This study revealed an overall decline in outpatient antibiotic prescriptions for persons under age 15 as well as other major changes in prescribing practices for the types of antibiotics studied. The observed marked rise in cephalosporin prescribing rates in all German states demands special attention because of the associated danger of increased antibiotic resistance and C. difficile superinfection. Oral cephalosporins are not recommended as drugs of first choice in current guidelines.

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Background Prescribing of systemic antibiotics in general and of cephalosporins in particular in German paediatric outpatients has previously been reported to be higher than in other European countries. Aim Our objective was to assess recent trends in antibiotic prescribing in German children. Methods This study was conducted as consecutive annual cross-sectional analyses and included all children aged 0–14 years (n = 9,389,183 in 2018) covered by statutory health insurance in Germany. Annual antibiotic prescription rates from 2010 to 2018 were calculated for the age groups 0–1, 2–5, 6–9 and 10–14 years. Poisson regression was used to estimate trends of prescription rates by age group and antibiotic subgroup. Results Overall, the age-standardised antibiotic prescription rate decreased significantly by 43% from 746 prescriptions per 1,000 persons in 2010 to 428 per 1,000 in 2018 (p < 0.001). Reductions were most pronounced in the age groups 0–1 year (−50%) and 2–5 years (−44%). The age group 2–5 years exhibited the highest prescription rate with 683 per 1,000 in 2018 (0–1 year: 320/1,000; 6–9 years: 417/1,000; 10–14 years: 273/1,000). Cephalosporins (second and third generation) accounted for 32% of prescribed antibiotics. Conclusions Marked reductions in antibiotic prescribing during the last decade indicate a change towards more judicious paediatric prescribing habits. Compared with other European countries, however, prescribing of second- and third-generation cephalosporins remains high in Germany, suggesting frequent first-line use of these substances for common respiratory infections. Considerable regional variations underline the need for regionally targeted interventions.

A necdotal evidence from clinicians in Germany suggests an increase in scabies; sales of scabicides by pharmacies in Germany have quadrupled during 2012-2017 (1,2). In addition, clinicians and scientists have raised concerns about resistance to standard treatment (3). In Germany, scabies is not reportable, and no recent national incidence estimates exist.Scabies is diagnosed clinically, but confi rmation through skin scrapings or dermatoscopy is not always performed in Germany (1). The national guideline recommends a single application of permethrin 5% cream for common scabies (4). Ivermectin, licensed in Germany in 2016, is recommended in cases of crusted scabies, immunosuppression, and contraindications for topical treatment (4). A second application is recommended after 7-15 days in outbreaks and patients with crusted scabies, immunosuppression, or persistent infestation. We investigated incidence of scabies in Germany for 2009-2018. The StudyWe analyzed claims data of outpatients insured by German statutory health insurance (SHI) funds, which applies to ≈90% of the population of Germany (5). Information on all ambulatory consultations and fi lled prescriptions of SHI-covered patients are gathered and stored up to 10 years for the SHI Physicians' Association by the Central Research Institute of Ambulatory Health Care.We defi ned a case as any patient consultation during 2009-2018 marked with code B86, "scabies," from the International Classifi cation of Diseases (ICD), 10th Revision. We counted patients with repeat consultations only once per year. We excluded cases with missing or implausible age or sex information. We extracted, aggregated, and analyzed time of diagnosis, age, sex, and area of residence. We calculated incidence as number of cases per 100,000 SHI members per year. We also analyzed prescribing data for allethrin, benzyl benzoate, crotamiton, ivermectin, lindane, and permethrin linked to cases. We assumed treatment failure and defi ned repeated prescriptions if a patient received prescriptions for 2 scabicides within a year >28 days apart, regardless of substance (6). Use of claims data is regulated by the Code of Social Law (Sozialgesetzbuch) in Germany; ethics approval and informed consent are not required.In 2009, German SHI funds had 70,011,508 members, and scabies was diagnosed 42,585 times in physician practices, out-of-hours services, and hospital emergency departments in the ambulatory setting. In 2018, diagnoses were 382,043 for 72,802,098 members, a 9-fold increase in 9 years (Figure 1) and an overall incidence of 525/100,000 persons.The highest incidence and a >11-fold increase during 2009-2018 were observed in persons 15-19 and 20-24 years of age (Figure 2). The increase in incidence was more pronounced in boys and men, especially for those 15-19 (23% lower incidence than girls and women in 2009 vs. 7% higher in 2018) and 20-24 years of age (5% lower incidence in 2009

The objective of this study was to analyse reports on adverse drug reactions (ADRs) from Germany in the particularly vulnerable patient group of children and adolescents. Reporting characteristics, demographic parameters and off-label use were examined among others. The ratio of ADR reports per number of German inhabitants and the ratio of ADR reports per number of German inhabitants exposed to drugs were calculated and compared. These parameters were examined to derive trends in reporting of ADRs. 20,854 spontaneous ADR reports for the age group 0–17 years were identified in the European ADR database EudraVigilance for the time period 01.01.2000–28.02.2019 and analysed with regard to the aforementioned criteria. 86.5% (18,036/20,854) of the ADR reports originated from Healthcare Professionals and 12.2% (2,546/20,854) from non-Healthcare Professionals. 74.4% (15,522/20,854) of the ADR reports were classified as serious. The proportion of ADR reports per age group was 11.8% (0–1 month), 11.0% (2 months—1 year), 7.4% (2–3 years), 9.3% (4–6 years), 25.8% (7–12 years), and 34.8% (13–17 years) years, respectively. Male sex slightly dominated (51.2% vs. 44.8% females). Only 3.5% of the ADR reports reported off-label use. The annual number of ADR reports increased since 2000, even if set in context with the number of inhabitants and assumed drug-exposed inhabitants. The pediatric population declined in the study period which argues against its prominent role for the increase in the total number of ADR reports. Instead, among others, changes in reporting obligations may apply. The high proportion of serious ADR reports underlines the importance of pediatric drug safety.