Talking to patients about biosimilars.

Biologic therapies target aberrant pathways in diseases including diabetes, cancer and autoimmune disorders. Despite recent scientific advances, patient access to these agents can be limited. Biosimilars are designed to be highly similar to the originator biologic, targeting the same biological pathways, with comparable efficacy and safety. Biosimilars have the advantage of lower treatment costs, offering the potential for increased clinical use and patient access. Several biosimilars are approved for clinical use in the USA and Europe; however, there is a lack of awareness about biosimilars among healthcare providers and patients. This overview of the scientific basis of biosimilars and current indications aim to enhance discussions with patients and increase understanding of the role of biosimilars in individual treatment plans.

How to select a nanosimilar.

Nanomedicines in the class of nonbiological complex drugs (NBCDs) are becoming increasingly available. Up to 23 nanomedicines have been approved, and approximately 50 are in clinical development. Meanwhile, the first nanosimilars have entered the market through the generic approval pathway, but clinical differences have been observed. Many healthcare professionals may be unaware of this issue and must be informed of these clinically relevant variances. This article provides a tool for rational decision making for the inclusion of nanomedicines into the hospital formulary, including defined criteria for evaluation of substitutability or interchangeability. The tool was generated by conducting a roundtable with an international panel of experts and follows the same thought process that was developed and published earlier for the selection of biologicals/biosimilars. In addition to the existing criteria for biosimilars, a set of seven criteria was identified that specifically apply to nanosimilars. These include (1) particle size and size distribution, (2) particle surface characteristics, (3) fraction of uncaptured bioactive moiety, (4) stability on storage, (5) bioactive moiety uptake and (6) distribution, and (7) stability for ready-to-use preparation. Pharmacists should utilize their pharmaceutical expertise to use the appropriate criteria to evaluate the comparability of the drug to decide on interchangeability or substitutability.

Hypokalaemia in hospitalised patients.

QUESTIONS UNDER STUDY: Hypokalaemia in inpatients is common, and is associated with morbidity and mortality. Its management is risky and not always effective. We launched an educational programme with the aim of increasing the rate of potassium normalisation during hospital stay, and of reducing unmonitored cases. METHODS: The project consisted of three phases: (I) retrospective analysis on 26 471 patients hospitalised in 2012 in five acute care hospitals of southern Switzerland (Ente Ospedaliero Cantonale, EOC) with identification of improvement goals on a sample survey (588 cases of hypokalaemia); (II) revision of internal guidelines, and implementation of educational activities in one of the five hospitals (Ospedale Regionale di Locarno, ODL); (III) follow-up analysis on the 26 726 patients hospitalised in 2014 and second sampling to complete the evaluation of the efficacy of the intervention. RESULTS: Phase I, ODL vs EOC: prevalence of hypokalaemia, 21.7 vs 23.2% (p <0.05); treated 53.1 vs 56.5% (not significant); normalisation 62.4 vs 61.1% (ns); absence of monitoring 18.3 vs 21.1% (p <0.05); time to normalisation 3.0 ± 2.7 vs 2.8 ± 2.4 days (ns); secondary hyperkalaemia 1.1 vs 1.4% (ns). Length of stay hypokalaemic vs normokalaemic 11.2 ± 11.7 vs 6.6 ± 7.9 days (p <0.001); falls 3.5 vs 1.7% (p <0.001), deaths 5.1 vs 3.1% (p <0.001). The severity/performance ratio suggested inefficiency. Phase III, ODL 2012 vs ODL 2014: treated 53.1 vs 75.7% (p <0.001); normalisation 62.4 vs 69.7% (p <0.01); absence of monitoring 20.1 vs 8.7 (p <0.01); time to normalisation 3.1 ± 2.7 vs 2.4 ± 2.6 days (ns); secondary hyperkalaemia 1.1 vs 1.8% (ns). CONCLUSIONS: The management of hypokalaemia is characterised by dysfunctions; it can, however, be ameliorated by the implementation of internal guidelines and targeted educational activities. The length of hospital stay is increased in patients with hypokalaemia, shifting the expected length of hospital stay based on the Swiss Diagnosis Related Group classification.

Biosimilars, generic versions of the first generation of therapeutic proteins: do they exist?

This contribution describes the present regulatory status in the EU of biosimilars, the generic versions of the first generation of therapeutic proteins. It points out why and where recombinant protein molecules and low-molecular-weight drugs differ in their behaviour and why biosimilars should be handled differently than generic low-molecular-weight drugs. This information is important for practitioners (pharmacists and physicians) while selecting the best supplier of a therapeutic protein.

Evaluation of prescription practices of antibiotics in a medium-sized Swiss hospital.

BACKGROUND: The use of guidelines standardises prescription practices for antibiotics against the most common infectious diseases (ID) and favours an early switch from intravenous (IV), to oral (PO) therapy. The goals of this observational study were to evaluate adherence to guidelines and streamlining of antibiotics. METHODS: Hospitalised patients, diagnosed with a possible ID and receiving antibiotics (ABs) for at least five days were included. Data for all patients receiving ABs in the Intensive Care Unit, medical and surgical ward were collected. The collected information was reviewed for indication of AB prescription. Patient's data were assigned into one of eight groups based on the ID diagnosis. RESULTS: Over a period of six months, 129 patients from three hospital wards were included; 124 patients with a confirmed ID diagnosis were considered for further analysis. The four most frequent diagnoses were: community acquired pneumonia, urinary tract infection, skin and soft tissue infection, and infection of surgical sites and of intravenous catheters; the remaining diagnoses were grouped together. Two-thirds of all antibiotics prescribed were for the four most frequent diagnoses. Overall adherence to the guidelines was 71% and was highest in the most frequent diagnostic groups (76%). Eighty-one patients (65%) received IV antibiotic treatment. Forty-seven patients (58%) had a delayed switch from IV to PO (mean delay of 5.1 days) with 240 days of cumulative delay. This delay resulted in additional pharmacy costs and supplementary hospitalisation costs. CONCLUSION: In general there was a good adherence to the local AB guidelines but we observed an unjustified delay in the switch from IV to PO in more than half of the patients, which started an IV antibiotic treatment.