Germany is the highest populated country in Europe with a population of 82.3 million in 2019. As in many other developed countries, it has an aging population. Approximately 10% of the gross domestic product is spent on healthcare. The healthcare system is characterized by its accessibility. Patients are generally free to choose their primary care physicians, both family doctors and specialists, pharmacy, dentist, or emergency service. Up to a certain income, health insurance is mandatory with the statutory health insurance (SHI) system, covering 88% of the population. Major challenges are the lack of cooperation and integration between the different sectors and healthcare providers. This is expected to change with the introduction of a telematic infrastructure that is currently being implemented. It will not only connect all providers in primary and secondary care in a secure network but will also enable access to patients’ electronic record/medical data and at the same time switch from paper to electronic prescriptions. Approximately 52,000 of the 67,000 pharmacists are working in approximately 19,000 community pharmacies. These pharmacies are owner-operated by a pharmacist. Pharmacists may own up to three subsidiaries nearby to their main pharmacy. Community pharmacy practice mainly consists of dispensing drugs, counselling patients on drug therapy and safety, and giving advice on lifestyle and healthy living. Many cognitive pharmaceutical services have been developed and evaluated in the past 20 years. Discussions within the profession and with stakeholders on the national level on the roles and responsibilities of pharmacists have resulted in nationally agreed guidelines, curricula, and services. However, cognitive services remunerated by the SHI funds on the national level remain to be negotiated and sustainably implemented. A law passed in November 2020 by parliament will regulate the remuneration of pharmaceutical services by the SHI funds with an annual budget of EUR 150 million. The type of services and their remuneration remain to be negotiated in 2021. The profession has to continue on all levels to advocate for a change in pharmacy practice by introducing pharmacy services into routine care.

Resumo Manufatura aditiva a laser é uma técnica de produção por camadas na qual uma peça pode ser produzida a partir de um modelo 3D sem remoção de material. Recentemente, esses processos ganharam atenção devido à disseminação de processos com polímeros em aplicações privadas e comerciais. Entretanto, devido ao desenvolvimento insuficiente da manufatura aditiva com metais há uma resistência na produção de componentes funcionais com esta tecnologia. Portanto, para superar essa limitação, o presente artigo propõe um estudo nos parâmetros de processo de deposição metálica de arame a laser (LMD-W) do aço ferramenta para trabalho a quente, H11. O estudo consiste na otimização de parâmetros para cordões individuais (potência do laser, velocidade de deslocamento e de alimentação do arame), bem como sobreposição lateral e vertical para a técnica de camada por camada envolvida no processo. Os resultados mostram que a seleção de um conjunto ideal de parâmetros afeta substancialmente a qualidade superficial, a uniformidade dos cordões e a aderência entre o substrato e o cordão. A discussão ainda inclui a função da sobreposição na estabilidade do processo em relação à homogeneidade da altura de cada camada, porosidade e presença de falhas. Foi comprovado que após a seleção dos parâmetros de deposição, a sobreposição lateral e vertical determina a integridade e qualidade das peças manufaturadas aditivamente.

Abstract Laser additive manufacturing (LAM) is a near-net-shape production technique by which a part can be built up from 3D CAD model data, without material removal. Recently, these production processes gained attention due to the spreading of polymer-based processes in private and commercial applications. However, due to the insufficient development of metal producing processes regarding design, process information and qualification, resistance on producing functional components with this technology is still present. To overcome this restriction further studies have to be undertaken. The present research proposes a parametric study of additive manufacturing of hot work tool steel, H11. The selected LAM process is wire-based laser metal deposition (LMD-W). The study consists of parameters optimization for single beads (laser power, travel speed and wire feed rate) as well as lateral and vertical overlap for layer-by-layer technique involved in LMD process. Results show that selection of an ideal set of parameters affects substantially the surface quality, bead uniformity and bond between substrate and clad. Discussion includes the role of overlapping on the soundness of parts based on the height homogeneity of each layer, porosity and the presence of gaps. For the conditions tested it was shown that once the deposition parameters are selected, lateral and vertical overlapping determines the integrity and quality of parts processed by LAM.

Background: Emergency hormonal contraceptives (EHC) are contraceptives used to prevent unintended pregnancy following unprotected sexual intercourse (USI) or contraceptive failure. The EHCs available without a prescription include medicines containing levonorgestrel (LNG) in more than 80 countries and, recently, based on an EU-switch ellaOne®, which contains ulipristal acetate (UPA). EHCs work by stopping or delaying ovulation. Those containing LNG can be used up to 72 hours after USI or contraceptive failure, while UPA can be used up to 120 hours. In the context of the UPA implementation process, Germany switched LNG to non-prescription status as well. Objectives: To develop recommendations, a protocol, and a continuing education program for pharmacists to assure quality when giving advice and dispensing EHCs in community pharmacies without a medical prescription. Methods: The recommendations were developed by an iterative process of drafting, recognizing, and discussing comments and proposals for amendments as well a seeking agreement with a number of stakeholders such as the Federal Ministry of Health (BMG), Federal Institute for Drugs and Medical Devices (BfArM), Federal Chamber of Physicians (BÄK), Drug Commission of German Physicians (AkdÄ), professional organizations/associations of gynaecologists, pharmaceutical OTC-industry as well as government-controlled, private, and church-based organizations and centres providing advice on sex education and family planning. Results: The recommendations were eventually endorsed by the BMG in consultation with the BfArM. Conclusions: The recommendations were made public, published in the professional journal and used in an uncounted number of continuing education programs based on the curriculum and provided by the State Chambers of Pharmacists.

Background: Generic substitution can have unintended consequences. In Germany, brand name to generic or generic to generic switching is mainly driven by rebate contracts. Frequent switching may raise concerns about bio- and therapeutic equivalence. Expected patient confusion may result in compromised medication adherence or new onset of other drug-related problems. Since 2008, pharmacists are allowed to deviate from rebate contracts by denying substitution due to pharmaceutical concerns on an individual basis. Objectives: To explore the frequency of documented pharmaceutical concerns in Germany between July 2011 and December 2013 and to identify the medicines most frequently related to pharmaceutical concerns in 2013. Methods: We analyzed documented pharmaceutical concerns in all prescribed drugs at the expense of any statutory health insurance company requiring pharmacies' generic substitution according to rebate contracts. Results: Since July 2011, the frequency of documented pharmaceutical concerns in relation to prescribed drug products with rebate contracts requiring substitution increased consistently and doubled between July 2011 and July 2013. Overall in 2013, the trend of the two previous years continued and reached approximately 1.5%. The most affected drugs/drug classes were thyroid hormones (in particular combinations with iodide; 15.9%) followed by ondansetron (12.5%), and levothyroxine (11.3%). For all drugs/drug classes under investigation, product-, patient- or disease-related aspects could be identified which are potential reasons to deny substitution and to document pharmaceutical concerns. Conclusions: Although there is no electronic recording of the specific reasons for pharmaceutical concerns in claims data, our analyses support the assumption that pharmacists make use of this instrument based on individual clinical decisions and as required by contract. Pharmaceutical concerns are, therefore, an important instrument for pharmacies to refuse generic substitution. They are considered to prevent compromised medication safety and to assure pharmacotherapy effectiveness in a generic substitution environment driven by low drug prizes above all.

Self-monitoring of blood glucose (SMBG) is clearly correlated with increased life expectancy and quality of life in type 2 diabetic patients. Objective: The objective of our study was to record and assess the errors patients make in preparing, performing, and processing self-monitoring of blood glucose (SMBG). Furthermore, the study aimed to determine to what extent a single standardized SMBG instruction session in a community pharmacy might reduce the number of patients making errors or the number of errors per patient. Methods: Between May and October 2005, SMBG of 462 randomly selected patients with type 2 diabetes was monitored in 32 pharmacies specialized in diabetes care. The patients performed blood glucose self-tests using their own blood glucose meters. Self-testing was monitored using a standardized documentation sheet on which any error made during the performance of the test was recorded. If necessary, patients were instructed in the accurate operation of their meter and the use of the necessary equipment. Additionally, patients obtained written instructions. Six weeks later, assessment of the quality of patient’s SMBG was repeated. Results: During the first observation, 383 patients (83%) made at least one mistake performing SMBG. By the time of the second observation, this frequency had fallen to 189 (41%) (p<0.001). The average number of mistakes fell from 3.1 to 0.8 per patient. Mistakes that may potentially have led to inaccurate readings were initially recorded for 283 (61%) and at study end for 110 (24%) patients (p<0.001). Conclusion: It is important to periodically instruct type 2 diabetic patients in the proper SMBG technique in order to ensure accurate measurements. In this study it was shown that community pharmacies specialized in diabetes care can provide this service effectively.

El auto-control de la glucemia está claramente correlacionado con un aumento de la esperanza de vida y la calidad de vida en diabéticos tipo 2. Objetivo: El objetivo de nuestro estudio fue registrar y evaluar los errores que cometen los pacientes al preparar, ejecutar y procesar el autocontrol de glucemia. Además el estudio trató de determinar como una formación estandarizada de autocontrol de glucemia en una farmacia comunitaria podría reducir el número de pacientes que cometen errores o el número de errores por pacientes. Métodos: Entre mayo y octubre de 2005, se seleccionaron autocontroles de glucemia de 462 pacientes con diabetes tipo 2 aleatoriamente elegidos en 32 farmacias especializadas en atención de diabetes. Los pacientes realizaron autocontroles de glucemia usando su propio medidor. El autocontrol fue monitorizado utilizando una hoja estandarizada de documentación en la que se registraba cada error cometido durante la ejecución. Si era necesario, se instruía a los pacientes en la operativa adecuada de su medidor y en el uso del equipo necesario. Además, se entregaban a los pacientes instrucciones escritas. Seis semanas después, se repetía la evaluación de la calidad del autocontrol de glucemia del paciente. Resultados: Durante la primera observación, 383 pacientes (83%) cometieron al menos un error en la ejecución. En la segunda observación esta frecuencia había caído a 189 (41%) (p<0,001). La media de errores calló de 3,1 a 0,8 por paciente. Los errores que podían potencialmente llevar a lecturas inadecuadas fueron inicialmente en 283 (61%) y el final del estudio en 110 (24%) de los pacientes (p<0,001). Conclusión: Es importante instruir periodicamente a los diabéticos tipo 2 en el uso correcto de la tecnica de autocontrol de la glucemia para asegurar mediciones exactas. En este estudio se mostró que las farmacias comunitarias especializadas en atención de diabetes pueden proporcionar este servicio de modo efectivo.