BackgroundDue to the toxicity of molecules involved and the seriousness of adverse drugs events, chemotherapy compounding is a high risk medical practice. To ensure high standards of safety and quality of the process, in September 2014 our hospital pharmacy developed a new oncology workflow, based on implementation of a robotic system for intravenous (IV) chemotherapy compounding. In order to avoid any mistakes that can lead to potential medication errors, the technology adopted was equipped with a set of different sensors able to guarantee the appropriate identification of the all components used for the compounding.PurposeTo present the improvement introduced by automation in terms of quality and safety of the cure offered to patients, highlighting the importance of a total controlled oncology workflow.Material and methodsWe analysed 8 weeks of automated IV production, focusing on potential medication errors intercepted by the automated system. All of these events were recorded and processed by APOTECAmanager, the pharmacy IV production management software.ResultsThe 2 month production evaluation results in 2312 IV chemotherapies prepared were analysed. The automated system detected 59 potential medication errors, preventing any erroneous therapy compounding. In detail:50 events associated with incorrect components barcode scanning (eg, sodium chloride instead of dextrose bag scanning);5 occurrences during the vial weighing procedure;4 episodes during the vial label identification.All these events were related to incorrect material loading carried out by the technician. We assessed the weekly trend in potential error occurrences: Monday and Tuesday results were the highest frequency (7.1% and 6.2%, respectively, of total daily production). We also noticed that 51% of detected errors occurred between 8am and 11am in the morning.ConclusionEvery step in the oncology workflow is now totally controlled, allowing the traceability of each operation, from prescription to administration. The results showed the added benefit of this technology in terms of reduction of potential medication errors and self-assessment of your own compounding procedure; at the same time, evidences point out to the need for implementing specific interventions in clinical practice to reduce the probability of occurrence of these events.No conflict of interest
samples. An important increase in the number of isoforms even with changes in their masses, including the main isoform, was detected. Conclusion and relevance Exposure to light may cause modifications in the nivolumab isoform profile which suggests protein degradation. This work shows the importance of protecting opened vials of the medicine Opdivo from light (and by extension, bags for infusion) when they are at room temperature (up to 25°C).
This paper discusses the fabrication challenges introduced by products targeted to the automotive market segment. Different methods to enhance intrinsic design robustness, along with the design flow will be discussed. Experimental results from simulations and daftafom the field will be presented to support the proposed solutions.
BackgroundThe European Resolution CM/ResAP(2011)1, by affirming the importance of medicinal products prepared in the pharmacy, states that before setting up a preparation, the clinical needs of the patient should be evaluated in relation to the risk associated. The resolution states that it is necessary to adopt strict protocols of preparation to ensure the quality of the product, in addition to pharmacopoeial requirements.PurposeTo assign a numerical risk value to each preparation in order to assess the risk/benefit ratio and then to apply an adequate system of quality assurance.Material and methodsAfter the recent drafting by our National Society of Compounding Pharmacists of a position paper on risk assessment, based on the resolution, pharmacists and technicians in our hospital pharmacy collaborated to classify preparations as low, medium-low, medium-high and high risk, by assigning values, as tabulated in the document, for pharmacological risk, preparation process risk and risk depending on number of preparations per year. By entering the values obtained and using a defined formula, on a specific Excel worksheet, we calculated the overall risk value.Results10 preparations (non-sterile, sterile, oncology IV, intrathecal, TPN) were analysed and classified using this method, resulting in different values. It was also noted that different formulations, with the same active molecule and therapeutic use, can generate different values. For example, spironolactone obtained a value of 34.6 (low risk) as an oral suspension versus 325 (high risk) as a unit dose oral powder. This instrument can be used to support the choice between different options of formulations, as well as a stimulus for development and improvement in quality, safety and effectiveness of drugs prepared in the pharmacy.ConclusionThe method of risk assessment proposed was very useful for the activities performed in our laboratory; however, there are some aspects which require further reflection, such as how much computerisation and automation of the processes or specialisation of operators, related to the annual amount of products prepared, affect the overall risk value related to pharmacy preparations.References and/or AcknowledgementsResolution CM/ResAP(2011)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patientsNo conflict of interest.
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