respiratory disease, immunodeficiencies, allergic fungal rhinosinusitis and the relationship between upper and lower airways. The chapters on paediatric acute and chronic rhinosinusitis are totally rewritten. All available evidence for the management of acute rhinosinusitis and chronic rhinosinusitis with or without nasal polyps in adults and children is systematically reviewed and integrated care pathways based on the evidence are proposed. Despite considerable increases in the amount of quality publications in recent years, a large number of practical clinical questions remain. It was agreed that the best way to address these was to conduct a Delphi exercise . The results have been integrated into the respective sections. Last but not least, advice for patients and pharmacists and a new list of research needs are included. The full document can be downloaded for free on the website of this journal: http://www.rhinologyjournal.com.

Food and Drug Administration (FDA)

Abstract: The Food and Drug Administration (FDA) is a regulatory agency of the United States federal government This article describes the scope of work of each of the FDA's major components, and addresses the role of statisticians at FDA Keywords: drug regulation; clinical trials; medical devices; safety; bioassay

Study on off-label use of medicinal products in the European Union.

Abstract: European Union (EU) legislation on marketing authorisation of medicinal products aims to safeguard public health and to protect the free movement of these products. As part of this authorisation, the terms under which a product can be used safely and effectively are described in the product information. However, medicinal products might be prescribed and used outside these terms; this is what is called ‘off-label use’. This report describes a study on the complex field of off-label use. It covers the public health aspects related to the off-label use of medicinal products. In particular, it investigates the balance between the benefits and risks that off-label use has for patients, and the regulatory framework for the off-label use of medicines. Applying a wide range of methods, including a systematic review of scientific literature and grey literature, a legal analysis, interviews with stakeholders and an expert meeting, this study provides information on a variety of aspects of off-label use. These include the prevalence and incidence of off-label use and its drivers as well as a description of the national frameworks, regulatory and other, governing off-label use of medicinal products in the various EU Member States. A factual analysis is provided of how authorities have addressed the issue of off-label use and the different ways patients, healthcare professionals and industry react to this. The report does not provide any recommendations. (aut. ref.)

Impact of GP gatekeeping on quality of care, and health outcomes, use, and expenditure: a systematic review

Abstract: Background GPs often act as gatekeepers, authorising patients’ access to specialty care. Gatekeeping is frequently perceived as lowering health service use and health expenditure. However, there is little evidence suggesting that gatekeeping is more beneficial than direct access in terms of patient- and health-related outcomes. Aim To establish the impact of GP gatekeeping on quality of care, health use and expenditure, and health outcomes and patient satisfaction. Design and setting A systematic review. Method The databases MEDLINE, PreMEDLINE, Embase, and the Cochrane Library were searched for relevant articles using a search strategy. Two authors independently screened search results and assessed the quality of studies. Results Electronic searches identified 4899 studies (after removing duplicates), of which 25 met the inclusion criteria. Gatekeeping was associated with better quality of care and appropriate referral for further hospital visits and investigation. However, one study reported unfavourable outcomes for patients with cancer under gatekeeping, and some concerns were raised about the accuracy of diagnoses made by gatekeepers. Gatekeeping resulted in fewer hospitalisations and use of specialist care, but inevitably was associated with more primary care visits. Patients were less satisfied with gatekeeping than direct-access systems. Conclusion Gatekeeping was associated with lower healthcare use and expenditure, and better quality of care, but with lower patient satisfaction. Survival rate of patients with cancer in gatekeeping schemes was significantly lower than those in direct access, although primary care gatekeeping was not otherwise associated with delayed patient referral. The long-term outcomes of gatekeeping arrangements should be carefully studied before devising new gatekeeping policies.