43. Jahrgang Heft 06, Juni 2020

Multiple Sclerosis - The basics

Multiple Sclerosis (MS) is a chronic inflammatory degenerative disease of the central nervous system (CNS) that mainly manifests itself between the age of 20 and 40. On average, women are affected 2-3 times more often than men. Germany currently counts approximately 250,000 MS patients. The worldwide prevalence strongly fluctuates between regions, with a definite north-south gradient. The multitude of symptoms notably impacts patients on a physical, psychological, and social level. Optic neuritis, an inflammation of the optic nerves, leads to visual problems very early in the disease course. Significant cognitive deficits are evident on several levels, especially concerning information processing speed. A permanent feeling of fatigue, severely limited motor functions in particular regarding gait, and reduced urinary retention further make up the symptom profile. The disease reduces patients' quality of life and greatly limits work productivity.

Multiple Sclerosis – Disease course and diagnostics

MS is the neurological condition that most frequently leads to permanent disability in adults. The specific disease course may either be relapsing or progressive, with the following known forms: clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), secondary progressive MS (SPMS), and primary progressive MS (PPMS). To specify appropriate treatment algorithms, it is vital to differentiate between active and inactive disease development. Obtaining a detailed medical history, clinical and laboratory evaluations, MRI assessment, plus cerebrospinal fluid (CSF) examination and measuring multimodal evoked potentials (somatosensory, motor, and visual EP) are the essential diagnostics. Animal experiments and human studies have shed light on MS development arising from interactions of genetic and environmental factors that essentially cause a breakdown of the immune tolerance network. Modern therapeutic approaches target different levels of immune system activation to limit disease activity.

Multiple Sclerosis – Therapy

Even early in the course of MS, essential neuronal structures are destroyed, making an early-onset therapy crucial. Disease course and degree of disability can be positively influenced by therapeutic agents that protect the CNS from immune cell infiltration. The drugs glatiramer acetate and interferon beta are recommended as therapy for CIS. Regarding RRMS, the level of disease activity dictates the appropriate treatment. A mild to moderate disease course can be treated with dimethyl fumarate, glatiramer acetate, interferon beta, or teriflunomide. For highly active disease courses, first choice therapeutics are alemtuzumab, cladribine, fingolimod, natalizumab, and ocrelizumab. PPMS can currently only be treated with ocrelizumab. Treatment possibilities for MS have improved dramatically in the last two decades.

Multiple Sclerosis – MS in older patients and aspects of the aging immune system

The availability of improved therapies has led to a higher average age of MS patients. Also, the prevalence of late-onset MS (LOMS) has increased in recent years. In this context, the aging immune system brings its specific challenges when treating older patients with MS, who may be essentially multimorbid and under concomitant medications. Most clinical studies on MS include patients between the age of 18 and 55, making it difficult to derive therapeutic guidelines that consider the specificities applying to older patients, especially concerning age-related pharmacodynamic and pharmacokinetic changes. For example, the dosage and therapeutic intervals may need to be revised for this group. The processes underlying immunosenescence, the deterioration of the immune system in natural aging, may reduce the effectiveness of immunomodulatory therapies, while side effect profiles remain. A strict risk-benefit analysis needs to be applied by the responsible physician before initiating or discontinuing treatment in older MS patients.

Multiple Sclerosis – A case report

Our case study reports on a 35-year-old RRMS patient who works as a teacher and has two healthy children. Initially diagnosed with CIS in 2012, she received confirmation of RRMS diagnosis in 2013. To stabilize disease progression, a basic therapy with interferon beta 1a was initiated but stopped three months later due to flu-like adverse events. Therapy was switched to glatiramer acetate until severe adverse effects in 2017 led to a therapy change back to interferon beta 1a. During the entire treatment period, MRI assessments and clinical evaluations revealed a continuous increase of relapsing disease activity, finally leading us to recommend an escalation therapy appropriate for highly active MS in 2017. Aspects to consider when selecting the right escalation therapy are the expected effectiveness and adverse effects as well as the patient's circumstances, for example, child-wish and family planning. In this context, "patient empowerment" requires a complete description of all available therapeutic options by the physician, relaying known side effects, treatment schedule and duration, and expected strain on day-to-day life, to enable a fully informed patient decision. Our patient is selected to continue treatment with oral pulsed cladribine.

Enteritic protozoan diseases: giardiasis and cryptosporidiosis

Giardiasis due to Giardia lamblia and cryptosporidiosis caused by Cryptosporidium species belong to the most common enteric protozoan diseases in humans worldwide. The intestinal diseases are associated with severe, often long-lasting diarrhea as well as some other symptoms. Giardiasis and cryptosporidiosis are observed most frequently in less developed regions of the world, but they are also not uncommon in industrialized countries such as Germany. For the treatment of giardiasis, nitroimidazoles such as metronidazole are the treatment of choice. Cryptosporidiosis, however, is usually treated symptomatically. In HIV-infected people with cryptosporidiosis, antiretroviral therapy for improvement of the immune function is particularly important. The prophylaxis of the diseases presents a special challenge due to the low infectious dose and the environmental stability of these pathogens.

The implementation of objective structured clinical examinations (OSCE) in clinical pharmacy course – one step towards practice-related and competency-based education and assessment

The role of the pharmacists has changed significantly over the last decades. In particular, the patient moved to the center of multi-professional therapeutic approaches. Therefore, the demands on pharmacists to participate in patient care and patients' therapy as a part of a multi-professional team are increasing. Competency standards have been defined to meet these current developments in pharmacy practice. Medication therapy management, pharmacotherapy safety and inter-professionalism are becoming more relevant in community and hospital pharmacy settings. To prepare future pharmacists for the challenges they will have to face in pharmacy practice, pharmacy education has to evolve accordingly.

Objective structured clinical examinations (OSCE) are an adequate tool to assess clinical competencies such as the students' clinical-pharmaceutical knowledge, problem-solving, communication and counselling skills. OSCE are an assessment method in which the examinees rotate through a series of time limited stations and are assessed with regards to their professional performance in a simulated environment against a standardized scoring system. OSCE show a high degree of objectivity and standardization. Certainly in the UK, USA, Canada and Australia, OSCE have proved their role as a reliable and valid assessment method in medicine and pharmacy courses. However, at German universities there is still the need for progression in practice-related, competency-based education and assessment methods to meet the current changes in the pharmacists' world. Only very few OSCE approaches have been established so far.

Thus, a study at Philipps-University Marburg was conducted with the aim to provide a scientific basis for the implementation and quality assurance of OSCE in pharmacy curricula in Germany. The reliability of the OSCE was assessed by means of Cronbach's Alpha. For further quality assurance “Cronbach’s Alpha, If Item Deleted” was calculated to identify OSCE stations that decrease overall reliability. The emerging costs and personnel needed were recorded to determine OSCE feasibility.

The results indicate a moderate to high reliability, comparable to international and national OSCE of internal medicine. None of the implemented OSCE stations was identified as decreasing overall reliability and needed to be subject to revision. Therefore, all OSCE stations used in the OSCE are applicable and appropriate for further use. The development and conduction of OSCE in cohorts of up to 100 students are feasible. However, there are high personnel and financial requirements for a well-functioning OSCE. In conclusion, the results shown in this study provide a basis for the implementation of OSCE in a clinical pharmacy course within the pharmacy curriculum with the important aspect of quality assurance. To meet the current changes in pharmacy practice, pharmacy education has to evolve accordingly. OSCE could be a step towards practice-related, competency-based education and assessment.