Real-Life Analysis with Erenumab: First Target Therapy in the Episodic and Chronic Migraine's Prophylaxis.

BACKGROUND: to research retrospectively the efficacy of Erenumab's treatment, thus allowing to describe a summary more in line with the reality observed every day in clinical practice, relative to a sample of patients widely heterogeneous. The study aims to confirm the efficacy of Erenumab, in terms of reduction of migraine days per month, from baseline to month 12 of treatment. Additional objectives included a reduction in the number of days of symptomatic drug use and change from baseline in the Migraine Disability Assessment Score Questionnaire (MIDAS); Methods: the analysis included all patients treated for 12 months with Erenumab during the year 2019-2020. The population analyzed consists of twenty-six patients from the Neurology outpatient clinic in Fossombrone. Several quantitative and qualitative variables were recorded by reading the medical records of the patients. The MIDAS was administered to patients to assess the disability related to migraine; Results: at the end of treatment, a statistically significant reduction in the mean number of monthly migraine days, acute medication use per month, and MIDAS questionnaire score was observed; Conclusions: as a preventive treatment of episodic and chronic migraine, our analysis data confirm the efficacy of Erenumab for the prevention of the migraine. The success is achieved in 96% of cases.

Microbiological validation of a robot for the sterile compounding of injectable non-hazardous medications in a hospital environment.

Objectives: To design and execute a comprehensive microbiological validation protocol to assess a brand-new sterile compounding robot in a hospital pharmacy environment, according to ISO and EU GMP standards. Methods: Qualification of the Class-A inner environment of the robot was performed through microbial air and surface quality assessment utilising contact plates, swabs and particulate matter monitoring. To evaluate the effectiveness of the microbial decontamination process (UV rays) challenge test against Pseudomonas aeruginosa, Staphylococcus aureus, Bacillus subtilis spores and Candida albicans was used. The challenge Media Fill test was used to validate the aseptic processing. Results: After 3 hours, no microorganisms retained viability. Monitoring inside the equipment evidenced complete absence of microorganisms. The Media Fill test was always negative. Conclusions: According to our results, the APOTECAunit meets the requirements for advanced aseptic processing in the hospital pharmacies and the pharmaceutical industry in general, providing advantages in terms of safety for patients compared with conventional procedures of parenteral preparation production. The protocol has demonstrated to be a comprehensive and valuable tool in validating, from a microbial point of view, a sterile-compounding technology. This study might represent an important benchmark in developing a contamination control strategy, as required, for example, in the Performance Qualification of the GMP in the case of drug manufacturing.

Robotic i.v. medication compounding: Recommendations from the international community of APOTECAchemo users.

PURPOSE: The development of recommendations for advancing automated i.v. medication compounding is described. SUMMARY: Managing the shift from manual to robotic compounding of i.v. therapies requires an awareness of how automation affects practice and how to best implement robotics into current practice. An international panel of pharmacy professionals, researchers, and technology leaders with experience in i.v. robotics collaborated during a two-day meeting in August 2014 to define a general set of principles to broaden the understanding of the fundamental elements of robotic compounding worldwide. Participants were divided into four working groups (technology and safety; drugs and products; personnel; and facilities and quality) to analyze specific aspects of robotic compounding practice. The four working groups produced an initial list of 92 statements. This list was condensed to 35 statements by consolidating similar and overlapping statements from the different work groups. Participants were surveyed again to assess agreement with the 35 statements and solicit additional clarification. Respondents expressed full agreement with 25 recommendations. Six statements received one or more "don't know" responses, with all other respondents in agreement. Four statements had a combination of "don't know" and "disagree" responses. A total of 32 comments were recorded in free-text fields, including requests for clarification and suggestions for rewording the statements. CONCLUSION: An international panel of pharmacy professionals, researchers, and technology leaders with experience in i.v. robotics developed a set of 35 recommendations toward a better understanding of the role of automated i.v. compounding in hospital and health-system pharmacies worldwide.

Robotized compounding of oncology drugs in a hospital pharmacy.

In 2005, the Pharmacy Department of the University Hospital of Ancona began collaboration with the engineers of the Loccioni group in order to realize a fully automated system for the preparation of cytostatic drugs, which could be safe for both healthcare workers and patients. At present, the cytotoxic laboratory of Ancona is equipped with two robots and one Class II biological-safety cabinet. The introduction of the robots in the cytotoxic laboratory has increased both efficiency and safety of the working process. The drug-preparation process begins when the pharmacist confirms the medical prescription (exact posology, modalities of reconstitution), and starts the preparation cycle. The sterility of the preparations is monthly tested in collaboration to the local microbiology laboratory. All preparations' results were germ-free even after storage at room temperature for two weeks. The dose accuracy is verified by visual and gravimetric independent systems. Drug concentration errors exceeding the limit of 10% fixed by the Italian Pharmacopeia were found only in 1.1% of the preparations. The average dose error was 0.8% (standard deviation 1.7%).

Robot-assisted preparation of oncology drugs: the role of nurses.

Since 2007, the preparation of cancer drugs at the Pharmacy of the University Hospital of Ancona has been progressively robotized. Currently, the process of preparation of intravenous cancer drugs is almost totally automated (95%). At present, the Cytotoxic laboratory of Ancona is the sole, in Europe, that can count on two robots. The robots handle 56 oncology molecules, which correspond to more than 160 different vials. The production rate in 2011 exceeded 19,000 preparations. The quality of compounding and the sterility controls are satisfactory, every step of the process is traceable. The nursing staff played a fundamental role in the robot development process. The nursing staff and the pharmacists are still collaborating with the robotic engineers in order to increase efficiency, ergonomics and user-friendliness of the robots.