[Cannabinoid Drugs in the Treatment of Psychiatric Disorders - Data from the German Federal Institute for Drugs and Medical Devices]. / Cannabisarzneimittel in der Behandlung psychischer Störungen ­ Befunde aus der Cannabis-Begleiterhebung des Bundesinstituts für Arzneimittel und Medizinprodukte.

BACKGROUND: Since 2017 physicians in Germany can prescribe cannabis based medicines or medical cannabis with subsequent funding by the statutory health insurance system. METHODS: Physicians prescribing cannabinoid drugs were legally required to take part in a survey conducted by the Federal Institute for Drugs and Medical Devices. This study analyses data from 16.809 case reports that were collected from 30.3.2017 to 31.12.2021. RESULTS: There were 5582 cases documenting the use of cannabinoid drugs in psychiatric disorders. More than half of the prescriptions were Dronabinol. 80% of the treatments concerned somatoform disorders. Most of the treatments for other psychiatric disorders also targeted pain. Doctors reported a positive effect on symptoms in at least 75% of the cases. DISCUSSION: Most patients with psychiatric disorders received cannabinoid drugs for pain. The evidence from randomized controlled clinical trials for the use of cannabinoid drugs in psychiatric indications is weak.

[Three years of cannabis as medicine-preliminary results of the survey accompanying the prescription of medical cannabis in Germany]. / 3 Jahre Cannabis als Medizin ­ Zwischenergebnisse der Cannabisbegleiterhebung.

In Germany, physicians who prescribe medical cannabis flowers or cannabis-based medicines (narcotic prescription) at the expense of the statutory health insurance are obliged to take part in a noninterventional accompanying survey that runs until 31 March 2022.At the time of this interim evaluation, 11 May 2020, there were 10,010 complete datasets collected. The most frequently treated symptoms were pain (73%), followed by spasticity (10%), and anorexia/wasting (6%). Dronabinol (i.e., prescription drug or Marinol®) was most frequently (65%) prescribed, followed by cannabis flowers (18%), Sativex® (13%), cannabis extract (4%, with increasing frequency), and nabilone (0.3%). The 6485 cases treated with dronabinol already allows a subgroup evaluation concerning efficacy. The typical cannabis side effects of tiredness, dizziness, dry mouth, and nausea occur with all cannabis medicines, and correspond to those already known from the product information of the cannabis-based medicinal products authorized under the pharmaceutical law. The potentially serious adverse effects of depression, suicidal ideation, delusions, hallucinations, dissociation, and misperceptions were each reported with a frequency higher than 0.1%. There were remarkable differences between patients treated with cannabis flowers and those with other cannabis medicines.Patients treated with cannabis flowers are significantly younger and predominantly male. They are treated more often by general practitioners and internists, their diagnosis differs more often from the typical diagnoses (pain, spasticity, anorexia/wasting), and they have more prior experience with cannabis. The underreporting in the accompanying survey is mainly in this patient group.

[Interim analysis of the survey accompanying insurance-covered prescriptions of cannabis-based medicines in Germany]. / Begleiterhebung zur Anwendung von Cannabisarzneimitteln in Deutschland ­ Zwischenauswertung.

In Germany, medical doctors who prescribe cannabis medicines at the expense of the statutory health insurance are obliged to take part in a noninterventional survey on the use of these cannabis medicines. The survey collects and evaluates anonymized treatment data and runs until 31 March 2022. Amongst other things, the results of the accompanying survey are the basis on which the Joint Federal Committee (G-BA) regulates the future assumption of treatment costs in the context of a therapy with cannabis medicines in accordance with the Social Code (SGB) V. The transmission of the data for the survey takes place via an online portal operated by the Federal Institute for Drugs and Medical Devices (BfArM). The first data transmission takes place after a treatment period of one year or, if the treatment discontinued before the end of one year, directly after discontinuation of therapy.At the time of the interim evaluation, 01 February 2019, there were 4153 complete datasets collected. Most frequently, the symptom "pain" was treated (69%), followed by spasticity (11%), and anorexia/wasting (8%). The observed adverse reactions correspond with those listed in the product information for the two cannabis-based proprietary medicinal products, Sativex® (GW Pharma Ltd, Salisbury, Wiltshire, UK) and Canemes® (AOP Orphan Pharmaceuticals AG, Vienna, Austria). Most often, insufficient effect was the reason for a discontinuation of treatment. The main indication of pain was already apparent in the licensing procedure for the acquisition of cannabis for medical purposes between the years 2005 and 2016. Further evaluations and subgroup analysis will be carried out when higher case numbers are available.

German nursing home professionals' knowledge and specific self-efficacy related to palliative care.

BACKGROUND: In Germany, more and more terminally ill patients spend their last days of life in nursing homes, and this presents a challenge for these institutions. Even though palliative care is a growing domain in health care, no quantitative in-depth evaluations of the status quo in nursing homes has been conducted so far in Germany, partly because of lacking measuring tools. OBJECTIVE: This study used a new questionnaire to assess German health care professionals' theoretical knowledge of palliative care and their perceived self-efficacy. Both variables have been proven to be indicators for the quality of the implementation of palliative care in nursing homes. METHODS: We used the Bonn Palliative Care Knowledge Test (Bonner Palliativwissenstest, BPW) questionnaire to measure knowledge of palliative care in the domains of medicine, care, and psychosocial care and to measure self-efficacy relating to palliative care. RESULTS: Care workers (N=130) in five nursing homes in the region of Aachen in western Germany answered the questionnaires. The results show low knowledge (on average 52.8% correct answers) and self-efficacy relating to palliative care, although work with dying people is their daily challenge. While general knowledge correlated with work experience, a negative correlation of specific self-efficacy with age and working experience was observed. CONCLUSIONS: Lower self-efficacy of care workers experienced in palliative care probably implies that the difficulty of palliative care skills is underestimated by inexperienced care workers. Palliative care training is urgently needed to improve knowledge and self-efficacy. Guidance to assist care professionals involved in palliative care in nursing homes needs to be developed and provided.

Vindesine and etoposide: A practical and well-tolerated therapy for elderly patients or patients in reduced clinical condition with extensive-stage small-cell lung cancer (SCLC).

BACKGROUND: Small-cell lung cancer is a disease affecting mostly elderly persons. Therefore, many patients show marked comorbidity and intensive chemotherapy is not possible in such patients. As the disease is most often in the 'extensive' stage at diagnosis, the therapy option is only palliative. MATERIALS/METHODS: [corrected] We used a combination therapy with vindesine and etoposide in treating 41 patients (median age: 63 years) over 155 cycles of chemotherapy. RESULTS: This treatment resulted in a response rate of 43.9% and a median survival time of 9.3 months and thus equals established schemes in its effectiveness. However, its rate of adverse effects (hematoxicity, gastrointestinal toxicity, neuropathy) is smaller than those of the established therapy schemes ACO, EPICO, or carboplatine/etoposide. CONCLUSIONS: Therapy of advanced SCLC with vindesine and etoposide can be applied in an ambulant setting and offers an improved quality of life with equivalent therapeutic effectivity. Therefore it is especially suitable for patients of older age and fragile condition due to comorbidity.

Non-viral and hybrid vectors in human gene therapy: an update.

Non-viral DNA vectors have several advantages over viral vectors. For example, virus production is expensive and there are safety concerns regarding viral manipulations. In addition, the size of the delivered plasmid is limited by the size of the viral capsid, whereas this is not a problem with non-viral vectors. The major disadvantage of using non-viral DNA delivery vectors, compared with their viral counterparts, is the low transfection efficiency. This has resulted in low levels of usage in clinical trials. Consequently, the majority of research into non-viral gene therapy has been focused on developing more efficient vectors.