OBJECTIVE: The aim of this article was to perform a narrative review of how pharmacogenetics and pharmacogenomics is being applied in the clinics, especially in Spain. METHOD: Publications and websites of major interest...OBJECTIVE: The aim of this article was to perform a narrative review of how pharmacogenetics and pharmacogenomics is being applied in the clinics, especially in Spain. METHOD: Publications and websites of major interest have been reviewed. RESULTS: Pharmacogenes and variants used in several hospitals, available methodologies, and the implementation process are discussed.
Cordero-Cruz AM, Fernández de Gamarra-Martínez E, Florencio M
… +7 more, González-Haba E, Marcos JA, Molina García T, Navarro Ruiz A, de Pourcq JT, Sáez de la Fuente J, Soy D
The training of hospital pharmacists in the coming years must adapt and respond to constant current and future social and technological challenges, without neglecting the basic areas of the profession. It is necessary to...The training of hospital pharmacists in the coming years must adapt and respond to constant current and future social and technological challenges, without neglecting the basic areas of the profession. It is necessary to acquire knowledge in what is known as digital comprehensive health: artificial intelligence, technology and automation, digital skills, and new forms of communication with patients, such as telemedicine and telepharmacy that are already a reality in many hospitals. We must provide knowledge in automated systems for the distribution and dispensing of medicines, robots for preparing sterile preparations, traceability systems, the use of drones in clinical care, etc. as well as training in the application of technology in pharmaceutical care, through devices and applications that help identify patients who require specific care early and effectively. In this digital scenario, new risks and challenges must be faced, such as cybersecurity and cyber resilience, which makes the training and education of healthcare professionals in general, and hospital pharmacists in particular, inexcusable. On the other hand, the appearance of increasingly complex and innovative therapies has a great impact not only on health population but also on economic and environmental issues, which makes new competencies and skills essential to develop and implement disruptive and competent financing, equity, and sustainability strategies. In this demanding and hyper-connected environment, it is understandable that the well-known "burned out worker syndrome" appears, which prevents the correct personal and professional development of the team and highlights the importance of quality training for its prevention and management. In short, in the next decade, the training of hospital pharmacists must be aimed at providing knowledge in innovation and in basic skills needed to adapt and succeed to current demands and changes.
Artificial intelligence is a broad concept that includes the study of the ability of computers to perform tasks that would normally require the intervention of human intelligence. By exploiting large volumes of healthcar...Artificial intelligence is a broad concept that includes the study of the ability of computers to perform tasks that would normally require the intervention of human intelligence. By exploiting large volumes of healthcare data, Artificial intelligence algorithms can identify patterns and predict outcomes, which can help healthcare organizations and their professionals make better decisions and achieve better results. Machine learning, deep learning, neural networks, or natural language processing are among the most important methods, allowing systems to learn and improve from data without the need for explicit programming. Artificial intelligence has been introduced in biomedicine, accelerating processes, improving accuracy and efficiency, and improving patient care. By using Artificial intelligence algorithms and machine learning, hospital pharmacists can analyze a large volume of patient data, including medical records, laboratory results, and medication profiles, aiding them in identifying potential drug-drug interactions, assessing the safety and efficacy of medicines, and making informed recommendations. Artificial intelligence integration will improve the quality of pharmaceutical care, optimize processes, promote research, deploy open innovation, and facilitate education. Hospital pharmacists who master Artificial intelligence will play a crucial role in this transformation.
OBJECTIVE: To develop by consensus a dashboard model to standardise and promote the evaluation of research activity in Spanish Hospital Pharmacy Services. METHODS: The study was carried out in 5 phases following the modi...OBJECTIVE: To develop by consensus a dashboard model to standardise and promote the evaluation of research activity in Spanish Hospital Pharmacy Services. METHODS: The study was carried out in 5 phases following the modified Delphi methodology: constitution of the coordinating group, elaboration of a list of scenarios, selection of participating centres, evaluation of the list of scenarios, and analysis of the results. The coordinating group designed a questionnaire with 114 questions. General research questions and different scenarios (indicators) were included to form the dashboard. The Hospital Pharmacy Services with the highest number of publications were identified to participate in the Delphi consultation. Two rounds of consultations were conducted in which the "Need" and/or "Feasibility" of their measurement was evaluated for each of the scenarios, using a numerical scale from 1 (lowest score) to 9 (highest score). RESULTS: Sixteen Hospital Pharmacy Services, belonging to 8 different Autonomous Communities, participated in the Delphi consultation. A total of 100% of them responded to all the questions in the 2 rounds of consultations. It was considered that the Hospital Pharmacy Services should have a research dashboard (Need=100%) with a basic structure and a common minimum set of data for all them (Need=87.5%). The consensus was reached on distinguishing research projects led by the Hospital Pharmacy Services from those led by other groups in which the Hospital Pharmacy Services collaborate (Need=87.5%), and a definition was approved on the leadership of these projects according to whether they are single-centre or multicentre. A consensus was reached on 40 indicators to form the dashboard, which evaluates publications (13 indicators), human resources (12 indicators), research projects (9 indicators), doctoral theses (4 indicators), and patents and intellectual property registrations (2 indicators). CONCLUSIONS: This is the first consensus dashboard developed to evaluate the research activity of the Hospital Pharmacy Services, which will help to analyse the productivity and impact of research systematically and continuously. In addition, it will allow comparison between them and will help to establish synergies and identify trends, patterns, and challenges.
Megías-Vericat JE, Bonora-Centelles A A, Palanques-Pastor T
… +5 more, Aguilar Gallardo CE, Guerreiro M, Gómez Seguí I, De La Rubia J, Poveda Andrés JL
The huge development that advanced therapy medicinal products (AMTPs) have experienced in recent years, both commercial and research, represent a challenge for hospital pharmacy at all levels. The aim of this article is...The huge development that advanced therapy medicinal products (AMTPs) have experienced in recent years, both commercial and research, represent a challenge for hospital pharmacy at all levels. The aim of this article is to describe the implementation of an advanced therapies unit (AUT) and the process of preparation of the AMTPs according to the "good manufacturing practices" (GMP), as well as the results obtained in a tertiary hospital, as an example of the challenges posed by MTA's academic production. The AUT meets the requirements established in the GMP by guaranteeing that the medicines produced therein are of the quality required for the use for which they are intended, and also provides support to various research groups involved in the development of AMTPs. The AUT is composed of a highly qualified multidisciplinary team, qualified and trained in GMP, and is authorized for the preparation of 5 types of AMTPs consisting of allogeneic virus-specific T cells (VST) with various viral specificities. A circuit has been established in collaboration between the UTA and the pharmacy service with the hematology service for the assessment of the clinical indication, the request, and preparation of VST, which allows the treatment of patients receiving hematopoietic stem cell transplants who present viral reactivations resistant or refractory to standard treatment, or who cannot tolerate it due to toxicity. Preliminary results from these AMTPs suggest that VSTs are an effective and safe alternative. Academic AMTPs have special interest in orphan indications or in the absence of alternative treatments, and their production through the "hospital exemption" can favor early access in the initial phases of development and at a lower cost. It is essential to promote the training of hospital pharmacists in GMP and their participation in collaboration with other clinicians and researchers to develop AMTPs that meet all logistical and regulatory requirements.
Alzola-Andrés M, Domingo-Echaburu S, Nogales-Garcia M
… +7 more, Palacios-Zabalza I, Urrutia-Losada A, Arteche-Elguizabal L, de Torre Querejazu AL, Basterra AQ, Orive G, Lertxundi U
Drugs do not disappear once they have been excreted. In fact, 992 active principles have already been measured in the different environmental matrices. A recent study led by scientists from the University of York has stu...Drugs do not disappear once they have been excreted. In fact, 992 active principles have already been measured in the different environmental matrices. A recent study led by scientists from the University of York has studied the presence of drugs in the rivers of more than 100 different countries, showing that environmental contamination by pharmaceuticals is a global issue and that, concentrations found are frequently harmful to the environment. In this work, we have tried to briefly expose the problem of environmental contamination with medicines, but above all, we have tried to address the possible solutions, with a perspective from the field of hospital pharmacy. This is a very complex matter (a wicked problem), since it involves multiple stakeholders with different visions and interests regarding medicines. In order to find solutions, we will probably need to act at all steps of the drug's life cycle. Until now, health professionals have been part of the problem. It is time for us to be part of the solution.
Hospital pharmacy is today a profession marked by therapeutic advances, with a proactive attitude, focused on people and their health. The evolution of processes is constant, with the full presence of digitalization, rob...Hospital pharmacy is today a profession marked by therapeutic advances, with a proactive attitude, focused on people and their health. The evolution of processes is constant, with the full presence of digitalization, robotization and even artificial intelligence, in an environment that also requires the efficient and sustainable use of these tools. In this context, it is necessary to have a roadmap that guides the advancement of the profession and hospital pharmacy services. Continuing with the philosophy of the 2020 initiative which, with the slogan "Towards the future, safely", defined the strategic lines to advance in the improvement of hospital pharmacy practice, the Spanish Society of Hospital Pharmacy wanted to raise the challenges the profession is currently facing and with a view to 2030. With this strategic planning objective, twenty challenges have been identified and developed, which cover the different areas of action and involvement of hospital pharmacy and which cover clinical activities, transversal aspects, training and research, as well as areas related to people and to the organizations or health systems. For each of them, the objectives, standards, tools and resources have been defined. It is also planned to provide tools that facilitate monitoring of implementation and the impact on the profession, patients and the environment.
OBJECTIVE: The aim of this article is to perform a narrative review of how pharmacogenetics and pharmacogenomics is being applied in the clinic, especially in Spain. METHOD: Publications and websites of major interest ha...OBJECTIVE: The aim of this article is to perform a narrative review of how pharmacogenetics and pharmacogenomics is being applied in the clinic, especially in Spain. METHOD: Publications and websites of major interest have been reviewed. RESULTS: Pharmacogenes and variants used in several hospitals, available methodologies, and the implementation process are discussed.
Cordero-Cruz AM, Fernández de Gamarra-Martínez E, Florencio M
… +7 more, González-Haba E, Marcos JA, Molina García T, Navarro Ruiz A, de Pourcq JT, Sáez de la Fuente J, Soy D
The training of hospital pharmacists in the coming years must adapt and respond to constant current and future social and technological challenges, without neglecting the basic areas of the profession. It is necessary to...The training of hospital pharmacists in the coming years must adapt and respond to constant current and future social and technological challenges, without neglecting the basic areas of the profession. It is necessary to acquire knowledge in what is known as digital comprehensive health: Artificial intelligence, technology and automation, digital skills, and new forms of communication with patients, such as telemedicine and telepharmacy that are already a reality in many hospitals. We must provide knowledge in automated systems for the distribution and dispensing of medicines, robots for preparing sterile preparations, traceability systems, the use of drones in clinical care, etc., as well as including training in the application of technology in pharmaceutical care, through devices and applications that help identify patients who require specific care early and effectively. In this digital scenario, new risks and challenges must be faced, such as cybersecurity and cyber-resilience, which makes the training and education of healthcare professionals in general, and hospital pharmacists in particular, essential. On the other hand, the appearance of increasingly complex and innovative therapies has a great impact not only on health population but also on economic and environmental issues, which makes new competencies and skills essential to develop and implement disruptive and competent financing, equity, and sustainability strategies. In this demanding and hyper-connected environment, it is understandable that the well-known "burned out worker syndrome" appears, which prevents the correct personal and professional development of the team and highlights the importance of quality training for its prevention and management. In short, in the next decade, the training of hospital pharmacists must be aimed at providing knowledge in innovation and in basic skills needed to adapt and succeed to current demands and changes.
Artificial intelligence (AI) is a broad concept that includes the study of the ability of computers to perform tasks that would normally require the intervention of human intelligence. By exploiting large volumes of heal...Artificial intelligence (AI) is a broad concept that includes the study of the ability of computers to perform tasks that would normally require the intervention of human intelligence. By exploiting large volumes of healthcare data, artificial intelligence algorithms can identify patterns and predict outcomes, which can help healthcare organizations and their professionals make better decisions and achieve better results. Machine learning, deep learning, neural networks or natural language processing are among the most important methods, allowing systems to learn and improve from data without the need for explicit programming. AI has been introduced in biomedicine, accelerating processes, improving safety and efficiency, and improving patient care. By using AI algorithms and Machine Learning, hospital pharmacists can analyze a large volume of patient data, including medical records, laboratory results, and medication profiles, aiding them in identifying potential drug-drug interactions, assessing the safety and efficacy of medicines, and making informed recommendations. AI integration will improve the quality of pharmaceutical care, optimize processes, promote research, deploy open innovation, and facilitate education. Hospital pharmacists who master AI will play a crucial role in this transformation.
OBJECTIVE: To develop by consensus a dashboard model to standardize and promote the evaluation of research activity in Spanish Hospital Pharmacy Services. METHODS: The study was carried out in 5 phases following the modi...OBJECTIVE: To develop by consensus a dashboard model to standardize and promote the evaluation of research activity in Spanish Hospital Pharmacy Services. METHODS: The study was carried out in 5 phases following the modified Delphi methodology: constitution of the coordinating group, elaboration of a list of scenarios, selection of participating centers, evaluation of the list of scenarios, and analysis of the results. The coordinating group designed a questionnaire with 114 questions. General research questions and different scenarios (indicators) were included to form the dashboard. The Hospital Pharmacy Services with the highest number of publications were identified to participate in the Delphi consultation. Two rounds of consultations were conducted in which the "Need" and/or "Feasibility" of their measurement was evaluated for each of the scenarios, using a numerical scale from 1 (lowest score) to 9 (highest score). RESULTS: Sixteen Hospital Pharmacy Services, belonging to 8 different autonomous communities, participated in the Delphi consultation. A total of 100% of them responded to all the questions in the 2 rounds of consultations. It was considered that the Hospital Pharmacy Services should have a research dashboard (need = 100%) with a basic structure and a common minimum set of data for all them (need = 87.5%). The consensus was reached on distinguishing research projects led by the Hospital Pharmacy Services from those led by other groups in which the Hospital Pharmacy Services collaborate (need = 87.5%), and a definition was approved on the leadership of these projects according to whether they are single-center or multicenter. A consensus was reached on 40 indicators to form the dashboard, which evaluates publications (13 indicators), human resources (12 indicators), research projects (9 indicators), doctoral theses (4 indicators), and patents and intellectual property registrations (2 indicators). CONCLUSIONS: This is the first consensus dashboard developed to evaluate the research activity of the Hospital Pharmacy Services, which will help to analyze the productivity and impact of research systematically and continuously. In addition, it will allow comparison between them and will help to establish synergies and identify trends, patterns, and challenges.
Megías-Vericat JE, Bonora-Centelles A A, Palanques-Pastor T
… +5 more, Aguilar Gallardo CE, Guerreiro M, Gómez Seguí I, De La Rubia J, Poveda Andrés JL
The huge development that Advanced Therapy Medicinal Products (AMTPs) have experienced in recent years, both commercial and research, represent a challenge for Hospital Pharmacy at all levels. The aim of this article is...The huge development that Advanced Therapy Medicinal Products (AMTPs) have experienced in recent years, both commercial and research, represent a challenge for Hospital Pharmacy at all levels. The aim of this article is to describe the implementation of an Advanced Therapies Unit (AUT) and the process of preparation of the AMTPs according to the "good manufacturing practices" (GMP), as well as the results obtained in a tertiary hospital, as an example of the challenges posed by MTA's academic production. The AUT meets the requirements established in the GMP by guaranteeing that the medicines produced therein are of the quality required for the use for which they are intended, and also provides support to various research groups involved in the development of AMTPs. The AUT is composed of a highly qualified multidisciplinary team, qualified and trained in GMP, and is authorized for the preparation of five types of AMTPs consisting of allogeneic virus-specific T cells (VST) with various viral specificities. A circuit has been established in collaboration between the UTA and the Pharmacy Service with the Hematology Service for the assessment of the clinical indication, the request and preparation of VST, which allows the treatment of patients receiving hematopoietic stem cell transplants who present viral reactivations resistant or refractory to standard treatment, or who cannot tolerate it due to toxicity. Preliminary results from these AMTPs suggest that VSTs are an effective and safe alternative. Academic AMTPs have special interest in orphan indications or in the absence of alternative treatments, and their production through the "hospital exemption" can favor early access in the initial phases of development and at a lower cost. It is essential to promote the training of hospital pharmacists in GMP and their participation in collaboration with other clinicians and researchers to develop AMTPs that meet all logistical and regulatory requirements.
Alzola-Andrés M, Domingo-Echaburu S, Nogales-Garcia M
… +7 more, Palacios-Zabalza I, Urrutia-Losada A, Arteche-Elguizabal L, de Torre Querejazu AL, Basterra AQ, Orive G, Lertxundi U
Drugs do not disappear once they have been excreted. In fact, 992 active principles have already been measured in the different environmental matrices. A recent study led by scientists from the University of York has stu...Drugs do not disappear once they have been excreted. In fact, 992 active principles have already been measured in the different environmental matrices. A recent study led by scientists from the University of York has studied the presence of drugs in the rivers of more than 100 different countries, showing that environmental contamination by pharmaceuticals is a global issue and that, concentrations found are frequently harmful to the environment. In this work, we have tried to briefly expose the problem of environmental contamination with medicines, but above all, we have tried to address the possible solutions, with a perspective from the field of hospital pharmacy. This is a very complex matter (a wicked problem), since it involves multiple stakeholders with different visions and interests regarding medicines. In order to find solutions, we will probably need to act at all steps of the drug's life cycle. Until now, health professionals have been part of the problem. It is time for us to be part of the solution.
PURPOSE: To review and analyse the available literature on peripheral administration of noradrenaline (NA) with the aim of providing recommendations to ensure correct use and patient safety. METHODS: Systematic review on...PURPOSE: To review and analyse the available literature on peripheral administration of noradrenaline (NA) with the aim of providing recommendations to ensure correct use and patient safety. METHODS: Systematic review on the databases PubMed, ISI Web of Science, SCOPUS, and Science Direct, using the following search terms: ("Noradrenaline" [Mesh]) AND ("Norepinephrine" [Mesh]) AND ("Vasopressors" [Mesh]) AND ("Peripheral infusions" [Mesh]) OR ("Extravasations" [Mesh]). A total of 1040 articles were identified. Animal studies and studies written in languages other than English were excluded. Finally, 83 articles were included. RESULTS: NA can be administered peripherally. The risk of extravasation should be taken into account, with phentolamine being the first pharmacological line of treatment. It has also been related to the appearance of thrombophlebitis, cellulitis, tissue necrosis, limb ischaemia, and gangrene, although its incidence seems to be low. The use of peripheral NA in children seems to be carried out without obvious complications. The use of standard concentrations is suggested to reduce the risk of errors. It is recommended to use 0.9% saline as the default diluent for peripheral NA. CONCLUSIONS: Peripheral infusions of NA could be a safe and beneficial option in early resuscitation provided that a number of guidelines are followed that reduce the likelihood of complications associated with this route.
BACKGROUND: We assessed pain, acceptability, patient preference, and tolerability of patients with psoriasis and psoriatic arthritis after switching guselkumab from a prefilled syringe to One-Press autoinjector pen. METH...BACKGROUND: We assessed pain, acceptability, patient preference, and tolerability of patients with psoriasis and psoriatic arthritis after switching guselkumab from a prefilled syringe to One-Press autoinjector pen. METHODS: Patients with psoriasis and psoriatic arthritis treated for at least 6 months with guselkumab syringe were recruited from Jan 2019 to Dec 2022. Gender, age, diagnosis, self-administration, and pain perception of guselkumab prefilled syringe were recorded. At the first visit, patients completed a post-auto-injection syringe questionnaire before starting auto-injection pen administration. After 2 and 6 months of guselkumab self-injection using the One-Press autoinjector pen, patient experience, adherence, preference, pain, and safety of each administration were assessed using post-guselkumab by One-Press autoinjector pen questionnaire. RESULTS: 40 patients [psoriasis n=34, psoriatic arthritis n=6] were included. All patients self-administered guselkumab by One-Press autoinjector pen. Pain at the injection site was significantly reduced with the use of the One-Press autoinjector pen. All patients considered that using One-Press autoinjector pen was easier than the syringe, 98% chose the pen as their preferred delivery system. CONCLUSION: The One-Press autoinjector pen for guselkumab administration is presented as a preferred option, with a high satisfaction and less painful compared to the administration of guselkumab in a prefilled syringe.
OBJECTIVE: To describe the authorisations and funding resolutions for new onco-haematological drugs in Spain between 2017 and 2020, as well as the results of their main trials. METHODS: Observational, cross-sectional, de...OBJECTIVE: To describe the authorisations and funding resolutions for new onco-haematological drugs in Spain between 2017 and 2020, as well as the results of their main trials. METHODS: Observational, cross-sectional, descriptive study conducted between October and December 2022. Onco-haematology drugs approved by the European Medicines Agency between 2017 and 2020 were included, according to EFPIA patients W.A.I.T Indicator 2021 Survey. Authorisation information was obtained from the main study of the European Public Assessment Report. Data were collected on medicines, their authorisation and main study, benefit shown, cost, and status and time to reimbursement. RESULTS: Forty-one new drugs authorised for 49 indications were identified. More than half (58.5%) were targeted therapies, and 61.2% were for the treatment of solid tumours (61.2%). Most had palliative intent (71.4%) and were indicated in relapsed or refractory disease (55.1%). Of the clinical trials, 57.1% were phase III and 63.3% were randomised. The primary endpoint was overall survival in 16.3%, increasing to 25.8% among randomised clinical trials. Regarding licensed drugs based on response rate, the median response rate was 56.4% [IQI 40-66.3]. In those authorised on the basis of surrogate time-to-event endpoints, the median hazard ratio was 0.54 [IQI 0.38-0.57], and among those using overall survival was 0.71 [IQI 0.59-0.77]. Globally, 22.4% had shown benefit in overall survival, with a median gain of 4 months [IQI 3.6-16.7]. One-third (33.3%) of the indications evaluable according to the European Society for Medical Oncology Magnitude of Clinical Benefit Scale showed substantial clinical benefit. Of the indications, 75.5% were funded, half (48.6%; 36.7% of the total) with restrictions. The median time to funding was 19.5 months [IQI 11.4-29.3]. CONCLUSIONS: Most main clinical trials of new onco-haematology drugs approved in Spain used surrogate primary endpoint and, at the time of authorisation, few had shown to prolong overall survival. More than a third were uncontrolled clinical trials.
INTRODUCTION: Older patients are more susceptible to medication use, and physiological changes resulting from aging and organic dysfunctions presented by critically ill patients may alter the pharmacokinetic or pharmacod...INTRODUCTION: Older patients are more susceptible to medication use, and physiological changes resulting from aging and organic dysfunctions presented by critically ill patients may alter the pharmacokinetic or pharmacodynamic behavior. Thus, critically ill older people present greater vulnerability to the occurrence of pharmacotherapeutic problems. OBJECTIVE: To evaluate pharmacotherapy and the development of potential adverse drug reactions (ADRs) in older patients admitted to an intensive care unit (ICU). METHOD: A cohort study was conducted in an ICU for adults of a Brazilian University Hospital during a 12-month period. The patients' pharmacotherapy was evaluated daily, considering the occurrence of ADRs and drug-drug interactions (DDIs), the use of potentially inappropriate medications (PIMs) for older people, and the pharmacotherapy anticholinergic burden (ACB). A trigger tool was used for active search of ADRs, with subsequent causality evaluation. PIM use was evaluated by means of the Beers criteria and the STOPP/START criteria. The ABC scale was employed to estimate ACB. The Micromedex® and Drugs.com® medication databases were employed to evaluate the DDIs. RESULTS: The sample of this study consisted of 41 patients, with a mean age of 66.8 years old (±5.2). The 22 triggers used assisted in identifying 15 potential ADRs, and 26.8% of the patients developed them. The mean estimated ACB score was 3.0 (±1.8), and the patients used 3.1 (±1.4) and 3.3 (±1.6) PIMs according to the Beers and the STOPP criteria, respectively. A total of 672 DDIs were identified, with a mean of 16.8 (±9.5) DDIs/patient during ICU hospitalization. Our findings show an association between occurrence of ADRs in the ICU and polypharmacy (p=.03) and DDIs (p=.007), corroborating efforts for rational medication use as a preventive strategy. CONCLUSIONS: Using tools to evaluate the pharmacotherapy for older people in intensive care can assist in the recognition and prevention of pharmacotherapeutic problems, with emphasis on the identification of ADRs through the observation of triggers and subsequent causality analysis.