Bald mehr und sicherere Arzneimittel für Kinder? Die Revision des Heilmittelgesetzes bringt im Bereich der Kinderarzneimittel eine Anpassung an europäische Standards

Die Ende Oktober 2009 vom Bundesrat eröffnete ordentliche Revision des Heilmittelgesetzes sieht im Bereich der Kinderarzneimittel erhebliche Neuerungen vor. Zur Verbesserung der Versorgung mit sicheren Kinderarzneimitteln soll in der Schweiz ein in Europa und den USA bereits etabliertes Anreizsystem für die Pharmaindustrie eingeführt werden. Das Ziel der Neuerungen ist die Anpassung des schweizerischen Heilmittelrechts an europäische Standards, wodurch die Versorgung mit pädiatrischen Arzneimitteln verbessert und die Sicherheit der Medikation in der Pädiatrie erhöht werden soll.

Ökologische Anforderungen an das Inverkehrbringen von Produkten: USG-Revision und Spielräume im internationalen Recht

Der verfassungsrechtliche Spielraum des Gesetzgebers bei der Konkretisierung der Ziele der Nachhaltigkeit im Wirtschafts- und Umweltrecht wird in erster Linie durch die völkerrechtlichen Rahmenbedingungen der WTO sowie die Rechtsbeziehungen der Schweiz mit der EU definiert. Der vorliegende Beitrag behandelt die Frage, ob und inwieweit die Einfuhr von Rohstoffen und unmittelbar daraus gewonnenen Basisprodukten von einer nachhaltigen Produktionsweise im Ausland abhängig gemacht werden darf. Diese Thematik ist in der Umwelt- und Klimapolitik von zunehmender Bedeutung. Herstellungsverfahren und ihre Auswirkungen auf Mensch und Umwelt rücken in den Vordergrund. Der Beitrag zeigt auf, dass die Förderung von freiwilligen Labels und internationalen Standards für Best Practices zwar im Vordergrund steht, einseitige Importrestriktionen von Produkten anknüpfend am Kriterium von sog. PPM (Production and Process Methods) im Rahmen des WTO-Rechts jedoch nicht ausgeschlossen sind, sofern die Grundsätze der Nichtdiskriminierung sowie der Verhältnismässigkeit beachtet werden und vorgängig eine einvernehmliche Lösung mit dem Exportstaat angestrebt wird. Solche Importrestriktionen haben – nebst freiwilligen Massnahmen − als wichtige Instrumente der Umwelt- und Klimapolitik in der Rechtsprechung Anerkennung gefunden. Dies sowohl im Rahmen des Allgemeinen Zoll- und Handelsabkommens als auch des Abkommens zur Beseitigung technischer Handelshemmnisse. Bisher wenig genutzte Möglichkeiten, die Einfuhr zu begrenzen, bestehen darüber hinaus in der Zollpolitik für Produkte, die von ausserhalb des Europäischen Wirtschaftraumes eingeführt werden. Das Freihandelsabkommen zwischen der Schweiz und der EU folgt im Wesentlichen den gleichen Grundsätzen wie das WTO-Recht und lässt PPMs als Unterscheidungsmerkmale für an sich gleichartige Produkte ebenfalls grundsätzlich zu.

Consecutive series of 226 journey bicruciate substituting total knee replacements: early complication and revision rates

BACKGROUND The Journey bicruciate substituting (BCS) total knee replacement (TKR) is intended to improve knee kinematics by more closely approximating the surfaces of a normal knee. The purpose of this analysis was to address the safety of Journey BCS knees by studying early complication and revision rates in a consecutive case series. METHODS Between December 2006 and May 2011, a single surgeon implanted 226 Journey BCS total knee prostheses in 191 patients (124 women, 67 men) who were eligible for study. Mean age at surgery was 68 years (41-85 years).Outcome measures were early complications and minor and major revision rates. All complications were considered, irrespective of whether conservative treatment or revision was required. RESULTS The average implantation time was 3.5 years (range 1.3-5.8 years). Thirty-three complications (14.6% of 226 knees) required minor or major revision surgery in 25 patients. The remaining eight patients were treated conservatively. Sixteen minor revisions were performed in 12 patients. Thirteen major revisions were required in 13 patients, which results in a rate of 1.65 major revisions per 100 component years. The linear trend of the early complication rate by treatment year was not significant (p = .22).Multivariate logistic regression showed no significant predictors for the occurrence of a complication or for revision surgery. A tendency towards higher complication rates was observed in female patients, although it was not significant (p = .066). CONCLUSIONS The complication and revision rates of the Journey BCS knee implant are high in comparison with those reported for other established total knee systems. Caution is advised when using this implant, particularly for less experienced knee surgeons.

„Lessons learned“ in der Revision von schriftlichen Prüfungs-Fragen

Fragestellung/Einleitung: Bisher existieren kaum Daten für den deutschsprachigen Raum, welche Fehler häufig bei der Erstellung von schriftlichen Prüfungsfragen gemacht werden. Diese Erkenntnisse könnten hilfreich sein, um Autoren in Schulungsworkshops mit dem Fokus auf die häufigsten Fehler zu schulen. Im vorliegenden Projekt wird der Frage nachgegangen, welche Fehler am häufigsten bei der Erstellung von schriftlichen Prüfungsfragen gemacht werden, und welche Schlussfolgerungen daraus für Autorenschulungen gezogen werden können. Methoden: Am Institut für Medizinische Lehre Bern werden die mit der inhaltlichen und/oder formalen Fragenrevision befassten MitarbeiterInnen (N=14) anhand von semi-strukturierten Interviews befragt, mit welcher Art von Mängeln sie bei den Fragen der von ihnen betreuten schriftlichen Prüfungen am häufigsten umgehen. Weiter wird erhoben, wie dem Revisionsbedarf aus ihrer Sicht in Schulungen am besten begegnet werden kann. Ergebnisse: Die vorläufigen Ergebnisse weisen darauf hin, dass in folgenden Bereichen am häufigsten Revisionsbedarf besteht: eindeutiger Focus auf ein konkretes Lernziel authentische und relevante Vignette für den Ausbildungsstand angemessener Schwierigkeitsgrad eindeutige Lösung formale und sprachliche Korrektheit Dementsprechend sollte auf diese Themenbereiche ein besonderer Schwerpunkt bei Schulungen gelegt werden. Diskussion/Schlussfolgerung: Die vorläufigen Ergebnisse weisen darauf hin, dass Mängel von schriftlichen Prüfungsfragen häufig in den Bereichen Focus, Vignette, Schwierigkeitsgrad, Eindeutigkeit und formal-sprachlichen Aspekten liegen. Autorenschulungen sollten diese Aspekte in den Vordergrund stellen. Unsere zum Zeitpunkt der GMA-Tagung vorliegenden definitiven Ergebnisse können dazu beitragen, Workshops zur Fragenerstellung noch besser am Schulungsbedarf auszurichten.

Is a Revision a Revision? An Analysis of National Arthroplasty Registries' Definitions of Revision.

BACKGROUND The reported survival of implants depends on the definition used for the endpoint, usually revision. When screening through registry reports from different countries, it appears that revision is defined quite differently. QUESTIONS/PURPOSES The purposes of this study were to compare the definitions of revision among registry reports and to apply common clinical scenarios to these definitions. METHODS We downloaded or requested reports of all available national joint registries. Of the 23 registries we identified, 13 had published reports that were available in English and were beyond the pilot phase. We searched these registries' reports for the definitions of the endpoint, mostly revision. We then applied the following scenarios to the definition of revision and analyzed if those scenarios were regarded as a revision: (A) wound revision without any addition or removal of implant components (such as hematoma evacuation); (B) exchange of head and/or liner (like for infection); (C) isolated secondary patella resurfacing; and (D) secondary patella resurfacing with a routine liner exchange. RESULTS All registries looked separately at the characteristic of primary implantation without a revision and 11 of 13 registers reported on the characteristics of revisions. Regarding the definition of revision, there were considerable differences across the reports. In 11 of 13 reports, the primary outcome was revision of the implant. In one registry the primary endpoint was "reintervention/revision" while another registry reported separately on "failure" and "reoperations". In three registries, the definition of the outcome was not provided, however in one report a results list gave an indication for the definition of the outcome. Wound revision without any addition or removal of implant components (scenario A) was considered a revision in three of nine reports that provided a clear definition on this question, whereas two others did not provide enough information to allow this determination. Exchange of the head and/or liner (like for infection; scenario B) was considered a revision in 11 of 11; isolated secondary patella resurfacing (scenario C) in six of eight; and secondary patella resurfacing with routine liner exchange (scenario D) was considered a revision in nine of nine reports. CONCLUSIONS Revision, which is the most common main endpoint used by arthroplasty registries, is not universally defined. This implies that some reoperations that are considered a revision in one registry are not considered a revision in another registry. Therefore, comparisons of implant performance using data from different registries have to be performed with caution. We suggest that registries work to harmonize their definitions of revision to help facilitate comparisons of results across the world's arthroplasty registries.

Virtual Patients in continuing medical education and residency training: a pilot project for acceptance analysis in the framework of a residency revision course in pediatrics.

AIM Virtual patients (VPs) are a one-of-a-kind e-learning resource, fostering clinical reasoning skills through clinical case examples. The combination with face-to-face teaching is important for their successful integration, which is referred to as "blended learning". So far little is known about the use of VPs in the field of continuing medical education and residency training. The pilot study presented here inquired the application of VPs in the framework of a pediatric residency revision course. METHODS Around 200 participants of a pediatric nephology lecture ('nephrotic and nephritic syndrome in children') were offered two VPs as a wrap-up session at the revision course of the German Society for Pediatrics and Adolescent Medicine (DGKJ) 2009 in Heidelberg, Germany. Using a web-based survey form, different aspects were evaluated concerning the learning experiences with VPs, the combination with the lecture, and the use of VPs for residency training in general. RESULTS N=40 evaluable survey forms were returned (approximately 21%). The return rate was impaired by a technical problem with the local Wi-Fi firewall. The participants perceived the work-up of the VPs as a worthwhile learning experience, with proper preparation for diagnosing and treating real patients with similar complaints. Case presentations, interactivity, and locally and timely independent repetitive practices were, in particular, pointed out. On being asked about the use of VPs in general for residency training, there was a distinct demand for more such offers. CONCLUSION VPs may reasonably complement existing learning activities in residency training.

Management of pelvic discontinuity in revision total hip arthroplasty: a review of the literature

Pelvic discontinuity is a complex problem in revision total hip arthroplasty. Although rare, the incidence is likely to increase due to the ageing population and the increasing number of total hip arthroplasties being performed. The various surgical options available to solve this problem include plating, massive allografts, reconstruction rings, custom triflanged components and tantalum implants. However, the optimal solution remains controversial. None of the known methods completely solves the major obstacles associated with this problem, such as restoration of massive bone loss, implant failure in the short- and long-term and high complication rates. This review discusses the diagnosis, decision making, and treatment options of pelvic discontinuity in revision total hip arthroplasty.

Behindertenpolitik – Positionen der Parteien nach der 6. IV-Revision

Für Menschen mit Behinderungen und ihr Umfeld ist es entscheidend zu wissen, welche Parteien sie mit ihrer Arbeit im Parlament unterstützen. In den Fragen rund um Behinderungen zeigt sich unter der Bundeshauskuppel tendenziell ein Rechts-Links-Graben. Die Mitte-Parteien, insbesondere die CVP, scheinen diese Tatsache allerdings in Frage zu stellen.

A legacy of human-induced ecosystem changes: spatial processes drive the taxonomic and functional diversities of testate amoebae in Sphagnum peatlands of the Galápagos

Aim Our aims were to compare the composition of testate amoeba (TA) communities from Santa Cruz Island, Galápagos Archipelago, which are likely in existence only as a result of anthropogenic habitat transformation, with similar naturally occurring communities from northern and southern continental peatlands. Additionally, we aimed at assessing the importance of niche-based and dispersal-based processes in determining community composition and taxonomic and functional diversity. Location The humid highlands of the central island of Santa Cruz, Galápagos Archipelago. Methods We survey the alpha, beta and gamma taxonomic and functional diversities of TA, and the changes in functional traits along a gradient of wet to dry habitats. We compare the TA community composition, abundance and frequency recorded in the insular peatlands with that recorded in continental peatlands of Northern and Southern Hemispheres. We use generalized linear models to determine how environmental conditions influence taxonomic and functional diversity as well as the mean values of functional traits within communities. We finally apply variance partitioning to assess the relative importance of niche- and dispersal-based processes in determining community composition. Results TA communities in Santa Cruz Island were different from their Northern Hemisphere and South American counterparts with most genera considered as characteristic for Northern Hemisphere and South American Sphagnum peatlands missing or very rare in the Galápagos. Functional traits were most correlated with elevation and site topography and alpha functional diversity to the type of material sampled and site topography. Community composition was more strongly correlated with spatial variables than with environmental ones. Main conclusions TA communities of the Sphagnum peatlands of Santa Cruz Island and the mechanisms shaping these communities contrast with Northern Hemisphere and South American peatlands. Soil moisture was not a strong predictor of community composition most likely because rainfall and clouds provide sufficient moisture. Dispersal limitation was more important than environmental filtering because of the isolation of the insular peatlands from continental ones and the young ecological history of these ecosystems.