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Objective. To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries’ regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are considered as trusted regulatory authorities to rely on. Methods. Websites from LAC regulators were searched to identify the official regulations to approve new drugs. Data collection was carried out in December 2019 and completed in June 2020 for the Caribbean countries. Two independent teams collected information regarding direct recognition or abbreviated processes to approve new drugs and the reference (trusted) regulators defined as such by the corresponding national legislation. Results. Regulatory documents regarding marketing authorization were found in 20 LAC regulators’ websites, covering 34 countries. Seven countries do not accept reliance on foreign regulators. Thirteen regulatory authorities (Argentina, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay, and the unique Caribbean Regulatory System for 15 Caribbean States) explicitly accept relying on marketing authorizations issued by the European Medicines Agency, United States Food and Drug Administration, and Health Canada. Ten countries rely also on marketing authorizations from Australia, Japan, and Switzerland. Argentina, Brazil, Chile, and Mexico are reference authorities for eight LAC regulators. Conclusions. Regulatory reliance has become a common practice in the LAC region. Thirteen out of 20 regulators directly recognize or abbreviate the marketing authorization process in case of earlier approval by a regulator from another jurisdiction. The regulators most relied upon are the European Medicines Agency, United States Food and Drug Administration, and Health Canada.

Objective. To assess all the incidents of substandard, falsified and unregistered medicines in 2017 and 2018 in Latin America, determining the types of products affected, stages of the supply chain in which incidents were detected, quality deviations identified in tested samples, and regulatory measures taken by authorities. Methods. A comprehensive search of the websites of the Latin American national regulatory authorities was conducted, identifying all eligible incidents during 2017-2018. Standardized values were collected from each incident for pre-determined variables: country, year, type of incident, therapeutic group, supply chain, regulatory measures and laboratory data. Results. A total of 596 incidents in 13 countries were included (236 substandard, 239 falsified, 116 unregistered and 5 stolen). The therapeutic categories with the highest incidents were: anti-infectives, medicines for pain/palliative care, hormones/contraceptives, medicines for the respiratory tract, and medicines for mental/ behavioural disorders. The most common places where incidents were detected were commercial establishment, pharmacies, health services and manufacturers. The most recurrent quality deviations were failure in parameters (appearance or physicochemical), incorrect labelling, different quantity of active pharmaceutical ingredient, presence of unknown particles, and microbiological contamination. The most frequent regulatory measures identified were alerts, withdrawals, seizures, and prohibition of marketing/distribution/use. Conclusions. In Latin America, substandard, falsified and unregistered medicines persist as a highly prevalent problem. An advanced degree of regulatory development in countries is associated with higher incident detection/reporting rates and a more comprehensive set of measures. The pharmaceutical supply chain is more vulnerable in its final node. Quality deviations identified in tested samples pose serious risks to public health.

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., Competing Interests: Declaration of competing interest None declared., (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). Publicado por Elsevier España, S.L.U. All rights reserved.)

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., (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). Publicado por Elsevier España, S.L.U. All rights reserved.)

Medicines are an economic good and a fundamental component of public and private spending and health decision-making. Assurance of their quality, efficiency and safety is essential. However, the variety of products on the Chilean market, including innovative and generic products—the latter accounted for by many products that are certified as bioequivalent while others are not—results in a potentially confusing scenario for consumers and health providers. In this review, we intend to shed light on the concepts of bioequivalency (applicable to compounds of small molecular size) and biosimilarity (applicable to biological compounds of greater molecular complexity). In both cases, how the active substance interacts with the host organism must be demonstrated by studies carried out for this purpose. A direct application of the concept of bioequivalence is interchangeability, defined as the possibility of using a product of the same active principle, as long as the pharmaceutical form and dosage scheme are the same. Regulations related to bioequivalence and biosimilarity must not only guarantee safety and efficacy when products are interchanged, but also facilitate cost savings and access to medicines. Likewise, the implementation of evidence-based guidelines that standardize concepts of interchangeability should be encouraged, as this could lead to a more educated usage and a reduction in the information asymmetry between patients (users) and the industry. The importance of interchangeability of medicines is particularly relevant in two governmental health initiatives in Chile: the Explicit Health Guarantees Plan (GES) and the Financial Protection for Diagnoses and Treatments of High Cost, known as the “Ricarte Soto” Act. Nonetheless, it is not possible to guarantee that all alternative products to an innovative drug on the Chilean market are bioequivalent. The synthesis of knowledge available on this subject may impact and contribute to decision-making by stakeholders. It could also help to develop better health policies regarding bioequivalent and biosimilar pharmaceutical products in our country.

Context: There are standards that allow establishing the microbiological and physicochemical stability of a medicine; however, beyond use date of drugs depends not only on these criteria, but also on individual institutional characteristics. The multiple factors that involve the allocation of the stability of a medication, if not properly articulated, can lead to therapeutic failures and adverse events in patients. Aims: To design an algorithm to determine the stability beyond use date of a drug in a high complexity healthcare institution. Methods: Pharmaceutical form, packaging, and administration route were defined for each drug. Physicochemical and microbiological stability were assigned to each product. An algorithm was built with the collected information. The stability beyond use date was the shortest time registered between microbiological and physicochemical stability, however, the information of the manufacturer was respected. Results: A total of 938 drugs were analyzed, which 606 (64.6%) were considered as single-dose and 332 (35.4%) as multiple-dose. The mean reason to assign a drug as a single-dose with 90.9% was pharmaceutical form unable to storage, tablet, capsule, and ampoule the most frequent. The main cause with 54.4% to assign a drug as multiple-dose was synthetic products with liquid and semisolid pharmaceutical forms whose packaging materials were allowed to storage after its first use. Conclusions: An algorithm was designed, which can assign the stability beyond use date of drugs using an easy and reliable, generating a more safety use inside the institution.

Background: heptahydrate magnesium sulfate was obtained by chemical synthesis using seawater. The physicochemical characterization of the product was performed, with specifications according to international standards. The study included the microbiological properties.Objective: to assess the microbiological properties of magnesium sulfate obtained from seawater as a natural source, for pharmaceutical uses.Methods: the microbiological studies were conducted at the Pharmaceutical Laboratory of Oral Liquids (MEDILIP) of the city of Bayamo, Cuba. The analysis of the microbial limits was carried out according to the methodology for non-sterile products described by the 38th United States Pharmacopeia. Different culture media were used.Results: during the study period, the product showed effective resistance to the growth of Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans, Aspergillus brasiliensis, E. coli, with counts according to the limits established for non-sterile products.Conclusions: the results of the microbiological study showed that synthesized heptahydrate magnesium sulfate fulfills the requirements for its pharmaceutical use.

Introduction: The primary objective of this study is to describe the design and implementation of a mobile application (App) for tracking preparations compounded in the Pharmacy Department. Secondary objectives include: i) evaluating the time spent on resolving incidents related to the distribution of preparations before and after implementation, ii) assessing users satisfaction with the application, and iii) establishing a panel of quality indicators based on the data extracted from the App., Methods: 1) Defining application requirements, identifying drugs to be included in the software and outlining different workflows. 2) Developing the App in collaboration with the supplier and integrating it with the computer programs involved in prescription and validation. Additionally, QR codes were created to identify delivery points at destination units, and suitable mobile devices were acquired. The initial phase involved user training in the application and a pilot test conducted in a hospital ward. 3) The subsequent phase focused on expansion and consolidation., Results: The system includes 86.9% of all sterile preparations prepared in the Hospital Pharmacy, encompassing chemotherapy, adult parenteral nutrition, and other non-hazardous sterile preparations. Furthermore, the application has been implemented in all hospitalisation wards, day care units and two external sites. On average, 5403 preparations were tracked per month (SD = 297.3). The time required to address incidents related to the distribution of preparations has decreased by 83% (from 38.9 to 6.6 min per day). The App regularly provides valuable management data for optimising workflow in the compounding area. Additionally, users have expressed satisfaction with the application., Discusion: The proposed application enables hospital staff to easily and intuitively track preparations compounded in the Pharmacy, irrespective of the computer program used for prescription. It has significantly reduced the need for manual record-keeping and has mitigated incidents associated with the distribution of sterile preparations., Competing Interests: Conflicts of interest None declared., (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). Publicado por Elsevier España, S.L.U. All rights reserved.)

Introduction: The primary objective of this study is to describe the design and implementation of a mobile application (App) for tracking preparations compounded in the Pharmacy Department. Secondary objectives include evaluating the time spent on resolving incidents related to the distribution of preparations before and after implementation, assessing users satisfaction with the application, and establishing a panel of quality indicators based on the data extracted from the App., Methods: Defining application requirements, identifying drugs to be included in the software and outlining different workflows. Developing the App in collaboration with the supplier and integrating it with the computer programs involved in prescription and validation. Additionally, QR codes were created to identify delivery points at destination units, and suitable mobile devices were acquired. The initial phase involved user training in the application and a pilot test conducted in a hospital ward. The subsequent phase focused on expansion and consolidation., Results: The system includes 86.9% of all sterile preparations prepared in the Hospital Pharmacy, encompassing chemotherapy, adult parenteral nutrition, and other non-hazardous sterile preparations. Furthermore, the application has been implemented in all hospitalization wards, day care units and two external sites. On average, 5,403 preparations were tracked per month (SD = 297.3). The time required to address incidents related to the distribution of preparations has decreased by 83% (from 38.9 to 6.6 minutes per day). The App regularly provides valuable management data for optimizing workflow in the compounding area. Additionally, users have expressed satisfaction with the application., Discusion: The proposed application enables hospital staff to easily and intuitively track preparations compounded in the pharmacy, irrespective of the computer program used for prescription. It has significantly reduced the need for manual record-keeping and has mitigated incidents associated with the distribution of sterile preparations., (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). Publicado por Elsevier España, S.L.U. All rights reserved.)

Introducción. Según la Organización Mundial de Salud, el cumplimiento del tratamiento de la tuberculosis puede definirse como el grado en que la toma de los medicamentos por parte de un paciente coincide con el tratamiento prescrito. La suma de los pacientes curados y de quienes finalizan el tratamiento (estrategia de observación directa), son indicadores pragmáticos del cumplimiento del tratamiento. Objetivos. Determinar la relación entre el cumplimiento del tratamiento contra la tuberculosis y los factores sociodemográficos, económicos y clínicos, y los relacionados con los medicamentos, tanto de índole objetiva como subjetiva, en pacientes mayores de 18 años. Materiales y métodos. Se hizo un estudio descriptivo transversal de 174 registros de pacientes del programa de control de la tuberculosis y de 15 entrevistas semiestructuradas hechas a los pacientes que no cumplían con el tratamiento durante el periodo comprendido entre junio de 2012 y junio de 2013. Resultados. El cumplimiento del tratamiento en pacientes con tuberculosis pulmonar fue de 94,8 % y fue mayor en los pacientes del régimen contributivo (p=0,035). El incumplimiento del tratamiento fue de 5,2 %. La intolerancia a los medicamentos fue mayor en el grupo de quienes no cumplieron el tratamiento. La falta de apoyo familiar, el abandono del trabajo, el impacto económico y la insatisfacción con la oportunidad de la atención en la institución de salud, fueron factores importantes a la hora de incumplir el tratamiento. Conclusiones. El régimen de afiliación al sistema de salud y la tolerancia a los medicamentos fueron los factores objetivos relacionados con el cumplimiento del tratamiento y, la carga social y económica de la enfermedad, el factor subjetivo.

Resumo: Este artigo teve como objetivo identificar as fontes de obtenção de medicamentos utilizadas por usuários do Sistema Único de Saúde (SUS) com relato de doenças crônicas, caracterizando tal população quanto a variáveis demográficas, socioeconômicas e de saúde nas diferentes regiões do Brasil. Foram analisados dados da Pesquisa Nacional sobre o Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil (PNAUM), um estudo transversal de base populacional. A variável dependente foi a “fonte de obtenção de medicamentos” e foram analisadas associações com variáveis demográficas, socioeconômicas e com o estado de saúde. Os usuários que obtiveram cuidado e medicamentos unicamente no SUS foram aqui designados como SUS-exclusivos. Cerca de 39% das pessoas obtiveram seus medicamentos exclusivamente em farmácias do SUS e 28,5% recorreram a outras fontes. Foram encontrados 42,9%, 41,8%, 40,2%, 31%, usuários SUS-exclusivos, respectivamente, no Sudeste, Sul, Norte, e Nordeste. Os usuários do SUS têm como fonte primária de medicamentos o próprio SUS, entretanto há uma participação relevante de outras fontes de obtenção, indicando problemas no acesso dentro do SUS. No Sul e Sudeste, a população busca menos a farmácia privada do que no Nordeste e Norte do país.

Background: adverse drug effects are a health problem on a worldwide scale and increase the costs of hospital care considerably.Objective: to describe the adverse drug reactions reported to the pharmacovigilance database of the province of Las Tunas, from January to June 2017.Methods: a pharmacovigilance, observational, descriptive and cross-sectional study was carried out at the aforementioned place and during the period herein declared. The sample consisted of 460 reports of adverse reactions. Descriptive statistics techniques were applied for the analysis of the information.Results: reports of adverse reactions were predominant in female patients, 61 %, and in pediatric age, 54 %. The organ system mostly affected was the general one in 37 %, followed by the skin, 22 %. Fever was present in 75,2 % of the reports; slight adverse reactions predominated in 73,2 % and probable reactions in 89,5 %; reported by nurses (47 %) and physicians (43 %). By drug class the highest incidences were from vaccines, where the pentavalent vaccine had 54,7 %; among the antimicrobials, beta-lactams contributed 60 % of the cases; angiotensin-converting enzyme inhibitors were reported in 60,6 %. Acupuncture caused 68,7 % of the adverse reactions brought on by natural medicine techniques and non-opioid analgesics reported 31 reactions.Conclusions: the adverse reactions reported in the pharmacovigilance database were described. The notification of adverse reactions reported by the application of acupuncture stands out.

Objective: Develop an App to use in healthcare practice, with updated and accurate information on the handling of medications in patients with dysphagia or deglution disorders, as well as their compatibility with food and thickeners., Methods: The development of the Deglufarm® App was based on the CRONOS, Nutrition and Techno working groups of the Sociedad Española de Farmacia Hospitalaria. A group of specialist pharmacists was created from different care areas for patients with dysphagia. The creation of Deglufarm® consisted of several stages: Selection of active drugs, literature review, content development, design (an expert company in App design was contacted), testing, launch, content update and follow-up., Results: Deglufarm® is available for Android and IOS free of charge from July 2022. It has been tested among the members of the research group and collaborators, currently, 540 monographs of active drugs have been reviewed and registered in Deglufarm. The first version is aimed at healthcare professionals., Conclusions: Deglufarm® is an easy tool to consult, with the most current evidence on handling the medicines it contains., (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). Publicado por Elsevier España, S.L.U. All rights reserved.)

Objective: Develop an App to use in healthcare practice, with updated and accurate information on the handling of medications in patients with dysphagia or deglution disorders, as well as their compatibility with food and thickeners., Methods: The development of the Deglufarm® App was based on the CRONOS, Nutrition and Techno working groups of the Sociedad Española de Farmacia Hospitalaria. A group of specialist pharmacists was created from different care areas for patients with dysphagia. The creation of Deglufarm® consisted of several stages: selection of active drugs, literature review, content development, design (an expert company in App design was contacted), testing, launch, content update and follow-up., Results: Deglufarm® is available for Android and IOS free of charge from July 2022. It has been tested among the members of the research group and collaborators, Currently, 540 monographs of active drugs have been reviewed and registered in Deglufarm. The first version is aimed at healthcare professionals., Conclusions: Deglufarm® is an easy tool to consult, with the most current evidence on handling the medicines it contains., (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). Publicado por Elsevier España, S.L.U. All rights reserved.)

Background: Sustainable management of healthcare waste has a positive impact on the global environment. In order to reduce it, the sustainable practice of the pharmacotherapeutic process in all its stages is essential., Objective: To analyze the sustainability strategies proposed by the pharmacy service to reduce drug waste derived from the pharmacotherapeutic process., Secondary Objectives: to analyze the stage of the pharmacotherapeutic process and the number and type of drugs involved., Methods: The study was carried out in a tertiary level hospital. To coordinate the proposals, a referent pharmacist from every pharmacy department area was selected. Four stages of the process were evaluated (procurement, validation, dispensing and compounding), patients concerned were classified as outpatients or inpatients, and drugs potentially involved were analyzed by the administration route: into oral or parenteral., Results: 28 ideas were proposed, which could affect more than 1200 drugs. 39.3% would affect the validation process, 17.9% the procurement management, 17.9% dispensing and 7.1% the compounding. Implementation feasibility and acceptability of these proposals were evaluated. Those with the greatest potential were: limiting the duration of treatments when possible, favoring the implementation of computer prescription order entry, favoring the use of the oral route over the parenteral route, and implementing computers in the preparation areas to avoid the use of paper guides., Discussion: In our study, many ideas have been proposed by hospital pharmacists to improve the sustainability of the medication use process. When assessing these proposals by impact and feasibility, according to our results, shorten as much as possible the duration of treatments, computerization of the medication use process and oral administration over intravenous should be prioritized in order to reduce environmental impact., Competing Interests: Conflict of interest The authors declare do not have any conflict of interest., (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). Publicado por Elsevier España, S.L.U. All rights reserved.)

Background: Sustainable management of healthcare waste has a positive impact on the global environment. In order to reduce it, the sustainable practice of the pharmacotherapeutic process in all its stages is essential., Objective: To analyse the sustainability strategies proposed by the pharmacy service to reduce drug waste derived from the pharmacotherapeutic process., Secondary Objectives: To analyse the stage of the pharmacotherapeutic process and the number and type of drugs involved., Methods: The study was carried out in a tertiary-level hospital. To coordinate the proposals, a referent pharmacist from every pharmacy department area was selected. Four stages of the process were evaluated (management, validation, dispensing and compounding), patients concerned were classified as outpatients or inpatients, and drugs potentially involved were analysed by the administration route: Into oral or parenteral., Results: Twenty eight ideas were proposed, which could affect more than 1200 drugs. 39.3% would affect the validation process, 17.9% the procurement management, 17.9% dispensing, and 7.1% the compounding. Implementation feasibility and acceptability of these proposals were evaluated. Those with the greatest potential were: Limiting the duration of treatments when possible, favouring the implementation of computer prescription order entry, favouring the use of the oral route over the parenteral route, and implementing computers in the preparation areas to avoid the use of paper guides., Discusion: In our study, many ideas have been proposed by hospital pharmacists to improve the sustainability of the medication use process. When assessing these proposals by impact and feasibility, according to our results, shorten as much as possible the duration of treatments, computerization of the medication use process, and oral administration over intravenous should be prioritized in order to reduce environmental impact., (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). Publicado por Elsevier España, S.L.U. All rights reserved.)

Resumo: Este artigo analisa a relação entre a demanda por importações de produtos farmoquímicos e farmacêuticos e variáveis econômicas (taxa de câmbio, preço das importações e renda agregada), no Brasil, fazendo uso de dados mensais do período 1997-2014. Os principais resultados mostraram que aumentos na renda agregada e reduções nos preços das importações têm impacto positivo e significativo, respectivamente de forma elástica e inelástica, sobre as importações. A taxa de câmbio foi significativa apenas no modelo mais agregado. Portanto, a renda agregada se mostrou uma variável bastante robusta e com forte impacto sobre as importações dos produtos farmoquímicos e farmacêuticos. Considerando os argumentos explicitados na literatura de que o déficit no comércio internacional dessa indústria se relaciona com déficit em conhecimento e tecnologia, somando aos resultados encontrados neste trabalho, há indícios de que conforme o nível de atividade econômica cresce, ocorre maior demanda por esse tipo de produto, e, não havendo produção nacional suficiente, existe necessidade de importações, o que pode gerar pressões no déficit comercial desse segmento, representando dependência do Brasil a outros países.

Background: The control of diabetes mellitus is multifactorial, the different therapeutic options make it necessary to compare the effectiveness with previous therapeutic schemes., Objective: Analize the indicators of control of diabetes mellitus after incorporating liraglutide, sitagliptin/metformin, linagliptin, and sitagliptin., Methods: Observational, analytical, longitudinal study. Glucose, glycosylated hemoglobin, and blood pressure were compared after the inclusion of new cues in patients with diabetes mellitus; in addition to the control indicators reported in the unit in october, november, and december 2000, with those of 2021 in the same months. A descriptive analysis was performed, T for related samples and McNemar, a value of < .05 was considered significant, a confidence level of 95%, with the IBM-SPSS 24 software., Results: 352 files were analyzed, 59% women, aged 26 to 88 years, and the percentage of control decreased after the change of scheme (38.4% vs 35.8%) without a statistical difference (p .503). There was no statistical difference between the levels of glucose, glycated hemoglobin, weight, and blood pressure before and six months after the change. In the unit, the regimen glycemic control indicator improved in October, November, and December 2020 compared to the same months in 2021, it increased (from 17.2, 18.7, and 16.3, to 41.6, 47.2, and 46.5%). Blood pressure control went from 64.5, 66.7, and 67 to 82.4, 85.1, and 83.1%., Conclusions: The control indicators in the unit improved, however, the patients who used the new keys did not show any difference., (Licencia CC 4.0 (BY-NC-ND) © 2023 Revista Médica del Instituto Mexicano del Seguro Social.)

Objetive: This study is the first part of the MEDPAIN project "Update of analgesic parenteral admixtures: studies of use, compatibility and stability", and its goal is to develop a national map about the use of analgesic parenteral admixtures in healthcare settings., Methods: Observational study, based on a survey aimed at Spanish hospital pharmacists, during the period December 2020-April 2021. The questionnaire was designed in the RedCap® platform and disseminated through the Spanish Society of Hospital Pharmacy distribution list. An analgesic parenteral admixture (AM) was defined as the combination of two or more drugs, with at least one of them being an analgesic. The same combination of active ingredients, at different concentration and/or administered by different routes, was considered as a unique AM in this study. Some registered endpoints were related to the characteristics of the healthcare settings participating in the study, and others were related to the AM, such as drugs, doses and concentration range, route of administration, frequency of use, indication and type of patient (adult/pediatric) and where they are prepared., Results: A total of 67 valid surveys from healthcare settings of 13 Spanish Autonomous Communities were received. They reported 462 AM. Every healthcare center informed an average of 6 AM (ICR p25-p75 =4.0-9.0). Most of the reported mixtures were used in adults (93.9%) at hospital settings (91.8%), and they were mostly protocolized and frequently used. The 21.4% of them were compounded at the Pharmacy service. The AM included 26 different drugs, with opioid analgesics being present at the 87.4% of them. Midazolam was the most usual adjuvant drug. According to the definition of AM in this study, there were finally 137 different combinations mainly with two drugs (40.6%), but also with three (37.7%), four (15.2%) and five ingredients (6.5%)., Conclusion: This study reveals the wide variability in current clinical practice and shows which are the most used analgesic parenteral admixtures in our country., (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). Publicado por Elsevier España, S.L.U. All rights reserved.)

Objective: This study is the first part of the MEDPAIN project "Update of analgesic parenteral admixtures: studies of use, compatibility and stability", and its goal is to develop a national map about the use of analgesic parenteral admixtures in healthcare settings., Methods: Observational study, based on a survey aimed at Spanish hospital pharmacists, during the period December 2020 - April 2021. The questionnaire was designed in the RedCap® platform and disseminated through the Spanish Society of Hospital Pharmacy distribution list. An analgesic parenteral admixture (AM) was defined as the combination of two or more drugs, with at least one of them being an analgesic. The same combination of active ingredients, at different concentration and/or administered by different routes, was considered as a unique AM in this study. Some registered endpoints were related to the characteristics of the healthcare settings participating in the study, and others were related to the AM, such as drugs, doses and concentration range, route of administration, frequency of use, indication and type of patient (adult/pediatric) and where they are prepared., Results: A total of 67 valid surveys from healthcare settings of 13 Spanish Autonomous Communities were received. They reported 462 AM. Every healthcare center informed an average of 6 AM (ICR p25-p75 = 4.0-9.0). Most of the reported mixtures were used in adults (93.9%) at hospital settings (91.8%), and they were mostly protocolized and frequently used. The 21.4% of them were compounded at the Pharmacy service. The AM included 26 different drugs, with opioid analgesics being present at the 87.4% of them. Midazolam was the most usual adjuvant drug. According to the definition of AM in this study, there were finally 137 different combinations mainly with two drugs (40.6%), but also with three (37.7%), four (15.2%) and five ingredients (6.5%)., Conclusion: In conclusion, this study reveals the wide variability in current clinical practice and shows which are the most used analgesic parenteral admixtures in our country., (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). Publicado por Elsevier España, S.L.U. All rights reserved.)

O estudo objetivou avaliar a existência de associações entre variáveis de serviços de farmácia hospitalar. Foram utilizadas 30 variáveis do projeto Diagnóstico da Farmácia Hospitalar no Brasil relativas à caracterização geral do hospital, caracterização geral do serviço de farmácia hospitalar e etapas da assistência farmacêutica. A análise de correspondência múltipla e a análise de agrupamentos foram utilizadas. A dimensão 1 da análise de correspondência múltipla explicou 90,6% da variabilidade, diferenciando os serviços de farmácia hospitalar conforme a presença de atividades, sugerindo assim um eixo de caracterização da estrutura dos serviços de farmácia hospitalar. Os resultados indicam relação direta entre cumprimento das atividades e tipo de hospital e farmacêuticos com especialização. A análise de agrupamentos identificou seis grupos relativos ao porte do hospital, tendo maior cumprimento de atividades os serviços de farmácia hospitalar em unidades de grande porte e com farmacêutico (maior tempo dedicado ao serviço de farmácia hospitalar e maior nível de treinamento). Conclui-se que as técnicas foram capazes de identificar as associações e um elenco conciso de variáveis para uma avaliação abrangente dos serviços de farmácia hospitalar no país.El estudio tuvo como objetivo evaluar la existencia de asociaciones entre variables de servicios de farmacia hospitalaria. Se utilizaron 30 variables del proyecto Diagnóstico de Farmacia Hospitalaria en Brasil, relativas a la caracterización general del hospital, caracterización general del servicio de farmacia hospitalaria y etapas de la asistencia farmacéutica. Se utilizaron técnicas estadísticas como el análisis de correspondencia múltiple y el análisis de agrupamientos. La dimensión 1 del análisis de correspondencia múltiple explicó un 90,6% de la variabilidad, diferenciando los servicios de farmacia hospitalaria conforme la presencia de actividades, sugiriendo así un eje de caracterización de la estructura de los servicios de farmacia hospitalaria. Los resultados indican la relación directa entre el cumplimiento de las actividades y el tipo de hospital y farmacéuticos con especialización. El análisis de agrupamientos identificó seis grupos relativos al porte del hospital, consiguiendo un mayor cumplimiento de actividades los servicios de farmacia hospitalaria en unidades de gran porte y con farmacéutico (mayor tiempo dedicado al servicio de farmacia hospitalaria y mayor nivel de experiencia). Se concluye que las técnicas fueron capaces de identificar las asociaciones y un elenco conciso de variables para una evaluación englobadora de los servicios de farmacia hospitalaria en el país.This study aimed to evaluate associations among variables in hospital pharmacy services. Thirty variables were used from the project Diagnosis of Hospital Pharmacies in Brazil pertaining to the overall description of the hospital, overall characterization of the hospital pharmacy service, and stages in pharmaceutical care. The statistical techniques were multiple correspondence and cluster analysis. Dimension 1 of the multiple correspondence analysis explained 90.6% of variance, differentiating between hospital pharmacy services based on the presence of certain activities, thus suggesting an axis of characterization for the hospital pharmacy services. The results indicate a direct relationship between compliance with the activities and the type of hospital and pharmacists with specialized training. Cluster analysis identified six clusters related to hospital size; greater compliance with the activities was associated with large hospitals and those with a pharmacist (more time dedicated to the hospital pharmacy service and higher level of training). The study concludes that the techniques were able to identify associations and a concise range of variables for a comprehensive evaluation of hospital pharmacy services in Brazil.

Objetivo: Analizar el grado en el que las vitaminas jugaron un papel en la estrategia de creación de un nuevo mercado de alimentos, alimentos-medicamento y especialidades farmacéuticas en España durante la primera mitad del siglo XX. Material y métodos: Se estudiaron todas las menciones a las vitaminas aparecidas en los diarios "ABC", "Heraldo de Madrid", "El Imparcial", "El Liberal" y "El Sol", publicados en Madrid; "La Vanguardia", publicado en Barcelona, y en el semanario "Blanco y Negro" entre 1917 y 1950. La fecha inicial, 1917, se fijó por ser el año en el que aparecieron las primeras noticias sobre vitaminas. La fecha final, 1950, se fijó por considerarse concluida la etapa más dura de la autarquía impuesta por el Franquismo. Las noticias aparecidas se clasificaron en las categorías: consejos dietéticos, curiosidades, noticias científicas, noticias económicas, noticias políticas, trivialidades y uso metafórico. Resultados: Los anuncios que usaron las vitaminas dentro de su estrategia comercial son el apartado más importante en el que se utiliza el concepto vitaminas con porcentajes superiores, en casi todos los casos, al 50%. Las noticias científicas sobre vitaminas le siguen en importancia. Las menciones a las vitaminas en el resto de categorías son inferiores al 5%. Conclusiones: Las vitaminas constituyen un elemento fundamental en la creación de un nuevo mercado de productos en España en la primera mitad del siglo XX, a juzgar por las menciones que aparecen en la prensa periódica analizada.Aim: To analyze the extent to which vitamins played a role in the strategy to create a new market of food, food-medicines, and medicines in Spain during the first half of the twentieth century. Materials and methods: A study was made of references to vitamins in the years between 1917 and 1950 in the daily newspapers "ABC", "Heraldo de Madrid", "El Imparcial", "El Liberal" and "El Sol", published in Madrid, "La Vanguardia", published in Barcelona, and the weekly publication "Blanco y Negro". The starting date was selected as the year in which the first news of vitamins appeared. The year 1950 marked the end of the harshest stage of autarky imposed by Franco's regime. The news that appeared was classified in the following categories: scientific news, nutritional advice, advertising, economy, politics, anecdotes and metaphors. Results: The advertisements that used vitamins as part of their marketing strategy are the most important section with over 50% of total references to the vitamin concept in almost all the newspapers. Scientific news on vitamins ranks second in importance. References to vitamins in the remaining categories were below 5%. Conclusions: Judging by the references which appear in the most important newspapers of the time vitamins represent a fundamental element in the creation of a new food product market in Spain in the first half of the twentieth century.

OBJETIVO: Descrever as desigualdades socioeconômicas referentes ao uso, gastos e comprometimento de renda com a compra de medicamentos. MÉTODOS: Estudo transversal de base populacional com 1.720 adultos de área urbana de Florianópolis, SC, em 2009. Realizou-se a seleção da amostra por conglomerados e as unidades primárias foram os setores censitários. Investigou-se o uso de medicamentos e os gastos com sua compra nos 30 dias anteriores, por meio de entrevista. Uso, gasto e comprometimento de renda devido a medicamentos foram analisados segundo a renda familiar per capita, a cor da pele auto-referida, idade e o sexo dos indivíduos, ajustado para amostra complexa. RESULTADOS: A prevalência de uso de medicamentos foi de 76,5% (IC95%: 73,8;79,3), maior entre as mulheres e naqueles com maior idade. A média de gastos com medicamentos foi igual a R$ 46,70, com valores mais elevados entre as mulheres, os brancos, os com idade mais elevada e entre os mais ricos. Enquanto 3,1% dos mais ricos comprometeram mais de 15% de seus rendimentos na compra de medicamentos, esse valor chegou a 9,6% nos mais pobres. A proporção de pessoas que tiveram de comprar medicamentos após tentativa fracassada de obtenção pelo Sistema Único de Saúde foi maior entre os mais pobres (11,0%), mulheres (10,2%) e naqueles com maior idade (11,1%). Grande parte dos adultos comprou medicamentos contidos na Relação Nacional de Medicamentos Essenciais (19,9%) ou na Relação Municipal de Medicamentos Essenciais (28,6%), com diferenças significativas segundo sexo, idade e renda. CONCLUSÕES: Existe desigualdade socioeconômica, de idade e de gênero no comprometimento de renda com a compra de medicamentos, com piores condições para os mais pobres, os de maior idade e para as mulheres.OBJETIVO: Describir las desigualdades socioeconómicas relacionadas con el uso, gastos y comprometimiento de la renta con la compra de medicamentos. MÉTODOS: Estudio transversal de base poblacional con 1.720 adultos de área urbana de Florianópolis, Sur de Brasil en 2009. Se realizó la selección de la muestra por conglomerados y las unidades primarias fueron los sectores censitarios. Se investigó el uso de medicamentos y los gastos con su compra en los 30 días anteriores, por medio de entrevista. Uso, gasto y comprometimiento de renta debido a medicamentos fueron analizados según la renta familiar per capita, el color de la piel auto-referida, edad y el sexo de los individuos, ajustado para muestra compleja. RESULTADOS: La prevalencia del uso de medicamentos fue de 76,5% (IC95%:73,8;79,3), mayor entre las mujeres y en aquellos con edad avanzada. El promedio de gastos con medicamentos fue igual a R$ 46,70, con valores más elevados entre las mujeres, los blancos, los de edad más elevada y entre los más ricos. Mientras que 3,1% de los más ricos comprometieron más de 15% de sus rendimientos en la compra de medicamentos, ese valor llegó a 9,6% en los más pobres. La proporción de personas que tuvieron que comprar medicamentos posterior al intento fracasado de obtenerlos por el Sistema Único de Salud fue mayor entre los más pobres (11,0%), mujeres (10,2%) y en aquellos con edad avanzada (11,1%). Gran parte de los adultos compró medicamentos ubicados en la Relación Nacional de Medicamentos Esenciales (19,9%) o en la Relación Municipal de Medicamentos Esenciales (28,6%), con diferencias significativas según sexo, edad y renta. CONCLUSIONES: Existe desigualdad socioeconómica, de edad y de género en el comprometimiento de renta con la compra de medicamentos, con peores condiciones para los más pobres, los de edad avanzada y para las mujeres.OBJECTIVE: To describe socioeconomic inequalities regarding the use, expenditures and the income committed to the purchase of medicines. METHODS: A cross-sectional population-based study was carried out with 1,720 adults living in the urban area of Florianópolis, Southern Brazil, in 2009. Cluster sampling was adopted and census tracts were the primary sampling units. Use of medicines and the expenditures incurred in their purchase in the past 30 days were investigated through interviews. Use, expenditures and the income committed concerning medicines were analyzed according to per capita family income, self-reported skin color, age and sex, adjusting for the complex sample. RESULTS: The prevalence of medicine use was 76.5% (95%CI: 73.8; 79.3), higher among women and in older individuals. The mean expenditure on medicine was R$ 46.70, with higher values among women, whites, older individuals and among richer people. While 3.1% of the richest committed more than 15% of their income to purchasing medicine, that figure reached 9.6% in the poorest group. The proportion of people that had to buy medicines after an unsuccessful attempt to obtain them in the public health system was higher among the poor (11.0%), women (10.2%) and the elderly (11.1%). A large part of the adults bought medicines contained in the National List of Essential Medicines (19.9%) or in the Municipal List of Essential Medicines (28.6%), with significant differences according to gender, age and income. CONCLUSIONS: There is socioeconomic, age and gender inequality in the income committed to the purchase of medicines, with worse conditions for the poor, older individuals and women.

Se exponen las principales líneas de investigación en nuevos fármacos y estrategias de tratamiento contra la hepatitis vírica tipo C. Esta es una enfermedad que supone un importante problema de salud pública, con más de 700.000 afectados en España y con una importante prevalencia entre las personas privadas de libertad. Las limitaciones del actual tratamiento contra la hepatitis vírica C han forzado la investigación de nuevos fármacos que se van sustanciando en dos líneas principales de productos, algunos de ellos pronto disponibles en el mercado: los inhibidores de la serín-proteasa NS3/4ª (telaprevir, boceprevir, danoprevir o vaniprevir) y los inhibidores de la RNA-polimerasa NS5B (RG-7128, RG-7227, Filibuvir, ANA-598), estos últimos en una fase de desarrollo algo más temprana. Previsiblemente habrá que utilizar estos nuevos fármacos añadidos al tratamiento estándar actual de interferón pegilado más ribavirina y en esas condiciones de uso todos estos fármacos han demostrado ya una mayor efectividad que el tratamiento estándar actual. A pesar de este esperanzador panorama, estos fármacos tienen limitaciones como el desarrollo de resistencias, la toxicidad o el poco conocimiento que tenemos de su efectividad en genotipos virales distintos del 1. No obstante su aparición abre muchas nuevas posibilidades en el tratamiento de esta enfermedad.The main lines of research into new drugs and treatment strategies against type C viral hepatitis are described. This disease is a major public health problem, with more than 700,000 people affected by the illness in Spain and with a high degree of prevalence amongst prison inmates. Limitations on current treatment for viral hepatitis C have led to research into new drugs in the form of two main product lines, some of which are soon to be available on the market: NS3/4ª serine-protease inhibitors (telaprevir, boceprevir, danoprevir and vaniprevir) and the NS5B RNA polymerase inhibitors (RG-7128, RG-7227, Filibuvir, ANA-598). The latter are in a somewhat earlier stage of development. It is expected that these new drugs will have to be used alongside the current standard treatment of pegylated interferon plus ribavirin and under these conditions of use the new drugs have already shown greater effectiveness than the current standard treatment. Despite this encouraging perspective, the new medicines have limitations such as the development of resistances, toxicity, and the little knowledge available of their effectiveness on viral genotypes that are different from 1. That being said, their appearance opens up new possibilities in the treatment of this disease.

Introduction: self-medication has become a growing practice in the world population. This phenomenon has been promoted as a form ofself-care, with a positive impact on reducing spending in healthsystems, however there is concern about the potential negativeeffects related to inadequate diagnosis and treatment, which can affect health of individuals. This dual perception of the phenomenonis partly related to a variety of terms and concepts used, that makedifficult its theoretical and empirical approach. Harmonization ofthe definitions involved is required in order to make adequateepidemiological comparisons. Objectives: analyze the concept of self medication and related terms from the definitions in the literatureof the subject. Conclusions: in the last four decades it has been anevolution of both the wording and the definitions related to self-medication, from a very simple concept that implies the absence of prescription, to more complex ones that encompass very diversebehaviors, even those mediated by an act of prescription but not followed or not completed by the patient. Additionally the conceptual proliferation seen, justify the ordering of the terms related to self-medication. This paper presents a proposal for classification in four groups: a. self-medication, b. self care, c. pharmaceutical preparations and medicines, and d. prescription. This proposal shouldfacilitate the exploration and analysis of the phenomenon and allow future theoretical approaches.

OBJETIVO: Avaliar os resultados de intervenção para melhoria da quantidade e relevância das notificações de reacções adversas a medicamentos. MÉTODOS: Foi implementado um estudo controlado aleatorizado, por agrupamentos em farmacêuticos a exercer actividade profissional na região norte de Portugal, em 2007. Após aleatorização, 364 indivíduos foram alocados ao grupo de intervenção (261 na intervenção telefónica e 103 nos workshops); o grupo de controlo foi constituído por 1.103 farmacêuticos. Na intervenção educativa foram abordados a problemática das reacções adversas a medicamentos, o impacto na saúde pública e a notificação espontânea. Quanto à relevância, as reações adversas foram classificadas em graves e inesperadas. A análise estatística foi efectuada com base no princípio intention-to-treat; aplicaram-se modelos lineares generalizados mistos, utilizando o método penalized quasi-likelihood. Os farmacêuticos estudados foram seguidos durante um período de 20 meses. RESULTADOS: A intervenção aumentou três vezes a taxa de notificação espontânea das reações adversas (RR = 3,22; IC 95%: 1,33; 7,80) relativamente ao grupo de controlo. Houve incremento da relevância das notificações com aumento das reações adversas graves em cerca de quatro vezes (RR = 3,87; IC 95%: 1,29;11,61) e inesperadas em cinco vezes (RR = 5,02; IC 95%: 1,33;18,93), relativamente ao grupo de controlo. CONCLUSÕES: As intervenções educativas aumentam significativamente, por até quatro meses, a quantidade e a relevância das notificações espontâneas de reacções adversas a medicamentos por parte dos farmacêuticos da região norte de Portugal.OBJETIVO: Evaluar los resultados de intervención para mejoría de la cantidad y relevancia de las notificaciones de reacciones adversas a medicamentos. MÉTODOS: Fue implementado un estudio controlado aleatorio, por agrupaciones de farmacéuticos que ejercen actividad profesional en la región norte de Portugal, en 2007. Posterior a la aleatoriedad, 364 individuos fueron distribuidos en el grupo de intervención (261 en la intervención telefónica y 103 en los workshops); el grupo control fue constituido por 1.103 farmacéuticos. En la intervención educativa fueron abordados la problemática de las reacciones adversas a medicamentos, el impacto en la salud pública y la notificación espontánea. Con relación a la relevancia, las reacciones adversas fueron clasificadas en graves e inesperadas. El análisis estadístico fue efectuado con base en el principio intention-to-treat; se aplicaron modelos lineares generalizados mixtos, utilizando el método penalized quasi-likelihood. Los farmacéuticos estudiados fueron seguidos durante un período de 20 meses. RESULTADOS: La intervención aumentó tres veces la tasa de notificación espontánea de las reacciones adversas (RR=3,22; IC95%:1,33;7,80) con relación al grupo control. Hubo un incremento en la relevancia de las notificaciones con aumento de las reacciones adversas graves en cerca de cuatro veces (RR=3,87; IC95%:1,29;11,61) e inesperadas en cinco veces (RR=5,02; IC 95%: 1,33;18,93), con relación al grupo control. CONCLUSIONES: Las intervenciones educativas aumentan significativamente, en hasta cuatro meses, la cantidad y la relevancia de las notificaciones espontáneas de reacciones adversas a medicamentos por parte de los farmacéuticos de la región Norte de Portugal.OBJECTIVE: To evaluate the results of an intervention to improve the number and relevance of reports of adverse drug reactions. METHODS: A cluster-randomized controlled trial was conducted with pharmacists working in Northern Portugal, in 2007. After randomization, 364 individuals were placed into the intervention group (261 in telephone interviews and 103 in workshops), while the control group was comprised of 1,103 pharmacists. The following were approached in the educational intervention: the problem of adverse drug reaction, the impact on public health and spontaneous reporting. With regard to relevance, adverse reactions were classified into severe and unexpected. Statistical analysis was performed, based on the intention-to-treat principle; generalized linear mixed models were applied, using the penalized quasi-likelihood method. The pharmacists studied were followed during a period of 20 months. RESULTS: The intervention increased the rate of spontaneous reporting of adverse reactions three times (RR = 3.22; 95% CI 1.33;7.80), when compared to the control group. The relevance of reporting rose, with an increase in severe adverse reactions by approximately four times (RR = 3.87; 95% CI 1.29;11.61) and in unexpected adverse reactions by five times (RR = 5.02; 95% CI 1.33;18.93), compared to the control group. CONCLUSIONS: During a period of up to four months, educational interventions significantly increased the number and relevance of spontaneous reporting of adverse drug reactions by pharmacists in Northern Portugal.

Sensitive and selective spectrophotometric and spectrofluorimetric methods have been developed for determination of some drugs such as Pramipexole, Nebivolol, Carvedilol, and Eletriptan, which commonly contain secondary amino group. The subject methods were developed via derivatization of the secondary amino groups with 7-Chloro-4-Nitrobenzofurazon in borate buffer where a yellow colored reaction product was obtained and measured spectrophotometrically or spectrofluorimetrically. Concentration ranges were found as 2.0 to 250 μg mL-1 and 0.1 to 3.0 μg mL-1, for spectrophotometric and spectrofluorimetric study, respectively. The described methods can be easily applied by the quality control laboratories in routine analyses of these drugs in pharmaceutical preparations.

El presente estudio es de tipo descriptivo metodológico con abordaje cuantitativo; tuvo como objetivo determinar la validez de constructo y confiabilidad del instrumento “Factores que influyen en la adherencia al tratamiento farmacológico y no farmacológico en pacientes con factores de riesgo de enfermedad cardiovascular”. Para obtener la información se aplicó el instrumento, diseñado por Bonilla y De Reales en al año 2006, conformado por 53 ítems y cuatro dimensiones, la cual cuenta con validez facial, de contenido y confiabilidad a 485 pacientes que cumplían los criterios de inclusión. Al instrumento se le realizó la validez de constructo por medio del análisis factorial de tipo exploratorio para determinar la correlación entre las variables y las cuatro dimensiones, por el método de extracción de componentes principales y rotación varimax con Kaiser. La consistencia interna del instrumento se realizó con los resultados que arrojó el análisis factorial (24 ítems y 4 dimensiones), a través del coeficiente alfa de Cronbach. Los resultados del estudio mostraron que la validez de constructo realizada al instrumento permitió reducir el número de ítems de 53 a 24 a través del análisis factorial, sin afectar las 4 dimensiones del instrumento; el índice de consistencia interna por medio del método del alfa de Cronbach fue de 0,60, lo cual se considera adecuado. Con la exclusión de los 29 ítems se generó una nueva versión del instrumento, que agrupa los 24 ítems en cuatro factores que explican el 45% de la varianza, lo que demostró que las variables se correlacionaban con lo que se pretendía medir, permitiendo sustentar teóricamente el constructo, haciéndolo más práctico en su aplicabilidad para los profesionales de enfermería en diferentes escenarios de cuidado. Esto demuestra que el instrumento es válido y confiable, y se puede aplicar en futuros estudios acerca de la adherencia, a fin de obtener una mejor comprensión de la adherencia y sus determinantes, para a partir de ellos desarrollar planes de mejoramiento en las prácticas de cuidado en busca de beneficios para los pacientes y sus familias, promoviendo en ellos una adherencia efectiva.O presente estudo descritivo metodológico com abordagem quantitativa objetiva determinar a validade de construto e confiabilidade do instrumento “Fatores que influem na aderência ao tratamento farmacológico e não farmacológico em pacientes com fatores de risco de doença cardiovascular”. A informação foi obtida através da aplicação de um instrumento desenhado por Bonilla e De Reales no ano 2006, conformado por 53 itens e quatro dimensões que contam com validez facial, de conteúdo e confiabilidade, a 485 pacientes que cumpriam com os critérios de inclusão. A validez de constrito foi aplicada ao instrumento através da análise fatorial de tipo exploratório para determinar a correlação entre as variáveis e as quatro dimensões, pelo método de extração de componentes principais e da rotação varimax com Kaiser. Conseguimos a consistência interna do instrumento partindo dos resultados da análise fatorial (24 itens e 4 dimensões), através do coeficiente alfa de Cronbach. Os resultados do estudo evidenciaram que a validez de construto aplicada ao instrumento possibilitou a redução do número de itens de 53 para 24 através da análise fatorial, sem afetar as 4 dimensões do instrumento; o índice de consistência interna através do método do Alfa de Cronbach foi de 0,60, o qual se considera adequado. A exclusão dos 29 itens gerou uma nova versão do instrumento que agrupa os 24 itens em quatro fatores que explicam 45% da variância. Isso demonstrou que as variáveis eram correlatas com o que se esperava medir, permitido sustentar teoricamente o construto, tornando-o mais prático quanto à aplicabilidade para os profissionais de enfermagem em diferentes situações de cuidado. Isto demonstra que o instrumento é válido e confiável e pode ser aplicado em futuros estudos sobre a aderência, visando compreender melhor a aderência e seus fatores determinantes, para assim, partindo dos resultados dos mesmos, desenvolver planos de melhoria nas práticas de cuidado na procura de benefícios para os pacientes e suas famílias, promovendo nessas pessoas uma aderência efetiva.This descriptive and methodological study with quantitative approach intended to determine the validity of construct and reliability of the instrument “Factors that affect the adhesion of the pharmacological and non-pharmacological treatment in patients with cardiovascular risk factors”. Information was gathered through an instrument designed by Bonilla e De Reales in 2006. This instrument was formed by 53 items and four domains, considering face value, content and reliability. The instrument was applied to 485 patients that met the inclusion criteria. Construct validity was applied to the instrument through an exploratory factorial analysis to determine the correlation among the variables and the four dimensions, using the method of main component extraction and varimax rotation with Kaiser. The internal consistency of the instrument was achieved with the results drawn from the factorial analysis (24 items and 4 domains), through the Cronbach Alpha coefficient. The aforesaid construct validity allowed for reducing the number of items from 53 to 24 through factorial analysis, without changing the 4 domains of the instrument; the internal consistency index obtained through the Cronbach Alpha was 0,60, which is deemed appropriate. Then, a new version of the instrument was created, grouping 24 items in four factors that account for 45% of the variance. This demonstrated that the variables were correlated with the measuring targets, which allows for theoretically grounding the construct, increasing its applicability for nursing professionals in different domains of health care. This shows that the instrument is valid and reliable, and applicable in future studies on adhesion in view to gain a deeper insight into adhesion and its determining factors so as to use them in developing improvement plans in health care practices in favor of patients and their families, thus, encouraging effective adhesion.

The aim of this study was to investigate medicine use and associated factors among adolescents. This was a prospective cohort study including 4,452 adolescents born in Pelotas, Rio Grande do Sul State, Brazil, in 1993. Information on medicine use in the 15 days prior to the interviews was collected from the mothers. Overall prevalence of medicine use was 30.9%, and 64.7% of the medicines had been prescribed by a physician. The most frequently used pharmacological groups were medicines for the nervous (35.9%) and respiratory systems (25.7%). Medicine use was directly associated with socioeconomic status, maternal schooling, complications during pregnancy or delivery, and neonatal problems resulting in the need for intensive care. Underweight and obese adolescents were more likely to use medicines as compared to those with normal body mass index. A direct association was observed between maternal use of hypnotic drugs and sedatives and adolescent medicine use. It is essential to implement educational policies aimed at promoting rational use of medicines by adolescents.O objetivo deste estudo foi investigar o uso de medicamentos e fatores associados em adolescentes. Trata-se de estudo de coorte prospectivo, incluindo 4.452 adolescentes nascidos em Pelotas, Rio Grande do Sul, Brasil, em 1993. As informações sobre o uso de medicamentos pelo adolescente nos 15 dias anteriores à entrevista foram fornecidas pelas mães. A prevalência global de uso de medicamentos foi de 30,9%, sendo que destes, 64,7% foram indicados por médicos. Os grupos farmacológicos mais utilizados foram os medicamentos que atuam nos sistemas nervoso (35,9%) e respiratório (25,7%). O uso de medicamentos esteve diretamente associado ao nível econômico, escolaridade da mãe, intercorrência na gravidez ou parto que gerou doença até a adolescência, problema de saúde no momento do nascimento que levou o recém-nascido à UTI, magreza e obesidade. Foi observada uma relação direta entre uso de medicamentos hipnóticos e sedativos pela mãe e uso de medicamentos pelo adolescente. É fundamental que medidas educativas sejam voltadas à promoção do uso racional de medicamentos nesta faixa etária.

This study evaluates the knowledge of nurses working in intensive care units concerning recommendations for the proper administration of medication through nasogastric and enteral tubes. This exploratory-descriptive study with a quantitative approach was carried out with 49 nurses in an intensive care unit of a tertiary hospital in Fortaleza, CE, Brazil. A total of 36.7% of nurses reported they disregard the dosage forms provided by the pharmacy at the time of administering the medication through tubes. Metal, wood, or a plastic mortar is the method most frequently reported (42.86%) for crushing prescribed solid forms; 32.65% leave the drugs in 20ml of water until dissolved; 65.3% place the responsibility for choosing the pharmaceutical formulation and its correlation with the tube site, either into the stomach or into the intestine, on the physician. The results indicate there is a gap between specific literature on medication administered through tubes and knowledge of nurses on the subject.El objetivo del estudio fue evaluar los conocimientos del enfermero de la unidad de cuidados intensivos sobre las recomendaciones para la correcta administración de medicamentos por sonda nasogástrica y nasoentérica. Se trata de un estudio exploratorio-descriptivo y cuantitativo con 49 enfermeros en una unidad de cuidados intensivos de un hospital terciario, en la ciudad de Fortaleza, estado de Ceará, Brasil. 36,7% no prestan atención a las formas disponibles en el sector de farmacia en el momento de su utilización por sonda. El pilón de metal, madera o plástico fue el método más citado (42,86%) para triturar las formas sólidas prescritas. 32,65% dejan los fármacos en 20mL de agua hasta que se disuelvan. 65,3% atribuyen al médico la responsabilidad de decidir sobre la formulación y la correlación con la ubicación de la sonda en el tracto gastrointestinal. Los resultados indican que hay una diferencia entre la literatura para los medicamentos administrados por sonda y el conocimiento de los enfermeros sobre el tema.O estudo objetivou avaliar o conhecimento do enfermeiro de unidade de terapia intensiva sobre as recomendações para a correta administração de medicamentos, por sondas nasogástrica e nasoenteral. Estudo exploratório-descritivo, com abordagem quantitativa, realizado com 49 enfermeiros em uma unidade de terapia intensiva de um hospital terciário, localizado na cidade de Fortaleza, no Estado do Ceará, Brasil. Dos enfermeiros, 36,7% relataram não dar atenção às formas farmacêuticas disponibilizadas pelo setor de farmácia na hora da utilização por sonda. O pilão de metal, madeira ou plástico foi o método mais referido (42,86%) para triturar as formas sólidas prescritas. Sendo que 32,65% costuma deixar os fármacos em 20mL de água até dissolver, 65,3% atribuem ao médico a responsabilidade sobre a decisão da formulação farmacêutica e a correlação com a localização da sonda no trato gastrointestinal. Os achados apontam para diferença entre a literatura específica para medicamentos administrados por sonda e o conhecimento de enfermeiros sobre o assunto.

Partindo-se de uma análise das ações judiciais individuais para o fornecimento de medicamentos propostas por usuários do Sistema Único de Saúde (SUS) contra o Estado do Rio de Janeiro, Brasil, no ano de 2005, este estudo tem como objetivo discutir a atuação e o comportamento do Poder Judiciário no julgamento dos referidos processos judiciais. O estudo corresponde a uma pesquisa documental exploratória, de caráter quali-quantitativo, na qual foram analisados alguns aspectos relacionados às ações judiciais, tais como, o tipo de medicamento pleiteado, o teor das decisões proferidas e os fundamentos mais freqüentes utilizados pelos magistrados no julgamento das ações. Com base no resultado da análise das ações, do conceito de judicialização e da padronização oficial em matéria de medicamentos, concluiu-se que, ao decidir sobre o fornecimento de medicamentos, o Poder Judiciário concede os pedidos formulados sem considerar a padronização de medicamentos adotada pelo Ministério da Saúde, exercendo assim uma excessiva intervenção na política de saúde.Based on an analysis of individual claims for provision of medicines brought by users of the Unified National Health System (SUS) against the State of Rio de Janeiro, Brazil, in the year 2005, this study aims to discuss the action and behavior of the court system in ruling on these suits. The study adopted a semi-qualitative exploratory documental research design, analyzing key aspects related to the claims, such as type of medication claimed by the plaintiff, wording of the court rulings, and the key elements used by judges in trying the cases. According to the analysis of the lawsuits and the concepts of judicialization and official standardization of medicines, the study concludes that when ruling on the provision of medicines, the court system grants the claims as submitted without considering the standardization of medicines adopted by the Ministry of Health, thus exercising excessive court intervention in health policy.

Foram analisados os resultados da implantação de estratégia de monitoramento de efeitos adversos aos medicamentos em hospital público no Rio de Janeiro, RJ, em 2007. Com base em análise retrospectiva de 32 prontuários foram encontrados efeitos adversos em 16%. Para identificá-los, foram precisos 38 critérios rastreadores, dos quais os principais foram: uso de antieméticos, interrupção abrupta de medicamentos e sedação excessiva. Apesar das dificuldades, sobretudo relacionadas ao acesso às informações e à qualidade dos registros, a aplicação dos critérios rastreadores parece ser viável. Para aprimorar a implantação do método, sugere-se informatizar a coleta de informações e buscar indicadores de ajuste de risco.Fueron analizados los resultados de la implantación de estrategia de monitoreo de efectos adversos a los medicamentos en hospital público en Rio de Janeiro, Sureste de Brasil, en 2007. Con base en análisis retrospectivo de 32 prontuarios fueron encontrados efectos adversos en 16%. Para identificarlos, fueron necesarios 38 criterios rastreadores, de los cuales los principales fueron: uso de antieméticos, interrupción abrupta de medicamentos y sedación excesiva. A pesar de las dificultades, sobre todo relacionadas con el acceso a las informaciones y a la calidad de los registros, la aplicación de los criterios rastreadores parece ser viable. Para perfeccionar la implantación del método, se sugiere informatizar la colecta de datos y buscar indicadores de ajuste del riesgo.The results from implementing a strategy for monitoring adverse effects from drugs in a public hospital in the municipality of Rio de Janeiro, Southeastern Brazil, in 2007, were analyzed. Based on retrospective analysis of 32 medical files, adverse effects were found in 16%. To identify these effects, 38 tracking criteria were needed. Among these, the main ones were the use of antiemetics, abrupt cessation of medication and over-sedation. Despite the difficulties, especially in relation to access to information and the record quality, application of these tracking criteria seems to be viable. To improve the implementation of the method, it is suggested that the data collection should be computerized and risk adjustment indicators should be sought.

O objetivo deste trabalho foi estimar a prevalência e avaliar os fatores associados à subutilização de medicamentos por motivos financeiros em amostra representativa de 1.134 idosos, residentes na Região Metropolitana de Belo Horizonte, Minas Gerais, Brasil. A prevalência da subutilização foi de 12,9%, estando independentemente associada à renda pessoal mensal inferior a dois salários mínimos (RP = 0,57; IC95%: 0,34-0,97), à filiação a plano privado de saúde (RP = 0,68; IC95%: 0,46-0,99), à freqüência com que o profissional de saúde esclareceu sobre a saúde/tratamento (raramente/nunca, RP = 1,79; IC95%: 1,10-2,90), à auto-avaliação de saúde (razoável, RP = 1,66; IC95%: 0,95-2,90 e ruim/muito ruim, RP = 2,49; IC95%: 1,38-4,48) e ao número de condições crônicas (uma, RP = 2,51; IC95%: 0,99-6,35; duas, RP = 3,51; IC95%: 1,40-8,72 e três ou mais, RP = 4,52; IC95%: 1,79-11,41). Os resultados confirmam a importância dos aspectos sócio-econômicos para a subutilização, mas indicam que sua determinação também está ligada à qualidade da comunicação médico-paciente. Evidencia-se ainda uma situação de risco para idosos em piores condições de saúde.The aim of this study was to estimate the prevalence of cost-related underuse of medicines and associated factors in a representative sample of 1,134 elderly individuals in Greater Metropolitan Belo Horizonte, Minas Gerais State, Brazil. Prevalence of cost-related underuse was 12.9%. After adjustments in the multivariate model, cost-related underuse was higher in individuals with income less than twice the minimum wage (PR = 0.57; 95%CI: 0.34-0.97), without health plan coverage (PR = 0.68; CI95%: 0.46-0.99), with low frequencies of physician-patient dialogue concerning health/treatment (rarely/never, PR = 1.79; 95%CI: 1.10-2.90), with fair to poor self-rated health (PR = 1.66; 95%CI: 0.95-2.90 and PR = 2.49; 95%CI: 1.38-4.48, respectively), and with multiple comorbidities (one, PR = 2.51; 95%CI: 0.99-6.35; two, PR = 3.51; 95%CI: 1.40-8.72 and three or more, PR = 4.52; 95%CI: 1.79-11.41). Our results suggest adherence problems within this population due to a communication gap between seniors and physicians on treatment-related aspects and to the lack of health plan coverage. Especially worrisome is the high risk of cost-related underuse among elderly with poor health.

A gas chromatographic method has been developed for the assay of fluvastatin sodium (FLU). FLU was silylated with N,O-bis(trimethylsilyl)trifluoroacetamide-1% trimethylchlorosilane at 90 ºC for 30 min and analysed in a DB-1 column by capillary gas chromatograph with a flame ionization detector. The method was validated. The assay was linear over the concentration range at 10.0 to 50.0 µg mL-1. The limit of detection and the limit of quantitation were 1.0 and 3.0 µg mL-1, respectively. The recoveries of FLU derivatives were in the range of 99.25-99.80%. In inter-day and intra-day analysis, the values of relative standard deviation (%) and the relative mean error (%) were found between 0.20-0.80% and -0.20-0.75%, respectively. The developed method was succesfully applied to analyze the FLU content in tablet formulation. The results were statistically compared with those obtained by the official method, and no significant difference was found between the two methods. Therefore, it can be recommended for the quality control assay of FLU in pharmaceutical industry.

Este estudo observacional determinou a freqüência de utilização de medicamentos parenterais em frascos-ampola em uma unidade pediátrica, e identificou as ações da equipe de enfermagem associadas ao preparo e administração desses medicamentos. Os dados foram coletados por meio da prescrição médica e observação direta dos medicamentos nas geladeiras e armários da unidade. A apresentação em frascos-ampola foi prescrita para 30,8% dos pacientes. Foram observados aspectos quanto à reconstituição, ao armazenamento, à temperatura e à rotulagem dos medicamentos, fatores importantes para utilização segura dos mesmos. As informações pesquisadas para avaliar o processo de preparo e de administração estavam todas presentes em apenas 6,8% dos medicamentos. A identificação correta dos frascos-ampola é importante para o uso seguro dos medicamentos. O treinamento da equipe de saúde e a adoção de diretrizes de terapia endovenosa são instrumentos essenciais para otimizar o processo de utilização de medicamentos parenterais.Este estudio de observación determinó la frecuencia para utilizar medicamentos parenterales en frascos-ampolla en una unidad pediátrica, identificando las acciones del equipo de enfermería con respecto a su preparación y administración. Para la recolección de datos se utilizó la prescripción médica y la observación directa de los medicamentos en los frigideres y estantes del servicio. La presentación en frascos-ampolla fue prescripta en 30.8% de los pacientes. Se observó la reconstitución, el almacenamiento, la temperatura y los rótulos de los medicamentos, factores importantes para asegurar su administración. Las informaciones investigadas para evaluar el proceso de preparación y administración estuvieron presentes en apenas 6.8% de los medicamentos. La correcta identificación de los frascos-ampolla es importante para su administración. El entrenamiento del equipo de salud y la adopción de directrices sobre tratamiento endovenoso son instrumentos esenciales para optimizar la utilización del medicamento parenteral.This observational study aimed to determine the frequency of utilization of vials containing parenteral medications in a pediatric unit, and to identify nursing team actions related to their preparation and administration. Data were collected from prescription forms and by checking these drugs in the refrigerator and stocks at the unit. Vials were prescribed to 30.8% of patients. Aspects such as: reconstitution, storage, temperature and drug label were observed. Only 6.8% of the drugs had all the information researched in order to evaluate the process of preparation and administration. The correct identification of vials is important for the safe use of medication. Training programs for the healthcare team and the adoption of intravenous therapy guidelines are essential tools to optimize the utilization of parenteral medication.

OBJETIVOS: Interações medicamentosas ocorrem quando os efeitos e/ou a toxicidade de um fármaco são alterados pela presença de outro. São geralmente imprevistas e indesejáveis. Realizado estudo com objetivo de verificar a prevalência e o valor clínico das interações medicamentosas potenciais em unidades de terapia intensiva. MÉTODOS: Incluídos todos pacientes de três unidades de terapia intensiva em um período de 2 meses, analisados transversalmente. Foram excluídos aqueles com tempo de permanência menor que 2 dias. Os dados foram tabulados de acordo com as combinações de fármacos observadas no período de 24 horas. A presença e o valor clínico das interações medicamentosas potenciais foram conferidos ao final do seguimento. RESULTADOS: Analisados 140 pacientes, 67,1% apresentaram alguma interações medicamentosas potenciais significativa e das 1069 prescrições, 39,2% tiveram este achado. De 188 interações medicamentosas potenciais diferentes, 29 foram consideradas altamente significativas. Por análise univariada, observou-se no grupo que apresentou interação significativa maior quantidade de medicamentos, fármacos/dia, número de médicos prescritores e tempo de internação na unidade de teapia intensiva. Por modelo de regressão logística multivariada, apenas o número de fármacos/dia correlacionou-se com o aumento do risco de interação medicamentosa potencial significativa (p = 0.0011); o uso de mais que 6 medicamentos/dia aumenta em 9.8 vezes este risco. CONCLUSÕES: Pacientes em unidades de terapia intensiva estão submetidos a alto risco de interações medicamentosas potenciais e o número de fármacos/dia é condição com alto valor preditivo positivo para tal. Os intensivistas devem ser alertados para o reconhecimento do problema e criados mecanismos para o manejo adequado e prudente, diminuindo iatrogenias.OBJECTIVES: Drug interactions occur when effects and/or toxicity of a drug are affected by presence of another drug. They are usually unpredictable and undesirable. A study was conducted to verify the prevalence and clinical value of potential drug interactions in intensive care units METHODS: All patients, of three intensive care units were included in a cross-sectional study, over a period of two months. Patients with less than a 2 days length of stay were excluded. Data were collected from twenty-four hour prescriptions and all possible paired combinations drug-drug were recorded. Prevalence and clinical value (significance) were checked at the end of follow-up. RESULTS: One hundred and forty patients were analyzed, 67.1% presented with some significant potential drug interactions and of the 1069 prescriptions, 39.2% disclosed the same potential. Of 188 different potential drug interactions, 29 were considered highly significant. Univariate analysis showed that in the group with significant potential drug interactions a higher number of different drugs, drugs/day had been used, there were more prescribing physicians and extended stay in intensive care units. Adjusted to the multivariate logistic regression model, only the number of drugs/day correlated with increased risk of significant potential drug interaction (p = 0.0011) and, furthermore that use of more than 6 drugs/day increased relative risk by 9.8 times. CONCLUSIONS: Critically ill patients are submitted to high risk of potential drug interactions and the number of drugs/day has a high positive predictive value for these interactions. Therefore, it is imperative that critical care physicians be constantly alert to recognize this problem and provide appropriate mechanisms for management, thereby reducing adverse outcomes.

En el trabajo se desarrolló un modelo con los factores que influyen sobre la decisión de I+D de la industria farmacéutica. Los factores son el riesgo de contagio y la posibilidad de controlarlo; la letalidad y la presencia de curas o tratamientos; el ingreso; el número de personas que demandan y los costos de oportunidad de la empresa. Las empresas invertirán en mercados con demandas más inelásticas (enfermedades muy contagiosas sin posibilidad de controlar la transmisión y/o muy letales sin curas o tratamientos) y/o donde los demandantes tienen elevados ingresos y/o son numerosos. No invertirá en mercados donde sus costos marginales son superiores a sus ingresos marginales, particularmente cuando sus costos incrementan permanentemente como consecuencia del aumento del costo de oportunidad generado por lo que dejaría de ganar en otros mercados. Para estos casos, las políticas de subsidio de la I+D no son efectivas, por lo tanto, éstas deben orientarse al fortalecimiento de las investigaciones, tanto básica como aplicada, realizadas por las instituciones públicas o sin fines de lucro.The authors present a model with factors that influence research and development decisions by the pharmaceutical industry: risk of disease transmission and possibility of control; case-fatality and the presence of cure or treatments; income; number of persons who demand the medicine; and opportunity costs for the company. Companies tend to invest in markets with inelastic demand (highly contagious diseases with no possibility of controlling transmission and/or very lethal diseases without treatment) and/or where there is a large population or high per capita income. Companies tend not to invest in markets where marginal costs exceed marginal income, particularly when costs increase permanently as a consequence of rising opportunity costs generated by foregoing profit in other markets. In such cases, policies to subsidize R&D are not effective, and policies must be orientated towards strengthening basic and applied research by public institutions.

Incidentes com medicamentos geram problemas aos pacientes e custos adicionais ao sistema de saúde. A variedade de termos utilizada para comunicá-los propicia divergências nos resultados de pesquisas e confundem notificadores. Objetivou-se revisar os termos utilizados para descrever estes incidentes confrontando-os com as conceituações/definições oficiais disponíveis. Pesquisaram-se as bases PubMed, MEDLINE, IPA e LILACS para selecionar estudos publicados entre janeiro de 1990 e dezembro de 2005. Selecionaram-se 33 publicações. Verificou-se que a terminologia supranacional recomendada para descrever incidentes com medicamentos é insuficiente, mas que há consenso de uso das expressões em função do gênero do incidente. O termo Reação Adversa a Medicamento é mais utilizado quando não se verifica intencionalidade. A expressão Evento Adverso a Medicamento foi mais usada quando se descreviam incidentes durante a hospitalização; e Problema Relacionado a Medicamento foi mais utilizada em estudos que avaliaram atenção/cuidados farmacêuticos (uso/falta do medicamento). Ainda assim, a linha divisória entre essas três categorias não é clara e simples. Futuros estudos das relações entre as categorias e investigações multidisciplinares sobre erro humano podem subsidiar a proposição de novas conceituações.In-hospital drug incidents cause problems for patients and additional costs for the health system. The variety of terms used to report them leads to disparities in research results and confuses the professionals that report them. This study aimed to review the terms used to describe drug incidents by collating them with the official concepts and definitions. PubMed, MEDLINE, IPA, and LILACS were searched to select studies published from January 1990 to December 2005. Thirty-three publications were selected. The supranational terminology recommended for describing drug incidents proved insufficient, but there was consensus that the expressions are used as a function of the type of incident. Adverse drug reaction is used when no intent is identified. Adverse drug event mainly describes incidents during hospitalization, and drug-related problem is used in studies on pharmaceutical care (use or lack of the drug). Still, the division between these categories is neither clear nor simple. Future studies on the relations between categories and multidisciplinary research on human error could support proposals for new concepts.

O preço elevado de medicamentos patenteados tem intensificado o debate em torno do impacto do regime da propriedade intelectual sobre o acesso a tratamentos de saúde, merecendo destaque o caso do HIV/AIDS. A política brasileira de tratamento anti-retroviral, parte de um programa nacional que integra medidas de prevenção e promoção da saúde, permitiu o alcance de uma ampla cobertura com qualidade, tendo sido apontada como modelo para outros países. Não obstante, conforme amadurece o Programa Nacional de DST e AIDS, os gastos com a incorporação de anti-retrovirais patenteados ao esquema terapêutico para pacientes em tratamento atinge um peso, cada vez maior, em seu orçamento. O presente artigo toma em conta os desafios apresentados pelas patentes farmacêuticas à saúde pública e discute possíveis caminhos para a sustentação da política de acesso universal e gratuito ao tratamento contra HIV/AIDS no Brasil.The high prices of patented drugs have fueled the debate regarding the impact of the intellectual property system on access to treatment, with a special focus on HIV/AIDS. The Brazilian policy for antiretroviral treatment, part of a comprehensive program that includes both disease prevention and health promotion activities, has allowed the country to meet goals for coverage and quality and has been considered a model for other countries. However, as the Brazilian STD/AIDS Program reaches maturity, the increasing incorporation of patented drugs into the AIDS treatment regimen imposes an increasing burden on the country's health budget. This article discusses the public health challenges raised by pharmaceutical patents and discusses possible ways to sustain the national policy for free, universal access to HIV/AIDS treatment.

Os medicamentos representam um dos itens mais importantes da atenção à saúde do idoso. Estes particularmente utilizam múltiplos medicamentos apresentando mais reações adversas. O estudo objetivou avaliar o perfil do consumo de medicamentos por idosos. Desenvolveu-se um estudo epidemiológico transversal mediante entrevistas domiciliares, numa amostra aleatória de 294 idosos, residentes em Santa Rosa, Rio Grande do Sul, Brasil. Os idosos representam 9% da população. Os resultados evidenciaram consumo médio de 2,79 medicamentos por idoso. O coeficiente de prevalência do uso de medicamentos na última semana foi de 82%, dos 827 medicamentos utilizados pelos idosos 794 (96%), foram prescritos. As classes farmacológicas mais utilizadas foram os anti-hipertensivos (21,3%) e diuréticos (11,3%). A prevalência do uso de medicamentos foi comparável ao encontrado em outros estudos, confirmando a importância dos medicamentos na atenção à saúde do idoso. A porcentagem de medicamentos utilizados sem prescrição médica foi baixa. Os medicamentos e forma de apresentação mais freqüentemente relatados foram os usualmente prescritos e dispensados gratuitamente na rede básica de saúde do município que está estruturada há mais de 10 anos com quase 100% de cobertura.Medicines are one of the most important health care items for the elderly, who are particularly prone to use multiple drugs with a higher number of adverse reactions. The current study aimed to assess the profile of pharmaceutical consumption by the elderly. A cross-sectional epidemiological study used household interviews in a random sample of 294 elderly living in Santa Rosa, Rio Grande do Sul State, Brazil. The elderly represent 9% of the local population. The results showed a mean consumption of 2.79 medicines per individual. The prevalence rate for use of medicines in the previous week was 82%, and of the 827 medicines used by the elderly, 794 (96%) had been prescribed. The most widely used pharmacological classes were anti-hypertensives (21.3%) and diuretics (11.3%). Prevalence of pharmaceutical use was comparable to the results from other studies, thus confirming the importance of medicines in the health of the elderly. The percentage of medicines used without a medical prescription was low. The most frequently reported medicines and formulations were those usually prescribed and dispensed free of cost in the municipal basic health care system, which has been organized for more than 10 years, with coverage of nearly 100%.

The objective of this study was to describe the creation cycle of the module "medication administration" and to evaluate it. It is an evaluation research, using the Engagement Theory as a methodological/theoretical approach carried out in two phases: the first related to the creation of the module and the second to its evaluation by specialists using the instrument based on the Model of Analytical Appreciation of Hypermedia Systems. The creation cycle of the module followed the following steps: gathering the objectives of the module, organization of the content, selection of the media, creation of the classes and activation of the learning process. It was evaluated by contents specialists, informatics specialists and nursing students. The evaluation of the distribution and the accessibility of the contents, the utilization of images, the clarity and ease of execution of the program were positive. The module was considered appropriate to be used with nursing students.Este estudio tuvo como objetivo describir el ciclo de creación de la disciplina "Administración de Medicamentos" y realizar su evaluación. Fue una investigación de evaluación, que utilizó la Teoría del Comprometimiento como referencia teórica metodológica, la que fue realizada en dos fases: la primera está relacionada a la creación del módulo y la segunda, a la evaluación por especialistas a través del instrumento basado en el Modelo de Apreciación Analítica de Sistemas Hipermedia. La descripción del ciclo de creación del módulo siguió las siguientes etapas: levantamiento de los objetivos del módulo, organización del contenido, selección de los medios de comunicación, creación de las clases y organización y ejecución del aprendizaje. El ciclo de creación analizado por especialistas en contenido en informática y por estudiantes de enfermería, evaluaron positivamente la distribución y accesibilidad del contenido, a la utilización de imágenes, a la claridad y a la facilidad de ejecución del programa. El módulo fue considerado apropiado para ser utilizado por los alumnos del curso de enfermería.Este estudo teve por objetivos descrever o ciclo de criação do módulo Administração de Medicamentos, bem como proceder à sua avaliação. Trata-se de pesquisa de avaliação, que utilizou a Teoria do Engajamento como referencial teórico-metodológico, realizada em duas fases: a primeira, relacionada à criação do módulo e a segunda, à avaliação por especialistas, através do instrumento baseado no Modelo de Apreciação Analítica de Sistemas Hipermídia. A descrição do ciclo de criação do módulo seguiu os seguintes passos: levantamento dos objetivos do módulo, organização do conteúdo, seleção da mídia, criação das aulas e operacionalização da aprendizagem. Foi avaliado por especialistas em conteúdo, em informática e por graduandos de enfermagem, os quais o avaliaram positivamente em relação à distribuição e acessibilidade de conteúdo, à utilização de imagens, à clareza e à facilidade de execução do programa. O módulo foi, pois, considerado apropriado para utilização com alunos do curso de enfermagem.

Introduction: Controversy 2. Drugs and their impact on nutritional status.

Despite the availability of drugs and pharmaceutical forms for the treatment of rheumatoid arthritis and osteoarthritis symptoms, their adverse effects and lack of response to therapy reinforces the need to search for new technological formulation strategies capable of delaying the progress of the disease, with better therapeutic results and prolonged control of arthropathy. The aim of this bibliographic review was to identify new reported therapeutic approaches for these diseases. The treatment of rheumatoid arthritis and osteoarthritis is an unresolved challenge, due to the complexity of these diseases. Thus, the new therapies aim to suppress inflammatory mediators and to reduce the degradation of the extracellular matrix. In addition, the use of nano and microtechnology takes advantage of the properties of polymers, lipids, peptides, and nucleic acids to develop controlled drug release systems, aiming to obtain highly effective precision therapies, whose usefulness should be evaluated in future clinical trials.

OBJETIVO: A ocorrência de agravos provocados por medicamentos no meio hospitalar é elevada e gera custos excedentes. O objetivo do estudo foi identificar problemas relacionados a medicamentos ocorridos durante a internação hospitalar e estimar a prevalência desses agravos. MÉTODOS: Estudo retrospectivo realizado no Estado do Rio de Janeiro. Foram analisadas as internações pagas pelo Sistema Único de Saúde entre 1999 e 2002. Os dados foram extraídos do Sistema de Informações Hospitalares. Selecionaram-se as internações que apresentaram um dos códigos da CID-10 (2000) suspeitos de serem agravos provocados por medicamentos, que estivessem nos campos do diagnóstico principal e/ou do diagnóstico secundário. Para as variáveis contínuas estimou-se a média, e o desvio-padrão, sendo a significância estatística entre as diferenças testada por meio de análise de variância (ANOVA, com intervalo de confiança de 95%). RESULTADOS: Foram identificados 3.421 casos equivalentes à freqüência de 1,8 casos/1.000 internações, ocorridos, sobretudo, em homens (64,5%), nos hospitais contratados (34,9%) e nos municipais (23,1%), nos leitos de psiquiatria (51,4%) e de clínica médica (45,2%), dos quais 84,1% resultaram em alta. A maioria dos agravos foi por reações adversas e de intoxicações e, entre essas categorias, há diferenças significativas (pOBJECTIVE: The occurrence of drug adverse events in hospital settings is high and generates cost excess. The purpose of the study was to identify drug-related events during hospital admissions and to estimate their prevalence. METHODS: A retrospective study was carried out in the State of Rio de Janeiro, Southeastern Brazil. Hospitalizations from the Brazilian Health System's national hospital database during the period between 1999 and 2002 were assessed. Admitted cases including suspected drug adverse event cases with ICD-10 (2000) coding in the main diagnosis and/or secondary diagnosis fields were included in the study. Means and standard deviations of continuous variables as well as the statistical significance of differences were estimated using variance analysis (ANOVA with a 95% confidence interval). RESULTS: There were identified 3,421 drug-related adverse events, and a prevalence of 1.8 cases per 1,000 hospitalizations was estimated. Most cases occurred in males (64.5%) admitted in contracted (34.9%) and local public hospitals (23.1%) in the departments of psychiatry (51.4%) and internal medicine (45.2%), of them, 84.1% were discharged. Most of them were adverse drug reactions or drug poisoning, and there were significant difference (p

OBJETIVO: Analisar as características epidemiológicas dos eventos toxicológicos relacionados a medicamentos. MÉTODOS: Realizou-se um estudo epidemiológico descritivo de série de casos. Utilizando a categoria "evento toxicológico relacionado a medicamentos", analisaram-se 6.673 casos registrados em centros de assistência toxicológica do Estado de São Paulo, no ano de 1998. As variáveis estudadas compreenderam características dos eventos, das pessoas afetadas, dos agentes tóxicos e das circunstâncias envolvidas. A análise dos agentes tóxicos considerou três níveis de desagregação: grupos terapêuticos, princípios ativos e nomes comerciais. RESULTADOS: Os medicamentos ocuparam o primeiro lugar entre todos os tipos de agentes tóxicos registrados pelos centros. Os eventos toxicológicos relacionados a medicamentos caracterizaram-se por serem registrados por telefone (78,5%), a partir de hospitais (86,6%); originaram-se de exposições agudas, pela via oral (90,2%), ocorridas em residência (85,7%) de área urbana (95%). Houve predomínio do sexo feminino (59%) e maior concentração na primeira década de vida (49,4%), sobretudo aos dois e três anos de idade. Os princípios ativos mais freqüentemente encontrados foram: fenobarbital, diazepam, haloperidol, carbamazepina e bromazepam. As principais circunstâncias foram as acidentais (38,8%) e tentativas de suicídio (36,5%). Entre os princípios ativos relacionados predominaram os dos grupos terapêuticos psiquiatria, analgesia/anestesia e respiratório. CONCLUSÕES: Aponta-se a necessidade de cumprimento da legislação quanto à venda de medicamentos sob receituário médico e de construção da toxicovigilância conforme diretrizes do Sistema Único de Saúde.OBJECTIVE: To assess the epidemiological characteristics of drug-related toxic events in the State of São Paulo, Brazil. METHODS: A descriptive epidemiological case series study was conducted. Using the category "drug-related toxic event", 6,673 registered cases were analyzed in the Toxicology Centers in the State of São Paulo throughout 1998. The variables studied comprised the characteristics of the events and the affected patients, toxic agents and the circumstances involved. The analysis of toxic agents took into consideration three levels of disaggregation: therapeutical groups, active ingredients and commercial brand names. RESULTS: Drugs ranked first among all toxic agents registered in the Centers. Drug-related toxic events were mostly reported by phone (78.5%) and hospitals (86.6%); they were originated from acute oral exposure (90.2%) at home (85.7%) in the urban area (95%). Most people affected were females (59%) in their first decade of life (49.4%), mainly between two and three years of age. The most common active ingredients found were: phenobarbital, diazepam, haloperidol, carbamazepine and bromazepam. The main circumstances were accidental ingestion (38.8%) and suicidal attempts (36.5%) and among the related active ingredients, the most prevailing therapeutical group were psychiatric, analgesic/anesthetic and respiratory. CONCLUSIONS: Law-abiding practices regarding prescription drugs are needed, as well as toxicological surveillance according to the National Health System guidelines.