Dietary fibre intake and its association with ultraprocessed food consumption in the general population of Switzerland: analysis of a population-based, cross-sectional national nutrition survey.

Objectives: The objective of this study was to describe the compliance to dietary fibre recommendations of the Swiss population and to investigate the association between dietary fibre intake and ultraprocessed food (UPF) consumption. Methods: Data were obtained from the cross-sectional Swiss National Nutrition Survey menuCH. We summarised the sociodemographic, lifestyle and anthropometric parameters as well as dietary data collected with two 24-hour dietary recalls for the whole population and subgroups according to absolute and relative dietary fibre intake. We analysed the associations between dietary fibre intake and UPF consumption by fitting multinomial logistic regression models. Data were weighted according to the menuCH weighting strategy to achieve a representation of the Swiss population. Results: Data obtained from 2057 adults were included in the analysis, of which 87% had a dietary fibre intake of <30 g/day. Participants with high UPF consumption had lower odds of being in the medium or high dietary fibre intake groups than participants with low UPF consumption. The odds of being in the medium or high dietary fibre intake groups decreased linearly across quartiles of UPF consumption (p for trend ≤0.004). Conclusions: Dietary fibre intake is insufficient in all population groups in Switzerland. UPF consumption is inversely and dose dependently associated with dietary fibre intake. To increase dietary fibre intake, public health measures should discourage UPF consumption and increase dietary fibre intake via unprocessed or minimally processed foods.

Selenium Supplementation in Patients with Hashimoto Thyroiditis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

Background: Hashimoto thyroiditis (HT) is the most common cause of hypothyroidism in iodine-sufficient areas. Selenium is an essential trace element required for thyroid hormone synthesis and exerts antioxidant effects. Therefore, it may be of relevance in the management of HT. Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the effect of selenium supplementation on thyroid function (thyrotropin [TSH], free and total thyroxine [fT4, T4], free and total triiodothyronine [fT3, T3]), thyroid antibodies (thyroid peroxidase antibodies [TPOAb], thyroglobulin antibodies [TGAb], thyrotropin receptor antibody [TRAb]), ultrasound findings (echogenicity, thyroid volume), immune markers, patient-reported outcomes, and adverse events in HT. The study protocol was registered on PROSPERO (CRD42022308377). We systematically searched MEDLINE, Embase, CINHAL, Web of Science, Google Scholar, and the Cochrane CENTRAL Register of Trials from inception to January 2023 and searched citations of eligible studies. Two independent authors reviewed and coded the identified literature. The primary outcome was TSH in patients without thyroid hormone replacement therapy (THRT); the others were considered secondary outcomes. We synthesized the results as standardized mean differences (SMD) or odds ratio (OR), assessed risk of bias using the Cochrane RoB 2 tool, and rated the evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Results: We screened 687 records and included 35 unique studies. Our meta-analysis found that selenium supplementation decreased TSH in patients without THRT (SMD -0.21 [confidence interval, CI -0.43 to -0.02]; 7 cohorts, 869 participants; I2 = 0%). In addition, TPOAb (SMD -0.96 [CI -1.36 to -0.56]; 29 cohorts; 2358 participants; I2 = 90%) and malondialdehyde (MDA; SMD -1.16 [CI -2.29 to -0.02]; 3 cohorts; 248 participants; I2 = 85%) decreased in patients with and without THRT. Adverse effects were comparable between the intervention and control groups (OR 0.89 [CI 0.46 to 1.75]; 16 cohorts; 1339 participants; I2 = 0%). No significant changes were observed in fT4, T4, fT3, T3, TGAb, thyroid volume, interleukin (IL)-2, and IL-10. Overall, certainty of evidence was moderate. Conclusions: In people with HT without THRT, selenium was effective and safe in lowering TSH, TPOAb, and MDA levels. Indications for lowering TPOAb were found independent of THRT.

Nutritional strategies for correcting low glucose values in patients with postbariatric hypoglycaemia: A randomized controlled three-arm crossover trial.

AIM: To evaluate the efficacy of nutritional hypoglycaemia correction strategies in postbariatric hypoglycaemia (PBH) after Roux-en-Y gastric bypass (RYGB). MATERIALS AND METHODS: In a randomized, controlled, three-arm crossover trial, eight post-RYGB adults (mean [SD] 7.0 [1.4] years since surgery) with PBH ingested a solid mixed meal (584 kcal, 85 g carbohydrates, 21 g fat, 12 g protein) to induce hypoglycaemia on three separate days. Upon reaching plasma glucose of less than 3.0 mmol/L, hypoglycaemia was corrected with 15 g of glucose (G15), 5 g of glucose (G5) or a protein bar (P10, 10 g of protein) in random order. The primary outcome was percentage of time spent in the target plasma glucose range (3.9-5.5 mmol/L) during 40 minutes after correction. RESULTS: Postcorrection time spent in the target glucose range did not differ significantly between the interventions (P = .161). However, postcorrection time with glucose less than 3.9 mmol/L was lower after G15 than P10 (P = .007), whereas time spent with glucose more than 5.5 mmol/L, peak glucose and insulin 15 minutes postcorrection were higher after G15 than G5 and P10 (P < .001). Glucagon 15 minutes postcorrection was higher after P10 than after G15 and G5 (P = .002 and P = .003, respectively). G15 resulted in rebound hypoglycaemia (< 3.0 mmol/L) in three of eight cases (38%), while no rebound hypoglycaemia occurred with G5 and P10. CONCLUSIONS: Correcting hypoglycaemia with 15 g of glucose should be reconsidered in post-RYGB PBH. A lower dose appears to sufficiently increase glucose levels outside the critical range in most cases, and complementary nutrients (e.g. proteins) may provide glycaemia-stabilizing benefits. REGISTRATION NUMBER OF CLINICAL TRIAL: NTC05250271 (ClinicalTrials.gov).

The Role of Dietary Fibre in Enteral Nutrition in Sepsis Prevention and Therapy: A Narrative Review.

OBJECTIVE: This narrative review summarises the current evidence on the role of dietary fibre in enteral nutrition in the prevention and therapy of sepsis, with a focus on critically ill patients. The aim is to discuss the implications for clinical practice and identify future directions for policy and research. RESOURCES: We searched MEDLINE and Google Scholar for records on sepsis, critically ill, enteral nutrition, and dietary fibre. We included all types of articles such as meta-analyses, reviews, clinical trials, preclinical studies, and in vitro studies. Data were evaluated for significance and clinical relevance. Synopsis of Review: Despite the ongoing debate, enteral nutrition containing dietary fibres showed great potential in attenuating sepsis-related outcomes and preventing the incidence of sepsis in critically ill patients on enteral nutrition. Dietary fibres target different underlying mechanisms such as microbiota, mucosal barrier integrity, local cellular immune response, and systemic inflammation. We discuss the clinical potential and concerns that currently exist with the standard implementation of dietary fibre in enterally fed intensive care patients. Additionally, we identified research gaps that should be addressed to determine effectiveness and the role of dietary fibres in sepsis itself and its associated outcomes.

Quality of Life in the Management of Home Parenteral Nutrition.

INTRODUCTION: Home parenteral nutrition (HPN) is a rare but challenging therapy for patients with mostly severe underlying diseases. We aimed to investigate patient-reported health-related quality of life (QOL) of patients receiving HPN and its development over time in particular. METHODS: We assessed QOL of HPN patients in a prospective multicenter observational study (SWISSHPN II study). We designed a questionnaire to record symptoms and negative impacts of HPN and completed the validated Optum® SF-36v2® Health Survey with the patients. RESULTS: Seventy patients (50% women) on HPN were included. HPN commonly affected feelings of dependency (n = 49, 70%), traveling/leaving home (n = 37, 53%), attending cultural and social events (n = 25, 36%), and sleep (n = 22, 31%). Most frequently reported symptoms were diarrhea (n = 30, 43%), polyuria (n = 28, 40%), nausea/emesis (n = 27, 39%), dysgeusia (n = 23, 33%), and cramps (n = 20, 29%). At baseline, mean (standard deviation) SF-36v2® physical and mental health component summary scores (PCS and MCS) were 45 (20) and 57 (19), respectively, and there was a trend toward improvement in PCS over the study period, while MCS remained stable. Satisfaction with health care professionals involved in HPN care was high. CONCLUSION: QOL is a crucial and decisive aspect of HPN patient care. Symptoms related to the underlying disease and PN are frequent. Impaired social life and an ambivalent attitude toward the life-saving therapy are major concerns for these patients and should be addressed in their care.

ESPEN practical guideline: Home parenteral nutrition.

This guideline will inform physicians, nurses, dieticians, pharmacists, caregivers and other home parenteral nutrition (HPN) providers, as well as healthcare administrators and policy makers, about appropriate and safe HPN provision. This guideline will also inform patients requiring HPN. The guideline is based on previous published guidelines and provides an update of current evidence and expert opinion; it consists of 71 recommendations that address the indications for HPN, central venous access device (CVAD) and infusion pump, infusion catheter and CVAD site care, nutritional admixtures, program monitoring and management. Meta-analyses, systematic reviews and single clinical trials based on clinical questions were searched according to the PICO format. The evidence was evaluated and used to develop clinical recommendations implementing Scottish Intercollegiate Guidelines Network methodology. The guideline was commissioned and financially supported by ESPEN and members of the guideline group were selected by ESPEN.

Aluminum and other chemical elements in parenteral nutrition components and all-in-one admixtures.

BACKGROUND & AIMS: Parenteral nutrition (PN) can lead to high or even toxic exposure to aluminum (Al). We aimed to quantify concentrations of Al and other chemical elements of all-in-one (AIO) PN admixtures for adults prepared from commercial multichamber bags (Olimel® 5.7%, Omegaflex® special, SmofKabiven®, all with and without electrolytes) and vitamin and trace element additives over a 48-h period. Secondly, we determined the level of Al contamination resulting from admixing and infusion set use. METHODS: We used dynamic reaction cell and kinetic energy discrimination inductively coupled plasma mass spectrometry (ICP-MS) to quantify Al, arsenic (As), cadmium (Cd), cobalt (Co), chromium (Cr), copper (Cu), iron (Fe), magnesium (Mg), manganese (Mn), molybdenum (Mo), nickel (Ni), antimony (Sb), selenium (Se), tin (Sn), vanadium (V), and zinc (Zn) in AIO PN admixtures. We extracted samples for analysis via the bag injection ports and infusion sets over a 48-h period after admixing. We compared the measured Al concentrations of AIO PN admixtures with calculated values based on the measured concentrations of individual chamber contents and additives. RESULTS: Mean (standard deviation) baseline Al concentrations in AIO PN admixtures ranged from 10.5 (0.5) to 59.3 (11.4) µg/L and decreased slightly over the 48 h (estimate [standard error] -0.09 [0.02] µg/L/hour, p <0.001). Thus, certain products exceeded the widely accepted limit of 25 µg/L. There was no significant difference in Al concentrations between samples extracted via the bag injection ports or infusion sets (p = 0.33), nor between measured and calculated Al concentrations of AIO PN admixtures (p = 0.91). CONCLUSION: Because certain commercially available PN admixtures for adults proved to contain excessively high levels of Al in our study, regulations and corresponding quality requirements at the authority level (e.g., Pharmacopoeia and regulatory authorities) are urgently required. Our results showed that the PN handling process (admixing and supplementing additives) or the materials of the infusion set did not lead to additional Al contamination to any extent. Moreover, calculated Al concentrations of AIO PN admixtures derived from individual chamber contents and additives are valid.

Attitudes and expectations of patients on home parenteral nutrition towards eHealth: A multicenter survey.

BACKGROUND & AIMS: Advances in technology enable patients on home parenteral nutrition (HPN) to manage their treatment more independently and safely. eHealth is a promising application of electronic means in healthcare, aimed at improving and simplifying processes and connecting the different parties involved. A thorough understanding of the attitudes and expectations of patients on HPN towards eHealth is a prerequisite for a successful implementation. However, to the best of our knowledge, such a survey preceding the implementation of HPN specific eHealth care has never been conducted. The objective of this preliminary survey is the acquisition of insights on the attitudes and expectations of patients on HPN towards eHealth. Resulting findings then serve as the basis for the design of an eHealth platform to facilitate communication among those involved in HPN care, improve the HPN management, and safeguard and monitor the treatment. METHODS: We conducted a survey on the attitudes and expectations of patients towards an envisioned eHealth platform for HPN. Patients were recruited from large Swiss hospitals by their treating physician or directly by the research team. The surveys were conducted between September 2020 and October 2021 by structured personal interviews based on a questionnaire. RESULTS: We included 35 patients on HPN (21 [60%] females) treated in ambulant care of 4 hospitals. They had a median (interquartile range) age of 55 (18) years and a median (interquartile range) duration of parenteral nutrition of 1.3 (3.1) years. Most patients (n = 30, 86%) were equipped with a smartphone, tablet, or computer and 22 (63%) used apps and rated themselves as proficient with the corresponding digital device. A majority of patients rated the following aspects and features of the platform as important: Data collection and storage (n = 29, 83%), checklists for PN, catheter, and infusion pump handling (n = 28, 80%), video instructions (n = 27, 77%), and videoconferencing with physicians (n = 25, 71%). Most patients (n = 26, 74%) were willing to enter data into the platform themselves. The type of data to be entered should be defined on an individual basis. CONCLUSIONS: Patients on HPN are open to videoconference consultations and using an eHealth platform. Two-thirds have the necessary technical skills including suitable digital devices for an eHealth care. We identified key features of an eHealth platform to improve HPN management.

Prolonged Isolated Soluble Dietary Fibre Supplementation in Overweight and Obese Patients: A Systematic Review with Meta-Analysis of Randomised Controlled Trials.

The prevalence of overweight and obesity is rising rapidly, currently affecting 1.9 billion adults worldwide. Prebiotic dietary fibre supplementation is a promising approach to improve weight loss and reduce metabolic complications in overweight and obese subjects due to modifications of the microbiota composition and function. Previous systematic reviews and meta-analyses addressing similar questions revealed discordant evidence and/or are outdated. We searched MEDLINE, Embase, Google Scholar, and forward and backward citations for randomised controlled trials (RCTs) with isolated soluble dietary fibre supplementation for at least 12 weeks in overweight and obese patients measuring body weight, published through April 2022. We expressed the results as mean differences (MDs) using the random-effects model of the metafor package in R and assessed risk of bias using the Cochrane RoB2 tool. We conducted the study according to the PRISMA guidelines and registered the protocol on PROSPERO (CRD42022295246). The participants with dietary fibre supplementation showed a significantly higher reduction in body weight (MD -1.25 kg, 95% CI -2.24, -0.25; 27 RCTs; 1428 participants) accompanied by a significant decrease in BMI, waist circumference, fasting blood insulin, and HOMA-IR compared to the control group. Certainty of evidence was high, paving the way for the implementation of isolated soluble dietary fibre supplementation into clinical practice.

Physicochemical Stability and Compatibility Testing of Voriconazole in All-in-One Parenteral Nutrition Admixtures.

(1) Drug compatibility with all-in-one (AiO) parenteral nutrition (PN) admixtures is a very important pharmaceutical quality issue to be answered based on appropriate laboratory testing. We assessed voriconazole (V), a poorly water-soluble (logP ≈ 1) single-daily dosed antifungal drug monitored in patients and thus candidate for AiO PN admixing for convenient and safe patient care. We evaluated V compatibility and stability in AiO PN admixtures through adapted therapeutic drug monitoring method (drug stability) and visual microscopic emulsion stability by lipid droplets analysis improved by an automated microscopic digital assessment. (2) V was added in concentrations of 0.05/0.25/0.5 mg/mL (143.1/715.7/1431.5 µM), correlating to daily therapeutic dosing, to three commercially available industrial AiO PN admixtures. Three aliquots were stored in the refrigerator (4 °C), at room temperature (24 °C) and under stress conditions in a water bath (37 °C). Samples taken at 0/24/48/72/168 h after admixing were subjected to a stability-indicating one-week analysis. Assessment included visual examination, lipid droplet measurement according to an established and validated method (bright-field microscopy using oil immersion), pH measurement (glass electrode) and V identification/quantification (LC-MS/MS). (3) After one week, all samples at 37 °C showed slight yellow discoloration. The pH values remained stable. All samples met specifications for lipid droplets according to size (upper size ≤8 µm, mean size <4.5 ± 2 µm) and number (n ≤ 9 lipid droplets >5 µm). V concentrations were within an acceptable range, calculated for every timepoint as percent of the theoretical concentration spiked into the AiO PN. The median recovery was 98.2% (min-max, 90-112%). (4) At therapeutic doses, commercial V formulations were compatible and stable within specifications over one week in commonly used volumes of commercial AiO PN admixtures at 4-37 °C.

How Do Hospital Pharmacists Approach Substitution of Nanomedicines? Insights from a Qualitative Pilot Study and a Quantitative Market Research Analysis in Five European Countries.

We conducted research to assess hospital pharmacists' familiarity with/interpretation of data requirements for the different regulatory approval frameworks and the impact of this on their approach to substitution in the formulary. The online questionnaire included a small molecule (acetylsalicylic acid-follow-ons approved via the generic pathway), two biologic drugs (insulin glargine and etanercept-follow-ons approved via the biosimilar pathway), a non-biologic complex drug (NBCD; glatiramer acetate-follow-ons approved via the hybrid pathway) and a nanomedicine, ferric carboxymaltose (no follow-ons approved as yet). The study was conducted in two phases: an initial qualitative pilot study with 30 participants, followed by a quantitative stage involving 201 pharmacists from five European countries. Most expected negligible safety/efficacy differences between reference and follow-on products. Head-to-head clinical data showing therapeutic equivalence as a prerequisite for reference product/follow-on substitution was perceived to be needed most for biologics (47%), followed by NBCDs (44%)/nanomedicines (39%) and small molecules (23%). Overall, 28% did not know the data requirements for follow-on approval via the hybrid pathway; 16% were familiar with this pathway, compared with 50% and 55% for the generic and biosimilar pathways, respectively. Overall, 19% of respondents thought the European Medicines Agency (EMA) was responsible for defining the substitutability of follow-ons. Education is required to increase hospital pharmacist's knowledge of regulatory approval frameworks and their relevance to substitution practices.

ESPEN practical guideline: Clinical Nutrition in cancer.

BACKGROUND: This practical guideline is based on the current scientific ESPEN guidelines on nutrition in cancer patients. METHODS: ESPEN guidelines have been shortened and transformed into flow charts for easier use in clinical practice. The practical guideline is dedicated to all professionals including physicians, dieticians, nutritionists and nurses working with patients with cancer. RESULTS: A total of 43 recommendations are presented with short commentaries for the nutritional and metabolic management of patients with neoplastic diseases. The disease-related recommendations are preceded by general recommendations on the diagnostics of nutritional status in cancer patients. CONCLUSION: This practical guideline gives guidance to health care providers involved in the management of cancer patients to offer optimal nutritional care.

Management of Home Parenteral Nutrition: Complications and Survival.

BACKGROUND AND AIMS: Parenteral nutrition (PN) has become an efficient, safe, and convenient treatment over years for patients suffering from intestinal failure. Home PN (HPN) enables the patients to have a high quality of life in their own environment. The therapy management however implies many restrictions and potentially severe lethal complications. Prevention and therapy of the latter are therefore of utmost importance. This study aims to assess and characterize the situation of patients with HPN focusing on prevalence of catheter-related complications and mortality. METHODS: Swiss multicentre prospective observational study collecting demographic, anthropometric, and catheter-related data by means of questionnaires every sixth month from 2017 to 2019 (24 months), focusing on survival and complications. Data were analysed using descriptive statistics. Logistic regression models were fitted to investigate association between infection and potential co-factors. RESULTS: Seventy adult patients (50% women) on HPN were included (≈5 patients/million adult inhabitants/year). The most common underlying diseases were cancer (23%), bariatric surgery (11%), and Crohn's disease (10%). The most prevalent indication was short bowel syndrome (30%). During the study period, 47% of the patients were weaned off PN; mortality rate reached 7% for a median treatment duration of 1.31 years. The rate of catheter-related infection was 0.66/1,000 catheter-days (0.28/catheter-year) while the rate of central venous thrombosis was 0.13/1,000 catheter-days (0.05/catheter-year). CONCLUSION: This prospective study gives a comprehensive overview of the adult Swiss HPN patient population. The collected data are prerequisite for evaluation, comparison, and improvement of recommendations to ensure best treatment quality and safety.

Tackling the challenges of nanomedicines: are we ready?

PURPOSE: This review provides an overview of the proceedings of the symposium "Tackling the Challenges of Nanomedicines: Are We Ready?" organized by the International Pharmaceutical Federation (FIP) Hospital Pharmacy Section and Non-Biological Complex Drugs (NBCDs) Working Group at the 2019 FIP World Congress of Pharmacy and Pharmaceutical Sciences. Debate centered on reasons underlying the current complex regulatory landscape for nanomedicines and their follow-on products (referred to as nanosimilars) and the pivotal role of hospital pharmacists in selecting, handling, and guiding usage of nanomedicines and nanosimilars. SUMMARY: The evaluation and use of nanomedicines are recognized among scientific, pharmaceutical, and regulatory bodies as complex. Interchangeability and substitutability of nanomedicines and nanosimilars are confounded by a lack of pharmaceutical and pharmacological equivalence, reflecting the inherent complex nature of these drug products and manufacturing processes. Consequences include implications for clinical safety and efficacy and, ultimately, comparability. Local regulatory approvals of some nanomedicines have occurred, but there is no standard to ensure streamlined evaluation and use of consistent measures of therapeutic equivalence of reference products and their nanosimilars. Hospital pharmacists are expected to be experts in the selection, handling, and substitution of nanomedicines and familiarize themselves with the limitations of current methods of assessing pharmaceutical and clinical equivalence of nanosimilars in order to ensure informed formulary decision-making and eventual patient benefit. CONCLUSION: Supportive guidance for pharmacists focusing on the substitutability and/or interchangeability of nanomedicines and their nanosimilars is needed. Current FIP guidance for pharmacists on therapeutic interchange and substitution should be extended to include nanomedicines and nanosimilars.

[Abuse deterrent drug formulations for opioids]. / Missbrauch von Opioiden und mögliche Auswege aus der Opioid-Krise.

Abuse deterrent drug formulations for opioids Abstract. Misuse of opioids is an increasing problem. Significant medical and social consequences including overdose-related deaths have led to the declaration of an "opioid crisis". The present review article discusses the extent of the problem with a special focus on the situation in Switzerland. Measures are proposed including training of health care providers, regulatory intervention and technical solutions such as the design of abuse-deterrent formulations.

ESPEN guideline on home parenteral nutrition.

This guideline will inform physicians, nurses, dieticians, pharmacists, caregivers and other home parenteral nutrition (HPN) providers, as well as healthcare administrators and policy makers, about appropriate and safe HPN provision. This guideline will also inform patients requiring HPN. The guideline is based on previous published guidelines and provides an update of current evidence and expert opinion; it consists of 71 recommendations that address the indications for HPN, central venous access device (CVAD) and infusion pump, infusion line and CVAD site care, nutritional admixtures, program monitoring and management. Meta-analyses, systematic reviews and single clinical trials based on clinical questions were searched according to the PICO format. The evidence was evaluated and used to develop clinical recommendations implementing Scottish Intercollegiate Guidelines Network methodology. The guideline was commissioned and financially supported by ESPEN and members of the guideline group were selected by ESPEN.

Pharmaceutical Aspects of Artificial Nutrition.

Artificial nutrition, including enteral (EN) and parenteral (PN) nutrition, is indicated whenever adequate oral nutrition fails to sufficiently supply the necessary nutrients to the body. It is a convenient, efficacious, safe, and well-tolerated form of clinical nutrition in the hospital and home setting. EN is administered via nasogastric tube or ostomies while PN usually requires a central venous access for administration, straight into the blood stream. The infused nutrients can then be taken up directly by the different organs. PN is targeted as a single daily portion formulated as an oil-in-water emulsion providing the necessary substrates for the catabolic and anabolic metabolism including macro- and micronutrients and fluids. PN has a complex pharmaceutical composition-all-in-one admixture-and its compounding or ready-to-use preparation. The use of PN is more challenging and more expensive compare to the use of EN, commercially available as ready-to-use formulations. EN and concomitant medication is highly challenging. Upon incorrect handling and administration, PN is associated with potentially severe or even fatal complications, mostly relating to the central venous access (e.g., catheter-related sepsis) or to a metabolic intolerance (e.g., hyperglycemia, refeeding syndrome) because of inappropriate administration. A correct order of admixing, correct dosing, and administration of the artificial is crucial for safety and efficacy; clinical and biochemical monitoring of the patient and treatment regimen adaption are necessary. The high number of reactive solutes allow only limited stability of a ready-to-use PN admixture. The potential for numerous incompatibilities and interactions renders PN admixtures generally unsuitable as drug vehicle. Laboratory compatibility and stability testing and pharmaceutical expertise are a prerequisite to define the PN composition including nutrients or even drugs admixed to define the appropriate and individualized nutrition and medication regimen. The aim of this narrative review is to present the actual state-of-the-art to deliver best quality artificial nutrition with special regard on pharmaceutical aspects such as instabilities, incompatibilities, and concomitant co-medication.

Nanomedicines: The magic bullets reaching their target?

Nanomedicines, since the approval of the first one in the 1950s, have been accompanied by expectations of higher efficiency and efficacy, compared to less complex drugs. The fulfilment of those expectations has been slower than anticipated, due to the high complexity of nanomedicine drugs combined with a lack of scientific understanding of nanomedicine interactions with biological systems. The unique properties of their size and their surface composition create difficulties in their physicochemical characterization, and as a consequence, difficulty in assessing the similarity of follow-on products (nanosimilars) to originator nanomedicines. During the 2018 European Federation for Pharmaceutical Sciences (EUFEPS) annual meeting "Crossing the barrier for future medicines" in Athens, there were several sessions on nanomedicines organised by the EUFEPS Nanomedicine Network. This review focuses on the session "Nanomedicines and nanosimilars: how to assess similar?", discussing the nature of nanomedicines, the regulatory aspects of the topic and the impact of practical use and handling of such medicinal products. Emphasis is put on the consequences their nanosize-related properties have on the establishment of their critical quality attributes and how this affects the demonstration of bioequivalence of nanosimilars to their originator products. The lack of an appropriate and harmonized regulatory evaluation procedure and the absence of corresponding education are also discussed, especially the uncertainty surrounding the practical use of nanosimilars, including the higher healthcare cost due to less than satisfactory number of safe and efficacious nanosimilars in the market.