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1.
BMJ ; 371: m3434, 2020 10 07.
Artigo em Inglês | MEDLINE | ID: mdl-33028575

RESUMO

OBJECTIVE: To characterize the therapeutic value of new drugs approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and the association between these ratings and regulatory approval through expedited programs. DESIGN: Retrospective cohort study. SETTING: New drugs approved by the FDA and EMA between 2007 and 2017, with follow-up through 1 April 2020. DATA SOURCES: Therapeutic value was measured using ratings of new drugs by five independent organizations (Prescrire and health authorities of Canada, France, Germany, and Italy). MAIN OUTCOME MEASURES: Proportion of new drugs rated as having high therapeutic value; association between high therapeutic value rating and expedited status. RESULTS: From 2007 through 2017, the FDA and EMA approved 320 and 268 new drugs, respectively, of which 181 (57%) and 39 (15%) qualified for least one expedited program. Among 267 new drugs with a therapeutic value rating, 84 (31%) were rated as having high therapeutic value by at least one organization. Compared with non-expedited drugs, a greater proportion of expedited drugs were rated as having high therapeutic value among both FDA approvals (45% (69/153) v 13% (15/114); P<0.001) and EMA approvals (67% (18/27) v 27% (65/240); P<0.001). The sensitivity and specificity of expedited program for a drug being independently rated as having high therapeutic value were 82% (95% confidence interval 72% to 90%) and 54% (47% to 62%), respectively, for the FDA, compared with 25.3% (16.4% to 36.0%) and 90.2% (85.0% to 94.1%) for the EMA. CONCLUSIONS: Less than a third of new drugs approved by the FDA and EMA over the past decade were rated as having high therapeutic value by at least one of five independent organizations. Although expedited drugs were more likely than non-expedited drugs to be highly rated, most expedited drugs approved by the FDA but not the EMA were rated as having low therapeutic value.


Assuntos
Aprovação de Drogas , Avaliação de Medicamentos , Serviços de Informação sobre Medicamentos , Disseminação de Informação , Vigilância de Produtos Comercializados , Aprovação de Drogas/métodos , Aprovação de Drogas/estatística & dados numéricos , Avaliação de Medicamentos/métodos , Avaliação de Medicamentos/estatística & dados numéricos , Serviços de Informação sobre Medicamentos/organização & administração , Serviços de Informação sobre Medicamentos/normas , Serviços de Informação sobre Medicamentos/estatística & dados numéricos , Europa (Continente) , Humanos , Vigilância de Produtos Comercializados/métodos , Vigilância de Produtos Comercializados/estatística & dados numéricos , Desenvolvimento de Programas , Melhoria de Qualidade , Estudos Retrospectivos , Estados Unidos
2.
Yakugaku Zasshi ; 140(9): 1185-1193, 2020.
Artigo em Japonês | MEDLINE | ID: mdl-32879250

RESUMO

Lipid lowering therapy using statins prevents the risk of cardiovascular events. However, since the year 2000, there have been some reports that statins increased the risk of developing diabetes (SIRDD). It is socially demanded that pharmacists must apply pharmacotherapy to patients by utilizing drug information like the above, such as selecting appropriate drugs and providing correct drug information. Accordingly, pharmacists must correct drug information, and they should analyze and evaluate such information. Therefore, we conducted a questionnaire survey for pharmacists in community pharmacies with an aim to verify relevance between methods of obtaining drug information and the utilization of the information of "SIRDD" as a subject. We sent a questionnaire by letter to 1522 pharmacists in Fukushima and Mie prefecture, and received the results of the questionnaire from them using "Google forms" that is software to make web questionnaire and letters. We obtained responses from 356 (23.4%) pharmacists out of 1522. The number of responses from the pharmacists that "know" the information of "SIRDD" was 135 (37.9%). We found that these pharmacists obtained the information by websites of pharmaceutical companies, m3, Inc. (Portal site for medical professionals), and Pharmaceuticals and Medical Devices Agency (PMDA), as the sources of information. Our results suggested that pharmacists responded that they "know" "SIRDD" utilized websites as a quick information tool. The difference in network environments will relate to the difference of providable medical quality. So, it is very important to maintain appropriate network environment in cooperation with medical institutions, professional associations and the government.


Assuntos
Conscientização , Serviços Comunitários de Farmácia , Diabetes Mellitus/induzido quimicamente , Serviços de Informação sobre Medicamentos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Aceitação pelo Paciente de Cuidados de Saúde , Farmácias , Farmacêuticos/psicologia , Adulto , Serviços de Informação sobre Medicamentos/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Risco , Inquéritos e Questionários
3.
Cochrane Database Syst Rev ; 8: CD012012, 2020 08 13.
Artigo em Inglês | MEDLINE | ID: mdl-32803893

RESUMO

BACKGROUND: A well-functioning routine health information system (RHIS) can provide the information needed for health system management, for governance, accountability, planning, policy making, surveillance and quality improvement, but poor information support has been identified as a major obstacle for improving health system management. OBJECTIVES: To assess the effects of interventions to improve routine health information systems in terms of RHIS performance, and also, in terms of improved health system management performance, and improved patient and population health outcomes. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE Ovid and Embase Ovid in May 2019. We searched Global Health, Ovid and PsycInfo in April 2016. In January 2020 we searched for grey literature in the Grey Literature Report and in OpenGrey, and for ongoing trials using the International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov. In October 2019 we also did a cited reference search using Web of Science, and a 'similar articles' search in PubMed. SELECTION CRITERIA: Randomised and non-randomised trials, controlled before-after studies and time-series studies comparing routine health information system interventions, with controls, in primary, hospital or community health care settings. Participants included clinical staff and management, district management and community health workers using routine information systems. DATA COLLECTION AND ANALYSIS: Two authors independently reviewed records to identify studies for inclusion, extracted data from the included studies and assessed the risk of bias. Interventions and outcomes were too varied across studies to allow for pooled risk analysis. We present a 'Summary of findings' table for each intervention comparisons broadly categorised into Technical and Organisational (or a combination), and report outcomes on data quality and service quality. We used the GRADE approach to assess the certainty of the evidence. MAIN RESULTS: We included six studies: four cluster randomised trials and two controlled before-after studies, from Africa and South America. Three studies evaluated technical interventions, one study evaluated an organisational intervention, and two studies evaluated a combination of technical and organisational interventions. Four studies reported on data quality and six studies reported on service quality. In terms of data quality, a web-based electronic TB laboratory information system probably reduces the length of time to reporting of TB test results, and probably reduces the overall rate of recording errors of TB test results, compared to a paper-based system (moderate certainty evidence). We are uncertain about the effect of the electronic laboratory information system on the recording rate of serious (misidentification) errors for TB test results compared to a paper-based system (very low certainty evidence). Misidentification errors are inaccuracies in transferring test results between an electronic register and patients' clinical charts. We are also uncertain about the effect of the intervention on service quality (timeliness of starting or changing a patient's TB treatment) (very low certainty evidence). A hand-held electronic device probably improves the length of time to report TB test results, and probably reduces the total frequency of recording errors in TB test results between the laboratory notebook and the electronic information record system, compared to a paper-based system (moderate-certainty evidence). We are, however, uncertain about the effect of the intervention on the frequency of serious (misidentification) errors in recording between the laboratory notebook and the electronic information record, compared to a paper-based system (very low certainty evidence). We are uncertain about the effect of a hospital electronic health information system on service quality (length of time outpatients spend at hospital, length of hospital stay, and hospital revenue collection), compared to a paper-based system (very low certainty evidence). High-intensity brief text messaging (SMS) may make little or no difference to data quality (in terms of completeness of documentation of pregnancy outcomes), compared to low-intensity brief text messaging (low-certainty evidence). We are uncertain about the effect of electronic drug stock notification (with either data management support or product transfer support) on service quality (in terms of transporting stock and stock levels), compared to paper-based stock notification (very low certainty evidence). We are uncertain about the effect of health information strengthening (where it is part of comprehensive service quality improvement intervention) on service quality (health worker motivation, receipt of training by health workers, health information index scores, quality of clinical observation of children and adults) (very low certainty evidence). AUTHORS' CONCLUSIONS: The review indicates mixed effects of mainly technical interventions to improve data quality, with gaps in evidence on interventions aimed at enhancing data-informed health system management. There is a gap in interventions studying information support beyond clinical management, such as for human resources, finances, drug supply and governance. We need to have a better understanding of the causal mechanisms by which information support may affect change in management decision-making, to inform robust intervention design and evaluation methods.


Assuntos
Assistência à Saúde/organização & administração , Sistemas de Informação em Saúde/normas , Política Organizacional , Melhoria de Qualidade , Viés , Sistemas de Informação em Laboratório Clínico/organização & administração , Sistemas de Informação em Laboratório Clínico/normas , Computadores de Mão , Coleta de Dados/normas , Tomada de Decisões , Assistência à Saúde/normas , Serviços de Informação sobre Medicamentos/normas , Sistemas de Informação Hospitalar/normas , Testes de Sensibilidade Microbiana , Inovação Organizacional , Preparações Farmacêuticas/provisão & distribução , Ensaios Clínicos Controlados Aleatórios como Assunto , Envio de Mensagens de Texto/normas , Tuberculose/diagnóstico , Tuberculose/tratamento farmacológico
4.
Yakugaku Zasshi ; 140(6): 759-761, 2020.
Artigo em Japonês | MEDLINE | ID: mdl-32475923

RESUMO

In the Basic Principles for the Preparation of the Japanese Pharmacopoeia (JP), 18th edition, the JP is referred to as an official document that defines the specifications, criteria, and standard test methods necessary to properly ensure the quality of medicines in Japan and as a public property that should be widely used by all parties concerned, such as pharmaceutical administrations, companies, and those involved in research, education, and medical practice. In addition, it states that the JP should play an appropriate role of providing information and proper understanding of drug quality to the public and should promote and maintain advances, consistency, and harmonization of technical requirements in the international community. These show that the JP not only contributes as a written standard but also as a provider of information on test methods and international understanding for drug quality control. JP articles refer to a wide range of drugs at various phases of the product life cycle, as it should cover all drugs in terms of importance from the healthcare viewpoint. When the JP is viewed from a panoramic perspective, these are the reasons why its contents are extremely profound and complex. This report discusses the JP's role and expected future as a scientific document from the author's viewpoint as a JP Expert Committee member for more than 30 years.


Assuntos
Farmacopeias como Assunto , Serviços de Informação sobre Medicamentos , Japão , Farmacopeias como Assunto/normas , Controle de Qualidade
5.
Stud Health Technol Inform ; 270: 63-67, 2020 Jun 16.
Artigo em Inglês | MEDLINE | ID: mdl-32570347

RESUMO

Drugs information systems, prescription support softwares, and drug decision support systems need to reason on drug properties. Combined pharmaceutical products need to be considered specifically because they may require a specific processing. Hence, they also need to be identified to automate the population of databases with up-to-date property values. We defined a set of digital filters designed for the identification of antibiotics in a public database. Four different filters are proposed, to be combined to extract the relevant information. Evaluation was conducted to combine filters and retrieve information about rand combined antibiotics with success. However, information provided in the structured files of the French drug database is limited; information provided in the HTML files suffers from a lack of quality. Hence, reuse of this data and this information should be performed very cautiously.


Assuntos
Bases de Dados Factuais , Serviços de Informação sobre Medicamentos , França
6.
Fundam Clin Pharmacol ; 34(3): 389-396, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: covidwho-246344

RESUMO

On March 16, 2020, the French Society of Pharmacology and Therapeutics put online a national Question and Answer (Q&A) website, https://sfpt-fr.org/covid19 on the proper use of drugs during the COVID-19 pandemic. The working group 'Drugs and COVID-19' was composed of a scientific council, an editorial team, and experts in the field. The first questions were posted online during the first evening of home-confinement in France, March 17, 2020. Six weeks later, 140 Q&As have been posted. Questions on the controversial use of hydroxychloroquine and to a lesser extent concerning azithromycin have been the most consulted Q&As. Q&As have been consulted 226 014 times in 41 days. This large visibility was obtained through an early communication on Twitter, Facebook, traditional print, and web media. In addition, an early communication through the French Ministry of Health and the French National Agency for Medicines and Health Products Safety ANSM had a large impact in terms of daily number of views. There is a pressing need to sustain a public drug information service combining the expertise of scholarly pharmacology societies, pharmacovigilance network, and the Ministry of Health to quickly provide understandable, clear, expert answers to the general population's concerns regarding COVID-19 and drug use and to counter fake news.


Assuntos
Betacoronavirus/efeitos dos fármacos , Informação de Saúde ao Consumidor/métodos , Infecções por Coronavirus , Serviços de Informação sobre Medicamentos/organização & administração , Pandemias , Pneumonia Viral , Sociedades Farmacêuticas , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/virologia , França , Humanos , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/epidemiologia , Pneumonia Viral/virologia , Saúde Pública/métodos , Rede Social
7.
Yakugaku Zasshi ; 140(5): 677-685, 2020.
Artigo em Japonês | MEDLINE | ID: mdl-32378672

RESUMO

The environment surrounding clinical pharmacy practices has changed greatly in the past thirty-some years, basically since the end of the 1980s. During this period, the separation ratio between pharmacists' dispensing and prescribing functions has increased, from 12% to 74%. The three big events in this timeline include the beginning of pharmaceutical care for inpatients by hospital pharmacists in 1988; the transition of pharmacy schools to a six-year educational program in 2006; and the revision of Pharmaceutical Affairs Law, as well as its name change, in 2014. In concert with these events, the central role of the pharmacist has changed from being dispensing-centric to an active participation in patient treatment via medication as a member of the medical care team. As a key participant in these changes, the author helped to improve the operations of hospital pharmacists, strengthened their role with advanced information and communication technology (ICT) support, and established a baseline for clinical pharmacy research and education. Accordingly, in this paper, the history of this development will be reviewed, and the future of a global standard for pharmaceutical education will be discussed.


Assuntos
Educação em Farmácia/normas , Educação em Farmácia/tendências , Internacionalidade , Farmacêuticos , Papel Profissional , Serviços de Informação sobre Medicamentos , Feminino , Humanos , Masculino , Equipe de Assistência ao Paciente , Serviço de Farmácia Hospitalar
8.
Fundam Clin Pharmacol ; 34(3): 389-396, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32394481

RESUMO

On March 16, 2020, the French Society of Pharmacology and Therapeutics put online a national Question and Answer (Q&A) website, https://sfpt-fr.org/covid19 on the proper use of drugs during the COVID-19 pandemic. The working group 'Drugs and COVID-19' was composed of a scientific council, an editorial team, and experts in the field. The first questions were posted online during the first evening of home-confinement in France, March 17, 2020. Six weeks later, 140 Q&As have been posted. Questions on the controversial use of hydroxychloroquine and to a lesser extent concerning azithromycin have been the most consulted Q&As. Q&As have been consulted 226 014 times in 41 days. This large visibility was obtained through an early communication on Twitter, Facebook, traditional print, and web media. In addition, an early communication through the French Ministry of Health and the French National Agency for Medicines and Health Products Safety ANSM had a large impact in terms of daily number of views. There is a pressing need to sustain a public drug information service combining the expertise of scholarly pharmacology societies, pharmacovigilance network, and the Ministry of Health to quickly provide understandable, clear, expert answers to the general population's concerns regarding COVID-19 and drug use and to counter fake news.


Assuntos
Betacoronavirus/efeitos dos fármacos , Informação de Saúde ao Consumidor/métodos , Infecções por Coronavirus , Serviços de Informação sobre Medicamentos/organização & administração , Pandemias , Pneumonia Viral , Sociedades Farmacêuticas , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/virologia , França , Humanos , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/epidemiologia , Pneumonia Viral/virologia , Saúde Pública/métodos , Rede Social
9.
Yakugaku Zasshi ; 140(4): 543-554, 2020.
Artigo em Japonês | MEDLINE | ID: mdl-32238637

RESUMO

I have been exploring methods for education and research on drug information for 43 years. There are various approaches to drug informatics research, which include collecting, evaluating, and analyzing information to solve drug related problems, sometimes producing new information from experiments and clinical research. All are based on information science. Drug informatics is information science from the viewpoint of pharmaceuticals. In addition to basic pharmacology, knowledge and skills such as epidemiology, data science, computer science, mathematical statistics, and communication studies are indispensable for the development of drug informatics.


Assuntos
Serviços de Informação sobre Medicamentos , Educação em Farmácia , Animais , Comunicação , Ciência de Dados , Epidemiologia , Humanos , Conhecimento , Matemática , Informática Médica
10.
Med Sci Monit ; 26: e920872, 2020 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-32114589

RESUMO

FUZI (Aconiti Lateralis Radix Praeparata) is a traditional Chinese medicine herb used extensively for nourishing yang (regarded as the positive, male universal force), which is critical in treatment of allergic rhinitis. In this paper, FUZI was explored based on network pharmacology. The active components of FUZI were screened out, its protein targets were assessed, and the protein interaction network map was built with the differential protein of allergic rhinitis, as an attempt to determine the critical targets of FUZI for treating allergic rhinitis. Subsequently, DAVID was employed to explore the biological function and pathway enrichment to determine the biological pathway of FUZI for treating allergic rhinitis. As suggested by the results, FUZI is likely to affect the inhibition of inflammation and the regulation of immunity, probably reducing the incidence of allergic rhinitis, or alleviating nasal discomfort attributed to allergic inflammation. The targets and pathways of FUZI for treating allergic rhinitis assessed by network pharmacology provided a direction for our subsequent studies and may be a novel therapeutic target.


Assuntos
Aconitum , Imunidade/efeitos dos fármacos , Extratos Vegetais/farmacologia , Rinite Alérgica , Anti-Inflamatórios/farmacologia , Serviços de Informação sobre Medicamentos , Medicamentos de Ervas Chinesas/farmacologia , Humanos , Medicina Tradicional Chinesa/métodos , Rinite Alérgica/tratamento farmacológico , Rinite Alérgica/imunologia
11.
Eur J Obstet Gynecol Reprod Biol ; 247: 42-48, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32058188

RESUMO

OBJECTIVE: We aimed to characterize drug exposures during pregnancy where the outcome was known that had benefited from counselling through our Teratology Information Service (TIS) between 1994-2016. STUDY DESIGN: This observational study analysed data collected through the drug exposures during pregnancy counselling. Data was analysed descriptively. RESULTS: Data from a total of 1'374 pregnant women were collected. Mean age was of 32 years. These women were exposed to more than ten drugs in 1.4 % (N = 19) of cases, with a mean drug intake of two. Analysis of the drugs altogether (N = 3'129) showed that FDA Pregnancy Category C drugs represented 42.9 % (N = 1'342) of drugs and ATC code N (nervous system) represented 36.4 % (N = 1'138). The onset of drug exposure was during the first trimester of pregnancy in 95.1 % (N = 2'982) of patients. Regarding outcomes, the rate of induced abortion was 10.8 % (N = 151), of pregnancy complications was 11.2 % (N = 157) and of malformations was 4.5 % (N = 49). CONCLUSION: Pregnant women counselled by our TIS take a mean of two drugs, ranging from one to 17. Drugs are from FDA Pregnancy Category C and ATC N drugs in most cases, 42.9 % and 36.4 % respectively. The rate of malformation of our cohort was of 4.5 %, close to the estimated spontaneous rate of malformation. This data gives a reassuring aspect of drug exposure in pregnancy but takes into account the outcome at birth only.


Assuntos
Anormalidades Induzidas por Medicamentos/epidemiologia , Resultado da Gravidez/epidemiologia , Efeitos Tardios da Exposição Pré-Natal/epidemiologia , Aborto Induzido/estatística & dados numéricos , Adulto , Aconselhamento , Serviços de Informação sobre Medicamentos , Feminino , Humanos , Gravidez , Estudos Prospectivos , Teratologia/estatística & dados numéricos , Adulto Jovem
12.
Drug Metab Pharmacokinet ; 35(1): 2-11, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31996310

RESUMO

The current EMA drug interaction guideline was published in 2012. This guideline gives important recommendations on the information required to elucidate the interaction potential of an investigational drug, both as effects of the investigational drug on the PK of other drugs and effects of other medicinal products on the PK of the investigational drug. Additional information on the use of PBPK modelling to inform drug interaction information, is also available in the guideline on the reporting of physiologically based modelling and simulation (2018). Some points of clarification on the drug interaction guideline, particularly in the area of enzyme induction screening, have been published as the EMA questions and answers (2014) and these points and further additional points, were proposed to be incorporated into a new update of the guideline, for which a concept paper was published in 2017. This update, which is still in progress, was to include new recommendations in line with relevant emerging scientific data (e.g. in the area of drug transporters). It is also intended to harmonise requirements on drug interactions with other Regulatory Agencies and this will be facilitated by the recently announced ICH initiative.


Assuntos
Serviços de Informação sobre Medicamentos , União Europeia , Órgãos Governamentais , Interações Medicamentosas , Guias como Assunto , Humanos
13.
Drug Metab Pharmacokinet ; 35(1): 12-17, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31902469

RESUMO

Drug interactions, in particular with concomitant drugs having a narrow therapeutic range, sometimes cause serious adverse drug reactions or attenuation of the therapeutic effect. Therefore, evaluation of the characteristics and severities of possible drug interactions in drug development is essential to understand such interactions to help prevent any potential risk for patients. In Japan, a regulatory document which was notified in 2001 to outline the basic principles of drug interaction studies during drug development was revised as a new guideline after 17 years to present general procedures that are currently considered scientifically valid. This article aims to present an overview of development process of the new Japanese guideline for investigating drug interactions and show the impact of implementating this guideline on drug interaction evaluations, thereby providing future perspectives of regulatory activities on drug interactions.


Assuntos
Desenvolvimento de Medicamentos , Serviços de Informação sobre Medicamentos , Preparações Farmacêuticas/metabolismo , Interações Medicamentosas , Guias como Assunto , Humanos , Japão
15.
Res Social Adm Pharm ; 16(1): 62-67, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-30853509

RESUMO

BACKGROUND: People with visual impairment presents difficulties to access the labels information of medicines. In this sense, technological tools can contribute to improve access to this information and the appropriate use of medicines in this population. However, currently, in Colombia, there are no tools to facilitate this process. OBJECTIVE: To design and development of a mobile app of drug information for people with visual impairment, which allows them to access information for the appropriate use of medicines. METHODS: A user-centered design process is carried out in four phases was used: a) Identification the needs and barriers for appropriate use of medicines; b) Lifting of requirements, c) Interface design and prototyping, and development of the mobile app, and d) Usability test. RESULTS: The study involved 48 people with visual disability, of which 69% required assistance for the use of medicines. The main barriers identified were access to information and dosing. A total of ten user requirements were identified, based on these and international accessibility standards FarmaceuticApp was designed and developed, incorporating the problems that were identified in the usability test. CONCLUSION: A mobile app of drug information for people with visual impairment using a user-centered design process was designed and developed, highlighting the importance of involving the users and other stakeholders in the design and development m-health technologies. FarmaceuticApp could contribute to the appropriate use of medicines and improve therapeutic adherence, as well as autonomy and independence in people with visual impairment.


Assuntos
Serviços de Informação sobre Medicamentos , Aplicativos Móveis , Transtornos da Visão , Humanos , Segurança do Paciente , Preparações Farmacêuticas
16.
Health Info Libr J ; 36(4): 295-298, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31829504

RESUMO

Journal clubs are an effective means to increase skills in handling evidence and support the continuing professional development of library and knowledge services workers. This editorial examines the progression of HILJ Club, an online journal club, from an idea to the launch of a dedicated platform. One article is selected per issue of the Health Information and Libraries Journal with an open discussion invited following a brief summary and reflections by a host. Participation in HILJ Club is growing. Future success is reliant on wider engagement, and an invitation is extended to join in the discussions or even host an edition.


Assuntos
Biblioteconomia , Publicações Periódicas como Assunto , Literatura de Revisão como Assunto , Informação de Saúde ao Consumidor , Serviços de Informação sobre Medicamentos , Humanos
17.
Pharm. pract. (Granada, Internet) ; 17(4): 0-0, oct.-dic. 2019. tab, graf
Artigo em Inglês | IBECS | ID: ibc-191953

RESUMO

BACKGROUND: The study was carried out as part of the European Network for Patient Safety (EUNetPas) project in 2008-2010. OBJECTIVE: To investigate facilitators and barriers in implementation process of selected medication safety practices across hospitals within European Union countries. METHODS: This was an implementation study of seven selected medication safety practices in 55 volunteering hospitals of 11 European Union (EU) member states. The selected practices were: two different versions of medicine bed dispensation; safety vest; discharge medication list for patients; medication reconciliation at patient discharge; medication reconciliation at patient admission and patient discharge, and sleep card. The participating hospitals submitted an evaluation report describing the implementation process of a chosen practice in their organisation. The reports were analysed with inductive content analysis to identify general and practice-specific facilitators and barriers to the practice implementation. RESULTS: Altogether 75 evaluation reports were submitted from 55 hospitals in 11 EU member states. Implementation of the medication safety practices was challenging and more time consuming than expected. The major reported challenge was to change the work process because of the new practice. General facilitators for successful implementation were: existence of safety culture, national guidelines and projects, expert support, sufficient resources, electronic patient records, interdisciplinary cooperation and clinical pharmacy services supporting the practice implementation. CONCLUSIONS: The key for the successful implementation of a medication safety practice is to select the right practice for the right problem, in the right setting and with sufficient resources in an organization with a safety culture


No disponible


Assuntos
Humanos , Gestão da Segurança/organização & administração , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Prescrição Inadequada/prevenção & controle , Assistência Farmacêutica/organização & administração , Serviços de Informação sobre Medicamentos/organização & administração , Serviço de Farmácia Hospitalar/organização & administração , União Europeia/estatística & dados numéricos , Segurança do Paciente/normas , Reconciliação de Medicamentos/normas , Pesquisas sobre Serviços de Saúde/estatística & dados numéricos , Registros de Saúde Pessoal , Registros Hospitalares/normas , Assistência à Saúde/organização & administração , Admissão do Paciente/normas , Implementação de Plano de Saúde/organização & administração , Sumários de Alta do Paciente Hospitalar/normas , Continuidade da Assistência ao Paciente/organização & administração
18.
Health Info Libr J ; 36(4): 299-317, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31617680

RESUMO

BACKGROUND: Pharmacy-led medicine information (MI) services are available in many countries to support clinicians and patients make decisions on use of medicines. OBJECTIVES: To establish what impact, if any, pharmacy-led MI services have on clinician and patient outcomes. METHODS: All published works indexed in Embase or PubMed, meeting this review's inclusion and exclusion criteria, that wholly or partially attempted to measure the effects of MI advice were retrieved and assessed. RESULTS: Twenty studies were reviewed. Five broad themes were identified describing study findings, three were specific to clinicians: their views on the effect MI answers had; actions they took; and influence on their decision making. A fourth theme centred on patient utilisation of advice, and the fifth on 'process measures' attempting to determine MI worth. DISCUSSION: Studies report on positive patient outcomes as a direct result of MI advice. Clinicians and patients acted upon the advice provided. Clinicians also reported using MI advice as a 'safety net', to check, reassure or confirm what to do. MI advice also demonstrated economic worth, although these studies are old. CONCLUSION: MI Service advice appears to affect clinician and patient outcomes. However, study design limitations require findings be viewed cautiously.


Assuntos
Tomada de Decisões , Serviços de Informação sobre Medicamentos , Serviço de Farmácia Hospitalar , Humanos , Comportamento de Busca de Informação , Resultado do Tratamento
19.
Farm. comunitarios (Internet) ; 11(3): 22-41, sept. 2019.
Artigo em Espanhol | IBECS | ID: ibc-186881

RESUMO

La prestación de servicios profesionales farmacéuticos asistenciales (SPFA) al paciente des-de la farmacia comunitaria ha de realizarse observando una serie de garantías sanitarias y legales previas que aseguren los derechos del paciente. Toda actuación en el ámbito de la salud de un paciente necesita su consentimiento libre y voluntario una vez que haya recibido la in-formación adecuada. Esta información que, como regla general, se proporcionará verbalmente (salvo en los casos de procedimientos invasivos, que son los que entrañan riesgos más graves), ha de ser veraz e incluir como mínimo la finalidad y la naturaleza de cada intervención, sus riesgos y sus consecuencias, y se debe comunicar al paciente de forma comprensible y adaptada a sus necesidades, de forma que le ayude a tomar decisiones de acuerdo con su propia y libre voluntad. De este modo, para que el paciente consienta que se le preste un SPFA ha de recibir previamente una información específica sobre dicho servicio. Aunque esta información se po-dría proporcionar solo verbalmente, al ser los SPFA servicios novedosos con los que el paciente no está familiarizado, es recomendable proporcionarla también por escrito ya que esta vía per-mite garantizar que se comunica de forma uniforme, comprensible, evitando equivocaciones y olvidos, y además el paciente tendrá más tiempo para estudiarla en su casa. Este artículo analiza la información mínima que se debe proporcionar a los pacientes y usuarios en la prestación de los SPFA. Además, muestra como ejemplo tanto la información que se proporciona al paciente en cinco de los SPFA que gestiona la aplicación SEFAC e_XPERT®, como un modelo de consen-timiento informado válido para dichos servicios y que incluye el resto de información necesaria que también se debe comunicar previamente al paciente


The provision of professional pharmaceutical care services (SPFA) to the patient from the community pharmacy must be carried out by observing a series of previous health and legal guarantees that ensure the rights of the patient. Any action in the area of a patient’s health requires his or her free and voluntary consent once he or she had received the appropriate information. This information will, as a general rule, be provided orally (except in the case of invasive procedures, which are the ones with the most serious risks), must be truthful and include at least the purpose and nature of each intervention, its risks and its consequences, and must be communicated to the patient in a way that is understandable and adapted to his or her needs, in a way that helps you make decisions according to your own free will. Thus, in order for the patient to consent to the provision of an SPFA, he must first receive specific information about that service. Although this information could be provided only verbally, as SPFAs are novel services with which the patient is not familiar, it’s advisable to provide it also in writing, as this way ensures that it communicates uniformly, comprehensively, avoiding mistakes and forgetfulness, and also that the patient will have more time to study it at home. This article discusses the minimum information to be provided to patients and users in the provision of SPFA. In addition, it shows, as an example, the information provided to the patient in five of the SPFA that manage the SEFAC e_XPERT®application, as well as an informed consent model which includes all other necessary information which must also be communicated to patient


Assuntos
Humanos , Assistência Farmacêutica/organização & administração , Farmácias , Serviços de Informação sobre Medicamentos , Informação de Saúde ao Consumidor , Tomada de Decisões , Autonomia Pessoal , Legislação de Medicamentos , Farmacêuticos/legislação & jurisprudência , Farmacêuticos/organização & administração
20.
PLoS One ; 14(8): e0221326, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31437201

RESUMO

OBJECTIVES: To assess the impact of sources of drug information on antibiotic prescribing patterns (quantity and quality) among primary care physicians. METHODS: We conducted a cohort study on primary care physicians who were actively engaged in medical practice in 2010 in a region in north-west Spain (Galicia), fulfilling inclusion criteria (n = 2100). As the independent variable, we took the perceived utility of 6 sources of information on antibiotics, as measured by the validated KAAR-11 questionnaire. As dependent variables, we used: (1) a quality indicator (appropriate quality, defined as any case where 6 of the 12 indicators proposed by the European Surveillance of Antimicrobial Consumption Network [ESAC-Net] were better than the mean values for Spain); and, (2) a quantity indicator (high prescribing), defined as any case where defined daily doses (DDD) per 1 000 inhabitants per day of antibacterials for systemic use were higher than the mean values for Spain. The adjusted odds ratio for a change in the interquartile range (IqOR) for each sources of information on antibiotics was calculated using Generalized Linear Mixed Models. RESULTS: The questionnaire response rate was 68%. Greater perceived utility of pharmaceutical sales representatives increases the risk of having high prescribing (1/IqOR = 2.50 [95%CI: 1.63-3.66]) and reduces the probability of having appropriate quality (1/IqOR = 2.28 [95%CI: 1.77-3.01]). Greater perceived utility of clinical guidelines increases the probability of having appropriate quality (1/IqOR = 1.25 [95%CI: 1.02-1.54]) and reduces the probability of high prescribing (1/IqOR = 1.25 [95%CI: 1.02-1.54]). CONCLUSIONS: Sources of information on antibiotics are an important determinant of the quantity and quality of antibiotic prescribing in primary care. Commercial sources of information influence prescribing negatively, and clinical guidelines are associated with better indicators.


Assuntos
Antibacterianos/uso terapêutico , Atitude do Pessoal de Saúde , Serviços de Informação sobre Medicamentos/provisão & distribução , Prescrições de Medicamentos/estatística & dados numéricos , Médicos de Atenção Primária/psicologia , Padrões de Prática Médica/estatística & dados numéricos , Seguimentos , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Razão de Chances , Guias de Prática Clínica como Assunto , Indicadores de Qualidade em Assistência à Saúde/estatística & dados numéricos , Espanha , Inquéritos e Questionários
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