Atenção farmacêutica e farmacoterapia do idoso: uma revisão integrativa / Pharmaceutical care and pharmacotherapy for the elderly: an integrative review / Atención farmacéutica y farmacoterapia de las personas mayores: una revisión integradora

Este trabalho tem como objetivo selecionar e sintetizar as evidências da literatura sobre o contexto atual da atenção farmacêutica e farmacoterapia do idoso, considerando os aspectos clínicos e sociais envolvidos. A revisão foi conduzida de acordo com as diretrizes do protocolo PRISMA, que consiste na busca, seleção, avaliação e síntese de estudos relevantes sobre o tema. Foram selecionados 15 artigos que atenderam aos critérios de inclusão e exclusão estabelecidos. A análise dos artigos permitiu identificar que a atenção farmacêutica é um serviço que visa otimizar o uso racional de medicamentos e melhorar a qualidade de vida dos pacientes, especialmente dos idosos, que apresentam maior risco de polifarmácia, interações medicamentosas e reações adversas. A farmacoterapia do idoso envolve aspectos fisiológicos, psicológicos, sociais e econômicos que devem ser considerados na prescrição, dispensação e acompanhamento dos medicamentos. No entanto, ainda há precariedade na integração do farmacêutico nas equipes de saúde. Conclui-se que a atenção farmacêutica é uma estratégia importante a ser implementada em todas as equipes de saúde públicas e privadas, para promover o uso seguro e efetivo dos medicamentos pelos idosos, contribuindo para um envelhecimento saudável e digno.

This paper aims to select and synthesize evidence from the literature on the current context of pharmaceutical care and pharmacotherapy of the elderly, considering the clinical and social aspects involved. The review was conducted according to the guidelines of the PRISMA protocol, which consists of the search, selection, evaluation and synthesis of relevant studies on the topic. Fifteen articles that have met the established inclusion and exclusion criteria were selected. The analysis of the articles allowed the identification that pharmaceutical care is a service that aims to optimize the rational use of medicines and improve the quality of life of patients, especially the elderly, who present a higher risk of polypharmacy, drug interactions, and adverse reactions. The pharmacotherapy of the elderly involves physiological, psychological, social, and economic aspects that must be considered when prescribing, dispensing, and monitoring medications. However, there is still a precariousness in the integration of the pharmacist in health teams. It is concluded that pharmaceutical care is an important strategy to be implemented in all public and private health teams, to promote the safe and effective use of medicines by the elderly, contributing to a healthy and dignified aging.

Este trabajo tiene como objetivo seleccionar y sintetizar la evidencia de la literatura sobre el contexto actual de la atención farmacéutica y la farmacoterapia de las personas mayores, considerando los aspectos clínicos y sociales implicados. La revisión se ha realizado siguiendo las directrices del protocolo PRISMA, que consiste en la búsqueda, selección, evaluación y síntesis de estudios relevantes sobre el tema. Se seleccionaron 15 artículos que cumplieron los criterios de inclusión y exclusión establecidos. El análisis de los artículos permitió identificar que la atención farmacéutica es un servicio que tiene como objetivo optimizar el uso racional de los medicamentos y mejorar la calidad de vida de los pacientes, especialmente de los ancianos, que presentan un mayor riesgo de polifarmacia, interacciones medicamentosas y reacciones adversas. La farmacoterapia del anciano implica aspectos fisiológicos, psicológicos, sociales y económicos que deben ser considerados a la hora de prescribir, dispensar y monitorizar los medicamentos. Sin embargo, todavía existe una precariedad en la integración del farmacéutico en los equipos de salud. Se concluye que la atención farmacéutica es una estrategia importante a ser implementada en todos los equipos de salud públicos y privados, para promover el uso seguro y eficaz de los medicamentos por los ancianos, contribuyendo para un envejecimiento saludable y digno.

Consumo de anticoncepcionais e fatores associados entre estudantes universitários / Contraceptive use and associated factors among university students

Introdução: o uso de anticoncepcionais vem crescendo a cada ano, sendo um dos principais motivos para a redução das taxas de fecundidade total, inclusive na população mais jovem, como a universitária. Objetivo: identificar o consumo de anticoncepcionais hormonais e fatores associados entre estudantes universitárias. Métodos: a população de estudo foi composta por estudantes universitárias matriculadas nos cursos de graduação da Universidade Estadual de Londrina (UEL), em Londrina, estado do Paraná, Brasil, no ano de 2019, integrantes do projeto maior denominado GraduaUEL. As estudantes responderam um instrumento construído em uma plataforma digital on-line. A variável dependente foi o consumo de contraceptivos hormonais, e as variáveis independentes foram aspectos sociodemográficos e hábitos de vida e de saúde. As associações medidas foram verificadas por meio de Regressão de Poisson, com cálculo da Razão de Prevalência (RP) e intervalo de confiança de 95% (IC 95%). Resultados: das 2.221 estudantes avaliadas, identificou-se o consumo de contraceptivos por 13,0%, maior entre mulheres brancas/amarelas, que relataram serem heterossexuais, que apresentavam pais com maior escolaridade, que referiram possuir plano privado de saúde e companheiro, e que praticavam atividade física pelo menos duas vezes na semana. Entretanto, apenas o fato de serem heterossexuais mostrou-se associação significativa após a análise ajustada (RP: 1,865; IC 95%: 1,308-2,659). Conclusões: diante do exposto, fica clara a necessidade de preparar os profissionais de saúde sobre os contraceptivos e seus efeitos adversos; ainda, que questões sociais devem ser consideradas no processo de uso dos contraceptivos, para combater a discriminação e as desigualdades social e econômica quanto ao acesso e uso destes medicamentos.

Introduction: the use of contraceptives has been growing every year, being one of the main reasons for the reduction in total fertility rates, including in the younger population, such as university students. Objective: identify the consumption of hormonal contraceptives and associated factors among university students. Methods: the study population consisted of university students enrolled in undergraduate courses at the Universidade Estadual de Londrina (UEL), in Londrina, Paraná state, Brazil, in 2019, members of the larger project called GraduaUEL. The students answered an instrument built on an on-line digital platform. The dependent variable was the consumption of hormonal contraceptives, and the independent variables were sociodemographic aspects, lifestyle and health. Measured associations were verified using Poisson Regression, with calculation of the Prevalence Ratio (PR) and 95% confidence interval (95% CI). Results: of the 2,221 students evaluated, the consumption of contraceptives was identified by 13.0%, higher among white/yellow women, who reported being heterosexual, who had parents with higher education, who reported having a private health plan and partner, and who practiced physical activity at least twice a week. However, only the fact of being heterosexual showed a significant association after the adjusted analysis (PR: 1.865; 95% CI: 1.308-2.659). Conclusions: in light of the above, the need to prepare health professionals about contraceptives and their adverse effects is clear, as well as what social issues should be considered in the process of using contraceptives, to combat discrimination, social and economic inequality regarding access and the use of these medications.

Análise da polifarmácia e de fatores associados ao uso racional de medicamentos em idosos moradores de residência de cuidados de longa permanência / Analysis of polypharmacy and factors associated with the rational use of medicines in elderly residents of long-term care residences

Este trabalho teve por objetivo analisar a polifarmácia e os fatores associados ao uso racional de medicamentos em idosos moradores de residência de cuidado de longa permanência na perspectiva do cuidado nas condições crônicas de saúde. Foi desenvolvido junto a 68 prontuários, prescrições médicas e/ou registros de administração de medicamentos de idosos moradores de um residencial filantrópico do Vale do Paranapanema/São Paulo. A coleta de dados foi realizada por meio de um instrumento com perguntas abertas e fechadas sobre a temática e a análise se deu por meio do cálculo de frequência absoluta e relativa. A polifarmácia fazia parte da vida de grande parte dos idosos. Não foi possível compreender, por falta de sistematização e de controle documental interno, como os responsáveis técnicos do setor administrativo e da saúde adquiriam medicamentos, nem os custos envolvidos com a compra e o desperdício. Os medicamentos e seus resíduos eram descartados no lixo orgânico. Não foi possível também determinar se idosos recebiam o medicamento apropriado às suas necessidades clínicas, na dose e no período adequado às suas condições de saúde. Conclui-se que idosos moradores do residencial estão expostos à polifarmácia e o uso racional de medicamentos não é praticado.

This study aimed to analyze polypharmacy and factors associated with the rational use of medicines in elderly residents of long-term care homes from the perspective of care in chronic health conditions. This study was developed with sixty-eight medical records, medical prescriptions, and/or medication administration records of elderly residents of a philanthropic home, located in a municipality in the Vale do Paranapanema/São Paulo. Data was collected using an instrument with open and closed questions on the theme. The analysis consisted of calculating absolute and relative frequency. Polypharmacy was part of the life of most elderly people. It was not possible to understand, due to the lack of systematization and internal document control, how the technicians responsible for the administrative and health sectors acquired the medicines, nor the costs involved with the purchase and waste. Medicines and their residues were disposed of in organic waste. It was also not possible to determine whether the elderly received medication appropriate to their clinical needs, in the dose and within the appropriate period to their health conditions. Therefore, elderly residents of the residential are exposed to polypharmacy and the rational use of medicines is not practiced.

General considerations of model-based meta-analysis / 中国临床药理学与治疗学

With the increasing cost of drug development and clinical trials, it is of great value to make full use of all kinds of data to improve the efficiency of drug development and to provide valid information for medication guidelines. Model-based meta-analysis (MBMA) combines mathematical models with meta-analysis to integrate information from multiple sources (preclinical and clinical data, etc.) and multiple dimensions (targets/mechanisms, pharmacokinetics/pharmacodynamics, diseases/indications, populations, regimens, biomarkers/efficacy/safety, etc.), which not only provides decision-making for all key points of drug development, but also provides effective information for rational drug use and cost-effectiveness analysis. The classical meta-analysis requires high homogeneity of the data, while MBMA can combine and analyze the heterogeneous data of different doses, different time courses, and different populations through modeling, so as to quantify the dose-effect relationship, time-effect relationship, and the relevant impact factors, and thus the efficacy or safety features at the level of dose, time and covariable that have not been involved in previous studies. Although the modeling and simulation methods of MBMA are similar to population pharmacokinetics/pharmacodynamics (Pop PK/PD), compared with Pop PK/PD, the advantage of MBMA is that it can make full use of literature data, which not only improves the strength of evidence, but also can answer the questions that have not been proved or can not be answered by a single study. At present, MBMA has become one of the important methods in the strategy of model-informed drug development (MIDD). This paper will focus on the application value, data analysis plan, data acquisition and processing, data analysis and reporting of MBMA, in order to provide reference for the application of MBMA in drug development and clinical practice.

Rational prescribing practice assessment among resident doctors in a tertiary care teaching hospital: a questionnaire based observational study

Background: One of the important factors in health policy is recognised to be rational use of medicines (RUM). Physicians can influence the health and well-being of patients by prescribing appropriate drug in right doses and they should be taught to prescribe rationally at the earliest of their professional carrier.Methods: This cross-sectional, questionnaire-based study was carried out in SMHS hospital which is a tertiary-care teaching hospital associated with Government Medical College, Srinagar, Jammu and Kashmir, India.Results: Out of 106 resident doctors enrolled in the study, 96.2% respondents were aware about the term essential medicines of India, and 47.6% had National List of Essential Medicines of India available at their work place. When the participants were questioned about the term RUM only 17% of them responded positively, but majority of the resident doctors (88.67%) were aware about the ingredients of the drugs they use to prescribe. Though only 3.7% of our participating doctors always use essential medicines during their prescription writing but majority of them (96.22%) would always use to inform the patient regarding disease, drug therapy and monitoring of drug therapy.Conclusions: Considering the fact that respondents are future prescribers they should be aware of all aspects about RUM and improper knowledge in certain areas of RUM is a matter of concern that needs to be addressed.

A systematic review of standard treatment guidelines in India

Background & objectives: Standard treatment guidelines (STGs) are the cornerstone to therapeutics. Multiple agencies in India develop STGs. This systematic review was conducted to find out STGs available in India, evaluate if these were as per World Health Organization (WHO) recommendations for STGs and compare these with National Institute for Health and Care Excellence (NICE) guidelines. Information on legal authority and responsibility for formulating STGs was also sought. Methods: PRISMA guidelines were followed. Publications from PubMed and Google Scholar were searched for STGs using terms 'Standard Treatment Guidelines AND India'. Data from STGs were compiled in excel as per the WHO and authors' criteria for STGs and compared with NICE guidelines. Results: PubMed and Google Scholar search provided 56 publications (out of 1695 search results) mentioning 27 STGs. Google search and replies from authors led us 36 STGs, totalling to 63 STGs. No STG mentioned any specific period of revision, eight STGs were not evidence-based, 55 had some Indian references, 48 STGs were for single disease and the remaining multi-disease, three STGs did not include diagnostic criteria, 16 STGs did not give prescribing information of recommended treatment and 16 STGs provide no referral criteria for patients. Fifty five STGs did not mention level of health care. While NICE is a single legal authority in England and guidelines are as per WHO recommendations for STGs, in India although Acts and rules do not vest authority, National Health Systems Resource Center is generally designated responsible for STGs. Interpretation & conclusions: In India, although there are multiple STGs developed by various authorities and professionals for the same conditions, these fulfil WHO recommendations only partially. Authority with statutory duty collaborating with professional organizations, a standard methodology for adopting international guidelines, Indian data for evidence base, attention to local needs will help in developing better STGs and their acceptance.

Assessment on awareness of rational prescribing practices among medical interns in a tertiary care hospital: a questionnaire based study

Background: Awareness about rational use of Medicines is required to improve the quality of health care system. Attitude towards rational drug use is also an utmost importance as they constitute the future generation doctors.Methods: A set of 13 questionnaire is given to the interns through an online link to their e-mail which contains informed consent and questionnaires. Respondents has to select the best suitable option and after which the data will be compiled and statistically analyzed.Results: Age of the study participants range from 22-26yrs. Half of them have finished major postings. Almost 96.1 % of them were aware of the term essential drugs. Only 25% of them said that they have NLEMI at work place, 75% of them were aware of the term Rational use of Medicines. Only 32% of them were aware of the term P drugs. 44% of them were aware of STEP criteria for selection of drug and 47% of them were aware of the updated prescribing format. 8% knew the difference between old and new prescription format, 25% of them always prescribe. Almost 82% of them narrate regarding the disease and drug therapy, 31% of them prescribe only generic name.Conclusions: Educational intervention like CME and practical hands on training in Rational use of Medicines would help them in better understanding of the subject and its clinical implications thereby decreasing the prescribing errors.

Polimedicação de idosos na universidade aberta à maturidade / Polymedication of elderly in the university opened to maturity

Objetivo: identificar os pacientes acometidos pela polifarmácia, pois, no Brasil cerca de 70% dos idosos sofrem de alguma doença crônica e tratam-se com uma ou mais drogas. Método: pesquisa descritiva, exploratória, e qualiquantitativa, realizada com alunos da Universidade Aberta à Maturidade ­ UAMA em Campina Grande ­ PB, no período de fevereiro a maio de 2018. Resultados: A maioria dos pacientes estudados foi representada pelas mulheres (70%) em comparação com os homens (30%). Observou-se que 67% dos idosos fazem uso de 5 medicamentos ou mais, enquanto apenas 33% destes tratam-se com menos de 5. Dentre os mais prescritos, destacam-se os utilizados no tratamento da hipertensão, como a Losartana (16%), tratamento do diabetes, como o Glifage (12%) e de dislipidemias, como a Sinvastatina (10%). Conclusão: A polifarmácia vem sendo uma realidade considerável entre a população e as intervenções terapêuticas têm sido melhores com o desenvolvimento de novos medicamentos, ajudando no aprimoramento da utilização destes e no aumento da sobrevida dos indivíduos.

Objective: to identify the patients affected by polypharmacy, because, in Brazil about 70% of the elderly suffer from some chronic disease and are treated with one or more drugs. Method: The research is descriptive, exploratory, qualitative and quantitative, held with students of the University Open to Maturity ­ in Campina Grande - PB, in the period from February to May 2018. A Most of the patients studied were represented by women (70%) compared to men (30%). Results: Most of patients were represented by women (70%) compared to men (30%).We observed that 67% of the elderly use 5 drugs or more, while only 33% of these are treated with less than 5. Among the most prescribed, those used in the treatment of hypertension, like the Losartan (16%), diabetes treatment, such as Glifage (12%) and dyslipidemia, such as Simvastatin (10%). Conclusion: Polypharmacy has been a considerable reality among the population and therapeutic interventions have been better with the development of new drugs, helping to improve their use and increase the survival of individuals.

Access and use of medicines by elderly individuals with dementia

The objective is to reveal the difficulties concerning the access and use of medicines by elderly individuals with dementia, reported by their caregivers. This qualitative study applied the participant observation method during pharmaceutical appointments performed in a specialized geriatrics service of the University Hospital of Brasília. Caregivers reported facing difficulties regarding the itinerary for medicines access in public pharmacies, as well as the high cost of these technologies in private establishments. Psychiatric symptoms, cognitive deficits, behavioral changes, apraxia, dysphagia, among other clinical manifestations of dementia syndromes, incapacitates the elderly for self-responsibility concerningthe use of drugs, which accentuates the complexity of medicines administration within the care process. In conclusion, it is fundamental to recognize caregivers' role in promoting the rational use of medicines, and so this theme should be highlighted within the pharmaceutical services context.

Awareness of rational use of medicines among interns at rural teaching hospital

Background: The concern of switching irrational towards rational prescribing behaviour by prescriber impacts the patient compliance. Thereby an attempt to bring down the drug resistance is possible. Aim and objective of the study was to know the knowledge and practices Rational prescription behaviour in medical interns (MBBS 2012 batch) at Adichunchanagiri Institute of Medical Sciences (AIMS), BG Nagara.Methods: Observational cross sectional validated questionnaire based study on Rational Use of Medicines (RUM) was administered to Interns (n=75) included both males and females (MBBS 2012 batch) at AIMS during March-April 2018.Results: Both the gender had similar knowledge on RUM. 32 (42.67%) male and 43 (57.33%) female interns participated and 88% were aware of term “Essential drug”. Though 61.33% were prescribing rationally, they lacked in terms of listing National essential drug list and steps involved in selecting “P-drug”. Only 4% rightly defined RUM. 92% agreed that RUM minimizes ADR incidence. 90.67% believed that RUM would reduce the development of drug resistance. And 85.33% were in opinion that doctors should use his/her gained knowledge despite of Medical representative advice to bring the justice towards RUM in practice before prescribing.Conclusions: Rational use of medicine in interns should be assessed periodically on prescribing knowledge and skills during their training to minimize prescribing and clinical errors.

Uso racional de medicamentos, farmaceuticalização e usos do metilfenidato / Rational use of medicines, pharmaceuticalization and uses of methylphenidate

Resumo O uso racional de medicamentos (URM) é considerado um dos elementos-chave recomendados pela Organização Mundial de Saúde (OMS) para as políticas de medicamentos. O crescimento excessivo no uso de medicamentos em muitos países tem sido apontado como uma importante barreira para o alcance do URM e faz parte de um fenômeno denominado ´farmaceuticalização´ da sociedade. Desta forma, o presente artigo objetiva apresentar movimentos para racionalizar o uso do metilfenidato no Brasil e discutir os limites impostos tendo como referência o conceito de farmaceuticalização da sociedade. Trata-se de estudo exploratório, realizado por meio de narrativa da literatura científica. As controvérsias acerca dos usos do metilfenidato o torna um bom exemplo deste fenômeno podendo auxiliar na reflexão e na construção de novos caminhos para os limites encontrados pelo conceito de uso racional de medicamentos.

Abstract The rational use of medicines (URM) is considered one of the key elements recommended by the World Health Organization (WHO) for pharmaceutical policies. The excessive increase in the use of medicines in many countries has been identified as a major barrier to the achievement of URM and is part of a phenomenon called the 'pharmaceuticalization' of the society. This paper aims to present innitiatives to rationalize the use of methylphenidate and its limits in Brazil, considering the concept of pharmaceuticalization of the society. It is an exploratory study, based on a narrative review of the scientific literature. Controversies about the uses of methylphenidate make it a good example of this phenomenon and may help in the reflection and construction of new paths to the limits found by the concept of rational use of medicines.

Construction of Essential Medicine Selection Model Based on Knapsack Theory / 中国药房

OBJECTIVE:To provide reference for replenishing and perfecting essential medicine selection method in China. METHODS:According to the requirements of essential medicine selection,based on the actual situation,target function and restraint conditions for essential medicine selection could be determined by the knapsack theory and the essential medicine selection model could be built. The feasibility of established model was analyzed by an sample. RESULTS:The objective function of estab-lished model was Min∑CjXj,the minimum cost of all the selected essential medicines. Other constraints included covered range of disease,ADR,contraindications,attentions,dosage forms and specifications. Nine kinds of common oral hypoglycemic drugs were selected as candidate drugs,from which glipizide,gliclazide,metformin and repaglinide were chosen as the essential hypogly-cemic medicines with the proposed model. CONCLUSIONS:Established essential medicine selection model based on knapsack the-ory is scientifical,objective and with strong practicality.

Perfil de riesgo de los antidepresivos inhibidores selectivos de la recaptación de serotonina (ISRS) / Risk profile of antidepressants selective reuptake inhibitors (SSRIs)

Los antidepresivos inhibidores selectivos de la recaptación de serotonina son ampliamente utilizados en la práctica clínica y han desplazado a otros grupos de antidepresivos en las últimas décadas. Esto parece estar vinculado al concepto de su mayor perfil de seguridad y a la minimización de los potenciales efectos adversos que su uso podría generar. Sin embargo el número de efectos adversos tanto leves como graves reportados no son despreciables y es importante su conocimiento con el fin de evitar o diagnosticar en forma precoz y actuar en consecuencia

Selective serotonin receptor inhibitor are widely used in clinical practice and have moved to other antidepressive drugs in recent decades. This seems to be linked to the concept of their greater safety profile and to minimize potential adverse effects that their use could generate. However, the number of both minor and serious reported adverse effects are not negligible and knowledge is important in order to prevent or diagnose early and act accordingly

Pharmaceutical care for anti-infectious treatment of febrile neutropenia：a case report / 药学实践杂志

Objective To discuss the pharmaceutical care experience of the clinical pharmacist in anti-infectious treatment of one patient with febrile neutropenia .Methods The clinical pharmacists participated in the treatment of the patient with fe-brile neutropenia .According to the patient's laboratory indices and vital signs ,the pharmacist assisted clinicians to formulate the anti-infection regimen ,recommend for rational use of drugs ,carried out drug education to the patient ,and track drug effi-cacy and adverse drug reactions (ADR) .Results The patient's infection was well controlled and effectively avoid the occurrence of ADR .Conclusion With pharmaceutical care through clinical pharmacists ,infection in the patient with febrile neutropenia would be controlled ,the patient's life quality could be improved .

Presurgical Antibiotic Prophylaxis Pattern In An Indian Tertiary Care Teaching Hospital.

The present study was performed to study the antibiotic prophylaxis pattern in patients admitted in Surgery and Obstetrics and Gynaecology wards of a Tertiary Care Teaching hospital in North India. It was an observational, non interventional and analytical study used to evaluate the patients undergoing surgery through period of one and half years. Information concerning demographic data, type of surgery, and parameters of antibiotic therapy (selection of antibiotic, dose, route and duration of therapy as well as cost) was collected from case records of 400 patients. Third generation cephalosporins were the most commonly prescribed class of antibiotics. No consistency was noted in the timing of administration of prophylactic antimicrobials agents which were prescribed 30 minutes to 6 hours before surgery. The dose was not repeated during surgery. Majority of antibiotics were prescribed from Essential Medicines List. Surgical prophylaxis was inappropriate in terms of choice of antimicrobial agent, timing of administration as well as the total duration of prescription, in majority of the cases. Interventions are warranted to promote the development, dissemination and adoption of evidence based guidelines for antimicrobial prophylaxis.

Barriers and facilitators to development of standard treatment guidelines in India.

This paper describes 15 years’ experience of the development process of the first set of comprehensive standard treatment guidelines (STGs) for India and their adoption or adaptation by various state governments. The aim is to shorten the learning curve for those embarking on a similar exercise, given the key role of high-quality STGs that are accepted by the clinical community in furthering universal health coverage. The main overall obstacles to STG development are: (i) weak understanding of the concept; (ii) lack of time, enthusiasm and availability of local expertise; and (iii) managing consensus between specialists and generalists. Major concerns to prescribers are: encroachment on professional autonomy, loss of treating the patient as an individual and applying the same standards at all levels of health care. Processes to address these challenges are described. At the policy level, major threats to successful completion and focused implementation are: frequent changes in governance, shifts in priorities and discontinuity. In the authors’ experience, compared with each state developing their own STGs afresh, adaptation of pre-existing valid guidelines after an active adaptation process involving local clinical leaders is not only simpler and quicker but also establishes local ownership and facilitates acceptance of a quality document. Executive orders and in-service sensitization programmes to introduce STGs further enhance their adoption in clinical practice.

Uso racional de medicamentos entre indivíduos com diabetes mellitus e hipertensão arterial no município do Rio de Janeiro, Brasil / Rational use of medicines by individuals with diabetes mellitus and arterial hypertension in the municipality of Rio de Janeiro, Brazil

Este estudo tem como objetivo o uso racional de medicamentos (URM) entre indivíduos com Hipertensão Arterial (HA) e/ou Diabetes Mellitus (DM) atendidos em unidades básicas de saúde no município do Rio de Janeiro. Trata-se de estudo transversal utilizando os dados de inquérito domiciliar realizado de janeiro a fevereiro de 2010. Foram elaborados indicadores para mensurar a taxa de adesão ao tratamento, automedicação e cuidados domiciliares relacionados aos medicamentos. O tratamento dos dados incluiu análise uni e multivariada. Dos 547 pacientes entrevistados, 77,5% relataram não costumar deixar sobrar medicamentos e 80,3% relataram não costumar esquecer de tomá-los. Quase a totalidade dos entrevistados relataram apenas tomar medicamentos prescritos por prescritores. Metade dos pacientes não tinham medicamentos com validade vencida ou embalagem danificada no domicílio. Os testes estatísticos mostraram que houve maior uso racional entre hipertensos, indivíduos casados, que trabalham, que referem receber orientações de seu médico sobre dieta e exercício físico e que não faltaram a consultas na unidade básica de saúde nos 6 meses anteriores à pesquisa. O achados reforçam a importância da atenção primária em saúde para a promoção do URM.

This study focuses on the rational use of medicines (RUM) by hypertensive and/or diabetic patients treated in primary health care units in the city of Rio de Janeiro. It involves a cross-sectional study conducted between January and February 2010. Indicators were created considering the following aspects: adherence to prescribed medicine, self-medication and how patients store medicines within their households. Univariate and multivariate data analysis was performed. Of the 547 patients studied, 77.5% reported that they usually take the entire course of medicines and 80.3% reported that they tend not to forget to take them. Almost all respondents reported that they only take medications prescribed by authorized health professionals. Half of the patients had no expired medicines or damaged medicine packages in the home. Statistical tests revealed that RUM is higher among hypertensive individuals who are married and working, who mention receiving medical guidance about diet and physical exercise, and who have not missed any scheduled medical appointments at the primary health care unit within the 6 months before this research was conducted. The findings emphasize the importance of primary health care in promoting the rational use of medicines.

Guía dirigida al farmacéutico que labora en asuntos regulatorios, sobre las funciones que debe cumplir en la vigilancia sanitaria del medicamento / Guide addressed to the pharmacist who works in regulatory affairs, on the functions that must be fulfilled in the sanitary surveillance of the drug

En Venezuela el Ministerio del Poder Popular para la Salud a través del Servicio Autónomo de Contraloría Sanitaria y el Instituto Nacional de Higiene "Rafael Rangel", regula lo concerniente a los medicamentos, siendo las principales funciones las siguientes: inspección de Buenas Prácticas de Manufactura, autorización de protocolos clínicos, registro sanitario, liberación de cada lote a comercializar, vigilancia farmacológica (farmacovigilancia), programa de control de productos comercializados. El Ministerio del Poder Popular para la Salud como Autoridad Regulatoria lleva a cabo los programas dirigidos a la prevención que proporcionan garantía a la población en la reducción de los riesgos al someterse a un tratamiento terapéutico, tiene carácter eminentemente preventivo y además colectivo redundando en el aseguramiento de la mejor calidad de vida de los pacientes durante los tratamiento. La vigilancia sanitaria de medicamentos es de gran importancia y debe aplicarse de manera ininterrumpida y eficaz, siendo el farmacéutico en asuntos regulatorios un ente responsable de esto como protagonista principal del medicamento, que debe trabajar en conjunto con la Autoridad Regulatoria y aliado a las regulaciones farmacéuticas vigentes, por esta razón, en la investigación, se planteó como objetivo general: elaborar uno guía dirigida al farmacéutico que labora en asuntos regulatorios, sobre las funciones que debe cumplir en la vigilancia sanitaria de medicamentos, a fin de que puedan coordinar, regular, evaluar, vigilar los medicamentos; para obtener este resultado, se revisó la normativa nacional e internacional existente relacionada con la vigilancia sanitaria de medicamentos y se desarrollaron las actividades y responsabilidades del farmacéutico en asuntos regulatorios en cada uno de los procesos involucrados en la vigilancia sanitaria de medicamentos.

In Venezuela, the Ministry for the Pupolar Power of Health, through the Autonomous Service of Sanitary Controllership and the National Institutte of Hygiene "Rafael Rangel", regulates what is concerned to medicines being the principal functions the following ones: inspection of Good Practices of Manufacture, authorization of clinical protocols, sanitary registering, liberation of every batch being commercialized, pharmacological vigilance (pharmacovigilance), program of control of commercialized products. The Ministry for the Pupolar Power of Health as Regulative Authority carries out directed activities towards prevention that is guarantee to population for the reduction of the risks on having surrendered to a therapeutic treatment. It has eminently preventive character in addition to collective redounding to the insurance of the best quality of life for patients during the treatments. The sanitary vigilance of medicines shows great importance be applied in an uninterrupted and effective way; being the pharmacist, in regulative affairs, an entity responsible for this as a principal actor of medicine which must work as a whole with the Authority of Health and aligned to the pharmaceutical issue in force regulations. As a matter of fact, in this investigation, a general objective is set up to: elaborate a guide directed to pharmacists who work in regulative affairs, on the functions that it must fulfilled in the sanitary vigilance of medicines, so that they could coordinate, regulate, evaluate, monitor the medicines; to obtain result, the national and international existing related to the sanitary vigilance of medicines was checked. Besides, the activities and responsibilities of the pharmacist were developed in regulative affairs in each of the processes involved in the sanitary vigilance of medicines.

Problemas relacionados a medicamentos; reações adversas a medicamentos e erros de medicação: a necessidade de uma padronização nas definições e classificações / Drug Related Problems; Adverse Drug Reaction, Medication Errors: The requirement of an uniform definition and classification

Problemas Relacionados a Medicamentos (PRMs) é um termo freqüentemente utilizado na Atenção Farmacêutica e na Farmácia Clínica. Os PRMs podem estar relacionados a Reações Adversas a Medicamentos (RAMs), consideradas não evitáveis e que sempre produzem dano ao paciente, ou Erros de Medicação (EM), considerados evitáveis e que podem ou não causar danos ao paciente. Os EM classificam-se em erros de prescrição, dispensação e administração. Uma proposta de classificação adaptada da PCNE (Pharmaceutical Care Network Europe) é descrita neste artigo.

Drug Related Problems (DRPs) is a term often used in pharmaceutical care and in the clinical pharmacy. Drug Related Problems can be related to Adverse Drug Reactions (ADRs) that are considered unavoidable and always induce harm and Medication Errors (MEs), considered avoidable and may or not induce harm. Medication Errors are classified in prescribing, dispensing and administration errors. A proposal for classification adapted from the Pharmaceutical Care Network Europe (PCNE) is described in this article.

Análise técnica para a tomada de decisão do fornecimento de medicamentos pela via judicial / A technical analysis of medicines request-related decision making in Brazilian courts / Análisis técnico para la toma de decisiones de abastecimiento de medicamentos por la vía judicial

OBJETIVO: Analisar a solicitação judicial de medicamentos previstos nos componentes da assistência farmacêutica no Sistema Único de Saúde. MÉTODOS: Foram analisados 81 processos judiciais para fornecimento de medicamentos no Estado de São Paulo, entre 2005 e 2009. As informações dos processos foram obtidas do Tribunal de Justiça do Estado de São Paulo. Portarias que regulamentam a assistência farmacêutica foram consultadas para identificar a solicitação judicial de medicamentos incorporados pelo Sistema Único de Saúde. Para análise do nível de evidência dos medicamentos nas indicações clínicas referidas, foi consultada a base de dados Thomson Micromedex®. RESULTADOS: O número de medicamentos solicitados em cada processo variou entre um e sete itens, nos quais foram identificados 77 fármacos diferentes. Dos medicamentos solicitados, 14,3 por cento deveriam estar disponíveis na atenção básica do Sistema Único de Saúde, 19,5 por cento no componente de medicamentos de dispensação excepcional e 66,2 por cento não pertenciam a nenhuma lista oficial. Medicamentos do componente de dispensação excepcional apresentaram melhor evidência clínica quando indicados no tratamento de doenças cobertas pelos Protocolos Clínicos e Diretrizes Terapêuticas do Ministério da Saúde. CONCLUSÕES: A via judicial tem sido utilizada para garantir o acesso a medicamentos cujo fornecimento está previsto no Sistema Único de Saúde e para solicitar aqueles não incorporados por ele. A avaliação do nível de evidência reforça a necessidade de análise técnica para a tomada de decisão do fornecimento de medicamentos pela via judicial.

OBJECTIVE: To analyze judicial requests for medications that are covered by the pharmaceutical assistance components of the Sistema Único de Saúde (SUS - Brazilian Unified Health System). METHODS: We analyzed 81 judicial requests for medications in the State of São Paulo between 2005 and 2009. The details of these cases were obtained electronically from the Court of Justice of the State of São Paulo. Directives that regulate pharmaceutical assistance were consulted to identify judicially requested medications that are covered by the SUS. To assess the level of evidence supporting the use of these medications to treat the clinical indications described, we consulted the Thomson Micromedex® database. RESULTS: The number of individual medications requested in each case ranged from 1 to 7; in total, 77 different pharmaceuticals agents were identified. Of the medications requested, 14.3 percent should have been available through SUS primary care, 19.5 percent were classified under the exceptionally dispensed medications component of the SUS, and 66.2 percent were not on any official list. Medications of the exceptionally dispensed medications component showed better clinical evidence when indicated for the treatment of medical conditions covered by the Clinical Protocols and Therapeutic Guidelines of Brazil's Ministry of Health. CONCLUSIONS: The judicial process has been used to ensure access to medications that are covered by the SUS and to request access to those that are not covered. Our assessment of the level of available evidence reinforces the need for technical analysis in the decision-making process in cases of judicially requested medications.

OBJETIVO: Analizar la solicitud judicial de medicamentos previstos en los componentes de la asistencia farmacéutica en el Sistema Único de Salud. MÉTODOS: Se analizaron 81 procesos judiciales para abastecimiento de medicamentos en el Estado de Sao Paulo, Sureste de Brasil, entre 2005 y 2009. Las informaciones de los procesos fueron obtenidas en el Tribunal de Justicia del Estado de Sao Paulo. Los documentos administrativos legales que regulan la asistencia farmacéutica fueron consultados para identificar la solicitud judicial de medicamentos incorporados por el Sistema Único de Salud. Para análisis del nivel de evidencia de los medicamentos en las indicaciones clínicas referidas, fue consultada la base de datos Thomson Micromedex®. RESULTADOS: El número de medicamentos solicitados en cada proceso varió entre uno y siete ítems, en los cuales fueron identificados 77 fármacos diferentes. De los medicamentos solicitados, 14,3 por ciento deberían estar disponibles en la atención básica del Sistema Único de Salud, 19,5 por ciento en el componente de medicamentos de dispensación excepcional y 66,2 por ciento no pertenecían a ninguna lista oficial. Medicamentos del componente de dispensación excepcional presentaron mejor evidencia clínica al ser indicados en el tratamiento de enfermedades cubiertas por los Protocolos Clínicos y Directrices Terapéuticas del Ministerio de la Salud. CONCLUSIONES: La vía judicial ha sido utilizada para garantizar el acceso a medicamentos cuyo abastecimiento está previsto en el Sistema Único de Salud y para solicitar aquellos no incorporados por él. La evaluación del nivel de evidencia refuerza la necesidad de análisis técnica para la toma de decisión del abastecimiento de medicamentos por la vía judicial.