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27 pages, 4827 KiB  
Technical Note
Design and Operation of a Multifunctional Pilot-Scale Bioreactor for Enhanced Aerobic Fermentation
by Mauro Moresi
Fermentation 2025, 11(2), 101; https://doi.org/10.3390/fermentation11020101 - 17 Feb 2025
Cited by 2 | Viewed by 2895
Abstract
The primary aim of this work was to share the results from a Research Project supported by the Italian National Research Council, which led to the development of a versatile jacketed tower bioreactor. Designed to optimize oxygen transfer efficiency and process control, the [...] Read more.
The primary aim of this work was to share the results from a Research Project supported by the Italian National Research Council, which led to the development of a versatile jacketed tower bioreactor. Designed to optimize oxygen transfer efficiency and process control, the reactor incorporated a reciprocating air compressor, centrifugal pumps, a draft tube with or without perforated plates, and a series of gas–liquid ejectors. Its flexible design enabled operation in both airlift and ejector-loop modes, making it suitable for a wide range of aerobic fermentation processes. By sharing the detailed engineering design, operational procedures of this pilot-scale bioreactor, as well as its performance data when cultivating yeasts on whey and potato wastewater, a detailed blueprint was given to researchers seeking to advance bioreactor technology, particularly in the context of emerging fields like cultured meat production, pharmaceutical manufacturing, and environmental bioremediation. Full article
(This article belongs to the Section Fermentation Process Design)
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10 pages, 912 KiB  
Article
Application of Accelerated Predictive Stability Studies in Extemporaneously Compounded Formulations of Chlorhexidine to Assess the Shelf Life
by Olga González-González, M. Paloma Ballesteros, Juan J. Torrado and Dolores R. Serrano
Molecules 2023, 28(23), 7925; https://doi.org/10.3390/molecules28237925 - 4 Dec 2023
Cited by 3 | Viewed by 3885
Abstract
Industrially fabricated medicines have a well-defined shelf life supported by rigorous studies before their approval for commercialization. However, the shelf life of extemporaneous compounding topical formulations prepared at hospitals tends to be shorter, especially when no data are available to prove a longer [...] Read more.
Industrially fabricated medicines have a well-defined shelf life supported by rigorous studies before their approval for commercialization. However, the shelf life of extemporaneous compounding topical formulations prepared at hospitals tends to be shorter, especially when no data are available to prove a longer stability period. Also, the storage conditions are unknown in many circumstances. Accelerated Predictive Stability (APS) studies have been shown to be a useful tool to predict in a faster and more accurate manner the chemical stability of extemporaneously compounded formulations requiring a minimum amount of formulation, thereby reducing the chemical drug waste per study. Shelf life will be allocated based on scientific data without compromising drug efficacy or safety. In this work, the APS approach was applied to the commercially available Cristalmina® (CR) and an extemporaneously compounded formulation of chlorhexidine (DCHX). A different degradation kinetic was found between DCHX and CR (Avrami vs. zero-order kinetics, respectively). This can explain the different shelf life described by the International Council for Harmonisation of Technical Requirements Registration Pharmaceuticals Human Use (ICH) conditions between both formulations. A predicted stability for the DCHX solution was obtained from the extrapolation of the degradation rate in long-term conditions from the Arrhenius equation. The estimated degradation from the Arrhenius equation for DCHX at 5 °C, 25 °C, and 30 °C at 365 days was 3.1%, 17.4%, and 25.9%, respectively. The predicted shelf life, in which the DCHX content was above 90%, was 26.67 months under refrigerated conditions and 5.75 and 2.24 months at 25 and 30 °C, respectively. Currently, the Spanish National Formulary recommends a shelf life of no longer than 3 months at room temperature for DCHX solution. Based on the predicted APS and confirmed by experimental long-term studies, we have demonstrated that the shelf life of DCHX extemporaneously compounded formulations could be prolonged by up to 6 months. Full article
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12 pages, 857 KiB  
Article
Identifying the Enablers and Barriers to Advance Nurse Prescribing of Medication in Spain According to Experts’ Views: A Delphi Study
by Francisco Javier Gomis-Jimeno and Manuel Lillo-Crespo
Int. J. Environ. Res. Public Health 2023, 20(6), 4681; https://doi.org/10.3390/ijerph20064681 - 7 Mar 2023
Cited by 3 | Viewed by 3123
Abstract
Nurses play an important role in pharmaceutical care worldwide in detecting clinical changes, communicating and discussing pharmacotherapy with patients, their families, and other healthcare professionals, proposing and implementing drug-related interventions, and ensuring the monitoring of patients and their medication regimens, among others. However, [...] Read more.
Nurses play an important role in pharmaceutical care worldwide in detecting clinical changes, communicating and discussing pharmacotherapy with patients, their families, and other healthcare professionals, proposing and implementing drug-related interventions, and ensuring the monitoring of patients and their medication regimens, among others. However, there is no global consensus across countries regarding the prescribing of medication by nurses. In Spain, for example, this topic is currently in transition since the approval of the Royal Decree 1302/2018 of October 22nd, which regulates the indication, use, and authorization for dispensing human-use medication by nurses. Our study aims to identify the enablers and barriers to advancing the nurse prescribing of medication in Spain through the views of experts in the field and according to the latest Royal Decree approved and the steps taken by the different Spanish autonomous communities. A modified qualitative Delphi study with three iterations was performed online through the perspectives of experts from the field of healthcare education, research, practice, management, and policy. Data extracted from the literature review were used to formulate the open-ended questions utilized in the three rounds. The experts involved (n = 15) belonged to different Spanish regions where the Royal Decree is being implemented with different speeds, and had distinct backgrounds and experiences. Our results highlight the importance of prospectively developing additional protocols based on chronic diseases as well as scaling up towards independent nursing prescription, the inclusion of a joint multidisciplinary pharmaceutical care model, the controversial role played by national nursing councils and boards, the variability in the speed of implementation among the autonomous communities, and the lack of nursing training in the field of medication prescription. Full article
(This article belongs to the Special Issue Knowledge, Attitudes, Beliefs and Hesitancy towards Nurse Prescribing)
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8 pages, 321 KiB  
Brief Report
Deploying and Maintaining Standards of New Pharmacy Services Provision in Poland-Introducing the National Pharmacist Competencies Assessment Tool: Pre-Registration Exam–Results of the Pilot Project
by Piotr Merks, Urszula Religioni, Aleksandra Howell, Marvin Munzu, Edwin Panford-Quainoo, Agnieszka Neumann-Podczaska, Radosław Jaskólski, Beata Kaczmarek, Justyna Kaźmierczak, Eliza Blicharska, Paweł Olczyk, Agnieszka Barańska, Magdalena Waszyk-Nowaczyk and Jerzy Krysiński
Int. J. Environ. Res. Public Health 2022, 19(13), 7809; https://doi.org/10.3390/ijerph19137809 - 25 Jun 2022
Viewed by 2132
Abstract
Despite the functioning of the Bologna Declaration, the knowledge and skills of graduates educated in different countries may differ significantly. Therefore, this article aims to present the differences in results of the final exam in pharmacy among Polish pharmacy students. This exam was [...] Read more.
Despite the functioning of the Bologna Declaration, the knowledge and skills of graduates educated in different countries may differ significantly. Therefore, this article aims to present the differences in results of the final exam in pharmacy among Polish pharmacy students. This exam was modeled on the British national exam supervised by the General Pharmaceutical Council. The exam was conducted in three cities in Poland, among a total of 175 final-year students (a full sample of those eligible was 451 with 276 refusals (38.58% response rate)). Taking the exam was voluntary and anonymous. The results indicate that none of the Polish students achieved the 70% mark required to pass the Great Britain exam. Significant differences in test results were noticed between cities. Students achieved the best average exam result in Bydgoszcz (46.35%), then in Warsaw (38.81%) and Łódź (38.35%). The pharmaceutical education system in Poland requires complete changes that will prepare future pharmacists for clinical work. Full article
21 pages, 579 KiB  
Article
Learn Today–Apply Tomorrow: The SMART Pharmacist Program
by Michael J Rouse and Arijana Meštrović
Pharmacy 2020, 8(3), 139; https://doi.org/10.3390/pharmacy8030139 - 6 Aug 2020
Cited by 10 | Viewed by 6088
Abstract
The SMART Pharmacist Program was initiated by the Accreditation Council for Pharmacy Education (ACPE) and Pharma Expert in 2014. It was designed to introduce a new continuing education model for pharmacists for the Turkish Pharmacists’ Association, and to support development of competencies for [...] Read more.
The SMART Pharmacist Program was initiated by the Accreditation Council for Pharmacy Education (ACPE) and Pharma Expert in 2014. It was designed to introduce a new continuing education model for pharmacists for the Turkish Pharmacists’ Association, and to support development of competencies for future practice. After successful implementation in Turkey, the Program spread to 16 additional countries. To assure quality, globally adopted and validated tools and best practices were used, respecting the national context. National competency frameworks and quality indicators for pharmaceutical care delivery were developed. Pharmacists’ learning portfolios were introduced and patient care modules created. Under the sub-title “Learn Today—Apply Tomorrow,” the changes in practice were introduced under the leadership of national host organizations. The Program showed an impact on the patient level in several countries, especially in areas of patient care in Asthma and Chronic Obstructive Pulmonary Disease (COPD), Hypertension and Dyslipidemia, Diabetes, and the patient care process in general (e.g., identifying drug-related problems, improving patient safety, collaborating with medical doctors). Changes are visible at the individual (pharmacists) and organizational levels. Barriers and facilitators to the change-management process during Program implementation are identified. In some countries, the Program is recognized as one of the most important initiatives in pharmacy education and practice, with visible support of national medicines agencies, academia, government, and WHO regional offices. Full article
(This article belongs to the Special Issue Continuing Professional Development in Pharmacy)
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7 pages, 178 KiB  
Commentary
The National Pharmaceutical Council: Endorsing the Construction of Imaginary Worlds in Health Technology Assessment
by Paul C Langley
Pharmacy 2020, 8(3), 119; https://doi.org/10.3390/pharmacy8030119 - 13 Jul 2020
Viewed by 2212
Abstract
All too often, organizations embrace standards for health technology assessment that fail to meet those of normal science. A value assessment framework has been endorsed that is patently in the realm of pseudoscience. If a value assessment framework is to be accepted, then [...] Read more.
All too often, organizations embrace standards for health technology assessment that fail to meet those of normal science. A value assessment framework has been endorsed that is patently in the realm of pseudoscience. If a value assessment framework is to be accepted, then claims for the value of competing products must be credible, evaluable and replicable. If not, for example, when the assessment relies on the construction of an imaginary lifetime incremental cost-per-quality-adjusted-life-year (QALY) world, then that assessment should be rejected. Such an assessment would fail one of the central roles of normal science: the discovery of new facts through an ongoing process of conjecture and refutation where provisional claims can be continually challenged. It is no good defending an endorsement of a value framework that fails expected standards on the grounds that it has been endorsed by professional groups and reflects decades of development. This is intellectually lazy. If this is the case, then the scientific revolution of the 17th century need not have happened. The purpose of this commentary is to consider the recommended standards for health technology assessment of the National Pharmaceutical Council (NPC), with particular reference to proposed methodological standards in value assessment and the commitment to mathematically impossible QALYs. Full article
(This article belongs to the Special Issue Medication Experiences)
14 pages, 1457 KiB  
Article
Development of a Platform to Align Education and Practice: Bridging Academia and the Profession in Portugal
by Filipa Alves da Costa, Ana Paula Martins, Francisco Veiga, Isabel Ramalhinho, José Manuel Sousa Lobo, Luís Rodrigues, Luiza Granadeiro, Matilde Castro, Pedro Barata, Perpétua Gomes, Vítor Seabra and Maria Margarida Caramona
Pharmacy 2020, 8(1), 11; https://doi.org/10.3390/pharmacy8010011 - 16 Jan 2020
Cited by 6 | Viewed by 3219
Abstract
Limited fitness for practice may result from a mismatch between education and practice. Aiming to meet the common interests of academics and practitioners, the Portuguese Pharmaceutical Society (PPS) developed the Education and Practice Platform (EPP). The EPP includes one representative from each pharmacy [...] Read more.
Limited fitness for practice may result from a mismatch between education and practice. Aiming to meet the common interests of academics and practitioners, the Portuguese Pharmaceutical Society (PPS) developed the Education and Practice Platform (EPP). The EPP includes one representative from each pharmacy faculty, and all Councils of Speciality Boards of Practice. Brainstorming with involved parties enabled sharing of interests, concerns and identifying a common path. Aims, mission, vision and values were set. The EPP’s mission is to: act as an enabler to foster the quality and adequacy of education through sharing best practices, ultimately leading to facilitate professional integration, and to foster quality development in teaching practices with recognition for autonomy in freedom to teach and to learn. Its vision is an alignment of education and practice with the PPS’ statutes to ensure validation of the competences defined for each practice area, and compliance with international guidance. Key performance indicators (KPIs) were set. Activities developed include the creation of a national forum to discuss education and practice, development of workshops on teaching methods and pharmacy internships, enhanced representation in international events and response to global and national requests. Ongoing work focuses on the creation of a common training framework in hospital and community pharmacy practice adapted to Portugal. The EPP is a worldwide case study, encouraging the development of discussion contributing to an open climate of sharing best practices, indirectly leading to foster a better alignment between education and practice. Many of these results are so far intangible in scientific terms but worth describing. Full article
(This article belongs to the Special Issue Pharmacy Education; Competency and beyond)
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14 pages, 1207 KiB  
Article
A Quantitative Curriculum Mapping of the Faculty of Pharmacy of Yeditepe University, Turkey: A Process to Assess the Consistency of a Curriculum with the Mission and Vision of an Institution and National Requirements
by Filiz Esra Önen Bayram and Meriç Köksal
Pharmacy 2019, 7(3), 78; https://doi.org/10.3390/pharmacy7030078 - 1 Jul 2019
Cited by 1 | Viewed by 3481
Abstract
The changing role of the pharmacist led to some improvements of pharmacy education worldwide these last years. Curricula have evolved and the content-based education has been converted into a competency-based education. The definition of a global practice-based competency framework by the International Pharmaceutical [...] Read more.
The changing role of the pharmacist led to some improvements of pharmacy education worldwide these last years. Curricula have evolved and the content-based education has been converted into a competency-based education. The definition of a global practice-based competency framework by the International Pharmaceutical Federation (FIP) and the European Pharmacy Competencies Framework by the European the Quality Assurance in European Pharmacy Education and Training (PHAR-QA) project helps Universities to keep in with these changes. The National Council of Deans of Faculties of Pharmacy in Turkey also defined 169 competencies with their sub-competencies that have to be reached upon the completion of a pharmacy education program, yet it did not indicate how the faculties can measure if their curricula are consistent with these competencies. This study aims to provide a method for a quantitative mapping of a given curriculum in order to analyze if a curriculum fulfills the requirements defined by the National Deans Council. It also helps to easily determine the weaknesses and strengths of a program. Moreover, with this study, the consistency of the content of the courses with the mission and vision defined by an institution can be easily determined. Thus, this study can also be a useful tool for the revision and enhancement of a program according to institutional targets. Full article
(This article belongs to the Special Issue Pharmacy Education; Competency and beyond)
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